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Lutikizumab Showed Positive Results in a Phase 2 Trial of Adults with Moderate to Severe Hidradenitis Suppurativa as Program Advances to Phase 3

Published: 2024-01-08 13:05:00 ET
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  • Phase 2 data in adults with hidradenitis suppurativa (HS) who had previously failed anti-TNF therapy who received lutikizumab (ABT-981) 300 mg weekly or 300 mg every other week showed higher response rates in HiSCR 50 at week 16 than those treated with placebo1,2
  • Higher response rates were also observed in patients receiving lutikizumab 300 mg weekly or 300 mg every other week than those treated with placebo in the secondary endpoint of skin pain NRS30 at week 16 among patients with baseline NRS≥31,2
  • HS is a chronic, often debilitating inflammatory skin disease that can form lumps, abscesses and scars under the arms, in the groin and other areas3,4,5,6,7
  • Program reflects AbbVie's leadership in immunology and history of investigating new options for patients with HS, where there remains a significant unmet medical need

NORTH CHICAGO, Ill., Jan. 8, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced Phase 2 results showing adults with moderate to severe hidradenitis suppurativa (HS) who had previously failed anti-TNF therapy who received lutikizumab (ABT-981) 300 mg every other week or 300 mg weekly achieved higher response rates (59.5 percent, nominal p=0.027 and 48.7 percent, nominal p=0.197, respectively) than placebo (35.0 percent) in the primary endpoint of achieving HS Clinical Response (HiSCR 50) at week 16. Based on these data, AbbVie will advance its clinical program of lutikizumab in HS to Phase 3.1,2

Lutikizumab is AbbVie's investigational, dual-variable-domain interleukin (IL) 1α/1β antagonist. Studies have shown IL 1α and 1β are elevated in HS lesions.8

"AbbVie continues to pioneer research in the pursuit of new treatment options for patients with hidradenitis suppurativa, a frequently overlooked, underserved, and often suffering patient population," said Roopal Thakkar, M.D., senior vice president, chief medical officer, global therapeutics, AbbVie. "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."

This study was a 16-week, Phase 2, randomized, double-blind, parallel group, placebo controlled, dose-ranging, multicenter study that evaluated the safety and efficacy of lutikizumab in 153 adult patients with moderate to severe HS who had previously failed anti-TNF therapy. Most patients (70.6 percent) had severe baseline Hurley Stage 3 disease – the most extensive form of HS – characterized by scarring, lesions and sinus tracts. Patients were randomized at baseline to receive one of three subcutaneous doses of lutikizumab (100 mg every other week, 300 mg every other week, or 300 mg every week) or placebo. The study's primary endpoint was an achievement of HiSCR 50 at week 16, and the secondary endpoint was skin pain NRS30 at week 16 among subjects with baseline NRS≥3.1  

In addition to achieving higher response rates in the primary endpoint and despite most patients having severe disease, the trial also showed patients receiving lutikizumab 300 mg weekly and 300 mg every other week achieved higher rates of improved skin pain via NRS30 and HiSCR75, a higher threshold of HS clinical response, compared to placebo. Lutikizumab 100 mg every other week did not show greater efficacy compared to placebo.1

Results from select endpoints are as follows:

Endpoints

(All at Week 16)

Response (%)

Response (%); Treatment Diff vs. PBO#

 P-value+1

PBO

(N=40)

Luti 100 mg EOW

(N=37)

Luti 300mg EOW

(N=37)

Luti 300mg EW

(N=39)

Primary

HiSCR 50

35.0

27.0

∆: -9.7

p=0.345

59.5

∆: 24.1

p=0.027

48.7

∆: 13.8

p=0.197

Secondary

Skin Pain NRS30*

N=31

12.9

N=27

22.2

∆: 9.4

p=0.330

N=29

34.5

∆: 21.8

p=0.039

N=23

34.8

∆: 19.8

p=0.066

Additional

HiSCR 75

17.5

16.2

∆: -2.2

p=0.795

45.9

∆: 28.2

p=0.005

38.5

∆: 21.0

p=0.031

#Cochran-Mantel-Haenszel test adjusted for the stratification factor (Baseline Hurley Stage