Lutikizumab shows promise in refractory hidradenitis suppurativa

Treatment with lutikizumab appears to improve outcomes in patients with moderate-to-severe hidradenitis suppurativa (HS) who have not responded to anti-TNF therapy, according to a phase II trial.

The trial included a 35-day screening period, a 16-week treatment period, and a 9-week safety follow-up. A total of 153 adults (mean age 40.5 years, 61.4 percent female) who had had HS for at least 12 months and experienced anti-TNF treatment failure participated in the study.

The patients were randomly assigned to receive lutikizumab at 300 mg every week (n=39), lutikizumab at 300 mg every other week (n=37), lutikizumab at 100 mg every other week (n=37), or placebo every week (n=40). Treatment was administered subcutaneously for 16 weeks.

At baseline, the mean total abscess and inflammatory nodule (AN) count was 18.2, and the mean draining tunnel count was 6.3. Most participants (70.6 percent) had Hurley stage III disease.

The primary endpoint was Hidradenitis Suppurativa Clinical Response 50 (HiSCR 50), defined as a minimum of 50-percent improvement from baseline in AN count without an increase in abscesses or draining tunnels, at week 16. The secondary endpoint was a ≥30-percent reduction and ≥1-unit reduction from baseline in Patient’s Global Assessment of skin pain (Numerical Rating Scale [NRS] 30) among patients with a baseline NRS ≥3. Additional endpoints included HiSCR 75 and HiSCR 90, change in draining tunnels, and change in Dermatology Life Quality Index (DLQI) total scores.

At week 16, HiSCR 50 was achieved in 48.7 percent, 59.5 percent, and 27 percent of participants who received lutikizumab 300 mg every week, 300 mg every other week, and 100 mg every other week, respectively, as opposed to 35 percent of those on placebo. The posterior probabilities of positive treatment effect vs placebo were 89.3 percent, 98.5 percent, and 22.8 percent with the respective lutikizumab dosing regimens.

Among participants with baseline NRS scores of ≥3, NRS30 response occurred for 34.5 percent who received lutikizumab 300 mg every other week and 34.8 percent of those who received lutikizumab 300 mg every week vs 12.9 percent of those who received placebo.

There were no documented deaths or treatment-emergent adverse events of neutropenia, serious hypersensitivity reactions, major adverse cardiovascular events, or opportunistic infections.