Positive top-line results from alemtuzumab Phase 3 trial on multiple sclerosis

October 28, 2017

The most common adverse events associated with alemtuzumab in the CARE-MS I study included infusion-associated reactions, the symptoms of which most commonly included headache, rash, fever, nausea, flushing, hives and chills. The incidence of infections was also increased, the most common infections involving the upper respiratory and urinary tract and oral herpes. Infections were predominantly mild to moderate in severity and there were no life-threatening or fatal infections.

No alemtuzumab patient discontinued from the study due to an adverse event. Less than 20 percent of alemtuzumab-treated patients developed an autoimmune thyroid-related adverse event and less than 1 percent developed immune thrombocytopenia during the 2 year study period. There were no cases of anti-GBM disease. Cases of autoimmunity were detected and managed using conventional therapies. Patient monitoring for immune cytopenias and thyroid or renal disorders is incorporated in all Genzyme-sponsored trials of alemtuzumab for the investigational treatment of MS. Analysis of the full CARE-MS I data is ongoing.

CARE-MS I, which enrolled 581 early, active RRMS patients who had received no prior MS therapy, was a global, randomized, rater-blinded clinical trial to determine the efficacy and safety of alemtuzumab in this population. The company anticipates presenting detailed CARE-MS I study findings at a medical meeting later this year.

Another Phase 3 clinical trial, CARE-MS II, is currently underway, evaluating alemtuzumab against Rebif? in relapsing-remitting multiple sclerosis patients who have relapsed while on therapy. Top-line results from that trial are expected to be available in the fourth quarter of 2011. Since it is not yet approved for the treatment of MS, alemtuzumab must not be used in MS patients outside of a formal, regulated clinical trial setting in which appropriate patient monitoring measures are in place.

Source: Sanofi