ra psa as - kropcache.krop.com/seminara-571738371d466e5.pdf · summary psa psoriatic arthritis...

Copyright © 2013 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,

Whitehouse Station, NJ, USA. All rights reserved. RHEU-1070841-0001 02/13

RA Rheumatoid arthritis

EFFICACY

QoL

SAFETY

EXPERIENCE

SUMMARY

PsA Psoriatic arthritis

EFFICACY

QoL

SAFETY

EXPERIENCE

SUMMARY

ASAnkylosing spondylitis

EFFICACY

QoL

SAFETY

EXPERIENCE

SUMMARY

Indications and Select Safety InformationSummary of Product Characteristics

SIMPONI® (golimumab)



SIMPONI helps deliver a sustained reduction in the

signs and symptoms of RA1

xxxxxxxEFFICACY xxxxxxxxxxxxxxx

RA

Signs and

symptoms of RAEFFICACY Pre-erosive lesionsClinical remission Structural damage

ACR response at Week 522

Placebo + MTX (n=39; switched to SIMPONI 50 mg monthly + MTX at Week 16)

SIMPONI 50 mg monthly + MTX (n=70)

90

60

30

0

Patients

, %

ACR20 ACR50 ACR70

82.9

57.1

31.4

59.0

30.8

17.9

HAQ-DI scoreWeek 14

ACR

improvements

were sustained

over 2 years.3



ACR

improvements

were sustained

over 2 years.3


RA

Signs and


ACR response at Week 141

Placebo (n=133)

SIMPONI 50 mg (n=89)

90

60

30

0

Patients

, %

ACR20 (PE) ACR50 ACR70

55.1

34.8

13.5

33.1

9.83.8

P=0.0001

P=0.0001

P=0.008

Week 52 HAQ-DI scoreWWeeeekk 1144





ACR

improvements

were sustained

over 2 years.3


RA

Signs and


Almost 3 times more improvement in

HAQ-DI scores vs placebo + MTX alone at

Week 24 (0.38 vs 0.13, P<0.001)

Week 52 HHAAQQ-DDII ssccoorreeWeek 14



RA = rheumatoid arthritis; ACR = American College of Rheumatology; MTX = methotrexate;

PE = primary end point; HAQ-DI = Health Assessment Questionnaire Disability Index.

References

1. Keystone EC, et al. Ann Rheum Dis. 2009;68(6):789–796. Erratum in: Ann Rheum Dis. 2011;70(1):238.

2. Keystone EC, et al. Ann Rheum Dis. 2010;69(6):1129–1135.

3. SIMPONI. Summary of Product Characteristics. March 2012.

Signs and




Signs and


GO-FORWARD: a multicenter, randomized, double-blind, placebo-controlled study (N=444) to examine the

effi cacy and safety of SIMPONI in patients with active RA despite MTX therapy. Patients were randomized in

a 3:3:2:2 ratio to treatment with placebo injections plus MTX capsules, injections of SIMPONI 100 mg plus

placebo capsules, SIMPONI 50 mg plus MTX, or SIMPONI 100 mg plus MTX. Injections were administered

subcutaneously every 4 weeks. Primary end points were the proportion of patients with ≥20% improvement in

the ACR criteria at Week 14 and the change from baseline in the HAQ-DI score at Week 24. Responder analysis.



SIMPONI helps achieve and maintain clinical remission1

DAS28 remission rates were

maintained through Week 104.2

RA

Signs and


DAS28 (CRP) remission at Week 241

Placebo + MTX

(n=133)

60

40

20

0

Patients

, %

27.0

6.8

SIMPONI 50 mg + MTX

monthly (n=89)

P<0.001

Week 52WWeekk 2244



SIMPONI helps achieve and maintain clinical remission1



RA

Signs and


DAS28 (CRP) remission at Week 241

Placebo + MTX

(n=133)

60

40

20

0

Patients

, %

27.0

6.8

SIMPONI 50 mg + MTX

monthly (n=89)

P<0.001

Week 52WWeekk 2244

4 times as many patients achieved DAS28 remission vs

MTX alone (27.0% vs 6.8%; P<0.001) at Week 24.1





WWeekk 5522Week 24

SIMPONI helps achieve and maintain clinical remission1RA

Signs and


Remission was sustained through Week 52—

61% of patients initially receiving

SIMPONI 50 mg + MTX achieved

DAS28 (CRP) remission.3



MTX = methotrexate; DAS28 = Disease Activity Score 28; CRP = C-reactive protein; RA = rheumatoid arthritis;

ACR = American College of Rheumatology; HAQ-DI = Health Assessment Questionnaire Disability Index.

References




Signs and








subcutaneously every 4 weeks. Primary end points were the proportion of patients with ≥20% improvement

in the ACR criteria at Week 14 and the change from baseline in the HAQ-DI score at Week 24.



Signs and


SIMPONI helps achieve early and sustained reduction in

pre-erosive lesions1,2,a,b

MRI synovitis and bone marrow edema osteitis in early RA

can predict later radiographic progression.3

Radiographic data for SIMPONI supported by MRI substudies1,2:

In a substudy of GO-BEFORE (N=318), signifi cant improvements in synovitis (P<0.001),

osteitis (P<0.001), and bone erosions (P<0.05) vs placebo + MTX were observed as early as

Week 12.1,c

In a substudy of GO-FORWARD (n=240), signifi cant reductions in synovitis and osteitis vs

MTX alone were observed despite low levels of disease activity in the total study population

(P<0.001).2,d

Improvements in synovitis, osteitis, and bone erosions were maintained to Week 24.1

RA

Synovitis

improvement

Signs and




RA

Signs and


Example of improvements in synovitis after treatment with SIMPONIe

Baseline Week 12 Week 24

STIR Postcontrast T1



RA



Signs and


Example of improvements in synovitis after treatment with SIMPONIe

STIR Postcontrast T1

Baseline Week 12 Week 24

a Early defi ned as treatment response at Week 12. Sustained defi ned as maintained improvements at Week 24.

bPre-erosive = synovitis and osteitis.

cGO-BEFORE: a multicenter, randomized, double-blind, placebo-controlled study (N=637) in patients with active

RA naïve to MTX. Radiographic progression was a primary end point.

dGO-FORWARD: a multicenter, randomized, double-blind, placebo-controlled study (N=444) in patients with

active RA despite MTX therapy. Primary end points were the proportion of patients with ≥20% improvement in

the ACR criteria at Week 14 and the change from baseline in the HAQ-DI score at Week 24.

ePlease note that treatment with SIMPONI 100 mg should only be considered in patients weighing over 100 kg

who have not achieved adequate clinical response with SIMPONI 50 mg. The increased risk of certain serious

adverse drug reactions with the 100-mg dose compared with the 50-mg dose should be taken into account.

MRI = magnetic resonance imaging; MTX = methotrexate; RA = rheumatoid arthritis; ACR = American College of

Rheumatology; HAQ-DI = Health Assessment Questionnaire Disability Index.

References

1. Østergaard M, et al. Arthritis Rheum. 2011;63(12):3712–3722.

2. Conaghan PG, et al. Ann Rheum Dis. 2011;70(11):1968–1974.

3. Boyesen P, et al. Ann Rheum Dis. 2011;70(3):428–433.

Signs and




GO-FORWARD: MRI of the wrist at baseline, Week 12, and Week 24 of a patient randomized to receive SIMPONI

100 mg plus placebo. Coronal short tau inversion recovery (STIR) images (A–C) show extensive bone edema at

baseline (A). The bone edema has markedly decreased at Week 12 (B) and has nearly resolved at Week 24 (C).

Corresponding postcontrast T1-weighted images with fat suppression (D–F) show substantial synovitis at baseline

(D) and markedly reduced synovitis at Week 12 (E) and Week 24 (F). Precontrast T1-weighted images without

fat suppression (G–I) show no progression of bone erosion during the 24-week follow-up period. Note: Series of

consecutive images were evaluated; the images displayed here are representative but not exhaustive.

Signs and




SIMPONI helps to significantly inhibit progression of

structural damage1

SIMPONI, in combination with MTX, has been shown to

reduce the rate of progression of joint damage as measured

by x-ray and to improve physical function—leading to

potential improvements in patient QoL.3

SIMPONI 50 mg + MTX signifi cantly inhibited radiographic progression at Week 52 in previously

MTX-naïve patients, as measured by SHS.1

Nearly half the radiographic progression seen vs MTX alone.

Benefi ts demonstrated even in patients with disease duration >3 years (established RA).

In MTX-experienced patients with active disease, SIMPONI 50 mg + MTX signifi cantly limited

radiographic progression at Week 24 and reduced RA signs and symptoms as measured by

ACR20 responses at Weeks 14 and 24.2

RA

MTX naive

MTX

experienced

Signs and




p

In MTX-experienced patients with active disea

radiographic progression at Week 24 and redu

ACR20 responses at Weeks 14 and 24.2

Change in SHS from baseline1,2RA

3.5

3

2.5

2

1.5

1

0.5

0

Mean c

hang

e f

rom

baselin

e

0.74

1.37

MTX naïve (Week 52)a

P=0.015

Placebo + MTX

(n=160)

SIMPONI 50 mg monthly

+ MTX (n=159)

MTX naive

MTX

experienced

Signs and





3.5

3

2.5

2

1.5

1

0.5

0

Mean c

hang

e f

rom

baselin

e

0.74

1.37

MTX naïve (Week 52)a

P=0.015

Placebo + MTX

(n=160)


+ MTX (n=159)

46% less progression



MTX naive

MTX

experienced

Signs and


Signs and



3.5

3

2.5

2

1.5

1

0.5

0

Mean c

hang

e f

rom

baselin

e

MTX experienced (Week 24)b

P=0.020

1.05

2.51

Placebo + MTX

(n=105)


+ MTX (n=101)

MTX naive

MTX

experienced



Signs and



3.5

3

2.5

2

1.5

1

0.5

0

Mean c

hang

e f

rom

baselin

e

MTX experienced (Week 24)b

P=0.020

1.05

2.51

Placebo + MTX

(n=105)


+ MTX (n=101)

58% less progression



MTX naive

MTX

experienced

aCoprimary end point at Week 52.

bWeek 24 data.

MTX = methotrexate; SHS = Sharp/van der Heijde score (higher SHS scores indicate greater radiographic

progression); RA = rheumatoid arthritis; QoL = quality of life.

References

1. Emery P, et al. Arthritis Rheum. 2011;63(5):1200–1210.

2. Tanaka Y, et al. Ann Rheum Dis. 2011;Epub ahead of print.




Signs and


GO-BEFORE: a multicenter, randomized, double-blind, placebo-controlled study (N=637) in patients with active

RA naïve to MTX. Radiographic progression was a primary end point.

Tanaka, et al: a multicenter, randomized, double-blind, placebo-controlled study in Japanese patients (N=261)

with active RA despite MTX therapy. Patients were randomized to SIMPONI 50 mg, SIMPONI 100 mg, or placebo,

subcutaneously, every 4 weeks. The primary end point was the proportion of patients achieving ACR20 at

Week 14. Radiographic progression was assessed by change from baseline in SHS at Week 24.



Signs and


Effective once-monthly treatment that helps improve

physical function and QoL1,2

Signifi cantly improved health-related QoL as measured

by SF-36 physical component score.3

SIMPONI 50 mg + MTX signifi cantly improved HAQ scores vs placebo + MTX1,2:

HAQ scores were maintained through Week 104.3

RA

HAQ

Physical functionQoL Summary



Improvement in HAQ from baseline

Week 24 Week 52

Placebo + MTX (switched to SIMPONI 50 mg monthly + MTX at Week 16)

SIMPONI 50 mg + MTX

0.7

0.6

0.5

0.4

0.3

0.2

0.1

0

Med

ian

im

pro

vem

ent

in H

AQ

-DI

0.38

0.13

0.63

P<0.001

n=133 n=89

0.38

n=81 n=70

RA




QoL = quality of life; MTX = methotrexate; HAQ = Health Assessment Questionnaire; HAQ-DI = HAQ Disability Index;

RA = rheumatoid arthritis; ACR = American College of Rheumatology; SF-36 = Short Form-36 Health Survey.

References











subcutaneously every 4 weeks. Primary end points were the proportion of patients with ≥20% improvement

in the ACR criteria at Week 14 and the change from baseline in the HAQ-DI score at Week 24.




Efficacy with monthly SC SIMPONI



Reduced

disease activity2,4–6

Reduced signs

and symptoms1–3

Provided proven

clinical remission2,3

RA





Reduced


Reduced signs

and symptoms1–3

Almost twice as many

patients achieved an ACR50

response vs MTX alone

ACR response maintained

through 2 years

Provided proven


RA





Reduced


Reduced signs

and symptoms1–3





through 2 years

Provided proven


DAS28 remission rates

sustained through Week 52

and Week 104

RA





Reduced


Signifi cantly reduced pre-

erosive lesions

Resulted in nearly half the

radiographic progression

vs MTX alone

Reduced signs

and symptoms1–3





through 2 years

Provided proven


DAS28 remission rates

sustained through Week 52

and Week 104

RA


ACR = American College of Rheumatology; MTX = methotrexate; SC = subcutaneous; DAS28 = Disease

Activity Score 28 (DAS28 remission was compiled using C-reactive protein [CRP]); HAQ = Health Assessment

Questionnaire; SF-36 = Short Form-36 Health Survey.

References



3. Keystone EC, et al. Ann Rheum Dis. 2010;69(6):1129–1135. Erratum in: Ann Rheum Dis. 2011;70(1):238–239.

4. Østergaard M, et al. Arthritis Rheum. 2011;63(12):3712–3722.

5. Conaghan PG, et al. Ann Rheum Dis. 2011;70(11):1968–1974.

6. Emery P, et al. Arthritis Rheum. 2011;63(5):1200–1210.




Safety profile of SIMPONI after 3 years1,2

In Phase 3 trials through 3 years1:

7.4% of patients receiving injections of SIMPONI 50 mg discontinued therapy

because of adverse events vs 4.9% of those receiving placebo injections.

SIMPONI has over 8 years of worldwide

clinical trial experience and has been

used in over 80,000 patients.2,3

3-year safety data SAFETYComprehensively

tested

Adverse

event data



RA

An analysis of pooled data from the long-term extensions of randomized,

double-blind, placebo-controlled studies in RA, PsA, and AS.1

Adverse event2 (Pooled data) SIMPONI 50 mg +/– MTX Placebo +/– MTX

Patients treated (n) 1,317 674

Deathsa 0.30 0.28

All serious infectionsa 3.03 5.31

Tuberculosis (TB)a 0.17 0.00

Opportunistic infections other than TBa

0.13 0.00

Malignancy Nonmelanoma skin cancersTotal patient-years of follow-upIncidence/100 patient-years

2,3050.43

3561.40

LymphomaTotal patient-years of follow-upIncidence/100 patient-years

2,3130.04

3580.00

Other malignanciesTotal patient-years of follow-upIncidence/100 patient-years

2,3080.78

3570.56

Includes SIMPONI SC

Phase 2b studies in

addition to Phase 3 RA,

PsA, and AS studies.


tested

RA



aIncidence per 100 patient-years.

RA = rheumatoid arthritis; PsA = psoriatic arthritis; AS = ankylosing spondylitis; MTX = methotrexate.

References

1. Kay J, et al. ACR 2011; abstract 2227.

2. Data on fi le. MSD SIMPONI PSUR 05.

3. http://clinicaltrials.gov/ct2/show/NCT00207714?term=cnto+148&rank=8. Accessed 31/01/12.


tested



SIMPONI —comprehensively tested in worldwide trials

SIMPONI has been extensively

tested in a worldwide clinical

trial program in more than 2,300

patients, including different RAa

patient groups, as well as those

with PsAb or ASc.1–6

A comprehensive development program:

Phase 3 clinical trials in over 2,300 rheumatology patients1–6

Trial Indication Patient type Subjects, N

GO-BEFORE Active RA MTX naïve 637

GO-FORWARD Active RA MTX nonresponders 444

GO-AFTER Active RA Anti-TNF experienced 461

GO-REVEAL Active PsADMARD

nonresponders405

GO-RAISE Active ASConventional therapy

nonresponders356


tested

RA



GO-BEFORE: a multicenter, randomized, double-blind, placebo-controlled study (N=637) in patients with active

RA naïve to MTX. Radiographic progression was a primary end point. ACR50 at Week 24 was a primary end point.


tested










tested



GO-AFTER: a double-blind, placebo-controlled trial (N=461) to evaluate the effi cacy and safety of SIMPONI in

patients with active rheumatoid arthritis (RA) who had previously received one or more TNFα inhibitors. Patients

with active RA were randomly assigned (1:1:1) to placebo or SIMPONI 50 mg or 100 mg. The primary end point

was the proportion of patients who achieved 20% or higher improvement in ACR criteria for assessment of RA

(ACR20) at Week 14. At Week 16, patients who had less than 20% improvement in tender and swollen joint

counts were given rescue therapy in a double-blinded manner: patients in the placebo group received

SIMPONI 50 mg, patients in the SIMPONI 50-mg group had a dose escalation to 100 mg, and patients in the

SIMPONI 100-mg group continued to receive 100 mg.


tested



GO-REVEAL: a multicenter, randomized, double-blind, placebo-controlled study (N=405) in patients with active

PsA. Patients were randomized to treatment with SC SIMPONI 50 mg, SIMPONI 100 mg, or placebo every 4

weeks to Week 20. The primary end point was the proportion of patients meeting the ACR20 improvement criteria

at Week 14.


tested



GO-RAISE: a multicenter, randomized, double-blind, placebo-controlled study (N=356) to evaluate the effi cacy

and safety of SIMPONI. Patients with active AS were randomly assigned (1.8:1.8:1) to SC SIMPONI 50 mg or

100 mg, or placebo every 4 weeks.

The primary end point was the proportion of patients who achieved ASAS20 response at Week 14. At Week 16,

patients who had failed to achieve ASAS20 response entered early escape in a double-blinded manner: patients

in the placebo group received SC SIMPONI 50 mg, patients in the group receiving SC SIMPONI 50 mg had a

dose escalation to 100 mg, and patients in the SC SIMPONI 100-mg group continued to receive 100 mg of

SC SIMPONI. All other patients in the placebo group were changed over in Week 24 to SC SIMPONI 50 mg.


tested



aSIMPONI, in combination with MTX, is indicated for:

• the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to DMARD therapy

including MTX has been inadequate.

• the treatment of severe, active, and progressive rheumatoid arthritis in adults not previously treated with MTX.

SIMPONI, in combination with MTX, has been shown to reduce the rate of progression of joint damage as

measured by x-ray and to improve physical function.

bSIMPONI, alone or in combination with MTX, is indicated for the treatment of active and progressive PsA in

adult patients when the response to previous DMARD therapy has been inadequate. SIMPONI has been shown

to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular

symmetrical subtypes of the disease and to improve physical function.

cSIMPONI is indicated for the treatment of severe, active AS in adults who have responded inadequately to

conventional therapy.

RA = rheumatoid arthritis; MTX = methotrexate; TNF = tumor necrosis factor; PsA = psoriatic arthritis;

DMARD = disease-modifying antirheumatic drug; AS = ankylosing spondylitis.

References



3. Emery P, et al. Arthritis Rheum. 2009;60(8):2272–2283. Erratum in: Arthritis Rheum. 2010;62(10):3005.

4. Smolen JS, et al. Lancet. 2009;374(9685):210–221.

5. Inman RD, et al. Arthritis Rheum. 2008;58(11):3402–3412.

6. Kavanaugh A, et al. Arthritis Rheum. 2009;60(4):976–986. Erratum in: Arthritis Rheum. 2010;62(8):2555.


tested



Convenience and features that fit with everyday life

Developed for convenience with only 1 injection per month.1–6

Features citric acid–free formulationa and low injection volume (0.5 mL).1

Low level of ISRs, including pain1:

5.8% of patients on SIMPONI (50 mg and 100 mg) experienced ISRs vs

2.2% on placebo.1

ConvenienceEXPERIENCEState-of-the-

art devicesMonthly dosing

Patient support

program

Dosing

information

RA



✔ Monthly SIMPONI autoinjector 50 mg

✔ Monthly SIMPONI prefi lled syringe 50 mg

✘ Adalimumab autoinjector 40 mg and prefi lled syringe 40 mg

✔ Etanercept autoinjector 50 mg

✔ Etanercept prefi lled syringe 25 mg

✔ Certolizumab prefi lled syringe 200 mg



Patient support

program

RA



Citric acid–free formulationa Injection volume



✘ Adalimumab autoinjector 40 mg

and prefi lled syringe 40 mg



✔ Certolizumab prefi lled syringe 200 mg


0.5 mL

0.5 mL

0.8 mL

1.0 mL

1.0 mL

0.5 mL



Patient support

program

RA



aA comparison of injection media found that a solution containing citrate as a buffer caused more pain

immediately after SC injection than did a solution with histidine as a buffer, which did not cause more pain

than the control saline solution.6

ISR = injection site reaction; SC = subcutaneous.

References


2. Humira. Summary of Product Characteristics. January 2012.

3. Enbrel. Summary of Product Characteristics. September 2011.

4. Cimzia. Summary of Product Characteristics. December 2011.

5. Jørgensen JT, et al. Ann Pharmacother. 1996;30(7–8):729–732.

6. Laursen T, et al. Basic Clin Pharmacol Toxicol. 2006;98(2):218–221.

Brands mentioned are trademarks of their respective owners.





Patient support

program

Only SC anti-TNF with monthly dosing1-6

Injections

per month

Injections

per year



Patient support

program

RA



Injections

per month


Injections

per year



Patient support

program

RA




Injections

per year



Patient support

program

RA

Injections

per month






Patient support

program

RA

Injections

per year



Injections

per month

References










Patient support

program



State-of-the-art SmartJect® autoinjector pen

Developed to help simplify administration

Also available as 0.5-mL,

single-use prefi lled syringe

Easy to handle

Easy-grip body

Large side button

Easy-twist cap

Easy to administer

2 audible clicks

Large observation window

Secure

Autoretract needle

Security seal

Built-in safety sleeve

In RA, SIMPONI has a recommended dose of 50 mg,

in combination with MTX, given once a month, on

the same date each month.1



Patient support

program

RA



Convenient, single-use prefilled syringe


Also available as 0.5-mL, single-use,

state-of-the-art SmartJect® autoinjector pen

Secure

Sturdy needle cover

Extra-fi ne needle

Easy to administer

Clear observation window

Easy-to-read labelEasy to handle

Needle guard

Thumb-sized plunger head



Patient support

program

RA

In RA, SIMPONI has a recommended dose of 50 mg,

in combination with MTX, given once a month, on

the same date each month.1



RA = rheumatoid arthritis; MTX = methotrexate.

Reference




Patient support

program



Carefully tailored SIMPONI® for Me™ patient support program

Patient support program designed to complement the patient-doctor relationship:

Developed to help give patients on therapy with SIMPONI the confi dence they need to self-inject

Personalized, ongoing educational advice and support

Tailored to meet needs of treatment-naïve and biologic-experienced patients

Program includes A starter kit

Personalized

monthly reminder-

to-inject service

FREE

help line

Online

information

resource



Any patients with medical questions concerning their condition

are advised to contact their health care professional.

Registering for

SIMPONI for Me



Patient support

program

RA

How patients can register for SIMPONI® for Me™

Complete and

return enrollment

form provided with

starter kit

Call

SIMPONI for Me at

<0000 0000 0000>

Visit

simponiforme.com





Patient support

program

RA

SIMPONISUMMARYREMICADE®

(infl iximab)

Convenience

and support1

Proven and sustained

clinical effi cacy1,2

Rigorous clinical

trial program1,3,4

Helps get patients back to everyday life in a monthly SC dose

Clinical effi cacyffi Clinical experience Conveniencei

RA





Provided sustained ACR50 response

Achieved and maintained DAS28

remission

Inhibited radiographic progression

Signifi cantly improved HAQ scores




(infl iximab)

RA



Convenience

and support1

Rigorous clinical

trial program1,3,4





remission



Rigorous clinical

trial program1,3,4

Effi cacy in RA demonstrated in

three Phase 3 trials

Over 8 years of worldwide clinical

trial experience across indications

Over 80,000 patients treated

globally across indications




(infl iximab)

RA



Convenience

and support1

Convenience

and support1

Only SC anti-TNF with monthly

dosing

Choice of prefi lled autoinjector

pen or syringe

Carefully tailored patient support

program






remission



Rigorous clinical

trial program1,3,4

Effi cacy in RA demonstrated in

three Phase 3 trials


trial experience across indications


globally across indications



(infl iximab)

RA



Effi cacy sustained through Week 52 with more than

half of patients achieving an ACR50 response.2Effi cacy sustained through Week 52 with more than

half of patients achieving an ACR50 response.2

Clinical efficacy

Effi cacy sustained through Week with more than


Almost times more improvement in HAQ-DI

scores vs placebo + MTX alone at Week 24 (P<0.001).2

14 4224 52

2 43 5

2 43 5

Clinical

experience

Clinical

effi cacy

Convenience


(infl iximab)

times as many patients achieved DAS28

remission vs MTX alone (P<0.001) at Week 24.2

RA



Clinical efficacy

Clinical

experience

Clinical

effi cacy

Convenience


(infl iximab)

RAClinical efficacy





14 4224

2 43 5

2 43 5

times as many patients achieved DAS28




Clinical

experience

Clinical

effi cacy

Convenience


(infl iximab)

RAClinical efficacy


half of patients achieving an ACR50 response.514 4224

2 3 5

2 43 5

4 times as many patients achieved DAS28






Clinical

experience

Clinical

effi cacy

Convenience


(infl iximab)

RAClinical efficacy



Almost 3 times more improvement in HAQ-DI


14 4224

2 3 5

2 4 5

4 times as many patients achieved DAS28




Clinical experience

Over patients treated globally.3,4

Over years of clinical trial experience.3,4

70,000 90,00080,000 100,000

3 85 10

Clinical

experience

Clinical

effi cacy

Convenience


(infl iximab)

RA



Over 80,000 patients treated globally.3,4


70,000 90,000 100,000

3 85 10

Clinical

experience

Clinical

effi cacy

Convenience


(infl iximab)

RA



Clinical experience


Over 8 years of clinical trial experience.3,4

70,000 90,000 100,000

3 5 10

Clinical

experience

Clinical

effi cacy

Convenience


(infl iximab)

RA



Clinical experience

Which of these products is NOT a citric acid–free formulation?1,6–10,a

Monthly SIMPONI autoinjector 50 mg

Monthly SIMPONI prefi lled syringe 50 mg

Adalimumab autoinjector 40 mg and prefi lled syringe 40 mg

Etanercept autoinjector 50 mg

Etanercept prefi lled syringe 25 mg

Certolizumab prefi lled syringe 200 mg

✘

Convenience

Clinical

experience

Clinical

effi cacy

Convenience


(infl iximab)

RA









Certolizumab prefi lled syringe 200 mg

✔

✔

✔

✔

✔

✘

Clinical

experience

Clinical

effi cacy

Convenience


(infl iximab)

Convenience RA




immediately after SC injection than did a solution with histidine as a buffer, which did not cause more pain


SC = subcutaneous; RA = rheumatoid arthritis; TNF = tumor necrosis factor;

ACR = American College of Rheumatology; MTX = methotrexate; DAS28 = Disease Activity Score 28;

HAQ= Health Assessment Questionnaire; HAQ-DI = Health Assessment Questionnaire Disability Index.

References













(infl iximab)



REMICADE provides an appropriate solution for patients with

active, uncontrolled disease who are at risk of noncompliance

and/or who have a preference for IV

REMICADE helps you deliver rapida relief, proven remission, and close management for patients with RA

In-offi ce infusion allows for closer patient monitoring and support

Improved signs and symptoms2

Weight-based dose optimization4

Helped prevent joint damage5

Improved quality of life1

Helped achieve biologic-free remission3REMICADE

rapida relief,

proven remission

REMICADE offers speeda and power

to help achieve sustained remission

in early and established RA.

Patient profi les


(infl iximab)

RA



The patient at risk

of noncompliance

or who prefers

IV treatment

The patient

with active,

uncontrolled

disease

High CRP levels

Signs of erosive disease

High infl amed

joint count

Unable to understand and/

or follow treatment regimen

Unwilling or unable

to self-inject

Needs the reassurance of

regular contact with an HCP


(infl iximab)

RA



IV = intravenous; RA = rheumatoid arthritis; CRP = C-reactive protein; HCP = health care professional.

References

1. Klarenbeek NB, et al. Ann Rheum Dis. 2011;70(6):1039–1046.

2. Maini R, et al. Lancet. 1999;354(9194):1932–1939.

3. Van der Kooij SM, et al. Ann Rheum Dis. 2009;68(6):914–921.

4. REMICADE. Summary of Product Characteristics. March 2012.

5. St Clair EW, et al. Arthritis Rheum. 2004;50(11):3432–3443.


(infl iximab)








EFFICACY

QoL

SAFETY

EXPERIENCE

SUMMARY


EFFICACY

QoL

SAFETY

EXPERIENCE

SUMMARY


EFFICACY

QoL

SAFETY

EXPERIENCE

SUMMARY

SIMPONI helps to provide proven reduction in disease

activity in PsA patients1,2

PsA

Signs and symptoms

of PsAEFFICACY Structural damage EnthesitisDisease activity Signs of psoriasis

Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n = 113)

SIMPONI 50 mg (n = 292)

ACR20 ACR50 ACR70

80

60

40

20

0

Patients

, %

9.0

30.0

2.0 1.0

P < 0.05

P < 0.05

P < 0.05

12.0

51.0

ACR response at Week 141,2

Week 24 Week 52 Week 104WWeeeekk 1144



SIMPONI 50 mg signifi cantly reduced signs and symptoms across all ACR criteria1,2:

The safety profi le

of SIMPONI in

PsA was

consistent with

that of other

anti-TNF agents.2

PsA

Signs and symptoms




Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n = 113)

SIMPONI 50 mg (n = 292)

ACR20 ACR50 ACR70

80

60

40

20

0

Patients

, %

12.0

32.0

4.0

19.0

1.0

P < 0.05

P < 0.05

P < 0.05

52.0

ACR response at Week 241,2

Week 52 Week 104Week 14




The safety profi le

of SIMPONI in

PsA was

consistent with

that of other

anti-TNF agents.2

PsA

Signs and symptoms




Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n =113)

SIMPONI 50 mg (n=146)

67.165.5

48.638.9

19.5

ACR20 ACR50 ACR70

35.6

80

60

40

20

0

Patients

, %

ACR response at Week 521– 3

Week 24 WWeeeekk 5522 Week 104Week 14


The safety profi le

of SIMPONI in

PsA was

consistent with

that of other

anti-TNF agents.2



Week 24 Week 52 WWeeeekk 110044Week 14


PsA

Signs and symptoms


Clinical improvements across all ACR

criteria were maintained through Week 104.2





The safety profi le

of SIMPONI in

PsA was

consistent with

that of other

anti-TNF agents.2

Signs and symptoms


PsA = psoriatic arthritis; ACR = American College of Rheumatology; SC = subcutaneous;

TNF = tumor necrosis factor.

References



3. Kavanaugh A, et al. Arthritis Rheum. 2012; Feb 29 doi: 10.1002/art.34436. [Epub ahead of print]



Signs and symptoms


GO-REVEAL: a multicenter, randomized, double-blind, placebo-controlled study (N = 405) in patients with active

PsA. Patients were randomized to treatment with SC SIMPONI 50 mg, SIMPONI 100 mg, or placebo every

4 weeks to Week 20. The primary end point was the proportion of patients meeting the ACR20 improvement

criteria at Week 14.



SIMPONI helps provide proven reduction in disease activity

in PsA patients1,2

PsA

Signs and symptoms


Placebo

(n=113)


(n=146)

2

1.5

1

0.5

0Imp

rove

ments

in D

AS

28

0.1

1.5P < 0.001

Week 52 Week 104

DAS28 scores

were maintained

through 2 years.2



DAS28 scores at Week 241,a

SIMPONI helped achieve a signifi cant improvement in DAS28 scores at Week 24 (P<0.001)1,a

PsA

Signs and symptoms


Week 24 WWeeeekk 5522 Week 104

DAS28-CRP response of good/moderate

was achieved by

82% of patients treated with

SIMPONI 50 mg at Week 52.3




in PsA patients1,2


DAS28 scores

were maintained

through 2 years.2

PsA

Signs and symptoms


Week 24 Week 52 WWeeeekk 110044

DAS28 scores were

maintained through 2 years.2




in PsA patients1,2


Signs and symptoms


aDAS28 remission was compiled using CRP; lower score equals improvement.

PsA = psoriatic arthritis; DAS28 = Disease Activity Score 28; CRP = C-reactive protein; SC = subcutaneous;

ACR = American College of Rheumatology.

References






Signs and symptoms


GO-REVEAL: a multicenter, randomized, double-blind, placebo-controlled study (N= 405) in patients with

active PsA. Patients were randomized to treatment with SC SIMPONI 50 mg, SIMPONI 100 mg, or placebo

every 4 weeks to Week 20. The primary end point was the proportion of patients meeting the ACR20 improvement




SIMPONI helps inhibit structural damage in active PsA

Helps prevent long-term damage

SIMPONI signifi cantly inhibited structural damage in active PsA through Week 24

(–0.16 vs 0.27 for placebo; P= 0.011).1

Prevention of structural damage was maintained through Week 52 and Week 104,

with 77% of patients experiencing no progression from baseline.1

PsA

Radiographic

progression

Signs and symptoms




0.4

0.2

0

-0.2

-0.4Mean c

hang

e in S

HS

fro

m b

aselin

e

0 Weeks

0.00 Weeks

0.0


(n=146)

Placebo

(n=113)

PsA

Signs and symptoms


Change in radiographic progression to Week 241,2

Week 52Week 24WWeekk 00



0.4

0.2

0

-0.2

-0.4Mean c

hang

e in S

HS

fro

m b

aselin

e

24 Weeks

-0.16

24 Weeks

0.27 P=0.011


(n=146)

Placebo

(n=113)

All patients randomized to placebo received

SIMPONI 50 mg monthly from Week 24

PsA

Signs and symptoms



Week 52WWeekk 2244Week 0



WWeekk 5522Week 24Week 0

0.4

0.2

0

-0.2

-0.4Mean c

hang

e in S

HS

fro

m b

aselin

e

52 Weeks

-0.22

52 Weeks

0.22


(n=146)

Placebo

(n=113)

PsA

Signs and symptoms





Signs and symptoms


PsA = psoriatic arthritis; SHS = Sharp/van der Heijde score; SC = subcutaneous;


References





Signs and symptoms




4 weeks through Week 20. All patients, including those randomized to placebo, received SIMPONI from Week 24

through Week 104. The primary end point was the proportion of patients meeting the ACR20 improvement criteria

at Week 14. Radiographs of the hands and feet were obtained at Weeks 0, 24, 52, and 104.



SIMPONI helps improve signs and symptoms of psoriasis

SIMPONI helped to signifi cantly reduce severity of skin psoriasisa (PASI50, 75, and 90; P<0.001)1

PsA

Signs and symptoms


Nail

appearance

Improvement in PASI scores at Week 241

Placebo (n=113)

SIMPONI 50 mg monthly (n=146)

80

60

40

20

0

Patients

, %

PASI50 PASI75 PASI90

76.0

8.0

56.0

1.0

32.0

0.0

P < 0.001

P < 0.001

P < 0.001

Week 52WWeekk 2244



PsA

Signs and symptoms


Nail

appearance

Improvement in PASI75 score at Week 522

Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=113)


80

60

40

20

0

Patients

, %

62.448.1

Week 24



SIMPONI helps improve signs and symptoms of psoriasis

SIMPONI helped to signifi cantly reduce severity of skin psoriasisa (PASI50, 75, and 90; P<0.001)1

Signs and symptoms


aAmong the 74% of patients in whom ≥3% of body surface area was affected by psoriasis at baseline.

PASI = Psoriasis Area and Severity Index; PsA = psoriatic arthritis; SC = subcutaneous;


References





Signs and symptoms


GO-REVEAL: a multicenter, randomized, double-blind, placebo-controlled study (N = 405) in patients with

active PsA. Patients were randomized to treatment with SC SIMPONI 50 mg, SIMPONI 100 mg, or placebo

every 4 weeks through Week 20. All patients, including those randomized to placebo, received SIMPONI from

Week 24 through Week 52. The study was unblinded at Week 52. The primary end point was the proportion

of patients meeting the ACR20 improvement criteria at Week 14.



SIMPONI helps restore normal appearance to nails1

NAPSI

improvements

were sustained

through

Week 52.2

SIMPONI helped to signifi cantly improve psoriatic nail disease as measured by NAPSI (P=0.015

Week 14; P<0.001 Week 24)1:

Improvement in NAPSI score1

Placebo (n=113)


40

20

0Med

ian c

hang

e in

NA

PS

I sco

re, %

25.0

0.0 0.0

33.0P<0.001

P=0.015

Week 14 Week 24

Signs and symptoms




Signs and symptoms


NAPSI = Nail Psoriasis Severity Index; PsA = psoriatic arthritis; SC = subcutaneous;


References

1. Kavanaugh A, et al. Arthritis Rheum. 2009;60:976–986. Erratum in: Arthritis Rheum. 2010;62(8):2555.




Signs and symptoms




4 weeks to Week 20. The primary end point was the proportion of patients meeting the ACR20 improvement




SIMPONI helps reduce the signs and symptoms

of enthesitis

SIMPONI has shown signifi cant

effi cacy against most of the

manifestations associated with PsA.1–4

In GO-REVEAL, SIMPONI signifi cantly improved enthesitis and reduced the

proportion of patients with enthesitis vs placebo at Week 241,a:

5 times greater improvement in PsA-modifi ed MASES score vs placebo at

Week 24 (60% vs 12%, P<0.001)

PsA

Signs and symptoms




Signs and symptoms


GO-REVEAL: a multicenter, randomized, double-blind, placebo-controlled study in patients with active PsA.

Patients were randomized to treatment with SC SIMPONI 50 mg, SIMPONI 100 mg, or placebo every 4 weeks

through Week 20. The primary end point was the proportion of patients meeting the ACR20 improvement criteria

at Week 14.



Signs and symptoms


aSIMPONI 50 mg monthly.

MASES = Maastricht Ankylosing Spondylitis Enthesitis Score; PsA = psoriatic arthritis; SC = subcutaneous;


References



3. Ritchlin CT, et al. Ann Rheum Dis. 2009;68(9):1387−1394.




SIMPONI helps improve patient QoL

10 times more improvement in QoL score with SIMPONI 50 mg vs placebo1:

Mean improvement in PCS component of SF36 of 6.5 in the group receiving

SIMPONI 50 mg vs 0.6 for placebo at Week 14 (P<0.001).

Improvement was maintained through Week 52.2

PsA

Improved QoLQoL Summary

Improvement in QoL

Placebo (n=113)


Week 14 Week 52

12

10

8

6

4

2

0Mean c

hang

e f

rom

baselin

e

in S

F36 P

CS

sco

re

6.5

0.6

9.98.3P<0.001

Safety

profi le



PsA


Safety profi le through Week 52:

Safety fi ndings through Week 52 were consistent with Week 24 results and with

other biologic agents, including anti-TNF agents.2

The most commonly reported AEs at Weeks 24 and 52 were respiratory infections

and nasopharyngitis (at Week 24, 9% SIMPONI vs 6% placebo, and 9% SIMPONI

vs 4% placebo, respectively).1,2

No patient developed active tuberculosis or an opportunistic infection

through Week 52.2

3% of the group receiving SIMPONI and 4% of the placebo group discontinued

treatment before Week 24.1

ISRs occurred in 3% of the groups receiving either placebo or SIMPONI at

Week 24. No ISR was severe, serious, or resulted in discontinuation of treatment.1



GO-REVEAL: a multicenter, randomized, double-blind, placebo-controlled study (N = 405) in patients with active


4 weeks through Week 20. All patients, including those randomized to placebo, received SIMPONI from Week

24 through Week 52. The study was unblinded at Week 52. The primary end point was the proportion of patients

meeting the ACR20 improvement criteria at Week 14.




QoL = quality of life; SF36 PCS = Short Form-36 physical component summary score; PsA = psoriatic arthritis;

SC = subcutaneous; ACR = American College of Rheumatology; TNF = tumor necrosis factor; AE = adverse

event; ISR = injection site reaction.

References






PsA

Improved most

PsA-associated

comorbidities2,3

Reduced signs

and symptoms1,2

Reduced

disease activity1,2





PsAEfficacy with monthly SC SIMPONI


Reduced signs

and symptoms1,2

8 times more patients achieved

an ACR50 response at Week 24a


through 2 yearsb



Improved most

PsA-associated

comorbidities2,3

Reduced

disease activity1,2

PsA

Reduced signs

and symptoms1,2




through 2 yearsb

Reduced

disease activity1,2

Signifi cant improvement in

DAS28 scores at Week 24,

maintained over 2 years

Helped to prevent structural

damage through Week 52 and

Week 104 to help maintain

everyday functioning





Improved most

PsA-associated

comorbidities2,3

PsA

Improved most

PsA-associated

comorbidities2,3


skin response (PASI), nail

disease (NAPSI), and enthesitis

(PsA-modifi ed MASES)



Reduced signs

and symptoms1,2




through 2 yearsb



Reduced

disease activity1,2


DAS28 scores at Week 24,

maintained over 2 years

Helped to prevent structural

damage through Week 52 and

Week 104 to help maintain

everyday functioning

aACR50 response at Week 24: 32% for SIMPONI 50 mg vs 4% for placebo.

bACR50 response at Week 104 of 46% for SIMPONI 50 mg.

ACR = American College of Rheumatology; PsA = psoriatic arthritis; PASI = Psoriasis Area and Severity Index;

NAPSI = Nail Psoriasis Severity Index; MASES = Maastricht Ankylosing Spondylitis Enthesitis Score;

DAS28 = Disease Activity Score 28; SC = subcutaneous; SF36 PCS = Short Form-36 physical component

summary score.

References



3. Ritchlin CT, et al. Ann Rheum Dis. 2009;68(9):138−1394.










used in over 80,000 patients.2,3


tested

Adverse

event data



PsA


double-blind, placebo-controlled studies in AS, RA, and PsA1:



Deathsa 0.30 0.28




0.13 0.00


2,3050.43

3561.40


2,3130.04

3580.00


2,3080.78

3570.56

Includes SIMPONI SC

Phase 2b studies in

addition to Phase 3

AS, RA, and PsA.


tested

PsA




MTX = methotrexate; AS = ankylosing spondylitis; RA = rheumatoid arthritis; PsA = psoriatic arthritis.

References





tested













GO-BEFORE Active RAa MTX naïve 637

GO-FORWARD Active RAa MTX nonresponders 444

GO-AFTER Active RAa Anti-TNF experienced 461

GO-REVEAL Active PsAbDMARD

nonresponders405

GO-RAISE Active AScConventional therapy

nonresponders356


tested

PsA



GO-BEFORE: a multicenter, randomized, double-blind, placebo-controlled study (N= 637) in patients with active



tested










tested



GO-AFTER: a multicenter, double-blind, placebo-controlled Phase III trial (N=461) to evaluate the effi cacy

and safety of SIMPONI in patients with active rheumatoid arthritis (RA) who had previously received one or

more TNFα inhibitors. Patients with active RA were randomly assigned (1:1:1) to placebo, SIMPONI 50 mg, or

SIMPONI 100 mg. The primary end point was the proportion of patients who achieved 20% or higher improvement

in ACR criteria for assessment of RA (ACR20) at Week 14. At Week 16, patients who had <20% improvement in

tender and swollen joint counts were given rescue therapy in a double-blinded manner: patients in the placebo

group received SIMPONI 50 mg, patients in the SIMPONI 50-mg group had a dose escalation to 100 mg, and

patients in the SIMPONI 100-mg group continued to receive 100 mg.


tested



GO-REVEAL: a randomized, double-blind, placebo-controlled study (N=405) in patients with active PsA. Patients

were randomized to treatment with SC SIMPONI 50 mg, SIMPONI 100 mg, or placebo every 4 weeks to Week 20.

The primary end point was the proportion of patients meeting the ACR20 improvement criteria at Week 14.


tested





100 mg or placebo, every 4 weeks. The primary end point was the proportion of patients who achieved ASAS20

response at Week 14. At Week 16, patients who had failed to achieve ASAS20 response entered early escape

in a double-blinded manner: patients in the placebo group received SC SIMPONI 50 mg, patients in the group

receiving SC SIMPONI 50 mg had a dose escalation to 100 mg, and patients in the 100-mg group continued to

receive 100 mg. All other patients in the placebo group were switched in Week 24 to SC SIMPONI 50 mg.


tested




• The treatment of moderate to severe, active rheumatoid arthritis in adults when the response to DMARD

therapy including MTX has been inadequate.

• The treatment of severe, active, and progressive rheumatoid arthritis in adults not previously treated with MTX.









RA = rheumatoid arthritis; MTX = methotrexate; TNF = tumor necrosis factor; PsA = psoriatic arthritis;

DMARD = disease-modifying antirheumatic drug; AS = ankylosing spondylitis.

References








tested





Features citric acid–free formulationa and low injection volume (0.5 mL).1

Low level of ISRs, including pain:


2.2% on placebo.1

ConvenienceEXPERIENCEState-of-the-art

devicesMonthly dosing

Patient support

program

Dosing

information

PsA










Patient support

program

PsA









0.5 mL

0.5 mL

0.8 mL

1.0 mL

0.5 mL



Patient support

program

PsA





immediately after SC injection than did a solution with histidine as buffer, which did not cause more pain


ISR = injection site reaction; SC=subcutaneous.

References











Patient support

program

Only SC anti-TNF with monthly dosing1 –5

Injections

per month

Injections

per year



Patient support

program

PsA



Injections

per month

Only SC anti-TNF with monthly dosing1–5

Injections

per year



Patient support

program

PsA




Injections

per year



Patient support

program

Injections

per month

PsA






Patient support

program

Injections

per year

PsA



Injections

per month

References






Brands mentioned are trademarks of their respective owners



Patient support

program





Also available as 0.5-mL,


Easy to handle

Easy-grip body

Large side button

Easy-twist cap

Easy to administer

2 audible clicks


Secure

Autoretract needle

Security seal


In PsA, SIMPONI 50 mg is given once a month,

on the same date each month.1



Patient support

program

PsA



Convenient, single-use prefilled syringe


Also available as 0.5-mL, single-use,


Secure

Sturdy needle cover

Extra-fi ne needle

Easy to administer



Needle guard




Patient support

program

In PsA, SIMPONI 50 mg is given once a month,


PsA



PsA = psoriatic arthritis.

Reference




Patient support

program




Patient support program designed to complement the patient–doctor relationship:





Personalized

monthly reminder-

to-inject service

FREE

help line

Online

information

resource





Registering for

SIMPONI for Me



Patient support

program

PsA


Complete and

return enrollment

form provided with

starter kit

Call

SIMPONI for Me at

<0000 0000 0000>

Visit

simponiforme.com





Patient support

program

PsA


(infl iximab)


Clinical effi cacyffi Safety Conveniencei

Convenience and support1


clinical effi cacy1–3

Rigorous clinical

trial program1

PsA






(infl iximab)




Sustained improvements in ACR

response criteria

Effi cacy against key manifestations

associated with PsA, including skin

and nail disease

Improved QoL

Rigorous clinical

trial program1

PsA






(infl iximab)





response criteria



and nail disease

Improved QoL

Rigorous clinical

trial program1

Approval for PsA, RA, and

AS at launch

Trials in wide range of patient

types and treatment experience

PsA




Only SC anti-TNF with

monthly dosing

Carefully tailored patient

support program





response criteria



and nail disease

Improved QoL

Rigorous clinical

trial program1

Approval for PsA, RA, and

AS at launch

Trials in wide range of patient

types and treatment experience



(infl iximab)

PsA



Clinical efficacy

Clinical improvements across all ACR criteria were

maintained through Week .1

times more improvement in QoL score with

SIMPONI 50 mg vs placebo.2

24 7652 104

37 7753 85

4 86 10

Clinical

experience

Clinical

effi cacy

Convenience


(infl iximab)

Prevention of structural damage was maintained

through Week 52 and Week 104, with % of

patients experiencing no progression from baseline.1

PsA



Clinical efficacy

Clinical

experience

Clinical

effi cacy

Convenience


(infl iximab)

Clinical efficacy PsA





24 7652

37 7753 85

4 86 10


through Week 52 and Week 104, with % of




Clinical

experience

Clinical

effi cacy

Convenience


(infl iximab)






24 7652

37 53 85

4 86 10


through Week 52 and Week 104, with 77% of




Clinical

experience

Clinical

effi cacy

Convenience


(infl iximab)




10 times more improvement in QoL score with


24 7652

37 53 85

4 86


through Week 52 and Week 104, with 77% of






70,000 90,00080,000 100,000

3 85 10

Clinical

experience

Clinical

effi cacy

Convenience


(infl iximab)

Clinical experience PsA





70,000 90,000 100,000

3 85 10

Clinical

experience

Clinical

effi cacy

Convenience


(infl iximab)

PsA



Clinical experience


70,000 90,000 100,000

3 5 10

Clinical

experience

Clinical

effi cacy

Convenience


(infl iximab)

PsA




Clinical experience







✘

Convenience

Clinical

experience

Clinical

effi cacy

Convenience


(infl iximab)

PsA









✔

✔

✔

✔

✘

Clinical

experience

Clinical

effi cacy

Convenience


(infl iximab)

Convenience PsA



a A comparison of injection media found that a solution containing citrate as a buffer caused more pain

immediately after SC injection than did a solution with histidine as a buffer, which did not cause more pain than

the control saline solution.9

SC = subcutaneous; ACR = American College of Rheumatology; QoL = quality of life;

AS = ankylosing spondylitis; RA = rheumatoid arthritis; PsA = psoriatic arthritis; TNF = tumor necrosis factor.

References



3. Ritchlin CT, et al. Ann Rheum Dis. 2009;68(9):1387–1394.


5. http://clinicaltrials.gov/ct2/show/NCT00207714?term=cnto+148&rank=8.





Brands mentioned are trademarks of their respective owners


(infl iximab)



REMICADE provides an appropriate solution for patients with

high disease activity who are at risk of noncompliance and/or

have a preference for IVREMICADE helps you deliver rapida relief, sustained improvement, and close management for patients with PsA


Improvements in PsA manifestations2–6

Long-term inhibition of radiographic progression8

Recommended by GRAPPA for all PsA manifestations9

Rapida relief of articular symptoms1–3

Sustained improvement in structural damage7REMICADE:

rapida relief,

proven remission

REMICADE offers speeda and power

to help achieve sustained remission

in early and established PsA.

Patient profi les


(infl iximab)

PsA



The patient at risk

of noncompliance

or who prefers

IV treatment

The patient

with active,

uncontrolled

disease

High CRP levels

Signs of erosive disease

High infl amed

joint count

Unable to understand and/

or follow treatment regimen

Unwilling or unable

to self-inject




(infl iximab)

PsA



aRapid and speed are defi ned as response by Week 2.

IV = intravenous; GRAPPA = Group for Research and Assessment of Psoriasis and Psoriatic Arthritis;

PsA = psoriatic arthritis.

References

1. Baranauskaite A, et al. Ann Rheum Dis. 2012;71(4):541–548.

2. Antoni C, et al. Arthritis Rheum. 2005;52(4):1227–1236.

3. Antoni C, et al. J Rheumatol. 2008;35(5):869–876.

4. Reich K, et al. Lancet. 2005;366(9494);1367–1374.

5. Antoni C, et al. Ann Rheum Dis. 2005;64(8):1150–1157.

6. Kavanaugh A, et al. Ann Rheum Dis. 2007;66(4):498–505.

7. Van der Heijde D, et al. Ann Rheum Dis. 2007;56(8);2698–2707.

8. Kavanaugh A, et al. Ann Rheum Dis. 2006;65(8):1038–1043.

9. Ritchlin CT, et al. Ann Rheum Dis. 2009;68(9):1387–1394.


(infl iximab)






EFFICACY

QoL

SAFETY

EXPERIENCE

SUMMARY


EFFICACY

QoL

SAFETY

EXPERIENCE

SUMMARY


EFFICACY

QoL

SAFETY

EXPERIENCE

SUMMARY



SIMPONI helps to significantly reduce signs and symptoms of AS

SIMPONI 50 mg helped achieve a greater ASAS20 response 4 weeks after

the fi rst injection vs placebo1: 59% of patients receiving SIMPONI 50 mg achieved the primary end

point of an ASAS20 response vs 22% of placebo patients by Week 14

(P<0.001).1,2

ASAS40

response data

Clinical improvements in ASAS20 and ASAS40 were

maintained through 2 years, and 32% of patients receiving

SIMPONI 50 mg were in ASAS partial remission.3

AS

Signs and symptomsEFFICACY Spinal infl ammationFunctioning




SIMPONI 50 mg (n=107 at Week 104)

100

80

60

40

20

0

Patients

, %

Week 64 76 88 104

EEPE XO

20161440 8 12 24 28 32 36 40 44 48 52

ASAS40 response at Week 1043

Week 104Week 28Week 14Week 4

AS

Signs and symptomsEFFICACY Spinal infl ammationFunctioningSigns and symptomsEFFICACY Spinal infl ammationFunctioning





100

80

60

40

20

0

Patients

, %

Week 64 76 88 104

EEPE XO

20161440 8 12 24 28 32 36 40 44 48 52



Greaateer proportions of patients in theroppp opop

SIMMPOONI grouups achieved an ASAS40 g pON

respponnse 4 weeeks after the fi rst injection.resporere pp


AS






100

80

60

40

20

0

Patients

, %

Week 64 76 88 104

EEPE XO

20161440 8 12 24 28 32 36 40 44 48 52

Week 4


43.5%% of SIMPONI patientsof43.5% S43 5% of S% of %% ofof

15.4%% of placebo patients4%

(switchhed to SIMPONI 50 mg (s((s

at Weeek 16 or Week 24)


AS


Week 104Week 28Week 14





100

80

60

40

20

0

Patients

, %

Week 64 76 88 104

EEPE XO

20161440 8 12 24 28 32 36 40 44 48 52



54% of SIMPONI patients54% of SIMPONI patients% S M I nt% of SIMPONI patients4% of SIMM%% oo SS

48% of placebo patients484

(switched to SIMPONI 50 mg ( it h d t SIMPONI 50

at Week 16 or Week 24)


AS






100

80

60

40

20

0

Patients

, %

Week 64 76 88 104

EEPE XO

20161440 8 12 24 28 32 36 40 44 48 52



75% of SIMPONI patientsPONI patientststspp

79% of placebo patients79% f l b ti t% of pl% of pla79% o%% ofof99

(switched to SIMPONI 50 mg (



AS




AS = ankylosing spondylitis; ASAS = ASsessment in AS international working group criteria;

PE = primary endpoint; EE = early escape; XO = crossover; SC = subcutaneous.

References



3. Braun J, et al. Ann Rheum Dis. 2011; Epub ahead of print.






100 mg, or placebo every 4 weeks. The primary end point was the proportion of patients who achieved ASAS20

response at Week 14. Observed data are presented without imputation. At Week 16, patients who had failed

to achieve ASAS20 response entered early escape in a double-blinded manner: patients in the placebo group

received SC SIMPONI 50 mg, patients in the group receiving SC SIMPONI 50 mg had a dose escalation to

100 mg, and patients in the 100-mg group continued to receive 100 mg. All other patients in the placebo group

were changed over in Week 24 to SC SIMPONI 50 mg.




SIMPONI helps to achieve sustained improvements in functioning,

pain, and stiffness over time

SIMPONI 50 mg helped improve disease activity (BASDAI50) and physical function

(BASFI) scores at Week 24 vs placebo (P<0.001)1:

Half of patients achieved BASDAI50 at Week 24 (51% vs 15% placebo; P<0.001).1

AS

Clinical improvements in disease activity and physical

function were maintained through 2 years with

SIMPONI 50 mg (both <3 at Week 104).2


BASDAI50

response data

BASFI

response data



10

8

6

4

2

0

Mean B

AS

DA

I sco

re

Week



PE XOEE

0 4 8 1412 16 20 2428 32 3640 4448 52 64 76 88 104


BASDAI50 response at Week 1042AS

BASDAI50

response data

BASFI

response data




10

8

6

4

2

0

Mean B

AS

DA

I sco

re

Week



PE XOEE

0 4 8 1412 16 20 2428 32 3640 4448 52 64 76 88 104

Week 28Week 14Week 4

BASDAI50 response at Week 1042

A ggreaater prooportion of patients in A greater proportion of patients inA greaAA grgreaea

thee SIIMPONI group achieved a ≥50% MPOMPMPOO

impproovemennt in BASDAI score 4 weeksimprovement in BASDAI score 4 weeksimp ovemeimprovemeent inntnt inin

afteer tthe fi rsst injection.st in e tiont injectionction.titionon


AS

BASDAI50

response data

BASFI

response data


Week 104



10

8

6

4

2

0

Mean B

AS

DA

I sco

re

Week



PE XOEE

0 4 8 1412 16 20 2428 32 3640 4448 52 64 76 88 104

Week 28Week 14Week 4 Week 104


45.9%% of SIMPONI patients4

15.4%% of placebo patients15 4% of placebo patients4% %%

(switcched to SIMPONI 50 mg ched to S MPON mched to SIMPONI 50 mg o SIMPONI toto SS MMPPONON

at Week 16 or Week 24)at Week 16 or Week 24)


AS

BASDAI50

response data

BASFI

response data




10

8

6

4

2

0

Mean B

AS

DA

I sco

re

Week



PE XOEE

0 4 8 1412 16 20 2428 32 3640 4448 52 64 76 88 104

Week 14Week 4 Week 104


53% of SIMPONI patients

50% of placebo patients5050

(switched to SIMPONI 50 mg ched to P 0hed to SIMPONI 50 mgtched to SIMPONI 50 mgwiwi hheded toto PP 00



AS

BASDAI50

response data

BASFI

response data




10

8

6

4

2

0

Mean B

AS

DA

I sco

re

Week



PE XOEE

0 4 8 1412 16 20 2428 32 3640 4448 52 64 76 88 104

Week 28Week 14Week 4 Week 104


72% of SIMPONI patients

74% of placebo patients74% of placebo patients77

(switched to SIMPONI 50 mg ( tched o O mwitched to SIMPONI 50 mgitched to SIMPONI 50 mg tctchehed d to o OO mm

at Week 16 or Week 24)W k 16 W k 24)


AS

BASDAI50

response data

BASFI

response data






10

8

6

4

2

0

Mean B

AS

FI sco

re

Week

EEPE XO

0 4 8 12 14 16 202428323640444852 64 76 88 104

AS


BASFI response at Week 1042AS

BASDAI50

response data

BASFI

response data






10

8

6

4

2

0

Mean B

AS

FI sco

re

Week

EEPE XO

0 4 8 12 14 16 202428323640444852 64 76 88 104

Week 14Week 4

BASFI response at Week 1042

Moore patieents in the SIMPONI group More pMMororee

achhieeved iimprovements in BASFI achieved improvements in BASFIimpd iimmpmp

scoorees 4 wweeks after the fi rst injection.4 weeks after the fi rst injection4 weeks a ter he fi eafter the fi rst aa teter r hehe fifi


AS

BASDAI50

response data

BASFI

response data


Week 104Week 28





10

8

6

4

2

0

Mean B

AS

FI sco

re

Week

EEPE XO

0 4 8 12 14 16 202428323640444852 64 76 88 104

Week 14Week 4 Week 104Week 28


3.6—SIMPONI patients3

5.0—placebo patients5 0—placepp acaceb

(swwitched to SIMPONI 50 mg o SIMPONI 50 mgt S MPON mgMPONI 50 mgSS MIMPPONON mgmg

at WWeek 16 or Week 24)


AS

BASDAI50

response data

BASFI

response data






10

8

6

4

2

0

Mean B

AS

FI sco

re

Week

EEPE XO

0 4 8 12 14 16 202428323640444852 64 76 88 104



Patients who switched from placebo

to SIMPONI experienced substantial to toto

improvement in BASFI within ment in BASFI withinp me B went in BASFI withinme BB ww

4–12 weeks.


AS

BASDAI50

response data

BASFI

response data






10

8

6

4

2

0

Mean B

AS

FI sco

re

Week

EEPE XO

0 4 8 12 14 16 202428323640444852 64 76 88 104



SIMPONI maintained BASFI responsemaintained BASFI responsepONI m S paintained BASFI responseNINI nene SS pp

from Week 52 to Week 104.


AS

BASDAI50

response data

BASFI

response data




BASDAI = Bath AS Disease Activity Index; BASFI = Bath AS Functional Index; PE = primary endpoint;

EE = early escape; XO = crossover; AS = ankylosing spondylitis.

References









response at Week 14. Observed data are presented without imputation. At Week 16, patients who had failed

to achieve ASAS20 response entered early escape in a double-blinded manner: patients in the placebo group

received SC SIMPONI 50 mg, patients in the group receiving SC SIMPONI 50 mg had a dose escalation to

100 mg, and patients in the 100-mg group continued to receive 100 mg. All other patients in the placebo group

were changed over in Week 24 to SC SIMPONI 50 mg.




SIMPONI helps achieve improvement in spinal inflammation1

SIMPONI 50 mg helped achieve a signifi cant improvement in MRI-detected

spinal infl ammation1:

5.9 reduction in mean ASspiMRI-a score with SIMPONI vs 2.5 with

placebo at Week 14 (P<0.05).

59% of patients receiving SIMPONI 50 mg with infl ammation at baseline

demonstrated minimal infl ammation at Week 104.1

Improvements in MRI-detected spinal infl ammation were

sustained through Week 104 with a mean reduction in

ASspiMRI-a score of 7.1.1

AS

MRI data






Changes in MRI-detected spinal infl ammation1,aAS


MRI scan at baseline

Active lesions at multiple

vertebral units (C7/T1 and T6/T7)

MRI scan at Week 14 MRI scan at Week 104




AS




MRI scan at Week 14

Spinal activity

markedly decreased

MRI scan at Week 104

Changes in MRI-detected spinal infl ammation1,a




AS




MRI scan at Week 14

Spinal activity

markedly decreased

MRI scan at Week 104

Spinal activity

almost fully resolved

Changes in MRI-detected spinal infl ammation1,a



aPlease note that treatment with SIMPONI 100 mg should only be considered in patients weighing over 100 kg

who have not achieved adequate clinical response with SIMPONI 50 mg. The increased risk of certain serious

adverse drug reactions with the 100-mg dose compared with the 50-mg dose should be taken into account.

MRI = magnetic resonance imaging; ASspiMRI-a = AS spine MRI-activity (assesses the presence of bone marrow

edema but not the degree of edema); AS = ankylosing spondylitis; SC = subcutaneous; ASAS = assessment in

AS international working group criteria.

Reference

1. Braun J, et al. Ann Rheum Dis. 2011 (Nov 29); Epub ahead of print.










receive 100 mg. All other patients in the placebo group were changed over in Week 24 to SC SIMPONI 50 mg.




SIMPONI helps improve patient quality of life

27% improvement from baseline in SF-36 PCS with

SIMPONI vs 7% with placebo at Week 24 (P<0.001).1

Patients who switched from placebo to SIMPONI 50 mg

at Week 24 demonstrated a quality-of-life bounce back,

achieving a 7-fold improvement in SF-36 PCS score

by Week 52.1,2

Improvements in health-related quality of life, as assessed

by SF-36 PCS scores, were sustained through 104 weeks.1,2

AS

Improved

patient QoLQoL Summary

Night back

pain & sleep

SF-36 PCS data



Sustained improvement in SF-36 PCS1,2

P<0.001

0 24 52 76 104

XO18

16

14

12

10

8

6

4

2

0

Mean c

hang

e f

rom

baselin

e

Week




AS

Improved


Night back

pain & sleep



P<0.001

0 24 52 76 104

XO18

16

14

12

10

8

6

4

2

0

Mean c

hang

e f

rom

baselin

e

Week





001 7.9 —SIMPONI patients9 SIMPONI iSIMPMP

2.0—placebo patients (switched to p p (2 —p

SIMPONI 50 mg at Week 16 or Week 24). g )SIM

Numbers are for mean change fromNumbers are for mean change fromN

baseline in SF-36 PCSbaseline in SF 36 PCS

0

Sustained improvement at Week 241

AS

Improved


Night back

pain & sleep



P<0.001

0 24 52 76 104

XO18

16

14

12

10

8

6

4

2

0

Mean c

hang

e f

rom

baselin

e

Week





12.8 —SIMPONI patientsS O

d to hed14.1—placebo patients (switchp p (

Week 24). r WSIMPONI 50 mg at Week 16 org

om e froNumbers are for mean changeNumbers are for mean change

baseline in SF-36 PCS.baseline in SF 36 PCS


AS

Improved


Night back

pain & sleep



P<0.001

0 24 52 76 104

XO18

16

14

12

10

8

6

4

2

0

Mean c

hang

e f

rom

baselin

e

Week





P<P 0 001

1133.44—SSIIMMPPOOONI patients

15.2—placebbo patients (switched to 15.2 placebo patients (switched toientss (sPP<<PP 00....000011

SIMPONI 50 mg at Week 16 or Week 24). SIMPONI 50 mg at Week 16 or Week 24)0 mg We0 m

Numbers aree for mean change from Numbers are for mean change fromrs a me

baseline in SF-36 PCSbaseline in SF 36 PCSseli -3


AS

Improved


Night back

pain & sleep



P<0.001

0 24 52 76 104

XO18

16

14

12

10

8

6

4

2

0

Mean c

hang

e f

rom

baselin

e

Week





001

14.2—SIMPONI patientsPONI patientsMPO

15.5—placebo patients (switched to 15 5 placebo patients (switched to5.5—pl

SIMPONI 50 mg at Week 16 or Week 24).SIMPONI 50 mg at Week 16 or Week 24)MPO

Numbers are for mean change from Numbers are for mean change fromNu

baseline in SF-36 PCS.baseline in SF 36 PCS

0


AS

Improved


Night back

pain & sleep



SF-36 = Short Form-36 Health Survey; PCS = physical component score, assessed on a 0 to 50 scale (higher

score represents improvement); AS = ankylosing spondylitis; XO = crossover.

References



Improved


Night back

pain & sleep



SIMPONI helps reduce night back pain and improve sleep1,2

Signifi cant reduction in night back pain with SIMPONI vs placebo at

Weeks 14 and 24 (P<0.001).1,2

Signifi cantly greater reduction in sleep disturbance with SIMPONI vs

placebo at Weeks 14 and 24 (P<0.001), as measured by the JSEQ.1

Changes in JSEQ scores signifi cantly correlated with

changes in SF-36 summary scores, BASFI scores, night

back pain, total back pain, BASDAI scores, and infl ammation

(morning stiffness).2

AS

VAS scores

Improved


Night back

pain & sleep



Week 24Week 14Baseline

Improvement in night back pain at Week 24

8

7

6

5

4

3

2

1

0

VA

S (0

–10 c

m)

Baseline

7.1Baseline

7.4


(n=138)

Placebo

(n=78)

AS

Improved


Night back

pain & sleep



Week 14

4.1P<0.001

Week 14

7.1

8

7

6

5

4

3

2

1

0

VA

S (0

–10 c

m)


(n=138)

Placebo

(n=78)

Improvement in night back pain at Week 24 AS

Improved


Night back

pain & sleep




Week 24

4.0P<0.001

Week 24

7.0

8

7

6

5

4

3

2

1

0

VA

S (0

–10 c

m)


(n=138)

Placebo

(n=78)

Improvement in night back pain at Week 24 AS

Improved


Night back

pain & sleep




VAS = visual analogue scale; AS = ankylosing spondylitis; SC = subcutaneous; ASAS = ASsessment in AS

international working group criteria; JSEQ = Jenkins Sleep Evaluation Questionnaire; SF-36 = Short Form-36

Health Survey (physical component score assessed on a 0 to 50 scale [higher score represents improvement]);

BASFI = Bath AS Functional Index; BASDAI = Bath AS Disease Activity Index.

References


2. Deodhar A, et al. Arthritis Care Res. 2010;62(9):1266–1271.

Improved


Night back

pain & sleep












Improved


Night back

pain & sleep

4 weeks 2 years1.5 years44 weeks14 weeks

Reduced signs

and symptoms1

Sustained

improvements2

Reduced

disease activity1

AS

Improved


Night back

pain & sleep




4 weeks 2 years1.5 years44 weeks14 weeks

Sustained

improvements2

Reduced

disease activity1

AS

Reduced signs

and symptoms1

Almost half of patients

achieved an ASAS20

response just 4 weeks

after the fi rst injection.


Improved


Night back

pain & sleep



4 weeks 2 years

Reduced signs

and symptoms1


achieved an ASAS20



1.5 years44 weeks14 weeks

Reduced

disease activity1

43% of patients achieved

BASDAI50 by Week 14.

Sustained

improvements2

Efficacy with monthly SC SIMPONI AS

Improved


Night back

pain & sleep



4 weeks 2 years

Sustained

improvements2

Improvements in signs

and symptoms, physical

function, and quality of

life were maintained

through 2 years.

1.5 years1 5 years44 weeks44 weeks14 weeks

SIMPONI can help

to improve quality of

life and functionality

4 times greater improvement

in SF-36 physical component

scores at Week 24 with

SIMPONI 50 mg compared

with placebo.1

Efficacy with monthly SC SIMPONI AS

Reduced signs

and symptoms1


achieved an ASAS20



Reduced

disease activity1

43% of patients achieved

BASDAI50 by Week 14.

Improved


Night back

pain & sleep



ASAS = ASsessment in AS international working group criteria; SC = subcutaneous; BASDAI = Bath AS Disease

Activity Index; SF-36 = Short Form-36 Health Survey (physical component score assessed on a 0 to 50 scale

[higher score represents improvement]).

References



Improved


Night back

pain & sleep







AS


tested

Adverse

event data



used in over 80,000 patients2,3




double-blind, placebo-controlled studies in AS, RA, and PsA1:



Deathsa 0.30 0.28




0.13 0.00


2,3050.43

3561.40


2,3130.04

3580.00


2,3080.78

3570.56

AS

Includes SIMPONI SC

Phase 2b studies in

addition to Phase 3

AS, RA, and PsA.


tested




MTX = methotrexate; AS = ankylosing spondylitis; RA = rheumatoid arthritis; PsA = psoriatic arthritis.

References




Accessed 01/31/12.


tested













GO-BEFORE Active RA MTX naïve 637

GO-FORWARD Active RA MTX nonresponders 444

GO-AFTER Active RA Anti-TNF experienced 461

GO-REVEAL Active PsADMARD

nonresponders405

GO-RAISE Active ASConventional therapy

nonresponders356

AS


tested



GO-BEFORE: A multicenter, randomized, double-blind, placebo-controlled study (N=637) in patients with active



tested



GO-FORWARD: A multicenter, randomized, double-blind, placebo-controlled study (N=444) to examine the




subcutaneously every 4 weeks. Primary end points were the proportion of patients with ≥20% improvement in the

ACR criteria at Week 14 and the change from baseline in the HAQ-DI score at Week 24. Responder analysis.


tested



GO-AFTER: a multicenter, randomized, double-blind, placebo-controlled, Phase III trial (N=461) to evaluate the

effi cacy and safety of SIMPONI in patients with active rheumatoid arthritis (RA) who had previously received one

or more TNFα inhibitors. Patients with active RA were randomly assigned (1:1:1) to placebo or SIMPONI 50 mg or

100 mg. The primary end point was the proportion of patients who achieved 20% or higher improvement in ACR

criteria for assessment of RA (ACR20) at Week 14. At Week 16, patients who had less than 20% improvement in

tender and swollen joint counts were given rescue therapy in a double-blinded manner: patients in the placebo

group received SIMPONI 50 mg, patients in the SIMPONI 50-mg group had a dose escalation to 100 mg, and

patients in the SIMPONI 100-mg group continued to receive 100 mg.


tested



GO-REVEAL: A multicenter, randomized, double-blind, placebo-controlled study (N=405) in patients with active

PsA. Patients were randomized to treatment with SC SIMPONI 50 mg, SIMPONI 100 mg, or placebo every 4

weeks to Week 20. The primary end point was the proportion of patients meeting the ACR20 improvement criteria

at Week 14.


tested



GO-RAISE: A multicenter, randomized, double-blind, placebo-controlled study (N=356) to evaluate the effi cacy








tested




• the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to DMARD therapy

including MTX has been inadequate.

• the treatment of severe, active, and progressive rheumatoid arthritis in adults not previously treated with MTX.









RA = rheumatoid arthritis; MTX = methotrexate; TNF = tumor necrosis factor; PsA = psoriatic arthritis; DMARD =

disease-modifying antirheumatic drug; AS = ankylosing spondylitis.

References








tested





Features citric acid–free formulationa and low injection volume.1

Low level of ISRs including pain:


2.2% on placebo.1



Patient support

program

AS

Dosing

information








AS



Patient support

program









0.5 mL

0.5 mL

0.8 mL

1.0 mL

0.5 mL

AS



Patient support

program





immediately after SC injection than did a solution with histidine as buffer, which did not cause more pain


ISR = injection site reaction; SC = subcutaneous.

References









Patient support

program



Only SC anti-TNF with monthly dosing1–5AS

Injections

per month

Injections

per year



Patient support

program



ASOnly SC anti-TNF with monthly dosing1–5

Injections

per month

Injections

per year



Patient support

program



ASOnly SC anti-TNF with monthly dosing1–5

Injections

per year



Patient support

program

Injections

per month



References









Patient support

program





Also available as 0.5-ml,


Easy to handle

Easy-grip body

Large side button

Easy-twist cap

Easy to administer

2 audible clicks


Secure

Autoretract needle

Security seal


In AS, SIMPONI 50 mg is given once a month,


AS



Patient support

program



Convenient single-use prefilled syringe


Also available as 0.5-ml, single-use,


Secure

Sturdy needle cover

Extra-fi ne needle

Easy to administer



Needle guard


AS

In AS, SIMPONI 50 mg is given once a month,




Patient support

program



AS = ankylosing spondylitis.

Reference




Patient support

program




Patient support program designed to complement the patient–doctor relationship:





Personalized

monthly reminder-

to-inject service

FREE

help line

Online

information

resource



AS

Registering for

SIMPONI for Me



Patient support

program




Complete

and return

enrollment form

provided with

starter kit

Call

SIMPONI for Me at

<0000 0000 0000>

Visit

simponiforme.com

AS



Patient support

program




(infl iximab)




Rigorous clinical

trial program3,5,6

Helps get patients back to everyday life in a monthly SC dose AS






Sustained improvement in ASAS

response, BASDAI50, and BASFI


MRI-detected spinal infl ammation


SF-36 quality-of-life scores

ASHelps get patients back to everyday life in a monthly SC dose



(infl iximab)


Rigorous clinical

trial program3,5,6



Rigorous clinical

trial program3,5,6

Approval for AS, RA, and PsA

at launch


trial experience


globally




(infl iximab)













Only SC anti-TNF with monthly

dosing

Choice of prefi lled autoinjector pen

or syringe

Innovative patient support program


Rigorous clinical

trial program3,5,6

Approval for AS, RA, and PsA

at launch


trial experience


globally



(infl iximab)











Clinical efficacy

Sustained improvement in ASAS response,

BASDAI50, and BASFI for weeks.1

of patients receiving SIMPONI 50 mg with

infl ammation at baseline demonstrated minimal

infl ammation at Week 104.4

24 7652 104

25% 59%38% 70%

2-fold 6-fold5-fold 7-fold

AS

Clinical

experience

Clinical

effi cacy

Convenience


(infl iximab)



achieving a improvement in SF-36 PCS score by

Week 52.1,2



Clinical efficacy


BASDAI50, and BASFI for 104 weeks.1

24 7652

25% 59%38% 70%


AS

Clinical

experience

Clinical

effi cacy

Convenience


(infl iximab)

of patients receiving SIMPONI 50 mg with






Week 52.1,2



Clinical efficacy



24 7652

25% 38% 70%


AS

Clinical

experience

Clinical

effi cacy

Convenience


(infl iximab)

59% of patients receiving SIMPONI 50 mg with






Week 52.1,2



Clinical efficacy



24 7652

25% 38% 70%

2-fold 6-fold5-fold

AS

Clinical

experience

Clinical

effi cacy

Convenience


(infl iximab)

59% of patients receiving SIMPONI 50 mg with





achieving a 7-fold improvement in SF-36 PCS score by

Week 52.1,2



Clinical experience



70,000 90,00080,000 100,000

3 85 10

Clinical

experience

Clinical

effi cacy

Convenience


(infl iximab)

AS



Clinical experience



70,000 90,000 100,000

3 85 10

Clinical

experience

Clinical

effi cacy

Convenience


(infl iximab)

AS



Clinical experience



70,000 90,000 100,000

3 5 10

Clinical

experience

Clinical

effi cacy

Convenience


(infl iximab)

AS









✘

Convenience AS

Clinical

experience

Clinical

effi cacy

Convenience


(infl iximab)









Convenience

✔

✔

✔

✔

✘

Clinical

experience

Clinical

effi cacy

Convenience


(infl iximab)

AS



aA comparison of injection media found that a solution containing citrate as a buffer caused more pain immediately

after SC injection than did a solution with histidine as buffer, which did not cause more pain than the control

saline solution.10

SC = subcutaneous; ASAS = ASsessment in AS international working group criteria; BASDAI = Bath AS Disease

Activity Index; BASFI = Bath AS Functional Index; MRI = magnetic resonance imaging; SF-36 = Short Form-36

Health Survey; AS = ankylosing spondylitis; RA = rheumatoid arthritis; PsA = psoriatic arthritis; TNF = tumor

necrosis factor.

References




4. Braun J, et al. Ann Rheum Dis. 2011 (Nov 29); Epub ahead of print.









(infl iximab)



REMICADE provides an appropriate solution

for patients with axial disease and the EAMs of AS

REMICADE helps you deliver rapida relief, sustained improvement, and close management for patients with AS.


Sustained improvement in axial symptoms2,3

Reduced IBD fl ares5

Reduced AU fl ares6

Rapida improvement in axial symptoms1

Helped resolve spinal infl ammation4

REMICADE

the only IV anti-TNF

to provide speeda

and power

REMICADE offers speeda and power to help achieve

early and sustained improvements in AS patients with

current, or a history of, EAMs.

Patient profi les


(infl iximab)

AS



The patient at risk

of noncompliance

or who prefers

IV treatment

The patient with

concomitant, or a

history of, EAMs

Uveitis

IBD

Psoriasis

Unable to understand and/or

follow treatment regimen

Unwilling or unable

to self-inject




(infl iximab)

AS



aRapid and speed are defi ned as response by Week 2.

AS = ankylosing spondylitis; EAM = extra-articular manifestation; IV = intravenous; TNF = tumor necrosis factor;

IBD = infl ammatory bowel disease; AU = anterior uveitis; HCP = health care professional.

References

1. Braun J, et al. Lancet. 2002;359(9313):1187−1193.

2. Braun J, et al. Ann Rheum Dis. 2008;67(3):340−345.

3. Baraliakos X, et al. Rheumatology. 2011;50(9):1690−1699.

4. Braun J, et al. Arthritis Rheum. 2006;54(5):1646−1652.




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ra psa as - kropcache.krop.com/seminara-571738371d466e5.pdf · summary psa psoriatic arthritis...

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