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Comorbidity and Disease Activity in Multiple Sclerosis
Amber Salter1,2, Samantha Lancia1, Kaarina Kowalec3,4
1Department of Neurology, Section on Statistical Planning and Analysis, UT Southwestern Medical Center, Dallas, Texas.
Importance:
Multiple studies suggest that comorbidity worsens clinically relevant outcomes in multiple sclerosis (MS), including the severity of disability at diagnosis and rate of disability worsening after diagnosis. However, less is known regarding the association of comorbidity with measures of disease activity, such as relapse rate and magnetic resonance imaging lesion accrual, which are relevant to clinicians and clinical trialists.
Objective:
To evaluate the association of comorbidities with disease activity in clinical trials of disease-modifying therapies (DMTs) in populations with MS.
Design, Setting, And Participants:
A 2-stage meta-analytic approach was used in this cohort study of individual participant data from phase 3 clinical trials of MS DMTs that had 2 years of follow-up and were conducted from November 2001 to March 2018. Data were analyzed from February 2023 to June 2024.
Exposure:
Comorbidity burden and individual comorbidities present at trial enrollment, including hypertension; hyperlipidemia; functional cardiovascular disease, ischemic heart, cerebrovascular, and peripheral vascular disease; diabetes; autoimmune thyroid and miscellaneous autoimmune conditions; migraine; lung and skin conditions; depression; anxiety; and other psychiatric disorders.
Main Outcomes And Measures:
The main outcome was evidence of disease activity (EDA) over 2 years of follow-up, defined as confirmed relapse activity, disability worsening, or any new lesions on magnetic resonance imaging.
Results:
A total of 16 794 participants with MS were included from 17 clinical trials (67.2% female). Over the 2-year follow-up, 61.0% (95% CI, 56.2%-66.3%; I2 = 97.9%) of the pooled trials had EDA. After adjusting for multiple factors, the presence of 3 or more comorbidities was associated with an increased hazard of EDA (adjusted hazard ratio [AHR], 1.14; 95% CI, 1.02-1.28) compared with no comorbidity. Presence of 2 or more cardiometabolic conditions was also associated with an increased hazard of EDA (AHR, 1.21; 95% CI, 1.08-1.37) compared with no cardiometabolic comorbidity. Presence of 1 psychiatric disorder was associated with an increased hazard of EDA (AHR, 1.07; 95% CI, 1.02-1.14).
Conclusions And Relevance:
In this study, a higher burden of comorbidity was associated with worse clinical outcomes in people with MS, although comorbidity could potentially be a partial mediator of other negative prognostic factors. Our findings suggest a substantial adverse association of the comorbidities investigated with MS disease activity and that prevention and management of comorbidities should be a pressing concern in clinical practice.
Insights
Comorbidity worsens multiple sclerosis (MS) disease activity, increasing relapse and MRI lesion risk. Managing comorbidities is crucial for better MS patient outcomes.
Area of Science:
- Neurology
- Immunology
- Clinical Trials
Background:
- Comorbidity is linked to worse multiple sclerosis (MS) outcomes, but its effect on disease activity is less understood.
- Disease activity in MS includes relapses, disability worsening, and magnetic resonance imaging (MRI) lesions.
Purpose of the Study:
- To investigate the association between comorbidities and disease activity in patients with MS participating in clinical trials.
- To assess how comorbidity burden impacts measures of MS disease activity relevant to clinical practice and research.
Main Methods:
- A meta-analysis of individual participant data from 17 phase 3 clinical trials of MS disease-modifying therapies (DMTs) was conducted.
- Data from 16,794 participants with MS were analyzed over a 2-year follow-up period.
- Comorbidity burden and specific conditions were assessed at trial enrollment; evidence of disease activity (EDA) was the primary outcome.
Main Results:
- Higher comorbidity burden was associated with an increased hazard of evidence of disease activity (EDA) in MS patients.
- Specifically, having three or more comorbidities (adjusted hazard ratio [AHR], 1.14) or two or more cardiometabolic conditions (AHR, 1.21) significantly increased EDA risk.
- The presence of one psychiatric disorder was also linked to a higher hazard of EDA (AHR, 1.07).
Conclusions:
- Increased comorbidity burden is associated with greater MS disease activity, including relapses and MRI lesions.
- Comorbidities may act as mediators of negative prognostic factors in MS.
- Prevention and management of comorbidities are essential in clinical practice for individuals with MS.
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