Long-term clinical safety and efficacy of brodalumab in the treatment of Japanese patients with moderate-to-severe plaque psoriasis

the Japanese Brodalumab Study Group

研究成果: ジャーナルへの寄稿記事

21 引用 (Scopus)

抄録

Background: Brodalumab (KHK4827) is a human anti-interleukin-17-receptor A monoclonal antibody. In Japanese patients with moderate-to-severe plaque psoriasis, brodalumab showed rapid and robust efficacy and a favourable safety profile in a 12-week, phase 2, double-blind, randomized controlled trial. Objectives: To evaluate the long-term safety and efficacy of brodalumab, an extension of a phase 2 trial of Japanese patients with moderate-to-severe psoriasis was performed. Methods: Patients received open-label brodalumab 210 or 140 mg subcutaneously every 2 weeks for 52 weeks. Efficacy was measured using the Psoriasis Area and Severity Index (PASI) score and the static physician global assessment (sPGA) instrument. The endpoint of psoriatic arthritis was 20% improvement in American College of Rheumatology response criteria (ACR 20). The patients were also monitored for treatment-emergent adverse events (AEs), including serious AEs (SAEs). Results: Of 145 patients, 133 completed the study. The percentage of patients with ≥75% reduction of PASI scores (PASI 75), ≥90% (PASI 90) and 100% (PASI 100) at Week 52 (the last observation carried forward) were 94.4%, 87.5% and 55.6%, respectively, in the 210-mg group, and the corresponding values in the 140-mg group were 78.1%, 71.2% and 43.8%. At Week 52, 75.0% patients in 210-mg group achieved ACR 20, compared with 37.5% patients in 140-mg group. The most commonly reported AEs were nasopharyngitis (35.2%), upper respiratory tract inflammation (10.3%) and contact dermatitis (9.7%). Conclusion: Brodalumab showed a sustained clinical response and an acceptable safety profile through 52 weeks in Japanese patients with moderate-to-severe plaque psoriasis in this open-label extension study.

元の言語英語
ページ(範囲)1957-1960
ページ数4
ジャーナルJournal of the European Academy of Dermatology and Venereology
30
発行部数11
DOI
出版物ステータス出版済み - 11 1 2016

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Psoriasis
Safety
Therapeutics
Interleukin-17 Receptors
Nasopharyngitis
brodalumab
Psoriatic Arthritis
Contact Dermatitis
Respiratory System
Randomized Controlled Trials
Monoclonal Antibodies
Observation
Inflammation
Physicians

All Science Journal Classification (ASJC) codes

  • Dermatology
  • Infectious Diseases

これを引用

Long-term clinical safety and efficacy of brodalumab in the treatment of Japanese patients with moderate-to-severe plaque psoriasis. / the Japanese Brodalumab Study Group.

:: Journal of the European Academy of Dermatology and Venereology, 巻 30, 番号 11, 01.11.2016, p. 1957-1960.

研究成果: ジャーナルへの寄稿記事

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title = "Long-term clinical safety and efficacy of brodalumab in the treatment of Japanese patients with moderate-to-severe plaque psoriasis",
abstract = "Background: Brodalumab (KHK4827) is a human anti-interleukin-17-receptor A monoclonal antibody. In Japanese patients with moderate-to-severe plaque psoriasis, brodalumab showed rapid and robust efficacy and a favourable safety profile in a 12-week, phase 2, double-blind, randomized controlled trial. Objectives: To evaluate the long-term safety and efficacy of brodalumab, an extension of a phase 2 trial of Japanese patients with moderate-to-severe psoriasis was performed. Methods: Patients received open-label brodalumab 210 or 140 mg subcutaneously every 2 weeks for 52 weeks. Efficacy was measured using the Psoriasis Area and Severity Index (PASI) score and the static physician global assessment (sPGA) instrument. The endpoint of psoriatic arthritis was 20{\%} improvement in American College of Rheumatology response criteria (ACR 20). The patients were also monitored for treatment-emergent adverse events (AEs), including serious AEs (SAEs). Results: Of 145 patients, 133 completed the study. The percentage of patients with ≥75{\%} reduction of PASI scores (PASI 75), ≥90{\%} (PASI 90) and 100{\%} (PASI 100) at Week 52 (the last observation carried forward) were 94.4{\%}, 87.5{\%} and 55.6{\%}, respectively, in the 210-mg group, and the corresponding values in the 140-mg group were 78.1{\%}, 71.2{\%} and 43.8{\%}. At Week 52, 75.0{\%} patients in 210-mg group achieved ACR 20, compared with 37.5{\%} patients in 140-mg group. The most commonly reported AEs were nasopharyngitis (35.2{\%}), upper respiratory tract inflammation (10.3{\%}) and contact dermatitis (9.7{\%}). Conclusion: Brodalumab showed a sustained clinical response and an acceptable safety profile through 52 weeks in Japanese patients with moderate-to-severe plaque psoriasis in this open-label extension study.",
author = "{the Japanese Brodalumab Study Group} and Y. Umezawa and H. Nakagawa and Hiroaki Niiro and K. Ootaki",
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T1 - Long-term clinical safety and efficacy of brodalumab in the treatment of Japanese patients with moderate-to-severe plaque psoriasis

AU - the Japanese Brodalumab Study Group

AU - Umezawa, Y.

AU - Nakagawa, H.

AU - Niiro, Hiroaki

AU - Ootaki, K.

PY - 2016/11/1

Y1 - 2016/11/1

N2 - Background: Brodalumab (KHK4827) is a human anti-interleukin-17-receptor A monoclonal antibody. In Japanese patients with moderate-to-severe plaque psoriasis, brodalumab showed rapid and robust efficacy and a favourable safety profile in a 12-week, phase 2, double-blind, randomized controlled trial. Objectives: To evaluate the long-term safety and efficacy of brodalumab, an extension of a phase 2 trial of Japanese patients with moderate-to-severe psoriasis was performed. Methods: Patients received open-label brodalumab 210 or 140 mg subcutaneously every 2 weeks for 52 weeks. Efficacy was measured using the Psoriasis Area and Severity Index (PASI) score and the static physician global assessment (sPGA) instrument. The endpoint of psoriatic arthritis was 20% improvement in American College of Rheumatology response criteria (ACR 20). The patients were also monitored for treatment-emergent adverse events (AEs), including serious AEs (SAEs). Results: Of 145 patients, 133 completed the study. The percentage of patients with ≥75% reduction of PASI scores (PASI 75), ≥90% (PASI 90) and 100% (PASI 100) at Week 52 (the last observation carried forward) were 94.4%, 87.5% and 55.6%, respectively, in the 210-mg group, and the corresponding values in the 140-mg group were 78.1%, 71.2% and 43.8%. At Week 52, 75.0% patients in 210-mg group achieved ACR 20, compared with 37.5% patients in 140-mg group. The most commonly reported AEs were nasopharyngitis (35.2%), upper respiratory tract inflammation (10.3%) and contact dermatitis (9.7%). Conclusion: Brodalumab showed a sustained clinical response and an acceptable safety profile through 52 weeks in Japanese patients with moderate-to-severe plaque psoriasis in this open-label extension study.

AB - Background: Brodalumab (KHK4827) is a human anti-interleukin-17-receptor A monoclonal antibody. In Japanese patients with moderate-to-severe plaque psoriasis, brodalumab showed rapid and robust efficacy and a favourable safety profile in a 12-week, phase 2, double-blind, randomized controlled trial. Objectives: To evaluate the long-term safety and efficacy of brodalumab, an extension of a phase 2 trial of Japanese patients with moderate-to-severe psoriasis was performed. Methods: Patients received open-label brodalumab 210 or 140 mg subcutaneously every 2 weeks for 52 weeks. Efficacy was measured using the Psoriasis Area and Severity Index (PASI) score and the static physician global assessment (sPGA) instrument. The endpoint of psoriatic arthritis was 20% improvement in American College of Rheumatology response criteria (ACR 20). The patients were also monitored for treatment-emergent adverse events (AEs), including serious AEs (SAEs). Results: Of 145 patients, 133 completed the study. The percentage of patients with ≥75% reduction of PASI scores (PASI 75), ≥90% (PASI 90) and 100% (PASI 100) at Week 52 (the last observation carried forward) were 94.4%, 87.5% and 55.6%, respectively, in the 210-mg group, and the corresponding values in the 140-mg group were 78.1%, 71.2% and 43.8%. At Week 52, 75.0% patients in 210-mg group achieved ACR 20, compared with 37.5% patients in 140-mg group. The most commonly reported AEs were nasopharyngitis (35.2%), upper respiratory tract inflammation (10.3%) and contact dermatitis (9.7%). Conclusion: Brodalumab showed a sustained clinical response and an acceptable safety profile through 52 weeks in Japanese patients with moderate-to-severe plaque psoriasis in this open-label extension study.

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