Correlation of disability with quality of life in patients with multiple sclerosis treated with natalizumab: primary results and post hoc analysis of the TYSabri ImPROvement study (PROTYS).

Achtnichts, Lutz; Zecca, Chiara; Findling, Oliver; Kamm, Christian P; Mueller, Stefanie; Kuhle, Jens; Lutterotti, Andreas; Gobbi, Claudio; Viviani, Camille; Villiger-Borter, Emanuela; Nedeltchev, Krassen (2023). Correlation of disability with quality of life in patients with multiple sclerosis treated with natalizumab: primary results and post hoc analysis of the TYSabri ImPROvement study (PROTYS). BMJ neurology open, 5(1), e000304. British Medical Association 10.1136/bmjno-2022-000304

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BACKGROUND

In patients with multiple sclerosis (MS), relapses and disability progression have been associated with decreased health-related quality of life (HRQoL).

METHODS

PROTYS, a prospective, multicentre, single-arm, observational study in seven Swiss MS centres, evaluated correlations between change in disability status (measured through the Expanded Disability Status Scale (EDSS)) and HRQoL changes (measured through the global Multiple Sclerosis International Quality of Life (MusiQoL) index questionnaire) in 35 patients with relapsing remitting MS on natalizumab for 1 year. In addition, several other scales were also used, such as: Multiple Sclerosis Intimacy and Sexuality Questionnaire-19, EuroQoL-5 Dimension, and Fatigue Scale of Motor and Cognitive Function. A post hoc analysis further assessed the association between HRQoL changes after 1 year and the MusiQoL subscores and other patient-reported outcome (PRO) measures.

RESULTS

At 1 year, patients were categorised into 'EDSS improved' (6/35), 'EDSS stable' (28/35) and 'EDSS worsened' (1/35). Mean disability scores decreased for 'EDSS improved' and 'EDSS stable' but increased for 'EDSS worsened'. Mean MusiQoL index score for 'EDSS improved' increased from 61.2 at baseline to 66.3 at 1 year, while the 'EDSS stable' group increased from 67.9 to 70.8. No meaningful statistical relationship was observed between EDSS group and changes in MusiQoL score. For the post hoc analysis, patients were categorised in 'MusiQoL improved' (n=21) and 'MusiQoL worsened' (n=14) groups. MusiQoL subscores for 'symptoms,' 'psychological well-being' and 'activities of daily living', as well as scores for several related PRO measures, correlated with improvement of the MusiQoL global index. There was no correlation between the changes in MusiQoL global index and EDSS score.

CONCLUSIONS

Natalizumab treatment for 1 year resulted in either improved or stable EDSS status in most patients, and although no significant relationship was observed between global HRQoL change and EDSS change, several domains of HRQoL seemed to improve with natalizumab treatment.

TRIAL REGISTRATION NUMBER

NCT02386566.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Neurology

UniBE Contributor:

Kamm, Christian Philipp

Subjects:

600 Technology > 610 Medicine & health

ISSN:

2632-6140

Publisher:

British Medical Association

Language:

English

Submitter:

Pubmed Import

Date Deposited:

06 Feb 2023 11:55

Last Modified:

12 Feb 2023 02:26

Publisher DOI:

10.1136/bmjno-2022-000304

PubMed ID:

36727105

Uncontrolled Keywords:

COGNITION MOTOR CONTROL MULTIPLE SCLEROSIS QUALITY OF LIFE

BORIS DOI:

10.48350/178317

URI:

https://boris.unibe.ch/id/eprint/178317

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