LYON, France -- October 16, 2012 -- Despite showing beneficial trends, minocycline does not provide significant improvement to either clinical or magnetic resonance imaging (MRI) outcomes as an add-on to interferon beta-1a treatment for patients with relapsing-remitting multiple sclerosis, according to a study presented here at the 28th European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
Finn Sellebjerg, MD, PhD, Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark, presented results from a double-blind trial on October 12 on behalf of the RECYCLINE study investigators.
Patients under treatment with interferon beta-1a 44 µg subcutaneously 3 times weekly were randomised to oral placebo (n = 155) or minocycline 100 mg (n = 149) twice daily for 96 weeks.
The minocycline add-on treatment showed no significant benefit in improving the time to first qualifying relapse (hazard ratio = 0.845; P = .48). There were some indications of benefit for minocycline in the range of clinical and MRI secondary outcomes at 2 years, but none of these figures reached statistical significance.
Comparing placebo with add-on minocycline, no significant benefits were seen for the number of new T2 lesions (3.0 vs 3.0), T2 lesion volume (5,717 vs 4,814 mm3), and T1 lesion volume (1,717 vs 1,599 mm3).
Beneficial trends toward minocycline add-on that did not reach significance were seen in the annual rate of qualifying relapses (0.28 vs 0.18 for placebo and minocycline, respectively; P = .37), clinically disease-free patients (29.6% vs 47.8%; P = .22), and annual rate of reported relapses (0.40 vs 0.27; P = .08).
Although minocycline was well tolerated and no unexpected adverse events were seen, Dr. Sellebjerg said, “There was a relatively large number of dropouts due to adverse events, but that was also seen with the placebo.”
More patients in the minocycline group withdrew because of adverse events (20% vs 32%), although more in the placebo arm withdrew because of lack of efficacy (8% vs 1%).
These high withdrawal rates, and the relatively low annualised relapse rates in both treatment arms also contributed to the study being underpowered.
“We did not see any significant effects on primary outcome or secondary outcome measures, although all trends were in favour of the minocycline group,” Dr. Sellebjerg concluded. “Thus, the magnitude of these effects do not warrant new studies with this combination of minocycline and interferon beta-1a.”
The patient baseline characteristics were well balanced across the 2 treatment groups.
Funding for this study was provided by Merck Serono S.A., Geneva, Switzerland.
[Presentation title: No Beneficial Effect of Minocycline as Add-on Therapy to Interferon beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis: Results of a Large Double-Blind, Randomised, Placebo-Controlled Trial. Abstract P941]
--[ TOP ]--