Background A randomised controlled trial (RCT) and its open label extension trial (OLE) demonstrated comparable pharmacokinetics (PK), efficacy and safety between CT-P10 and innovator rituximab (RTX) (including switched from RTX to CT-P10) up to 2 years in rheumatoid arthritis (RA) patients (NCT01534884 and NCT01873443).1,2
Objectives To compare time to retreatment and confirm clinical similarity in efficacy and safety by the number of treatment courses in the RCT between CT-P10 and RTX in RA patients up to 2 years.
Methods One hundred fifty three patients were randomised in 2:1 ratio and received up to 2 treatment courses of either CT-P10 or RTX in RCT, and they had a chance to receive up to 2 additional courses of CT-P10 in OLE. Retreatments were given based on disease activity. Post-hoc analyses using combined data obtained from the RCT and OLE studies were performed in 2 different groups according to the number of treatment courses in RCT as following; Group 1: patients who received 2 courses in RCT; Group 2: patients who received 1 course in RCT.
Results A total of 82 patients (59 received CT-P10 and 23 received RTX) were in Group 1 and 20 (13 received CT-P10 and 7 received RTX) were in Group 2. Time to retreatment was similar between CT-P10 and RTX (including switched to CT-P10) in each group (Figure 1).
DAS28 improvement at Week 24 of each course was similar between CT-P10 and RTX (including switched to CT-P10) in both groups (Table 1).
Infusion related reactions by treatment course up to 2 years was similar between the CT-P10 and RTX groups and tended to decrease over time in line with RTX historical data.3 Incidence rate of adverse event, serious adverse event and infection was comparable between CT-P10 and RTX groups.
Conclusions The results of the post-hoc analyses demonstrated comparable duration of disease control between CT-P10 and RTX (including switched to CT-P10) with clinical similarity in efficacy for 2 years. The safety profile of CT-P10 was similar to that of RTX and in line with RTX historical data.
Yoo DH, et al. Arthritis Rheum 2013; 65 (Suppl10): S736
Yoo DH, et al. Arthritis Rheum 2015; 67 (Suppl10): 2449–245
van Vollenhoven RF, et al. EULAR 2013 (Madrid, Spain): Poster SAT0131
Disclosure of Interest W. Park Consultant for: CELLTRION,INC., D. H. Yoo Consultant for: CELLTRION,INC., C. H. Suh Consultant for: CELLTRION,INC., S. C. Shim Consultant for: CELLTRION,INC., S. J. Lee Employee of: CELLTRION,INC., S. Y. Lee Employee of: CELLTRION,INC., T. S. Kwon Employee of: CELLTRION,INC., S. M. Kim Employee of: CELLTRION,INC.