Eficacia y seguridad del biosimilar ABP 501 (Adalimumab) comparado con biosimilar CT-P13 (Infliximab) en pacientes adultos con artritis reumatoide. Revisión sistemática

Abstract

Introduction: There is no scientific evidence of comparative studies between biosimilars that demonstrate safety and efficacy, this being relevant for clinicians and insurers to feel supported at the time of acquiring and prescribing this type of molecules. In Colombia, since it is a disease with late diagnosis and that consequently presents a greater risk of severity and complication, contemplating a broader portfolio that guarantees the safety profile, quality, and adequate response to treatment would generate a positive impact on access to this type of therapies. Objectives: To determine whether or not there are differences in efficacy according to control of rheumatoid arthritis activity and safety associated with treatment with Biosimilar ABP 501 (Adalimumab), Biosimilar CT-P13 (Infliximab). Methodology: A systematic review of the literature was carried out that included intervention studies, evaluating the clinical responses according to the ACR20, ACR50, ACR 70, DAS 28 PCR, and safety scales evaluated by the formation of anti-drug antibodies and the presence of any adverse events. Results: For ABP 501 80% of the studied population reached an ACR 20 response, 49% for ACR 50 and 26% for ACR 70 at week 24, for CT-P13 71% of the studied population reached an ACR 20 response , 41% ACR 50 and 20% ACR 70 for week 30, while at week 54 and 102 an ACR 20, ACR 50, ACR70 response of 72%, 42% and 33% was evidenced. And 71.7%, 48% and 24.3% respectively. Anti-drug antibodies ABP 502 Week 24 of 38.3%, week 52 54%. CT-P13, week 30, 54, 102 of 40%, 41% and 41% respectively. Discussion: ABP 501 and CT-P13 showed safety and effectiveness in patients with moderate to severe RA, showing a superior clinical response in those patients treated with ABP 501, in long-term safety CT-P13 presented greater safety by presenting a lower proportion of patients with anti-drug antibodies.