Longitudinal Effectiveness of Abatacept in JIA: Results From an Ongoing JIA Registry

Daniel Lovell¹, Nicolino Ruperto², Jennifer Huggins³, Ekaterina Alexeeva⁴, Colleen Correll⁵, John Bohnsack⁶, Stacey Tarvin⁷, Gabriele Simonini⁸, Thomas Griffin⁹, Andrew Zeft¹⁰, Gerd Horneff¹¹, Pierre Quartier¹², Iionka Orban¹³, Heather Walters¹⁴, Valda Stanevica¹⁵, Julisa Patel¹⁶, Adam M Huber¹⁷, Margalit Rosenkranz¹⁸, Daniel Kingsbury¹⁹, Rosie Scuccimarri²⁰, Gabriel Vega Cornejo²¹, Joost Swart²², Robert Carroll²³, Hermine Brunner¹, Tina Sherrard²⁴, Chiara Pallotti²⁵, Clara Malattia²⁶ and Alberto Martini²⁶, ¹Cincinnati Children's Hospital Medical Center, Cincinnati, OH, ²Università degli Studi Milano-Bicocca, Milan, Italy, ³Cincinnati Children's Medical Center, Cincinnati, OH, ⁴National Medical Research Center for Children’s Health Federal State Autonomous Institution of the Russian Federation Ministry of Health and I.M. Sechenov First Moscow State Medical University (Sechenovskiy University), Moscow, Russia, ⁵University of Minnesota, Minneapolis, MN, ⁶University of Utah, Salt Lake City, UT, ⁷Riley Hospital for Children at Indiana University, Indianapolis, IN, ⁸Rheumatology Unit, ERN-ReCONNET center, Meyer Children's Hospital IRCCS, Firenze, Firenze, Italy, ⁹Atrium Health Levine Children’s Hospital, Charlotte, NC, ¹⁰Cleveland Clinic, Cleveland, OH, ¹¹Asklepios Klinik, Hamburg, Germany, ¹²Hôpital Necker-Enfants Malades, Paris, France, ¹³Department of Rheumatology and Clinical Immunology of Semmelweis University, Budapest, Hungary, ¹⁴Northwell, New Hyde Park, NY, ¹⁵Riga Stradiņš University, Riga, Latvia, ¹⁶Children’s Hospital of Georgia, Augusta University, Augusta, GA, ¹⁷IWK Grace Health Centre, Halifax, NS, Canada, ¹⁸University of Pittsburgh, Pittsburgh, PA, ¹⁹Randall Children’s Hospital at Legacy Emanuel, Portland, OR, ²⁰McGill University Health Centre, Montreal, QC, Canada, ²¹Clinica de reumatología Guadalajara, Guadalajara, Jalisco, Mexico, ²²Wilhelmina Children's Hospital / UMC Utrecht, Utrecht, Utrecht, Netherlands, ²³Bristol Myers Squibb, London, United Kingdom, ²⁴Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, ²⁵Istituto G. Gaslini, Servizio di Sperimentazioni Cliniche Pediatriche, Genova, Italy, ²⁶Istituto G. Gaslini Pediatria II Reumatologia and University of Genova, Genova, Italy

Meeting: ACR Convergence 2025

Keywords: Biologicals, clinical trial, Juvenile idiopathic arthritis, longitudinal studies, Pediatric rheumatology

Session Information

Date: Sunday, October 26, 2025

Title: (0387–0429) Pediatric Rheumatology – Clinical Poster I

Session Type: Poster Session A

Session Time: 10:30AM-12:30PM

Background/Purpose: Abatacept is a selective T-cell co-stimulation modulator approved for use in JIA. Efficacy and safety of abatacept in patients (pts) with JIA have been demonstrated previously in 2 phase 3 trials1,2 and earlier results from this phase 4 Abatacept JIA Registry (NCT01357668).3 The objective of this analysis was to provide data from a real-world setting for longitudinal safety and effectiveness of intravenous (IV) and subcutaneous (SC) abatacept in pts with JIA.

Methods: By protocol, clinical sites in the Pediatric Rheumatology Collaborative Study Group and Pediatric Rheumatology International Trial Organization enrolled pts meeting the ILAR criteria for 1 of the categories of JIA and currently taking or starting IV or SC abatacept. Planned duration of follow-up (FU) is 10 years; data were collected up to March 31, 2024. Effectiveness was assessed at day of entry into registry (baseline [BL]), 3 and 6 months, and 1, 2, 3, 4, and 5 years. Safety data were collected at each visit.

Results: Of the 740 pts enrolled, 701 were included in the analysis (476 IV, 225 SC); 561/701 (80%) were female. At BL, median age was 13.6 years and 28 (4%) pts were aged 2–5 years; JIA disease duration was 4.5 years. Median abatacept treatment duration was 6.1 months and number of active joints was 1.0 (mean 2.7). JIA categories were systemic (2%), oligo (25%), polyarticular RF-negative (48%), polyarticular RF-positive (10%), psoriatic (5%), enthesitis-related (4%), and undifferentiated (6%). Total abatacept exposure was 1513.2 pt-years with a mean/median duration of abatacept treatment of 25.9/19.7 months. At 1-year FU, pts had low Physician Global Disease Activity, low Juvenile Arthritis Multidimensional Assessment Report scores, and improvement in the number of joints with active arthritis compared with BL (Table 1). A higher percentage of pts achieved clinically inactive disease after 1 year of FU vs BL (46% vs 32%; Table 1). This trend continued despite low numbers of pts with 4 and 5 years of FU. There were 11 serious infections reported (incidence rate [IR] 0.52/100 pt-years of FU, 95% CI: 0.26, 0.92; IR 0.73/100 pt-years on treatment, 95% CI: 0.36, 1.30). There were 17 autoimmune events (IR 0.80/100 pt-years of FU, 95% CI: 0.46, 1.28; IR 1.12/100 pt-years on treatment, 95% CI: 0.65, 1.80). There were 2 adverse event malignancies (n=1 each: medulloblastoma, T-cell lymphoma). No cases of tuberculosis were reported. There was 1 unrelated death (pre-existing cardiac problems).

Conclusion: In this real-world JIA cohort, abatacept was safe and well-tolerated with no new safety risks identified. This longitudinal analysis further supports the persistent effectiveness of abatacept in pts with JIA.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. Rheumatology 2024;63:S1195-S1026.Medical writing: Alexus Shirk, PhD (Caudex, an IPG Health Company), funded by Bristol Myers Squibb.

Table 1. Assessment of disease activity and impact. Data are mean (SE), unless otherwise indicated. a: Visual analog scale 0–10; 0=inactive; b: Range 0–15, 0=no functional limitation; c: Range 0–15, 0=best possible HRQoL. HRQoL, health-related quality of life; JAMAR, Juvenile Arthritis Multidimensional Assessment Report; SE, standard error.

Disclosures: D. Lovell: AbbVie, 2, Bristol-Myers Squibb(BMS), 2, Canadian Arthritis Society, 12, DSMB memberNIH-NIAMS and NIAID, Canadian Arthritis Society, Novartis, 2; N. Ruperto: AbbVie/Abbott, 2, AClaris, 2, AlfaSigma, 2, Amgen, 2, AstraZeneca, 2, Aurinia, 2, Boehringer-Ingelheim, 2, Bristol-Myers Squibb(BMS), 2, Eli Lilly, 2, Galapagos, 2, Genentech, 2, Guidepoint, 2, Idorsia, 2, Janssen, 2, Novartis, 2, Pfizer, 2, Roche, 2, Sanofi, 2, Takeda, 2; J. Huggins: None; E. Alexeeva: Amgen, 12,, 5, AstraZeneca, 6, Biocad, 12,, 5, Eli Lilly, 12,, 5, Generium, 5, 6, Johnson & Johnson, 5, 6, Novartis, 5, 6, Pfizer, 12,, 5, Roche, 6, R-Pharm JSC, 5, 6, Sanofi, 12,, 5, Skopinpharm, 6, Sobi, 6, Swixx Biopharma, 6, UCB, 12,, 5; C. Correll: None; J. Bohnsack: Bristol-Myers Squibb(BMS), 5, Janssen, 5, Pfizer, 5; S. Tarvin: AbbVie/Abbott, 5, American Academy of Pediatrics, 12, Editor, Amgen, 5, Childhood Arthritis Rheumatology Research Alliance, 5, Roche, 5, UCB, 5; G. Simonini: None; T. Griffin: None; A. Zeft: GE Healthcare, 12,, Merck/MSD, 12,, Opko, 12,, Sobi, 1, Teva, 12,; G. Horneff: Janssen, 5, MSD, 5, 6, Novartis, 5, 6, Pfizer, 5, 6, Roche, 5, Sanofi, 6; P. Quartier: AbbVie, 2, 6, Chugai-Roche, 2, 6, Eli Lilly, 2, 6, Novartis, 2, 6, Pfizer, 2, 6, Sanofi, 1, 2, Sobi, 2, 6; I. Orban: None; H. Walters: None; V. Stanevica: None; J. Patel: None; A. Huber: None; M. Rosenkranz: None; D. Kingsbury: None; R. Scuccimarri: Bristol-Myers Squibb(BMS), 5, Sobi, 12, Attendee of sponsored CME; G. Vega Cornejo: None; J. Swart: None; R. Carroll: Bristol-Myers Squibb(BMS), 3; H. Brunner: AbbVie, 2, AstraZeneca-Medimmune, 2, Biogen, 2, Boehringer-Ingelheim, 2, Bristol-Myers Squibb(BMS), 2, Eli Lilly, 2, EMD Serono, 2, F. Hoffmann-La Roche, 2, Genentech, 5, GlaxoSmithKline, 2, Merck, 2, Novartis, 2, Pfizer, 2, 5, Sanofi, 2, UCB, 2; T. Sherrard: None; C. Pallotti: None; C. Malattia: None; A. Martini: Pfizer, 2.

To cite this abstract in AMA style:

Lovell D, Ruperto N, Huggins J, Alexeeva E, Correll C, Bohnsack J, Tarvin S, Simonini G, Griffin T, Zeft A, Horneff G, Quartier P, Orban I, Walters H, Stanevica V, Patel J, Huber A, Rosenkranz M, Kingsbury D, Scuccimarri R, Vega Cornejo G, Swart J, Carroll R, Brunner H, Sherrard T, Pallotti C, Malattia C, Martini A. Longitudinal Effectiveness of Abatacept in JIA: Results From an Ongoing JIA Registry [abstract]. Arthritis Rheumatol. 2025; 77 (suppl 9). https://acrabstracts.org/abstract/longitudinal-effectiveness-of-abatacept-in-jia-results-from-an-ongoing-jia-registry-2/. Accessed .

ACR Meeting Abstracts - https://acrabstracts.org/abstract/longitudinal-effectiveness-of-abatacept-in-jia-results-from-an-ongoing-jia-registry-2/