The extended Baseline Disability Status Scale (EDSS) and the annualized relapse rate (ARR) are the main determinants of therapeutic delay in patients with multiple sclerosis (MS). This is evident from the study results published in Multiple Sclerosis.
The study researchers attempted to examine the relationships between MS characteristics and therapeutic delay in relapse and disease progression. To do this, they pooled data from the MSBase registry, which was collected from 125 centers in 37 countries, and the Register des Observatoire Français de la Sclérose en Plaques (OFSEP), which was collected from 39 centers in France. They then stratified the patients into cohorts with disability progression (n = 5415) and disease relapse (n = 10,192) and rated the patients on EDSS and ARR.
Patients from the two registries were balanced in terms of baseline characteristics, but injectable therapy was more common in MSBase patients (51.7% and 44.6%) than in OFSEP (41.4% and 33.1%) in the progression group. or relapse cohort.
In the cohort with disability progression, there was a longer therapeutic delay in men (mean 55.8 weeks; 95% CI 45.6-66.0), patients with EDSS values of at least 6 (mean 47.5 weeks; 95% CI 23.7-71.3) associated. and an ARR of at least 1 (mean 52.4 weeks; 95% CI 38.9-65.9) compared to women (mean 31.8 weeks; 95% CI 26.2-37.5), patients with EDSS – scores less than 6 (mean 17.2) weeks; 95% CI, 13.6-20.5) or those with an ARR of less than 1 (mean 29.2 weeks; 95% CI, 21.1-37.2).
In a multivariate model, women with an EDSS less than 6 and an ARR less than 1 had a mean time of therapeutic delay in disability progression of 26.6 (95% CI, 18.2-34.9) weeks . While this was not significantly different from men with an EDSS score of less than 6 and an ARR of less than 1 (mean 31.0 weeks; 95% CI, 25.3-36.8), were in women with an EDSS – Value of at least 6 longer delay times observed and ARR less than 1 (mean 54.3 weeks; 95% CI 47.2-61.5).
In the disease relapse cohort, there was a longer therapeutic delay in women (mean 14.3 weeks; 95% CI 12.7-15.9) and patients with EDSS scores of at least 6 (mean 16.9 weeks; 95% CI 13.8 -19.9) associated. and ARR less than 2 (mean 14.9 weeks; 95% CI 13.4-16.4) compared to men (mean 9.8 weeks; 95% CI 7.2-12.4), patients with EDSS Scores less than 2 (mean 9.2 weeks); 95% CI, 7.0-11.4) or those with an ARR of at least 2 (mean 11.1 weeks; 95% CI, 9.3-12.8).
The results of this study may not generalize to patients within 3 years of their diagnosis of MS or less than 1 year of treatment, as such patients were excluded from this analysis.
The study’s researchers concluded, “Our results are relevant to re-analyzing clinical trials in patients with advanced disease and designing clinical trials in progressive MS. Treatment outcomes in cohorts enriched with patients with higher disability scores and relapse activity should be interpreted with the expected duration of therapeutic delay in sight. ”
Disclosure: Several authors have stated that they are part of the pharmaceutical industry. For a full list of details, see the original article.
Roos I., Leray E., Frascoli F. et al. Determinants of therapeutic delay in multiple sclerosis. Mult Scler. Published online January 11, 2021. doi: 10.1177 / 1352458520981300