Shinichi Imafuku1, Chika Ohata2, Yukari Okubo3, Rie Tobita3, Hidehisa Saeki4, Tomotaka Mabuchi5, Yuki Hashimoto6, Kenta Murotani7, Hiroki Kitabayashi8, Yasumasa Kanai8. 1. Department of Dermatology, Fukuoka University Faculty of Medicine, Fukuoka, Japan. Electronic address: dermatologist@mac.com. 2. Department of Dermatology, Osaka General Medical Center, Osaka, Japan. 3. Department of Dermatology, Tokyo Medical University, Tokyo, Japan. 4. Department of Dermatology, Nippon Medical School, Tokyo, Japan. 5. Department of Dermatology, Tokai University School of Medicine, Kanagawa, Japan. 6. Department of Dermatology, Toho University School of Medicine, Tokyo, Japan. 7. Biostatistics Center, Kurume University, Fukuoka, Japan. 8. Medical Affairs, Kyowa Kirin Co., Ltd., Tokyo, Japan.
Abstract
BACKGROUND: Real-life evidence on the quality of treatment with brodalumab in patients with plaque psoriasis based on patient-reported outcomes remains limited. OBJECTIVE: To assess the effectiveness of brodalumab in achieving treatment satisfaction for real-life Japanese patients with psoriasis. METHODS: As part of a single-arm, open-label, multicenter, prospective study (ProLOGUE), Psoriasis Area and Severity Index (PASI) scores, body surface area (BSA), and Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) domain scores were assessed at baseline and Weeks 12 and 48 of brodalumab treatment. Patient Global Assessment (PtGA) scores were captured at Weeks 12 and 48. RESULTS: Seventy-five patients were enrolled, of whom 73 received brodalumab. PASI scores and BSA significantly reduced from baseline at Weeks 12 and 48 (all P < 0.0001). Most (90%) patients felt the treatment was effective on the PtGA scale at Weeks 12 and 48. TSQM-9 domain scores significantly improved at Weeks 12 and 48 (all P < 0.0001). A PASI score of ≤ 2 was suggested as a treatment goal for biologic treatment of psoriasis from a receiver operating characteristic curve analysis, although some of the TSQM-9 domain scores did not improve in patients achieving this goal. No new safety signals were observed. CONCLUSION: Treatment with brodalumab was associated with improved objective symptoms and satisfaction in Japanese patients with psoriasis. A PASI score of ≤ 2 as a goal for biologic treatment of psoriasis may be feasible, although achieving this PASI goal alone may be insufficient to clearly improve long-term patient satisfaction (Japan Registry of Clinical Trials identifier: jRCTs031180037).
BACKGROUND: Real-life evidence on the quality of treatment with brodalumab in patients with plaque psoriasis based on patient-reported outcomes remains limited. OBJECTIVE: To assess the effectiveness of brodalumab in achieving treatment satisfaction for real-life Japanese patients with psoriasis. METHODS: As part of a single-arm, open-label, multicenter, prospective study (ProLOGUE), Psoriasis Area and Severity Index (PASI) scores, body surface area (BSA), and Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) domain scores were assessed at baseline and Weeks 12 and 48 of brodalumab treatment. Patient Global Assessment (PtGA) scores were captured at Weeks 12 and 48. RESULTS: Seventy-five patients were enrolled, of whom 73 received brodalumab. PASI scores and BSA significantly reduced from baseline at Weeks 12 and 48 (all P < 0.0001). Most (90%) patients felt the treatment was effective on the PtGA scale at Weeks 12 and 48. TSQM-9 domain scores significantly improved at Weeks 12 and 48 (all P < 0.0001). A PASI score of ≤ 2 was suggested as a treatment goal for biologic treatment of psoriasis from a receiver operating characteristic curve analysis, although some of the TSQM-9 domain scores did not improve in patients achieving this goal. No new safety signals were observed. CONCLUSION: Treatment with brodalumab was associated with improved objective symptoms and satisfaction in Japanese patients with psoriasis. A PASI score of ≤ 2 as a goal for biologic treatment of psoriasis may be feasible, although achieving this PASI goal alone may be insufficient to clearly improve long-term patient satisfaction (Japan Registry of Clinical Trials identifier: jRCTs031180037).