FDA last week approved ublituximab-xiiy (Briumvi, TG Therapeutics) for treating adult patients with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The efficacy of the anti-CD20 monoclonal antibody was demonstrated in a pair of 96-week trials of patients with RMS. Compared with participants randomized to teriflunomide (an active comparator), ublituximab-xiiy had a significantly lower annualized relapse rate (the number of T1 Gd-enhancing lesions and the number of new or enlarging T2 lesions) over the treatment period. The most common adverse reactions with the new agent were infusion reactions, upper and lower respiratory tract infections, herpesvirus-associated infections, pain in extremities, insomnia, and fatigue. Serious, life-threatening, or fatal bacterial or viral infections may occur.
New on the iForumRx.org website are commentaries and podcasts on the levothyroxine product substitution conundrum, cost-effectiveness of icosapent-ethyl, level up your smoking cessation game, and as-needed SABA-only rescue therapy.