Safety of Exemptia - CMC Vellore experience

Ashish J Mathew DNB (Gen Med), DM (Rheum)

Assistant ProfessorClinical Immunology & RheumatologyChristian Medical College, Vellore

Background

Dorner T, Kay J. Nat Rev Rheumatol 2015

Exemptia vs Humira safety in RA

• Comparable

Exemptia (n=60) Humira (n=60)

Adverse events 7 subjects – 13 events 10 subjects – 13 events

Pyrexia, headache, cough

Serious adverse events 2 1

Pyrexia, dizziness, cough

TB reactivation 1

Jani RH, et al. Int J Rheum Dis 2015

Objective

• Evaluate the safety profile of Exemptia for treatment of RA, PsA, AS, JIA

• Department of Clinical Immunology & Rheumatology, Christian Medical College, Vellore

• Dec 2014 – Aug 2016

Method

• Retrospective chart review

• All patients initiated on Exemptia during the mentioned period and having continued treatment at least for 3 months

• RA/AS/PsA/JIA/TA

Assessment

• Patients assessed every month up to 1 year

• Safety profile noted from the electronic medical records

Pre-TNFi screening protocol

• HRCT thorax AND

• Quantiferon TB Gold / Mantoux

• If screening positive – INH + RIF for three months

Safety assessments

• Data gathered from the first dose through 70 days (5 half-lives) after the last dose

• SAE – fatal or immediately life-threatening; requiring hospitalisation; resulting in persistent or significant disability/incapacity; congenital anomaly or requiring medical or surgical intervention to prevent a serious outcome

Results (N=105)

Male Female0

10

20

30

40

50

60

70

8073 (69.5%)

32 (30.5%)

Gender distribution

Indications

AS RA PsA JIA TA0

10

20

30

40

50

6052 (49.5%)

11 (10.5%)13 (12.4%)

24 (22.8%)

5 (4.8%)

Biologic Naïve/Experienced

• Naïve – 96 (91.4%)

• Experienced – 9 (8.6%)

Treatment Adherence

75 (71.4%)

12 (11.4%)

10 (9.5%)8 (7.6%)

Completed

Ongoing

Lost to follow up

Drop-out

Adverse events (n = 4)

Abdominal pain

Injection site reaction

Nausea

0 0.2 0.4 0.6 0.8 1 1.2 1.4 1.6 1.8 2

2

2

1

Serious adverse events (n = 3)

• Psoriasis flare – 1

• Pneumonia – 1

• TB reactivation - 1

Limitations

• Short-term efficacy

• Retrospective chart review

Conclusions

• Safety profile comparable to published literature

• Safety profile seen in clinical trials are being translated to actual practice

• Well-designed studies with long-term follow up needed

Thank you