Titre
Minocycline added to subcutaneous interferon β-1a in multiple sclerosis: randomized RECYCLINE study.
Type
article
Institution
UNIL/CHUV/Unisanté + institutions partenaires
Périodique
Auteur(s)
Sørensen, P.S.
Auteure/Auteur
Sellebjerg, F.
Auteure/Auteur
Lycke, J.
Auteure/Auteur
Färkkilä, M.
Auteure/Auteur
Créange, A.
Auteure/Auteur
Lund, C.G.
Auteure/Auteur
Schluep, M.
Auteure/Auteur
Frederiksen, J.L.
Auteure/Auteur
Stenager, E.
Auteure/Auteur
Pfleger, C.
Auteure/Auteur
Garde, E.
Auteure/Auteur
Kinnunen, E.
Auteure/Auteur
Marhardt, K.
Auteure/Auteur
Groupes de travail
RECYCLINE Study Investigators
Liens vers les personnes
Liens vers les unités
ISSN
1468-1331
Statut éditorial
Publié
Date de publication
2016-05
Volume
23
Numéro
5
Première page
861
Dernière page/numéro d’article
870
Peer-reviewed
Oui
Langue
anglais
Notes
Publication types: Journal Article
Publication Status: ppublish
Publication types: Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
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.
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.
Sujets
PID Serval
serval:BIB_806D46117F12
PMID
Date de création
2016-02-20T14:47:01.169Z
Date de création dans IRIS
2025-05-21T04:40:16Z