A Phase II Open-Label Study of Bermekimab in Patients with Hidradenitis Suppurativa Shows Resolution of Inflammatory Lesions and Pain
| Autor: | Alice B. Gottlieb, Jessica A. Kaffenberger, Edgar Gonzalez, Diego Montes, Michael H. Gold, Chad Babcock, J Simard, Liliam Hernandez, Francisco A. Kerdel, Gilberto Jimenez, Giancarlo Guido, Nicola E. Natsis, Seth B Forman, Kathryn Lucas |
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| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Adult Male medicine.medical_specialty Visual analogue scale Injections Subcutaneous Pain Dermatology Antibodies Monoclonal Humanized Biochemistry Gastroenterology Severity of Illness Index Drug Administration Schedule 03 medical and health sciences 0302 clinical medicine Pharmacokinetics Internal medicine Interleukin-1alpha Severity of illness Medicine Humans Hidradenitis suppurativa Adverse effect Molecular Biology Pain Measurement biology Dose-Response Relationship Drug business.industry C-reactive protein Cell Biology Dermatology Life Quality Index Middle Aged medicine.disease Hidradenitis Suppurativa Injection Site Reaction Clinical trial 030104 developmental biology Treatment Outcome 030220 oncology & carcinogenesis biology.protein Quality of Life Female business |
| Zdroj: | The Journal of investigative dermatology. 140(8) |
| ISSN: | 1523-1747 |
| Popis: | 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% (P0.004) and 46% (P0.001) 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% (P0.001) and 54% (P0.001) 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. |
| Databáze: | OpenAIRE |
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