Author Topic: (Abst.) Beta-interferons vs. Copaxone for RRMS (Read 154 times)

agate · « **on:** July 27, 2014, 02:01:45 pm »

This is an abstract from an article in Cochrane Database of Systematic Reviews. They've collected studies on the topic of glatiramer acetate (Copaxone) versus the beta interferons for RRMS and published their results.

It looks as if the interferons have a slight edge when it comes to MRI lesion load accrual. Otherwise they're similar in their effects.

From PubMed, July 27, 2014:

Quote

Cochrane Database Syst Rev. 2014 Jul 26;7:CD009333.

Interferons-beta versus glatiramer acetate for relapsing-remitting multiple sclerosis

La Mantia L1, Di Pietrantonj C, Rovaris M, Rigon G, Frau S, Berardo F, Gandini A, Longobardi A, Weinstock-Guttman B, Vaona A.

Author information

1Unit of Neurorehabilitation - Multiple Sclerosis Center, I.R.C.C.S. Santa Maria Nascente - Fondazione Don Gnocchi, Via Capecelatro, 66, Milano, Italy, 20148.

BACKGROUND:

Interferons (IFNs)-beta and glatiramer acetate (GA) were the first two disease-modifying therapies (DMTs) approved 15 years ago for the treatment of multiple sclerosis (MS). DMTs prescription rates as first or switching therapies and their costs have increased substantially over the past decade. As more DMTs become available, the choice of a specific DMT should reflect the risk/benefit profile, as well as the impact on quality profile. As MS cohorts enrolled in different studies can vary significantly, head-to-head trials are considered the best approach for gaining objective reliable data when two different drugs are compared. The purpose of this study is to summarise available evidence on the comparative effectiveness of IFNs-beta and GA on disease course through a systematic review of head-to-head trials.

OBJECTIVES:

To assess whether IFNs-beta and GA differ in terms of safety and efficacy in the treatment of patients with relapsing-remitting MS (RRMS).

SEARCH METHODS:

We searched the Trials Specialised Register of the Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System Group (29 October 2013) and the reference lists of retrieved articles. We contacted trialists and pharmaceutical companies.

SELECTION CRITERIA:

Randomised controlled trials (RCTs) comparing directly IFNs-beta versus GA in study participants affected by RRMS.

DATA COLLECTION AND ANALYSIS:

We used standard methodological procedures as expected by The Cochrane Collaboration.

MAIN RESULTS:

Five trials contributed to this review. A total of 2858 participants were randomly assigned to IFNs (1679) and GA (1179). The treatment duration was three years for one study and two years for the other four RCTs. The IFNs analysed in comparison with GA were IFN-beta 1b 250 mcg (two trials, 933 participants), IFN-beta 1a 44 mcg (two trials, 441 participants) and IFN-beta 1a 30 mcg (two trials, 305 participants). Enrolled participants were affected by active RRMS. All studies were at high risk for attrition bias.

Both therapies showed similar clinical efficacy at 24 months, given the primary outcome variables (number of participants with relapse (risk ratio (RR) 1.04, 95% confidence interval (CI) 0.87 to 1.24) or progression (RR 1.11, 95% CI 0.91 to 1.35)). However, at 36 months, evidence from a single study suggests that relapse rates were higher in the group given IFNs than in the GA group (RR 1.40, 95% CI 1.13 to 1.7, P value 0.002).Secondary magnetic resonance imaging (MRI) outcomes analysis showed that effects on new or enlarging T2- or gadolinium (Gd)-enhancing lesions at 24 months were similar (mean difference (MD) -0.01, 95% CI -0.28 to 0.26, and MD -0.14, 95% CI -0.30 to 0.02, respectively). However, the reduction in T2- and T1-weighted lesion volume was significantly greater in the groups given IFNs than in the GA groups (MD -0.58, 95% CI -0.99 to -0.18, P value 0.004, and MD -0.20, 95% CI -0.33 to -0.07, P value 0.003, respectively).

The number of participants who dropped out of the study because of adverse events was similar in the two groups (RR 0.95, 95% CI 0.64 to 1.40).

The quality of evidence for primary outcomes was judged as moderate for clinical end points, but for safety and some MRI outcomes (number of active T2 lesions), quality was judged as low.

AUTHORS' CONCLUSIONS:

The effects of IFNs-beta and GA in the treatment of patients with RRMS, including clinical (e.g. patients with relapse, risk to progression) and MRI (Gd-enhancing lesions) activity measures, seem to be similar or to show only small differences. When MRI lesion load accrual is considered, the effect of the two treatments differs, in that IFNs-beta were found to limit the increase in lesion burden as compared with GA. Evidence was insufficient for a comparison of the effects of the two treatments on patient-reported outcomes, such as quality of life measures.

PMID: 25062935

The abstract can be seen here.

agate · « **Reply #1 on:** January 23, 2015, 07:14:37 pm »

From the MS Discovery Forum, January 20, 2015:

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Glatiramer Acetate and the Interferon Betas Are Clinically Similar

Following on the heels of a Cochrane meta-analysis earlier in 2014 [see previous post in this thread], a new study finds that MS patients followed over 10 years have similar annualized relapse rates whether they take glatiramer acetate or one of the interferon betas

CYNTHIA MCKELVEY

No matter how you slice it, glatiramer acetate (GA) and the interferon betas (IFN-β) appear to be equally good treatment options for patients with relapsing-remitting multiple sclerosis (RRMS). A recent study from the Multiple Sclerosis Journal looked at 10 years of data on over 3,000 RRMS patients registered in MSBase, a global database of MS patients, and found that GA and IFN-β were similarly successful in reducing relapses (Kalincik et al., 2014). The study’s conclusions are similar to, though slightly different from, those of a Cochrane meta-analysis published in the summer of 2014 (La Mantia et al., 2014).

In the new study, researchers pulled data from MSBase on 3,326 RRMS patients who were using either IFN-β or GA as their first-ever disease-modifying therapy (DMT) for at least 6 months, and had started treatment within 10 years of their first symptom. To be included in the study, patients also had to have had at least one relapse recorded during the two years leading up to the start of their initial DMT. Each patient also had to have a minimal data set recording sex, age, date of first MS symptoms, dates of relapses, clinical MS score, their treatment center, and their baseline disability described by the Expanded Disability Status Scale.

The researchers looked at patients in four different treatment groups: IFN-β-1a intramuscular (IM), IFN-β-1a subcutaneous (SC), IFN-β-1b, and GA. They noted that, generally, patients treated with IFN-β-1a IM were less disabled at baseline than patients treated with the other interferons. Patients on GA were also generally older than patients on interferons. The researchers then paired each treatment group in six different head-to-head comparisons. The patients were also matched in clinical and demographic characteristics in each comparison.

For all treatments, the average annualized relapse rate (ARR) ranged from 0.38 to 0.56 relapses per year. The researchers noted that patients in the GA and IFN-β-1a SC groups had the lowest average ARR, with a relatively small range (0.15–0.16 relapses per year for GA and 0.09–0.1 relapses per year for IFN-β-1a SC).

Additionally, approximately one-third to one-half of all relapses were treated with steroids, and the researchers saw no significant differences in the efficacy of steroid treatment between the groups. The researchers also observed a significantly higher portion of relapse-free patients in the GA group compared to the IFN-β-1a IM and IFN-β-1b groups (p ≤ 0.02).

These findings match up with those of the Cochrane meta-analysis, which looked at a number of clinical outcomes, including relapse rate. In the Cochrane meta-analysis, the researchers found that in one head-to-head trial, patients on GA had a slightly better outcome in relapse rates at a 3-year follow-up. The Cochrane meta-analysis also found a number of small but significant variations in other outcome measures such as MRI data, but the new study did not look at the same outcomes.

The conclusions of both studies were that, by and large, GA and the IFN-βs are relatively similar in clinical outcome. None of the treatments showed major differences in accrued disability over time. It appears that GA and IFN-β-1a SC may be slightly superior in lowering ARR, but the data for all treatments are relatively limited.

The authors of the current study noted that they are “eagerly awaiting” similar reviews on newer treatment options.

...

Disclosures and sources of funding

The work was supported by Multiple Sclerosis Research Australia, several NHMRC awards and grants, and the MSBase Foundation. The MSBase Foundation is a not-for-profit organization that receives support from Merck Serono, Biogen Idec, Novartis Pharma, Bayer Schering, Sanofi-Aventis, and BioCSL. The study was conducted separately and apart from the guidance of the sponsors.

MS Speaks

Author Topic: (Abst.) Beta-interferons vs. Copaxone for RRMS (Read 154 times)

agate

(Abst.) Beta-interferons vs. Copaxone for RRMS

agate

Re: Copaxone and the interferons are clinically similar