Two clinical trials investigating the long-term effects of Lemtrada (alemtuzmab) in multiple sclerosis (MS) patients has revealed that the drug maintained outcomes, even in the absence of further treatment.
The trials are both in the third phase of investigating and both studies were presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) 2017 forum.
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,” evaluated the six-year effectiveness and safety of Lemtrada in patients with relapsing-remitting MS (RRMS) who had an inadequate response to prior therapy.
Patients taking 12mg of Lemtrada demonstrated significantly better improvements on clinical and MRI outcomes when compared to Rebif (interferon beta-1a), another drug approved as an MS therapy.
In addition, some Lemtrada treated patients were followed for an additional four years in an extension study. They 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, including Lemtrada or any other disease-modifying therapies.
In patients with active RRMS who had inadequate response to previous therapy upon entering the study and were not under any continuous treatment, researchers found that Lemtrada maintained its durable efficacy throughout the six year study. The treatment revealed low annual relapse rates and stabilised or improved disability in most patients. Better still, the majority of patients achieved no evidence of disease activity (NEDA).
The second study evaluated the effects of Lemtrada on brain volume loss over the six year period from both studies. Participants from the first study had not previously received any MS disease-modifying therapy.
Researchers analysed 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 from 0.59% in the first year to 0.17% in the sixth year. In patients with an inadequate response to prior therapy, the median yearly BVL also decreased in time and remained low at 0.48% in year 1, and 0.10% in year 6.
The research teams for both studies 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.”
Source: MS-UK (28/02/17)