Young Ho Lee1, Gwan Gyu Song2. 1. Division of Rheumatology, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, 73, Goryeodae-ro, Seongbuk-gu, 02841, Seoul, Korea (Republic of). lyhcgh@korea.ac.kr. 2. Division of Rheumatology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea (Republic of).
Abstract
OBJECTIVE: We assessed the relative efficacy and safety of adalimumab and biosimilars in patients with active rheumatoid arthritis (RA) presenting an inadequate response to methotrexate (MTX). METHODS: We performed a Bayesian network meta-analysis combining direct and indirect evidence from randomized controlled trials (RCTs) examining efficacy and safety of adalimumab biosimilars versus adalimumab in patients with active RA despite MTX therapy. RESULTS: Overall, 8 RCTs involving 3577 patients, including 8 biologic types, met the inclusion criteria. MSB11022 is listed at the top left of the diagonal of the league table, as it was associated with the most favorable surface under the cumulative ranking curve (SUCRA) for the American College of Rheumatology 20 (ACR20) response rate; FKB327 is listed at the bottom right of the diagonal of the league table, as it was associated with the least favorable results. Based on SUCRA, MSB11022 presented the highest probability of being the best treatment for achieving the ACR20 response rate (SUCRA = 0.623), followed by PF-06410293, CinnoRA, BI 695501, ABP 50, Exemptia, SB5, adalimumab, and FKB327 (SUCRA = 0.390); no difference was observed in ACR20 response rates between biosimilars and adalimumab. Although statistically non-significant, differences in safety ranking were observed for serious adverse events (SAEs) among the interventions, with MSB11022 presenting the highest probability of being safe (SUCRA = 0.865) and Exemptia the lowest (SUCRA = 0.300). CONCLUSION: No significant difference was detected between adalimumab biosimilars and the originator in terms of ACR20 response rates and SAEs in the studied patients.
OBJECTIVE: We assessed the relative efficacy and safety of adalimumab and biosimilars in patients with active rheumatoid arthritis (RA) presenting an inadequate response to methotrexate (MTX). METHODS: We performed a Bayesian network meta-analysis combining direct and indirect evidence from randomized controlled trials (RCTs) examining efficacy and safety of adalimumab biosimilars versus adalimumab in patients with active RA despite MTX therapy. RESULTS: Overall, 8 RCTs involving 3577 patients, including 8 biologic types, met the inclusion criteria. MSB11022 is listed at the top left of the diagonal of the league table, as it was associated with the most favorable surface under the cumulative ranking curve (SUCRA) for the American College of Rheumatology 20 (ACR20) response rate; FKB327 is listed at the bottom right of the diagonal of the league table, as it was associated with the least favorable results. Based on SUCRA, MSB11022 presented the highest probability of being the best treatment for achieving the ACR20 response rate (SUCRA = 0.623), followed by PF-06410293, CinnoRA, BI 695501, ABP 50, Exemptia, SB5, adalimumab, and FKB327 (SUCRA = 0.390); no difference was observed in ACR20 response rates between biosimilars and adalimumab. Although statistically non-significant, differences in safety ranking were observed for serious adverse events (SAEs) among the interventions, with MSB11022 presenting the highest probability of being safe (SUCRA = 0.865) and Exemptia the lowest (SUCRA = 0.300). CONCLUSION: No significant difference was detected between adalimumab biosimilars and the originator in terms of ACR20 response rates and SAEs in the studied patients.
Authors: Josef S Smolen; Gerd-Rüdiger Burmester; Bernard Combe; Jeffrey R Curtis; Stephen Hall; Boulos Haraoui; Ronald van Vollenhoven; Christopher Cioffi; Cécile Ecoffet; Leon Gervitz; Lucian Ionescu; Luke Peterson; Roy Fleischmann Journal: Lancet Date: 2016-11-15 Impact factor: 79.321
Authors: Daniel E Furst; Michael H Schiff; Roy M Fleischmann; Vibeke Strand; Charles A Birbara; Daniele Compagnone; Steven A Fischkoff; Elliot K Chartash Journal: J Rheumatol Date: 2003-12 Impact factor: 4.666
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