1. Post-marketing of disease modifying drugs in multiple sclerosis: an exploratory analysis of gender effect in interferon beta treatment
- Author
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Trojano, M, Pellegrini, F, Paolicelli, D, Fuiani, A, Zimatore, Gb, Tortorella, C, Simone, Il, Patti, F, Ghezzi, A, Portaccio, E, Rossi, P, Pozzilli, C, Salemi, G, Lugaresi, A, Bergamaschi, R, Millefiorini, E, Clerico, Marinella, Lus, G, Vianello, M, Avolio, C, Cavalla, P, Iaffaldano, P, Direnzo, V, D'Onghia, M, Lepore, V, Livrea, P, Comi, G, Amato, Mp, Italian Multiple Sclerosis Database Network Group, Trojano, M., Pellegrini, F., Paolicelli, D., Fuiani, A., Zimatore, G., Tortorella, C., Simone, I., Patti, F., Ghezzi, A., Portaccio, E., Rossi, P., Pozzilli, C., Salemi, G., Lugaresi, A., Bergamaschi, R., Millefiorini, E., Clerico, M., Lus, Giacomo, Vianello, M., Avolio, C., Cavalla, P., Iaffaldano, P., Direnzo, V., D'Onghia, M., Lepore, V., Livrea, P., Comi, G., Amato, M., ITALIAN MULTIPLE SCLEROSIS DATABASE NETWORK, . ., Trojano M, Pellegrini F, Paolicelli D, Fuiani A, Zimatore GB, Tortorella C, Simone IL, Patti F, Ghezzi A, Portaccio E, Rossi P, Pozzilli C, Salemi G, Lugaresi A, Bergamaschi R, Millefiorini E, Clerico M, Lus G, Vianello M, Avolio C, Cavalla P, Iaffaldano P, Direnzo V, D'Onghia M, Lepore V, Livrea P, Comi G, Amato MP, M Trojano, F Pellegrini, D Paolicelli, A Fuiani, GB Zimatore, C Tortorella C, IL Simone, F Patti, A Ghezzi, E Portaccio, P Rossi, C Pozzilli, G Salemi, A Lugaresi, and on behalf of Italian Multiple Sclerosis Database Network (MSDN) group
- Subjects
Adult ,Male ,medicine.medical_specialty ,Multiple Sclerosis ,Propensity score ,Disease ,gender ,interferon beta ,multiple sclerosis ,observational study ,propensity score ,Lower risk ,Severity of Illness Index ,Multiple sclerosis, Interferon beta, Gender, Observational study, Propensity score ,Cohort Studies ,Disability Evaluation ,Young Adult ,Sex Factors ,gender, multiple sclerosis, treatment, interferon ,Double-Blind Method ,Internal medicine ,Observational study ,medicine ,Confidence Intervals ,Odds Ratio ,Product Surveillance, Postmarketing ,Humans ,Immunologic Factors ,Multiple sclerosi ,Proportional Hazards Models ,Expanded Disability Status Scale ,Proportional hazards model ,business.industry ,Multiple sclerosis ,Drug Administration Routes ,Interferon-beta ,medicine.disease ,Interferon beta ,Surgery ,Neurology ,Italy ,Cohort ,Propensity score matching ,Regression Analysis ,Settore MED/26 - Neurologia ,Female ,Neurology (clinical) ,business - Abstract
Background: There are a few and conflicting results from randomised controlled trials (RCTs) pertaining to the influence of gender in response to currently used disease modifying drugs in Multiple 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 (IFN beta) treatment response in a cohort of relapsing (RR) MS patients. Methods: A cohort of 2570 IFN beta-treated RRMS was prospectively followed for Lip to 7 years in 15 Italian MS Centers. Cox proportional hazards regression models were used to assess gender differences for risk of reaching 1st relapse and risk of progression by I 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 I 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% Cl = 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 I point EDSS progression (HR = 1.33; 95% Cl: 1.00-1.76; p
- Published
- 2009