BioCentury
ARTICLE | Clinical News

Anti-IL-6R: Final Phase II data

February 18, 2013 8:00 AM UTC

Ablynx reported final 24-week data from 34 evaluable patients with moderate to severe active RA on a stable background of methotrexate in the Phase II portion of a double-blind, placebo-controlled, European Phase I/II trial evaluating IV ALX-0061 given in doses of 1 mg/kg every 4 weeks, 3 mg/kg every 4 weeks and 6 mg/kg every 8 weeks. In 24 evaluable patients whose treatment regimen remained unmodified throughout the trial, IV ALX-0061 produced ACR20 response rates at week 24 of 75% in the 1 mg/kg dose group, 100% in the 3 mg/kg dose group and 75% in the 6 mg/kg dose group. ACR50 response rates at week 24 were 63% for 1 mg/kg ALX-0061, 75% for 3 mg/kg ALX-0061 and 75% for 6 mg/kg ALX-0061. ACR70 response rates at week 24 were 50% for 1 mg/kg ALX-0061, 63% for 3 mg/kg ALX-0061 and 63% for 6 mg/kg ALX-0061. Additionally, the proportion of patients who achieved DAS28 remission, defined as a DAS28 score of <2.6 points, at week 24 was 50% for 1 mg/kg ALX-0061, 75% for 3 mg/kg ALX-0061 and 63% for 6 mg/kg ALX-0061. ...