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The results of the faSScinate trial were published in Lancet showing that treatment with Actemra (tocilizumab) resulted in a reduction in skin thickness and an improvement in lung function in patients with systemic sclerosis (SSc).
This study was previously reported at the 2015 ACR meeting. This study is the first placebo-controlled Phase II trial of Actemra for the treatment of SSc.
Eighty-seven patients with progressive SSc were enrolled in the phase II, randomized, double-blind, placebo-controlled "faSScinate" study; a multinational trial. Patients randomly received either weekly subcutaneous tocilizumab 162 mg (n=44) or placebo (n=43) for 48 weeks, followed by open-label weekly tocilizumab for 48 weeks. The study did not meet its primary endpoint, which was the difference in mean change from baseline in mRSS at 24 weeks.
However, a clinically meaningful decline in modified Rodnan Skin Scores (mRSS) over 48 weeks was seen in the Actemra group compared with the placebo group. Moreover, tocilizumab-treated patients had less decline in lung function compared to patients on placebo. No new safety concerns for tocilizumab were raised by this trial.
“This study supports the important role of Actemra in the treatment of progressive systemic sclerosis,” said lead investigator Dr. Dinesh Khanna, MD, MS, Professor of Internal Medicine in the Division of Rheumatology and director of the University of Michigan Scleroderma Program. “After 48 weeks of treatment, patients treated with Actemra exhibited a greater decrease in skin sclerosis than patients on placebo and less decline in forced vital capacity. These results, along with the fact there is no approved disease-modifying treatment for systemic sclerosis, reinforces the need for a Phase III study for Actemra for the treatment of systemic sclerosis." The Phase III international study that is currently recruiting. More information can be found at Clinicaltrials.gov - NCT02453256.
“The FDA granted Breakthrough Therapy Designation to Actemra for systemic sclerosis in 2015,” said Jeffrey Siegel, MD, Senior Group Medical Director of Immunology at Genentech. “We hope to confirm with the Phase III trial that treatment with Actemra results in improvement in skin thickening over time and preservation of lung function.”
Correction: There was a typo in the study name, which was corrected on 5/11/16.