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AbbVie's lutikizumab wins Phase 3 hidradenitis suppurativa trial but underwhelms investors

2 reports2 sourcesupdated 4 hours ago

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AbbVie's lutikizumab met the primary endpoint in the Phase 3 Intrepid trial for hidradenitis suppurativa, but the results fell short of market expectations. Among 1,400 patients with moderate-to-severe disease, 31.4% of those receiving weekly injections achieved at least a 75% reduction in inflammatory nodules and abscesses at 16 weeks, versus 23.4% on placebo. The drug also met eight secondary endpoints, including improvements in skin pain and flares, and was generally safe and well tolerated, with adverse event rates close between treatment and placebo groups. Despite the trial's success, experts doubt lutikizumab can compete with the current standard of care, leaving its commercial prospects in question.

Written by a model from the reports · updated 3 hours ago

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Oct 23
  1. biospace.comPick
    AbbVie’s skin disease drug lessens abscess burden in Phase 3 but falls below expectations

    AbbVie's lutikizumab met the primary endpoint in the Phase 3 INTREPID study of about 1,400 patients with hidradenitis suppurativa, but efficacy fell below analyst expectations. The week-16 response rate in abscess and nodule count reduction was 31.4% versus 23.4% for placebo, a difference of 8%; prior Phase 2 data had shown a placebo-adjusted improvement of 28%. The study also hit eight secondary endpoints, with BMO citing reductions in pain and flares; Guggenheim said the results could support regulatory approval but expects limited monotherapy commercial uptake.

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

    AbbVie reported that lutikizumab met the primary endpoint in the Phase 3 Intrepid trial for hidradenitis suppurativa but missed market expectations, and experts question whether it can compete with the current standard of care. The trial enrolled 1,400 patients with moderate-to-severe disease; after 16 weeks, 31.4% of the weekly injection group had at least a 75% reduction in inflamed bumps and abscesses versus 23.4% on placebo. The drug also met eight secondary endpoints, including improvements in skin pain and flares, and was generally safe and well tolerated, with adverse event rates similar between treatment and placebo groups.

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