PMID- 34984792 OWN - NLM STAT- MEDLINE DCOM- 20220406 LR - 20220731 IS - 1529-8019 (Electronic) IS - 1396-0296 (Print) IS - 1396-0296 (Linking) VI - 35 IP - 4 DP - 2022 Apr TI - Efficacy and safety of omalizumab in Chinese patients with anti-histamine refractory chronic spontaneous urticaria. PG - e15303 LID - 10.1111/dth.15303 [doi] LID - e15303 AB - Chronic spontaneous urticaria (CSU) is characterized by the spontaneous development of wheals, itching, and/or angioedema, for >/=6 weeks. In China, non-sedating H1-antihistamines (H1AH) are the recommended first-line treatment, with escalation up to 4x the standard dose in symptomatic patients to achieve control. Treatment options for Chinese patients who remain symptomatic on H1AH treatment are limited. This 20-week randomized, double blind, placebo-controlled, parallel-group study investigated the efficacy and safety of omalizumab as an add-on therapy for the treatment of patients with CSU who remained symptomatic despite H1AH treatment in China. Adult patients (N = 418) diagnosed with refractory CSU for >/=6 months were randomized (2:2:1) to receive omalizumab 300 mg (OMA300), omalizumab 150 mg (OMA150) or placebo, subcutaneously, every 4 weeks. Primary outcome was change from baseline to week 12 in weekly itch severity score (ISS7). Safety was assessed by rates of adverse events (AEs). Demographic and disease characteristics at baseline were comparable across treatment groups. At week 12, statistically significant greater decreases from baseline were observed in ISS7 with OMA300 (least square mean difference [LSM]: -4.23; 95% confidence interval [CI]: -5.70, -2.77; p < 0.001) and OMA150 (LSM: -3.79; 95% CI: -5.24, -2.33; p < 0.001) versus placebo. Incidence of treatment-emergent AEs over 20 weeks was slightly higher with OMA300 (71.3%) compared to OMA150 and placebo groups (64.7% and 63.9%, respectively). The incidences of serious AEs were balanced between groups. This study demonstrated the efficacy and safety of omalizumab in Chinese adult patients with CSU who remained symptomatic despite H1AH therapy. CI - (c) 2022 The Authors. Dermatologic Therapy published by Wiley Periodicals LLC. FAU - Yuan, Weiru AU - Yuan W AD - Department of Dermatology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. FAU - Hu, Shuling AU - Hu S AD - China Novartis Institutes for BioMedical Research Co., Ltd., Shanghai, China. FAU - Li, Min AU - Li M AD - Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China. FAU - Yang, Lijia AU - Yang L AD - Wuxi No.2 People's Hospital, Wuxi, China. FAU - Liu, Lingling AU - Liu L AD - Peking University First Hospital, Beijing, China. FAU - Zheng, Min AU - Zheng M AD - The Second Affiliated hospital of Zhejiang University School of Medicine, Zhejiang, China. FAU - Guo, Zaipei AU - Guo Z AD - West China Hospital, Sichuan University, Chengdu, China. FAU - Song, Zhiqiang AU - Song Z AD - Department of Dermatology, The First Affiliated Hospital of Army Military Medical University, Chongqing, China. FAU - Zhang, Chunlei AU - Zhang C AD - Department of Dermatology, Peking University Third Hospital, Beijing, China. FAU - Diao, Qingchun AU - Diao Q AD - Chongqing Traditional Chinese Medicine Hospital, Chongqing, China. FAU - Xu, Jinhua AU - Xu J AD - Huashan Hospital, Fudan University, Shanghai, China. FAU - Richard, Alexia AU - Richard A AD - Novartis Pharma AG, Basel, Switzerland. FAU - Patwardhan, Moreshwar AU - Patwardhan M AD - Novartis Healthcare Pvt. Ltd., Hyderabad, India. FAU - Lyu, Tianmeng AU - Lyu T AD - Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA. FAU - Uddin, Alkaz AU - Uddin A AD - Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA. FAU - Fogel, Robert AU - Fogel R AD - Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA. FAU - Ligueros-Saylan, Monica AU - Ligueros-Saylan M AD - Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA. FAU - Zheng, Jie AU - Zheng J AUID- ORCID: 0000-0002-7961-6427 AD - Department of Dermatology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. LA - eng PT - Journal Article PT - Randomized Controlled Trial DEP - 20220117 PL - United States TA - Dermatol Ther JT - Dermatologic therapy JID - 9700070 RN - 0 (Anti-Allergic Agents) RN - 0 (Histamine H1 Antagonists) RN - 2P471X1Z11 (Omalizumab) SB - IM MH - Adult MH - *Anti-Allergic Agents/adverse effects MH - Chronic Disease MH - *Chronic Urticaria/diagnosis/drug therapy MH - Histamine H1 Antagonists MH - Humans MH - Omalizumab/adverse effects MH - Treatment Outcome MH - *Urticaria/chemically induced/diagnosis/drug therapy PMC - PMC9286033 OTO - NOTNLM OT - Chinese OT - chronic spontaneous urticaria OT - efficacy OT - omalizumab OT - safety COIS- Weiru Yuan (MD, PhD), Min Li (MD, PhD), Lijia Yang (MD), Lingling Liu (MD), Min Zheng (MD, PhD), Zaipei Guo (MD), Zhiqiang Song (MD, PhD), Chunlei Zhang (MD, PhD), Qingchun Diao (MD, PhD), Jinhua Xu (MD, PhD), and Jie Zheng (MD, PhD) declare no potential conflicts of interest. Robert Fogel (MD), Monica Ligueros-Saylan (MD), and Alkaz Uddin (PhD) report being employees and shareholders of Novartis Pharmaceuticals Corporation (USA). Alexia Richard (MSc) being employee and shareholder of Novartis Pharma AG (Switzerland). Tianmeng Lyu (PhD) is an employee of Novartis Pharmaceuticals Corporation (USA). Shuling Hu (MD, PhD) is an employee of Novartis Institutes for BioMedical Research (China). Moreshwar Patwardhan (MPharm) is an employee of Novartis Healthcare Pvt Ltd (India). EDAT- 2022/01/06 06:00 MHDA- 2022/04/07 06:00 PMCR- 2022/07/15 CRDT- 2022/01/05 06:16 PHST- 2021/12/13 00:00 [revised] PHST- 2021/10/05 00:00 [received] PHST- 2022/01/03 00:00 [accepted] PHST- 2022/01/06 06:00 [pubmed] PHST- 2022/04/07 06:00 [medline] PHST- 2022/01/05 06:16 [entrez] PHST- 2022/07/15 00:00 [pmc-release] AID - DTH15303 [pii] AID - 10.1111/dth.15303 [doi] PST - ppublish SO - Dermatol Ther. 2022 Apr;35(4):e15303. doi: 10.1111/dth.15303. Epub 2022 Jan 17.