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Positive Phase II Results for Anti-Interleukin Nanobody ALX-0061 in Rheumatoid Arthritis
Positive efficacy and safety data have been reported from the phase II part of a combined phase I/II study of the anti–interleukin-6 receptor (anti-IL-6R) nanobody ALX-0061 (Ablynx) in patients with moderately to severely active rheumatoid arthritis (RA) on a stable background of methotrexate.
In this phase II analysis, 37 patients with RA were randomly assigned to three groups of intravenously administered ALX-0061 (1 mg/kg every 4 weeks, 3 mg/kg every 4 weeks, or 6 mg/kg every 8 weeks) or placebo. A total of 34 patients were evaluable for efficacy at the 12-week interim period, and all of these patients continued treatment until week 24.
Depending on the patient’s disease status at week 10, the monthly dose was increased (from 1 mg/kg to 3 mg/kg, or from 3 mg/kg to 6 mg/kg) or the dosing regimen was intensified (from 6 mg/kg every 8 weeks to 6 mg/kg every 4 weeks), and patients receiving placebo could start monthly ALX-0061 treatment at 3 mg/kg. Twenty-four patients (86%) completed the study on their ALX-0061 starting regimen (the “unmodified” group); the dosing regimen was modified for four patients (the “modified” group); and three patients were switched from placebo to ALX-0061 (the “switchers” group).
The American College of Rheumatology (ACR) criteria for 20%, 50%, and 70% improvement (ACR20, ACR50, and ACR70) were achieved in 83%, 71%, and 58% of the pooled “unmodified” group, respectively. The corresponding ACR rates in the pooled “modified” group were 75%, 50%, and 50%. The pooled “switchers” group showed rates of 100%, 67%, and 0%.
DAS28 is an RA disease activity score based on C-reactive protein (CRP), tender and swollen joint counts of 28 defined joints, and the physician’s global health assessment. DAS28 remission was achieved by 63% of the pooled “unmodified” group, by 50% of the pooled “modified” group, and by 33% of the pooled “switchers” group.
At all doses tested, ALX-0061 was well-tolerated. No clinically relevant neutropenia or clinically significant increases in lipid levels (cholesterol and triglycerides) were observed, and there were no serious infections.
ALX-0061 targets the interleukin 6 pathway via its IL-6 receptor (IL-6R), which plays a key role in the inflammation process in RA. The drug can be administered both intravenously and subcutaneously.
Source: Ablynx; February 13, 2013.