Oral interferon beta-1a in relapsing-remitting multiple sclerosis

A double-blind randomized study

C. Polman, F. Barkhof, L. Kappos, C. Pozzilli, R. Sandbrink, F. Dahlke, P. Jakobs, A. Lorenz, J. Hern, R. Coleman, P. Soelberg Srensen, H. P. Hartung, S. Fredrikson, K. Selmaj, J. Pelletier, M. B. D'Hooghe, G. Comi, R. Hohfeld, R. Gold, M. Panelius & 17 others J. Ruutiainen, M. Clanet, M. De Vos, M. Jonker, T. Van Ijken, E. Jansen, R. Van Schijndel, G. Karas, K. Wagner, M. Ghazi, D. Kurth, K. Sauerbrey, E. Tries, H. F. McFarland, D. H. Miller, X. Montalban, J. Petkau

Research output: Contribution to journalArticle

29 Citations (Scopus)

Abstract

Background: Interferon beta (IFNB) is available in parenteral formulations for treatment of multiple sclerosis (MS). The purpose of this study was to evaluate safety, tolerability and effects on MRI lesions of three different doses of oral IFNB-1a compared with placebo over six months in relapsing-remitting (RR) MS patients. Methods: In this multicenter, double-blind randomized trial, RR-MS patients received 0.06, 0.6 or 6 million international units (MIU) IFNB-1a or placebo every other day for up to six months. Gadolinium DTPA-enhanced brain MRI scans were performed at screening and monthly during treatment. The primary variable was the cumulative number of newly active lesions. Secondary variables included volume of enhancing lesions on T1-weighted images each month and lesion volume on T2-weighted images at months three and six. Safety measures included adverse events, laboratory variables, vital signs, ECG, physical examination, EDSS and number of relapses. Neopterin was measured in 21 patients and neutralizing antibodies in 24 patients. Results: Of 194 screened patients, 173 were randomized (42-44 patients per group) in 15 centers. Median cumulative numbers of newly active lesions over six months were 4.0 in the placebo and 0.6 MIU groups, compared with 7.5 and 9.0 in the 0.06 and 6 MIU groups (no significant differences). Secondary efficacy endpoints showed small and inconsistent differences between groups. Adverse events showed no notable group differences. Approximately two-thirds of patients in each group remained relapse free. No patients showed neutralizing antibodies. Neopterin levels were comparable between groups. Conclusion: Oral IFNB-1a showed neither beneficial effects in RRMS nor any systemic biological effects. Treatment was safe and well tolerated.

Original languageEnglish
Pages (from-to)342-348
Number of pages7
JournalMultiple Sclerosis Journal
Volume9
Issue number4
DOIs
Publication statusPublished - Aug 2003

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Relapsing-Remitting Multiple Sclerosis
Double-Blind Method
Neopterin
Placebos
Neutralizing Antibodies
Safety
Recurrence
Gadolinium DTPA
Interferon beta-1a
Vital Signs
Interferon-beta
Multiple Sclerosis
Physical Examination
Electrocardiography
Therapeutics
Magnetic Resonance Imaging
Brain

Keywords

  • Multiple sclerosis
  • Oral interferon beta-1a
  • Relapsing-remitting

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Polman, C., Barkhof, F., Kappos, L., Pozzilli, C., Sandbrink, R., Dahlke, F., ... Petkau, J. (2003). Oral interferon beta-1a in relapsing-remitting multiple sclerosis: A double-blind randomized study. Multiple Sclerosis Journal, 9(4), 342-348. https://doi.org/10.1191/1352458503ms923oa

Oral interferon beta-1a in relapsing-remitting multiple sclerosis : A double-blind randomized study. / Polman, C.; Barkhof, F.; Kappos, L.; Pozzilli, C.; Sandbrink, R.; Dahlke, F.; Jakobs, P.; Lorenz, A.; Hern, J.; Coleman, R.; Soelberg Srensen, P.; Hartung, H. P.; Fredrikson, S.; Selmaj, K.; Pelletier, J.; D'Hooghe, M. B.; Comi, G.; Hohfeld, R.; Gold, R.; Panelius, M.; Ruutiainen, J.; Clanet, M.; De Vos, M.; Jonker, M.; Van Ijken, T.; Jansen, E.; Van Schijndel, R.; Karas, G.; Wagner, K.; Ghazi, M.; Kurth, D.; Sauerbrey, K.; Tries, E.; McFarland, H. F.; Miller, D. H.; Montalban, X.; Petkau, J.

In: Multiple Sclerosis Journal, Vol. 9, No. 4, 08.2003, p. 342-348.

Research output: Contribution to journalArticle

Polman, C, Barkhof, F, Kappos, L, Pozzilli, C, Sandbrink, R, Dahlke, F, Jakobs, P, Lorenz, A, Hern, J, Coleman, R, Soelberg Srensen, P, Hartung, HP, Fredrikson, S, Selmaj, K, Pelletier, J, D'Hooghe, MB, Comi, G, Hohfeld, R, Gold, R, Panelius, M, Ruutiainen, J, Clanet, M, De Vos, M, Jonker, M, Van Ijken, T, Jansen, E, Van Schijndel, R, Karas, G, Wagner, K, Ghazi, M, Kurth, D, Sauerbrey, K, Tries, E, McFarland, HF, Miller, DH, Montalban, X & Petkau, J 2003, 'Oral interferon beta-1a in relapsing-remitting multiple sclerosis: A double-blind randomized study', Multiple Sclerosis Journal, vol. 9, no. 4, pp. 342-348. https://doi.org/10.1191/1352458503ms923oa
Polman, C. ; Barkhof, F. ; Kappos, L. ; Pozzilli, C. ; Sandbrink, R. ; Dahlke, F. ; Jakobs, P. ; Lorenz, A. ; Hern, J. ; Coleman, R. ; Soelberg Srensen, P. ; Hartung, H. P. ; Fredrikson, S. ; Selmaj, K. ; Pelletier, J. ; D'Hooghe, M. B. ; Comi, G. ; Hohfeld, R. ; Gold, R. ; Panelius, M. ; Ruutiainen, J. ; Clanet, M. ; De Vos, M. ; Jonker, M. ; Van Ijken, T. ; Jansen, E. ; Van Schijndel, R. ; Karas, G. ; Wagner, K. ; Ghazi, M. ; Kurth, D. ; Sauerbrey, K. ; Tries, E. ; McFarland, H. F. ; Miller, D. H. ; Montalban, X. ; Petkau, J. / Oral interferon beta-1a in relapsing-remitting multiple sclerosis : A double-blind randomized study. In: Multiple Sclerosis Journal. 2003 ; Vol. 9, No. 4. pp. 342-348.
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AU - Polman, C.

AU - Barkhof, F.

AU - Kappos, L.

AU - Pozzilli, C.

AU - Sandbrink, R.

AU - Dahlke, F.

AU - Jakobs, P.

AU - Lorenz, A.

AU - Hern, J.

AU - Coleman, R.

AU - Soelberg Srensen, P.

AU - Hartung, H. P.

AU - Fredrikson, S.

AU - Selmaj, K.

AU - Pelletier, J.

AU - D'Hooghe, M. B.

AU - Comi, G.

AU - Hohfeld, R.

AU - Gold, R.

AU - Panelius, M.

AU - Ruutiainen, J.

AU - Clanet, M.

AU - De Vos, M.

AU - Jonker, M.

AU - Van Ijken, T.

AU - Jansen, E.

AU - Van Schijndel, R.

AU - Karas, G.

AU - Wagner, K.

AU - Ghazi, M.

AU - Kurth, D.

AU - Sauerbrey, K.

AU - Tries, E.

AU - McFarland, H. F.

AU - Miller, D. H.

AU - Montalban, X.

AU - Petkau, J.

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N2 - Background: Interferon beta (IFNB) is available in parenteral formulations for treatment of multiple sclerosis (MS). The purpose of this study was to evaluate safety, tolerability and effects on MRI lesions of three different doses of oral IFNB-1a compared with placebo over six months in relapsing-remitting (RR) MS patients. Methods: In this multicenter, double-blind randomized trial, RR-MS patients received 0.06, 0.6 or 6 million international units (MIU) IFNB-1a or placebo every other day for up to six months. Gadolinium DTPA-enhanced brain MRI scans were performed at screening and monthly during treatment. The primary variable was the cumulative number of newly active lesions. Secondary variables included volume of enhancing lesions on T1-weighted images each month and lesion volume on T2-weighted images at months three and six. Safety measures included adverse events, laboratory variables, vital signs, ECG, physical examination, EDSS and number of relapses. Neopterin was measured in 21 patients and neutralizing antibodies in 24 patients. Results: Of 194 screened patients, 173 were randomized (42-44 patients per group) in 15 centers. Median cumulative numbers of newly active lesions over six months were 4.0 in the placebo and 0.6 MIU groups, compared with 7.5 and 9.0 in the 0.06 and 6 MIU groups (no significant differences). Secondary efficacy endpoints showed small and inconsistent differences between groups. Adverse events showed no notable group differences. Approximately two-thirds of patients in each group remained relapse free. No patients showed neutralizing antibodies. Neopterin levels were comparable between groups. Conclusion: Oral IFNB-1a showed neither beneficial effects in RRMS nor any systemic biological effects. Treatment was safe and well tolerated.

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