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AB0954 A randomised, double-blind trial comparing the efficacy, safety and immunogenicity of msb11022, a proposed biosimilar of adalimumab, versus adalimumab originator in patients with moderate-to-severe plaque psoriasis
  1. J. Hercogová1,
  2. K.A. Papp2,
  3. C.J. Edwards3,
  4. V. Chyrok4,
  5. T. Halady4,
  6. M. Ullmann4,
  7. P. Vlachos5
  1. 1Charles University, Prague, Czech Republic
  2. 2Probity Medical Research Inc, Waterloo, ON, Canada
  3. 3University of Southampton, Southampton, UK
  4. 4Fresenius Kabi, Aubonne
  5. 5Cytel, Geneva, Switzerland

Abstract

Background: Adalimumab is a fully human anti-TNF mAb, indicated for the treatment of multiple inflammatory disorders. MSB11022 is a proposed adalimumab biosimilar that has shown analytical similarity [1] and bioequivalence to US-licensed and EU-approved adalimumab originator, as well as comparable safety, tolerability and immunogenicity in a phase I trial [2].

Objectives: The aims of this multicentre, double-blind, parallel-group, 52-week phase III study (AURIEL-PsO, NCT02660580) were to demonstrate equivalence in efficacy (Psoriasis Area and Severity Index [PASI] 75) and to compare the safety and immunogenicity of MSB11022 vs. adalimumab originator in patients with moderate-to-severe chronic plaque psoriasis. This study was designed in-line with the biosimilar regulatory framework as part of the totality of evidence to confirm similarity and rationale for extrapolation.

Methods: A total of 443 eligible patients (391 evaluable, including 43 with psoriatic arthritis) from 69 sites in 12 countries were randomised 1:1 and treated with MSB11022 (n=202) or adalimumab originator (n=189) (80 mg subcutaneously [SC] on day 1; 40 mg SC every other week from weeks 2−14). The primary endpoint was PASI 75 at week 16; equivalence was established if the 95% confidence interval (CI) for the treatment difference was within ±18%. Secondary endpoints included % change from baseline in PASI (equivalence confirmed if 95% CI within ±15%), Physician Global Assessment (PGA), quality of life (QoL), immunogenicity and safety. Interim results at week 16 are presented.

Results: Patient baseline characteristics were comparable between MSB11022 and adalimumab originator groups: mean age 44.8 vs. 42.4 years, male 66.8% vs. 68.3%, mean PASI score 20.7 vs. 21.2, respectively. PASI 75 scores were 89.6% for MSB11022 and 91.5% for adalimumab originator (difference −1.9% [95% CI −7.82–4.16]). Mean % change from baseline in PASI was −90.6% for MSB11022 and −91.7% for adalimumab originator (difference −1.0% [95% CI −1.23–2.98]). PGA and QoL scores were comparable between treatment groups. The incidence of treatment-emergent adverse events (TEAEs)/serious TEAEs was 51.1/3.6% for MSB11022 and 53.2/2.7% for adalimumab originator. Immunogenicity profiles of MSB11022 and adalimumab originator were also similar and consistent.

Conclusions: Week 16 results of this phase III confirmatory study demonstrated equivalent efficacy and similar safety and immunogenicity profiles for MSB11022 vs. adalimumab originator at 16 weeks in patients with moderate-to-severe chronic psoriasis.

References [1] Magnenat L, et al. Demonstration of physicochemical and functional similarity between the proposed biosimilar adalimumab MSB11022 and Humira®. MAbs. 2017;9:127–139.

[2] Hyland E, et al. Comparison of the pharmacokinetics, safety, and immunogenicity of MSB11022, a biosimilar of adalimumab, with Humira® in healthy subjects. Br J Clin Pharmacol. 2016;82:983–93.

Disclosure of Interest: J. Hercogová Grant/research support from: Fresenius Kabi, Consultant for: Fresenius Kabi, K. Papp Grant/research support from: Fresenius Kabi, C. Edwards Grant/research support from: Fresenius Kabi, Consultant for: Fresenius Kabi, V. Chyrok Employee of: Fresenius Kabi, T. Halady Employee of: Fresenius Kabi, M. Ullmann Employee of: Fresenius Kabi, P. Vlachos Consultant for: Fresenius Kabi

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