Original Article

Real-life impact of early interferonβ therapy in relapsing multiple sclerosis†

  1. M. Trojano MD1,*,
  2. F. Pellegrini MDeStat2,
  3. D. Paolicelli MD1,
  4. A. Fuiani MD1,
  5. G.B. Zimatore MD1,
  6. C. Tortorella MD1,
  7. I.L. Simone MD1,
  8. F. Patti MD3,
  9. A. Ghezzi MD4,
  10. V. Zipoli MD5,
  11. P. Rossi MD6,
  12. C. Pozzilli MD7,
  13. G. Salemi MD8,
  14. A. Lugaresi MD9,
  15. R. Bergamaschi MD10,
  16. E. Millefiorini MD11,
  17. M. Clerico MD12,
  18. G. Lus MD13,
  19. M. Vianello MD14,
  20. C. Avolio MD15,
  21. P. Cavalla MD16,
  22. V. Lepore MD2,
  23. P. Livrea MD1,
  24. G. Comi MD6,
  25. M.P. Amato MD5

Article first published online: 28 MAY 2009

DOI: 10.1002/ana.21757

Issue

Annals of Neurology

Annals of Neurology

Volume 66, Issue 4, pages 513–520, October 2009

Additional Information

How to Cite

Trojano, M., Pellegrini, F., Paolicelli, D., Fuiani, A., Zimatore, G., Tortorella, C., Simone, I., Patti, F., Ghezzi, A., Zipoli, V., Rossi, P., Pozzilli, C., Salemi, G., Lugaresi, A., Bergamaschi, R., Millefiorini, E., Clerico, M., Lus, G., Vianello, M., Avolio, C., Cavalla, P., Lepore, V., Livrea, P., Comi, G. and Amato, M. (2009), Real-life impact of early interferonβ therapy in relapsing multiple sclerosis. Annals of Neurology, 66: 513–520. doi: 10.1002/ana.21757

Author Information

  1. 1

    Department of Neurological and Psychiatric Sciences, University of Bari, Bari, Italy

  2. 2

    Department of Clinical Pharmacology and Epidemiology, Consorzio Mario Negri Sud, Santa Maria Imbaro, Chieti, Italy

  3. 3

    Department of Neurology, University of Catania, Catania, Italy

  4. 4

    Multiple Sclerosis Centre, Hospital of Gallarate, Gallarate, Italy

  5. 5

    Department of Neurology, University of Florence, Florence, Italy

  6. 6

    Department of Neurology, Hospital of San Raffaele, Milan, Italy

  7. 7

    Multiple Sclerosis Center, S. Andrea Hospital, University of Rome “La Sapienza,” Rome, Italy

  8. 8

    Department of Clinical Neurosciences, University of Palermo, Palermo, Italy

  9. 9

    Department of Oncology and Neuroscience, University G. d'Annunzio, Chieti, Italy

  10. 10

    Multiple Sclerosis Center, Neurological Institute C. Mondino, Pavia, Italy

  11. 11

    Department of Neurological Sciences, University “La Sapienza,” Rome, Italy

  12. 12

    Department of Neurology, S. Luigi Gonzaga Hospital, University of Turin, Turin, Italy

  13. 13

    Department of Neurological Sciences, 2nd University of Naples, Naples, Italy

  14. 14

    O. U. Neurology, Ca' Foncello Hospital, Treviso, Italy

  15. 15

    Department of Medical and Occupational Sciences, University of Foggia, Foggia, Italy

  16. 16

    Department of Neuroscience, University of Turin, Turin, Italy

*Department of Neurological and Psychiatric Sciences, University of Bari, Piazza Giulio Cesare 11-70124, Bari, Italy

  1. †

    Potential conflicts of interest: M.T. received honoraria for consultancy or speaking from Sanofi-Aventis, Biogen, and Bayer Schering, and research grants from Merck Serono; F.P.2 received honoraria for speaking from Biogen; I.L.S. received honoraria for speaking from Sanofi-Aventis and Biogen, and research grants from Sanofi-Aventis; F.P.3 received honoraria for speaking from Sanofi-Aventis and Merck Serono; A.G. received honoraria for speaking from Bayer Schering, Merck Serono, and research grants from Sanofi-Aventis, Biogen Dompè, and Merck Serono; C.P. received honoraria for consultancy or speaking from Sanofi-Aventis, Biogen, Bayer Schering, and Novartis, and research grants from Merck Serono and Sanofi Aventis; A.L. received honoraria for speaking from Biogen and research grants from Sanofi-Aventis, Merck Serono, Biogen, and Bayer Schering; E.M. received honoraria for speaking from Bayer Schering and research grants from Merck Serono, Sanofi-Aventis, Biogen-Dompè, and Bayer Schering; C.A. received honoraria for consultancy or speaking from Sanofi-Aventis, Biogen-Dompè, Bayer Schering, and Merck Serono; M.C. received honoraria for speaking from Bayer Schering; P.L. received research grants from Sanofi-Aventis, Merck Serono, and Biogen; G.C. received honoraria for consultancy or speaking from Teva Neuroscience Plough Corporation and Merck Serono; M.P.A. received honoraria for speaking from Merck Serono and Biogen, and research grants from Sanofi-Aventis, Merck Serono, Biogen, and Bayer Schering. The other authors declare that they have no conflicts of interest.

Publication History

  1. Issue published online: 8 OCT 2009
  2. Article first published online: 28 MAY 2009
  3. Accepted manuscript online: 28 MAY 2009 12:00AM EST
  4. Manuscript Accepted: 18 MAY 2009
  5. Manuscript Revised: 11 MAY 2009
  6. Manuscript Received: 20 FEB 2009

Funded by

  • Italian University and Research Ministry (MIUR). Grant Number: COFIN 2005–2006 M.T. Proselto Stzetegieo Regiolle Puque “Nurobío tech” PS 124

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Abstract

Objective

Recent findings support greater efficacy of early vs. delayed interferon beta (IFNβ) treatment in patients with a first clinical event suggestive of multiple sclerosis (MS). We aimed to evaluate the effectiveness of early IFNβ treatment in definite relapsing-remitting MS (RRMS) and to assess the optimal time to initiate IFNβ treatment with regard to the greatest benefits on disability progression.

Methods

A cohort of 2,570 IFNβ-treated RRMS patients was prospectively followed for up to 7 years in 15 Italian MS Centers. A Cox proportional hazards regression model adjusted for propensity score (PS) quintiles was used to assess differences between groups of patients with early vs. delayed IFNβ treatment on risk of reaching a 1-point progression in the Expanded Disability Status Scale (EDSS) score, and the EDSS 4.0 and 6.0 milestones. A set of PS-adjusted Cox hazards regression models were calculated according to different times of treatment initiation (within 1 year up to within 5 years from disease onset). A sensitivity analysis was performed to assess the robustness of findings.

Results

The lowest hazard ratios (HRs) for the three PS quintiles–adjusted models were obtained by a cutoff of treatment initiation within 1 year from disease onset. Early treatment significantly reduced the risk of reaching a 1-point progression in EDSS score (HR = 0.63; 95% CI = 0.48–0.85; p < 0.002), and the EDSS 4.0 milestone (HR = 0.56; 95% CI = 0.36–0.90; p = 0.015). Sensitivity analysis showed the bound of significance for unmeasured confounders.

Interpretation

Greater benefits on disability progression may be obtained by an early IFNβ treatment in RRMS. Ann Neurol 2009;66:513–520

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