Objectives To compare the efficacy and safety of infliximab-\nbiosimilar with other biological drugs for the treatment\nof active ankylosing spondylitis (AS).\nMethods Systematic literature review for randomized\ncontrolled trials (RCTs) with adalimumab, etanercept, golimumab,\ninfliximab and infliximab-biosimilar in AS was\nperformed and indirect meta-analysis (Bayesian mixed\ntreatment comparison) was carried out. The proportion of\npatients reaching 20 % improvement by the assessment of\nSpondyloarthritis International Society response criteria\n(ASAS20) at weeks 12 and 24 was used as efficacy endpoints,\nand the occurrence of serious adverse events at week\n24 was applied to compare the safety of the biologicals.\nResults Altogether, 13 RCTs, identified by the systematic\nliterature search, were included in the analysis. Results on\nthe ASAS20 efficacy endpoint were reported for week 12\nin 12 RCTs involving 2,395 patients, and for week 24 in 5\nRCTs comprising 1,337 patients. All the five biological\nagents proved to be significantly superior to placebo. Infliximab\nshowed the highest odds ratio (OR) of 7.2 (95 %\nCI 3.68ââ?¬â??13.19) compared to placebo, followed by infliximab-\nbiosimilar with OR 6.25 (95 % CI 2.55ââ?¬â??13.14), both\nassessed at week 24. No significant difference was found\nbetween infliximab-biosimilar and other biological treatments\nregarding their efficacy and safety.\nConclusions This is the first study which includes a\nbiosimilar drug in the meta-analysis of biological treatments\nin AS. The results have proven the similar efficacy\nand safety profile of infliximab-biosimilar treatment compared\nto other biologicals.
Loading....