Incidence of Antidrug Antibodies in Rheumatoid Arthritis Patients From Argentina Treated With Adalimumab, Etanercept, or Infliximab in a Real-World Setting.

Autor: Maid PJ, Xavier R; Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil., Real RM; Pfizer, Collegeville, PA., Pedersen R; Pfizer, Collegeville, PA., Shen Q; Pfizer, Collegeville, PA., Marshall L; Pfizer, Collegeville, PA., Solano G; Pfizer, San José, Costa Rica., Borlenghi CE; Pfizer, Buenos Aires, Argentina., Hidalgo RP; Clínica Enfermedades Reumatoideas San Juan, San Juan, Argentina.
Jazyk: angličtina
Zdroj: Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases [J Clin Rheumatol] 2018 Jun; Vol. 24 (4), pp. 177-182.
DOI: 10.1097/RHU.0000000000000612
Abstrakt: Background: Biologic agents may induce immune responses that could impact drug action.
Objectives: The aims of this study were to assess antidrug antibodies (ADAs) in patients with rheumatoid arthritis (RA) from Argentina treated with etanercept, adalimumab, or infliximab at a single visit and correlate it with efficacy outcomes.
Methods: In this subset analysis of a noninterventional, multinational, cross-sectional study (NCT01981473), adult patients with RA treated continuously for 6 to 24 months with etanercept, adalimumab, or infliximab were evaluated for ADAs and trough drug concentrations of 2 days or less prior to the next scheduled dose. Efficacy measurements included Disease Activity Score based on a 28-joint count-erythrocyte sedimentation rate, low disease activity, and Health Assessment Questionnaire-Disability Index. Targeted medical history of injection site/infusion reactions, serum sickness, and thromboembolic events were reported.
Results: Baseline demographics, disease characteristics, and duration of treatment of the 119 patients (etanercept: n = 54, adalimumab: n = 52, infliximab: n = 13) were similar across all groups. No etanercept-treated patient tested positive for ADAs compared with 19 (36.5%) of 52 patients and 4 (30.8%) of 13 patients treated with adalimumab and infliximab, respectively. In adalimumab- and infliximab-treated patients, ADA presence correlated negatively with trough drug levels. A greater proportion of ADA-negative patients achieved Health Assessment Questionnaire-Disability Index of 0.5 or less and had better composite efficacy measures compared with ADA-positive patients. The rate of targeted medical events reported was low.
Conclusions: In this subset analysis, RA patients from Argentina treated with adalimumab or infliximab, but not etanercept, tested positive for ADAs. Antidrug antibody-negative patients showed a tendency toward better clinical outcomes compared with ADA-positive patients.
Databáze: MEDLINE