Date: 2012-09-26
Type of information:
phase: 2b
Announcement: results
Company: UCB (Belgium)
Product: olokizumab
Action mechanism: Olokizumab is a humanized monoclonal antibody targeting the IL-6 cytokine. IL-6 is involved in several autoimmune and inflammatory pathways. Olokizumab is the first of a new type of IL-6 inhibitor that selectively blocks the final assembly of the IL-6 receptor signaling complex.
Disease: rheumatoid arthritis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country:
Trial details: The three-months trial was a randomized, double-blind, placebo-controlled, dose ranging study with an active comparator (tocilizumab) to evaluate the efficacy and safety of olokizumab (CDP6038) administered subcutaneously for 12 weeks. Approximately 220 patients with moderately- to severely-active RA who had an unsuccessful response to previous anti-TNF therapy were enrolled in the study. The treatment arms for olokizumab evaluated 60, 120 and 240 mg administered subcutaneously, every two weeks or every four weeks. In the active comparator arm, 8 mg/kg tocilizumab was administered intravenously every four weeks. All patients received concomitant methotrexate treatment.
Latest
news: UCB has announced the top-line results from a phase 2b study of olokizumab (CDP6038) in adult patients suffering from rheumatoid arthritis (RA) having previously failed anti-TNF therapy. The primary objective of this study was to evaluate the efficacy of various doses and dose administration frequencies of olokizumab relative to placebo.
This phase 2b study met its primary endpoint of demonstrating a significant reduction in the disease activity score at week 12 across all olokizumab dose groups relative to placebo. All doses of olokizumab demonstrated statistically significant improvement in disease activity score (DAS 28) (p<0.001) when compared with placebo.
In addition, this study included an active comparator arm (tocilizumab). The exploratory analyses of these data suggest that olokizumab and tocilizumab demonstrated comparable efficacy, as measured by DAS scores in this difficult to treat population. Olokizumab was well tolerated across all doses and demonstrated a safety profile comparable to tocilizumab and consistent with known effects of IL-6 inhibitors.
Further analyses are on-going and detailed results of this study will be submitted to an appropriate future medical congress.
