Sex-Based Comparison of Remission in Patients with Severe Type 2 Asthma Treated with Biologics: A Real-World Analysis from the “Southern Italy Network on Severe Asthma Therapy”

Introduction: Sex influences asthma phenotypes and treatment outcomes. However, real-world data on sex-related differences in severe asthma patients treated with biologics are limited. The objective of this study was to assess sex differences in baseline characteristics and treatment outcomes in a cohort of severe eosinophilic asthma (SEA) patients treated with biologics. Methods: We retrospectively analyzed 370 SEA patients (235 females, 135 males) treated with mepolizumab, benralizumab, or dupilumab. Clinical remission was defined as no OCS use plus at least two of: no exacerbations, ACT >= 20, or FEV1 >80%. Logistic regression was used to identify sex-specific predictors of remission at 24 months. Results: Severe type 2 asthma showed a prevalence in females (female-to-male ratio of 1.7:1). Baseline characteristics revealed higher prevalence of obesity (p = 0.015) and osteoporosis (p = 0.006) in females, and greater tobacco exposure (p = 0.05), FeNO (p = 0.03), and nasal polyposis (p = 0.0002) in males. Males had greater reduction in FeNO (p <= 0.05) and more male patients stopped exacerbations at 24 months (p < 0.0001), while females showed greater FEF25-75% (p <= 0.05) improvement and larger IgE drops (p < 0.0001). Remission rates were similar across sexes at both 12 months (64.3% versus 74.1%; p = 0.06) and 24 months (71.5% versus 77.0%; p = 0.27). In females, remission was associated with eosinophils >300/mu L (OR: 2.68; 95% CI: 1.41-5.07; p = 0.003), FeNO >50 ppb (OR: 21.05; 95% CI: 10.24-43.34; p < 0.0001), and nasal polyposis (OR: 2.74; 95% CI: 1.46-5.13; p = 0.001); obesity (OR: 0.20; 95% CI: 0.11-0.37; p < 0.0001), smoking (OR: 0.38; 95% CI: 0.21-0.70; p = 0.002), anxiety (OR: 0.47; 95% CI: 0.23-0.94; p = 0.04), and reflux (OR: 0.47; 95% CI: 0.27-0.84; p = 0.01) were negative predictors. In males, OCS dependency (OR: 0.35; 95% CI: 0.13-0.94; p = 0.03) and FEV1 <80% (OR: 0.18; 95% CI: 0.05-0.63; p = 0.004) were negative predictors. Conclusion: Biologics were equally effective in inducing clinical remission across sexes, but different predictors influenced outcomes. Sex-aware strategies may support personalized asthma care.