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 (IFNbeta) treatment response in a cohort of relapsing (RR) MS patients. METHODS: A cohort of 2570 IFNbeta-treated RRMS was prospectively followed for up 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 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; p<0.05) in the subgroup with 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 IFNbeta treatment in the same way of females.
RCT Entities:
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 (IFNbeta) treatment response in a cohort of relapsing (RR) MS patients. METHODS: A cohort of 2570 IFNbeta-treated RRMS was prospectively followed for up 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 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; p<0.05) in the subgroup with 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 IFNbeta treatment in the same way of females.
Authors: Giancarlo Comi; Stuart D Cook; Gavin Giovannoni; Kottil Rammohan; Peter Rieckmann; Per Soelberg Sørensen; Patrick Vermersch; Anthony C Hamlett; Vissia Viglietta; Steven J Greenberg Journal: J Neurol Date: 2012-12-21 Impact factor: 4.849
Authors: Tomas Kalincik; Timothy Spelman; Maria Trojano; Pierre Duquette; Guillermo Izquierdo; Pierre Grammond; Alessandra Lugaresi; Raymond Hupperts; Edgardo Cristiano; Vincent Van Pesch; Francois Grand'maison; Daniele La Spitaleri; Maria Edite Rio; Sholmo Flechter; Celia Oreja-Guevara; Giorgio Giuliani; Aldo Savino; Maria Pia Amato; Thor Petersen; Ricardo Fernandez-Bolanos; Roberto Bergamaschi; Gerardo Iuliano; Cavit Boz; Jeannette Lechner-Scott; Norma Deri; Orla Gray; Freek Verheul; Marcela Fiol; Michael Barnett; Erik van Munster; Vetere Santiago; Fraser Moore; Mark Slee; Maria Laura Saladino; Raed Alroughani; Cameron Shaw; Krisztian Kasa; Tatjana Petkovska-Boskova; Leontien den Braber-Moerland; Joab Chapman; Eli Skromne; Joseph Herbert; Dieter Poehlau; Merrilee Needham; Elizabeth Alejandra Bacile Bacile; Walter Oleschko Arruda; Mark Paine; Bhim Singhal; Steve Vucic; Jose Antonio Cabrera-Gomez; Helmut Butzkueven Journal: PLoS One Date: 2013-05-21 Impact factor: 3.240
Authors: Francesco Patti; Vincenzo Brescia Morra; Maria Pia Amato; Maria Trojano; Stefano Bastianello; Maria Rosalia Tola; Salvatore Cottone; Andrea Plant; Orietta Picconi Journal: PLoS One Date: 2013-08-30 Impact factor: 3.240