“To evaluate the efficacy and safety of switching from intravenous (IV) tocilizumab (TCZ) to subcutaneous (SC) TCZ monotherapy in rheumatoid arthritis patients” Ogata et al (2015).
Ogata, A., Atsumi, T., Fukuda, T. et al (2015) Results of switching from intravenous to subcutaneous tocilizumab monotherapy in patients with rheumatoid arthritis: Extension of the MUSASHI study. Arthritis Care & Research. April 6th. .
Objective: To evaluate the efficacy and safety of switching from intravenous (IV) tocilizumab (TCZ) to subcutaneous (SC) TCZ monotherapy in rheumatoid arthritis patients.
Methods: Patients who had completed 24 weeks’ TCZ-SC (162 mg/2 weeks) or TCZ-IV (8 mg/kg/4 weeks) monotherapy in the MUSASHI study double-blind period were enrolled in an 84-week open-label extension period (OLE). All received TCZ-SC (162 mg/2 weeks) monotherapy. Effects of the IV-to-SC switch were evaluated at week 36 (12 weeks after switching).
Results: Overall, 319 patients received at least one dose of TCZ-SC during OLE; 160 switched from TCZ-IV to TCZ-SC (TCZ IV/SC) and 159 continued TCZ-SC (TCZ SC/SC). DAS28-ESR clinical remission rates were 62.5% (100/160) for TCZ IV/SC and 50.0% (79/158) for TCZ SC/SC at week 24, and were maintained at 62.5% (100/160) and 57.0% (90/158), respectively, at week 36. In the TCZ IV/SC group, 9% (9/100) of patients who had achieved remission at week 24 could not maintain remission at week 36. In TCZ IV/SC patients weighing ≥ 70 kg, the percentage with sufficient serum TCZ concentration (≥1 μg/mL) decreased from 90.9% (10/11) at week 24 to 45.5% (5/11) at week 36. Overall safety profiles were similar in TCZ IV/SC and TCZ SC/SC except for mild injection site reactions in TCZ IV/SC.
Conclusions: Efficacy is adequately maintained in most patients switching from TCZ-IV (8 mg/kg/4 weeks) to TCZ-SC (162 mg/2 weeks) monotherapy. Patients receiving TCZ-IV can switch to TCZ-SC without serious safety concerns. Clinical efficacy may be reduced after switching in some high-body-weight patients.
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