Disease-activity on IFN-beta predicts poor long-term outcome

Bermel et al. Predictors of long-term outcome in MS patients treated with interferon beta. Ann Neurol; 2012: DOI: 10.1002/ana.23758

Objective: To identify early predictors of long-term outcomes in MSers with RRMS treated with IM interferon beta-1a (IM IFNβ-1a).

Methods: Multi-center, observational, 15-year follow-up study of MSers who completed =2 years in the pivotal trial of IM IFNß-1a for RRMS. 136 MSers participated in the 15-year follow-up (69 originally randomized to IM IFNβ-1a and 67 to placebo). After the 2-year clinical trial, treatment was not regulated by study protocol. Disease activity during the 2-year trial was defined as: 2 or more gadolinium-enhancing lesions (cumulative) on year 1 and/or year 2 MRI; 3 or more new T2 lesions on year 2 MRI compared to baseline; and 2 or more relapses over two years. Odds ratios were calculated for early disease activity predicting severe EDSS worsening (worst quartile of change, > 4.5 EDSS points) during the 15-year interval.

Results: The proportion of MSers experiencing early disease activity was lower in patients on IM IFNβ-1a than placebo for all disease activity markers (range 23.5%-29.0% vs. 41.0%-45.5%). In the IM IFNβ-1a group, persistent disease activity predicted severe EDSS worsening: gad lesions (OR=8.96, p<0.001); relapses (OR=4.44, p=0.010); and new T2 lesions (OR=2.90, p=0.080). In placebo MSers, early disease activity was not as strongly associated with long-term outcomes (OR range=1.53-2.62, p=0.069-0.408).

Interpretation: Disease activity despite treatment with IFNβ is associated with unfavorable long-term outcomes. Particular attention should be paid to gadolinium-enhancing lesions on IFNβ therapy, as their presence strongly correlates with severe disability 15 years later. The results provide rationale for monitoring IFNβ treated MSers with MRI, and for changing therapy in patients with active disease.

"Disease is another data set supporting DMT treatment and the suppression of all measurable disease activity and supports the concept of treating to a target of DAF or disease activity free. Are you disease activity free. If you have not completed our survey on this issue please do. Thanks."



Other posts on this issue you may find interesting

20 Sep 2012
I would therefore appreciate it if you could help by completing the following survey, which will take less than a minute, to see if if you have been exposed to the "disease-activity free " concept in clinic. Please note that all ...
29 Sep 2012
why would any doctor not want their patients to free of disease activity? Surely you start patients on a first line thrapy and them monitor them e.g. MRI, clinical examination. If their is disease activity e.g. MRI shos inflammation, ...
23 Sep 2012
The meeting went well and the preliminary results of the disease-activity free (DAF) survey were very helpful to illustrate the point that concept of disease-activity free (DAF) status has yet to diffuse into clinical practice.
23 Sep 2012
The meeting went well and the preliminary results of the disease-activity free (DAF) survey were very helpful to illustrate the point that concept of disease-activity free (DAF) status has yet to diffuse into clinical practice.

Labels: ,