Patients with unresponsive hidradenitis suppurativa find relief with lutikizumab 300 mg
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Key takeaways:
- Response rates for lutikizumab 300 mg every other week and 300 mg every week were 59.5% and 48.7%, respectively.
- All doses were safe and well tolerated.
SAN DIEGO — Lutikizumab showed positive results in the treatment of patients with hidradenitis suppurativa that failed anti-TNF treatment, according to a late-breaking presentation at the 2024 American Academy of Dermatology Annual Meeting.
“Hidradenitis suppurativa (HS) is a chronic, recurrent and progressive disease that causes irreversible skin damage and disability due to the formation of painful cysts, abscesses and draining fistula,” Alexa B. Kimball, MD, MPH, president and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, professor of dermatology at Harvard Medical School and lead investigator of the study, told Healio. “There are limited treatments available for patients with moderate to severe hidradenitis suppurativa, especially for those who fail currently validated treatments such as TNF alpha inhibitors.”
In this phase 2, randomized, double-blind, placebo-controlled, dose-ranging, multicenter study, researchers assessed the safety and efficacy of lutikizumab, a dual-variable-domain interleukin 1 alpha/1 beta antagonist, vs. placebo for the treatment of moderate to severe HS in adults who have previously failed anti-TNF therapy.
The 153 patients were randomly assigned 1:1:1:1 to placebo or one of the following three lutikizumab groups: 300 mg every week, 300 mg every other week or 100 mg every other week. Baseline characteristics showed that 70.6% of patients had severe baseline Hurley stage 3 disease.
By week 16, the primary endpoint of HS Clinical Response (HiSCR) 50 was reached by 27% of the lutikizumab 100 mg every other week group — a lower response rate than placebo (35%). In comparison, the response rate for lutikizumab 300 mg every week was 48.7%, and the response rate for lutikizumab 300 mg every other week was 59.5%, which was a significant difference vs. placebo (P = .027).
Among patients that had baseline pain scores of 3 or more, 12.9% of the placebo group achieved 30% reductions in pain at week 16 compared with 34.5% of the lutikizumab 300 mg every other week group (P = .039) and 34.8% of the lutikizumab 300 mg every week group.
Additionally, HiSCR 75 was achieved by 17.5% of the placebo group vs. 45.9% (P = .005) and 38.5% (P = .031) of the lutikizumab 300 mg groups, respectively.
According to the presentation, all doses were generally safe and well-tolerated.
“Current research in the clinic is leading to both better treatment options and a better understanding of relevant biology in this hard-to-manage disease,” Kimball told Healio. “These new data ... are encouraging, add critical evidence about the role of IL1 in HS and highlight the opportunity to target this pathway as a treatment option for patients with HS.”
Reference:
- Lutikizumab showed positive results in a phase 2 trial of adults with moderate to severe hidradenitis suppurativa as program advances to phase 3. https://news.abbvie.com/2024-01-08-Lutikizumab-Showed-Positive-Results-in-a-Phase-2-Trial-of-Adults-with-Moderate-to-Severe-Hidradenitis-Suppurativa-as-Program-Advances-to-Phase-3. Published Jan. 8, 2024. Accessed March 9, 2024.
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Kimball AB, et al. A phase 2 multicenter, randomized, double-blind placebo-controlled study to evaluate the safety and efficacy of lutikizumab in adult patients with moderate to severe hidradenitis suppurativa who have failed anti-TNF therapy. Presented at: American Academy of Dermatology Annual Meeting; March 8-13, 2024; San Diego.
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