: Biological drugs are used to treat severe asthma with an improvement of clinical symptoms. Data on sex-difference of these drugs in patients with severe asthma are sparse. This study aimed to assess the effects of sex-related differences on biological drugs, in patients with severe asthma. In this observational open-label prospective non-controlled, single-center cohort pilot study, we enrolled adult patients > 18 years diagnosed with severe asthma and not previously treated with biological drugs. The first clinical endpoint was the statistical difference (P<0.05) in the efficacy of biological drugs evaluated using asthma control test (ACT) and spirometry between sexes. The first safety endpoint was the statistical difference (P<0.05) in developing adverse drug reactions (ADRs) between sexes. We enrolled 74 severe asthmatic patients (48 women and 26 men) with a mean age of 59.4 (11.8) years. The mean forced expiratory volume in one second was 6.9 (13.9) for women and 9.4 (10.7) for men and improved significantly after the treatment (P<0.01), with no significant differences in sex [P = 0.8]. Similarly, ACT improved 12 months after the beginning of the treatment, without significant differences between men and women (P = 0.5). The most common drug used was omalizumab (45.9% of the patients, P<0.01) without significant differences between sex (P > 0.05). We didn't observe the development of ADRs during the study. In conclusion, in asthmatic patients, sex does not have a role in both the effectiveness and safety of biological drugs. This article is protected by copyright. All rights reserved.
What is the Role of Sex-Related Differences in the Effectiveness and Safety of Biological Drugs used in Patients' Severe Asthma?
Cione, Erika;Mazzuca, Daniela;
2022-01-01
Abstract
: Biological drugs are used to treat severe asthma with an improvement of clinical symptoms. Data on sex-difference of these drugs in patients with severe asthma are sparse. This study aimed to assess the effects of sex-related differences on biological drugs, in patients with severe asthma. In this observational open-label prospective non-controlled, single-center cohort pilot study, we enrolled adult patients > 18 years diagnosed with severe asthma and not previously treated with biological drugs. The first clinical endpoint was the statistical difference (P<0.05) in the efficacy of biological drugs evaluated using asthma control test (ACT) and spirometry between sexes. The first safety endpoint was the statistical difference (P<0.05) in developing adverse drug reactions (ADRs) between sexes. We enrolled 74 severe asthmatic patients (48 women and 26 men) with a mean age of 59.4 (11.8) years. The mean forced expiratory volume in one second was 6.9 (13.9) for women and 9.4 (10.7) for men and improved significantly after the treatment (P<0.01), with no significant differences in sex [P = 0.8]. Similarly, ACT improved 12 months after the beginning of the treatment, without significant differences between men and women (P = 0.5). The most common drug used was omalizumab (45.9% of the patients, P<0.01) without significant differences between sex (P > 0.05). We didn't observe the development of ADRs during the study. In conclusion, in asthmatic patients, sex does not have a role in both the effectiveness and safety of biological drugs. This article is protected by copyright. All rights reserved.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
