OBJECTIVES: MSB11022 is a proposed adalimumab biosimilar that has shown structural and functional similarity to the reference product (Humira^®). In addition, it has demonstrated bioequivalence in healthy volunteers and comparable efficacy, safety and immunogenicity in psoriasis patients. This analysis aims to show comparability of MSB11022 and reference adalimumab on QoL in psoriasis.

METHODS: In the double-blind, multicenter, pivotal efficacy and safety AURIEL-PsO study, patients were randomized 1:1 to MSB11022 or reference adalimumab. At Week 16, PASI 50 responders receiving reference product were re-randomized 1:1 to continue treatment or switch to MSB11022 until Week 52. QoL was assessed at scheduled visits using the Dermatology Life Quality Index (DLQI) and EuroQol 5-dimension 5-level (EQ-5D-5L) questionnaires. For the subpopulation of patients with psoriatic arthritis, the Health Assessment Questionnaire-Disability Index (HAQ-DI) and the Psoriatic Arthritis Joint Activity-Visual Analog Scale (PJA-VAS) were also used.

RESULTS: The per-protocol analysis included 203 and 191 patients in the MSB11022 and reference adalimumab arms, respectively. Similarity of efficacy, safety and immunogenicity between treatment arms was demonstrated, including equivalent efficacy for the primary endpoint of PASI 75 at Week 16. Improvements from baseline to Week 16 for all QoL scores were also comparable. At Week 16, the least square mean difference (95% CI) for MSB11022 versus reference adalimumab was −0.12 (−0.83, 0.58) for DLQI, 0 (−0.02, 0.02) for EQ-5D-5L, −1.39 (−4.16, 1.38) for EQ-5D-5L-VAS, 0.05 (−0.15, 0.25) for HAQ-DI (n=43) and 2.05 (−12.4, 16.5) for PJA-VAS (n=43). Improvements in QoL scores to Week 52 were equally maintained in all treatment arms, including the 96 patients who switched from reference adalimumab to MSB11022 at Week 16.

CONCLUSIONS: Treatment with MSB11022 and reference adalimumab resulted in comparable improvements in QoL at Week 16. QoL improvements were maintained to Week 52, and no impact of switching from reference product to MSB11022 was observed.