Abstract | BACKGROUND: METHODS: NORMIMS (NORdic trial of oral Methylprednisolone as add-on therapy to Interferon beta-1a for treatment of relapsing-remitting Multiple Sclerosis) was a randomised, placebo-controlled trial done in 29 neurology departments in Denmark, Norway, Sweden, and Finland. We enrolled outpatients with relapsing-remitting multiple sclerosis who had had at least one relapse within the previous 12 months despite subcutaneous interferon beta-1a treatment (44 microg three times per week). We randomly allocated patients by computer to add-on therapy of either 200 mg methylprednisolone or matching placebo, both given orally on 5 consecutive days every 4 weeks for at least 96 weeks. The primary outcome measure was mean yearly relapse rate. Primary analyses were by intention to treat. This trial is registered, number ISRCTN16202527. FINDINGS: 66 patients were assigned to interferon beta and oral methylprednisolone and 64 were assigned to interferon beta and placebo. A high proportion of patients withdrew from the study before week 96 (26% [17 of 66] on methylprednisolone vs 17% [11 of 64] on placebo). The mean yearly relapse rate was 0.22 for methylprednisolone compared with 0.59 for placebo (62% reduction, 95% CI 39-77%; p<0.0001). Sleep disturbance and neurological and psychiatric symptoms were the most frequent adverse events recorded in the methylprednisolone group. Bone mineral density had not changed after 96 weeks. INTERPRETATION:
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Authors | Per Soelberg Sorensen, Svein Ivar Mellgren, Anders Svenningsson, Irina Elovaara, Jette Lautrup Frederiksen, Antonie Giaever Beiske, Kjell-Morten Myhr, Lise Vejby Søgaard, Inge Christoffer Olsen, Magnhild Sandberg-Wollheim |
Journal | The Lancet. Neurology
(Lancet Neurol)
Vol. 8
Issue 6
Pg. 519-29
(Jun 2009)
ISSN: 1474-4422 [Print] England |
PMID | 19409854
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Adjuvants, Immunologic
- Antibodies
- Glucocorticoids
- Interferon-beta
- Methylprednisolone
- Interferon beta-1a
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Topics |
- Adjuvants, Immunologic
(therapeutic use)
- Adolescent
- Adult
- Antibodies
(metabolism)
- Confidence Intervals
- Disability Evaluation
- Double-Blind Method
- Drug Administration Routes
- Drug Therapy, Combination
- Europe
- Female
- Follow-Up Studies
- Glucocorticoids
(therapeutic use)
- Humans
- Interferon beta-1a
- Interferon-beta
(therapeutic use)
- Kaplan-Meier Estimate
- Male
- Methylprednisolone
(therapeutic use)
- Middle Aged
- Multiple Sclerosis, Relapsing-Remitting
(drug therapy, immunology, physiopathology)
- Psychomotor Performance
(drug effects, physiology)
- Retrospective Studies
- Severity of Illness Index
- Young Adult
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