STAT+: AbbVie skin disorder drug succeeds in late-stage trial, but results miss market expectations

AbbVie announced on Thursday that a new treatment for hidradenitis suppurativa, a chronic skin disorder, performed well in a late-stage trial but fell short of market expectations, leaving analysts skeptical about its ability to compete with existing treatments. The Phase 3 clinical study, known as Intrepid, involved 1,400 patients with moderate-to-severe hidradenitis suppurativa.

Participants received weekly injections of AbbVie's drug, lutikizumab, for 16 weeks. The primary outcome measured whether the drug led to a 75% or greater decrease in the number of inflamed bumps and abscesses on the patients' skin, compared to a placebo group. Lutikizumab achieved this primary endpoint, as 31.4% of those receiving the treatment experienced a significant reduction, compared to 23.4% in the placebo group.

Additionally, the drug met eight secondary endpoints, such as improvements in skin pain and flare-ups. Lutikizumab was generally considered safe, with adverse events occurring at nearly the same rate in both the treatment and placebo groups. Despite these positive results, the drug's performance did not meet analysts' market expectations, prompting concerns about its potential to challenge current standard treatments for the skin condition.