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

Daniel J Lovell; Nikolay Tzaribachev; Michael Henrickson; Gabriele Simonini; Thomas A Griffin; Ekaterina Alexeeva; John F Bohnsack; Andrew Zeft; Gerd Horneff; Richard K Vehe; Valda Staņēviča; Stacey Tarvin; Maria Trachana; Ana Quintero Del Río; Adam M Huber; Daniel Kietz; Ilonka Orbán; Jason Dare; Ivan Foeldvari; Pierre Quartier; Alyssa Dominique; Teresa A Simon; Alberto Martini; Hermine I Brunner; Nicolino Ruperto

doi:10.1093/rheumatology/keae025

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

Daniel J Lovell (Corresponding Author), Nikolay Tzaribachev, Michael Henrickson, Gabriele Simonini, Thomas A Griffin, Ekaterina Alexeeva, John F Bohnsack, Andrew Zeft, Gerd Horneff, Richard K Vehe, Valda Staņēviča, Stacey Tarvin, Maria Trachana, Ana Quintero Del Río, Adam M Huber, Daniel Kietz, Ilonka Orbán, Jason Dare, Ivan Foeldvari, Pierre QuartierAlyssa Dominique, Teresa A Simon, Alberto Martini, Hermine I Brunner, Nicolino Ruperto

Rīga Stradiņš University

Research output: Contribution to journal › Article › peer-review

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.

TRIAL REGISTRATION: Clinicaltrials.gov, NCT01357668.

Original language	English
Pages (from-to)	SI195-SI206
Journal	Rheumatology
Volume	63
Issue number	SI2
DOIs	https://doi.org/10.1093/rheumatology/keae025
Publication status	Published - 1 Sept 2024

Keywords*

adolescent rheumatology
biological therapies
DMARDs
juvenile idiopathic arthritis
paediatric/juvenile rheumatology

Field of Science*

3.2 Clinical medicine

Publication Type*

1.1. Scientific article indexed in Web of Science and/or Scopus database

Access to Document

10.1093/rheumatology/keae025Licence: CC BY-NC

Safety and effectiveness of abatacept in juvenile idiopathicFinal published version, 617 KBLicence: CC BY-NC

Cite this

Lovell, D. J., Tzaribachev, N., Henrickson, M., Simonini, G., Griffin, T. A., Alexeeva, E., Bohnsack, J. F., Zeft, A., Horneff, G., Vehe, R. K., Staņēviča, V., Tarvin, S., Trachana, M., Del Río, A. Q., Huber, A. M., Kietz, D., Orbán, I., Dare, J., Foeldvari, I., ... Ruperto, N. (2024). Safety and effectiveness of abatacept in juvenile idiopathic arthritis: results from the PRINTO/PRCSG registry. Rheumatology, 63(SI2), SI195-SI206. https://doi.org/10.1093/rheumatology/keae025

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title = "Safety and effectiveness of abatacept in juvenile idiopathic arthritis: results from the PRINTO/PRCSG registry",

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.TRIAL REGISTRATION: Clinicaltrials.gov, NCT01357668.",

keywords = "adolescent rheumatology, biological therapies, DMARDs, juvenile idiopathic arthritis, paediatric/juvenile rheumatology",

author = "Lovell, {Daniel J} and Nikolay Tzaribachev and Michael Henrickson and Gabriele Simonini and Griffin, {Thomas A} and Ekaterina Alexeeva and Bohnsack, {John F} and Andrew Zeft and Gerd Horneff and Vehe, {Richard K} and Valda Staņēvi{\v c}a and Stacey Tarvin and Maria Trachana and {Del R{\'i}o}, {Ana Quintero} and Huber, {Adam M} and Daniel Kietz and Ilonka Orb{\'a}n and Jason Dare and Ivan Foeldvari and Pierre Quartier and Alyssa Dominique and Simon, {Teresa A} and Alberto Martini and Brunner, {Hermine I} and Nicolino Ruperto",

note = "{\textcopyright} The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: [email protected].",

year = "2024",

month = sep,

day = "1",

doi = "10.1093/rheumatology/keae025",

language = "English",

volume = "63",

pages = "SI195--SI206",

journal = "Rheumatology",

issn = "1462-0324",

publisher = "Oxford University Press",

number = "SI2",

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Lovell, DJ, Tzaribachev, N, Henrickson, M, Simonini, G, Griffin, TA, Alexeeva, E, Bohnsack, JF, Zeft, A, Horneff, G, Vehe, RK, Staņēviča, V, Tarvin, S, Trachana, M, Del Río, AQ, Huber, AM, Kietz, D, Orbán, I, Dare, J, Foeldvari, I, Quartier, P, Dominique, A, Simon, TA, Martini, A, Brunner, HI & Ruperto, N 2024, 'Safety and effectiveness of abatacept in juvenile idiopathic arthritis: results from the PRINTO/PRCSG registry', Rheumatology, vol. 63, no. SI2, pp. SI195-SI206. https://doi.org/10.1093/rheumatology/keae025

TY - JOUR

T1 - Safety and effectiveness of abatacept in juvenile idiopathic arthritis

T2 - results from the PRINTO/PRCSG registry

AU - Lovell, Daniel J

AU - Tzaribachev, Nikolay

AU - Henrickson, Michael

AU - Simonini, Gabriele

AU - Griffin, Thomas A

AU - Alexeeva, Ekaterina

AU - Bohnsack, John F

AU - Zeft, Andrew

AU - Horneff, Gerd

AU - Vehe, Richard K

AU - Staņēviča, Valda

AU - Tarvin, Stacey

AU - Trachana, Maria

AU - Del Río, Ana Quintero

AU - Huber, Adam M

AU - Kietz, Daniel

AU - Orbán, Ilonka

AU - Dare, Jason

AU - Foeldvari, Ivan

AU - Quartier, Pierre

AU - Dominique, Alyssa

AU - Simon, Teresa A

AU - Martini, Alberto

AU - Brunner, Hermine I

AU - Ruperto, Nicolino

PY - 2024/9/1

Y1 - 2024/9/1

N2 - 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.

AB - 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.

KW - adolescent rheumatology

KW - biological therapies

KW - DMARDs

KW - juvenile idiopathic arthritis

KW - paediatric/juvenile rheumatology

U2 - 10.1093/rheumatology/keae025

DO - 10.1093/rheumatology/keae025

M3 - Article

C2 - 38243722

SN - 1462-0324

VL - 63

SP - SI195-SI206

JO - Rheumatology

JF - Rheumatology

IS - SI2

ER -

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

Abstract

Keywords*

Field of Science*

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