gms | German Medical Science

Introduction: GP2017 is an adalimumab biosimilar, indicated for the treatment of rheumatoid arthritis (RA). The objective of this abstract is to describe the baseline characteristics, incidence of malignancies and mortality rates of patients with RA treated with GP2017 enrolled in the RABBIT registry. The registry is a prospective observational cohort study which aims to access the long-term safety of biologic agents in patients with RA [1].

Methods: This cohort from RABBIT was based on the use of routinely provided safety data from standardised reports to the Marketing Authorization Holder (MAH), and included adult patients with RA who started GP2017 at enrolment to the registry. The analysis included patients who started GP2017 treatment from Jan 1, 2019 onwards until the data cut-off date Oct 31, 2021. Descriptive analyses were performed to summarize the data. Cumulative incidence of malignancies and all-cause mortality were analysed as incidence per patient-years.

Results: In total, 108 patients treated with GP2017 were enrolled to the registry. Patients were predominantly females (n=79, 73.1%). While entering the registry, the mean age was 56.5±12.1 years and the mean duration from symptom onset was 8.5±7.7 years; 21.3% patients were previously treated with biologic/targeted synthetic DMARDs (n=23) and 79.6% had at least one comorbidity. The mean Disease Activity Score-28 was 4.4±1.4 while initiating treatment with GP2017 after failure of previous treatments. The mean pain Visual Activity Score was 5.5±2.2. The mean 28 tender/swollen joint counts were 6.3±5.9/4.8±4.9 and the mean C-reactive protein was 11.3±18.9 mg/L. 61.1% of patients were rheumatoid factor positive. Malignancies and deaths in patients who were under GP2017 treatment are shown in Table 1 [Tab. 1].

Conclusion: The baseline characteristics of patients enrolled in the RABBIT registry match the expected profile for patients with RA2-4 and the observed number of malignancies is low. Further, long-term follow-up of patients will be required for validation.

Disclosures: X. Baraliakos: Consultancy honoraria and research grants: AbbVie, Biocad, Chugai, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Roche and UCB, R. Behrens: Consultancy/speaker honoraria: Pfizer, AbbVie, Sanofi, Eli Lilly, Novartis, Genzyme, Boehringer Ingelheim, Janssen, MSD, Celgene, Roche and Chugai, Grant/research support: Pfizer, Janssen, Chugai, Celgene and Roche, F. Furlan: Employee: Sandoz Hexal AG, C. Salvati: Employee: Sandoz Hexal AG, J. Fan: Employee: Sandoz Inc., K. Krüger: Grants/research support: AbbVie, BMS, Celgene, Gilead, Hexal, Janssen Biologics, Lilly, MSD Sharp & Dohme GmbH, Pfizer, Roche, Sanofi-Aventis, UCB.