SAN FRANCISCO, CA—Patients with rheumatoid arthritis (RA) who were inadequate responders or intolerant of anti-TNF therapy had significant and clinically meaningful outcomes with sarilumab at doses of 150mg or 200mg every 2 weeks plus a DMARD, reported Vibeke Strand, MD, from Stanford University Medical Center, Palo Alto, CA, at the 2015 ACR/ARHP Annual Meeting.
Fatigue, morning stiffness, pain, ability to participate in family/leisure activities, and work are important outcomes to assess RA treatment effectiveness. Dr. Strand and her team set out to evaluate the effects of sarilumab, an investigational human monoclonal antibody directed against the interleukin-6 receptor, plus a DMARD on these secondary outcomes and HRQoL at Week 24, as well as change in patient global assessment of disease activity (PtGA) and physical function by the Health Assessment Questionnaire (HAQ).
The study enrolled 546 patients who were randomized 1:1:1 to placebo, sarilumab 150mg or 200mg every two weeks with background DMARDs. Changes in patient-reported outcomes (PRO), including Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), morning stiffness, Pain VAS, Work Productivity Survey (WPS), Rheumatoid Arthritis Impact of Disease (RAID), and Short Form-36 (SF-36), were assessed from baseline to Week 24.
Patients receiving either dose of sarilumab demonstrated statistically significant improvements compared with placebo plus a DMARD in FACIT-F, morning stiffness, pain, WPS, and RAID (P<0.025, simple Bonferroni adjustment). Both doses showed significantly improved SF-36 Physical Component Summary Measure with no worsening of SF-36 Mental Component Summary Measure. Significant improvements were seen for five of eight SF-36 domain scores for sarilumab 150mg plus a DMARD and seven of eight domain scores for sarilumab 200mg plus a DMARD. Statistically significant improvements were also seen in PtGA and HAQ with both sarilumab doses.
“With few exceptions, statistically significant improvements between sarilumab treatment groups and placebo exceeded the minimum clinically important difference (MCID) for those PROs with established MCIDs,” reported Dr. Strand.