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Published on: December 9, 2015
Relating relapse and T2 lesion changes to disability progression in multiple sclerosis: a systematic literature
Kyle Fahrbach1, Rachel Huelin, Amber L Martin
1Evidera, 430 Bedford Street, Suite 300, Lexington, MA 02420, USA. Kyle.Fahrbach@evidera.com.
Background:
In the treatment of multiple sclerosis (MS), the most important therapeutic aim of disease-modifying treatments (DMTs) is to prevent or postpone long-term disability. Given the typically slow progression observed in the majority of relapsing-remitting MS (RRMS) patients, the primary endpoint for most randomized clinical trials (RCTs) is a reduction in relapse rate. It is widely assumed that reducing relapse rate will slow disability progression. Similarly, MRI studies suggest that reducing T2 lesions will be associated with slowing long-term disability in MS. The objective of this study was to evaluate the relationship between treatment effects on relapse rates and active T2 lesions to differences in disease progression (as measured by the Expanded Disability Status Scale [EDSS]) in trials evaluating patients with clinically isolated syndrome (CIS), RRMS, and secondary progressive MS (SPMS).
Methods:
A systematic literature review was conducted in Medline, Embase, CENTRAL, and PsycINFO to identify randomized trials published in English from January 1, 1993-June 3, 2013 evaluating DMTs in adult MS patients using keywords for CIS, RRMS, and SPMS combined with keywords for relapse and recurrence. Eligible studies were required to report outcomes of relapse and T2 lesion changes or disease progression in CIS, RRMS, or SPMS patients receiving DMTs and have a follow-up duration of at least 22 months. Ultimately, 40 studies satisfied these criteria for inclusion. Regression analyses were conducted on RCTs to relate differences between the effect of treatments on relapse rates and on active T2 lesions to differences between the effects of treatments on disease progression (as measured by EDSS).
Results:
Regression analysis determined there is a substantive clinically and statistically significant association between concurrent treatment effects in relapse rate and EDSS; p < 0.01. Lower treatment effects were associated with higher relative rates of disease progression. Significant associations between T2 lesion measures and EDSS measures also were found (p < 0.05), with some suggestion that the strength of the association may differ for older versus newer DMTs.
Conclusions:
Treatment differences in relapse reduction and T2 lesions are positively related to differences in disease progression over the first two years of treatment.
Insights
Reducing relapses and T2 lesions in multiple sclerosis (MS) treatment is linked to slower disability progression. This finding supports current therapeutic goals for MS disease-modifying treatments (DMTs).
Area of Science:
- Neurology
- Clinical Trials
- Immunology
Background:
- Disease-modifying treatments (DMTs) aim to prevent long-term disability in multiple sclerosis (MS).
- Reducing relapse rates and T2 lesions are primary endpoints in MS clinical trials, assumed to slow disability progression.
- The relationship between treatment effects on relapses/lesions and disability progression needs further evaluation.
Purpose of the Study:
- To evaluate the relationship between treatment effects on relapse rates and active T2 lesions.
- To assess how these effects correlate with differences in disease progression (Expanded Disability Status Scale [EDSS]).
- To analyze data from trials involving clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and secondary progressive MS (SPMS).
Main Methods:
- Systematic literature review of randomized trials (1993-2013) in Medline, Embase, CENTRAL, and PsycINFO.
- Included studies evaluated DMTs in adult MS patients with outcomes for relapse, T2 lesions, or EDSS, and a minimum 22-month follow-up.
- Regression analyses correlated treatment effects on relapse/lesions with effects on EDSS.
Main Results:
- A significant association (p < 0.01) was found between treatment effects on relapse rates and EDSS.
- Lower treatment effects correlated with higher rates of disease progression.
- Significant associations (p < 0.05) were observed between T2 lesion measures and EDSS measures, with potential differences for older vs. newer DMTs.
Conclusions:
- Treatment-induced reductions in relapses and T2 lesions are positively associated with slower disease progression within the first two years.
- These findings support the clinical relevance of monitoring relapse rates and T2 lesions as surrogates for long-term disability in MS.
- The study highlights the importance of treatment efficacy in mitigating MS progression.
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