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Review
.2012 Jan 18;1(1):CD005181.
doi: 10.1002/14651858.CD005181.pub3.

Interferon beta for secondary progressive multiple sclerosis

Affiliations
Review

Interferon beta for secondary progressive multiple sclerosis

Loredana La Mantia et al. Cochrane Database Syst Rev..

Abstract

Background: Therapy with either recombinant beta-1a or beta-1b interferons (IFNs) is worldwide approved for Relapsing Remitting Multiple Sclerosis (RRMS). A major unanswered question is whether this treatment is able to safely reverse or retard the progressive phase of the disease.

Objectives: The main objective was to verify whether IFNs treatment in Secondary Progressive Multiple Sclerosis (SPMS) is more effective than placebo in reducing the number of patients who experience disability progression.

Search methods: We searched the Cochrane Multiple Sclerosis Group's Trials Register (1995 to 15 February 2011), the reference lists of relevant articles and conference proceedings. Regulatory agencies were used as additional sources of information.

Selection criteria: We included all randomised, double or single blind, placebo-controlled trials (RCTs) evaluating the efficacy of IFNs versus placebo in SPMS patients.

Data collection and analysis: Two review authors independently assessed all reports retrieved from the search. They independently extracted clinical, safety and MRI data, using a predefined data extraction form, resolving disagreements after discussion with a third reviewer. Risk of bias was evaluated to assess the quality of the studies. Treatment effect was measured using Risk Ratio (RR) with 95% confidence intervals (CI) for the binary outcomes and Standard Mean Difference with 95% CI for the continuous outcomes.

Main results: Five RCTs met the inclusion criteria, from which 3122 (1829 IFN and 1293 placebo) treated patients contributed to the analysis. Included population was heterogeneous in terms of baseline clinical characteristics of the disease, in particular the percentage of patients affected by secondary progression with superimposed relapse ranging from 72% to 44%. IFN beta 1a and 1b did not decrease the risk of progression sustained at 6 months (RR, 95% CI: 0.98, [0.82-1.16]) after three years of treatment. A significant decrease of the risk of progression sustained at 3 months (RR, 95% CI: 0.88 [0.80, 0.97]) and of the risk of developing new relapses at three years (RR 0.91, [0.84-0.97]) were found. The risk of developing new active brain lesions decreased over time but this data was obtained from single studies on Magnetic Resonance Imaging (MRI), performed in subgroups of patients; in spite of no effect on progression, the radiological data supported an effect on MRI parameters. The safety profile reflects what is commonly reported in MS IFN-treated patients.

Authors' conclusions: Well designed RCTs, evaluating a high number of patients were included in the review. Recombinant IFN beta does not prevent the development of permanent physical disability in SPMS. We were unable to verify the effect on cognitive function for the lack of comparable data. This treatment significantly reduces the risk of relapse and of short -term relapse-related disability.Overall, these results show that IFNs' anti-inflammatory effect is unable to retard progression, when established. In the future, no new RCTs for IFNs versus placebo in SPMS will probably be undertaken, because research is now focusing on innovative drugs. We believe that this review gives conclusive evidence on the clinical efficacy of IFNs versus placebo in SPMS.

PubMed Disclaimer

Conflict of interest statement

Dr La Mantia has participated in clinical trials sponsored by SCHERING, and meetings sponsored by SCHERING, BAYER SERONO and BIOGEN.

Dr Fredrikson has received honoraria for lectures and educational activities sponsored by Bayer Schering Pharma, BiogenIdec, Merck Serono, Teva, Sanofi‐Aventis.

Prof Ebers, Dr Vacchi, Dr Filippini, Dr. Di Pietrantonj, Dr. Rovaris have no conflict of interest.

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1 Disability progression, Outcome 1 Sustained (6 months) EDSS increase after 3 years.
1.2
1.2. Analysis
Comparison 1 Disability progression, Outcome 2 Sustained (3 or 6 months) EDSS increase at 3 years in patients with or without pre‐study relapses.
1.3
1.3. Analysis
Comparison 1 Disability progression, Outcome 3 Sustained (3 months) EDSS increase.
1.4
1.4. Analysis
Comparison 1 Disability progression, Outcome 4 Sustained (3 or 6 months') EDSS increase according to pre‐study clinical characteristics of patients.
2.1
2.1. Analysis
Comparison 2 Adverse Events, Outcome 1 Total number of patients with Serious AEs.
2.2
2.2. Analysis
Comparison 2 Adverse Events, Outcome 2 Patients who had discontinuated for AEs (including SAEs) *.
2.3
2.3. Analysis
Comparison 2 Adverse Events, Outcome 3 Deaths.
2.4
2.4. Analysis
Comparison 2 Adverse Events, Outcome 4 Patients who done or attempted suicide.
2.5
2.5. Analysis
Comparison 2 Adverse Events, Outcome 5 Allergy/Rash (number of events).
2.6
2.6. Analysis
Comparison 2 Adverse Events, Outcome 6 Cutaneous necrosis *.
2.7
2.7. Analysis
Comparison 2 Adverse Events, Outcome 7 Injection site reactions *.
2.8
2.8. Analysis
Comparison 2 Adverse Events, Outcome 8 Patients with psychiatric disorders.
2.9
2.9. Analysis
Comparison 2 Adverse Events, Outcome 9 Patients with headache.
2.10
2.10. Analysis
Comparison 2 Adverse Events, Outcome 10 Patients with influenza like syndrome *.
2.11
2.11. Analysis
Comparison 2 Adverse Events, Outcome 11 Patients with myalgia.
2.12
2.12. Analysis
Comparison 2 Adverse Events, Outcome 12 Patients with fatigue/asthenia.
2.13
2.13. Analysis
Comparison 2 Adverse Events, Outcome 13 Patients with leucopenia *.
2.14
2.14. Analysis
Comparison 2 Adverse Events, Outcome 14 Patients with liver dysfunction.
3.1
3.1. Analysis
Comparison 3 Relapses' outcomes, Outcome 1 Number of patients with at least one relapse during follow.
3.2
3.2. Analysis
Comparison 3 Relapses' outcomes, Outcome 2 Relapse rate.
4.1
4.1. Analysis
Comparison 4 MRI: role of treatment, Outcome 1 Number of patients with combined lesions at different times (6, 9 and 24 months).
4.2
4.2. Analysis
Comparison 4 MRI: role of treatment, Outcome 2 Mean absolute change of T2 lesion load.
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