Cătălin Codreanu1, Claudiu C Popescu2, Corina Mogoșan1, Luminița Enache1, Sânziana Daia3, Ruxandra Ionescu3, Daniela Opriș-Belinski3. 1. "Dr. Ion Stoia" Clinical Centre of Rheumatic Diseases, Bucharest, Romania; "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania. 2. "Dr. Ion Stoia" Clinical Centre of Rheumatic Diseases, Bucharest, Romania; "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania. Electronic address: claudiu.popescu@reumatologiedrstoia.ro. 3. "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania; "Sfanta Maria" Clinical Hospital, Bucharest, Romania.
Abstract
OBJECTIVE: The study aims to compare the efficacy and safety of biosimilar etanercept (SB4) to original etanercept (ETN) in a real-life national cohort of rheumatoid arthritis (RA). METHODS: Data from RA patients were retrieved electronically from the Romanian Registry of Rheumatic Diseases (RRBR), which contains all patients receiving biologics in the country. RESULTS: The study included 242 patients with efficacy and safety data after 6 months of treatment: 123 (50.8%) with ETN, 119 (49.2%) with SB4. There were no significant differences after 6 months regarding composite scores of RA activity between patients on ETN and SB4 (e.g. DAS28 remission: 18.7% in ETN group and 17.6% in SB4 group, p = 0.823; Boolean remission: 11.4% in ETN group and 11.8% in SB4 group, p = 0.926). There were 11 adverse events (AE) in the ETN subgroup (including 3 severe AE: lower respiratory tract infection, enterocolitis and anaphylaxis) and 12 AE in SB4 subgroup (including 4 severe AE: lower respiratory tract infection, vasculitis, anaphylaxis and rash). CONCLUSION: Biosimilar and original etanercept showed similar efficacy and safety after the first 6 months of treatment in RA patients from a national registry, which brings further evidence for biosimilarity in unselected patients in real-world setting.
OBJECTIVE: The study aims to compare the efficacy and safety of biosimilar etanercept (SB4) to original etanercept (ETN) in a real-life national cohort of rheumatoid arthritis (RA). METHODS: Data from RApatients were retrieved electronically from the Romanian Registry of Rheumatic Diseases (RRBR), which contains all patients receiving biologics in the country. RESULTS: The study included 242 patients with efficacy and safety data after 6 months of treatment: 123 (50.8%) with ETN, 119 (49.2%) with SB4. There were no significant differences after 6 months regarding composite scores of RA activity between patients on ETN and SB4 (e.g. DAS28 remission: 18.7% in ETN group and 17.6% in SB4 group, p = 0.823; Boolean remission: 11.4% in ETN group and 11.8% in SB4 group, p = 0.926). There were 11 adverse events (AE) in the ETN subgroup (including 3 severe AE: lower respiratory tract infection, enterocolitis and anaphylaxis) and 12 AE in SB4 subgroup (including 4 severe AE: lower respiratory tract infection, vasculitis, anaphylaxis and rash). CONCLUSION: Biosimilar and original etanercept showed similar efficacy and safety after the first 6 months of treatment in RApatients from a national registry, which brings further evidence for biosimilarity in unselected patients in real-world setting.