the latest medical treatment advances in ibd › education › static › mcgre… · the latest...
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The Latest MedicalTreatment Advances in IBD
Nancy McGreal, MDAssociate Professor of Medicine and Pediatrics
Divisions of Adult and Pediatric GastroenterologyDuke University Medical Center
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Disclosures
• None
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IBD Medical Treatment Options in 2019
Anti-inflammatory
5-ASA
Steroids
Antibiotics
Immunomodulators
6-MP, AZA, MTX
CSA, FK506, GMCSF
Thalidomide
Anti-TNF α
Infliximab
Adalimumab
Certolizumab
Golimumab
Anti-integrin
Natalizumab
Vedolizumab
Anti-cytokine
Ustekinumab
JAK inhibitor
Tofacitinib
Duijvestein M et al. Curr Treat Options Gastro 2018; 16:129-146
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Choosing an IBD Therapy….
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Latest Additions to the IBD Armamentarium
• Biologics
- Vedolizumab (UC/CD) 2014
- Ustekinumab (CD) 2016
• Small molecules
- Tofacitinib (UC) 2018
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Case
• 31 yo ♀ with a history of multiple sclerosis is diagnosed with ileocolonic Crohn’s disease on colonoscopy and confirmed by MRE. No strictures noted but a small entero-enteric fistula is present on MRE. She is started on prednisone but needs steroid sparing therapy. Which would you start?
- Thiopurine monotherapy
- Infliximab +/- immunomodulator
- Adalimumab +/- immunomodulator
- Ustekinumab +/- immunomodulator
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Case
• 31 yo ♀ with a history of multiple sclerosis is diagnosed with ileocolonic Crohn’s disease on colonoscopy and confirmed by MRE. No strictures noted but a small entero-enteric fistula is present on MRE. She is started on prednisone but needs steroid sparing therapy. Which would you start?
- Thiopurine monotherapy
- Infliximab +/- immunomodulator
- Adalimumab +/- immunomodulator
- Ustekinumab +/- immunomodulator
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Ustekinumab
Deepak P et al. Drug, Design, Develop and Ther 2016; 10:3685-3698
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6 Real World Cohorts – 578 Ustekinumab Treated Crohn’s Patients97.7% Anti-TNF Experienced
Engel T et al. Dig Liv Dis 2019; 51: 1232-1240Feagan B et al. NEJM 2016; 375(20): 1946-1960
CERTIFI Week 6 - 39%
CERTIFI Week 22 – 69.4%
IM-UNITI Week 44 – 53.1%
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• Week 24 – 39%
• Week 52 – 51% (IM-UNITI: 46.9%)
Pooled Remission
Steroid-free Response
• Week 52 – 66%
• Week 52 – 31% (IM-UNITI: 33%)
Endoscopic Response
Mucosal Healing
• Positive – colonic disease, concurrent IS
• Negative – stricturing disease, prior resectionPredictors of Clinical
Response
• 88 patients
• Response/Remission – 31% to 61% (CERTIFI - 47%)Perianal Disease
• Common 21% – Musculoskeletal, HA, URI
• Serious 3.2% - ALS, pancreatitis, CRC Safety
Engel T et al. Dig Liv Dis 2019; 51: 1232-1240
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Barre A et al. AP&T 2018; 47: 896-905
Clinical trials suggest better response in anti-TNF naïve pts
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Ustekinumab is Associated with Low Immunogenicity
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Adverse Effects are Uncommon with Ustekinumab
Ustekinumab Prescribing InformationShim H et al. JGHF 2018; 2: 223-234
• Larger volume of safety data in psoriasis than CD; lower dose in psoriasis
• No ↑ risk of malignancy (including skin ca), cardiovascular events
• Lower risk of active TB than anti-TNF (0.02/100 pt yrs vs. 0.28/100 pt yrs)
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Safety in Special Populations
Elderly
No increased risk of AE in pts over 65 yrs in psoriasis study at
1 yr
Pregnancy
Compatible with pregnancy and lactation
Perioperative
No ↑ risk of surgical site infection
Shim H et al. JGHF 2018; 2: 223-234Mahadevan U et al. Gastroenterology 2019; 156: 1508-1524
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DDW 2019
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• Clinical response as early as week 3
• Anti-TNF >> Anti-cytokine >> Anti-integrinInduction of Remission
• Efficacy/durability = anti-TNF, anti-integrin
• Better efficacy in anti-TNF naïve – start first?Maintenance of
Remission
• Anti-TNF contraindications: MS, CHF, lymphoma
• Concomitant psoriasis
• Low immunogenicity – monotherapy
Patient Factors/
Safety
• Injectable, fewest injections of biologics
• Savings programCost/Convenience
Engel T et al. Dig Liv Dis 2019; 51: 1232-1240
Considerations in Positioning Ustekinumab for CD
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Case
• 25 yo ♂ with a history of left-sided UC on maintenance 5-ASA develops a flare. Colonoscopy shows extension of disease with moderate to severe pancolitis. He responds to prednisone but demonstrates steroid dependence. What is your next management choice?
- Thiopurine monotherapy- Methotrexate monotherapy- Adalimumab +/- immunomodulator- Vedolizumab +/- immunomodulator
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Case
• 25 yo ♂ with a history of left-sided UC on maintenance 5-ASA develops a flare. Colonoscopy shows extension of disease with moderate to severe pancolitis. He responds to prednisone but demonstrates steroid dependence. What is your next management choice?
- Thiopurine monotherapy- Methotrexate monotherapy- Adalimumab +/- immunomodulator- Vedolizumab +/- immunomodulator
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Vedolizumab
Vedolizumab – anti-α4β7 integrin antibody: gutNatalizumab – anti-α4β1 integrin antibody: brain, bone marrow, skin, gut
Honap S et al. Curr Opin Gastroenterol 2019; 35(4): 296-301
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Amiot A et al. AP&T 2019; 50: 40-53Shim H et al. JGHF 2018; 2: 223-234
GEMINI 2Clinical remission Wk 52Anti-TNF failure 27.7%
98% Anti-TNF Experienced
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Amiot A et al. AP&T 2019; 50: 40-53Shim H et al. JGHF 2018; 2: 223-234
GEMINI 1Clinical remission Wk 52
41.8%
98% Anti-TNF Experienced
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Amiot A et al. AP&T 2019; 50: 40-53
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Feagan B et al. JCC 2018; 621-626
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Barre A et al. AP&T 2018; 47: 896-905
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Treatment Response by Prior Anti-TNF Exposure
Vedolizumab Adalimumab P Value
Clinical Remission
Anti-TNF naïve 34.2% 24.3% 0.007
Anti-TNF exposed 20.3% 16% Not significant
Mucosal Healing
Anti-TNF naïve 43.1% 29.5% 0.0005
Anti-TNF exposed 26.6% 21% Not significant
Vedolizumab Shows Superior Efficacy Versus AdalimumabResults of VARSITY – The First Head-to- Head Study of Biologic Therapy
in Moderate to Severe UC
• Randomized: 385 VDZ vs. 386 ADA
• Prior IFX use limited to 25% of patients
• Groups equivalent: prior anti-TNF use, concomitant steroids/IS, Mayo score
• Safety equivalent except ↑ respiratory infections with ADA
Sands B et al, DDW 2019
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VISIBLE 1: Efficacy and Safety of Vedolizumab Subcutaneous Formulation in a Randomized Trial of
Patients with Ulcerative Colitis
Sandborn W et al. Gastroenterology, August 2019
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Adverse Effects are Uncommon with Vedolizumab
*(One case in HIV patient)
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Safety in Special Populations
Elderly
Similar safety profile across all ages
Pregnancy
Compatible with pregnancy and lactation
Perioperative
Conflicting data re: post-operative infection
Shim H et al. JGHF 2018; 2: 223-234Mahadevan U et al. Gastroenterology 2019; 156: 1508-1524
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• Slower in CD than UC; may need steroid bridge
• Anti-TNF >> Anti-cytokine >> Anti-integrinInduction of Remission
• Efficacy/durability = anti-TNF, anti-cytokine
• Better efficacy in anti-TNF naïve – start first?
Maintenance of Remission
• Anti-TNF contraindications: MS, CHF, lymphoma
• Favorable profile: elderly, prior malignancy, transplant
Patient Factors/
Safety
• Severe hospitalized UC→ favor infliximab
• Severe outpt IBD (on verge of hospitalization)
• EIMs not coinciding with gut activity (spondyloarthritis, PG, AS)
Special Scenarios
Not to Use
• Currently infusion is only option but injectable formulation may be available in the future
• Savings programCost/Convenience
Engel T et al. Dig Liv Dis 2019; 51: 1232-1240
Considerations in Positioning Vedolizumab for IBD
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Case
• Your patient responds well to vedolizumab Q8 weeks for 12 months but develops hematochezia and diarrhea. VDZ level is > 20 without antibodies. Colonoscopy demonstrates moderate to severe pancolitis. What would you offer next?
- Increase frequency of vedolizumab to Q4 weeks
- Continue vedolizumab Q8 weeks + immunomodulator
- Start tofacitinib
- Refer to surgery for colectomy
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Case
• Your patient responds well to vedolizumab Q8 weeks for 12 months but develops hematochezia and diarrhea. VDZ level is > 20 without antibodies. Colonoscopy demonstrates moderate to severe pancolitis. What would you offer next?
- Increase frequency of vedolizumab to Q4 weeks
- Continue vedolizumab Q8 weeks + immunomodulator
- Start tofacitinib
- Refer to surgery for colectomy
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Tofacitinib
Sabino J et al. Ther Adv Gastroenterol 2019; 12:1-14
Blocks lymphocyte proliferation, T-cell differentiation, innate defense
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• 58 pts (53 UC, 4 CD, 1 pouchitis)
• Disease extent, previous medical therapy and steroid exposure were not predictive of response
• 20% systemic infections – most with concomitant steroids
Weisshof E et al. Dig Dis Sci 2019; 64:1945-1951
33%33%
27%
51% of patientsremained on drug at 1 year
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Improvement in stool frequency Improvement in rectal bleeding
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Tofacitinib Safety: Bone Marrow Suppression,Liver Toxicity, Hyperlipidemia
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• 1613 patient-years of exposure (median 1.4 years, 84% were on 10mg BID dose)
• Most common adverse effects: nasopharyngitis, headache
Sandborn WJ, Clin Gastroenterol Hepatol 2019
Placebo (incidence rate) Tofacitinib (incidence rate)
Serious infections 1.9 2.0
Herpes Zoster 1.0 4.1
Opportunistic infections (excluding zoster)
0.0 0.2
Malignancy 1.0 0.7
NMSC 1.0 0.7
MACE (cardiovascular events) 0.0 0.2
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• Mortality“Rheumatoid arthritis patients 50 years of age and older with at least one cardiovascular (CV) risk factor treated with XELJANZ 10 mg twice a day had a higher rate of all-cause mortality, including sudden CV death, compared to those treated with XELJANZ 5 mg given twice daily or TNF blockers in a large, ongoing, postmarketing safety study.”
• Thrombosis“Thrombosis, including pulmonary embolism, deep venous thrombosis, and arterial thrombosis, has been observed at an increased incidence in rheumatoid arthritis patients who were 50 years of age and older with at least one CV risk factor treated with XELJANZ 10 mg twice daily compared to XELJANZ 5 mg twice daily or TNF blockers in a large, ongoing postmarketing safety study. “
• IndicationThe ulcerative colitis (UC) indication has been modified to state that it is for the treatment of adult patients with moderately to severely active ulcerative colitis, who have an inadequate response or who are intolerant to TNF blockers. There are also modifications to the dosing section for UC, including that the maintenance dose is XELJANZ 5 mg twice daily, and limit use of 10 mg twice daily beyond induction to those with loss of response.
FDA approves Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib- July 26, 2019
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• Rapid induction of remissionInduction of Remission
• Efficacy/durability = biologics
• Anti-TNF agnostic
• No immunogenicity – can start and stop if needed
Maintenance of Remission
• Anti-TNF contraindications: MS, CHF, lymphoma
• Safe perioperatively – short ½ life
• Avoid in pregnancy for now
Patient Factors/
Safety
• Oral administration
• Savings program Cost/Convenience
Engel T et al. Dig Liv Dis 2019; 51: 1232-1240
Considerations in Positioning Tofacitinib for UC
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Considerations for Positioning Therapies in IBD
Drug Factors
Rapid induction of remission
Durable maintenance of remission
Steroid sparing
Immunogenicity (need for combo tx)
Favorable safety profile
Patient Preference Factors
Mode of administration
Cost-effectiveness
Convenience
Patient Clinical Factors
Phenotype: strictures, fistulas
Extra-intestinal manifestations
Age/ co-morbidities
Tolerance of IS
Steroid refractory
Provider Factors
Market time/Comfort
Ease of use
Personal experience
Afif W. CAG Symposium 2018
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Putting It All Together: Crohn’s DiseaseAnti-TNF Ustekinumab Vedolizumab
Induction of Remission ++ ++ +Maintenance of Remission + + +Fistulizing Disease ++ ++ +Immunogenicity + ++ +ExtraintestinalManifestations
++ ++ +
Safety + ++ +++Convenience ++ ++ +Cost + + +
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Putting It All Together: Ulcerative Colitis
Anti-TNF Vedolizumab Tofacitinib
Induction of Remission ++ + ++Maintenance of Remission + + +Immunogenicity + + +++ExtraintestinalManifestations
++ + +
Safety + +++ +Convenience + + ++Cost + + +
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Thank You for Your Time and Attention
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Predictors of Favorable Response
Fewer previous anti-TNF α agents
Cessation of anti-TNF α agent for intolerance vs. efficacy
Lower endoscopic severity at initiation
Adverse Events 12%
Dermatologic
Infections: Respiratory and GI
Iborra M et al. AP&T 2019; 50:278-288
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Tofacitinib is Effective for Clinical Remission
Sandborn WJ, NEJM 2017
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Tofacitinib is effective for mucosal healing
Sandborn WJ, NEJM 2017
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D’Amico F et al. Ther Adv Gastroenterol 2019; 12: 1-10