A prospective open-label clinical trial of adalimumab for the treatment of hidradenitis suppurativa

Autor:	Annika Grant, Masahiro Amano, Francisco A. Kerdel
Rok vydání:	2010
Předmět:	medicine.medical_specialty Visual analogue scale business.industry Phases of clinical research Dermatology medicine.disease humanities Clinical trial Regimen Internal medicine Adalimumab Medicine Hidradenitis suppurativa business Adverse effect Prospective cohort study medicine.drug
Zdroj:	International Journal of Dermatology. 49:950-955
ISSN:	1365-4632 0011-9059
DOI:	10.1111/j.1365-4632.2010.04545.x
Popis:	Summary Objective To evaluate the safety and efficacy of adalimumab for the management of hidradenitis suppurativa (HS). Methods In a prospective open-label phase II study, adalimumab was administered subcutaneously in a dose of 160 mg induction regimen at week 0, followed by 80 mg at week 1, and 40 mg at alternate weeks for 12 weeks in 10 patients. The patients were followed up to 13 weeks and their disease activity was assessed using the HS Severity Index (HSSI) as well as with the numbers of daily dressing changes, the Visual Analogue Scale (VAS), Dermatologic Life Quality Index (DLQI), and Physician’s Global Assessment of disease severity (PGA). Results Ten patients were enrolled in this study. Of these, six patients completed the 12-week treatment period. A ≥ 50% decrease of HSSI score was not found in any of the patients at week 2, 4, 8, and 12. None of the 10 patients was classified as a responder at week 12 compared with baseline. Statistically significant difference in HSSI score was found between baseline and week 8 (P
Databáze:	OpenAIRE
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