ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 0243

Effectiveness of Abatacept in Patients with JIA, Classified by Category: Results from the PRCSG/PRINTO JIA Real-World Registry

Daniel Lovell1, Nikolay Tzaribachev2, Tracy Ting3, Ekaterina Alexeeva4, Teresa Giani5, Thomas Griffin6, John Bohnsack7, Andrew Zeft8, Richard Vehe9, Stacey Tarvin10, Gerd Horneff11, Maria Trachana12, Alyssa Dominique13, Lixian Dong13, Tzuyung Douglas Kou13, Robert Wong14, Alberto Martini15, Hermine Brunner3 and Nicolino Ruperto16, 1Cincinnati Children’s Hospital Medical Center, University of Cincinnati, Cincinnati, OH, 2PRI Research, Bad Bramstedt, Germany, 3Cincinnati Children's Hospital Medical Center, Cincinnati, OH, 4Scientific Center of Children Health of RAMS, Moscow, Russia, 5Università di Siena, Siena, Italy, 6Levine Children's Hospital, Charlotte, NC, 7University of Utah, Salt Lake City, UT, 8Cleveland Clinic, Cleveland, OH, 9University of Minnesota, Twin Cities, MN, 10Riley Hospital for Children at Indiana University, Indianapolis, IN, 11Paediatric Rheumatology International Trials Organisation (PRINTO), Sankt Augustin, Germany, 12Aristotle University of Thessaloniki, Thessaloniki, Greece, 13Bristol Myers Squibb, Princeton, NJ, 14Bristol Myers Squibb, Basking Ridge, NJ, 15Paediatric Rheumatology International Trials Organisation (PRINTO), Genoa, Italy, 16IRCCS 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: Long-term treatment with abatacept, a selective T-cell co-stimulation modulator, is effective and well tolerated in patients with JIA.1–4 The objective of this analysis was to provide real-world data on the longitudinal effectiveness of intravenous (IV) and subcutaneous (SC) abatacept in patients with JIA, classified by category, enrolled in the Pediatric Rheumatology Collaborative Study Group (PRCSG)/Paediatric Rheumatology INternational Trials Organisation (PRINTO) registry.

Methods: Following a standardized protocol and data collection process, clinical sites across 23 countries enrolled patients with JIA receiving/initiating IV or SC abatacept with a planned 10-year duration of follow-up. Treatment response was assessed at 3, 6, 9, 12, 24, 36, 48, and 60 months, and was evaluated in this analysis by clinical 10-joint Juvenile Arthritis Disease Activity Score (cJADAS10). The cJADAS10 used validated cut-offs for low disease activity (LDA; ≤3.8), inactive disease (ID; ≤ 1.0)5, and remission (ID for ≥ 6 months). An as-observed analysis is presented.

Results: As of March 31, 2020, 569 patients were enrolled in the PRCSG/PRINTO registry; 454 (79.8%) were female. Mean age at enrollment was 13.1 years, mean time since JIA diagnosis was 66.1 months, and mean abatacept treatment duration was 13.1 months. Half of the patients (n = 289; 50.8%) had polyarticular RF− JIA and a quarter (n = 134; 23.6%) had extended oligoarticular JIA; other enrolled patients had polyarticular RF+ (n = 54; 9.5%), psoriatic (n = 26; 4.6%), enthesitis-related (n = 20; 3.5%), undifferentiated (n = 33; 5.8%), and systemic (n = 13; 2.3%) JIA. The treatment response (patient and parent cJADAS10 score) by JIA category from baseline to month 60 is shown in Table 1. The change in mean cJADAS10 score over time by JIA category (Figure 1) demonstrates a general trend towards reduced score over time. The proportions of patients achieving cJADAS10 LDA and ID by JIA category were generally improved or sustained over time (Figure 2). The low patient numbers in some JIA categories at later time points were mainly due to patients being lost to follow-up or not having reached those time points due to ongoing enrollment. At 60 months, 30% and 20% of patients with polyarticular RF− JIA (most prevalent category) had achieved and maintained cJADAS10 LDA and ID, respectively. Overall, 14.7% of patients achieved cJADAS10 remission by month 12; similar trends (7–22%) were seen in most JIA categories.

Conclusion: A proportion of patients in each JIA category achieved cJADAS10 LDA and ID. As sample size decreased over time in some JIA categories, these data should be interpreted with caution. Clinically important and sustained responses with abatacept, generally up to 36 and 48 months, were seen in all JIA categories.

References: 1. Brunner HI, et al. Arthritis Rheumatol 2018;70:1144–1154. 2. Ruperto N, et al. Lancet 2008;372:383–391. 3. Lovell DJ, et al. Arthritis Rheumatol 2015;67:2759–2770. 4. Ruperto N, et al. Arthritis Rheumatol 2010;62:1792–1802. 5. Consolaro A, et al. Arthritis Care Res (Hoboken) 2014;66:1703–1709.

Medical writing: Fiona Boswell, PhD (Caudex), funded by Bristol Myers Squibb

Disclosures: 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; N. Tzaribachev, None; T. Ting, None; E. Alexeeva, Novartis, 6, Pfizer, 6, Sanofi, 6, MSD, 6, Amgen, 6, Eli Lilly, 6, Roche, 6; T. Giani, None; T. Griffin, None; J. Bohnsack, Pfizer, 12, Site Investigator, Funded Research, Janssen, 12, Site Investigator, Funded Research, Bristol Myers Squibb, 12, Site Investigator, Funded Research, Abbvie, 12, Site Investigator, Funded Research, Roche, 12, Site Investigator, Funded Research, Baxter, 12, Site Investigator, Funded Research, General Electric, 11; A. Zeft, Merck, 11, Opko Health, 11, Lixte Biotechnology, 12, Teva, 11; R. Vehe, None; S. Tarvin, None; G. Horneff, Novartis, 5, 6, Janssen, 5, 6, Roche, 5, Eli-Lilly, 6, Glaxo Smith and Kline, 6, Pfizer, 6, Sobi, 6; M. Trachana, 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; 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. 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:

Lovell D, Tzaribachev N, Ting T, Alexeeva E, Giani T, Griffin T, Bohnsack J, Zeft A, Vehe R, Tarvin S, Horneff G, Trachana M, Dominique A, Dong L, Kou T, Wong R, Martini A, Brunner H, Ruperto N. Effectiveness of Abatacept in Patients with JIA, Classified by Category: Results from the PRCSG/PRINTO JIA Real-World Registry [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/effectiveness-of-abatacept-in-patients-with-jia-classified-by-category-results-from-the-prcsg-printo-jia-real-world-registry/. Accessed .

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