All abstracts being presented at EULAR 2015 are based on the SARIL-RA-MOBILITY Phase 3 clinical study, which randomized 1,197 adult patients with active, moderate-to-severe RA and inadequate response to methotrexate (MTX) therapy to receive sarilumab 200 mg, sarilumab 150 mg or placebo every other week, all in combination with MTX. As presented at EULAR 2014, both sarilumab groups showed statistically significant improvements compared to the placebo group in all three co-primary endpoints, demonstrating improvement in disease signs and symptoms at 24 weeks, physical function at 16 weeks and inhibition of joint damage progression at 52 weeks.
The abstracts are as follows:
• FRI0058: Improvements in Health Related Quality of Life (HRQOL) Reported by Rheumatoid Arthritis (RA) Patients in a Randomized Controlled Trial [RCT] of Sarilumab [MOBILITY] that met or Exceeded the Patient Acceptable Symptom State [PASS] and Normative Values
• FRI0173: Efficacy of Sarilumab in Moderate and Severe Rheumatoid Arthritis as Defined by Baseline DAS28-CRP Scores: The MOBILITY Study
• FRI0186: Impact of Concomitant Methotrexate Dose on the Efficacy and Safety of Sarilumab for Treatment of Moderate-to-Severe Rheumatoid Arthritis: The MOBILITY Study
• SAT0204: Clinical and Radiographic Efficacy of Sarilumab in Rheumatoid Arthritis Patients with Varied Disease Duration
• SAT0198: Effect of Increased Sarilumab Dose on Efficacy and Safety Outcomes in Poorly Responding Rheumatoid Arthritis (RA) Patients: The MOBILITY Study
• SAT0185: Clinical and Radiographic Efficacy of Sarilumab Plus Methotrexate in Biologic-Experienced and Biologic-Naïve Patients with Rheumatoid Arthritis in a Phase 3, Randomized, Double-Blind, Placebo-Controlled International Study
About Sarilumab
Sarilumab (REGN88/SAR153191) is the first fully human monoclonal antibody directed against the IL-6 receptor (IL-6R). Sarilumab binds with high affinity to the IL-6 receptor. It blocks the binding of IL-6 to its receptor and interrupts the resultant cytokine-mediated inflammatory signaling. Sarilumab was developed using Regeneron’s VelocImmune® antibody technology.
The investigational agent described above is currently under clinical development, and its safety and efficacy have not been evaluated by any regulatory authority.
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