Ab0227 safety and Effectiveness of Adalimumab Reference Product and Biosimilar in Patients With Inflammatory Arthropathies

Abstract

Background:Biological therapy revolutionized the treatment and prognosis of inflammatory arthropathies; however, its high cost has an economic impact on health system and limits its access. Biosimilars are products with similar molecular structure, equivalent efficacy, and comparable safety and immunogenicity, which arise as a necessity to reduce costs. Although, their long-term safety is still to be confirmed1.Objectives:Our aim is to compare the safety and effectiveness between adalimumab reference product and biosimilar in patients with inflammatory arthropathies.Methods:Cohort study of 92 patients with ankylosing spondylitis (AS), rheumatoid arthritis (RA) and psoriatic arthritis (PsA) in a specialized multicenter health institution in Colombia. Ratio of incidence rates (IR) for Adverse Drug Reactions (ADR) and therapeutic failure (TF) is estimated among patients exposed to reference product and biosimilar. 95% confidence interval (CI) for the ratio is also calculated. ADR and TF Incidences in both groups were calculated using the Kaplan Meier curve.Results:Between October 2019 and October of 2020, 92 patients started adalimumab, 64% (n = 59) reference product and 36% (n = 33) biosimilar (18 naive and 15 switch). 41.3% of patients had a diagnosis of RA, 35% AS and 24% PAs. Additionally, 62% were women, with median age of 53 years (Interquartile Range (IQR): 41-62); disease evolution time of 9 years (IQR: 5-20); and treatment time of 0.8 years (IQR: 0.4-1.04). No statistically significant differences were found according to the drug between diagnosis, evolution time, or disease activity. Of all patients 21 presented ADR; 11 events with reference product (IR 0.18 per 100 person-years), and 10 with biosimilar (IR 0.30 per 100 person-years), IR ratio of 0.61 (95%CI 0.26-1.44; p-value = 0.36). From ADR reactions, 35% were infections, 13% skin disorders and 7.4% hepatobiliary disorders; all were classified as non-serious ADR. 5 TF events were presented, 3 with reference product (IR 0.05 per 100 person-years) and 2 with biosimilar (IR 0.06 per 100 person-years); IR ratio of 0.83 (95% CI 0.09-10.04; p value= 1.00). There was no statistically significant between reference product and biosimilar in time of ADR presentation (Log Rank Test 0.74; p= 0.39) or on TF (Log Rank Test 0.55; p= 0.45).Conclusion:Results shown that analyzed biosimilar is a safe product with a similar rate of ADR and without differences in effectiveness evaluated by TF, although 95% CIs are imprecise. This suggests that use of biosimilars in a real-life setting could be safe and with similar effectiveness, which is correlated with other studies carried out in RA and is an appropriate measure to reduce treatment costs in patients with inflammatory arthropathy.References:[1]Cohen, S. B. et al. Long-term safety, efficacy, and immunogenicity of adalimumab biosimilar BI 695501 and adalimumab reference product in patients with moderately-to-severely active rheumatoid arthritis: results from a phase 3b extension study (VOLTAIRE-RAext). Expert Opin. Biol. Ther.19, 1097–1105 (2019).Acknowledgements:To Medicarte for the supportDisclosure of Interests:Wilmer Gerardo Rojas Zuleta Speakers bureau: Pfizer, Jannsen Cilag, Novartis, Bristol Myers Squibb, Biopass, Amgen, Paid instructor for: Pfizer, Jannsen Cilag, Novartis, Bristol Myers Squibb, Biopass, Amgen, Oscar Jair Felipe Díaz Speakers bureau: Amgen, Jannsen Cilag, Bristol Myers Squibb, Novartis, Ely-Lilly, Catalina Orozco Gonzalez: None declared, Jhyld Barbosa Camacho: None declared, Claudia Lucía Giraldo Herrera Speakers bureau: Jannsen Cilag, Bristol Myers Squib, Amgen, Pfizer, Novartis, Roche, Paid instructor for: Jannsen Cilag, Bristol Myers Squib, Amgen, Pfizer, Novartis, Roche, Jesús G Ballesteros Speakers bureau: Bristol Myers, Pfizar, Amgen, Jannsen Cilag, Paid instructor for: Bristol Myers, Pfizar, Amgen, Jannsen Cilag, Jorge Hernando Donado Gómez: None declared, Natalia Duque Zapata: None declared