ASSESSING THE CLINICAL RELEVANCE AND RISK MINIMIZATION OF ANTIBODIES TO BIOLOGICS IN JUVENILE IDIOPATHIC ARTHRITIS (JIA) (ABIRISK) - PRELIMINARY RESULTS
- Autori: Martina Finetti, Gabriella Giancane, Francesca Bagnasco, Pavla Dolezalova, Elena Tsitsami, Maria Trachana, Isabelle Koné-Paut, Despoina Maritsi, Erkan Demirkaya, Giovanni Filocamo, Pierre Quartier, Olga Vougiouka, Rolando Cimaz, Rebecca Nicolai, Helga Sanner, Alina L. Boteanu, Alma N. Olivieri, Elzbieta Smolewska, Elisabeth Solau Gervais, Maria C. Maggio, Valda Stanevicha, Seza Ozen, Michael Hofer, Mihaela Spirchez, Maria G. Magnolia, Veronika Vargova, Denis Mulleman, Florian Deisenhammer, Marc Pallardy, Xavier Mariette, Laura Carenini, Mariangela Rinaldi, Alberto Martini, Nicolino Ruperto
- Anno di pubblicazione: 2018
- Tipologia: Poster pubblicato in rivista
- OA Link: http://hdl.handle.net/10447/369317
Abstract
Introduction: ABIRISK is a project funded by Innovative Medicine Initiative, with the aim to investigate anti-drug antibody (ADA) formation in the treatment of JIA with biologics (BPs). A major limitation to the use of biologics is the development of ADA that may decrease the efficacy of BPs. Objectives: The aim of this project is to improve the capability to predict biologic immunogenicity in JIA patients. Methods: JIA Patients (by ILAR criteria) followed by 24 PRINTO centres in 12 countries were prospectively enrolled and treated with Etanercept, Adalimumab or Tocilizumab. Patient’s data were obtained from Pharmachild, a pharmacovigilance data registry of JIA patients. For each patient detailed demographic and clinical information were reported; biologic samples were collected for PK and ADA detection before therapy start as well as at periodic visits up to month 18 of follow-up. Disease activity was assessed with Juvenile Arthritis Disease Activity Score-10 (JADAS10) and JIA American College of Rheumatology (JIA ACR) criteria. Results: 148 patients were included in the analysis. Five patients were considered twice because treated with 2 different sequential biologics. Demographic and clinical data by therapy are represented in the table. 54% of the patients were treated with Adalimumab. Disease duration was higher in the group receiving Tocilizumab. Disease activity showed a pattern of improvement over time both globally and for each treatment group (Table 1). Anti-adalimumab and antitocilizumab antibodies were detected respectively in 14 and 3 patients, while no patient developed antibodies anti-etanercept. Conclusion: Preliminary data show a global improvement of disease activity during follow-up period. Analysis of the correlation between drug concentration/ADA development and clinical information will help to determine which patients will respond best to which biologic.