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Background: In cholinergic urticaria (CholU), itchy wheal and flare-type skin reactions are triggered by sweat-inducing activities. The CholU activity score, CholUAS, is used to assess disease activity, but has not yet been validated. The aim of the study was to validate the CholUAS, develop an English version, and provide instructions for scoring., Methods: Cognitive debriefing of CholUAS was performed. CholU patients (n =75) used the CholUAS on 7 consecutive days, underwent provocation testing, and completed additional anchor instrument questionnaires including global evaluation tools and established quality of life instruments. A scoring protocol for the calculation of the weekly CholUAS, the CholUAS7, was developed. The CholUAS7 was tested for validity, reliability, and influencing factors. An English version of the CholUAS was developed., Results: The final CholUAS contains 3 questions that are used for scoring as well as one global question. The weekly CholUAS, CholUAS7, showed excellent test-retest reliability and good correlations with anchor instruments. Statistical analysis showed no significant influence of age or duration of disease on CholUAS7 results., Conclusion: The validated CholUAS is ready for use in clinical trials and routine clinical practice., (Copyright © 2024. Published by Elsevier Inc.)

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.

Background: Chronic spontaneous urticaria is characterized by fluctuating symptoms. Its activity is assessed with the urticaria activity score (UAS). Two versions of the urticaria activity score used for 7 consecutive days (UAS7) are available: (1) The guideline-recommended UAS7, with once-daily documentation, and (2) the UAS7 TD , with twice-daily documentation., Objective: To better characterize both UAS7 versions with regard to their validity, reliability, sensitivity to change, minimal important difference (MID), and smallest detectable change (SDC)., Methods: One hundred thirty adult patients with chronic spontaneous urticaria completed both UAS7 versions, the Patients Global Assessment (PatGA) of disease activity, the Urticaria Control Test (UCT), the Chronic Urticaria Quality of Life Questionnaire, and the Dermatology Life Quality Index before and after the initiation of omalizumab therapy. Physicians completed a Physician Global Assessment of disease activity., Results: The UAS7 and the UAS7 TD showed high correlation with the activity anchor PatGA (r = 0.568, P < .001 and r = 0.605, P < .001) and the UCT (r = -0.580, P < .001 and r = -0.585, P < .001). The wheal and pruritus scores of the UAS7 and the UAS7 TD exhibited respectable internal consistency and, in each UAS7 version, correlated well with each other (Cronbach α = 0.78, r = 0.640, P < .001, and Cronbach α = 0.77, r = 0.626, P < .001). Changes in the UAS7 and UAS7 TD correlated well with PatGA changes (r = 639, P < .001, and r = .763, P < .001) and with UCT changes (r = -0.642, P < .001, and r = -0.703, P < .001). The MID was 11 for the UAS7 (SDC = 12) and 12 for the UAS7 TD (SDC = 11)., Conclusions: The UAS7 and UAS7 TD show good and comparable clinimetric properties, including good sensitivity to change, and similar MIDs., (Copyright © 2017 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: Omalizumab is highly effective in controlling chronic spontaneous urticaria (CSU) symptoms; however, patients can experience symptom return on treatment discontinuation. Pivotal clinical trials have identified 2 categories of patients who experience symptom return: rapid and slow., Objective: The objective of this study was to identify potential predictors of the speed of symptom return after stopping omalizumab treatment., Methods: Phase III randomized controlled trial (RCT) data from ASTERIA I (n = 319; 6 × 4 weekly injections of omalizumab 75, 150, 300 mg or placebo; NCT01287117) and ASTERIA II (n = 323; 3 × 4 weekly injections of omalizumab 75, 150, 300 mg, or placebo; NCT01292473) were pooled to identify predictors of symptom return after stopping omalizumab treatment (16-week follow-up). The least absolute shrinkage and selection operator regularization regression model was used to select predictive variables, and relapse probability was represented using heatmap visualizations. Model accuracy was tested using data from the GLACIAL phase III RCT (n = 336; 6 × 4 weekly injections of omalizumab 300 mg or placebo; NCT0126493)., Results: Of 746 variables assessed, 2 were selected by the model as predictors of symptom return: baseline urticaria activity score over 7 days (UAS7) and early area above the curve (AAC; determined by plotting the UAS7 scores across time points). Results suggest that high baseline UAS7 and low UAS7 AAC (slow decrease of symptoms) indicate a higher probability of rapid symptom return than low baseline UAS7 and high UAS7 AAC., Conclusions: These results suggest that the probability of rapid symptom return in patients with CSU who discontinue treatment with omalizumab can be estimated based on baseline UAS7 and early treatment response., (Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.)