Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA)

Roche F. Hoffmann-La Roche, Ltd. Objectives To evaluate the long-term efficacy and safety of subcutaneous (SC) tocilizumab (TCZ) versus intravenous (IV) TCZ, including switching formulations, in patients with rheumatoid arthritis (RA) and inadequate response to disease-modifying antirheumatic drugs (DMARDs). Methods Patients (n=1262) were randomised 1: 1 to receive TCZ-SC 162 mg weekly (qw)+placebo-IV every four weeks (q4w) or TCZ-IV 8 mg/kg q4w+placebo-SC qw in combination with DMARD(s). After a 24-week double-blind period, patients receiving TCZ-SC were re-randomised 11: 1 to TCZ-SC (n=521) or TCZ-IV (TCZ-SCIV, n=48), and patients receiving TCZ-IV were re-randomised 2: 1 to TCZ-IV (n=372) or TCZ-SC (TCZ-IV-SC n=186). Maintenance of clinical responses and safety through week 97 were assessed. Results The proportions of patients who achieved American College of Rheumatology (ACR) 20/50/70 responses, Disease Activity Score in 28 joints remission and improvement from baseline in Health Assessment Questionnaire Disability Index >= 0.3 were sustained through week 97 and comparable across arms. TCZ-SC had a comparable safety profile to TCZ-IV through week 97, except that injection site reactions (ISRs) were more common with TCZ-SC. Safety profiles in patients who switched were similar to those in patients who received continuous TCZ-SC or TCZ-IV treatment. The proportion of patients who developed anti-TCZ antibodies remained low across treatment arms. No association between anti-TCZ antibody development and clinical response or adverse events was observed. Conclusions The long-term efficacy and safety of TCZ-SC was maintained and comparable to that of TCZ-IV, except for ISRs. Profiles in patients who switched formulations were comparable to those in patients who received TCZ-IV or TCZ-SC. TCZ-SC provides additional treatment options for patients with RA. Free Univ Berlin, Berlin, Germany Humboldt Univ, D-10099 Berlin, Germany Klinikum Univ Koln, Cologne, Germany Ctr Hosp Univ Toulouse, Toulouse, France Cabrini Med Ctr, Malvern, Vic, Australia Poznan Med Univ, Poznan, Poland Univ Fed Sao Paulo, Sao Paulo, Brazil Arthrit & Diabet Clin Inc, Monroe, LA USA Rheumatol Associates South Carolina, Charleston, SC USA East Penn Rheumatol Associates, Bethlehem, PA USA Genentech Inc, San Francisco, CA 94080 USA Roche Prod Ltd, Welwyn Garden City AL7 3AY, Herts, England Org Med Invest, Buenos Aires, DF, Argentina Universidade Federal de São Paulo, São Paulo, Brazil Web of Science