Results of a registry study confirmed that early intensive treatment enhances long-term clinical outcomes by minimizing the accumulation of neurological damage.
The observational study presented by Dr. Pietro Iaffaldano (University of Bari, Italy) compared the long-term effect of EIT with escalation (ESC) on disability trajectories over time; specifically, on time to first 6-months confirmed disability accrual (CDA), on progression independent of relapse activity (PIRA), and on relapse-associated worsening (RAW).
From the Italian Multiple Sclerosis Registry, the researchers extracted data of 4,878 patients with relapsing-onset MS, 5 or more years of follow-up, a first disease-modifying therapy (DMT) prescription within 3 years from onset, and a score of ≥3 on the Expanded Disability Status Scale (EDSS) at baseline. The first prescribed DMT determined if participants were classified in the early intensive treatment (EIT) or the ESC group. A total of 908 pairs were established. In the ESC group, the first DMT (before escalation) was interferon beta in 655 patients (72%) and glatiramer acetate in 163 (18%). In the EIT group, the first DMT in the majority of cases was natalizumab (n=498; 55%), followed by fingolimod (n=241; 27%).
A 10-year comparison of disability trajectories revealed that mean EDSS differences between ESC and EIT groups tended to increase between year 1 and year 10:
- -0.16 (-0.25; -0.07; P=0.0007) at 1 year;
- -0.46 (-0.59; -0.43; P<0.0001) at 5 years; and
- -0.63 (-0.83; -0.43, P<0.0001) at 10 years.
Comparing ESC and EIT by Cox proportional hazards regression showed that patients in the ESC group were at a significantly higher risk to reach a first CDA event (HR, 1.36; 95% CI, 1.20–1.54; P<0.0001), both relapse-dependent and relapse-independent; a first PIRA event (HR, 1.22; 95% CI, 1.05–1.40; P=0.01); and a first RAW event (HR, 1.55; 95% CI, 1.17–2.05; P<0.01).
Dr. Iaffaldano said that further studies to establish the long-term safety of the EIT approach are warranted. However, he hoped that these findings may drive the treatment decisions of neurologists, especially in treatment-naïve patients with an unfavorable prognosis.
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