Researchers Present Findings on Biosimilar Adalimumab Products

During the European League Against Rheumatism’s Annual European Congress of Rheumatology, held from June 13-16 in Amsterdam, Netherlands, researchers presented findings on adalimumab biosimilars, referencing Humira.

Potential adalimumab biosimilar demonstrates similar safety and immunogenicity to reference

In a multicenter, double-blind, parallel-group, 52-week phase 3 study,¹ researchers compared the safety and efficacy of Fresenius Kabi’s proposed adalimumab biosimilar, MSB11022, with the originator product in patients with moderate-to-severe chronic plaque psoriasis.

The study included 443 patients from 69 sites that spanned 12 countries. Participants were randomized to receive either MSB11022 (n = 202) or the reference adalimumab (n = 189) at a dose of 80 mg subcutaneously on day 1, and 40 mg every other week from weeks 2 to 14. The primary endpoint of the study was Psoriasis Area and Severity Index (PASI) 75 at week 16.

Researchers presented interim results of the trial’s progression at 16 weeks during the conference. The study demonstrated that 89.6% of MSB11022 patients reached PASI 75, versus 91.5% of patients taking the originator product. The immunogenicity profiles were comparable.

Study finds trial dropouts do not affect determinations of clinical similarity

Amgen’s ABP 501, an EMA- and FDA-approved adalimumab biosimilar, was recently studied² in a tipping point sensitivity analysis compared with reference adalimumab in the treatment of rheumatoid arthritis.

The study authors noted that patient withdrawals from trials can often lead to incomplete data collection and subsequent loss of statistical power of the trial. The goal of this study was to examine the potential effects of missing data and determine how sensitive the results are.

The primary endpoint of the study was measured by the American College of Rheumatology’s 20% improvement criteria (ACR20) at week 24. Among participants who completed the study, the ACR20 response rate was 77% for the biosimilar adalimumab group and 74.7% for the reference adalimumab group.

Researchers found that, overall, the tipping point sensitivity analyses demonstrated that the effects of missing data due to study dropouts would not change the overall conclusion of clinical similarity between the reference and the biosimilar products.

References

1. Hercogova J, Papp KA, Edwards CJ, et al. A randomized, 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. Presented at the European League Against Rheumatism’s Annual European Congress of Rheumatology, June 13-16, 2018; Amsterdam, Netherlands. Abstract AB0954. doi: 10.1136/annrheumdis-2018-eular.5146.

2. Zhang N, Wang H, Krishnan E. Clinical equivalence in efficacy between ABP 501 and adalimumab in patients with moderate to severe rheumatoid arthritis: a tipping point analysis. Presented at the European League Against Rheumatism’s Annual European Congress of Rheumatology, June 13-16, 2018; Amsterdam, Netherlands. Abstract AB0457. doi: 10.1136/annrheumdis-2018-eular.6855.