Long term safety and efficacy of ligelizumab in the treatment of Japanese patients with chronic spontaneous urticaria
Background: In Japan, urticaria is a common skin disorder with chronic spontaneous urticaria (CSU) being the most frequent subtype. This study evaluated the safety of ligelizumab (anti-IgE monoclonal antibody) in Japanese CSU patients. Methods: This was a Phase 3 multicenter, open-label, single-arm...
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Elsevier
2025-01-01
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| Series: | Allergology International |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S1323893024001072 |
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| author | Hidetoshi Takahashi Atsushi Fukunaga Koremasa Hayama Takayoshi Sasajima Ayako Fujishige Ryohei Ichishita Naoko Tomimatsu Eva Hua Vineeth Varanasi Alis Burciu Michihiro Hide Thomas Severin |
| author_facet | Hidetoshi Takahashi Atsushi Fukunaga Koremasa Hayama Takayoshi Sasajima Ayako Fujishige Ryohei Ichishita Naoko Tomimatsu Eva Hua Vineeth Varanasi Alis Burciu Michihiro Hide Thomas Severin |
| author_sort | Hidetoshi Takahashi |
| collection | DOAJ |
| description | Background: In Japan, urticaria is a common skin disorder with chronic spontaneous urticaria (CSU) being the most frequent subtype. This study evaluated the safety of ligelizumab (anti-IgE monoclonal antibody) in Japanese CSU patients. Methods: This was a Phase 3 multicenter, open-label, single-arm 52-week study in adult Japanese patients with CSU inadequately controlled with locally approved doses of H1-antihistamines. The primary objective reported the safety of ligelizumab 120 mg subcutaneously every 4 weeks, by evaluation of treatment emergent adverse events (TEAE). Secondary objectives evaluated efficacy by absolute change from baseline (CFB) in weekly urticaria activity score (UAS7), and the proportion of patients with UAS7 = 0, and dermatology life quality index (DLQI) = 0–1 over time. Results: From a total of 66 CSU patients (80.3% females; mean ± SD age 46.4 ± 13.2 years; mean ± SD baseline UAS7 28.7 ± 6.5) enrolled, 53 patients (80.3%) reported ≥1 TEAE during the study, with no severe or serious adverse events, no anaphylaxis events and low frequency of TEAEs leading to treatment discontinuations (6.1%). Absolute mean CFB of UAS7 showed a rapid onset of response at Week 4 (−14.2) with further improvement until end of treatment at Week 52 (−22.9). The proportion of patients achieving UAS7 = 0 improved over time (14.5% at Week 4; 50.0% at Week 52). A sizable proportion of patients achieved DLQI 0–1 with the first dose of ligelizumab (38.5%), and improvements observed throughout the study until Week 52 (68.8%). Conclusions: Treatment with ligelizumab 120 mg was well-tolerated with mild to moderate adverse events and was efficacious in Japanese patients. |
| format | Article |
| id | doaj-art-32342431126a4724b9d71f980447e1fb |
| institution | Kabale University |
| issn | 1323-8930 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Allergology International |
| spelling | doaj-art-32342431126a4724b9d71f980447e1fb2025-01-04T04:56:07ZengElsevierAllergology International1323-89302025-01-01741136143Long term safety and efficacy of ligelizumab in the treatment of Japanese patients with chronic spontaneous urticariaHidetoshi Takahashi0Atsushi Fukunaga1Koremasa Hayama2Takayoshi Sasajima3Ayako Fujishige4Ryohei Ichishita5Naoko Tomimatsu6Eva Hua7Vineeth Varanasi8Alis Burciu9Michihiro Hide10Thomas Severin11Takagi Dermatological Clinic, Hokkaido, JapanDepartment of Dermatology, Division of Medicine for Function and Morphology of Sensory Organs, Faculty of Medicine, Osaka Medical and Pharmaceutical University, Osaka, JapanDepartment of Dermatology, Nihon University Itabashi Hospital, Tokyo, JapanNovartis Pharma K.K., Tokyo, JapanNovartis Pharma K.K., Tokyo, JapanNovartis Pharma K.K., Tokyo, JapanNovartis Pharma K.K., Tokyo, JapanChina Novartis Institutes for Biomedical Research Co., Ltd., Shanghai, ChinaNovartis Healthcare Pvt. Ltd., Hyderabad, IndiaNovartis Pharma AG, Basel, SwitzerlandDepartment of Dermatology, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan; Department of Dermatology, Hiroshima University, Hiroshima, Japan; Corresponding author. Department of Dermatology, Hiroshima City Hiroshima Citizens Hospital, 7-33 Motomachi, Naka-ku, Hiroshima 730-8518, Japan.Novartis Pharma AG, Basel, SwitzerlandBackground: In Japan, urticaria is a common skin disorder with chronic spontaneous urticaria (CSU) being the most frequent subtype. This study evaluated the safety of ligelizumab (anti-IgE monoclonal antibody) in Japanese CSU patients. Methods: This was a Phase 3 multicenter, open-label, single-arm 52-week study in adult Japanese patients with CSU inadequately controlled with locally approved doses of H1-antihistamines. The primary objective reported the safety of ligelizumab 120 mg subcutaneously every 4 weeks, by evaluation of treatment emergent adverse events (TEAE). Secondary objectives evaluated efficacy by absolute change from baseline (CFB) in weekly urticaria activity score (UAS7), and the proportion of patients with UAS7 = 0, and dermatology life quality index (DLQI) = 0–1 over time. Results: From a total of 66 CSU patients (80.3% females; mean ± SD age 46.4 ± 13.2 years; mean ± SD baseline UAS7 28.7 ± 6.5) enrolled, 53 patients (80.3%) reported ≥1 TEAE during the study, with no severe or serious adverse events, no anaphylaxis events and low frequency of TEAEs leading to treatment discontinuations (6.1%). Absolute mean CFB of UAS7 showed a rapid onset of response at Week 4 (−14.2) with further improvement until end of treatment at Week 52 (−22.9). The proportion of patients achieving UAS7 = 0 improved over time (14.5% at Week 4; 50.0% at Week 52). A sizable proportion of patients achieved DLQI 0–1 with the first dose of ligelizumab (38.5%), and improvements observed throughout the study until Week 52 (68.8%). Conclusions: Treatment with ligelizumab 120 mg was well-tolerated with mild to moderate adverse events and was efficacious in Japanese patients.http://www.sciencedirect.com/science/article/pii/S1323893024001072Chronic spontaneous urticariaIgEJapaneseLigelizumabLong-term adverse events |
| spellingShingle | Hidetoshi Takahashi Atsushi Fukunaga Koremasa Hayama Takayoshi Sasajima Ayako Fujishige Ryohei Ichishita Naoko Tomimatsu Eva Hua Vineeth Varanasi Alis Burciu Michihiro Hide Thomas Severin Long term safety and efficacy of ligelizumab in the treatment of Japanese patients with chronic spontaneous urticaria Allergology International Chronic spontaneous urticaria IgE Japanese Ligelizumab Long-term adverse events |
| title | Long term safety and efficacy of ligelizumab in the treatment of Japanese patients with chronic spontaneous urticaria |
| title_full | Long term safety and efficacy of ligelizumab in the treatment of Japanese patients with chronic spontaneous urticaria |
| title_fullStr | Long term safety and efficacy of ligelizumab in the treatment of Japanese patients with chronic spontaneous urticaria |
| title_full_unstemmed | Long term safety and efficacy of ligelizumab in the treatment of Japanese patients with chronic spontaneous urticaria |
| title_short | Long term safety and efficacy of ligelizumab in the treatment of Japanese patients with chronic spontaneous urticaria |
| title_sort | long term safety and efficacy of ligelizumab in the treatment of japanese patients with chronic spontaneous urticaria |
| topic | Chronic spontaneous urticaria IgE Japanese Ligelizumab Long-term adverse events |
| url | http://www.sciencedirect.com/science/article/pii/S1323893024001072 |
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