Background SC ABA formulation is under development as an additional treatment option for Japanese rheumatoid arthritis (RA) patients.
Objectives To compare the efficacy and safety of SC and IV ABA in RA patients with inadequate response (IR) to methotrexate (MTX).
Methods This was a 24 weeks, double-dummy. double-blind study in active RA with MTX-IR (≥10 swollen and ≥12 tender joints, CRP≥0.8mg/dL). Patients were randomized 1:1 to weekly SC (125mg) with additional IV loading (10mg/kg) on Day1, or IV (10mg/kg, Day 1, 15, 29, and every 4weeks thereafter) for 24 weeks, both with MTX (6-8mg/week). The primary endpoint was ACR20 response at 24 week. The key secondary efficacy endpoints were ACR50 and 70 response, HAQ-DI response (improvement from baseline of ≥0.3), and DAS28-CRP remission (of <2.6) at 24 weeks. Efficacy and safety were assessed by intent to treat (ITT) population.
Results A total of 118 patients (59 for each group) were randomized and treated. 57 (96.6%) of SC and 56 (94.9%) of IV completed 24 weeks double-blind period. Mean baseline characteristics were similar between groups. Mean age (±SD) was 55.6±12.9 years, disease duration was 6.4±8.3 years, swollen joints were 17.0±7.1, tender joints were 21.6±9.6, DAS28-CRP was 5.79±0.89, and MTX dose was 7.3±0.9 mg/week for entire population. At week 24, SC and IV ACR20 response were similar, 91.5% (54/59; 95% CI 81.3, 97.2) and 83.1% (49/59; 95% CI 71.0, 91.6), respectively. At week2, 12, 24, ACR20 of SC was 28.8%, 81.4%, 91.5% and IV was 22.0%, 79.7%, 83.1%. ACR50/70 responses over 24 weeks were also comparable between both groups (ACR50 of SC and IV were 66.1% and 62.7%, ACR70 were 37.3% and 30.5%). HAQ-DI response and DAS28-CRP remission of SC and IV were 69.5% and 50.8%, 50.9% and 40.4% respectively. Frequencies of AEs and serious AEs over 24 weeks were comparable between both groups (52.5% vs 59.3% and 6.8% vs 5.1%). Most common AEs were infections with mild or moderate in intensity (33.9% vs 49.2%). Local injection site reactions occurred in 3 patients (1 in SC and 2 in IV). All of them were mild or moderate. In total, anti-Ig and/or junction region antibody was detected in 1 of SC (1.7%) and anti-CTLA4 and possibly Ig antibody was detected in 1 of IV (1.7%).
Conclusions In this study, SC shows comparable efficacy and safety to IV with low immunogenecitiy. SC will provide an additional treatment option for patients with RA.
Disclosure of Interest None Declared
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