Omalizumab for the Treatment of Chronic Spontaneous Urticaria in Adults and Adolescents: An Eight-Year Real-Life Experience.

Background: Omalizumab, an anti-IgE monoclonal antibody, is an effective treatment for patients with chronic spontaneous urticaria (CSU) resistant to antihistamines, but about 10% are unresponsive. Our aim was to assess the effectiveness, safety, and drug survival (DS) of omalizumab by considering clinical and laboratory characteristics. Methods: We conducted a retrospective study on 296 patients with severe CSU treated with omalizumab. Disease activity, comorbidities, and serum levels of total IgE and anti-thyroid autoantibodies were evaluated over a period of up to 8 years. DS was analyzed using unadjusted Kaplan-Meier survival curves. When applicable, the risk of discontinuation was assessed using Cox regression analysis. Results: Out of 296 patients, 118 (40.4%) were early responders, 72 (25.0%) were late responders, 76 (26.0%) were partial responders, and 25 (8.6%) were non-responders. Early responders were more likely to be patients without associated inducible urticaria (p = 0.021, χ2 = 9.692), without autoimmune thyroiditis (p = 0.007, χ2 = 12.037), and those with higher IgE levels (p = 0.039, χ2 = 8.385). Overall, DS was 53.5% at 8 years, primarily due to clinical remission. DS due to inefficacy and clinical remission were 83.9% and 62.1%, respectively, at 8 years. No patients discontinued omalizumab due to adverse events. Patients with normal IgE levels (p = 0.012, HR = 4.639, CI: 1.393-15.445) and those with autoimmune thyroiditis (p = 0.028, HR = 3.316, CI: 1.128-8.718) had a higher risk of discontinuing omalizumab due to inefficacy. Conclusions: This study confirms the long-term effectiveness and safety of omalizumab in the treatment of CSU over a period of up to 8 years. Most patients discontinued omalizumab due to clinical remission, while only 5.1% discontinued it due to ineffectiveness.

Five-year real-world drug survival of dupilumab in severe atopic dermatitis and associate predictors.

BACKGROUND: Atopic dermatitis (AD) profoundly impacts patients' lives, necessitating long-term systemic treatments. METHODS: This retrospective study involved 709 severe AD patients receiving dupilumab. Drug survival (DS) was analyzed using Kaplan-Meier curves, evaluating reasons for discontinuation. The log-rank test and Cox regression analysis were applied to assess differences in drug survival across baseline clinical characteristic groups. RESULTS: Dupilumab showcased remarkable overall drug survival, reaching 74.1% at 65 months. Survival rates remained robust even when considering discontinuation solely due to primary or secondary inefficacy (86.4% at 65 months). For overall DS, the log-rank test did not reveal a statistically significant difference among the groups. Cox regression analysis showed that patients with nummular eczema-like as a phenotype have an increased risk of discontinuing dupilumab due to the development of psoriasis (p < .001, hazard ratio = 26.15, confidence interval [CI] 6.903-99.016). The multivariate logistic regression analysis confirmed these results (p < .001, OD = 18.956, CI 4.205-85.458), even when considering other clinical and epidemiological characteristics. CONCLUSION: This investigation establishes dupilumab's enduring efficacy and safety in severe AD, emphasizing its potential as a sustained therapeutic option over 5+ years. Baseline characteristics did not seem to influence DS, with the exception of the nummular eczema-like phenotype, which emerged as a significant predictor of psoriasis occurrence.

Successful adalimumab graded challenge after allergic delayed reaction to golimumab in a woman with rheumatoid arthritis.

A graded challenge with adalimumab could be safe in case of a delayed allergic reaction to golimumab, after a detailed allergological evaluation and the exclusion of allergic sensitization using skin tests.

Successful fractionated undiluted doses of COVID-19 vaccine in five cases of suspected allergic reactions to the first dose.

After a suspected allergic reaction to first dose of mRNA COVID-19 vaccine, given the PEG skin tests negativity and tolerance in vivo to PEG containing drugs, five patients were vaccinated with the second dose of Pfizer-Biontech undergoing a fractional protocol, with antihistamine premedication, without presenting immediate or delayed reactions.