TY - JOUR
T1 - Long-term efficacy and safety results from an open-label phase III study (UNCOVER-J) in Japanese plaque psoriasis patients
T2 - impact of treatment withdrawal and retreatment of ixekizumab
AU - the Japanese Ixekizumab Study Group
AU - Umezawa, Y.
AU - Torisu-Itakura, H.
AU - Morisaki, Y.
AU - ElMaraghy, H.
AU - Nakajo, K.
AU - Akashi, N.
AU - Saeki, H.
AU - Akasaka, Toshihide
AU - Asano, Yoshihide
AU - Etoh, Takafumi
AU - Fujita, Yasuyuki
AU - Hashimoto, Takashi
AU - Higashiyama, Mari
AU - Igarashi, Atsuyuki
AU - Ihn, Hironobu
AU - Iwatsuki, Keiji
AU - Kabashima, Kenji
AU - Kawada, Akira
AU - Kawashima, Makoto
AU - Nakamura, Koichiro
AU - Okubo, Yukari
AU - Okuyama, Ryuhei
AU - Ozawa, Akira
AU - Sayama, Koji
AU - Seishima, Mariko
AU - Shiohara, Tetsuo
AU - Takahara, Masakazu
AU - Takahashi, Hidetoshi
AU - Takehara, Kazuhiko
AU - Tanese, Keiji
AU - Tani, Mamori
AU - Watanabe, Hideaki
AU - Yamanaka, Keiichi
N1 - Funding Information:
Medical writing assistance was provided by Cassandra Haley, PhD, CMPP and Luke Carey, PhD of ProScribe – Envision Pharma Group, and was funded by Eli Lilly Japan K.K. ProScribe’s services complied with international guidelines for Good Publication Practice (GPP3).
Funding Information:
Funding source This study was sponsored by Eli Lilly Japan K.K., the manufacturer/licensee of Taltz?. Medical writing assistance was provided by Cassandra Haley, PhD, CMPP and Luke Carey, PhD of ProScribe ? Envision Pharma Group, and was funded by Eli Lilly Japan K.K. ProScribe's services complied with international guidelines for Good Publication Practice (GPP3). Other contributors/acknowledgements: The authors would like to thank all study participants and the Japanese Ixekizumab Study Group: Toshihide Akasaka of Iwate Medical University Hospital, Yoshihide Asano of The University of Tokyo Hospital, Takafumi Etoh of Tokyo Teishin Hospital, Yasuyuki Fujita of Hokkaido University Hospital, Takashi Hashimoto of Kurume University Hospital, Mari Higashiyama of Nissay Hospital, Atsuyuki Igarashi of NTT Medical Center Tokyo, Hironobu Ihn of Kumamoto University, Keiji Iwatsuki of Okayama University Hospital, Kenji Kabashima of Kyoto University Hospital, Akira Kawada of Kinki University Faculty of Medicine, Makoto Kawashima of Tokyo Women's Medical University, Koichiro Nakamura of Saitama Medical University Hospital, Yukari Okubo of Tokyo Medical University Hospital, Ryuhei Okuyama of Shinshu University School of Medicine, Akira Ozawa of Tokai University School of Medicine, Koji Sayama of Ehime University Graduate School of Medicine, Mariko Seishima of Gifu University Graduate School of Medicine, Tetsuo Shiohara of Kyorin University Hospital, Masakazu Takahara of Kyusyu University Hospital, Hidetoshi Takahashi of Asahikawa Medical University Hospital, Kazuhiko Takehara of Kanazawa University Hospital, Keiji Tanese of Keio University Hospital, Mamori Tani of Osaka University Hospital, Yoshinori Umezawa of The Jikei University Hospital, Hideaki Watanabe of Showa University School of Medicine, and Keiichi Yamanaka of Mie University Graduate School of Medicine. Role of the sponsor: Eli Lilly Japan K.K. was involved in the study design, data collection, data analysis and preparation of the manuscript.
Publisher Copyright:
© 2018 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.
PY - 2019/3
Y1 - 2019/3
N2 - 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.
AB - 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.
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U2 - 10.1111/jdv.15292
DO - 10.1111/jdv.15292
M3 - Article
C2 - 30325534
AN - SCOPUS:85056405806
VL - 33
SP - 568
EP - 576
JO - Journal of the European Academy of Dermatology and Venereology
JF - Journal of the European Academy of Dermatology and Venereology
SN - 0926-9959
IS - 3
ER -
