ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 0245

Long-term Safety and Effectiveness of Abatacept Treatment in Patients with JIA: 5-year Results from the PRCSG/PRINTO JIA Real-World Registry

Hermine Brunner1, Daniel Lovell2, Michael Henrickson1, Ruy Carrassco3, Kirsten Minden4, Lyudmila Grebenkina5, James Nocton6, Ingrid Louw7, Linda Wagner-Weiner8, Gabriel Vega Cornejo9, Sylvia Kamphuis10, Vyacheslav Chasnyk11, Heather Walters12, Simone Appenzeller13, Jordi Anton14, Alyssa Dominique15, Robert Wong16, Lixian Dong15, Tzuyung Douglas Kou15, Alberto Martini17 and Nicolino Ruperto18, 1Cincinnati Children's Hospital Medical Center, Cincinnati, OH, 2Cincinnati Children’s Hospital Medical Center, University of Cincinnati, Cincinnati, OH, 3Presbyterian Health Services, Albuquerque, NM, 4Charite University Hospital Berlin, Berlin, Germany, 5Togliatti City Clinical Hospital №5, Togliatti, Russia, 6Medical College of Wisconsin, Milwaukee, WI, 7Panorama Medical Centre, Cape Town, South Africa, 8University of Chicago (Comer Children's), Chicago, IL, 9Crea de Guadalajara/Hospital México Americano, Guadalajara, Mexico, 10Sophia Children’s Hospital, Erasmus University Medical Center, Rotterdam, Netherlands, 11Saint-Petersburg State Pediatric Medical Academy, Saint Petersburg, Russia, 12Cohen Children's Hospital, New York, NY, 13Hospital das Clínicas da Universidade Estadual de Campinas, Campinas, Brazil, 14Hospital Sant Joan de Deu, University of Barcelona, Barcelona, Spain, 15Bristol Myers Squibb, Princeton, NJ, 16Bristol Myers Squibb, Basking Ridge, NJ, 17Paediatric Rheumatology International Trials Organisation (PRINTO), Genoa, Italy, 18IRCCS Istituto Giannina Gaslini; PRINTO, Clinica Pediatrica e Reumatologia, Genova, Italy

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: Abatacept (ABA) is well tolerated and effective in patients with JIA.1 The Pediatric Rheumatology Collaborative Study Group (PRCSG)/ Paediatric Rheumatology INternational Trials Organisation (PRINTO) registry monitors long-term safety and efficacy of ABA for JIA treatment.2 The objective of this analysis was to assess long-term (5-year) safety and efficacy of ABA in patients with JIA in a real-world setting using data from the PRCSG/PRINTO registry.

Methods: All patients with JIA receiving IV/SC ABA enrolled in the PRCSG/PRINTO registry with ≥ 5 years follow-up were included. Safety and efficacy were assessed at 3, 6, 12, 24, 36, 48, and 60 months. Safety was evaluated by recording serious adverse events (SAEs), events of special interest (ESI; incidence rate [IR]/100 patient-years (py) [95% CI]) and anti-ABA antibody levels. Efficacy outcomes: physician global assessment of disease activity, physician assessment of JIA severity, Juvenile Arthritis Multidimensional Assessment Report (JAMAR) functionality score, overall well-being score, number of active joints, joints with limited range of motion (LOM), clinical 10-joint Juvenile Arthritis Disease Activity Score (cJADAS10), and JIA-ACR30, 50, 70, and 90. cJADAS10 used validated cut-offs for low disease activity (LDA), inactive disease (ID), and remission (ID for ≥ 6 months). As-observed analysis is presented.

Results: Data for 569 patients (1214.61 py of follow-up) were available up to Mar 31, 2020. Baseline characteristics are summarized in Table 1. Over 60 months, IRs/100 py (95% CIs) of patients with ≥ 1 SAE, treatment-related SAE, or ESI were 5.5 (4.3–7.0), 1.3 (0.8–2.1), and 3.6 (2.6–4.9), respectively (Table 2). Overall, 5.9% (12/202) anti-ABA antibody tests were positive. From months 3–60, median physician global disease activity, number of active joints, and joints with LOM were unchanged. The proportion of patients with physician-assessed mild JIA increased from 86% to 96%; corresponding proportions of patients with moderate or severe JIA decreased from 11% to 4% and from 3% to 0%, respectively. Median JAMAR functional scores were 2.0 (patient) and 3.0 (parent) at month 3, and 1.0 each at month 60; a similar pattern was observed for overall well-being scores. Median cJADAS10 scores were 4.0 (patient) and 4.5 (parent) at baseline, and 4.3 (patient) and 3.3 (parent) at month 60. As early as month 3, cJADAS10 LDA and ID were achieved by 37% and 28% of patients, respectively, and sustained over time (Figure 1).

Conclusion: Overall, in patients with JIA, abatacept was well tolerated with no new safety signals. Treatment with abatacept resulted in well-controlled disease activity, with approximately 30% of patients achieving cJADAS10 ID by month 3, which was sustained over 2 years. For the majority of patients, initial improvement on abatacept occurred prior to registry enrollment; therefore the ability to maintain response with ongoing treatment is reflected. These real-world data support the safety and efficacy profile of abatacept as seen in clinical trials.

References:
1. Lovell DJ, et al. Arthritis Rheumatol 2015;67:2759–2770.
2. Lovell DJ, et al. ACR 2020. Abstract 0714.

Medical writing: Rachel Rankin, PhD (Caudex), funded by Bristol Myers Squibb

Disclosures: 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; 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; M. Henrickson, None; R. Carrassco, Novartis, 1; K. Minden, Pfizer, 2, 6, Pfizer, 5, Abbvie, 5, 6, Novartis, 2, 6, Novartis, 5, Sanofi, 2, German Arthritis Foundation, 5, Roche, 5, Chugai, 5, GSK, 5, BMS, 5, Biogen, 5; L. Grebenkina, None; J. Nocton, Bristol Myers Squibb, 5, 12, Site PI for Abatacept Registry research study; I. Louw, None; L. Wagner-Weiner, Bristol-Myers Squibb, 12, PI / researcher at University of Chicago, Pfizer, 12, PI / researcher at University of Chicago, Abbott, 12, PI / researcher at University of Chicago, UCB, 12, PI / researcher at University of Chicago; G. Vega Cornejo, Grin Laboratories, 6, Abbvie, 6, Bayer, 6; S. Kamphuis, GlaxoSmithKline, 7, Aurinia, 2; V. Chasnyk, Pfizer, 5, Novartis, 5, Amgen, 5, Elli Lilly, 5, Bristol Myers Squibb, 5, GlaxoSmithKline, 5, Roche, 5; H. Walters, None; S. Appenzeller, None; J. Anton, Abbvie, 5, Pfizer, 2, GSK, 2, 5, 6, Roche, 5, Sobi, 2, 5, 6, Novartis, 2, 5, 6, Amgen, 5, Lilly, 5, BMS, 5; A. Dominique, Bristol Myers Squibb, 3; R. Wong, Bristol Myers Squibb, 3; L. Dong, Bristol-Myers Squibb, 3; T. Kou, 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; 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.

To cite this abstract in AMA style:

Brunner H, Lovell D, Henrickson M, Carrassco R, Minden K, Grebenkina L, Nocton J, Louw I, Wagner-Weiner L, Vega Cornejo G, Kamphuis S, Chasnyk V, Walters H, Appenzeller S, Anton J, Dominique A, Wong R, Dong L, Kou T, Martini A, Ruperto N. Long-term Safety and Effectiveness of Abatacept Treatment in Patients with JIA: 5-year Results from the PRCSG/PRINTO JIA Real-World Registry [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/long-term-safety-and-effectiveness-of-abatacept-treatment-in-patients-with-jia-5-year-results-from-the-prcsg-printo-jia-real-world-registry/. Accessed .

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