January 08, 2024
AbbVie aims to bring another HS therapy after Humira, announced positive Phase 2 trial of lutikizumab
Positive outcomes have emerged from a Phase 2 trial of lutikizumab in adults with moderate to severe Hidradenitis Suppurativa (HS), marking a pivotal step as the program advances to Phase 3. The Phase 2 data showcases enhanced response rates in HiSCR 50 at week 16 among adults with HS who had previously encountered anti-TNF therapy, receiving lutikizumab (ABT-981) at either 300 mg weekly or 300 mg every other week, surpassing those treated with a placebo.
HS is a persistent inflammatory skin condition causing lumps, abscesses, and scarring in areas like the underarms and groin, poses a significant medical challenge, especially for those who have not found success with anti-TNF therapy.
Lutikizumab, AbbVie's investigational interleukin (IL) 1α/1β antagonist with dual-variable domains, has exhibited its potential by targeting elevated IL 1α and 1β levels in HS lesions.
AbbVie presented these Phase 2 findings, demonstrating that lutikizumab yielded response rates of 59.5 percent and 48.7 percent in the HiSCR 50 primary endpoint, outperforming the placebo's 35.0 percent. With this promising data, AbbVie is poised to propel lutikizumab into Phase 3 of its clinical program.
The 16-week Phase 2 study involved 153 adult patients grappling with moderate to severe HS, having previously failed anti-TNF therapy. Notably, 70.6 percent of patients had severe baseline Hurley Stage 3 disease, characterized by extensive scarring and lesions.
Randomized at the study's outset, patients received subcutaneous doses of lutikizumab (100 mg every other week, 300 mg every other week, or 300 mg every week) or a placebo. The primary endpoint was achieving HiSCR 50 at week 16, with the secondary endpoint focusing on skin pain NRS30 at week 16 for subjects with baseline NRS≥3.
Beyond achieving higher response rates in the primary endpoint, the trial demonstrated that patients receiving lutikizumab at 300 mg weekly and 300 mg every other week experienced improved rates in skin pain, measured through NRS30 and HiSCR75—a higher threshold of HS clinical response—compared to those on a placebo. However, the efficacy of lutikizumab at 100 mg every other week did not surpass that of the placebo.
All doses were generally well-tolerated, with a comparable percentage of subjects experiencing treatment-emergent adverse events across combined lutikizumab treatment arms (70.8 percent) and the placebo (75.0 percent).