Two Phase 3 clinical trials investigating the long-term effects of Lemtrada (alemtuzumab) in multiple sclerosis (MS) patients showed the drug maintained improved outcomes, even in the absence of further treatment.
Both studies were presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) 2017 Forum, held Feb. 23-25 in Orlando, Florida.
In the first study, “Efficacy of Alemtuzumab is Durable Over 6 Years Without Continuous Treatment in Patients With RRMS and an Inadequate Response to Prior Therapy,” scientists evaluated the six-year effectiveness and safety of Lemtrada in patients with relapsing-remitting MS (RRMS) who had an inadequate response to prior therapy.
In these patients, part of the CARE-MS II study (NCT00548405), Lemtrada (12 mg) treatment demonstrated significantly greater improvements on clinical and MRI outcomes when compared to Rebif (interferon beta-1a), another drug approved as an MS therapy.
Also, Lemtrada-treated patients who were followed an additional four years in an extension study (NCT00930553) showed durable effectiveness on clinical and MRI outcomes in the absence of continuous treatment. In fact, the majority of the patients received no additional therapy — neither Lemtrada nor any other disease-modifying therapies.
Now, researchers observed that in patients with active RRMS who had an inadequate response to prior therapy upon entering CARE-MS II, and who were not under any continuous treatment, Lemtrada maintained its durable efficacy throughout the six-year study period analyzed. The treatment induced low annual relapse rates and stabilized or improved disability scores in most patients. Moreover, the majority of the patients achieved “no evidence of disease activity” (NEDA).
In the second study, titled “Alemtuzumab Durably Slows Brain Volume Loss Over 6 Years in the Absence of Continuous Treatment in Patients With RRMS (CARE-MS I and II)“, researchers evaluated the effects of Lemtrada on brain volume loss (BVL) over six years in patients from the CARE-MS I and CARE-MS II studies.
Participants in the CARE-MS I study (NCT00530348) had not previously received any MS disease-modifying therapy.
Researchers analyzed patients’ MRI scans at baseline and annually thereafter assessing BVL. They found that Lemtrada markedly slowed BVL throughout the six years in patients who received no additional treatment (CARE-MS I, from 0.59% in the first year to 0.17% in the sixth year). In patients with an inadequate response to prior therapy (CARE-MS II), the median yearly BVL also decreased in time and remained low (0.48% in year 1, and 0.10% in year 6).
Overall, both research teams concluded that based on the BVL decrease observed and the improved clinical and MRI lesion outcomes over six years, “alemtuzumab may provide a unique treatment approach with durable efficacy in the absence of continuous treatment,” the researchers wrote in their abstracts.