Real-world safety and effectiveness of omalizumab in Japanese patients with chronic spontaneous urticaria: A post-marketing surveillance study

The safety and efficacy of omalizumab in chronic spontaneous urticaria (CSU) patients has been established, but real-world long-term data remain scarce, especially in Japan. 52-week, open-label, single-arm, observational study evaluated the safety and effectiveness of first-time omalizumab in Japane...

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Bibliographic Details
Published in:Allergology international 2023-04, Vol.72 (2), p.286-296
Main Authors: Hide, Michihiro, Fukunaga, Atsushi, Suzuki, Takayuki, Nakamura, Noriko, Kimura, Mine, Sasajima, Takayoshi, Kiriyama, Junna, Igarashi, Atsuyuki
Format: Article
Language:English
Subjects:
Anti-Allergic Agents - adverse effects
Chronic Disease
Chronic spontaneous urticaria
Chronic Urticaria - drug therapy
Drug-Related Side Effects and Adverse Reactions
East Asian People
Humans
Japan
Omalizumab
Omalizumab - adverse effects
Product Surveillance, Postmarketing
Real-world
Safety
Treatment Outcome
Urticaria - chemically induced
Urticaria - drug therapy
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Summary:The safety and efficacy of omalizumab in chronic spontaneous urticaria (CSU) patients has been established, but real-world long-term data remain scarce, especially in Japan. 52-week, open-label, single-arm, observational study evaluated the safety and effectiveness of first-time omalizumab in Japanese CSU patients responding inadequately to conventional therapies. Overall, 235 of 280 patients completed the study. Most patients were aged ≥ 18 and 
ISSN:1323-8930
1440-1592
DOI:10.1016/j.alit.2022.09.003