Safety and effectiveness of abatacept in juvenile idiopathic arthritis: results from the PRINTO/PRCSG registry.

Autor:	Lovell DJ; Division of Rheumatology, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, USA., Tzaribachev N; PRI Research, Bad Bramstedt, Germany., Henrickson M; Division of Rheumatology, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, USA., Simonini G; IRCCS Meyer Children's Hospital, Rheumatology Unit, ERN-ReCONNECT Center, Florence, Italy., Griffin TA; Atrium Health, Levine Children's Hospital, Charlotte, NC, USA., Alexeeva E; Department of Rheumatology, National Medical Research Center of Children's Health, Moscow, Russia.; Sechenov First Moscow State Medical University, Moscow, Russia., Bohnsack JF; Division of Allergy, Immunology and Pediatric Rheumatology, University of Utah, Salt Lake City, UT, USA., Zeft A; Center for Pediatric Rheumatology and Immunology, Cleveland Clinic, Cleveland, OH, USA., Horneff G; Asklepios Clinic Sankt Augustin, Sankt Augustin, Germany.; Department of Pediatric and Adolescent Medicine, Medical Faculty, University Hospital of Cologne, Cologne, Germany., Vehe RK; Department of Pediatrics, Division of Pediatric Rheumatology, University of Minnesota, Minneapolis, MN, USA., Staņēviča V; Riga Stradins University, Riga, Latvia., Tarvin S; Riley Hospital for Children at Indiana University, Indianapolis, IN, USA., Trachana M; Aristotle University of Thessaloniki, Thessaloníki, Greece., Del Río AQ; University of Oklahoma Health Science Center, Oklahoma City, OK, USA., Huber AM; IWK Health Centre and Dalhousie University, Halifax, NS, Canada., Kietz D; Children's Hospital of Pittsburgh, Pittsburgh, PA, USA., Orbán I; National Institute of Locomotor Diseases and Disabilities, Budapest, Hungary., Dare J; University of Arkansas for Medical Sciences, Little Rock, AR, USA., Foeldvari I; Hamburg Centre for Pediatric and Adolescent Rheumatology, Hamburg, Germany., Quartier P; Necker-Enfants Malades University Hospital, Assistance Publique-Hopitaux de Paris, Paris, France.; Université Paris-Cité, Paris, France., Dominique A; Bristol Myers Squibb, Princeton, NJ, USA., Simon TA; Bristol Myers Squibb, Princeton, NJ, USA., Martini A; Dipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili (DiNOGMI), Università degli Studi di Genova, Genova, Italy., Brunner HI; Division of Rheumatology, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, USA., Ruperto N; IRCCS Istituto Giannina Gaslini, UOSID Centro Trial-PRINTO, Genova, Italy.
Jazyk:	angličtina
Zdroj:	Rheumatology (Oxford, England) [Rheumatology (Oxford)] 2024 Sep 01; Vol. 63 (SI2), pp. SI195-SI206.
DOI:	10.1093/rheumatology/keae025
Abstrakt:	Objective: The aim of this study was to report the interim 5-year safety and effectiveness of abatacept in patients with JIA in the PRINTO/PRCSG registry. Methods: The Abatacept JIA Registry (NCT01357668) is an ongoing observational study of children with JIA receiving abatacept; enrolment started in January 2013. Clinical sites enrolled patients with JIA starting or currently receiving abatacept. Eligible patients were assessed for safety (primary end point) and effectiveness over 10 years. Effectiveness was measured by clinical 10-joint Juvenile Arthritis Disease Activity Score (cJADAS10) in patients with JIA over 5 years. As-observed analysis is presented according to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines. Results: As of 31 March 2020, 587 patients were enrolled; 569 are included in this analysis (including 134 new users) with 1214.6 patient-years of safety data available. Over 5 years, the incidence rate (IR) per 100 patient-years of follow-up of serious adverse events was 5.52 (95% CI: 4.27, 7.01) and of events of special interest was 3.62 (95% CI: 2.63, 4.86), with 18 serious infections [IR 1.48 (95% CI: 0.88, 2.34)]. As early as month 3, 55.9% of patients achieved cJADAS10 low disease activity and inactive disease (20.3%, 72/354 and 35.6%, 126/354, respectively), sustained over 5 years. Disease activity measures improvement over 5 years across JIA categories. Conclusion: Abatacept was well tolerated in patients with JIA, with no new safety signals identified and with well-controlled disease activity, including some patients achieving inactive disease or remission. Trial Registration: Clinicaltrials.gov, NCT01357668. (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Rheumatology.)
Databáze:	MEDLINE
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