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Review
. 2023 Jan;30(1):9-21.
doi: 10.1111/ene.15593. Epub 2022 Oct 25.

Diagnosis and treatment of progressive multiple sclerosis: A position paper

Carlo Pozzilli  1   2 , Maura Pugliatti  3   4 , Patrick Vermersch  5 , Nikolaos Grigoriadis  6 , Mona Alkhawajah  7 , Laura Airas  8   9 , Celia Oreja-Guevara  10   11
Affiliations
Review

Diagnosis and treatment of progressive multiple sclerosis: A position paper

Carlo Pozzilli et al. Eur J Neurol. 2023 Jan.

Abstract

Background and purpose: Multiple sclerosis (MS) is an unpredictable disease characterised by a highly variable disease onset and clinical course. Three main clinical phenotypes have been described. However, distinguishing between the two progressive forms of MS can be challenging for clinicians. This article examines how the diagnostic definitions of progressive MS impact clinical research, the design of clinical trials and, ultimately, treatment decisions.

Methods: We carried out an extensive review of the literature highlighting differences in the definition of progressive forms of MS, and the importance of assessing the extent of the ongoing inflammatory component in MS when making treatment decisions.

Results: Inconsistent results in phase III clinical studies of treatments for progressive MS, may be attributable to differences in patient characteristics (e.g., age, clinical and radiological activity at baseline) and endpoint definitions. In both primary and secondary progressive MS, patients who are younger and have more active disease will derive the greatest benefit from the available treatments.

Conclusions: We recommend making treatment decisions based on the individual patient's pattern of disease progression, as well as functional, clinical and imaging parameters, rather than on their clinical phenotype. Because the definition of progressive MS differs across clinical studies, careful selection of eligibility criteria and study endpoints is needed for future studies in patients with progressive MS.

Keywords: diagnosis; multiple sclerosis; primary progressive; secondary progressive; treatment.

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Conflict of interest statement

Carlo Pozzilli has served on scientific advisory boards for Novartis, Merck, Biogen, Sanofi‐Genzyme, Roche, Janssen, Alexion, has received funding for travel and speaker honoraria from Merck, Serono, Biogen, Sanofi‐Genzyme, Roche, Almirall, Janssen, Alexion and Novartis, and receives research support from Merck, Biogen, Novartis and Almirall. Maura Pugliatti has served on scientific advisory boards for Merck Serono, Biogen and Mylan, has received funding for travel and speaker honoraria from Merck Serono, Biogen, Sanofi‐Genzyme, Teva and Almirall, and has received financial support for research and scientific events from Biogen Idec and Sanofi‐Genzyme. Patrick Vermersch has received honoraria and consulting fees from Biogen, Sanofi‐Genzyme, Novartis, Teva, Merck, Roche, Imcyse, AB Science and Celgene, and research support from Novartis, Sanofi‐Genzyme and Roche. Nikolaos Grigoriadis has received honoraria, travel support, consultancy fees and research grants from Biogen Idec, Biologix, Genesis Pharma, Novartis, TEVA, Bayer, Merck Serono, Sanofi – Genzyme, ROCHE, Celgene and ELPEN. Mona Alkhawajah has received speaker honorarium, consultation fees and/or educational travel support from Roche, Merck, Biogen, Novartis, SAJA, Hikma, Actelion and/or Sanofi. Laura Airas has served on scientific advisory boards for Novartis, Merck Serono, Biogen, Sanofi‐Genzyme and Roche, and has received institutional research support from Merck Serono and Sanofi‐Genzyme. Celia Oreja‐Guevara has received speaker and consultation fees from Biogen Idec, Celgene, Sanofi‐Genzyme, Novartis, Roche, Merck and Teva.

Figures

FIGURE 1
FIGURE 1
Time to confirmed disability progression in the North American (NA) and European (EU) studies with interferon β‐1b (IFNB‐1b) in patients with secondary progressive multiple sclerosis (SPMS) [67]. Confirmed progression was defined as time to a ≥1.0 point increase in Expanded Disability Status Scale (EDSS) sustained for ≥6 months or 0.5 point increase in patients with baseline EDSS of 6.0–6.5. [Kappos L, Weinshenker B, Pozzilli C, et al. Interferon beta‐1b in secondary progressive MS: a combined analysis of the two trials. Neurology. 2004;63(10):1779–1787. doi:10.1212/01.wnl.0000145561.08973.4f, with permission.]
See this image and copyright information in PMC

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