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AAD 2024: Remibrutinib well-tolerated for moderate-to-severe hidradenitis suppurativa
In this randomized, 16-week phase 2 trial, researchers found that Novartis’ investigational oral Bruton’s tyrosine kinase (BTK) inhibitor, remibrutinib, performed better than placebo in patients with moderate-to-severe hidradentis suppurativa (HS). These findings were presented at the American Academy of Dermatology’s 2024 annual meeting in San Diego.
- Investigators enrolled 77 patients who received either remibrutinib 25 mg twice a day (n=33), 100 mg twice a day (n=33), or placebo twice per day (n=11).
- The primary endpoint was the simplified HS clinical response (sHiSCR), which assesses the reduction in number of inflammatory lesions at week 16.
- 80.2% of patients completed the treatment (87.9% received remibrutinib 25 mg and 78.8% receiving remibrutinib 100 mg).
- 72.7% patients treated with remibrutinib 25 mg twice-daily achieved the sHiSCR endpoint, compared with 48.5% of those in the 100 mg cohort and 34.7% of those in the placebo arm.
- Additionally, remibrutinib had a greater effect on number of inflammatory lesions, draining abscesses and pain response.
- Adverse events were mild or moderate, with only one serious adverse event. Infections, primarily upper respiratory, were the most common adverse events in the treatment arms.
Source:
Kimball, A. Efficacy and safety of the oral Bruton’s tyrosine kinase inhibitor, remibrutinib, in patients with moderate to severe hidradenitis suppurativa in a randomized, phase 2, double-blind, placebo-controll. Late-breaking research: session 1. Presented at: 2024 American Academy of Dermatology Meeting; March 8-12, 2024; San Diego, CA. https://am2024.aad.org/sessions/16895 [link requires log-in].