Multiple Sclerosis Evidence Brief
- 1 day ago
- 2 min read
There are more than 20 approved drugs. There is still not enough evidence to answer the questions sponsors actually need to answer.
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609,410 Diagnoses. Most of Them Invisible to Existing Evidence.
Multiple sclerosis has 20+ FDA-approved disease-modifying therapies and global registries covering hundreds of thousands of patients. Yet sponsors walking into an MS program face the same problem: available evidence does not tell them what they need to know about their specific patient population, their specific disease subtype, or their specific market access question.
The gap is not volume. It is representativeness.
The numbers:
1 million people with MS in the US. 2.9 million globally.
$85.4 billion in annual US economic burden.
40–65% experience cognitive impairment — rarely measured in clinical trials.
Up to 47% higher risk of ambulatory disability in Black patients vs. White patients.
609,410 diagnosis records across all four subtypes; 97.2% representing diverse-descent populations.
Most MS research flows through specialty centers and academic networks. Rural patients, low-income families, communities of color, and patients with fragmented care access are largely absent from clinical evidence. That absence creates structural risk: uncertainty in health economic models, limited confidence in subgroup-specific efficacy claims, and weaker positioning in formulary and payer negotiations.
A 2023 study found Black individuals with MS experience higher relapse rates, greater lesion burden, faster disability accumulation, and up to a 47% higher risk of ambulatory disability. Caribbean-descent populations carry additional complexity given elevated NMOSD prevalence. These patterns are not captured in most published registries.
The pipeline is expanding — BTK inhibitors targeting progressive disease are entering late-stage development. But testing them on populations that do not resemble the patients who will actually receive them generates evidence with limited translational value.
What Rubix LS offers.
Existing registries are valuable. They are also predominantly White, predominantly academic-center-based, and concentrated in North America and Northern Europe. None characterize MS at scale in the diverse-descent populations that now represent the majority of people with the disease in the US.
Rubix LS has built an MS evidence asset — 609,410 diagnosis records across all four major subtypes, with 97.2% representing diverse-descent populations — to complement, not replace, existing registries. Designed for:
Medical Affairs — subgroup-specific outcome characterization, publication-ready real-world evidence, KOL discussion support.
Business Development — market sizing grounded in actual diagnosis patterns, identification of underserved segments, competitive intelligence.
Alliance & Partnering — a differentiated data foundation for co-development discussions and joint evidence generation plans.
The question is not whether representative evidence matters. It is whether your current evidence strategy answers the questions your program actually faces — or is built on data that looks nothing like the patients you will treat.
