Pragmatic trials may offer one way to increase minority populations in multiple sclerosis (MS) studies, investigators for the DELIVER-MS trial suggested.

Race and ethnicity did not appear to influence decisions to participate in either the randomized or observational cohorts of the pragmatic DELIVER-MS study, or in treatment choices, reported Sarah Planchon, PhD, of the Cleveland Clinic Mellen Center for Multiple Sclerosis in Ohio.

“Enrollment in DELIVER-MS mirrors the racial and ethnic distributions in the U.S. and U.K.,” she said in a presentation at the 2022 meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

“It is vital that clinical research is performed on diverse populations, so that we detect effects that may only be relevant in certain groups, ensure that results are relevant to all, and try to minimize health disparities,” she added.

MS occurs at the same rate in Black populations as it does in white populations and is significantly lower among Hispanic and Asian persons. But non-white persons with MS are dramatically underrepresented in MS clinical trials, noted Olga Ciccarelli, MD, PhD, of University College London, who wasn’t involved with the study. However, “DELIVER-MS showed a very good representation of ethnic groups,” Ciccarelli said.

There were several reasons for this, Planchon noted. “Pragmatic trials overcome the difficulty some trial participants see in the extra visits standard randomized clinical trials require,” Planchon told MedPage Today. “They are embedded in clinical practice, so visits are linked to those that would normally occur outside of a clinical trial.”

“Some assessments are added, but extra visits are not,” she continued. “This makes it easier for individuals who have busy lives or have mobility issues to participate.”

DELIVER-MS is a pragmatic, randomized, multisite trial for treatment-naïve patients recently diagnosed with relapsing-remitting MS. The study aims to compare the effects of an early, highly-effective treatment approach versus treatment escalation.

“The randomized portion of the trial will enroll 400 participants and a parallel observational cohort — in which the participants are not randomized, but instead choose their initial DMT [disease-modifying therapy] as with standard clinical practice — will also enroll 400 participants,” Planchon said. “We have very permissive inclusion criteria so that almost anyone who is newly diagnosed could qualify.”

The primary outcome is brain volume loss at 3 years. The intervention is the initial DMT choice between two MS treatment approaches: early highly-effective approach including alemtuzumab (Lemtrada), natalizumab (Tysabri), ocrelizumab (Ocrevus), rituximab (Rituxan), and ofatumumab (Kesimpta), or an escalation approach, which includes all other approved DMTs. “After the initial DMT, any subsequent DMT choice may be any approved DMT, from either arm,” Planchon noted.

The study has 32 sites, 15 in the U.S. and 17 in the U.K. Enrollment demographics were collected for the first 600 participants, representing 75% of anticipated recruitment.

Of the first 600 participants, 82% were white, 9.3% were Black, 2.9% were Asian, 3.6% were multi-race, and 1.8% were classified as other. “Overall, non-white minorities made up 17.6% of overall enrollment, with 22.1% in the U.S. and 9.9% in the U.K.,” Planchon said. Minority groups were, however, over-represented in screen failures, withdrawals, and lost to follow-ups, she noted.

By studying the racial composition of each DELIVER site location, the researchers calculated what an expected racial distribution would be. “Our racial and ethnic diversity has been representative in DELIVER-MS, with the U.S. slightly exceeding the expected percentage of non-white individuals and the U.K. just a bit below that level,” Planchon reported.

There were no differences in racial breakdown between those who were willing to be randomized and those who were not. While there were differences in the proportions of participants who chose each treatment approach in each country, “this difference, however, was not shown to be a result of race,” Planchon said.

“An important factor is that in DELIVER — as is the case with many pragmatic trials — patients can continue to make decisions freely with respect to DMT,” she added. “This allows patient to retain flexibility with medication decisions and they’re more likely to participate in a study.”

The DELIVER-MS trial’s enrollment current stands at 92%. “We hope to complete enrollment by early 2023,” Planchon noted.

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