Efficacy of disease-modifying therapies in relapsing remitting multiple sclerosis: A systematic comparison
ABSTRACT The treatment of relapsing-remitting multiple sclerosis (RRMS) has become more effective over the last decade with the advent of the currently available disease-modifying therapies (DMTs). Pivotal clinical studies differ in many characteristics, such that cross-comparisons of relative risk reductions are of limited value and can be misleading. Our objective was to compare the clinical efficacy of currently approved first-line DMTs in patients with RRMS, applying an evidence-based medicine approach. We reviewed all phase III pivotal trials of DMTs. Six clinical trials of Avonex, Betaseron, Copaxone, Rebif and Tysabri in patients with RRMS were identified for analysis. Only randomized, placebo-controlled, double-blind studies were included. The clinical efficacy endpoints compared were: proportion of relapse-free patients at 1 and 2 years; annualized relapse rate at 2 years; proportion of progression-free patients at 2 years, and proportion of patients free of gadolinium-enhancing lesions at 1 year or 9 months. Based on these analyses, Betaseron, Rebif, and Tysabri show comparable effects, whereas for several endpoints Avonex or Copaxone did not significantly differ from placebo. In the absence of head-to-head studies for all products used to treat RRMS, it still may be possible to compare treatment effects by applying evidence-based medicine principles.
SourceAvailable from: Alessandra Solari[Show abstract] [Hide abstract]
ABSTRACT: People with multiple sclerosis (MS) are confronted with a number of important uncertainties concerning many aspects of the disease. Among others, these include diagnosis, prognosis, disease course, disease-modifying therapies, symptomatic therapies and non-pharmacological interventions. It has been shown that people with MS demand adequate information to be able to actively participate in medical decision making and to self-manage their disease. On the other hand, it has been found that patients' disease-related knowledge is poor. Therefore, guidelines have recommended clear and concise high-quality information at all stages of the disease. Several studies have outlined communication and information deficits in the care of people with MS and, accordingly, a number of information and decision support programmes have been published. To evaluate the effectiveness of information provision interventions for people with MS that aim to promote informed choice and improve patient-relevant outcomes. We searched the Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System Group Specialised Register which contains trials from CENTRAL (The Cochrane Library 2013, Issue 6), MEDLINE, EMBASE, CINAHL, LILACS, PEDro and clinical trials registries (12 June 2013) as well as other sources. In addition, we searched PsycINFO, trial registries, and reference lists of identified articles. We also contacted trialists. Randomised controlled trials, cluster randomised controlled trials and quasi-randomised trials comparing information provision for people with MS or suspected MS (intervention groups) with usual care or other types of information provision (control groups) were eligible. Two review authors independently assessed the retrieved articles for relevance and methodological quality, and extracted data. Critical appraisal of studies addressed the risk of selection bias, performance bias, attrition bias and detection bias. We contacted authors of relevant studies for additional information. Ten randomised controlled trials involving a total of 1314 participants met the inclusion criteria and were analysed. The interventions addressed a variety of topics using different approaches for information provision in different settings. Topics included disease-modifying therapy, relapse management, self-care strategies, fatigue management, family planning and general health promotion. The interventions contained decision aids, educational programmes, self-care interventions and personal interviews with physicians. All interventions were complex interventions using more than one active component, but the number and extent of the intervention components differed markedly between studies. The studies had a variable risk of bias. We did not perform meta-analyses due to marked clinical heterogeneity. All four studies assessing MS-related knowledge (524 participants; moderate-quality evidence) detected significant differences between groups as a result of the interventions indicating that information provision may successfully increase participants' knowledge. There were mixed results from four studies reporting effects on decision making (836 participants; low-quality evidence) and from five studies assessing quality of life (605 participants; low-quality evidence). There were no adverse events in the six studies reporting on adverse events. Information provision for people with MS seems to increase disease-related knowledge, with less clear results on decision making and quality of life. There seem to be no negative side effects from informing patients about their disease. Interpretation of study results remains challenging due to the marked heterogeneity of the interventions and outcome measures.Cochrane database of systematic reviews (Online) 04/2014; 4(4):CD008757. DOI:10.1002/14651858.CD008757.pub2 · 5.94 Impact Factor
[Show abstract] [Hide abstract]
ABSTRACT: To explore if vitamin D modulates interferon-β1a treatment effects in relapsing-remitting multiple sclerosis, we examined relationships between serum vitamin D and magnetic resonance imaging (MRI) activity and ten systemic inflammation markers in 88 patients, before and during treatment. Odds ratios for all MRI parameters were negatively associated with vitamin D levels before therapy, but converged to equally low values irrespective of vitamin D status during treatment. During therapy, similar alterations of MRI activity and inflammation markers were found across patients categorized by mean vitamin D values. This suggests that vitamin D status has no major influence on interferon-β1a treatment effects. Copyright © 2015 Elsevier B.V. All rights reserved.Journal of Neuroimmunology 02/2015; 280. DOI:10.1016/j.jneuroim.2015.02.001 · 2.79 Impact Factor
Article: Dietrich Hoffmann, 1924–2011Preventive Medicine 06/2011; 52(6):483-483. DOI:10.1016/j.ypmed.2011.05.006 · 2.93 Impact Factor