A phase II trial does not support use of atorvastatin monotherapy after a clinically isolated syndrome, but magnetic resonance imaging measures suggest potentially beneficial immunomodulatory effects.
Statin medications have a plethora of effects, including immunomodulation, as previously demonstrated in animal models of multiple sclerosis (MS). In this phase II, investigator-initiated, NIH-sponsored trial, researchers examined whether atorvastatin could delay a second relapse in the first year after presentation with a first demyelinating event and an abnormal magnetic resonance imaging (MRI) scan consistent with a clinically isolated syndrome. The primary endpoint was a second clinical event or ≥3 new brain MRI T2 lesions; those with a second event were offered weekly interferon beta-1a.
The trial was halted because of slow recruitment after 82 of the planned 152 participants were randomized to placebo or 80 mg of atorvastatin. The grou…
Reviewing Author
DisclosuresConsultant/Advisory BoardAlexion Pharmaceuticals; Amgen; Astoria; Biogen; Bristol Myers Squibb; Celltrion; Genentech; Hoffmann-La Roche; Genzyme; EMD Serono; Immpact-Bio; Immunic Therapeutics; Kyverna; Lundbeck; Novartis; Sandoz; TG Therapeutics
Grant/Research SupportNational Institutes of Health; National Multiple Sclerosis Society; U.S. Department of Defense
Leadership Positions in Professional SocietiesConsortium of Multiple Sclerosis Centers (Treasurer)
DisclosuresConsultant/Advisory BoardAlexion Pharmaceuticals; Amgen; Astoria; Biogen; Bristol Myers Squibb; Celltrion; Genentech; Hoffmann-La Roche; Genzyme; EMD Serono; Immpact-Bio; Immunic Therapeutics; Kyverna; Lundbeck; Novartis; Sandoz; TG Therapeutics
Grant/Research SupportNational Institutes of Health; National Multiple Sclerosis Society; U.S. Department of Defense
Leadership Positions in Professional SocietiesConsortium of Multiple Sclerosis Centers (Treasurer)