Rituximab Efficacy in Systemic Sclerosis Save
The DESIRES trial studied rituximab (RTX) in patients with systemic sclerosis (SSc) and showed clinically significant improvement in skin and lung outcomes after a subsequent 24-week open-label extension phase.
This multicenter, Japanese study was a double-blind phase 2 trial that enrolled adults with SSc and skin thickening as measured by a baseline modified Rodnan Skin Score (mRSS) of 10 or greater. After 24 weeks of blinded (PBO vs RTX) therapy, all patients received RTX (375 mg/m2 IV for intravenously, weekly for 4 consecutive weeks) and follwed for 24 weeks in an open-label extension. The primary endpoint was change in mRSS at week 24 and 48.
A total of 56 patients were randomlized and treated and 46 patients transitioned to the open-label study and all received at least one dose of rituximab; 43 patients completed the extension phase.
Changes in skin scores (mRSS) are shown below:
While the PBO patients worsened during blinded therapy (wk 24), changing to open-label RTX resulted in improved mRSS scores.
There were 2 serious adverse events (cholangitis and pneumococcal pneumonia) and no deaths.
Two courses of RTX appears to be safe and effective in this limited SSc trial.