Assessment of comparative efficacy between candidate biosimilar AVT05 and reference golimumab

Introduction: Golimumab is a safe and effective treatment for patients with RA. Biosimilars to the reference product (RP; Simponi) may make treatment more accessible.

Objectives: We assessed comparable efficacy of AVT05, a golimumab candidate biosimilar, and RP, each used in combination with MTX , in participants with moderate to severe RA (NCT05842213).

Methodology: This was a 52-week, randomized, double-blind, 2-arm, parallel group, active control study. Participants were randomized 1:1 to receive AVT05 (n=251) or RP (n=251), 50 mg subcutaneously every 4 weeks to Week 12 inclusive. Randomization was stratified by baseline Disease Activity Score-28 for RA using C-reactive Protein (DAS28-CRP) score (≤5.1 and>5.1). The primary endpoint was change from baseline in DAS28-CRP at Week 16.

At Week 16, responder participants (DAS28-CRP decreased by>0.6 from baseline and disease activity DAS28-CRP≤5.1) initially enrolled in the AVT05 arm, continued to receive AVT05 every 4 weeks. Responder participants initially randomized to RP were re-randomized 1:1 to either continue receiving RP or switch to AVT05. Non-responders were discontinued from study drug. Additional efficacy measures, as well as efficacy at additional timepoints, were assessed as secondary endpoints.

Safety and immunogenicity endpoints were also assessed.

Results: At Week 16 the two-sided 95% confidence interval of the least squares mean difference was entirely contained within the prespecified equivalence margin of -0.6, 0.6 (-0.07, 0.25), supporting a demonstration of comparative efficacy. Two sensitivity analyses supported the robustness of the primary endpoint estimates. There were no notable differences in subgroup analyses ([Fig. 1]). Secondary efficacy analyses were consistent with the primary endpoint, including in participants who switched treatments.

Fig. 1  

Overall safety profiles showed no clinically meaningful differences between treatments, including in participants who switched treatments. Immunogenicity profiles were comparable between treatment arms at all timepoints, including in participants who switched treatments.

Conclusion: Analysis of the change in DAS28-CRP from baseline to Week 16 supported the assessment of comparative efficacy between AVT05 and RP. Secondary efficacy endpoints were consistent with this, including in participants who switched. AVT05 had a safety and immunogenicity profile similar to that observed for RP at all timepoints, including in participants who switched.

Informationen zum Einsatz von KI: N/A

 

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Publication History

Article published online:
04 September 2025