Establishing
clinical equivalence

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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 or Flixabi™. Patients receiving IFX who completed 54 weeks and were willing to participate in the extension study were 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.

REFERENCES

Comparable long-term efficacy and safety profile up to Week 78 in RA1-3

  • ACR20 at Week 30 post-switch was comparable between patients receiving reference infliximab and FlixabiTM2
  • Primary endpoint of ACR20 at 30 weeks was 64.1% for Flixabi vs 66.0% for reference infliximab; 95% CI for the rate difference -10.26% to 6.51%, which was within the pre-specified equivalence margin of +-15% (per protocol set analysis)

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 541

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).3

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