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VIDEO: Khanna discusses tocilizumab SSc extension trial

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.

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.

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