Daniel M. Keller, PhD

July 16, 2012

July 16, 2012 (Prague, Czech Republic) — In a retrospective observational analysis of outcomes using various disease-modifying treatments (DMTs) for relapsing-remitting multiple sclerosis (RRMS), researchers found similar efficacy among the 4 drugs studied in real life practice.

Mathias Mäurer, MD, head of the Department of Neurology at Caritas Hospital Bad Mergentheim in Bad Mergentheim, Germany, reported results of his open-label study of more than 7000 patients from 488 German outpatient centers here, at the 22nd Meeting of the European Neurological Society.

From these open-label, retrospective observational data, Dr. Mäurer concluded, "There's no difference regarding the different immunomodulatory drugs…regarding the relapse-free proportion of patients and patients who had relapses."

TYPIC Survey

The population for this study was taken from a large cohort of German patients with multiple sclerosis (MS) studied in the TYPIC survey. Previous results from this cohort published last year showed that immunomodulatory treatment was effective in most patients. This report is a subgroup analysis of those patients with an RRMS diagnosis for at least 12 months.

Of 7284 patients, 2154 (29.6%) received interferon (IFN) beta-1a intramuscularly via prefilled syringe (Avonex, Biogen Idec), 1642 (22.5%) received IFN beta-1b subcutaneously (Betaferon, Bayer Schering Pharma), 1124 (15.4%) and 741 (10.2%) received 22 µg and 44 µg, respectively, of IFN beta-1a subcutaneously (Rebif, Merck Serono), and 1623 (22.3%) received glatiramer acetate (Copaxone, Teva/Sanofi Aventis).

Because of the relatively small number (n = 278) receiving Avonex using Bio-Set IFN powder for reconstitution and injection, these individuals were excluded from the analysis. Also, a relatively small number of patients from each group were missing, leaving a population of 7006 patients in the final analysis.

The groups were well matched for age (mean, 39 to 42 years), gender (26% to 30% males), and duration of disease (mean, 8.08 to 9.23 years), with similar proportions of patients in each of the age bands with disease duration less than or equal to 5 years, 6 to 10 years, and longer than 10 years.

Similar Clinical and Imaging Efficacy

The analysis included outcomes for the previous 12 months. With all treatments, about the same proportions of patients were free of relapse during that period. The proportion of patients without relapse ranged from 69.7% to 69.9% with IFN beta-1a (Avonex or Rebif 22 µg) or with IFN beta-1b.

With Rebif 44 µg, 62.7% were free of relapse, as were 65.9% of those on glatiramer acetate. The rest of the patients experienced at least 1 relapse in the previous year. Statistical analysis revealed no differences in relapse rates among the DMTs (P = .144).

Magnetic resonance imaging (MRI) findings were also similar among the groups. The proportion of patients with fewer than 9 T2-lesions ranged from 36.2% to 45.1%. The proportion of patients with only 1 gadolinium-enhancing lesion ranged from 45% to 64.1%, with Rebif 22 µg at the low end. In all of the other treatment groups, at least 55% of patients showed only 1 gadolinium-enhancing lesion.

Dr. Mäurer sees both good news and not so good news in these findings. "It's certainly good news that most patients in Germany are stable under immunomodulatory treatment, I mean, 66% – that's great – but 34% have already relapses."

Oliver Findling, MD, a neurologist at the University Hospital in Bern, Switzerland, who led the poster discussion in which this study was presented, said that although the study was retrospective, the large number of patients adds to the validity of the findings, and the findings did not surprise him.

"That's what we thought…that these medications work in the same way. In our opinion, there is no difference between Avonex and Rebif or Betaferon. That's our clinical experience," he said. These medications "slow the disease progression for about one third," of patients Dr. Findling noted.

The study was supported by Biogen Idec GmbH, Germany, which also funded medical writing assistance and editorial support. Dr. Mäurer has received honoraria for lectures from Bayer Schering, Teva, Merck Serono, Biogen Idec, Novartis, Sanofi Aventis, Talecris, and Boehringer Ingelheim. Dr. Findling, who was not involved in the study, receives compensation from Bayer Schering for being a consultant for patients on the Internet.

22nd Meeting of the European Neurological Society. Abstract P-476. Presented June 11, 2012.

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