Lutikizumab Shows Promise in Phase 2 Trial for Hidradenitis Suppurativa, Moves to Phase 3

A recent study conducted by AbbVie has revealed promising Phase 2 trial results for adults with moderate to severe hidradenitis suppurativa (HS) who previously did not respond to anti-TNF therapy. The study evaluated lutikizumab (ABT-981), an investigational interleukin (IL) 1α/1β antagonist, administered either 300 mg weekly or 300 mg every other week. The results demonstrated that these patients achieved higher response rates compared to the placebo group when measured by HiSCR 50 and improvements in skin pain NRS30 at week 16.

Hidradenitis suppurativa is a chronic inflammatory skin condition characterized by painful lumps, abscesses, and scarring. It particularly affects areas such as the armpits and groin. Despite advancements, there remains a significant unmet need for effective treatments for this debilitating disease.

The Phase 2 trial was a 16-week, randomized, double-blind, parallel-group study involving 153 adults with moderate to severe HS. These participants had previously failed anti-TNF therapy and were randomized to receive one of three subcutaneous doses of lutikizumab or a placebo. The primary endpoint of the study was the achievement of HiSCR 50 at week 16, which indicates a 50% reduction in abscess and inflammatory nodule count without an increase in abscesses or draining fistulas compared to baseline.

Secondary endpoints included skin pain NRS30, an assessment of at least a 30% reduction in skin pain from baseline. The results were promising, showing that patients receiving 300 mg of lutikizumab, either weekly or bi-weekly, experienced significant improvements across the primary and secondary endpoints compared to those receiving a placebo.

Further analysis revealed that most participants had severe Hurley Stage 3 disease at baseline, characterized by extensive scarring and sinus tracts. Despite the severity, the higher doses of lutikizumab showed substantial efficacy. Particularly, the 300 mg weekly and every other week doses significantly outperformed the placebo in HiSCR 50 and skin pain NRS30, with the 100 mg every other week dose not showing a notable efficacy.

Safety outcomes indicated that lutikizumab was generally well-tolerated across doses, with treatment-emergent adverse events (TEAEs) being similar in both the combined lutikizumab treatment groups and the placebo group. Common adverse events included HS, diarrhea, headaches, pruritus, contact dermatitis, eczema, and nasopharyngitis. Serious adverse events were infrequent and occurred at slightly higher rates in the treatment group compared to placebo, but there were no deaths, instances of neutropenia, or severe laboratory abnormalities reported.

The results highlight the potential of lutikizumab as a treatment for patients with HS, showcasing significant improvements in clinical outcomes and manageable safety concerns. AbbVie plans to proceed to Phase 3 trials to further investigate and potentially bring this new treatment option to patients suffering from this debilitating condition. These findings underscore AbbVie's commitment to advancing care in immunological conditions and addressing the needs of patients with severe skin diseases.