Background: Multiple sclerosis (MS) is an autoimmune disease which attacks the central nervous systems (CNS) white substance. The damages cause MS-plaques which lead to disability in the CNS. There are currently around 20,000 people in Sweden who live with the diagnosis and every year another 1,000 people develop MS. It is twice as common for women to suffer from MS in comparison with men. Objective: The purpose of the study was to investigate the efficacy and safety of the alemtuzumab and daclizumab infusion drugs. Methods: This work is a literature study based on 6 scientific articles. Results: Based on at least one of the studied parameters, which are improvement in Expanded Disability Status Scale (EDSS), annual relapse rate and sustained accumulation of disability (IFS), showed that all four studies on alemtuzumab provided a higher therapeutic effect than IFN-β-1a. The two studies on daclizumab showed in one article in comparison with placebo a better treatment effect. The article comparing daclizumab with IFN-β-1a did not show major differences between the preparations but a reduced annual relapse rate was observed. Conclusion: The studies showed that both alemtuzumab and daclizumab yield better effect than IFN-β-1a and placebo. Treatment with alemtuzumab gave slightly better results in persistent worsening of the disease (IFS) compared with daclizumab, IFN-β- 1a and placebo. Patients who were treated with alemtuzumab had worse adverse events in comparison to the group of patients who were treated with IFN-β-1a. This shows that the safety of treatment with alemtuzumab was lower in comparison to treatment with IFN-β-1a. Most fatal outcomes were found during treatment with alemtuzumab. These aspects makes one consider whether alemtuzumab may or may not be the best treatment option. Also daclizumab had some serious side effects, but those did not occur as much as with alemtuzumab treatment. IFN-β-1a has been a safer drug to use as compared to alemtuzumab and dalclizumab. On the other hand, the mechanism of action differs between the three drugs, which means that these can be tailored more individually to MS-affected patients and a more individual-based drug treatment may be possible.

<p></p> <p><strong><em>Background </em></strong></p> <p>Oral pharmacotherapy has the potential to offer multiple sclerosis patients improved clinical outcomes compared to traditional therapies.</p> <p><strong><em>Objectives </em></strong></p> <p>This review assesses the effects of oral therapies compared to placebo and interferon beta-1a in adults with relapsing-remitting multiple sclerosis (RRMS).</p> <p><strong><em> </em></strong></p> <p><strong><em>Search methods </em></strong></p> <p>We searched the MEDLINE, EMBASE, Cochrane Library, Web of Science (January 1980 to April 2011) and clinincaltrials.gov (April 2011) databases and reference lists of articles. The FDA website was also searched.</p> <p><strong><em>Selection criteria </em></strong></p> <p>Double-blind, placebo-controlled, randomized trials of RRMS patients who were treated with fingolimod, cladribine, laquinimod or interferon beta-1a.</p> <p><strong><em>Data collection and analysis </em></strong></p> <p>Two reviewers independently assessed articles for inclusion. Data extraction and quality assessment was completed by one reviewer and verified for accuracy. Meta-analysis and indirect treatment comparison methods were used to estimate relative measures of efficacy.</p> <p><strong><em>Results </em></strong></p> <p>Although 11 trials involving 7,127 participants were included in this review, only 2,109 (30%) and 1,738 (24%) participants contributed to the direct and indirect estimates respectively, for the primary outcome, annualized relapse rate. Oral therapy and interferon beta-1a had a significantly different rate of relapse compared to placebo (Mean difference [MD] -0.21, 95% confidence interval [CI] -0.27 to -0.16 , p < 0.00001 and MD -0.33 95% CI -0.65 to -0.01). There was a significant risk reduction of 37% and 19% in the number of patients with at least one relapse for oral therapy and interferon beta-1a compared to placebo respectively. Safety analysis favoured placebo for both sets of trials (p=0.002 and p=0.04). Indirect estimates were not significant for all three outcomes however; comparability between direct evidence was noted.</p> <p><strong><em>Conclusions </em></strong></p> <p>Oral pharmacotherapy and interferon beta-1a are effective compared to placebo in controlling relapse rate in patients with RRMS. The indirect measures of effect provide initial estimates of comparative efficacy and incorporation of future evidence will be necessary.</p> / Master of Science (MSc)