Alemtuzumab Has Continued Efficacy for Patients With Multiple Sclerosis After 8 years of Follow-Up

 

Phase 3 extension studies for alemtuzumab (Lemtrada; Sanofi-Genzyme, Cambridge, MA) has continued efficacy after 8 years of treatment according to results presented at the European Committee on Research and Treatment in Multiple Sclerosis (ECTRIMS) in Berlin, Germany Oct. 10-12. 

For those who continued follow-up care for 8 years, the mean annualized relapse rates (ARR) for patients treated with alemtuzumab were 0.18 (CARE-MS I) and 0.26 during the trials and 0.14 and 0.18, respectively, at year 8. The majority of patients (71% of those from MS-CARE I and 64% of those from MS-CARE II) had no worsening of disability, and 41% and 47%, respectively, had disability improvements. In years 3- 8, patients treated with alemtuzumab had decreases in brain-volume loss as well (Table).

Table. Brain-volume loss percentages.

 

Brain-volume loss year 1

Brain-volume loss year 2

Brain-volume loss year 3-8

CARE-MS I

-.59%

-.25%

-.22%

CARE-MS II

-.48%

-.22%

-.19%

Of the patients who participated in CARE-MS I (NCT) and CARE-MS II (NCT) clinical trials, 77% (n = 292/376) and 69% (n = 300/435) completed 8 years of long-term follow up. After the first 2 courses of alemtuzumab (upon entering trial and 12 months later), 56% of patients (MS-CARE I, n = 197 and MS-CARE II, n = 172) received no other treatments for the full 8 years of follow-up care; patients were eligible to receive retreatment with alemtuzumab or another disease-modifying treatment (DMT).

The incidence of adverse events (AEs) declined over time (CARE-MS I: 93.6% in years 1-2 and 50.7% at year 8; CARE-MS II: 94.7% in year 1-2 and 52.6% at year 8). Thyroid adverse events were highest in year 3 (CARE-MS I: 15 percent; CARE-MS II: 17 percent) and declined thereafter. At year 8, 2 people in CARE-MS I and 4 people in CARE-MS II had died. 

“The extension study data being presented at ECTRIMS this year showed the effects of Lemtrada were maintained in patients across clinical and MRI outcomes, including brain volume loss, over eight years,” said Barry Singer, M.D., Director of The MS Center for Innovations in Care at Missouri Baptist Medical Center, St. Louis, MO. “After their initial two courses of Lemtrada, approximately half of patients received no additional treatment through eight years. Almost two-thirds of patients did not experience disability worsening through year eight, providing important insight into the effects of Lemtrada seen over time.”

 

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