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NEUROLOGY 2009;72:1989-1993
© 2009 American Academy of Neurology

Effect of statins on clinical and molecular responses to intramuscular interferon beta-1a

R. A. Rudick, MD, A. Pace, ScD, M.R.S. Rani, PhD, R. Hyde, PhD, M. Panzara, MD, S. Appachi, BS, J. Shrock, BA, S. L. Maurer, PharmD, P. A. Calabresi, MD, C. Confavreux, MD, S. L. Galetta, MD, F. D. Lublin, MD, E. -W. Radue, MD and R. M. Ransohoff, MD

From the Mellen Center for Multiple Sclerosis Treatment and Research (R.A.R., R.M.R.) and Neuroinflammation Research Center, Lerner Research Institute (M.R.S.R., S.A., J.S., R.M.R.), Cleveland Clinic, Cleveland, OH; Biogen Idec, Inc. (A.P., R.H., M.P.), Cambridge, MA; Scientific Connexions (S.L.M.), Newtown, PA; Johns Hopkins Multiple Sclerosis Center (P.A.C.), Baltimore, MD; Hôpital Neurologique (C.C.), Lyon, France; University of Pennsylvania School of Medicine (S.L.G.), Philadelphia; Mt. Sinai School of Medicine (F.D.L.), New York, NY; and University Hospital Basel (E.-W.R.), Basel, Switzerland.

Address correspondence and reprint requests to Dr. Richard A. Rudick, Mellen Center for Treatment and Research in Multiple Sclerosis, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195 rudickr{at}ccf.org

Background: Findings from a small clinical study suggested that statins may counteract the therapeutic effects of interferon beta (IFNβ) in patients with relapsing-remitting multiple sclerosis (RRMS).

Methods: We conducted a post hoc analysis of data from the Safety and Efficacy of Natalizumab in Combination With IFNβ-1a in Patients With Relapsing-Remitting Multiple Sclerosis (SENTINEL) study to determine the effects of statins on efficacy of IFNβ. SENTINEL was a prospective trial of patients with RRMS treated with natalizumab (Tysabri®, Biogen Idec, Inc., Cambridge, MA) plus IM IFNβ-1a (Avonex®, Biogen Idec, Inc.) 30 µg compared with placebo plus IM IFNβ-1a 30 µg. Clinical and MRI outcomes in patients treated with IM IFNβ-1a only (no-statins group, n = 542) were compared with those of patients taking IM IFNβ-1a and statins at doses used to treat hyperlipidemia (statins group, n = 40).

Results: No significant differences were observed between treatment groups in adjusted annualized relapse rate (p = 0.937), disability progression (p = 0.438), number of gadolinium-enhancing lesions (p = 0.604), or number of new or enlarging T2-hyperintense lesions (p = 0.802) at 2 years. More patients in the statins group reported fatigue, extremity pain, muscle aches, and increases in hepatic transaminases compared with patients in the no-statins group. Statin treatment had no ex vivo or in vitro effect on induction of IFN-stimulated genes.

Conclusions: Statin therapy does not appear to affect clinical effects of IM interferon beta-1a in patients with relapsing-remitting multiple sclerosis or the primary molecular response to interferon beta treatment.

Abbreviations: ANCOVA = analysis of covariance; CI = confidence interval; EDSS = Expanded Disability Status Scale; GAPDH = glyceraldehyde-3-phosphate dehydrogenase; Gd+ = gadolinium-enhancing; IFNβ = interferon beta; ISG = IFN-stimulated gene; RRMS = relapsing-remitting multiple sclerosis; SENTINEL = Safety and Efficacy of Natalizumab in Combination With IFNβ-1a in Patients With Relapsing-Remitting Multiple Sclerosis.

Supplemental data at www.neurology.org

The interferon biological response studies were supported by the US National Institutes of Health (NINDS PO1 NS38667 and NCRR MO1 RR-018390) and the National Multiple Sclerosis Society (RG 3604A6/1).

Disclosure: Author disclosures are provided at the end of the article.

Medications and Medical Devices: A list of medications and medical devices used in this study is provided at the end of the article.

Presented in part at the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis, Prague, Czech Republic, October 11–14, 2007.

Received September 30, 2008. Accepted in final form March 10, 2009.




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Effect of Statins on Responses to Interferon Beta-1a
Journal Watch Neurology, October 6, 2009; 2009(1006): 2 - 2.
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