Late-Breaking Data: Lutikizumab Shows Positive Results in Difficult-to-Treat HS After Failed TNF Therapy

New data on lutikizumab, a dual-variable-domain interleukin 1α/1β antagonist, for difficult-to-treat moderate to severe hidradenitis suppurativa (HS) was presented in a late-breaking data session at the 2024 American Academy of Dermatology Annual Meeting in San Diego, California. Kimball et al assessed the safety and efficacy of lutikizumab 300 mg every week, 300 mg every other week, and 100 mg every other week versus placebo for the treatment of signs and symptoms of moderate to severe HS in adult patients who have failed anti-TNF therapy.

The primary end point of the study was the achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) of a ≥50% reduction in the number of inflammatory lesions at week 16. The secondary end point was the achievement of at least a 30% reduction and at least 1-unit reduction from baseline in worst skin pain (maximal daily pain) at week 16, as assessed by the Patient's Global Assessment (PGA) of Skin Pain (Numeric Rating Scale [NRS] 30) among patients with baseline NRS ≥ 3.

Adult patients with a clinical diagnosis of HS, who failed anti-TNF treatment, were centrally randomized at baseline in a 1:1:1:1 ratio to one of 4 treatment groups, each with a planned n=40 of lutikizumab 300 mg every week; lutikizumab 300 mg every other week; lutikizumab 100 mg every other week; and placebo every week. The study drug was administered at baseline from weeks 1 to 15, and the final efficacy was evaluated at week 16.

153 patients were randomized across 54 sites. The majority of patients (70.6%) had severe baseline Hurley Stage 3 disease. While the response rate for libivirumab 100 mg was 27.0%, both lutikizumab 300 mg every other week (59.5%) and 300 mg every week (48.7%) showed greater response rates over placebo (35.0%) in the primary end point, HiSCR 50 at week 16, with a posterior probability of observing a positive treatment difference versus placebo of 98.5% and 89.3%, respectively. Greater efficacies were also observed in the secondary end point of the achievement of pain NRS30 among baseline NRS ≥ 3 (34.5% and 34.8%, respectively, versus 12.9% of placebo) and an additional endpoint, HiSCR 75 (45.9% and 38.5%, respectively, versus 17.5% of placebo). Overall, all doses were generally safe and well-tolerated.

“In this hard-to-treat moderate-to-severe HS patient population that has failed anti-TNF therapy, lutikizumab300 mg every week and 300 mg every other week showed positive results versus PBO placebo,” concluded Kimball et al.

Study author Alexandra Kimball, MD, FAAD, spoke to Dermatology Times about the late-breaking data and shared some of the important highlights for dermatologists to know.

Reference

Kimball A, Ackerman L, Lima H, 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: 2024 American Academy of Dermatology Annual Meeting; March 8-12, 2024; San Diego, California.