AbbVie’s hidradenitis suppurativa (HS) candidate lutikizumab has demonstrated its potential to significantly reduce flares of the disease, though a the response difference between the drug and placebo was narrower than analysts expected.
Through the Phase III INTREPID trial (NCT06468228), AbbVie assessed the effectiveness and safety of lutikizumab – a dual-variable-domain interleukin (IL) 1α/1β antagonist – in adults and adolescents with HS. Researchers primarily focused on the drug’s potential to reduce the number of abscesses and inflammatory nodules from baseline.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
During the study, 31.4% of patients treated with lutikizumab achieved a Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) compared with 23.4% in the placebo arm at 16 weeks – meeting the trial’s primary endpoint.
On top of this, the drug demonstrated significant impacts on HS-linked skin pain after eight weeks of treatment, as 26.2% of patients achieved a three-point baseline reduction on the numeric rating scale versus 15% in the placebo group. Meanwhile, 36% of patients reported at least a 30% and 2-unit reduction from baseline in HS-related skin pain through the NRS30 scale compared with 22.8% of patients in the placebo arm.
Lutikizumab also demonstrated its potential to significantly diminish the occurrence of disease flares during the first 16 weeks over placebo, with 18.4% versus 28.1% of patients in the treatment and placebo groups experiencing a flare within this period, respectively.
Patients tolerated the drug well, with no new safety signals uncovered. The treatment-emergent adverse event (TEAE) and TEAE-linked discontinuation rates were similar between the lutikizumab and placebo groups.
Analysts lukewarm on INTREPID
AbbVie debuts these results as many patients with HS continue to face unmet needs, despite the availability of a range of targeted biologics to treat the condition characterised by painful, inflamed boil-like lumps and nodules that go under the skin.
According to Alexa Kimball, professor of dermatology at Harvard Medical School, who is also a consultant and investigator for AbbVie, said the INTREPID data are important as the use of HiSCR75 as a primary endpoint “sets a rigorous bar for defining clinical response.”
” These are also the first Phase III data evaluating the effect of targeting both IL-1α and IL-1β on this disease. Taken together, these results underscore the promising potential of this investigational treatment,” Kimball commented.
However, Leerink analysts were a little more lukewarm on the trial results. While lutikizumab achieved INTREPID’s primary endpoint, “the study’s ~8% placebo-adjusted HiSCR75 response rate at week 16 is well below our sense of investor expectations (≥17-20%), driving some perceived uncertainty regarding the IL-1 pathway and the ability to replicate mid-stage HS results into larger, late-stage trials,” they said in a research note.
However, AbbVie is yet to disclose other findings from the trial, such as HiSCR50 and HiSCR90 scores, as well as results among the biologic-exposed subpopulation, which analysts say would give a more rounded view of lutikizumab’s potential positioning within the HS market.
Currently, there are a range of targeted therapies approved for the treatment of HS – including AbbVie’s once best-selling therapy, Humira (adalimumab), Novartis’ Cosentyx (secukinumab) and UCB’s Bimzelx (bimekizumab).
Cosentyx, an IL-17 blocker, has emerged as a frontrunner in the HS market, with the drug having pulled in over $6.7bn in sales across its range of approved conditions in 2025. However, Novartis does not provide a breakdown of the drug’s sales by indication.
Analysts at GlobalData, parent company of Clinical Trials Arena, predict that the HS market will quadruple by 2034 – reaching a value of $7.8bn. This, they say, will primarily be driven by the potential emergence of first-in-class mechanisms.
