Phase II Tocilizumab Trial Shows Little Benefit for Systemic Sclerosis

May 31, 2016

The next Rheumatology Journal Club Twitter chat will be from 4-5 p.m. and 10-11 p.m. EST, June 2. The chat will focus on tocilizumab for systemic sclerosis.

Writing in the journal Lancet, researchers are calling for phase III clinical trials to evaluate the efficacy and safety of tocilizumab, an interleukin 6 receptor-a inhibitor, in patients with systemic sclerosis.

IL-6 has been implicated in the disease pathogenesis of systemic sclerosis (SSc), a progressive disease with few treatment options. Tocilizumab (TCZ), an IL-6 receptor inhibitor, is under evaluation in the ongoing faSScinate study, a randomized, double-blind, placebo-controlled trial in phase II.

Published in the May 5 issue of The Lancet , the study showed that tocilizumab was not associated with a significant reduction in skin thickening. “However, the difference was greater in the tocilizumab group than in the placebo group and we found some evidence of less decline in forced vital capacity,” wrote researchers who were led by Dinesh Khanna, M.D., of the University of Michigan.  

The study will be featured on Thursday (June 2) during the Rheumatology Journal Club’s monthly Twitter chat scheduled for 4-5 p.m. EST and 10-11 p.m. EST. To participate in the Rheumatology Journal Club chat via Twitter use #RheumJC or participate via the website tchat.io.

The Lancet study was a double-blind, placebo-controlled study of 87 patients with progressive systemic sclerosis of five years or less. It included patients from Canada, France, Germany, the United Kingdom and United States.

Patients were randomly assigned to weekly subcutaneous tocilizumab 162 mg or placebo (43 assigned to tocilizumab and 44 assigned to placebo). The primary endpoint was the difference in mean change from baseline in modified Rodnan skin score at 24 weeks.

Fewer patients in the tocilizumab group than in the placebo group had a decline in percent predicted forced vital capacity at 48 weeks (p=0·0373). However, researchers detected no significant difference in disability, fatigue, itching, or patient or clinician global disease severity. 42 (98%) of 43 patients in the tocilizumab group versus 40 (91%) of 44 in the placebo group had adverse events. 14 (33%) versus 15 (34%) had serious adverse events. Serious infections were more common in the tocilizumab group (seven [16%] of 43 patients) than in the placebo group (two [5%] of 44). One patient died in relation to tocilizumab treatment.

Disclosures:

The study was funded by F. Hoffmann-La Roche, Genentech.

References:

Dinesh Khanna, M.D., Christopher P. Denton, Ph.D., et al. Safety and efficacy of subcutaneous tocilizumab in adults with systemic sclerosis (faSScinate): a phase 2, randomised, controlled trial. May 5, 2016. The Lancet. DOI: http://dx.doi.org/10.1016/S0140-6736(16)00232-4