Sanofi Genzyme will present new results on follow-up studies of its products Lemtrada (alemtuzumab) and Aubagio (teriflunomide), both of which have been approved for the treatment of relapsing-remitting multiple sclerosis (RRMS). The new data will be presented at the American Academy of Neurology (AAN) Annual Meeting taking place through April 28 in Boston.
Lemtrada and the CARE II extension trial
Lemtrada is an antibody treatment that specifically targets the CD52 protein, which is present on the surface of certain immune cells, such as T- and B-lymphocytes, thereby blocking their action.
This drug was under investigation in RRMS patients in the Phase 3 CARE-MS II trial (NCT00548405). Results showed that most patients on Lemtrada (330 patients, or 76%) had no relapses between their first and second treatment courses, but 24% (105 patients) did relapse between courses.
Nonetheless, relapsing patients receiving Lemtrada presented significantly greater improvements on clinical and brain imaging outcomes compared to Rebif (interferon beta-1a), another drug approved as an MS therapy.
Results of an extension trial (NCT00930553) with six years of follow-up showed that this group of patients had similar improvement to those who did not relapse between courses:
- In patients who relapsed, the annualized relapse rate (ARR) decreased from 1.2 in year 1 to 0.5 in year 2 after the second treatment course. The ARR continued to decrease through year 6. In patients who did not relapse between courses, the ARR in years 2 to 5 was 0.2 and 0.1 in year 6.
- Most patients who relapsed (80%) were free of disability worsening in year 2, and 60% remained free at year 6. Most patients who had no relapse (91%) were free of disability worsening in year 2, and 75% remained so at year 6.
- Twenty-eight percent of patients who relapsed had confirmed disability improvement (CDI) at year 2, a percentage that increased to 34% at year 6. Among those who did not relapse, 31% achieved CDI at year 2, a percentage that increased to 45% at year 6.
- No evidence of disease activity (NEDA) was achieved in 38% in year 2 and 58% in year 6 in patients with relapses, and in 64% in year 2 and 60% in year 6 in patients who had no relapse between courses.
“The new Lemtrada data being presented at AAN suggest that occurrence of relapses in patients after receiving their initial course but before receiving their second course is not an indicator of lack of response to the treatment, and support the importance of administering the full two-course regimen,” Barry Singer, MD, said in a news release.
“The 24% of Lemtrada-treated patients in CARE-MS II who relapsed between their first and second courses experienced a marked improvement in clinical and MRI disease activity at year 2, which was maintained through six years,” he said. “The results observed in these patients through six years were similar to those observed in the 76% of patients who were relapse-free between courses one and two.”
Aubagio and the TOPIC trial
Aubagio is a once-daily oral immunomodulatory drug with anti-inflammatory properties. The Phase 3 TOPIC trial (NCT00622700) investigated whether early treatment with Aubagio in patients with a first clinical episode suggestive of MS could prevent or delay a second clinical attack.
Results showed that patients on Aubagio were less prone to experience further attacks. Also, this treatment significantly prevented the loss of cortical gray matter (outer surface of the brain) over two years of follow-up.
“Accelerated cortical gray matter atrophy can be evident from the earliest stages of MS, which highlights the need for early intervention,” Robert Zivadinov, an MD and PhD, said in a news release.
“Pathologic changes in gray matter are recognized as important contributors to disease worsening in MS, and strong predictors of potential future disability and impaired cognitive function,” he said. “The data being presented at AAN demonstrating that Aubagio slowed the rate of cortical atrophy in patients showing early signs of MS are very promising.”