ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 0247

Three-year Effectiveness in Patients with JIA Initiating Abatacept: Results from the PRCSG/PRINTO JIA Real-World Registry

Nicolino Ruperto1, Hermine Brunner2, Nikolay Tzaribachev3, Ilonka Orbán4, Valda Staņēviča5, Ana Quintero del Rio6, Pierre Quartier7, Adam Huber8, Dan Kietz9, Jason Dare10, Daniel Kingsbury11, T. Brent Graham12, Ivan Foeldvari13, Julisa Patel14, Alyssa Dominique15, Lixian Dong15, Tzuyung Douglas Kou15, Robert Wong16, Alberto Martini17 and Daniel Lovell18, 1IRCCS Istituto Giannina Gaslini; PRINTO, Clinica Pediatrica e Reumatologia, Genova, Italy, 2Cincinnati Children's Hospital Medical Center, Cincinnati, OH, 3PRI Research, Bad Bramstedt, Germany, 4National Institute of Rheumatology and Physiotherapy, Budapest, Hungary, 5Riga Stradins University, Riga, Latvia, 6Dr. Ramon Ruiz Arnau University Hospital, Bayamόn, PR, 7Necker-Enfants Malades University Hospital, Assistance Publique-Hopitaux de Paris, Paris, France, 8Dalhousie University, Halifax, NS, Canada, 9Children’s Hospital of Pittsburgh, Pittsburg, PA, 10University of Arkansas for Medical Sciences, Little Rock, AR, 11Randall Children's Hospital at Legacy Emanuel, Portland, OR, 12Vanderbilt University Medical Center, Nashville, TN, 13Hamburg Centre for Pediatric and Adolescent Rheumatology, Hamburg, Germany, 14Children’s Hospital of Georgia, Augusta University Medical Center, Augusta, GA, 15Bristol Myers Squibb, Princeton, NJ, 16Bristol Myers Squibb, Basking Ridge, NJ, 17Paediatric Rheumatology International Trials Organisation (PRINTO), Genoa, Italy, 18Cincinnati Children’s Hospital Medical Center, University of Cincinnati, Cincinnati, OH

Meeting: ACR Convergence 2021

Keywords:

Session Information

Date: Saturday, November 6, 2021

Title: Pediatric Rheumatology – Clinical Poster I: JIA (0241–0265)

Session Type: Poster Session A

Session Time: 8:30AM-10:30AM

Background/Purpose: The ongoing phase 4 Pediatric Rheumatology Collaborative Study Group (PRCSG)/Paediatric Rheumatology INternational Trials Organisation (PRINTO) registry was designed to assess the long-term (up to 10 years) safety and efficacy of abatacept in pediatric patients with all JIA subtypes in a real-world setting.1 The objective of this analysis was to assess the real-world effectiveness of intravenous and subcutaneous abatacept over 3 years in patients with JIA who initiated treatment with abatacept within 1 month of enrollment in the PRCSG/PRINTO registry.

Methods: Using a standardized protocol and data collection process, clinical sites enrolled patients with JIA receiving/starting abatacept. For the current analysis, all patients with JIA who initiated abatacept within 1 month of enrollment in the PRCSG/PRINTO registry were included. Effectiveness was assessed at baseline and at 3, 6, 9, 12, 24, and 36 months. Outcomes include physician global assessment of disease activity, overall well-being score, number of active joints and joints with limited range of motion, the clinical 10-joint Juvenile Arthritis Disease Activity Score (cJADAS10), and JIA-ACR30, 50, 70, and 90. The cJADAS10 used validated cut-offs for low disease activity (LDA; ≤ 3.8), inactive disease (ID; ≤ 1.0), and remission (ID for ≥ 6 months). An as-observed analysis is presented.

Results: As of March 31, 2020, 134 patients who initiated abatacept within 1 month of enrollment in the PRCSG/PRINTO registry were included in this analysis. Of these, 110 (82.1%) were female, the baseline mean (median) age at enrollment was 12.8 (13.1) years, the time since JIA diagnosis was 60.2 (45.6) months, and the time on abatacept treatment at baseline was 0.28 (0.03) months. Median cJADAS10 scores decreased from month 3 to month 36 and the proportions of patients achieving cJADAS10 LDA and cJADAS10 ID increased over time (Figure 1). JIA-ACR 30, 50, 70, and 90 responses were seen as early as month 3 and were sustained over time to month 24; the percentage of patients achieving these responses at month 36 was influenced by the relatively low number of patients (due to ongoing enrollment and loss to follow-up) available for the analysis (Table 1). In addition, physician global assessment of disease activity and number of active joints decreased over time (Table 1).

Conclusion: In patients with JIA who initiated abatacept within 1 month of joining the PRCSG/PRINTO registry, there were rapid, clinically relevant responses, such as improvement in cJADAS10 scores, number of active joints, number of joints with a limited range of motion and overall well-being. These improvements were sustained over 24 months.

Reference:
1. Lovell DJ, et al. ACR 2020. Abstract 0714.
Medical writing: Claire Line, PhD (Caudex), funded by Bristol Myers Squibb

Disclosures: N. Ruperto, Ablynx, 2, 6, Amgen, 2, 6, Astrazeneca-Medimmune, 2, 6, Aurinia, 2, 6, Bayer, 2, 6, Bristol Myers and Squibb, 2, 6, 12, The IRCCS IGG, where NR works as full-time public employee has received contributions, this has been reinvested for research activities of the hospital in a fully independent manner, without any commitment with third parties, Cambridge Healthcare Research (CHR, 2, 6, Celgene, 2, 6, Domain therapeutic, 2, 6, Eli-Lilly, 2, 6, 12, The IRCCS IGG, where NR works as full-time public employee has received contributions, this has been reinvested for research activities of the hospital in a fully independent manner, without any commitment with third parties, EMD Serono, 2, 6, Glaxo Smith and Kline, 2, 6, Idorsia, 2, 6, Janssen, 2, 6, Novartis, 2, 6, 12, The IRCCS IGG, where NR works as full-time public employee has received contributions, this has been reinvested for research activities of the hospital in a fully independent manner, without any commitment with third parties, Pfizer, 2, 6, 12, The IRCCS IGG, where NR works as full-time public employee has received contributions, this has been reinvested for research activities of the hospital in a fully independent manner, without any commitment with third parties, Sobi, 2, 6, 12, The IRCCS IGG, where NR works as full-time public employee has received contributions, this has been reinvested for research activities of the hospital in a fully independent manner, without any commitment with third parties, UCB, 2, 6, F Hoffmann-La Roche, 12, The IRCCS IGG, where NR works as full-time public employee has received contributions, this has been reinvested for research activities of the hospital in a fully independent manner, without any commitment with third parties; H. Brunner, Novartis, 6, Pfizer, 6, Roche, 6, GlaxoSmithKline, 6, Abbvie, 12, Contributions to employer (Cincinatti Children's Hospital) *NOTE: This funding has been reinvested for the research activities of the hospital in a fully independent manner without any commitment to third parties, Biogen, 12, Contributions to employer (Cincinatti Children's Hospital) *NOTE: This funding has been reinvested for the research activities of the hospital in a fully independent manner without any commitment to third parties, AstraZeneca-Mediimmune, 12, Contributions to employer (Cincinatti Children's Hospital) *NOTE: This funding has been reinvested for the research activities of the hospital in a fully independent manner without any commitment to third parties, Boehringer, 12, Contributions to employer (Cincinatti Children's Hospital) *NOTE: This funding has been reinvested for the research activities of the hospital in a fully independent manner without any commitment to third parties, BMS, 12, Contributions to employer (Cincinatti Children's Hospital) *NOTE: This funding has been reinvested for the research activities of the hospital in a fully independent manner without any commitment to third parties, Celgene, 12, Contributions to employer (Cincinatti Children's Hospital) *NOTE: This funding has been reinvested for the research activities of the hospital in a fully independent manner without any commitment to third parties, Eli Lilly, 12, Contributions to employer (Cincinatti Children's Hospital) *NOTE: This funding has been reinvested for the research activities of the hospital in a fully independent manner without any commitment to third parties, EMD Serono, 12, Contributions to employer (Cincinatti Children's Hospital) *NOTE: This funding has been reinvested for the research activities of the hospital in a fully independent manner without any commitment to third parties, Idorsia, 12, Contributions to employer (Cincinatti Children's Hospital) *NOTE: This funding has been reinvested for the research activities of the hospital in a fully independent manner without any commitment to third parties, Cerocor, 12, Contributions to employer (Cincinatti Children's Hospital) *NOTE: This funding has been reinvested for the research activities of the hospital in a fully independent manner without any commitment to third parties, F.Hoffman-La Roche, 12, Contributions to employer (Cincinatti Children's Hospital) *NOTE: This funding has been reinvested for the research activities of the hospital in a fully independent manner without any commitment to third parties, Merck, 12, Contributions to employer (Cincinatti Children's Hospital) *NOTE: This funding has been reinvested for the research activities of the hospital in a fully independent manner without any commitment to third parties, Novartis, 12, Contributions to employer (Cincinatti Children's Hospital) *NOTE: This funding has been reinvested for the research activities of the hospital in a fully independent manner without any commitment to third parties, Sanofi, 12, Contributions to employer (Cincinatti Children's Hospital) *NOTE: This funding has been reinvested for the research activities of the hospital in a fully independent manner without any commitment to third parties, Aurina, 2; N. Tzaribachev, None; I. Orbán, None; V. Staņēviča, Sandoz, 2, Abbvie, 2, Roche, 2; A. Quintero del Rio, Abbott, 2; P. Quartier, Abbie, 2, 6, BMS, 2, 6, Chugai-Roche, 2, 6, Lilly, 2, Novartis, 2, 6, Novimmune, 2, Sanofi, 1, 12, Member of a data safety monitoring board, Swedish Orphan Biovitrum, 2, 6; A. Huber, None; D. Kietz, None; J. Dare, Abbvie, 5, Bristol-Myers Squibb, 5, Pfizer, 5, Roche, 5, UCB, 5, Centene Corporation, 3, 11; D. Kingsbury, Pfizer, 2; T. Graham, None; I. Foeldvari, Novartis, 1, Hexal, 1, Pfizer, 1, Lilly, 1, Gilead, 1, Thermo Fischer, 1; J. Patel, None; A. Dominique, Bristol Myers Squibb, 3; L. Dong, Bristol-Myers Squibb, 3; T. Kou, Bristol Myers Squibb, 3; R. Wong, Bristol Myers Squibb, 3; A. Martini, Aurinia, 2, 6, Bristol Myers and Squibb, 2, 6, Eli-Lilly, 2, 6, EMD Serono, 2, 6, Janssen, 2, 6, Pfizer, 2, 6, Roche, 2, 6; D. Lovell, Bristol Myers Squibb, 12, PI, Abatacept, Juvenile Idiopathic Arthritis, AstraZeneca Pharm, 2, Boehringer Ingleheim, 2, GSK, 2, Hoffman LaRoche, 2, Janssen, 12, Co-PI of overall studies of IV and sub-Q Golimumab in JIA, NIH / NIAMS, 12, R01 AR074098-01A1, NIH / NICHD, 12, NIH / R01 HD 089928-01A1, Novartis, 2, Pfizer, 3, Roche, 12, PI, Tociluzumab, Juvenile Idiopathic Arthritis, UBC, 2.

To cite this abstract in AMA style:

Ruperto N, Brunner H, Tzaribachev N, Orbán I, Staņēviča V, Quintero del Rio A, Quartier P, Huber A, Kietz D, Dare J, Kingsbury D, Graham T, Foeldvari I, Patel J, Dominique A, Dong L, Kou T, Wong R, Martini A, Lovell D. Three-year Effectiveness in Patients with JIA Initiating Abatacept: Results from the PRCSG/PRINTO JIA Real-World Registry [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/three-year-effectiveness-in-patients-with-jia-initiating-abatacept-results-from-the-prcsg-printo-jia-real-world-registry/. Accessed .

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