Background: There are a few and conflicting results from randomised controlled trials (RCTs) pertaining to the influence of gender inresponse to currently used diseasemodifying drugs inMultiple Sclerosis(MS).Observational studies may be especially valuable for answering effectiveness questions in subgroups not studied in RCTs. Objective: To conduct a post-marketing analysis aimed to evaluate the gender effect on Interferon beta (IFNβ) treatment response in a cohort of relapsing (RR) MS patients. Methods: A cohort of 2570 IFNβ-treated RRMSwas prospectively followed for up to 7 years in 15 ItalianMS Centers. Cox proportional hazards regression modelswere used to assess gender differences for risk of reaching 1st relapse and risk of progression by 1 point on Expanded Disability Status Scale (EDSS) score. Gender effects were also explored by a propensity score (PS) matching algorithm, and a tree-growing technique. Results: The multivariate Cox Regression analyses showed that male patients had a significant (p=0.0097) lower risk for 1st relapse and a trend (p=0.0897) for a higher risk to reach 1 point EDSS progression than females. The PS matched multivariate Cox Regression confirmed these results. The RECPAM analysis showed that male sex conferred a significant reduction in the risk for 1st relapse (HR=0.86; 95% CI=0.76–0.98; p=0.0226) in the subgroup with a low pre-treatment number of bouts, and a significant increase in the risk for 1 point EDSS progression (HR=1.33; 95% CI: 1.00–1.76; pb0.05) in the subgroupwith a delayed treatment, but a still young age at the start of treatment. Conclusion: The results of this exploratory analysis seem to suggest that male patients do not respond to IFNβ treatment in the same way of females.
Post-marketing of disease modifying drugs in multiple sclerosis: An exploratory analysis of gender effect in interferon beta treatment.
LUS, Giacomo;
2009
Abstract
Background: There are a few and conflicting results from randomised controlled trials (RCTs) pertaining to the influence of gender inresponse to currently used diseasemodifying drugs inMultiple Sclerosis(MS).Observational studies may be especially valuable for answering effectiveness questions in subgroups not studied in RCTs. Objective: To conduct a post-marketing analysis aimed to evaluate the gender effect on Interferon beta (IFNβ) treatment response in a cohort of relapsing (RR) MS patients. Methods: A cohort of 2570 IFNβ-treated RRMSwas prospectively followed for up to 7 years in 15 ItalianMS Centers. Cox proportional hazards regression modelswere used to assess gender differences for risk of reaching 1st relapse and risk of progression by 1 point on Expanded Disability Status Scale (EDSS) score. Gender effects were also explored by a propensity score (PS) matching algorithm, and a tree-growing technique. Results: The multivariate Cox Regression analyses showed that male patients had a significant (p=0.0097) lower risk for 1st relapse and a trend (p=0.0897) for a higher risk to reach 1 point EDSS progression than females. The PS matched multivariate Cox Regression confirmed these results. The RECPAM analysis showed that male sex conferred a significant reduction in the risk for 1st relapse (HR=0.86; 95% CI=0.76–0.98; p=0.0226) in the subgroup with a low pre-treatment number of bouts, and a significant increase in the risk for 1 point EDSS progression (HR=1.33; 95% CI: 1.00–1.76; pb0.05) in the subgroupwith a delayed treatment, but a still young age at the start of treatment. Conclusion: The results of this exploratory analysis seem to suggest that male patients do not respond to IFNβ treatment in the same way of females.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
