PHASE lll CLlNlCAL STUDY
STUDY DESlGN
N=584 Moderate to severe RA despite methotrexate
Baseline to Week 78
Phase III, randomised, double-blind study.
RA patients randomised (1:1) to receive reference infliximab (IFX) or Flixabi™. At Week 54, patients receiving IFX rerandomised to either switch to Flixabi™ or continue receiving IFX
Primary efficacy endpoint: ACR20 (Week 30). Efficacy, safety (including TEAEs), and immunogenicity up to Week 78
Abbreviations: ACR20, American College of Rheumatology 20% improvement criteria; CI, confidence interval; DAS28, disease activity score based on 28-joint count; IFX, reference infliximab; RA, rheumatoid arthritis; TEAE, treatment-emergent adverse event.
Comparable long-term efficacy and safety profile up to Week 78 in RA1,2
- ACR20 at Week 30 post-switch was comparable between patients receiving reference infliximab and FlixabiTM2
Adapted from: Choe JY, et al. 2017.2
a Curve is fitted by non-linear mixed models employing an exponential time-response model. The upper limit of the 95% CI for the 2-norm was 35.8, which was below the prespecified equivalence margin of 61.8.
- DAS28 time-response curves up to week 78 were similar among the three treatment groups1,2
Adapted from: Smolen JS, et al. 2018.1
- Comparable safety profile demonstrated across multiple parameters up to Week 543
Treatment emergent adverse events reported in ≥2% of patients in either treatment group at up to Week 541
Adapted from: Smolen JS, et al. 2017.3
lncidence of treatment-emergent adverse events, severe adverse events, injection site reactionsa were comparable for both treatment groups1
a Five cases were serious (two cases of hypersensitivity and one case of anaphylactic reaction with Flixabi™ and one case of anaphylatic shock and one case of urticaria with reference infliximab).