Discussing New Phase 2 Findings on Lutikizumab for Hidradenitis Suppurativa with Alexa Kimball, MD, MPH

In an evaluation of the safety and effectiveness of lutikizumab at several different dosages, patients with moderate-to-severe hidradenitis suppurativa (HS) who had not responded to anti-TNF therapy exhibited favorable outcomes.

These phase 2 findings, presented as late-breaking data at the 2024 American Academy of Dermatology (AAD) Annual Meeting, indicated that dosages of 300 mg every week (EW) and every other week (EOW) were the most effective in achieving the primary endpoint of Hidradenitis Suppurativa Clinical Response (HiSCR) 50.

In an interview at AAD with Alexa Kimball, MD, MPH, president and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center and professor of dermatology at Harvard Medical School, Kimball spoke with HCPLive about these findings on the interleukin (IL) 1α/1β antagonist.

“We've really validated, over time, the TNF-alpha inhibition pathway, the IL-17 pathway, and the JAK pathway,” Kimball explained. “But one of the questions that has been out there is around interleukin 1, and that's because there's been mixed data from different studies…So I was very pleased to have a presentation at this meeting about the effects of the molecule that affects both interleukin 1 alpha and beta, which is lutikizumab.”

Kimball’s team's primary objective was to assess the proportion of participants achieving at least a 50% reduction in HiSCR at the 16-week mark. They assessed reductions in worst skin pain from the point of baseline by at least 30% and a single unit on the Numeric Rating Scale (NRS 30) at the sixteenth week, using Patient's Global Assessment (PGA).

She explained that the investigators had randomized individuals with HS who had failed anti-TNF treatment in a 1:1:1:1 ratio, with 4 treatment arms. These were lutikizumab 300 mg EW, 300 mg EOW, 100 mg EOW, and placebo EW.

“What was found using the measurement of the HiSCR 50, the gold standard currently in HS studies, was a very nice performance,” Kimball said. “Interestingly…the placebo performed about as expected, 30 - 35% efficacy. The lutikizumab 100 every other week performed about the same as placebo. But the 300 every other week actually outperformed all of the groups as well, hitting almost a 60% increase in the HiSCR 50 at Week 16.”

Kimball also noted that the safety profile looked straightforward and went as-expected. She added that neutropenia had been considered, but there were no occurrences during the study.
“This really opens up this mechanism of action and helps to affirm that interleukin 1, particularly interleukin 1 beta, may be an important target,” Kimball concluded. “And I certainly hope to see it progress to further studies.”

For further information, view the full interview with Kimball posted above.

The quotes contained in this summary were edited for clarity.