BIOSIMILAR ADALIMUMAB SYMPOSIUM- Exemptia safety - Dr Ashish Jacob Mathew
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Transcript of BIOSIMILAR ADALIMUMAB SYMPOSIUM- Exemptia safety - Dr Ashish Jacob Mathew
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Safety of Exemptia - CMC Vellore experience
Ashish J Mathew DNB (Gen Med), DM (Rheum)
Assistant ProfessorClinical Immunology & RheumatologyChristian Medical College, Vellore
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Background
Dorner T, Kay J. Nat Rev Rheumatol 2015
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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
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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
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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
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Assessment
• Patients assessed every month up to 1 year
• Safety profile noted from the electronic medical records
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Pre-TNFi screening protocol
• HRCT thorax AND
• Quantiferon TB Gold / Mantoux
• If screening positive – INH + RIF for three months
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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
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Results (N=105)
Male Female0
10
20
30
40
50
60
70
8073 (69.5%)
32 (30.5%)
Gender distribution
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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%)
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Biologic Naïve/Experienced
• Naïve – 96 (91.4%)
• Experienced – 9 (8.6%)
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Treatment Adherence
75 (71.4%)
12 (11.4%)
10 (9.5%)8 (7.6%)
Completed
Ongoing
Lost to follow up
Drop-out
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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
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Serious adverse events (n = 3)
• Psoriasis flare – 1
• Pneumonia – 1
• TB reactivation - 1
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Limitations
• Short-term efficacy
• Retrospective chart review
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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
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Thank you