Establishing clinical equivalence

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PHASE lll CLlNlCAL STUDY

STUDY DESlGN1

N=544 patients with moderate to severe RA, despite MTX treatment

Baseline to Week 52

Phase lll study; patients randomised (1:1) to lmraldiTM or reference adalimumab (40 mg/0.8 ml injections EOW). At Week 24, patients in latter arm were re-randomised (1:1) to continue reference adalimumab or transitioned to lmraldiTM (adalimumab) (40 mg/0.8 ml injections EOW)

ACR20 at Week 24; additional efficacy, PK, safety and immunogenicity assessments to Week 52

Abbreviations: ACR20, American College of Rheumatology 20% improvement criteria; EOW, every other week; MTX, methotrexate; PK, pharmacokinetics; RA, rheumatoid arthritis; rADL, reference adalimumab.

REFERENCES

Imraldi™ (adalimumab) controlled disease activity as well as reference adalimumab1

Comparable ACR20 response to reference adalimumab up to Week 24

  • The difference in ACR20 response rate was 0.1%, (95% Cl -7.83, 8.13), which was well contained within the predefined equivalence margin (± 15%) at Week 241
  • Comparable efficacy was observed for the secondary endpoints (ACR50 and ACR70)

Adapted from: Weinblatt ME, et al. 2018.

Abbreviations: ACR20, American College of Rheumatology 20% improvement criteria; ACR50, American College of Rheumatology 50% improvement criteria; ACR70, American College of Rheumatology 70% improvement criteria; rADL, reference adalimumab; Cl, confidence interval.

Comparable response rates up to Week 521,2

  • ACR response rates were maintained after transition from reference adalimumab to lmraldiTM at Week 24
  • Results for the rADL/lmraldiTM and the rADL/rADLa groups were comparable up to Week 52
  • Efficacy between the lmraldiTM/lmraldiTM and rADL/rADL groups was comparable throughout the study
  • Efficacy was maintained from Week 24 to Week 52 across all treatment groups

Adapted from: Weinblatt ME, et al. 2018.

a Patients who initially received rADL and continued to do so after re-randomisation at Week 24.

Abbreviations: ACR20, American College of Rheumatology 20% improvement criteria; ACR50, American College of Rheumatology 50% improvement criteria; ACR70, American College of Rheumatology 70% improvement criteria; Cl, confidence interval; rADL, reference adalimumab.

Comparable DAS28 response to reference adalimumab at Week 241

  • Mean change from baseline to Week 24 in DAS28 was comparable between lmraldiTM (adalimumab) and reference adalimumab
  • The least squares mean for the treatment difference in DAS28 at Week 24 was −0.04 (95% Cl −0.26, 0.17), which was contained within the predefined equivalence margin (−0.6 to 0.6)1

Adapted from: Weinblatt ME, et al. 2018.

Abbreviations: Cl, confidence interval; DAS28, Disease Activity Score in 28 joints based on the erythrocyte sedimentation rate; rADL, reference adalimumab.

Patients who switched to Imraldi™ (adalimumab) maintained DAS28 outcomes3

  • lmprovement in disease activity was maintained when patients switched from reference adalimumab to lmraldiTM

Adapted from: CHMP Assessment Report, 2017.

a Patients who initially received rADL and continued to do so after re-randomisation at Week 24.

Abbreviations: DAS28, Disease Activity Score in 28 joints based on the erythrocyte sedimentation rate; rADL, reference adalimumab.

lmraldi™ (adalimumab) slowed radiographic progression similarly to reference adalimumab1,2

Radiographic progression was comparable up to Week 52

  • Radiographic progression was minimal and comparable across the treatment arms for lmraldiTM (adalimumab) and reference adalimumab

Adapted from: Weinblatt ME, et al. 2018.

a Patients who initially received rADL and continued to do so after re-randomisation at Week 24.

Abbreviations: mTSS, Modified total Sharp/van der Heijde score; rADL, reference adalimumab.

Comparable safety profile to reference adalimumab2

Comparable safety profile demonstrated across multiple parameters up to Week 521

  • lncidence of treatment-emergent adverse events, severe adverse events, injection site reactions and anti-drug antibodies were comparable for both treatment groups1,3
  • For full safety information, please refer to the lmraldiTM (adalimumab) Summary of Product Characteristics here
Treatment emergent adverse events reported in ≥2% of patients in either treatment group at up to Week 52

Adapted from: CHMP Assessment Report, 2017.

Abbreviations: rADL, reference adalimumab.