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

R. A. Rudick, A. Pace, M. R S Rani, R. Hyde, M. Panzara, S. Appachi, J. Shrock, S. L. Maurer, Peter Calabresi, C. Confavreux, S. L. Galetta, F. D. Lublin, E. W. Radue, R. M. Ransohoff

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1989-1993
Number of pages5
JournalNeurology
Volume72
Issue number23
DOIs
StatePublished - Jun 9 2009

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Hydroxymethylglutaryl-CoA Reductase Inhibitors
Relapsing-Remitting Multiple Sclerosis
Interferon-beta
Interferon beta-1a
Myalgia
Gadolinium
Therapeutic Uses
Therapeutics
Transaminases
Hyperlipidemias
Fatigue
Extremities
Placebos
Safety
Recurrence
Pain

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Rudick, R. A., Pace, A., Rani, M. R. S., Hyde, R., Panzara, M., Appachi, S., ... Ransohoff, R. M. (2009). Effect of statins on clinical and molecular responses to intramuscular interferon beta-1a. Neurology, 72(23), 1989-1993. https://doi.org/10.1212/WNL.0b013e3181a92b96

Effect of statins on clinical and molecular responses to intramuscular interferon beta-1a. / Rudick, R. A.; Pace, A.; Rani, M. R S; Hyde, R.; Panzara, M.; Appachi, S.; Shrock, J.; Maurer, S. L.; Calabresi, Peter; Confavreux, C.; Galetta, S. L.; Lublin, F. D.; Radue, E. W.; Ransohoff, R. M.

In: Neurology, Vol. 72, No. 23, 09.06.2009, p. 1989-1993.

Research output: Contribution to journalArticle

Rudick, RA, Pace, A, Rani, MRS, Hyde, R, Panzara, M, Appachi, S, Shrock, J, Maurer, SL, Calabresi, P, Confavreux, C, Galetta, SL, Lublin, FD, Radue, EW & Ransohoff, RM 2009, 'Effect of statins on clinical and molecular responses to intramuscular interferon beta-1a', Neurology, vol. 72, no. 23, pp. 1989-1993. https://doi.org/10.1212/WNL.0b013e3181a92b96
Rudick RA, Pace A, Rani MRS, Hyde R, Panzara M, Appachi S et al. Effect of statins on clinical and molecular responses to intramuscular interferon beta-1a. Neurology. 2009 Jun 9;72(23):1989-1993. https://doi.org/10.1212/WNL.0b013e3181a92b96
Rudick, R. A. ; Pace, A. ; Rani, M. R S ; Hyde, R. ; Panzara, M. ; Appachi, S. ; Shrock, J. ; Maurer, S. L. ; Calabresi, Peter ; Confavreux, C. ; Galetta, S. L. ; Lublin, F. D. ; Radue, E. W. ; Ransohoff, R. M. / Effect of statins on clinical and molecular responses to intramuscular interferon beta-1a. In: Neurology. 2009 ; Vol. 72, No. 23. pp. 1989-1993.
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abstract = "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 {\circledR}, Biogen Idec, Inc., Cambridge, MA) plus IM IFNβ-1a (Avonex {\circledR}, 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.",
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AU - Rani, M. R S

AU - Hyde, R.

AU - Panzara, M.

AU - Appachi, S.

AU - Shrock, J.

AU - Maurer, S. L.

AU - Calabresi, Peter

AU - Confavreux, C.

AU - Galetta, S. L.

AU - Lublin, F. D.

AU - Radue, E. W.

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N2 - 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.

AB - 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.

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