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Bicocca Open Archive
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.
Lovell, D., Tzaribachev, N., Henrickson, M., Simonini, G., Griffin, T., Alexeeva, E., et al. (2024). Safety and effectiveness of abatacept in juvenile idiopathic arthritis: Results from the PRINTO/PRCSG registry. RHEUMATOLOGY, 63(2), 195-206 [10.1093/rheumatology/keae025].
Safety and effectiveness of abatacept in juvenile idiopathic arthritis: Results from the PRINTO/PRCSG registry
Lovell D. J.;Tzaribachev N.;Henrickson M.;Simonini G.;Griffin T. A.;Alexeeva E.;Bohnsack J. F.;Zeft A.;Horneff G.;Vehe R. K.;Stanevica V.;Tarvin S.;Trachana M.;Del Rio A. Q.;Huber A. M.;Kietz D.;Orban I.;Dare J.;Foeldvari I.;Quartier P.;Dominique A.;Simon T. A.;Martini A.;Brunner H. I.;Ruperto N.;Brunner J.;Fernandes T.;Appenzeller S.;Oliveira S.;Terreri M. T.;Tzaribachev N.;Minden K.;Hufnagel M.;Foeldvari I.;Horneff G.;Helling-Bakki A.;Herlin T.;Moreno E.;Anton J.;Del-Castillo P. M. -.;Udaondo C.;Penades I. C.;Quartier P.;Brochard K.;Ramanan A.;Trachana M.;Orban I.;Hashkes P. P.;Ruperto N.;Simonini G.;Olivieri A. N.;Zulian F.;Montin D.;Peroni D.;Stanevicha V.;Cornejo G. V.;Wulffraat N.;Kamphuis S.;Gastanaga M. E. P.;Miraval T.;Oliveira-Ramos F.;Lazar C.;Nikishina I.;Alexeeva E.;Sarychev A.;Chasnyk V.;Grebenkina L.;Suwairi W. M. S.;Koskova E.;Ally M.;Louw I.;Breedt J.;Brunner H.;Ting T.;Taylor J.;Huggins J.;Henrickson M.;Dewitt E. M.;Grom A.;Lovell D.;Schulert G.;Rodriguez-Smith J.;Dare J.;Morris P.;Sukumarain S.;Gitelman M. K.;Miller M.;Curran M.;Alperin R.;Ardalan K.;De Ranieri D.;Hiskey M.;Nolan B.;Chalom B.;Zelf A.;Spalding S.;Costanzo D.;Rennebohm R.;Waugaman B.;Brodus E.;Robinson A.;Panupattanapong S.;Kietz D.;Rosenkranz M.;Cassidy E.;Torok K.;Kingsbury D.;Cartwright V.;Lasky A.;Brown D.;Reiff A.;Shaham B.;Marzan K.;Wagner-Weiner L.;Onel K.;Tesher M.;Edens C.;Moore T.;Syed R.;Pepmueller P.;Tuttle P.;Dalrymple A.;Barhula S.;Feller L.;Horwitz M.;Justice M.;Nocton J.;Olson J.;Williams C.;Versbsy J.;Co D.;Roth-Wojcicki E.;Correll C.;Vehe R.;Binstadt B.;Hobday P.;Brueck D.;Griffin T.;Gillispie-Taylor M.;Vora S.;Tarvin S.;O'Neil K.;Ballinger S.;Blakley M.;Klausmeier T.;Oliver M.;Stevens B.;Rodriguez M.;Go E.;Bohnsack J.;Inman C.;Hersh A.;Stern S.;Woodward A.;Durkee D.;Boulva S. F.;James K.;Treemarcki E.;Goldsmith D.;Lvovich S.;Toib D.;Patel J.;Jerath R.;Sharma N.;Newhall L.;Carrasco R.;Moorthy N.;Boneparth A.;Quintero A.;Graham T.;Spence S.;Davis A.;Gotte A.;Mehta J.;Walters H.;Mian Z.;Parkinson E.;Hui-Yen J.;Steigerwald K.;Guzman M.;Gottlieb B.;Quintero A.;Whitaker C.;Kelly L.;Carrasco R.;Succimarri R.;Hazel E.;Chedeville G.;Compillo S.;Leblance C.;Tucker L.;Cabral D.;Houghton K.;Guzman J.;Morishita K.;Huber A.;Stringer E.;Ramsey S.;Lang B.;Levy D.;Silverman E.;Schmeling H.;Johnson N.;Luca N.;Dhalla M.
2024
Abstract
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.
Lovell, D., Tzaribachev, N., Henrickson, M., Simonini, G., Griffin, T., Alexeeva, E., et al. (2024). Safety and effectiveness of abatacept in juvenile idiopathic arthritis: Results from the PRINTO/PRCSG registry. RHEUMATOLOGY, 63(2), 195-206 [10.1093/rheumatology/keae025].
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10281/524212
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simulazione ASN
Il report seguente simula gli indicatori relativi alla propria produzione scientifica in relazione alle soglie ASN 2023-2025 del proprio SC/SSD. Si ricorda che il superamento dei valori soglia (almeno 2 su 3) è requisito necessario ma non sufficiente al conseguimento dell'abilitazione. La simulazione si basa sui dati IRIS e sugli indicatori bibliometrici alla data indicata e non tiene conto di eventuali periodi di congedo obbligatorio, che in sede di domanda ASN danno diritto a incrementi percentuali dei valori. La simulazione può differire dall'esito di un’eventuale domanda ASN sia per errori di catalogazione e/o dati mancanti in IRIS, sia per la variabilità dei dati bibliometrici nel tempo. Si consideri che Anvur calcola i valori degli indicatori all'ultima data utile per la presentazione delle domande.
La presente simulazione è stata realizzata sulla base delle specifiche raccolte sul tavolo ER del Focus Group IRIS coordinato dall’Università di Modena e Reggio Emilia e delle regole riportate nel DM 598/2018 e allegata Tabella A. Cineca, l’Università di Modena e Reggio Emilia e il Focus Group IRIS non si assumono alcuna responsabilità in merito all’uso che il diretto interessato o terzi faranno della simulazione. Si specifica inoltre che la simulazione contiene calcoli effettuati con dati e algoritmi di pubblico dominio e deve quindi essere considerata come un mero ausilio al calcolo svolgibile manualmente o con strumenti equivalenti.
