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Review
. 2020 Dec 7:13:1756286420975223.
doi: 10.1177/1756286420975223. eCollection 2020.

Factors influencing daily treatment choices in multiple sclerosis: practice guidelines, biomarkers and burden of disease

Thomas Berger  1 , Monika Adamczyk-Sowa  2 , Tünde Csépány  3 , Franz Fazekas  4 , Tanja Hojs Fabjan  5 , Dana Horáková  6 , Alenka Horvat Ledinek  7 , Zsolt Illes  8 , Gisela Kobelt  9 , Saša Šega Jazbec  7 , Eleonóra Klímová  10 , Fritz Leutmezer  11 , Konrad Rejdak  12 , Csilla Rozsa  13 , Johann Sellner  14 , Krzysztof Selmaj  15 , Pavel Štouracˇ  16 , Jarmila Szilasiová  17 , Peter Turcˇáni  18 , Marta Vachová  19 , Manuela Vanecková  20 , László Vécsei  21 , Eva Kubala Havrdová  6
Affiliations
Review

Factors influencing daily treatment choices in multiple sclerosis: practice guidelines, biomarkers and burden of disease

Thomas Berger et al. Ther Adv Neurol Disord. .

Abstract

At two meetings of a Central European board of multiple sclerosis (MS) experts in 2018 and 2019 factors influencing daily treatment choices in MS, especially practice guidelines, biomarkers and burden of disease, were discussed. The heterogeneity of MS and the complexity of the available treatment options call for informed treatment choices. However, evidence from clinical trials is generally lacking, particularly regarding sequencing, switches and escalation of drugs. Also, there is a need to identify patients who require highly efficacious treatment from the onset of their disease to prevent deterioration. The recently published European Committee for the Treatment and Research in Multiple Sclerosis/European Academy of Neurology clinical practice guidelines on pharmacological management of MS cover aspects such as treatment efficacy, response criteria, strategies to address suboptimal response and safety concerns and are based on expert consensus statements. However, the recommendations constitute an excellent framework that should be adapted to local regulations, MS center capacities and infrastructure. Further, available and emerging biomarkers for treatment guidance were discussed. Magnetic resonance imaging parameters are deemed most reliable at present, even though complex assessment including clinical evaluation and laboratory parameters besides imaging is necessary in clinical routine. Neurofilament-light chain levels appear to represent the current most promising non-imaging biomarker. Other immunological data, including issues of immunosenescence, will play an increasingly important role for future treatment algorithms. Cognitive impairment has been recognized as a major contribution to MS disease burden. Regular evaluation of cognitive function is recommended in MS patients, although no specific disease-modifying treatment has been defined to date. Finally, systematic documentation of real-life data is recognized as a great opportunity to tackle unresolved daily routine challenges, such as use of sequential therapies, but requires joint efforts across clinics, governments and pharmaceutical companies.

Keywords: biomarkers; burden of disease; cognitive dysfunction; magnetic resonance imaging; multiple sclerosis; neurofilament.

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Conflict of interest statement

Conflict of interest statement: Thomas Berger has participated in meetings sponsored by and received honoraria (lectures, advisory boards, consultations) from pharmaceutical companies marketing treatments for multiple sclerosis: Almirall, Bayer, Biogen, Biologix, Bionorica, Genzyme, MedDay, Merck, Novartis, Octapharma, Roche, Sanofi/Genzyme, TG Pharmaceuticals, TEVA-ratiopharm and UCB. His institution has received financial support in the last 12 months by unrestricted research grants (Biogen, Merck, Novartis, Sanofi/Genzyme) and for participation in clinical trials in multiple sclerosis sponsored by Biogen, Merck, Novartis, Roche, Sanofi/Genzyme, and TEVA. Monika Adamczyk-Sowa has participated in meetings sponsored by and received honoraria (lectures, advisory boards, consultations) from pharmaceutical companies marketing treatments for multiple sclerosis: Bayer, Biogen, Merck, Novartis, Roche, Sanofi/Genzyme, TEVA. Tunde Csepany has participated in meetings sponsored by and received honoraria (lectures, advisory boards, consultations) from pharmaceutical companies marketing treatments for multiple sclerosis: Biogen, Merck, Novartis, Roche, Sanofi/Genzyme, TEVA. Tanja Hojs Fabjan received speaker honoraria and consultant fees from Bayer, Biogen, Lek, Novartis, Roche, Sanofi/Genzyme and for participations in trials in multiple sclerosis sponsored by Bayer, Biogen, Roche. Dana Horakova received compensation for travel, speaker honoraria, and consultant fees from Bayer, Biogen, Merck, Novartis, Roche, Sanofi/Genzyme and Teva, as well as support for research activities from Biogen. She is also supported by the Czech Ministry of Education research project PROGRES Q27/LF1. Zsolt Illes has participated in meetings sponsored by and received honoraria (lectures, advisory boards, consultations) from pharmaceutical companies marketing treatments for multiple sclerosis: Biogen, Merck, Novartis, Roche, Sanofi/Genzyme, TEVA, and received research grants from Biogen, Merck and Sanofi/Genzyme in the last 12 months. Eleonóra Klímová has participated in meetings sponsored by and received honoraria (lectures, advisory boards, consultations) from pharmaceutical companies marketing treatments for multiple sclerosis: Biogen, Merck, Novartis, Roche, Sanofi/Genzyme and TEVA. Gisela Kobelt has provided consulting and speaking services to Almirall, Bayer, Biogen, Merck, Novartis, Oxford PharmaGenesis, Roche, Sanofi/Genzyme, and Teva. Fritz Leutmezer has participated in meetings sponsored by and received honoraria (lectures, advisory boards, consultations) from pharmaceutical companies marketing treatments for multiple sclerosis: Biogen, Celgene, MedDay, Merck, Novartis, Roche, Sanofi/Genzyme and TEVA. Konrad Rejdak has participated in meetings sponsored by and received honoraria (lectures, advisory boards, consultations) from pharmaceutical companies marketing treatments for multiple sclerosis: Bayer, Biogen, Merck, Novartis, Roche, Sanofi/Genzyme, TEVA. Saša Šega Jazbec received travelling grants and speaking honoraria from Biogen, Merck, Roche, Sanofi/Genzyme and Teva. Csilla Rozsa has participated in meetings sponsored by and received honoraria (lectures, advisory boards) for multiple sclerosis: Biogen, Merck, Novartis, Roche, Sanofi/Genzyme and TEVA. Johann Sellner has participated in meetings sponsored by and received honoraria (lectures, advisory boards, consultations) from pharmaceutical companies marketing treatments for multiple sclerosis: Alexion, Biogen, Celgene, MedDay, Merck, Novartis, Roche, Genzyme/Sanofi, TEVA-ratiopharm. His institution has received financial support in the last 12 months by unrestricted research grants (Biogen, Merck, Sanofi/Genzyme) and for participation in clinical trials sponsored by Merck and Roche. Krzysztof Selmaj received honoraria for consulting and speaking from Biogen, Celgene, Merck, Novartis, Roche and TG Therapeutics. Jarmila Szilasiova has participated in meetings sponsored by and received honoraria (lectures, advisory boards, consultations) from pharmaceutical companies marketing treatments for multiple sclerosis: Biogen, Merck, Novartis, Roche, Sanofi/Genzyme and TEVA. Manuela Vaneckova has participated in meetings sponsored by and received honoraria (lectures, advisory boards, consultations) from pharmaceutical companies marketing treatments for multiple sclerosis: Biogen, Novartis, Roche, Sanofi/Genzyme, TEVA, and received research grants from Biogen and Roche in the last 12 months; supported by the Czech Ministry of Education research project PROGRES Q27/LF1 and RVO-VFN64165. Peter Turcˇáni has participated in meetings sponsored by and received honoraria (lectures, advisory boards, consultations) from pharmaceutical companies marketing treatments for multiple sclerosis: Bayer, Biogen, Merck, Novartis, Roche, Sanofi/Genzyme, Teva. His institution has received financial support in the last 12 months by unrestricted research grants (Merck, Novartis, Roche, Sanofi/Genzyme) and for participation in clinical trials in multiple sclerosis sponsored by Biogen, Merck, Novartis, Roche, Sanofi/Genzyme, and Teva. László Vécsei has participated in meetings sponsored by and received honoraria (lectures, advisory boards, consultations) for multiple sclerosis: Biogen, Merck, Novartis, Roche, Sanofi/Genzyme and TEVA. Eva Kubala Havrdová: honoraria/research support from Biogen, Merck, Novartis, Roche, and Teva; advisory boards for Actelion, Biogen, Celgene, Merck, Novartis, and Sanofi/Genzyme; supported by the Czech Ministry of Education research project PROGRES Q27/LF1.

Figures

Figure 1.
Figure 1.
Multiple sclerosis related clinical and scientific fields of interests of expert panel participants (N = 23, multiple answers possible).
Figure 2.
Figure 2.
Confirmed disability progression EDSS: one-third of patients shows relatively stable disease over time. ASA, Avonex Steroid Azathioprine Study,; CDP, confirmed disability progression; EDSS, Expanded Disability Status Scale; RRMS, relapsing–remitting multiple sclerosis.
Figure 3.
Figure 3.
Correlation between neurofilament-light chain levels and T2 lesion load/gadolinium-enhanced magnetic resonance imaging lesions. Gd, gadolinium; sNFL, serum neurofilament-light.
Figure 4.
Figure 4.
MS Cost of Illness Study: prevalence of fatigue, cognitive difficulties, and reduced productivity across all EDSS levels in multiple sclerosis patients. EDSS, Expanded Disability Status Scale; VAS, Visual Analogue Scale.
See this image and copyright information in PMC

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