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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | SI195-SI206 |
| Journal | Rheumatology (United Kingdom) |
| Volume | 63 |
| Issue number | SI2 |
| DOIs | |
| State | Published - Sep 1 2024 |
Funding
We thank the patients and all the investigators who participated in the study. We are grateful to Lisa Clark, Jennifer O'Shaughnessy, and Najima Mwase from PRCSG and Chiara Pallotti, Silvia Scala, Luca Villa, and all research assistants from PRINTO and PRCSG who have overseen the collection of data, merger of databases, and analysis of the data. We would also like to thank the PRCSG and PRINTO staff at the coordinating centres for their dedication and support in managing the data and data analysis. We are indebted to them for their research regulatory support. A full list of PRCSG and PRINTO investigators can be found in Supplementary Data S1 and S2, available at Rheumatology online. We are also grateful to Robert Wong and Doug Kou, both of Bristol Myers Squibb, for helpful discussions. We thank Ngoc-Bao Duong from the Clinical Research Unit at the Necker Hospital, Paris, France. Professional medical writing and editorial assistance was provided by Katerina Kumpan, PhD, and Candice Dcosta, MSc, at Caudex, and was funded by Bristol Myers Squibb under the supervision of PRINTO and PRCSG officers (D.J.L., H.I.B., A.M. and N.R.).
Keywords
- DMARDs
- adolescent rheumatology
- biologic therapies
- juvenile idiopathic arthritis
- paediatric/juvenile rheumatology
ASJC Scopus subject areas
- Rheumatology
- Pharmacology (medical)