Assessing and understanding relapse independent progression in different disease stages
ECTRIMS Online Library. Comi G. 09/13/19; 279570; 313
Prof. Giancarlo Comi
Prof. Giancarlo Comi
Contributions Biography
Abstract

Abstract: 313

Type: Scientific Session

Abstract Category: ECTRIMS - EAN Session: Emerging concepts of relapsing and progressiv

G. Comi

Institute of Experimental Neurology, Scientific Institute San Raffaele, Milan, Italy

By definition in relapsing remitting multiple sclerosis (RRMS) the worsening of disability can only be explained by an incomplete recovery from attacks. However post hoc analysis of some clinical trial performed in RR patients have revealed that in a variable proportion of patients the worsening of disability was apparently independent from the occurrence of a relapse. This observation may be due to variable causes: poor reproducibility of Expanded Disability Status Scale (EDSS), errors in the application of EDSS, undetected relapses, the transition from a relapsing remitting to a secondary progressive course, etc. Wrong classification of confirmed disability progression induces also errors on the estimation of NEDA (No Evidence of Disease Activity). Methodological strategies to minimize errors will be discussed. In progressive multiple sclerosis (PMS) courses the worsening of disability can be due both to the phenomenon of progression and to an incomplete recovery from overlapping relapses, with this second mechanism usually playing a minor role. Since most of the drugs tested in PMS clinical trials have a predominant antinflammatory effect it is of great importance to try to define if in clinical trials exploring the efficacy of an intervention the positive results in term of reduction of the risk of disability progression can be predominantly or exclusively due to an effect on relapses, or if they depend on positive effects on the pathophysiological mechanisms underlying progression. In more recent years a large number of observational studies performed in real word setting including large cohorts of RRMS and PMS patients have complemented the results of gold standard clinical trials in defining the efficacy profile of disease modifying treatments in MS. Because of the increased impact of methodological problems and the difficulty to estimate quality of the data, the definition of the contribution of relapses on the variation of disability is sometimes very difficult.
Disclosure: In the past 3 years, GC has received compensation for consulting services and/or speaking activities from Novartis, Teva, Sanofi Genzyme, Merck, Biogen, Roche, Almirall, Celgene, Forward Pharma, Medday and Excemed.

Abstract: 313

Type: Scientific Session

Abstract Category: ECTRIMS - EAN Session: Emerging concepts of relapsing and progressiv

G. Comi

Institute of Experimental Neurology, Scientific Institute San Raffaele, Milan, Italy

By definition in relapsing remitting multiple sclerosis (RRMS) the worsening of disability can only be explained by an incomplete recovery from attacks. However post hoc analysis of some clinical trial performed in RR patients have revealed that in a variable proportion of patients the worsening of disability was apparently independent from the occurrence of a relapse. This observation may be due to variable causes: poor reproducibility of Expanded Disability Status Scale (EDSS), errors in the application of EDSS, undetected relapses, the transition from a relapsing remitting to a secondary progressive course, etc. Wrong classification of confirmed disability progression induces also errors on the estimation of NEDA (No Evidence of Disease Activity). Methodological strategies to minimize errors will be discussed. In progressive multiple sclerosis (PMS) courses the worsening of disability can be due both to the phenomenon of progression and to an incomplete recovery from overlapping relapses, with this second mechanism usually playing a minor role. Since most of the drugs tested in PMS clinical trials have a predominant antinflammatory effect it is of great importance to try to define if in clinical trials exploring the efficacy of an intervention the positive results in term of reduction of the risk of disability progression can be predominantly or exclusively due to an effect on relapses, or if they depend on positive effects on the pathophysiological mechanisms underlying progression. In more recent years a large number of observational studies performed in real word setting including large cohorts of RRMS and PMS patients have complemented the results of gold standard clinical trials in defining the efficacy profile of disease modifying treatments in MS. Because of the increased impact of methodological problems and the difficulty to estimate quality of the data, the definition of the contribution of relapses on the variation of disability is sometimes very difficult.
Disclosure: In the past 3 years, GC has received compensation for consulting services and/or speaking activities from Novartis, Teva, Sanofi Genzyme, Merck, Biogen, Roche, Almirall, Celgene, Forward Pharma, Medday and Excemed.

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