Alexa B. Kimball, MD, MPH

Credit: Beth Israel Deaconess Medical Center

Adult hidradenitis suppurativa (HS) patients that had failed anit-TNF therapy previously respond well to treatment with lutikizumab (ABT-981), according to recent findings, compared to the same patients given a placebo.¹

These phase 2 data were announced by AbbVie on January 8, 2024, with the company highlighting that lutikizumab 300 mg per-week or 300 mg every other week led to higher response rates in HS Clinical Response (HiSCR 50) at the 16-week mark versus those in the placebo arm of the study.

"The burdens of HS are high and include long times to diagnosis, significant pain, disability, isolation, and reduced quality of life," Alexa B. Kimball, MD, MPH, a study investigator from Beth Israel Deaconess Medical Center and professor of dermatology for Harvard Medical School, said in a statement. "These results are encouraging and help us further understand the use of lutikizumab in patients with HS as we work to address the need for additional treatment options for patients living with this disease."

The chronic inflammatory skin condition, often debilitating due to lumps, abscesses, and even scars, saw several specific improvements in the treatment arm. Specifically, the investigators observed higher rates of response in both the aforementioned primary endpoint and the secondary endpoint of skin pain NRS30 at the 16-week mark among those with a baseline of Numeric Rating Scale (NRS) ≥3.

Lutikizumab itself is an investigational, dual-variable-domain interleukin (IL) 1α/1β antagonist by AbbVie. The announcement by the company also highlighted prior research’s having indicated IL 1α and 1β elevation in patients with HS lesions, suggesting benefits of the treatment.

The study itself had taken place over 16 weeks, with a randomized, parallel group, double-blinded, placebo controlled, dose-ranging study design taking place in multiple centers. The research team assessed the drug’s use in 153 adult participants with moderate to severe HS who had failed anti-TNF treatments previously.

These subjects, with notably severe disease, saw strong results and also showed a higher threshold of clinical response in HS versus those in the placebo cohort. The 100 mg every other week dose also attempted among treatment cohort participants did not result in greater efficacy results versus placebo.

In addition to being well-tolerated, the drug led to similar results with regard to treatment-emergent adverse events (TEAE) across combined treatment and placebo arms (70.8% and 75.0%, respectively). The investigators found the most common ones to be HS (10.6 percent), headache (8.8%), diarrhea (8.8%), itch (6.2 percent), eczema (5.3%), contact dermatitis (5.3%), and nasopharyngitis (5.3%) in the combined treatment arm.

They also found that serious adverse events (SAEs) were observed in 5.3% of those in the combined treatment arm and in 2.5% in the placebo arm. No deaths, no neutropenia, and no Grade 3 or 4 laboratory assessments of neutropenia were observed by the research team.

These results are set to be presented at an upcoming medical congress. The new findings will allow AbbVie to advance its clinical program for the drug to phase 3.

"These results help us further understand the use of lutikizumab in adults with moderate to severe hidradenitis suppurativa, and we will continue to apply our more than 25 years of expertise in immune-mediated diseases in advancing our clinical program for lutikizumab in HS to Phase 3,” Roopal Thakkar, MD, senior vice president and chief medical officer of global therapeutics at AbbVie, said in a statement.

References

1. ^{Lutikizumab Showed Positive Results in a Phase 2 Trial of Adults with Moderate to Severe Hidradenitis Suppurativa as Program Advances to Phase 3. AbbVie. January 8, 2024. https://www.prnewswire.com/news-releases/lutikizumab-showed-positive-results-in-a-phase-2-trial-of-adults-with-moderate-to-severe-hidradenitis-suppurativa-as-program-advances-to-phase-3-302027605.html. Date accessed: January 8, 2024.}