Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA)
Gerd R Burmester, Andrea Rubbert-Roth, Alain Cantagrel, Stephen Hall, Piotr Leszczynski, Daniel Feldman, Madura J Rangaraj, Georgia Roane, Charles Ludivico, Min Bao, Lucy Rowell, Claire Davies, Eduardo F Mysler. - Ann Rheum Dis. 10 May 2015 doi:10.1136/annrheumdis-2015-207281 [Epub ahead of print]
Tocilizumab (TCZ) has demonstrated efficacy and a well-established safety profile for intravenous (IV) administration. The Phase III SUMMACTA study evaluated the efficacy and safety of subcutaneous tocilizumab (TCZ-SC) in combination with DMARDS in patients with moderate-to-severe RA and inadequate response to ≥1 DMARD. Patients were randomised to receive TCZ-SC 162 mg weekly or TCZ-IV 8 mg/kg q4w in combination with DMARDs. After a 24-week double-blind period, patients receiving TCZ-SC were re-randomised 11:1 to TCZ-SC or TCZ-IV, and patients receiving TCZ-IV were re-randomised 2:1 to TCZ-IV or TCZ-SC. Maintenance of clinical responses and safety through week 97 were assessed.
Findings from the study show an efficacy and safety profile for TCZ-SC comparable to the established profile for TCZ-IV, with the exception of injection site reactions (ISRs) which were more common with TCZ-SC. Safety profiles of patients who switched treatments were similar to those who received continuous TCZ-SC or TCZ-IV treatment. Anti-TCZ antibody development was low across treatment arms and there was no association between antibody development and clinical response or adverse events. With a comparable efficacy and safety profile to TCZ-IV, TCZ-SC provides additional treatment options for patients with RA.