Dataset Information

Comparing azathioprine with cyclosporine in the treatment of antihistamine refractory chronic spontaneous urticaria: A randomized prospective active-controlled non-inferiority study.

ABSTRACT:

Background

Literature on the efficacy of azathioprine in antihistamine refractory chronic spontaneous urticaria (CSU) is limited.

Objective

To compare the efficacy and safety of azathioprine with respect to cyclosporine in the treatment of refractory CSU.

Methods

In this prospective, randomized, active-controlled, non-inferiority study, 80 patients of refractory CSU were administered either cyclosporine (group A, n = 40) or azathioprine (group B, n = 40) for 90 days and followed up for further 90 days. The treatment efficacy was assessed every 15th day using urticaria activity score (UAS7) and outcome scoring scale (OSS). Serum IgE levels, autologous serum skin test (ASST) and autologous plasma skin test (APST) were additionally measured at baseline and 90th day.

Results

Primary end point (≥75% reduction in UAS7 at 90th day) was achieved by 31/40 (79.5%) patients in group A and 32/40 (80%) patients in group B (proportion difference -0.5%, 95% confidence interval [CI] of difference -17.13 to 18.09; point estimates favoring B, CIs demonstrating non-inferiority). At 180th day, ≥75% reduction in UAS7 was maintained in 19/40 (47.95%) patients in group A and 24/40 (60%) patients in group B (proportion difference -12.5%, 95% CI of difference -9.00 to 32.46, point estimates favoring B, CIs demonstrating non-inferiority). Thus, the number of patients who could maintain ≥75% reduction in UAS7 at 180th day reduced significantly in group A (proportion difference 30%, 95% CI of difference 8.78 to 47.77), but not in group B (proportion difference 20%, 95% CI of difference -0.10 to 38.10). The values of mean UAS7 significantly decreased from 28.70 ± 4.42 and 28.88 ± 4.25 at baseline, to 5.56 ± 5.12 and 7.0 ± 4.48 at 90th day in group A and B respectively (group A, mean difference -23.27, 95% CI of difference -25.33 to -21.22; group B, mean difference -21.87, 95% CI of difference -23.78 to -19.96). It increased significantly to 9.98 ± 5.46 in group A at 180th day (mean difference 4.55, 95% CI of difference 2.98 to 6.12), but not in group B (mean UAS7 180th day 7.88 ± 5.53, mean difference 0.88, 95% CI of difference -0.82 to 2.57). The reduction in number of patients having positive ASST post-treatment was significant in group A, whereas reduction in IgE levels was more significant in group B.

Conclusion

The present study concludes that azathioprine is not inferior to cyclosporine in the treatment of refractory CSU, and it can be a valuable adjunct, especially in resource poor settings.

SUBMITTER: Pathania YS

PROVIDER: S-EPMC6518319 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Publications

Comparing azathioprine with cyclosporine in the treatment of antihistamine refractory chronic spontaneous urticaria: A randomized prospective active-controlled non-inferiority study.

Pathania Yashdeep Singh YS Bishnoi Anuradha A Parsad Davinder D Kumar Ashok A Kumaran Muthu Sendhil MS

The World Allergy Organization journal 20190510 5

<h4>Background</h4>Literature on the efficacy of azathioprine in antihistamine refractory chronic spontaneous urticaria (CSU) is limited.<h4>Objective</h4>To compare the efficacy and safety of azathioprine with respect to cyclosporine in the treatment of refractory CSU.<h4>Methods</h4>In this prospective, randomized, active-controlled, non-inferiority study, 80 patients of refractory CSU were administered either cyclosporine (group A, n = 40) or azathioprine (group B, n = 40) for 90 days and ...[more]

PMID: 31193160

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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:BackgroundTreating chronic urticaria (CU) that is unresponsive to H1-antihistamines (H1AHs) is challenging, and the real-world effectiveness of omalizumab remains unclear.ObjectiveOur aim was to evaluate the real-world effectiveness of omalizumab, optimal response assessment timing, and predictive factors.MethodsInitially, 5535 patients with CU who were receiving at least 20 mg of loratadine daily for at least 6 months (January 2007-August 2021) were screened. Ultimately, 386 patients who had been receiving omalizumab add-on treatment for >6 months were followed-up for more than 2 years. Predictors of treatment response to omalizumab add-on therapy for patients with antihistamine-refractory CU were identified by using a generalized linear model.ResultsIn our retrospective cohort, omalizumab treatment showed cumulative response rates of 55.2% at 3 months, 71.0% at 6 months, and 81.4% at 9 months for patients with H1AH-refractory CU. Analysis of longitudinal responses to omalizumab treatment revealed 3 distinct clusters: favorable (cluster 1 [n = 158]), intermediate (cluster 2 [n =1 43]), and poor responses (cluster 3 [n = 85]). Subjects were categorized on the basis of whether they had achieved a complete response within 3 months; 213 early responders, 117 late responders, and 56 nonresponders were identified. The initial dose of omalizumab differed significantly among the 3 clusters. Low total IgE level (<40 kU/L) predicted nonresponse (odds ratio [OR] = 3.10 [P = .018]). Early responders were associated with a higher initial omalizumab dose (≥300 mg) (OR = 2.07 [P = .016]), higher basophil counts (OR = 2.0 [P = .014]), total IgE levels exceeding 798 kU/L (OR = 0.37 [P = .047]), and lower platelet-to-lymphocyte ratio (OR = 0.50 [P = .050]).ConclusionReal-world data reveal 3 distinct clusters for response to omalizumab treatment; confirm low serum total IgE level (<40 kU/L) as a predictor of nonresponse; and identify potential biomarkers, including IgE level, basophil count, and PLR, for early responders.

Project description:Background and objectiveChronic spontaneous urticaria (CSU) is a histamine-mediated inflammatory skin disease, and second-generation non-sedating H1-antihistamines (nsAH) at licensed doses have long been the first-line therapy in CSU. However, about 50% of patients are resistant to nsAH, and the precise pathogenesis remains largely unknown but seems to be associated with low-level systemic or intestinal inflammation. We aim to determine the fecal microbial composition and clarify its correlation with the clinical profiles og CSU with nsAH resistance.MethodsA total of 25 CSU patients with or 19 CSU patients without nsAH resistance and 19 healthy controls (HC) were enrolled in this study. The intestinal microbiome was detected by 16S rRNA sequencing. The data were analyzed using R language software.ResultsSignificantly higher urticarial activity score for 7 days, stool calprotectin, erythrocyte sedimentation rate, serum C-reactive protein, and interleukin-6, but much lower alpha-diversity and evenness of fecal bacterial community were observed in CSU patients with nsAH resistance than in those without (P <0.05 for all variables). Compared to patients with nsAH-responsiveness, the abundance of fecal genera Prevotella, Megamonas, and Escherichia were significantly increased, while that of Blautia, Alistipes, Anaerostipes, and Lachnospira were remarkably reduced in nsAH-resistant patients (uncorrected P <0.05 for all variables). Finally, systemic not intestinal inflammation degree was positively correlated with genera Escherichia, while negatively with genera Blautia, Dorea, Lactobacillus, Eubacterium_hallii_group, and Roseburia. CSU without nsAH resistance and HC individuals showed almost unchanged genera bacterium.ConclusionsAmong CSU patients, pro-inflammation phenotype relating to enteric dysbacteriosis features nsAH resistance in CSU patients. The results provide clues for future microbial-based or anti-inflammatory therapies on nsAH resistant CSU.

Dataset Information

Comparing azathioprine with cyclosporine in the treatment of antihistamine refractory chronic spontaneous urticaria: A randomized prospective active-controlled non-inferiority study.

Background

Objective

Methods

Results

Conclusion

Publications

Comparing azathioprine with cyclosporine in the treatment of antihistamine refractory chronic spontaneous urticaria: A randomized prospective active-controlled non-inferiority study.

Similar Datasets

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