The U.S. Food and Drug Administration (FDA) has issued a black-box warning about a risk of stroke and arterial dissection in patients with multiple sclerosis who have been exposed to alemtuzumab (www.fda.gov/Drugs/DrugSafety/ucm624247.htm?fbclid=IwAR2eBbqp24E0J3VIk8jbUZZ5pet…). The announcement was issued on November 29, 2018 and a black-box warning was added to the U.S. product label. The Canadian product monograph had not been updated at the time of writing. Read More
The most recent iterations of the McDonald criteria have enabled an earlier diagnosis of multiple sclerosis (Lee et al. Eur J Neurol 2018; epublished October 26, 2018). However, it is unclear if MS is being diagnosed earlier in real-world practice, or if patients are then receiving earlier treatment with a disease-modifying therapy. Read More
A newly-published set of recommendations advocates increased professional and patient awareness of MS-related cognitive symptoms and their management. The recommendations were endorsed by the U.S. National MS Society, the Consortium of Multiple Sclerosis Centers and the International MS Cognition Society (Kalb et al. Mult Scler 2018; epublished October 10, 2018). Use of the Symbol Digit Modalities Test (SDMT) or other validated test is advised early on when the patient is clinically stable, with re-assessments at least annually to detect new-onset cognitive impairment, detect disease activity and evaluate progression of cognitive impairment. Annual screening for depression is also recommended. Read More
The following summarizes the long-term treatment data presented at ECTRIMS 2018.
Teriflunomide: The long-term (up to 12.5 years) efficacy and safety of teriflunomide were examined in a pooled analysis of phase II and phase III trials and their extensions (Freedman et al. ECTRIMS 2018; abstract P1233); cumulative drug exposure was 1357 patient-years. The annualized relapse for patients treated with teriflunomide 14 mg was 0.38 vs. 0.59 with placebo. The proportion of patients with serious adverse events and the proportion discontinuing due to adverse events was comparable with teriflunomide and placebo (12.4% vs. 12.8%; and 6.9% vs. 13.1%, respectively). Read More
The Canadian Agency for Drugs and Technologies in Health (CADTH) has recommended that oral cladribine (Mavenclad) be reimbursed by provincial drug plans for the treatment of relapsing-remitting multiple sclerosis (RRMS). Patients who are eligible for oral cladribine are those with an inadequate response or poor tolerability with one prior disease-modifying therapy (DMT), and who have had at least one relapse within the previous 12 months. Read More