|The following article is part of conference coverage from the 2018 American College of Rheumatology and Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in Chicago, Illinois. Rheumatology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in rheumatology. Check back for the latest news from ACR/ARHP 2018 .|
CHICAGO — In patients with moderate to severe active rheumatoid arthritis (RA), the efficacy, safety, and immunogenicity of an infliximab biosimilar (PF-06438179/GP1111) and an infliximab reference product from the European Union were comparable from 54 to 78 weeks, according to the results of a randomized, double-blind, clinical study presented at the 2018 ACR/ARHP Annual Meeting, held October 19-24 in Chicago, Illinois.
The investigators compared the 2 formulations in patients with moderate to severe active RA who had an inadequate response to methotrexate and ≤2 doses of 1 non-depleting, non-infliximab biologic. They reported their results from 54 to 78 weeks.
A total of 650 patients, stratified by geographic region, were randomly assigned during the first treatment period to receive the biosimilar or reference product 3 mg/kg intravenously at weeks 0, 2, and 6, and then every 8 weeks, with both agents administered along with methotrexate 10 to 25 mg per week. The primary study end point was 20% improvement in ACR criteria (ACR20) response at 14 weeks. Secondary end points included ACR20 at different time points, 28-joint Disease Activity Score based on C-reactive protein (DAS28-CRP), and other measures of clinical response or disease remission
At 30 weeks, patients who received the reference product were reassigned to continue receiving the same agent or to transition to the biosimilar for 24 weeks. At 54 weeks, all patients received open-label treatment with the biosimilar.
Among the 650 patients who initially enrolled (biosimilar group, n=324; reference product group, n=326), 566 individuals entered the second treatment period at 30 weeks. At 54 weeks, 505 patients continued to participate in the study. Overall, 79.2% of the patients at 54 weeks were women and 78.6% were white. ACR20 response rates and DAS28-CRP scores were maintained and were comparable across the 3 treatment groups between 54 and 78 weeks.
The safety profile was also comparable across all 3 groups. The incidence of treatment-emergent adverse events reported between 54 and 78 weeks was 29.3% overall. In addition, the incidence of infusion-related reactions was 2.0% overall.
The investigators concluded that in accordance with earlier findings from this study, results from 54 to 78 weeks demonstrated the absence of clinically meaningful differences in safety, efficacy, and immunogenicity between the treatment groups, which was independent of a switch from the reference product to the biosimilar at 30 weeks or at 54 weeks.
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Cohen S, Kivitz AJ, Tee M, et al. A randomized, double-blind phase III study comparing the effcacy, safety and immunogenicity of PF-06438179/GP1111 (Ixifi™), an infliximab biosimilar, and infliximab reference product (Remicade®) in patients with moderate to severe active RA: results from week 54 to week 78. Presented at: 2018 ACR/ARHP Annual Meeting; October 19-24, 2018; Chicago, IL. Abstract 2521.
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