Minocycline added to subcutaneous interferon β-1a in multiple sclerosis: randomized RECYCLINE study.

Détails

ID Serval
serval:BIB_806D46117F12
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Minocycline added to subcutaneous interferon β-1a in multiple sclerosis: randomized RECYCLINE study.
Périodique
European journal of neurology
Auteur(s)
Sørensen P.S., Sellebjerg F., Lycke J., Färkkilä M., Créange A., Lund C.G., Schluep M., Frederiksen J.L., Stenager E., Pfleger C., Garde E., Kinnunen E., Marhardt K.
Collaborateur(s)
RECYCLINE Study Investigators
ISSN
1468-1331 (Electronic)
ISSN-L
1351-5101
Statut éditorial
Publié
Date de publication
05/2016
Peer-reviewed
Oui
Volume
23
Numéro
5
Pages
861-870
Langue
anglais
Notes
Publication types: Journal Article
Publication Status: ppublish
Publication types: Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't

Résumé
Combining different therapies may improve disease control in patients with relapsing-remitting multiple sclerosis (RRMS). This study assessed the efficacy and safety of minocycline added to subcutaneous (sc) interferon (IFN) β-1a therapy.
This was a double-blind, randomized, placebo-controlled multicentre study. Within 3 months (±1 month) of starting sc IFN β-1a 44 μg three times weekly, patients with RRMS were randomized to minocycline 100 mg twice daily or placebo, added to sc IFN β-1a, for 96 weeks. The primary efficacy endpoint was the time to first qualifying relapse. Secondary efficacy endpoints were the annualized relapse rate for qualifying relapses, the number of new/enlarging T2-weighted lesions and change in brain volume [magnetic resonance imaging (MRI) was performed only in a few selected centres]. In addition, a number of tertiary efficacy endpoints were assessed.
One hundred and forty-nine patients received minocycline and 155 received placebo; MRI data were available for 23 and 27 patients, respectively. The time to first qualifying relapse did not differ significantly for minocycline versus placebo (hazard ratio 0.85; 95% confidence interval 0.53, 1.35; log-rank = 0.50; P = 0.48). There were no statistically significant differences between the two groups on other efficacy endpoints, although some numerical trends in favour of minocycline were observed. No unexpected adverse events were reported, but more patients discontinued because of adverse events with minocycline versus placebo.
Minocycline showed no statistically significant beneficial effect when added to sc IFN β-1a therapy.

Mots-clé
Adolescent, Adult, Anti-Bacterial Agents/therapeutic use, Brain/diagnostic imaging, Brain/drug effects, Brain/pathology, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Interferon beta-1a/therapeutic use, Magnetic Resonance Imaging/methods, Male, Middle Aged, Minocycline/therapeutic use, Multiple Sclerosis/diagnostic imaging, Multiple Sclerosis/drug therapy, Multiple Sclerosis/pathology, Organ Size/drug effects, Treatment Outcome, Young Adult
Pubmed
Création de la notice
20/02/2016 16:47
Dernière modification de la notice
20/08/2019 15:40
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