A Phase II Open-Label Study of Bermekimab in Patients with Hidradenitis Suppurativa Shows Resolution of Inflammatory Lesions and Pain

• Published in: Journal of investigative dermatology Vol. 140; no. 8; pp. 1538 - 1545.e2
• Main Authors: Gottlieb, Alice, Natsis, Nicola E., Kerdel, Francisco, Forman, Seth, Gonzalez, Edgar, Jimenez, Gilberto, Hernandez, Liliam, Kaffenberger, Jessica, Guido, Giancarlo, Lucas, Kathryn, Montes, Diego, Gold, Michael, Babcock, Chad, Simard, John
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.08.2020
• Subjects: Adult; Antibodies, Monoclonal, Humanized - administration & dosage; Antibodies, Monoclonal, Humanized - adverse effects; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Hidradenitis Suppurativa - complications; Hidradenitis Suppurativa - diagnosis; Hidradenitis Suppurativa - drug therapy; Hidradenitis Suppurativa - immunology; Humans; Injection Site Reaction - epidemiology; Injection Site Reaction - etiology; Injections, Subcutaneous; Interleukin-1alpha - antagonists & inhibitors; Interleukin-1alpha - immunology; Male; Middle Aged; Pain - diagnosis; Pain - drug therapy; Pain - immunology; Pain Measurement; Quality of Life; Severity of Illness Index; Treatment Outcome; VAS; HS; PGA; AE; HiSCR; SAE
• ISSN: 0022-202X; 1523-1747
• DOI: 10.1016/j.jid.2019.10.024

The objective of this study was to evaluate the safety and efficacy of bermekimab, an IL-1α inhibitor, in the treatment of hidradenitis suppurativa (HS). This study was a phase II, multicenter, open-label study of two dose cohorts of bermekimab in patients with moderate-to-severe HS who are naïve to or have failed prior anti-TNF therapy. Patients with HS (n = 42) were divided into groups A and B based on whether or not they had previously failed an anti-TNF therapy. In group A (n = 24), bermekimab was administered subcutaneously at a dose of 400 mg weekly (13 doses) in patients who had previously failed anti-TNF therapy; in group B (n = 18), bermekimab was administered subcutaneously at a dose of 400 mg weekly (13 doses) in patients who were anti-TNF naïve. Bermekimab, previously found to be effective in treating HS, was evaluated using a subcutaneous formulation in patients with HS naïve to or having failed anti-TNF therapy. There were no bermekimab-related adverse events with the exception of injection site reactions. Bermekimab was effective despite treatment history, with 61% and 63% of patients naïve to and having failed anti-TNF therapy, respectively, achieving HS clinical response after 12 weeks of treatment. A significant reduction in abscesses and inflammatory nodules of 60% (P < 0.004) and 46% (P < 0.001) was seen in anti-TNF naïve and anti-TNF failure groups, respectively. Clinically and statistically significant reduction was seen in patients experiencing pain, with the Visual Analogue Scale pain score reducing by 64% (P < 0.001) and 54% (P < 0.001) in the anti-TNF naïve and anti-TNF failure groups, respectively. IL-1α is emerging as an important clinical target for skin disease, and bermekimab may represent a new therapeutic option for treating moderate-to-severe HS.