Lemtrada (alemtuzumab) as a first treatment option for relapsing multiple sclerosis (MS) patients reduced relapse rates and disability progression throughout a study period of six years — although most patients received treatment only in the first two years. The study showed that Lemtrada has the potential to harness disease activity in the long run.
The findings were presented at the Parallel Session 11 — “Insights to long term treatment effects from MS registries and databases” — of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2016 Congress, held in London (Sept. 14-17), by Alasdair Coles from the University of Cambridge School of Medicine.
The talk was titled “Alemtuzumab provides durable improvements in clinical outcomes in treatment-naive patients with active relapsing-remitting multiple sclerosis over 6 years in the absence of continuous treatment (CARE-MS I).”
Researchers analyzed data from two studies of Lemtrada. The two-year CARE-MS I Phase 3 trial (NCT00530348) enrolled patients who had never been treated with an MS drug before and who were randomized to receive either Lemtrada or Rebif (interferon beta-1a), and a four-year extension study (NCT00930553) that enrolled patients from CARE I and from another study of Lemtrada or Rebif in relapsing MS (CARE II), but these patients were not treatment naive.
Those in CARE I who received Lemtrada were treated with two courses of 12 mg: five days of treatment in the beginning and three days of treatment after 12 months. At the end of the second year, patients could enter the extension study (93 percent of them did), where they received Lemtrada only if they had a relapse or if disease activity was detected by brain imaging. Patients were allowed, at investigators’ discretion, to use another disease-modifying drug during this trial.
After six years, 63 percent of patients did not require further Lemtrada treatment in addition to the first two rounds. The study showed that annual relapse rates were low. Through six years, 77 percent of patients did not experience worsening disability at six-month controls, while another 34 percent showed improvements in their level of disability.
At year six, 81 percent of the participants had either a stable or an improved Expanded Disability Status Scale (EDSS) score, and each year, a large proportion of patients showed no evidence of disease activity, known as NEDA. At year six, 57 percent of Lemtrada-treated patients had achieved NEDA.
“The Lemtrada data being presented at ECTRIMS from the ongoing extension study illustrate that more than half of patients experienced sustained effects of treatment on disease activity, despite receiving their last treatment course five years previously,” said Coles in a press release. “It is very promising to see these consistent effects over time across relapse, disability and MRI measures.”
The extension study also found that the rate of side effects decreased over time. Effects on the thyroid were most commonly seen to peak at three years of treatment and decline after that. Likewise, reactions triggered by the infusion became rarer as the number of infusions increased.
The research team noted that severe side effects, such as severe infections, were rare and occurred early on in the study.
“Clinical efficacy of alemtuzumab was maintained for 6 years in patients who were treatment-naive [CARE I], despite most receiving no additional treatment since the initial 2 courses of alemtuzumab. Based on these findings, alemtuzumab may provide a unique treatment approach with durable efficacy in the absence of continuous treatment for RRMS [relapsing-remitting MS] patients,” the team wrote in its ECTRIMS’ abstract.