Dazukibart Effective in Adults with Dermatomyositis Save
Lancet reports that the use of dazukibart, a selective monoclonal antibody against interferon B (IFNβ), was clinically effective in reducing disease activity in adults with active dermatomyositis (DM).
Dermatomyositis is a chronic autoimmune disease whose pathophysiology involves type I interferon (IFN) dysregulation.
A multicentre, double-blind, randomised, placebo-controlled, phase 2 trial enrolled adults with moderate-to-severe skin-predominant DM. Patients were assessed using the Cutaneous Dermatomyositis Disease Area and Severity Index-Activity (CDASI-A. Patients were treated with placebo or dazukibart 600 mg, dazukibart 150 mg, or placebo at different stages of investigation. Therapy was administered intravenously on day 1 every 4 weeks, up to and including week 8 or on week 12 every 4 weeks, up to and including week 20. The primary outcome was the change from baseline in CDASI-A score at week 12.
A total of 75 DM patients were randomized (15 to dazukibart 150 mg, 37 to dazukibart 600 mg, and 23 to placebo). Most were female (93%)in the skin-predominant cohort vs 72% in the 18 patients with muscle-predominant DM.
At week 12, the mean CDASI-A change:
- In the Full Cohort - dazukibart 600 mg was –18·8 (placebo-adjusted difference –14·8 [–20·3 to –9·4]; p<0·0001).
- In the skin cohort - dazukibart 600 mg –19·2 (placebo-adjusted difference –16·3 [–20·4 to –12·1]; p<0·0001)
- dazukibart 150 mg group was –16·6 (placebo-adjusted difference –13·7 [–18·3 to –9·0]; p<0·0001).
Adverse events were similar between groups with infections and infestations most common. Serious adverse events were seen in 4 (11%) dazukibart 150 mg group and 1 (4%) placebo group. One patien (dazukibart 600 mg) died during follow-up due to haemophagocytic lymphohistiocytosis and macrophage activation syndrome.
Interpretation
Inhibition of IFNβ with Dazukibart appears to be an effective therapeutic strategy in adults with dermatomyositis.
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The author has no conflicts of interest to disclose related to this subject
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