Tacrolimus vs. Azathioprine in myasthenia gravis treatment: a multicenter, prospective, randomized, double blind, head to head clinical trial

Abstract

Current evidences show that tacrolimus could be a good therapeutic option in patients non-responsive to first-line treatments and even it could become one of the first-line drugs for treating MG. Our study will try to determine the effectivity and safety of tacrolimus in 190 myasthenia gravis patients with suboptimal response to azathioprine: after 12 months of treatment they will be randomized to continue with azathioprine or they will be switched to tacrolimus. Patients will follow the allocated treatment during 14 months and the response will be assessed as well as adverse effects PURPOSE: To compare azathioprine vs. tacrolimus effectivity and safety in MG patients with suboptimal response to azathioprine at 12 months DESIGN: A 14 months multicenter, prospective, randomized, double blind, head to head clinical trial