Background CT-P13 is a biosimilar of innovator infliximab (INX), approved by the European Medicines Agency in 2013. Clinical data up to 1 year from PLANETRA have been reported at EULAR 20131
Objectives To compare the radiographic progression between CT-P13 and INX treatment and to assess its association with anti-drug antibody (ADA) and clinical disease activity in active rheumatoid arthritis (RA) patients, who participated in the PLANETRA study.
Methods Radiographs obtained at baseline and week 54 were evaluated with the “paired review” method and the evaluation was performed by two independent readers without knowing the time point of the radiographs. The individual component scores of the joint damage progression (JDP) were calculated according to the van der Heijde modification of the Sharp scoring system. The analysis was performed to demonstrate comparability in JDP between two treatment groups using Student's t-test and elucidate an association of JDP with ADA and clinical parameters such as ACR20, IgM rheumatoid factor (RF), and anti-CCP.
Results Among the 606 patients, 336 patients had radiographs both at baseline and week 54. The mean change from baseline JDP was similar between CT-P13 and INX treatment groups with respect to total Sharp score (TSS), joint space narrowing (JSN) score and erosion score at week 54 (CT-P13, 1.0/0.4/0.7; INX, 0.6/0.7/0.0, respectively). At week 54, a higher progression of TSS could be observed in the ADA positive patients (CT-P13, 1.1; INX, 1.2) compared with the ADA negative patients (CT-P13, 0.9; INX, 0.0), but the scores were comparable between two groups. The ACR20 responders tended to show a similar progression of TSS between two treatment groups (CT-P13, 0.6; INX, 0.5) at week 54. The mean change of TSS in ACR20 non-responders from baseline to week 54 were also comparable between the two treatment groups (CT-P13, 2.0; INX, 0.9). ACR20 responders showed less progression of TSS compared with non-responders in both treatment groups but these results were statistically not significant with respect to response status and treatment groups. At week 54, the progression of TSS was similar between treatment groups for each of the negative and positive baseline IgM RF subgroups (CT-P13, -0.5/1.4; INX, -0.2/0.7, respectively). The patients who belong to the negative and positive baseline anti-CCP subgroups showed also a comparable radiographic progression between treatment groups (CT-P13, 0.5/1.0; INX, 0.2/0.7, respectively). In both CT-P13 and INX, there was less progression of TSS in the patients who had negative baseline IgM RF or anti-CCP but the changes were statistically not significant.
Conclusions Patients treated with CT-P13 showed a comparable radiographic progression as compared to those treated with INX at week 54. The ADA and clinical parameters such as ACR20, IgM RF, and anti-CCP showed tendency of association with radiographic progression.
Yoo DH, et al. Ann Rheum Dis 2013;72(S3):73
Disclosure of Interest : D. Yoo Grant/research support: CELLTRION, Inc., Consultant for: CELLTRION, Inc., Speakers bureau: CELLTRION, Inc., W. Park Grant/research support: CELLTRION, Inc., Consultant for: CELLTRION, Inc., Speakers bureau: CELLTRION, Inc., P. Miranda Grant/research support: CELLTRION, Inc., M. Piotrowski Grant/research support: CELLTRION, Inc., E. Ramiterre Grant/research support: CELLTRION, Inc., S. Shevchuk Grant/research support: CELLTRION, Inc., A. Baranauskaite Grant/research support: CELLTRION, Inc., S. Lee Employee of: CELLTRION, Inc., U. Müller-Ladner Speakers bureau: CELLTRION, Inc.