Switching from injectable platform therapies to first-line oral therapies such as dimethyl fumarate (DMF) or teriflunomide (TFL) did not increase the risk of worsening the Extended Disability Status Scale (EDSS) in patients with clinically stable relapsing-remitting multiple sclerosis (RRMS). According to a study published in the Journal of Neurology, Neurosurgery and Psychiatry.
Although multiple sclerosis (MS) patients often switch therapy for reasons other than disease activity, there is limited evidence of the effects of this switch. The study researchers tried to provide doctors with more evidence for treatment decisions by conducting a cohort study.
They included 3206 patients (1543 in the DMF analysis and 1663 in the TFL analysis) with data from the Danish registry for multiple sclerosis. Patients had clinically stable RRMS on injectable platform therapy for at least 1 year prior to the start of the study. This was either the date on which previous therapy was discontinued for patients who switched to another treatment (“Switch”), or the date of the first recorded EDSS score in 2014 for those who remained on initial treatment (” Stayer “).
Patients were observed until death, emigration, or the date of their last valid EDSS score. Study researchers adjusted the groups to ensure baseline similarity across all analyzes in the covariates.
They found no change in the risk of EDSS worsening after 6 months in patients who switched to DMF. The hazard ratios (HRs) for switches compared to standing were 1.15 (95% CI, 0.88-1.50; P = 0.31) for DMF and 1.16 (95% CI, 0.92- 1.46; P = 0.21) for TFL. The HRs for relapse during follow-up for switch versus standing were 0.73 (95% CI, 0.51-1.04) for DMF and 1.25 (95% CI, 0.96-1.63) for TFL.
During the first year of study entry, the annualized relapse rates (ARRs) for switchers were 0.01 (95% CI, 0.01-0.02) for DMF and 0.04 (95% CI, 0.03-0.07) for TFL. Throughout the treatment periods with DMF and TFL, their ARRs were 0.05 (95% CI, 0.03-0.06) and 0.08 (95% CI, 0.06-0.1), respectively.
The cohort of patients under 40 years of age had a similar risk of 6-month confirmed EDSS worsening in changers compared to standing ones and a greater decrease in the risk of first relapse (HR, 0.52; 95% CI, 0.28-0 , 95)) for DMF. In TFL, the risk of 6-month confirmed EDSS deterioration tended to increase in switchers (HR 1.54; 95% CI 0.99-2.40) and the risk of first relapse was comparable to the main analysis.
Patients who switched to DMF during follow-up had a lower risk of first relapse (HR 0.50; 95% CI 0.30-0.85) and a similar risk of EDSS worsening compared to injectable therapy. Switching to TFL made no difference in the risk of first relapse or worsening of the EDSS.
Limitations of the study included the lack of MRI data and the inability to accurately quantify the causal effect of the decision to switch therapy, as well as the differences in efficacy and pharmacokinetics among therapy patients who were switched.
The study’s researchers concluded that, “For patients treated with injectable MS therapies and no recent evidence of MS activity, switching to first-line oral DMTs can be considered a safe strategy for practical reasons. “But, as they noted,” special consideration should be given in younger patients. ”
Disclosure: Several authors of the study have stated that they are part of the pharmaceutical industry. For a full list of the authors’ information, see the original reference.
Buron MD, Kalincik T., Sellebjerg F., Sørensen PS, Magyari M. The effect of lateral therapy switches to oral drugs with moderate effectiveness in multiple sclerosis: a nationwide cohort study. J Neurol Neurosurg Psychiatry. Published online January 12, 2021. doi: 10.1136 / jnnp-2020-324869