Effectiveness of Long-Term Treatment with Brodalumab on Anxiety or Depressive Symptoms in Japanese Patients with Psoriasis: The ProLOGUE Study

Chika Ohata; Yasumasa Kanai; Kenta Murotani; Fumikazu Yamazaki; Hidetoshi Takahashi; Yayoi Tada; Tomotaka Mabuchi; Yoko Mizutani; Takanobu Nomura; Shinichi Imafuku

doi:10.1007/s13555-023-00909-z

Effectiveness of Long-Term Treatment with Brodalumab on Anxiety or Depressive Symptoms in Japanese Patients with Psoriasis: The ProLOGUE Study

Dermatol Ther (Heidelb). 2023 Apr;13(4):1039-1052. doi: 10.1007/s13555-023-00909-z. Epub 2023 Mar 6.

Authors

Chika Ohata^{1

2}, Yasumasa Kanai³, Kenta Murotani⁴, Fumikazu Yamazaki⁵, Hidetoshi Takahashi⁶, Yayoi Tada⁷, Tomotaka Mabuchi⁸, Yoko Mizutani⁹, Takanobu Nomura³, Shinichi Imafuku¹⁰

Affiliations

¹ Department of Dermatology, Kurume University School of Medicine, 67 Asahi-machi, Kurume-shi, Fukuoka, 830-0011, Japan. ohata.chika@gmail.com.
² Department of Dermatology, Osaka General Medical Center, 3-1-56 Bandaihigashi, Sumiyoshi, Osaka, 558-8558, Japan. ohata.chika@gmail.com.
³ Medical Affairs, Kyowa Kirin Co., Ltd., 1-9-2 Otemachi, Chiyoda-ku, Tokyo, 100-0004, Japan.
⁴ Biostatistics Center, Kurume University, 67 Asahi-machi, Kurume-shi, Fukuoka, 830-0011, Japan.
⁵ Department of Dermatology, Kansai Medical University, 2-5-1 Shin-machi, Hirakata-shi, Osaka, 573-1010, Japan.
⁶ Takagi Dermatological Clinic, Nishi 3 Minami 4-16, Obihiro-shi, Hokkaido, 080-0013, Japan.
⁷ Department of Dermatology, Teikyo University School of Medicine, 2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605, Japan.
⁸ Department of Dermatology, Tokai University School of Medicine, 143 Shimokasuya, Isehara-shi, Kanagawa, 259-1193, Japan.
⁹ Department of Dermatology, Gifu University Graduate School of Medicine, 1-1 Yanagido, Gifu-shi, Gifu, 501-1193, Japan.
¹⁰ Department of Dermatology, Faculty of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan.

Abstract

Introduction: Evidence on treatment effectiveness in patients with psoriasis having anxiety or depressive symptoms helps shared decision-making. This single-arm, open-label, prospective study-ProLOGUE-was conducted to assess the effectiveness of brodalumab on self-assessed anxiety and depressive symptoms in Japanese patients with psoriasis.

Methods: Patients aged ≥ 18 years with plaque psoriasis without peripheral arthritis symptoms who had responded inadequately to current therapies were enrolled at 15 Japanese facilities and received brodalumab 210 mg subcutaneously.

Results: A total of 73 patients were enrolled (male, 82%; median age, 54 years). The proportion of patients without anxiety symptoms changed significantly from baseline (72.6%) to weeks 12 (88.9%, p = 0.008) and 48 (87.7%, p = 0.02); the proportion of patients without depressive symptoms did not change significantly. The Generalized Anxiety Disorder-7 score (median [quartile(Q)1-Q3], 1.0 [0.0-5.0] at baseline; 0.0 [0.0-2.0] at week 12, p = 0.008; and 0.0 [0.0-1.0] at week 48, p = 0.007) and Patient Health Questionnaire-8 score (median [Q1-Q3], 2.0 [0.0-4.0] at baseline; 1.0 [0.0-4.0] at week 12, p = 0.03; and 0.0 [0.0-2.0] at week 48, p = 0.004) significantly decreased after treatment. The median Psoriasis Area and Severity Index scores after treatment were < 1, irrespective of the presence of baseline anxiety or depressive symptoms. At week 12, the health-related quality of life was more impaired in patients with versus without baseline depressive symptoms, which largely resolved at week 48.

Conclusions: Brodalumab treatment resulted in the reduction of the levels of self-assessed anxiety and depressive symptoms in Japanese patients with psoriasis. Unlike anxiety symptoms, depressive symptoms did not resolve completely with brodalumab treatment. Patients with psoriasis having depressive symptoms may require long-term treatment.

Trial registration: UMIN Clinical Trials Registry identifier: UMIN000027783, Japan Registry of Clinical Trials identifier: jRCTs031180037.

Keywords: Anxiety symptoms; Brodalumab; Depressive symptoms; Health-related quality of life; Psoriasis.