Long-term safety and efficacy of weekly subcutaneous tocilizumab monotherapy in patients with rheumatoid arthritis who had an inadequate response to subcutaneous tocilizumab every other week: Results from the open-label extension of the SHINOBI study.

Abstract	Objective: To evaluate the long-term safety and efficacy of subcutaneous tocilizumab (TCZ-SC) monotherapy administered weekly (qw) in patients with rheumatoid arthritis who had an inadequate response to TCZ-SC every other week (q2w). Methods: Patients who completed 12 weeks of double-blind treatment with either TCZ-SC q2w monotherapy or TCZ-SC qw monotherapy were switched to or continued to receive open-label treatment with TCZ-SC qw monotherapy for 40 weeks. Safety and efficacy were assessed. Subgroup analyses of Disease Activity Score based on 28 joints using erythrocyte sedimentation rate (DAS28-ESR) were performed at 12 weeks. Results: The incidence of adverse events was 464.4/100 patient-years (PY). The incidence of infection was 121.3/100 PY. The safety profile of TCZ-SC qw monotherapy was consistent with that of prior studies of TCZ. No additional safety concerns were observed. Improvement from baseline in DAS28-ESR was maintained at week 52 in patients who continued TCZ-SC qw and improved in patients who switched from TCZ-SC q2w to qw. At week 12, the efficacy of TCZ-SC qw monotherapy was greater than that of TCZ-SC q2w monotherapy irrespective of weight and BMI subgroups. Conclusion: The long-term weekly dosing of TCZ-SC monotherapy was well tolerated and efficacy was maintained over 52 weeks.
Authors	Atsushi Ogata, Yoshiya Tanaka, Tomonori Ishii, Motohide Kaneko, Hiroko Miwa, Shino Ohsawa, Reiji Yamakawa, SHINOBI Study Group
Journal	Modern rheumatology (Mod Rheumatol) Vol. 29 Issue 5 Pg. 767-774 (Sep 2019) ISSN: 1439-7609 [Electronic] England
PMID	30299202 (Publication Type: Journal Article, Randomized Controlled Trial)
Chemical References	Antibodies, Monoclonal, Humanized Antirheumatic Agents tocilizumab
Topics	Adult Aged Antibodies, Monoclonal, Humanized (administration & dosage, adverse effects, therapeutic use) Antirheumatic Agents (administration & dosage, adverse effects, therapeutic use) Arthritis, Rheumatoid (drug therapy) Female Humans Injections, Subcutaneous Male Middle Aged

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