The following is a summary of “Investigating the Prevalence of Comorbidity in Multiple Sclerosis Clinical Trial Populations,” published in the February 2024 issue of Neurology by Salter et al.
Multiple Sclerosis (MS) patients often experience comorbidity (depression, anxiety, etc.), but clinical trials might miss this due to limited data.
Researchers conducted a retrospective study investigating the prevalence of comorbid conditions among participants in MS clinical trials.
They requested individual-level data from multiple sponsors for a 2-stage meta-analysis of phase III clinical trials on MS disease-modifying therapies. Adhering to the Maelstrom retrospective harmonization guidelines ensured consistency. Chronic comorbidities recommended by the International Advisory Committee on Clinical Trials in MS at trial enrollment, including depression, anxiety, hypertension, hyperlipidemia, migraine, diabetes, and chronic lung disease, were considered. Additional comorbidities were categorized based on medical history data. The classification was based on medical history data, and individual comorbidities were summed and categorized as 0, 1, 2, or ≥3. The pooled prevalence (95% CI) of comorbidity was reported, along with prevalence ratios across age, sex, race, disability level, and treatment. I2 statistics used to assess heterogeneity.
The results showed that seventeen trials involving 17,926 participants, were included. Fourteen trials enrolled participants with relapsing MS (RMS), while 3 enrolled participants with progressive MS (PMS). When pooled, almost half of trial participants (46.5%) had one or more comorbidities (1: 25.0%, 95% CI 23.0–27.0, I2 = 89.9; 2: 11.4% [9.3–14.0], I2 = 96.3; ≥3: 6.0% [4.2–8.4], I2 = 97.7). Depression (16.45% [12.96–20.88], I2 = 98.3) was the most prevalent comorbidity, followed by hypertension (10.16% [8.61–11.98], I2 = 93.2). Heterogeneity was high across trials. Older age and female participants were associated with an increased number of comorbidities. Older individuals and male participants had a higher prevalence of hyperlipidemia, while older individuals and female participants had a higher prevalence of depression and anxiety.
Investigators concluded that comorbid patients found in MS trials, but potential underrepresentation and impact on outcomes require further investigation.