OBJECTIVES: Recently medical research has begun to recognize that symptoms and responses to medical treatment may differ by gender. Novartis Farma, Italy started the gender-medicine project MetaGeM, which includes 11 observational stud­ies conducted in Italy between 2002 and 2016 in different areas aimed to describe clinical outcomes, therapeutic approaches and safety data of these studies by sex. This post-hoc analysis of the PROXIMA study was aimed at assessing gender differences in Italian severe allergic asthma (SAA) patients in a real-world (RW) setting, focusing on disease perception and impact on quality of life (QoL).

METHODS: The PROXIMA was an observational, multicenter study, including adult outpatients diagnosed with SAA at step 4 requiring a therapeutic step-up. Patients on omalizumab treatment at baseline were included in the 12-month longitudinal phase. The level of disease control was assessed by the Asthma Control Questionnaire (ACQ) score, patients’ disease perception by the Brief Illness Perception Questionnaire (BIPQ) and QoL by the EuroQoL five-dimensional three-level questionnaire (EQ-5D-3 L) at baseline and after 6 and 12 months. Two regression models for repeated measures were used to evaluate the association between gender and BIPQ total and EQ-5D-3L scores.

RESULTS: 99 patients (62.6% females) were considered for this post-hoc analysis. Asthma perception was worse among women at all study visits reaching statistical significance at 12 months (mean±SD B-IPQ total score 41.8±9.4 vs 35.6±12.0; T-test p-value (males vs females) =0.007). Multivariate regression models showed that omalizumab treatment improved asthma perception overtime by 10.97 points of B-IPQ total score regardless from gender and that men reported a significantly better QoL compared to women at both 6 and 12 months.

CONCLUSIONS: In this RW setting women confirmed to have a worse perception of asthma and suffer a greater impact on their QoL, although having similar baseline severity and obtaining similar level of control.