International journal of dermatology · 2010
A prospective open-label clinical trial of adalimumab for the treatment of hidradenitis suppurativa.
Клиническое исследование II фазыСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Amano Masahiro, Grant Annika, Kerdel Francisco A
Аннотация
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 < 0.05) only but no significant differences were found between baseline and week 2, 4, and 12. Comparison of baseline with week 12 VAS and DLQI scores failed to show statistically significant improvement. Adalimumab was well tolerated and there were no serious adverse events reported.
CONCLUSIONS: Our study demonstrated statistically clinical improvement is not observed in the treatment of HS with adalimumab. Future studies using higher doses of adalimumab are warranted.
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 < 0.05) only but no significant differences were found between baseline and week 2, 4, and 12. Comparison of baseline with week 12 VAS and DLQI scores failed to show statistically significant improvement. Adalimumab was well tolerated and there were no serious adverse events reported.
CONCLUSIONS: Our study demonstrated statistically clinical improvement is not observed in the treatment of HS with adalimumab. Future studies using higher doses of adalimumab are warranted.