This month, researchers published data from a phase 3 study of the biosimilar in patients with moderate to severe rheumatoid arthritis (RA) after previous phase 3 data were reported for a study in patients with severe plaque psoriasis.
Fresenius Kabi’s biosimilar adalimumab, Idacio, recently launched in the German market. The biosimilar was authorized in the European Union in April 2019 on the basis of a data package including results from a phase 3 study in patients with severe plaque psoriasis. Data from that study, AURIEL-PsO, have been previously reported.
This month, researchers published data from another phase 3 study of the biosimilar in patients with moderate to severe rheumatoid arthritis (RA).
The paper, appearing in Clinical Rheumatology, describes the AURIEL-RA study, a multicenter, randomized, double-blind, parallel-group trial in 288 patients with RA who did not have an adequate response to methotrexate. Patients were randomized to receive either the EU-licensed reference Humira with a citrate-based buffer (n = 145) or the biosimilar with an acetate-based buffer (n = 143).
The study’s primary end point was the incidence of treatment-emergent adverse events (AEs) of special interest, defined as hypersensitivity reactions, up to week 52.
The proportion of patients who experienced 1 or more hypersensitivity reaction by week 52 was similar between arms; 6 patients in the biosimilar arm and 8 patients in the reference arm reported hypersensitivity. Two reactions qualified as serious AEs: 1 event of grade 3 dermatitis was observed in the reference arm, and 1 grade 4 anaphylactic reaction was recorded in the biosimilar arm. No patients discontinued treatment or withdrew from the study due to hypersensitivity.
Fewer injection-site reactions were reported in the biosimilar arm (23 patients reported 56 reactions) than in the reference arm (33 patients reported 298 reactions).
The proportion of patients who achieved the secondary end point of the American College of Rheumatology’s criteria for 20% improvement (ACR20) at week 12 was similar between the biosimilar arm (79.6%) and the reference arm (80.9%). The similarity was maintained up tot week 52. Other response rates, including ACR50 and ACR70, were also similar up to week 52.
Quality of life questionnaire scores were injection site pain scores were also similar between groups.
Over the course of the 52 weeks, 80.4% of patients in the biosimilar arm and 71.4% of patients in the reference arm had at least 1 positive antidrug antibody result, and 39.9% and 39.3% of patients in the 2 arms, respectively, had a positive result for neutralizing antibodies.
These results, write the authors, are consistent with the findings of the prior phase 3 study in patients with psoriasis, and support the overall biosimilarity of Idacio with its reference, Humira.
Edwards CJ, Monnet J, Ullman M, Vlachos P, Chyrok V, Ghori V. Safety of adalimumab biosimilar MSB11022 (acetate-buffered formulation) in patients with moderately-to-severely active rheumatoid arthritis [published online August 8, 2019]. Clin Rheumatol. doi: 10.1007/s10067-019-04679-y.