A study released at #ACTRIMS2018 has revealed that patients who experienced relapses after two courses of Lemtrada (alemtuzumab) showed improvement in relapse rate and disability progression after a third course of the drug.
Patients in the CARE-MS II study had active relapsing remitting MS (RRMS) and an inadequate response to prior therapy at core study baseline. They received two courses of alemtuzumab 12 mg/day intravenously (on five consecutive days at baseline and on three consecutive days 12 months later).
In the extension study, patients could receive additional treatment with alemtuzumab (on three consecutive days ≥12 months after the most recent course) as needed for relapse or MRI activity, or receive other licensed DMTs at the investigator’s discretion.
435 patients received alemtuzumab 12 mg in the CARE-MS II study, with 423 (97%) completing the core study; 393/423 (93%) entered the extension and 344/393 (88%) remained on study through month 72 (year six).
Of the 393, 178 (45%) patients who entered the extension received alemtuzumab retreatment through year six and of those 178 patients, the majority received only one alemtuzumab retreatment (i.e. course three) through year six. Course three was most frequently given in year three.
Of the 178 patients who received ≥1 retreatment through year six, 144 (81%) fulfilled the criteria of receiving course three before month 61 and receiving no DMT to be included in the analyses. 78 of the 144 patients included in the analyses received retreatment for relapse only.
Researchers concluded that patients who received one or more alemtuzumab retreatments due to relapse and/or MRI activity, alemtuzumab effectively reduced relapses and improved disability. The mean time from course two to course three was 2.3 years. A similar profile was observed for patients who received one or more alemtuzumab retreatments due to relapse only.
Efficacy outcomes, including disability improvement, were favourable and clinically meaningful in the years following course three. These data support the administration of additional alemtuzumab treatment to achieve durable disease control in patients with disease activity following course two.
≥ = more than or equal to.