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Rituximab Efficacy in Systemic Sclerosis

Aug 18, 2022 1:17 pm

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:

 

Week 24

Blinded Rx

Week 48

Open-Label RTX

RTX-RTX  -5.81  -8.88
PBO-RTX  +2.4  -6.05

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.

Disclosures
The author has no conflicts of interest to disclose related to this subject

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