Background CT-P13 is the first biosimilar product of innovator infliximab (INX) approved in 55 countries including EU, and there is a need of better understanding for the safety of CT-P13 compared with INX in patients with rheumatoid arthritis (RA) and ankylosing spondylitis (AS).
Objectives To compare safety profiles of CT-P13 and INX in the treatment of RA and AS, we systematically reviewed published literatures and conducted meta-analysis.
Methods We conducted a systematic search for clinical trials of INX in patients with RA and AS by using PubMed database. We included the published safety profiles in randomized controlled trials (RCT) of INX for RA and AS. Eight of 660 articles in RA and 6 of 52 articles in AS were relevant RCTs and included. Safety parameters provided by INX trials were assessed, and the incidences reported in 1454 patients with the same dose regimen were used. Results were calculated using meta-analysis of incidence and compared with the safety data of CT-P13 clinical programs.
Results Overall, the safety profiles of CT-P13 were within the range of historical data of INX in both RA and AS. In the combined RA and AS studies with CT-P13, 42.4% of patients reported infections which was comparable with the rates reported in historical studies with INX (55.2%; range 35.3 – 68.5%), and 3.6% of patients with CT-P13 reported serious infections which was also in line with the rates reported in historical studies with INX (3.2%; range 1.0 – 8.5%). The rate of infusion related reaction was 9.2% and aligned with historical data with INX (18.5%; range 0.0 – 67.4%). Malignancies/lymphoma was reported in 0.5% of patients treated with CT-P13, and the respective incidence with INX was 0.7%; range 0.0 – 1.2%. In addition, there is no noticeable risk in safety of CT-P13 based on the comparison with the historical data of INX in the incidences of the adverse events (100 patient-years) (Table 1).
Conclusions The meta-analysis of published clinical studies of INX provides good evidence that the overall safety profiles of infliximab biosimilar, CT-P13, is consistent with that of the historical safety data of INX in RA and AS patients.
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Disclosure of Interest W. Park Grant/research support from: CELLTRION, Inc., Consultant for: CELLTRION, Inc., Speakers bureau: CELLTRION, Inc., D. H. Yoo Grant/research support from: CELLTRION, Inc., Consultant for: CELLTRION, Inc., Speakers bureau: CELLTRION, Inc., C. H. Suh Grant/research support from: CELLTRION, Inc., Consultant for: CELLTRION, Inc., S. C. Shim Grant/research support from: CELLTRION, Inc., Consultant for: CELLTRION, Inc., S. J. Lee Employee of: CELLTRION, Inc., S. Y. Lee Employee of: CELLTRION, Inc., J. H. Park Employee of: CELLTRION, Inc., Y. M. Bae Employee of: CELLTRION, Inc., S. H. Kim Employee of: CELLTRION, Inc., S. G. Lee Employee of: CELLTRION, Inc.
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