O27 Subcutaneous Tocilizumab in Adults with Systemic Sclerosis: 24 and 48 Week Safety and Efficacy Data from the Fasscinate Trial

Author: C. Denton, D. Khanna, A. Jahreis, J. van Laar, et al
Date Published: May-2016
Source: Oxford Journals Rheumatology

Background: Interleukin-6 (IL-6) appears to play a key role in the pathogenesis of SSc, a debilitating disease with limited treatment options. Methods: A double-blind, placebo-controlled, phase 2, proof-of-concept study of the efficacy and safety of the IL-6 receptor inhibitor tocilizumab (TCZ) (weekly s.c. injection; TCZ 162 mg vs placebo for 48 weeks) in patients ≥18 years of age with active SSc. The primary end point was a mean change in the modified Rodnan skin score (mRSS) from baseline at week 24. Change in the mRSS at week 48, patient-reported outcomes (PROs) and pulmonary function (week 48) were exploratory measures.