10.6084/m9.figshare.5114647 Atsushi Ogata Atsushi Ogata Yoshiya Tanaka Yoshiya Tanaka Tomonori Ishii Tomonori Ishii Motohide Kaneko Motohide Kaneko Hiroko Miwa Hiroko Miwa Shino Ohsawa Shino Ohsawa A randomized, double-blind, parallel-group, phase III study of shortening the dosing interval of subcutaneous tocilizumab monotherapy in patients with rheumatoid arthritis and an inadequate response to subcutaneous tocilizumab every other week: Results of the 12-week double-blind period Taylor & Francis Group 2017 Dose interval rheumatoid arthritis subcutaneous tocilizumab 2017-06-16 17:06:54 Journal contribution https://tandf.figshare.com/articles/journal_contribution/A_randomized_double-blind_parallel-group_phase_III_study_of_shortening_the_dosing_interval_of_subcutaneous_tocilizumab_monotherapy_in_patients_with_rheumatoid_arthritis_and_an_inadequate_response_to_subcutaneous_tocilizumab_every_other_week_Results_of_the/5114647 <p><b>Objective:</b> To determine the efficacy and safety of subcutaneous tocilizumab (TCZ-SC) monotherapy every week (qw) versus every other week (q2w) in patients with rheumatoid arthritis who had an inadequate response to TCZ-SC q2w.</p> <p><b>Methods:</b> Adult patients in Japan with inadequate response to TCZ-SC q2w were randomized to either TCZ-SC 162 mg qw monotherapy or TCZ-SC 162 mg q2w monotherapy for 12 weeks (double-blind). The primary endpoint was the change from baseline in adjusted Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) at week 12. Efficacy, safety and pharmacokinetics were assessed.</p> <p><b>Results:</b> TCZ-SC qw was superior to TCZ-SC q2w for adjusted mean change in DAS28-ESR from baseline to week 12. The difference in the change in DAS28-ESR between TCZ-SC qw and q2w was −1.21 (95%CI: −2.13, −0.30, <i>p</i> = .0108). A higher proportion of patients receiving TCZ-SC qw achieved DAS28-ESR remission/low disease activity than TCZ-SC q2w. Adverse events were 71.4% and 66.7% for TCZ-SC qw and q2w, respectively; infection was the most common event with one fatal case with TCZ-SC qw.</p> <p><b>Conclusions:</b> In patients with inadequate response to TCZ-SC q2w, shortening the dosing interval to qw improved efficacy with acceptable tolerability. Occurrence of infection for both TCZ q2w and qw is important and needs careful attention.</p>