EVALUATING THE EFFICACY OF BIOSIMILAR INFLIXIMAB WITH THE ACR50 RESPONSE IN PATIENTS WITH RHEUMATOID ARTHRITIS; A META-ANALYSIS IN BAYESIAN FRAMEWORK

Author(s)

Brodszky V*;Gulacsi L;Balogh O;V. Hevér N;Baji P, Péntek M Corvinus University of Budapest, Budapest, Hungary

OBJECTIVES: The main aims of this systematic review were to identify all relevant literature on clinical efficacy and safety evidence for biosimilar infliximab (CT-P13) and comparator biological medications in rheumatoid arthritis and to conduct an up-to-date meta-analysis. METHODS: The following comparators were considered for this analysis: abatacept, adalimumab, certolizumab, etanercept, golimumab, infliximab, rituximab and tocilizumab. A MEDLINE search was conducted until March 2013. The Cochrane Highly Sensitive Search Strategy was applied to identify randomized controlled publications and was combined with ‘arthritis, rheumatoid’ MeSH terms and drug names. Randomized, controlled, clinical trials with adults with moderate-to-severe RA and reporting endpoints for 6 months where the full paper can be obtained were included. Direct and indirect evidences were combined in a mixed treatment comparisons in a Bayesian framework. Efficacy measured by ACR50 endpoint and frequency of serious adverse events at 24-30 weeks were analysed. RESULTS: Altogether 41 trials were included into current meta-analysis. The relative odds ratios (and 95% credible intervals) for ACR50 of biosimilar infliximab treatments compared to abatacept, adalimumab, certolizumab, etanercept, golimumab, rituximab, tocilizumab and infliximab were 1.0 (0.3-3.8), 0.9 (0.2-3.4), 0.3 (0.1-1.4), 1.0 (0.2-4.2), 1.2 (0.3-5.1), 0.9 (0.2-3.6), 0.5 (0.1-2.2), 1.0 (0.3-3.2), respectively. Similarly, relative odds ratios for serious adverse events were 1.9 (0.8-4.8), 2.0 (0.6-5.8), 0.7 (0.2-2.1), 2.0 (0.8-5.7), 1.5 (0.5-4.2), 1.1 (0.7-2.0), 1.3 (0.8-2.2), 1.3 (0.8-2.1), respectively. CONCLUSIONS: The results showed that efficacy and safety of biosimilar infliximab is not significantly different from innovator infliximab and from other biologics.

Conference/Value in Health Info

2013-11, ISPOR Europe 2013, The Convention Centre Dublin

Value in Health, Vol. 16, No. 7 (November 2013)

Code

PMS11

Topic

Clinical Outcomes

Topic Subcategory

Comparative Effectiveness or Efficacy

Disease

Musculoskeletal Disorders

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