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“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).

Reference:

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. .

Abstract:

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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