WASHINGTON — At the American College of Rheumatology Annual Meeting, Dinesh Khanna, MD, rheumatologist and director of the scleroderma program at the University of Michigan, reviewed open-label extension data from the fasscinate trial. The trial was a phase 2 randomized controlled study of subcutaneous tocilizumab for patients with early systemic sclerosis (SSc) that was extended an additional 48 weeks from the initial 48-week period.
Khanna mentioned the following take-home messages from the trial:
- most patients who completed the first phase also enrolled in the extension;
- there were no unforeseen safety concerns;
- there were six events of serious infections in patients who transitioned from placebo to tocilizumab;
- patients reported improvements in both skin thickness and patient-reported outcome measures that achieved or exceeded the minimally important difference; and,
- patients who transitioned to tocilizumab showed no significant decline — with significance defined as 10% or more.
Khanna said researchers are enrolling patients for a phase 3 trial and data should be ready by early 2018.