Sanofi Genzyme has announced that a new long-term analysis detailing 10 years of clinical efficacy of Lemtrada (alemtuzumab) in people with relapsing-remitting multiple sclerosis (RRMS) will be presented at the 68th American Academy of Neurology (AAN) 2016 Annual Meeting (15-21 April, Vancouver, Canada).
Results from the on-going, long-term extension study of the phase 2 CAMMS223 study showed that over 10 years of follow-up, 76% of patients were shown to be free from six-month confirmed disability worsening (increase of ≥1.0 EDSS point [or ≥1.5 points if baseline EDSS=0]) and 78% had an Expanded Disability Status Scale [EDSS] score that was either stable or showed greater than or equal to one point improvement in EDSS vs. baseline. In addition, a low annualised relapse rate (ARR) was maintained (0.08) over the period. The long-term safety observed in this group of patients was in line with that of other Lemtrada clinical trials.
People who entered the CAMMS223 study had not previously received other treatments for RRMS and the majority of those who were followed for 10 years received a maximum of three courses of Lemtrada.
“These data provide further evidence of the long-term response with Lemtrada in treatment-naïve patients with relapsing-remitting MS”, said Professor Alasdair Coles, lead investigator, University of Cambridge School of Clinical Medicine, Cambridge, UK. “It is remarkable that such infrequent dosing with Lemtrada offers stability or improvement of disability over 10 years. These findings confirm that Lemtrada is a valid treatment approach for people with multiple sclerosis, without the need for continuous treatment.”
“We are very pleased with these new data, which are part of our extensive clinical development programme and our commitment to the field of MS,” commented Peter Kuiper, General Manager UK & Ireland at Sanofi Genzyme. “Being able to offer this treatment option, which was discovered and developed in the UK to clinicians and their patients, is of incredible importance to us.”
The data on Durable Efficacy of Alemtuzumab Over 10 Years: Long-Term Follow-Up of Patients with RRMS from the CAMMS223 Study were presented as a poster presentation on Monday, 18 April 2016.
More than 100,000 people in the UK have Multiple Sclerosis (MS), with around 85% diagnosed with RRMS. Lemtrada is the second of Sanofi Genzyme’s treatments for MS to receive approval for use from NICE and on the NHS in England and Wales.