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Effectiveness and Safety of Immunosuppressants and Biological Therapy for Chronic Spontaneous Urticaria: A Network Meta-Analysis.

ABSTRACT: Chronic spontaneous urticaria (CSU) is the most common phenotype of chronic urticaria. We compared treatment effects and safety profiles of the medications in patients with CSU. We searched PubMed, MEDLINE, and Web of Science for randomized control trials (RCTs), from 1 January 2000 to 31 July 2021, which evaluated omalizumab and immunosuppressants. Network meta-analyses (NMAs) were performed with a frequentist approach. Outcome assessments considered the efficacy (Dermatology Life Quality Index (DLQI) and weekly urticaria activity score (UAS7)) and tolerability profiles with evaluations of study quality, inconsistencies, and heterogeneity. We identified 14 studies which we included in our direct and indirect quantitative analyses. Omalizumab demonstrated better efficacy in DLQI and UAS7 outcomes compared to a placebo, and UAS7 assessments also demonstrated better outcomes compared to cyclosporine. Alongside this, omalizumab demonstrated relatively lower incidences of safety concerns compared to the other immunosuppressants. Cyclosporin was also associated with higher odds of adverse events than other treatment options. Our findings indicate that omalizumab resulted in greater improvements in terms of the DLQI and UAS7 with good tolerability in CSU patients compared to the other immunosuppressants.

SUBMITTER: Lin WK

PROVIDER: S-EPMC9496015 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

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Effectiveness and Safety of Immunosuppressants and Biological Therapy for Chronic Spontaneous Urticaria: A Network Meta-Analysis.

Lin Wen-Kuang WK Lin Shwu-Jiuan SJ Lee Woan-Ruoh WR Lin Chia-Chieh CC Lin Weei-Chin WC Chang Hua-Ching HC Cheng Chi-Tsun CT Hsu Jason C JC

Biomedicines 20220901 9

Chronic spontaneous urticaria (CSU) is the most common phenotype of chronic urticaria. We compared treatment effects and safety profiles of the medications in patients with CSU. We searched PubMed, MEDLINE, and Web of Science for randomized control trials (RCTs), from 1 January 2000 to 31 July 2021, which evaluated omalizumab and immunosuppressants. Network meta-analyses (NMAs) were performed with a frequentist approach. Outcome assessments considered the efficacy (Dermatology Life Quality Index ...[more]

PMID: 36140253

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Project description:ImportanceThe comparative benefits and harms of all available treatments for H1 antihistamine-refractory chronic spontaneous urticaria (CSU) have not been established.ObjectiveTo evaluate different treatment effects of pharmacologic treatments among patients with H1 antihistamine-refractory CSU.Data sourcesSearches were conducted of MEDLINE, Embase, PubMed, Cochrane Library, Web of Science, Scopus, and CINAHL from inception to April 19, 2021, with no language restrictions. Gray literature from Google Scholar, ongoing trial registers, and preprint reports was added to the searches of electronic databases.Study selectionRandomized clinical trials using validated measurement tools that investigated the benefits and harms of pharmacologic treatments among adolescent or adult patients with CSU who had an inadequate response to H1 antihistamines were screened for inclusion independently by 2 investigators.Data extraction and synthesisTwo investigators independently extracted study data according to the predefined list of interests. A random-effects model was used to calculate the network estimates reported as standardized mean differences and odds ratios with corresponding 95% CIs.Main outcomes and measuresThe primary outcomes that reflect the patient's perspective included changes in urticaria symptoms from baseline and unacceptability of treatment (all-cause dropouts).ResultsTwenty-three randomized clinical trials with 2480 participants that compared 18 different interventions or dosages and placebo were included. The standardized mean differences for change in urticaria symptoms were -1.05 (95% CI, -1.37 to -0.73) for ligelizumab, 72 mg; -1.07 (95% CI, -1.39 to -0.75) for ligelizumab, 240 mg; -0.77 (95% CI, -0.91 to -0.63) for omalizumab, 300 mg; and -0.59 (95% CI, -1.10 to -0.08) for omalizumab, 600 mg. No significant differences in treatment unacceptability were observed. With respect to benefits and harms, the network estimates illustrated that the most efficacious treatments were achieved with ligelizumab, 72 or 240 mg (large beneficial effect) and omalizumab, 300 or 600 mg (moderate beneficial effect).Conclusions and relevanceThe findings in this meta-analysis suggest that the biologic agents ligelizumab, 72 or 240 mg, and omalizumab, 300 or 600 mg, can be recommended as effective treatments for patients with CSU who have had an inadequate response to H1 antihistamines. Head-to-head trials with high methodologic quality and harmonized design and outcome definitions are needed to help inform subsequent international guidelines for the management of CSU.

Project description:IntroductionThe impact of chronic spontaneous urticaria (CSU) on patients' health-related quality of life (HRQoL) is well documented. However, considerable gaps remain in understanding the experience, perception and needs of patients with CSU. In this study, we investigate the perspective of patients with CSU about the disease journey, treatment and management of the condition as well as the physical and psychosocial impact of the disease.MethodsA multinational, cross-sectional online survey was completed by patients with chronic urticaria (CU) and physicians treating CU. This analysis focuses on data from the patients with CSU. The patient survey included customized questions and a validated patient-reported outcomes measure, the Urticaria Control Test (UCT).ResultsA total of 582 patients with CSU (62% women; mean [standard deviation, SD] age: 42.2 [11.9] years) completed the online survey. Patients reported a mean (SD) diagnostic delay of 2 (5.4) years and saw 6.1 (8.9) physicians. The majority (79%) of patients were on antihistamines, of which 84% were inadequately controlled (UCT score of < 12) and reported a significantly higher negative impact of CSU on the HRQoL domains than adequately controlled patients, with the highest impact on mental and emotional well-being and social life and intimate relationships. More than half (55%) of the patients experienced angioedema with a mean (SD) of 7.7 (14.0) episodes per year. In addition, sleeping problems (62%), pain (55%) and fatigue (49%) were frequently reported physical symptoms during an exacerbation.ConclusionPatients with CSU experience substantial burden due to delayed diagnosis, insufficient symptom control (despite treatment) as well as mental and emotional well-being and social impact, particularly when uncontrolled. Early diagnosis and patient-centered approaches to symptom management and disease control should be prioritized to minimize the negative impact of CSU on patients' life.

Dataset Information

Effectiveness and Safety of Immunosuppressants and Biological Therapy for Chronic Spontaneous Urticaria: A Network Meta-Analysis.

Publications

Effectiveness and Safety of Immunosuppressants and Biological Therapy for Chronic Spontaneous Urticaria: A Network Meta-Analysis.

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