Safety of adalimumab biosimilar MSB11022 (acetate-buffered formulation) in patients with moderately-to-severely active rheumatoid arthritis

Abstract

Objectives To compare the safety, efficacy, and immunogenicity of MSB11022 (acetate-buffered formulation), an adalimumab biosimilar, with the reference product. Method AURIEL-RA study was a phase 3, multicenter, randomized, double-blind, parallel group trial (NCT03052322). Patients with moderately-to-severely active rheumatoid arthritis (RA) with an inadequate response to methotrexate were randomized 1:1 to MSB11022 or reference adalimumab. The primary endpoint was the incidence of treatment-emergent adverse events of special interest (AESIs) (predefined as hypersensitivity) up to week 52. The key secondary endpoint was ACR20 (≥ 20% improvement in American College of Rheumatology core set measurements from baseline) at week 12. Other efficacy endpoints, quality of life, immunogenicity, and pharmacokinetic parameters were evaluated up to week 52. Secondary safety endpoints were evaluated up to week 52 and at a 4-month safety follow-up. Results In total, 288 patients were randomized. The proportion of patients experiencing ≥ 1 treatment-emergent AESI up to week 52 was similar between trial arms: 6 patients (4.2%; 95% CI 1.56, 8.91) receiving MSB11022, and 8 patients (5.5%; 95% CI 2.41, 10.58) receiving reference adalimumab. No clinically meaningful differences in efficacy, quality of life, or immunogenicity were seen between treatment arms up to week 52. No notable difference in the incidence of treatment-emergent adverse events was observed between treatment arms up to the end of the follow-up period. Conclusions These results suggest MSB11022 and reference adalimumab are similar in patients with moderately-to-severely active rheumatoid arthritis in terms of safety, immunogenicity, and efficacy. AURIEL-RA provides evidence to support the similarity of MSB11022 and adalimumab. Key Points• Incidences of hypersensitivity events were similar for MSB11022 (modified buffer) and reference adalimumab.• There was no difference in local reactions between MSB11022 (modified buffer) and reference adalimumab.• AURIEL-RA confirms the equivalence in efficacy and immunogenicity of MSB11022 (modified buffer) and reference adalimumab.

Efficacy and Safety of Adalimumab Biosimilars: Current Critical Clinical Data in Rheumatoid Arthritis

“…The similarity persisted up to week 52. The proportion of patients achieving ACR50 and ACR70, DAS28-ESR scores, SDAI, and CDAI scores were also similar between the two treatments throughout the trial (26).…”

“…There were fewer injection site reactions (ISRs) in the MSB11022 group than in the ADL group (9.1 vs. 22.8%, respectively). These differences were not considered notable (26).…”

“…A phase I trial conducted in healthy subjects has demonstrated bioequivalence with the reference drug in terms of PK, safety, tolerability, and immunogenicity (25). Edwards et al (26) conducted a phase III randomized, double blind parallel group, 52-week trial which included 288 patients with moderately-to-severely active RA on stable MTX treatment with an inadequate response. The phase III trial consisted of a 4-week screening period, a 52-week double-blind treatment period, and a 4-month safety follow-up period (26).…”

Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity

“…In a phase 3, randomized, double-blind, 52-week trial of 288 patients with moderate-tosevere, active RA receiving either MSB11022 (n = 143) or the adalimumab RP (n = 145), the primary endpoint was the incidence of TEAEs of special interest (AESIs) [27]. The ACR20 at week 12 was the key secondary endpoint.…”

“…No treatment-related deaths were reported, and no hypersensitivity reactions led to study discontinuation. [27].…”