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Patient-reported outcomes associated with transition to secondary progressive multiple sclerosis

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Abstract

Purpose

To investigate patient-reported outcome (PRO) measures in patients with relapsing–remitting multiple sclerosis (RRMS) who transition to secondary progressive multiple sclerosis (SPMS).

Methods

Subjects enrolled in the Comprehensive Longitudinal Investigation of Multiple Sclerosis at Brigham and Women’s Hospital (CLIMB) who completed PRO measures in the RRMS and SPMS phases were identified (n = 52). The PRO measures were Medical Outcomes Study Short-Form 36 Health Survey (SF-36), the Modified Fatigue Impact Scale (MFIS), and the Center for Epidemiologic Studies Depression Scale (CESD). Two control groups of RRMS CLIMB patients who did not progress to SPMS were identified based on different matching criteria related to age, sex, disease duration and Expanded Disability Status Scale (EDSS). Summary statistics for each PRO were calculated at the last RRMS measurement and first SPMS measurement, and the change over this transition was calculated using a paired t-test. Patients who transitioned were compared to the control groups using linear regression to adjust for age, disease duration and EDSS and a mixed model to further account for the matching with a random effect for matched group.

Results

Patients who transitioned from RRMS to SPMS had noticeable deficits in terms of Quality of Life (QOL) and fatigue at the visit prior to the transition. Patients worsened in terms of SF-36 Role Physical (− 3.6 [− 6.6, − 0.7]), Social Functioning (− 3.7 [− 6.4, − 1.0]), and Physical Component Summary (− 2.3 [− 4.5, − 0.1]) during the transition from RRMS to SPMS. When patients who transitioned were compared to the matched subjects, they had worse scores on several outcomes, including Physical Functioning (adjusted mean difference =  − 10.8 [− 14.1, − 7.5]), Physical Component Summary (− 5.2 [− 9.3, − 1.0]), fatigue (8.9 [1.7, 16.1]), and depression (3.1 [0.3, 5.9]).

Conclusions

Patients in the period closely preceding transition from RRMS to SPMS have worse physical QOL and fatigue compared to subjects who remain RRMS.

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Data availability

Anonymized data related to the findings of this analysis are available from the corresponding author, upon reasonable request from qualified investigators.

Code availability

R code for this analysis is available from the corresponding author, upon reasonable request from qualified investigators.

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Funding

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Authors and Affiliations

  1. Partners MS Center, Brigham and Women’s Hospital, Boston, MA, USA

    Brian C. Healy, Jonathan Zurawski, Tanuja Chitnis, Howard L. Weiner & Bonnie I. Glanz

  2. Department of Neurology, Harvard Medical School, Boston, MA, USA

    Brian C. Healy, Jonathan Zurawski, Tanuja Chitnis, Howard L. Weiner & Bonnie I. Glanz

  3. Biostatistics Center, Massachusetts General Hospital, 60 Fenwood Rd, Boston, MA, 02115, USA

    Brian C. Healy

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  1. Brian C. Healy
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Correspondence to Brian C. Healy.

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Conflict of interest

Brian Healy has received grant support from Analysis Group, Celgene (Bristol-Myers Squibb), Verily, Novartis, Merck Serono, and Genzyme. Jonathan Zurawski reports no disclosures relevant to the manuscript. Tanuja Chitnis has provided advisory board/consulting services to Biogen-Idec, Merck Serono, Novartis, Sanofi, Bayer, Celgene (Bristol-Myers Squibb), and Alexion and has received research support from Verily, Merck Serono, and Novartis. Howard Weiner has received grant support from National Institutes of Health, National Multiple Sclerosis Society, Verily, Google Life Sciences, EMD Serono, Biogen, Teva, and Novartis, has received grant support and provided consulting services to Sanofi and Genentech, has provided personal, consulting, and/or advising services to Tilos, Tiziana, IM Therapeutics, vTv Therapeutics, and MedDay. Bonnie Glanz has received research support from Merck Serono and Verily.

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This study was approved by the Mass General Brigham IRB.

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All subjects provided written informed consent.

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Healy, B.C., Zurawski, J., Chitnis, T. et al. Patient-reported outcomes associated with transition to secondary progressive multiple sclerosis. Qual Life Res 31, 1799–1805 (2022). https://doi.org/10.1007/s11136-021-03034-6

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  • DOI: https://doi.org/10.1007/s11136-021-03034-6

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