Post-marketing of disease modifying drugs in multiple sclerosis: An exploratory analysis of gender effect in interferon beta treatment

M. Trojano, F. Pellegrini, D. Paolicelli, A. Fuiani, G. B. Zimatore, C. Tortorella, I. L. Simone, F. Patti, A. Ghezzi, E. Portaccio, P. Rossi, C. Pozzilli, G. Salemi, A. Lugaresi, R. Bergamaschi, E. Millefiorini, M. Clerico, G. Lus, M. Vianello, C. AvolioP. Cavalla, P. Iaffaldano, V. Direnzo, M. D'Onghia, V. Lepore, P. Livrea, G. Comi, M. P. Amato

Research output: Contribution to journalArticle

23 Citations (Scopus)

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 (IFNβ) treatment response in a cohort of relapsing (RR) MS patients. Methods: A cohort of 2570 IFNβ-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 IFNβ treatment in the same way of females.

Original languageEnglish
Pages (from-to)109-113
Number of pages5
JournalJournal of the Neurological Sciences
Volume286
Issue number1-2
DOIs
Publication statusPublished - Nov 15 2009

Fingerprint

Interferon-beta
Marketing
Multiple Sclerosis
Propensity Score
Pharmaceutical Preparations
Recurrence
Randomized Controlled Trials
Therapeutics
Risk Reduction Behavior
Proportional Hazards Models
Observational Studies
Regression Analysis

Keywords

  • Gender
  • Interferon beta
  • Multiple sclerosis
  • Observational study
  • Propensity score

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology

Cite this

Post-marketing of disease modifying drugs in multiple sclerosis : An exploratory analysis of gender effect in interferon beta treatment. / Trojano, M.; Pellegrini, F.; Paolicelli, D.; Fuiani, A.; Zimatore, G. B.; Tortorella, C.; Simone, I. L.; 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, M. P.

In: Journal of the Neurological Sciences, Vol. 286, No. 1-2, 15.11.2009, p. 109-113.

Research output: Contribution to journalArticle

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 2009, 'Post-marketing of disease modifying drugs in multiple sclerosis: An exploratory analysis of gender effect in interferon beta treatment', Journal of the Neurological Sciences, vol. 286, no. 1-2, pp. 109-113. https://doi.org/10.1016/j.jns.2009.06.036
Trojano, M. ; Pellegrini, F. ; Paolicelli, D. ; Fuiani, A. ; Zimatore, G. B. ; Tortorella, C. ; Simone, I. L. ; 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, M. P. / Post-marketing of disease modifying drugs in multiple sclerosis : An exploratory analysis of gender effect in interferon beta treatment. In: Journal of the Neurological Sciences. 2009 ; Vol. 286, No. 1-2. pp. 109-113.
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T2 - An exploratory analysis of gender effect in interferon beta treatment

AU - Trojano, M.

AU - Pellegrini, F.

AU - Paolicelli, D.

AU - Fuiani, A.

AU - Zimatore, G. B.

AU - Tortorella, C.

AU - Simone, I. L.

AU - Patti, F.

AU - Ghezzi, A.

AU - Portaccio, E.

AU - Rossi, P.

AU - Pozzilli, C.

AU - Salemi, G.

AU - Lugaresi, A.

AU - Bergamaschi, R.

AU - Millefiorini, E.

AU - Clerico, M.

AU - Lus, G.

AU - Vianello, M.

AU - Avolio, C.

AU - Cavalla, P.

AU - Iaffaldano, P.

AU - Direnzo, V.

AU - D'Onghia, M.

AU - Lepore, V.

AU - Livrea, P.

AU - Comi, G.

AU - Amato, M. P.

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N2 - 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 (IFNβ) treatment response in a cohort of relapsing (RR) MS patients. Methods: A cohort of 2570 IFNβ-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 IFNβ treatment in the same way of females.

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