AbbVie HS drug misses market bar despite trial win — SkimNews
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- AbbVie reported that its experimental therapy lutikizumab achieved a 31.4% response rate in reducing inflamed skin lesions in patients with moderate-to-severe hidradenitis suppurativa after 16 weeks, compared to 23.4% on placebo, meeting the trial’s primary endpoint.
- Lutikizumab met eight secondary endpoints in the Phase 3 Intrepid trial, including improvements in skin pain and flare frequency, and showed a safety profile nearly identical to placebo.
- The Intrepid trial, which enrolled 1,400 patients, was designed to evaluate the efficacy and safety of weekly lutikizumab injections in a population with limited treatment options for chronic hidradenitis suppurativa.
- Experts expressed skepticism about lutikizumab’s commercial viability despite its statistical success, noting the modest absolute benefit over placebo and uncertainty about how it compares to existing biologic therapies.
Why it matters: While AbbVie cleared the regulatory bar for approval, the 8-percentage-point improvement over placebo falls short of the 15+ point gains seen with rival biologics, making it less likely to displace current standard-of-care treatments or gain strong payer support despite meeting trial endpoints.
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