Safety and effectiveness of subcutaneous tocilizumab in patients with rheumatoid arthritis in a real-world clinical setting

<p><b>Objectives:</b> The objective of this study is to evaluate the safety and effectiveness of subcutaneous tocilizumab (TCZ-SC) in a real-world clinical setting in Japan.</p> <p><b>Methods:</b> This single arm, 26-week prospective observational study enrolled patients with RA who were either TCZ naïve or switched from TCZ-IV to TCZ-SC (TCZ-IV-SC group) (UMIN Clinical Trials Registry UMIN000011102). All patients received TCZ-SC 162 mg every 2 weeks and data were collected until week 26 or discontinuation.</p> <p><b>Results:</b> Overall 784 (78.1%) were TCZ naïve and 219 (21.8%) were in the TCZ-IV-SC group. 70.9% received disease-modifying antirheumatic drugs at baseline. Adverse events (AEs) and serious AEs occurred in 28.2% and 4.9% of patients, respectively (TCZ-naïve: 29.5% and 5.2%; TCZ-IV-SC: 23.2% and 4.1%). Infections and infestations were the most common AEs (7.4%) and serious AEs (1.7%). Two TCZ-naïve patients died. TCZ-naïve patients had an improvement in median Clinical Disease Activity Index (CDAI) score and mean Disease Activity Score in 28 joints as measured by erythrocyte sedimentation rate (DAS28-ESR) from baseline to week 26. The TCZ-IV-SC group had similar median CDAI scores and mean DAS28-ESR over 26 weeks.</p> <p><b>Conclusions:</b> There were no unexpected safety signals with TCZ-SC. TCZ-SC was effective in reducing disease activity in TCZ-naïve patients and maintaining remission in TCZ-IV-SC patients.</p

Additional file 1: of A randomized controlled trial comparing PF-06438179/GP1111 (an infliximab biosimilar) and infliximab reference product for treatment of moderate to severe active rheumatoid arthritis despite methotrexate therapy

Supplementary methods and results, supplementary figures and figure legends, and supplementary tables. (PDF 394 kb

Additional file 2: of Effect of subcutaneous tocilizumab treatment on work/housework status in biologic-naĂŻve rheumatoid arthritis patients using inverse probability of treatment weighting: FIRST ACT-SC study

Overall baseline demographic and clinical characteristics of each group in the modified intention-to-treat set (unadjusted, adjusted). (DOCX 25 kb

Additional file 1: of Effect of subcutaneous tocilizumab treatment on work/housework status in biologic-naĂŻve rheumatoid arthritis patients using inverse probability of treatment weighting: FIRST ACT-SC study

Baseline demographic and clinical characteristics of patients in each group adjusted using inverse probability of treatment weighting in the modified intention-to-treat set (paid worker, house worker). (DOCX 22 kb