Key clinical point: Blocking toll-like receptor 4 with NI-0101 did not improve disease in rheumatoid arthritis (RA) patients with insufficient responses to methotrexate.
Major finding: Measures of efficacy were not significantly different between patients who received NI-0101 dosed at 5 mg/kg every 2 weeks for 12 weeks and those who received a placebo; 55% and 59% of the treatment and placebo groups, respectively, achieved 20% improvement in American College of Rheumatology response criteria (ACR20).
Study details: The data come from 86 adults with RA who completed a proof-of-concept, phase 2 randomized trial.
Disclosures: The study was supported by Novimmune; lead author Dr. Monnet and several coauthors are Novimmune employees and stockholders.
Monnet E et al. Ann Rheum Dis. 2019 Dec 31. doi: 10.1136/ annrheumdis-2019-216487