Long‐term efficacy and safety results from an open‐label phase III study (UNCOVER‐J) in Japanese plaque psoriasis patients: impact of treatment withdrawal and retreatment of ixekizumab

• Published in: Journal of the European Academy of Dermatology and Venereology 2019-03, Vol.33 (3), p.568-576
• Main Authors: Umezawa, Y., Torisu‐Itakura, H., Morisaki, Y., ElMaraghy, H., Nakajo, K., Akashi, N., Saeki, H., Akasaka, Toshihide, Asano, Yoshihide, Etoh, Takafumi, Fujita, Yasuyuki, Hashimoto, Takashi, Higashiyama, Mari, Igarashi, Atsuyuki, Ihn, Hironobu, Iwatsuki, Keiji, Kabashima, Kenji, Kawada, Akira, Kawashima, Makoto, Nakamura, Koichiro, Okubo, Yukari, Okuyama, Ryuhei, Ozawa, Akira, Sayama, Koji, Seishima, Mariko, Shiohara, Tetsuo, Takahara, Masakazu, Takahashi, Hidetoshi, Takehara, Kazuhiko, Tanese, Keiji, Tani, Mamori, Watanabe, Hideaki, Yamanaka, Keiichi
• Format: Article
• Language: English
• Subjects: Adult; Antibodies, Monoclonal, Humanized - adverse effects; Antibodies, Monoclonal, Humanized - therapeutic use; Dermatologic Agents - adverse effects; Dermatologic Agents - therapeutic use; Female; Humans; Japan; Male; Middle Aged; Original; Psoriasis; Psoriasis - drug therapy; Recurrence; Retreatment; Severity of Illness Index; Time Factors; Treatment Outcome; Withholding Treatment
• ISSN: 0926-9959; 1468-3083
• DOI: 10.1111/jdv.15292

Background Long‐term management of moderate‐to‐severe psoriasis is usually discussed in terms of continuous administration; however, there are many situations in clinical practice where treatment may be withdrawn with subsequent retreatment. Objective To assess the clinical course after ixekizumab treatment withdrawal and retreatment, as well as the effectiveness of ixekizumab retreatment, in Japanese patients with plaque psoriasis. Methods This single‐arm, open‐label study (UNCOVER‐J; NCT01624233) comprised 78 patients with plaque psoriasis. After ixekizumab treatment (160‐mg loading dose, 80 mg every 2 weeks for the first 12 weeks, and then 80 mg every 4 weeks (IXE Q4W) until Week 52), 70 patients achieved a Psoriasis Area Severity Index (PASI)75 response at Week 52. These 70 patients withdrew from ixekizumab treatment from Weeks 52 to 100. Patients who relapsed (PASI ≤50) during the Treatment Withdrawal Period were retreated with IXE Q4W for 192 weeks. Results At Weeks 52, 76 and 100, PASI75 response rates were 100%, 26% and 7%; PASI90 response rates were 87%, 11% and 3%; and PASI100 response rates were 53%, 0% and 0%. After treatment withdrawal, 87% of patients relapsed; median time to relapse was 143 days. After 12 weeks of retreatment with IXE Q4W, 83% of relapsed patients achieved PASI75, 68% achieved PASI90 and 25% achieved PASI100; improvements were maintained up to 120 weeks of retreatment. Treatment‐emergent adverse events and serious adverse events were reported in 56% and 4% of patients during the Treatment Withdrawal Period, and in 88% and 14% of patients during the Retreatment Period. Conclusion In patients withdrawn from ixekizumab after achieving PASI75, approximately half relapsed within 5 months of withdrawal; however, most patients recaptured response within 12 weeks, and response was maintained for up to 120 weeks of retreatment.