Two phase III extension studies of Lemtrada shows drug impacts multiple sclerosis through 8 years.- Sanofi.

Patients with relapsing remitting multiple sclerosis who received Lemtrada (alemtuzumab), from Sanofi, continued to experience effects of treatment on disease activity through eight years, according to extension data of two Phase III studies. Among patients treated with Lemtrada in the two-year studies, 77 percent (n=290/376) from one of the studies called CARE-MS I and 69 percent (n=300/435) from the second study called CARE-MS II completed long-term follow-up through year eight.

After receiving the initial two courses of Lemtrada, upon study entry and 12 months later, 56 percent (n=197) of Lemtrada patients from CARE-MS I and 44 percent (n=172) from CARE-MS II who entered the extension received no further treatment through year eight of the extension. Patients were eligible to receive either retreatment with Lemtrada or treatment with another MS disease-modifying therapy. The annualized relapse rates observed in patients who received Lemtrada in CARE-MS I (0.18) and CARE-MS II (0.26) over 2 years (both p<0.0001 versus treatment with sc ifnb-1a), remained low throughout the extension (0.14 and 0.18 at year eight, respectively). at year eight, 71 percent (n="252)" and 64 percent (n="260)" of lemtrada-treated patients from care-ms i and care-ms ii, respectively, did not experience confirmed disability worsening1; 41 percent (n="84)" and 47 percent (n="135)," respectively, experienced confirmed disability improvement. through year eight, patients who received lemtrada in care-ms i and ii experienced a slowing of brain volume loss. in years three through eight, the yearly brain volume loss was -0.22 percent or less, and -0.19 percent or less, respectively, which was lower than what was observed in the lemtrada-treated patients during the two-year pivotal studies (care-ms i: -0.59 percent in year one; -0.25 percent in year two; care-ms ii: -0.48 percent in year one; -0.22 percent in year two). in years two through eight, most patients had no evidence of magnetic resonance imaging (mri) disease activity4 (66 � 77 percent in care-ms i and 66 � 76 percent in care-ms ii, in years 2 � 8, respectively).>

Overall, the incidence of adverse events (AEs) during the extension through year eight was reduced compared with the core pivotal studies and declined over time (CARE-MS I: 50.7 percent in year eight compared to 93.6 percent in year one and 84 percent in year two; CARE-MS II: 52.6 percent in year eight compared to 94.7 percent in year one and 92.6 percent in year two). These results will be presented at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).