Tajerian Amin, Pourvali Ali, Khoshkhui Maryam, Movahedi Aliabadi Mehraneh, Mobinikhaledi Mahya, Faridzadeh Arezoo
School of Medicine, Arak University of Medical Sciences, Arak, Iran.
Department of Pediatrics, School of Medicine, Arak University of Medical Sciences, Arak, Iran.
Arch Dermatol Res. 2024 Dec 14;317(1):131. doi: 10.1007/s00403-024-03629-2.
Chronic urticaria is a persistent skin condition characterized by recurrent wheals (hives) and/or angioedema lasting more than six weeks, significantly impacting quality of life and often requiring long-term management. Limited access to costly treatments like omalizumab poses challenges in low-income countries with high healthcare expenses and limited insurance coverage, prompting research into cost-effective dosages for effective management. This study aims to find the most cost-effective dosage for treating chronic urticaria in countries with healthcare affordability challenges. PubMed, MEDLINE, and Web of Science databases were searched for randomized controlled trials (RCTs) from January 1, 2010, to October 29, 2023. Studies assessing Omalizumab's efficacy in chronic spontaneous urticaria (CSU) patients unresponsive to antihistamines were included. Network meta-analyses (NMAs) were conducted using the "multinma" package in R, employing Bayesian random-effects models to synthesize data from multiple studies. Each outcome underwent separate analysis, with effect sizes illustrated via forest plots generated using Plotly in R. Individual studies' risk of bias was assessed using the Cochrane Risk of Bias Tool 2, and effect estimate certainty was rated via the GRADE approach. Consistency assumption was evaluated using the unrelated mean effects (UME) model, focusing on each data point's contribution to model fit. Present study showed that the 300 mg dose outperformed others and placebo in reducing urticaria activity score over 7 days (UAS7), weekly itch severity score (WWS), and weekly number of hives score (WIS). Response rates were notably higher with 300 mg, indicating its superiority in achieving treatment response. Given the significantly greater effect sizes of 150 mg and 300 mg over 75 mg and placebo, low doses aren't recommended for antihistamine-resistant cases. Initiating treatment with either a 300 mg dose for six months or starting with 150 mg and adjusting upwards as necessary is recommended, aligning with economic considerations until optimal dosages are established.
慢性荨麻疹是一种持续性皮肤病，其特征为反复出现风团（荨麻疹）和/或血管性水肿，持续时间超过六周，对生活质量有显著影响，且通常需要长期治疗。在医疗费用高昂且保险覆盖有限的低收入国家，使用奥马珠单抗等昂贵治疗方法的机会有限，这促使人们研究具有成本效益的剂量以进行有效管理。本研究旨在找出在面临医疗可负担性挑战的国家中治疗慢性荨麻疹最具成本效益的剂量。检索了PubMed、MEDLINE和科学网数据库中2010年1月1日至2023年10月29日期间的随机对照试验（RCT）。纳入了评估奥马珠单抗对组胺不耐受的慢性自发性荨麻疹（CSU）患者疗效的研究。使用R语言中的“multinma”软件包进行网络荟萃分析（NMA），采用贝叶斯随机效应模型综合多项研究的数据。对每个结果进行单独分析，效应大小通过使用R语言中的Plotly生成的森林图展示。使用Cochrane偏倚风险工具2评估个体研究的偏倚风险，并通过GRADE方法对效应估计的确定性进行评级。使用无关均值效应（UME）模型评估一致性假设，重点关注每个数据点对模型拟合的贡献。本研究表明，300毫克剂量在降低7天内的荨麻疹活动评分（UAS7）、每周瘙痒严重程度评分（WWS）和每周荨麻疹数量评分（WIS）方面优于其他剂量和安慰剂。300毫克剂量的缓解率显著更高，表明其在实现治疗缓解方面的优越性。鉴于150毫克和300毫克剂量的效应大小显著大于75毫克剂量和安慰剂，不建议对组胺不耐受的病例使用低剂量。建议以300毫克剂量开始治疗六个月，或从150毫克开始并根据需要向上调整，这符合经济考量，直到确定最佳剂量。
