People with newly diagnosed multiple sclerosis (MS) who initiated B-cell–depleting therapy had lower relapse rates and greater reduction in T2 lesion volume over 2 years compared with those who initiated oral platform therapies, according to results from the pan-European MultipleMS study (EudraCT 2017-002634-24) published in Neurology: Open Access.

In the study, investigators evaluated 509 treatment-naive adults aged 18 to 50 years who were newly diagnosed with relapsing or progressive MS and enrolled at 9 centers across Europe. Participants were followed prospectively with harmonized clinical, MRI, and serum biomarker assessments.

Participants were categorized according to the first disease-modifying therapy (DMT) initiated within 6 months of baseline: injectable platform therapies, oral platform therapies, high-efficacy therapies, B-cell–depleting therapies (BCDTs), or no treatment. Oral platform therapy was used as the reference group in regression models. Outcomes included annualized relapse rate (ARR) through month 24, change in T2 lesion volume, serum neurofilament light chain (sNfL) Z-scores, serum glial fibrillary acidic protein (sGFAP) Z-scores, Expanded Disability Status Scale (EDSS) change, and treatment persistence.

Key results include the following:

  • Of 509 participants, 455 (89.4%) completed 24 months of follow-up.
  • Median age was 33.0 years, 63.9% of participants were women, median disease duration was 0.66 years, and median baseline EDSS score was 1.5.
  • Initial treatment groups included injectable platform therapies in 87 participants (17.1%), oral platform therapies in 152 (29.9%), high-efficacy therapies in 79 (15.5%), BCDTs in 101 (19.8%), and no treatment in 90 (17.7%).
  • The 2-year ARR was 0.04 among people who initiated BCDT compared with 0.16 among those who initiated oral platform therapy (adjusted incidence rate ratio, 0.38; 95% CI, 0.15-0.92).
  • People who initiated high-efficacy therapy had a numerically lower ARR than those who initiated oral platform therapy, although the adjusted comparison did not meet statistical significance (ARR, 0.11 vs 0.16; adjusted incidence rate ratio, 0.52; 95% CI, 0.27 to 1.00).
  • In adjusted analyses, people who initiated BCDT had greater reduction in T2 lesion volume compared with those who initiated oral platform therapy (volume ratio, 0.87; 95% CI, 0.76 to 0.99).
  • A similar trend was observed among people who initiated high-efficacy therapy, although the adjusted comparison did not meet statistical significance (volume ratio, 0.92; 95% CI, 0.83 to 1.03).
  • At month 24, sNfL Z-scores did not differ significantly across treatment groups in adjusted analyses.
  • EDSS change from baseline to month 24 did not differ significantly across treatment groups.
  • Treatment persistence at month 24 was highest among people who initiated BCDT (93.8%), followed by high-efficacy therapy (86.5%), oral platform therapy (72.3%), no treatment at baseline (62.5%), and injectable platform therapy (60.8%).
  • Compared with oral platform therapy, the likelihood of remaining on the initial DMT was higher among people who initiated BCDT (adjusted odds ratio, 4.88; 95% CI, 1.56 to 15.31) or high-efficacy therapy (adjusted odds ratio, 3.09; 95% CI, 1.32 to 7.21), and lower among those who initiated injectable platform therapy (adjusted odds ratio, 0.47; 95% CI, 0.24 to 0.90).

The authors concluded that people who initiated BCDT, and to a lesser extent high-efficacy therapy, had greater control of focal inflammatory disease activity over 2 years. Differences were most apparent for relapse activity and T2 lesion volume, whereas progression-related measures, including EDSS change and sGFAP findings, were less clearly differentiated across treatment groups.

The findings also highlighted substantial variation in treatment selection across European countries. BCDT use was most common in Sweden; oral platform therapy was the most frequent initial choice in Italy, Spain, Denmark, and Belgium; injectable platform therapy was most common in Germany; and high-efficacy therapy was most frequent in Norway. The authors noted that these patterns may reflect differences in national treatment practices, access, and prescribing restrictions. 

Source: Uibel P, Trogu F, Flaskamp M, et al; MultipleMS Consortium. Therapy choices and outcomes in newly diagnosed multiple sclerosis: the pan-European MultipleMS study. Neurol Open Access. 2026;2:e000168. doi:10.1212/WN9.000000000000016