Different doses and courses of omalizumab for patients with chronic spontaneous urticaria: A systematic review with meta-analysis and trial sequential analysis

Background: The stability, efficacy, and safety of omalizumab at different doses and regimens for chronic spontaneous urticaria (CSU) are yet to be studied. Objective: A systematic review (SR) with meta-analysis (MA) and trial sequential analysis (TSA) was performed to assess the efficacy and safety...

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Main Authors: Haiyan Qin, MD, Xianjun Xiao, MD, PhD, Di Qin, MD, Peiwen Xue, MD, Huilin Liu, MD, Ying Li, MD, PhD, Yunzhou Shi, MD, PhD
Format: Article
Language:English
Published: Elsevier 2024-04-01
Series:World Allergy Organization Journal
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S1939455124000292
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author Haiyan Qin, MD
Xianjun Xiao, MD, PhD
Di Qin, MD
Peiwen Xue, MD
Huilin Liu, MD
Ying Li, MD, PhD
Yunzhou Shi, MD, PhD
author_facet Haiyan Qin, MD
Xianjun Xiao, MD, PhD
Di Qin, MD
Peiwen Xue, MD
Huilin Liu, MD
Ying Li, MD, PhD
Yunzhou Shi, MD, PhD
author_sort Haiyan Qin, MD
collection DOAJ
description Background: The stability, efficacy, and safety of omalizumab at different doses and regimens for chronic spontaneous urticaria (CSU) are yet to be studied. Objective: A systematic review (SR) with meta-analysis (MA) and trial sequential analysis (TSA) was performed to assess the efficacy and safety of omalizumab in CSU. Methods: Randomised controlled trials (RCTs) of administering omalizumab versus placebo for CSU were searched. Random-effects MAs were performed using planned subgroup analyses. TSA was performed to control for the risk of random errors and assess the stability of our MA results. Publication bias was visually assessed using a contour-enhanced funnel plot and the trim-and-fill method. The quality of RCTs was assessed using the Cochrane Risk of Bias Tool 2. Results: Twelve studies met the inclusion criteria. Omalizumab had remarkable effects on the patient percentage of the weekly urticaria activity score is zero (UAS = 0) [RR 4.64, 95% CI (3.38, 6.37)], percentage of no angioedema-burdened days [MD 3.15, 95% CI (0.10, 6.19], patient percentage of UAS ≤6 [RR 3.05, 95% CI (2.46, 3.78)], and patient percentage of the weekly itch severity score minimally important difference (ISS7 MID) [RR 1.50, 95% CI (1.36, 1.66)]. Omalizumab was well tolerated across studies [RR 0.98, 95% CI (0.90, 1.08)]. TSA confirmed the above results, except for “the percentage of no angioedema-burdened day”. Conclusion: Among the different doses and courses assessed, omalizumab (300 mg, 12 weeks) can be recommended as an effective treatment for patients with CSU. However, whether omalizumab improves angioedema requires further investigation. The clinical management of angioedema accompanying CSU requires further attention.
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spelling doaj.art-2728ab7efdda48f287e10eb5aef32a042024-04-12T04:45:04ZengElsevierWorld Allergy Organization Journal1939-45512024-04-01174100898Different doses and courses of omalizumab for patients with chronic spontaneous urticaria: A systematic review with meta-analysis and trial sequential analysisHaiyan Qin, MD0Xianjun Xiao, MD, PhD1Di Qin, MD2Peiwen Xue, MD3Huilin Liu, MD4Ying Li, MD, PhD5Yunzhou Shi, MD, PhD6Department of Acupuncture and Moxibustion, Chengdu University of Traditional Chinese Medicine, Chengdu, ChinaSchool of Health Preservation and Rehabilitation, Chengdu University of Traditional Chinese Medicine, Chengdu, ChinaDepartment of Acupuncture and Moxibustion, Chengdu University of Traditional Chinese Medicine, Chengdu, ChinaSchool of Health Preservation and Rehabilitation, Chengdu University of Traditional Chinese Medicine, Chengdu, ChinaDepartment of Acupuncture and Moxibustion, Chengdu University of Traditional Chinese Medicine, Chengdu, ChinaDepartment of Acupuncture and Moxibustion, Chengdu University of Traditional Chinese Medicine, Chengdu, ChinaDepartment of Acupuncture and Moxibustion, Chengdu University of Traditional Chinese Medicine, Chengdu, China; Corresponding author. No. 37 Shierqiao Road, Jinniu District, Chengdu, 610075, Sichuan, China.Background: The stability, efficacy, and safety of omalizumab at different doses and regimens for chronic spontaneous urticaria (CSU) are yet to be studied. Objective: A systematic review (SR) with meta-analysis (MA) and trial sequential analysis (TSA) was performed to assess the efficacy and safety of omalizumab in CSU. Methods: Randomised controlled trials (RCTs) of administering omalizumab versus placebo for CSU were searched. Random-effects MAs were performed using planned subgroup analyses. TSA was performed to control for the risk of random errors and assess the stability of our MA results. Publication bias was visually assessed using a contour-enhanced funnel plot and the trim-and-fill method. The quality of RCTs was assessed using the Cochrane Risk of Bias Tool 2. Results: Twelve studies met the inclusion criteria. Omalizumab had remarkable effects on the patient percentage of the weekly urticaria activity score is zero (UAS = 0) [RR 4.64, 95% CI (3.38, 6.37)], percentage of no angioedema-burdened days [MD 3.15, 95% CI (0.10, 6.19], patient percentage of UAS ≤6 [RR 3.05, 95% CI (2.46, 3.78)], and patient percentage of the weekly itch severity score minimally important difference (ISS7 MID) [RR 1.50, 95% CI (1.36, 1.66)]. Omalizumab was well tolerated across studies [RR 0.98, 95% CI (0.90, 1.08)]. TSA confirmed the above results, except for “the percentage of no angioedema-burdened day”. Conclusion: Among the different doses and courses assessed, omalizumab (300 mg, 12 weeks) can be recommended as an effective treatment for patients with CSU. However, whether omalizumab improves angioedema requires further investigation. The clinical management of angioedema accompanying CSU requires further attention.http://www.sciencedirect.com/science/article/pii/S1939455124000292Chronic spontaneous urticariaOmalizumabTrial sequential analysisEfficacyStability
spellingShingle Haiyan Qin, MD
Xianjun Xiao, MD, PhD
Di Qin, MD
Peiwen Xue, MD
Huilin Liu, MD
Ying Li, MD, PhD
Yunzhou Shi, MD, PhD
Different doses and courses of omalizumab for patients with chronic spontaneous urticaria: A systematic review with meta-analysis and trial sequential analysis
World Allergy Organization Journal
Chronic spontaneous urticaria
Omalizumab
Trial sequential analysis
Efficacy
Stability
title Different doses and courses of omalizumab for patients with chronic spontaneous urticaria: A systematic review with meta-analysis and trial sequential analysis
title_full Different doses and courses of omalizumab for patients with chronic spontaneous urticaria: A systematic review with meta-analysis and trial sequential analysis
title_fullStr Different doses and courses of omalizumab for patients with chronic spontaneous urticaria: A systematic review with meta-analysis and trial sequential analysis
title_full_unstemmed Different doses and courses of omalizumab for patients with chronic spontaneous urticaria: A systematic review with meta-analysis and trial sequential analysis
title_short Different doses and courses of omalizumab for patients with chronic spontaneous urticaria: A systematic review with meta-analysis and trial sequential analysis
title_sort different doses and courses of omalizumab for patients with chronic spontaneous urticaria a systematic review with meta analysis and trial sequential analysis
topic Chronic spontaneous urticaria
Omalizumab
Trial sequential analysis
Efficacy
Stability
url http://www.sciencedirect.com/science/article/pii/S1939455124000292
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