Date: 2011-07-12
Type of information: Initiation of preclinical development
phase: 2b
Announcement: results
Company: Sanofi (France) Regeneron Pharmaceutical (USA)
Product: sarilumab
Action
mechanism: This fully-human antibody targets the interleukin-6 receptor (IL-6R).
Disease: rheumatoid arthritis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country:
Trial
details: The MOBILITY study is a 306-patient, dose-ranging, multi-national, randomized, multi-arm, double-blind, placebo-controlled study, that compared five different dose regimens of sarilumab in combination with MTX to placebo plus MTX. The primary endpoint of the study was the proportion of patients achieving at least a 20% improvement in rheumatoid arthritis symptoms (ACR20) after 12 weeks. (NCT01061736)
Latest
news: Sanofi and Regeneron Pharmaceuticals have announced results from Phase 2b trials in rheumatoid arthritis with sarilumab (REGN88/ SAR153191 ), a novel, high-affinity, subcutaneously administered, fully-human antibody targeting the interleukin-6 receptor (IL-6R). The Phase 2b MOBILITY trial in rheumatoid arthritis demonstrated that patients treated with sarilumab in combination with a standard rheumatoid arthritis treatment, methotrexate (MTX), achieved a significant and clinically meaningful improvement in signs and symptoms of moderate-to-severe rheumatoid arthritis compared to patients treated with MTX alone.
In the MOBILITY trial, there was a dose response observed in patients receiving sarilumab in combination with MTX. An ACR20 response after 12 weeks was seen in 49.0% of patients receiving the lowest sarilumab dose regimen and 72.0% of patients receiving the highest dose regimen compared to 46.2% of patients receiving placebo and MTX (p=0.02, corrected for multiplicity, for the highest sarilumab dose regimen). The most common adverse events (>5%) reported more frequently in active treatment arms included infections (non-serious), neutropenia, and liver function test abnormalities. The types and frequencies of adverse events were consistent with those previously reported with IL-6 inhibition. The incidence of serious adverse events among the five sarilumab treatment groups and placebo group were comparable. Sarilumab also demonstrated significant benefit compared to placebo in secondary endpoints, including ACR 50, ACR 70, and DAS 28 scores, additional measures of clinical activity used in RA trials.
Sanofi and Regeneron are now discussing the dose(s) of sarilumab to advance into the Phase 3 portion of the MOBILITY trial.
