Fresenius Kabi's Adalimumab Biosimilar Produces Comparable QOL Improvements to Humira

Fresenius Kabi’s adalimumab biosimilar, approved in the European Union as Idacio, has demonstrated that it has similar pharmacokinetics, safety, and immunogenicity to its reference, Humira, in healthy volunteers as well as in patients with moderate to severe plaque psoriasis. In a study presented at the ISPOR 2019 meeting, researchers presented new data on the comparability of quality of life (QOL) improvements in patients treated with the biosimilar versus those treated with the reference.

In the double-blind, multicenter, 52-week phase 3 AURIEL-PsO study (for which data have been reported elsewhere, and which was included in Fresenius Kabi’s data package presented to the European Medicines Agency), patients were randomized to receive either the biosimilar or the reference. At week 16, patients who had a PASI 50 response were re-randomized to continue treatment or to switch to the biosimilar until week 52.

The per-protocol set included 203 patients receiving the biosimilar and 191 patients receiving the reference product. Patients’ QOL was assessed using the Dermatology Life Quality Index (DLQI) and EuroQol 5-dimension 5-level questionnaires (EQ-5D-5L). Among the 43 patients who also had psoriatic arthritis, the Health Assessment Questionnaire-Disability Index (HAQ-DI) and Psoriatic Arthritis Joint Activity-Visual Analog Scale (PJA-VAS) were also used.

Improvements from baseline to week 16 for all QOL scores were comparable, report the investigators. At week 16, the least squares mean differences for the biosimilar versus reference were as follows:

• −0.12 (05% CI, −0.83 to 0.58) for DLQI
• 0 (95% CI, −0.02 to 0.02) for EQ-5D-5L
• −1.39 (95% CI, −4.16 to 1.38) for EQ-5D-5L-VAS
• 0.05 (95% CI, −0.15 to 0.25) for HAQ-DI
• 2.05 (95% CI, −12.4 to 16.5) for PJA-VAS

Improvements in QOL scores were maintained across treatment arms to week 52, including in the patients who switched from to the biosimilar at the week 16 switch.

Treatment with the biosimilar, the investigators concluded, resulted in comparable, maintained QOL improvements, and switching from the reference did not impact QOL.

Reference

Hercogová J, Papp KA, Chyrok V, et al. Quality-of-life outcomes comparing the proposed biosimilar MSB11022 to reference adalimumab in patients with moderate-to-severe chronic plaque-type psoriasis. Presented at: International Society for Pharmacoeconomics and Outcomes Research 24th Annual International Meeting; May 18-22, 2019; New Orleans, Louisiana. Abstract PBI35.