Observational studyJournal of neurology2026
Patient profiling in relapsing multiple sclerosis: insights from a real-world observational study into the unmet medical needs of patients on disease-modifying therapy.
Observational study in Journal of neurology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
7 authors.
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Abstract
backgroundPatient-centred care is essential for effectively managing relapsing multiple sclerosis (RMS). The PROFILE-RMS study aimed to characterise unmet medical needs using clinically meaningful patient profiles.
methodsThis 12 month observational study collected real-world data across Germany. Adults with RMS receiving disease-modifying therapy (DMT) were classified into predefined profiles: ongoing disease activity (Profile 1), significant adverse drug reactions (ADRs; Profile 2), or low treatment satisfaction (Profile 3). Outcomes included treatment response, disease activity, patient-reported outcomes (PROs), and safety.
resultsIn total, 488 patients were analysed. In Profile 1 (n = 246), 41.6% had insufficient response to therapy, with severe fatigue identified as an indicator (hazard ratio [HR]: 2.08; 95% confidence interval [CI]: 1.12-3.88), but only 14.2% changed treatment (mainly for disease activity); 4.1% experienced a serious adverse event (SAE). In Profile 2 (n = 179), 31.5% had insufficient response, but only 18.4% changed treatment (mainly for disease activity); 1.6% experienced an SAE. In Profile 3 (n = 63), 33.3% had insufficient response, with male sex identified as an indicator (HR: 3.09; 95% CI: 1.40-6.82), but only 17.5% changed treatment (mainly for low satisfaction); 1.6% experienced an SAE. Across profiles, most patients received low-moderate efficacy DMTs, the percentage of patients without DMTs increased, and PROs were impaired.
conclusionsPatient profiling highlights gaps in real-world RMS management, where DMTs are often discontinued without substitution and escalation to high-efficacy regimens often delayed, reinforcing the need for patient-centred care. Fatigue may indicate non‑response (Profile 1), disease activity outweighs ADR burden (Profile 2), and symptom load drives dissatisfaction (Profile 3).
trial registrationProtocol number ML39348.
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