Adalimumab in Japanese patients with moderate to severe chronic plaque psoriasis: Efficacy and safety results from a Phase II/III randomized controlled study |
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| Authors: | Akihiko ASAHINA Hidemi NAKAGAWA Takafumi ETOH Mamitaro OHTSUKI THE ADALIMUMAB M‐ STUDY GROUP |
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| Affiliation: | 1. National Hospital Organization Sagamihara National Hospital, Kanagawa;2. The Jikei University School of Medicine;3. Tokyo Teishin Hospital, Tokyo;4. Jichi Medical University School of Medicine, Tochigi, Japan;5. The Adalimumab M04‐688 study investigators: Hajime Iizuka (Asahikawa Medical College);6. Daisuke Sawamura, Riichiro Abe (Hokkaido University School of Medicine);7. Toshihide Akasaka (Iwate Medical University School of Medicine);8. Ryuhei Okuyama (Tohoku University School of Medicine);9. Fumio Kaneko, Koichiro Nakamura (Fukushima Medical University School of Medicine);10. Kenji Takamori (Juntendo University Urayasu Hospital);11. Tadashi Terui (Nihon University School of Medicine);12. Atsuyuki Igarashi (Kanto Medical Center NTT EC);13. Makoto Kawashima (Tokyo Women’s Medical University);14. Ryoji Tsuboi (Tokyo Medical University);15. Mayumi Komine (The University of Tokyo Faculty of Medicine);16. Tsuyoshi Mitsuishi (Nippon Medical School);17. Kazuhito Hayakawa (Kyorin University Faculty of Medicine);18. Hirohiko Sueki, Amane Kitami (Showa University School of Medicine);19. Makoto Adachi (Kanto Rosai Hospital);20. Akira Ozawa (Tokai University School of Medicine);21. Hideki Mukai (Yokohama Rosai Hospital);22. Kazuhiko Takehara (Kanazawa University College of Medical, Pharmaceutical and Health Sciences);23. Hajime Takagi, Yoshiro Ichiki (Gifu University School of Medicine);24. Kayoko Iwasaki (Shizuoka Kousei Hospital);25. Masahiro Takigawa (Hamamatsu University School of Medicine);26. Akimichi Morita (Nagoya City University Medical School);27. Koji Habe (Mie University Faculty of Medicine);28. Saburo Kishimoto (Kyoto Prefectural University of Medicine);29. Kenzo Takahaski (Kyoto University Faculty of Medicine);30. Shigetoshi Sano, Mamori Tani, Shoji Taniguchi, Yukiko Shoda (Sumitomo Hospital);31. Mari Higashiyama (Nissay Hospital);32. Masahito Tarutani (Osaka University Faculty of Medicine);33. Kiyofumi Yamanishi (Hyogo College of Medicine);34. Takashi Ohno (Okayama University Faculty of Medicine);35. Yoshikazu Kameyoshi (Hiroshima University Faculty of Medicine);36. Masahiko Muto (Yamaguchi University School of Medicine);37. Hajimu Oura (The University of Tokushima Faculty of Medicine);38. Hajime Kodama (Kochi University Medical School);39. Shinichiro Yasumoto (Kurume University School of Medicine);40. Juichiro Nakayama (Fukuoka University Faculty of Medicine);41. Hisashi Kokuba, Masakazu Takahara (Kyushu University School of Medicine);42. Shinichi Sato (Nagasaki University School of Medicine);43. Yuko Higashi, Noriko Yoshii (Kagoshima University Faculty of Medicine). The committee for evaluation of efficacy and safety: Nobuyuki Miyasaka and Yasuyuki Yoshizawa (Tokyo Medical and Dental University). Central respiratory evaluation members for chest X‐ray: Yakuyuki Yoshizawa, Shuji Miyake, Yutaka Usui, Naohiko Inase, Nobuyuki Koyama, Susumu Isogai, Yasunari Miyazaki, Yoshio Otani, and Masashi Furuie (Tokyo Medical and Dental University). |
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| Abstract: | Incidence of psoriasis vulgaris in Asians is estimated at 0.05–0.3%. Studies in North America and Europe demonstrated that adalimumab, a fully human, recombinant, immunoglobulin G1 monoclonal antibody, was efficacious and well‐tolerated in patients with chronic plaque psoriasis. This 24‐week, placebo‐controlled study evaluated the efficacy and safety of three different dosing regimens of adalimumab in Japanese patients with moderate to severe chronic plaque psoriasis (n = 169). Patients were randomized to receive adalimumab 40 mg every other week (eow), adalimumab 80‐mg loading dose at week 0 followed by adalimumab 40 mg eow starting at week 2, adalimumab 80 mg eow, or placebo eow given as s.c. injections. The primary efficacy endpoint was the percentage of patients achieving a 75% or greater improvement in Psoriasis Area and Severity Index (PASI 75) score at week 16. At week 16, PASI 75 response rates were significantly greater for all three adalimumab groups (40 mg eow: 57.9%, P < 0.001; 40 mg eow plus loading dose: 62.8%, P < 0.001; 80 mg eow: 81.0%, P < 0.001) versus placebo (4.3%). As early as week 4, the 40‐mg eow plus loading dose and 80‐mg eow groups achieved significantly greater PASI 75 response rates compared with placebo. Injection‐site reactions and hepatic events occurred in greater percentages of adalimumab‐treated patients compared with placebo. Adalimumab therapy demonstrated efficacy and safety at all three dosage regimens. Rapid response rate in patients receiving 40 mg eow plus loading dose supports using an 80‐mg loading dose in the treatment of psoriasis. |
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| Keywords: | adalimumab Japanese plaque psoriasis tumor necrosis factor antagonist |
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