ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 0714

Response to Abatacept in JIA Categories: Results from the PRCSG/PRINTO JIA Abatacept Phase IV Registry

Daniel J Lovell1, Nikolay Tzaribachev2, Esi Morgan3, Gabriele Simonini4, Thomas Griffin5, Ekaterina Alexeeva6, John Bohnsack7, Andrew Zeft8, Gerd Horneff9, Richard Vehe10, Valda Stanevicha11, Stacey Tarvin12, Maria Trachana13, Adam Huber14, Daniel Kietz15, Ilonka Orban16, Jason Dare17, Ivan Foeldvari18, Pierre Quartier19, Alyssa Dominique20, Tzuyung Douglas Kou20, Robert Wong20, Alberto Martini21, Hermine Brunner3 and Nicolino Ruperto22, 1PRCSG, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, 2Pediatric Rheumatology Research Institute, Bad Bramstedt, Germany, 3Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, 4Anna Meyer Children's Hospital, Firenze, Italy, 5Levine Children's Hospital, Charlotte, NC, 6Scientific Center of Children’s Health of RAMS, Moscow, Russia, 7University of Utah and Primary Children's Hospital, Cincinnati, OH, 8Cleveland Clinic, Cleveland, OH, 9Asklepios Clinic Sankt Augustin, Sankt Augustin, Germany, 10University of Minnesota, Minneapolis, MN, 11Riga Stradins University, Riga, Latvia, 12Riley Children’s Health, Indianapolis, IN, 13Aristotle University of Thessaloniki, Thessaloníki, Greece, 14Dalhousie University, Halifax, NS, Canada, 15Children’s Hospital of Pittsburgh, Pittsburgh, PA, 16National Institute of Rheumatology and Physiotherapy, Budapest, Hungary, 17University of Arkansas for Medical Sciences, Little Rock, AR, 18Hamburg Centre for Pediatric and Adolescent Rheumatology, Hamburg, Germany, 19Necker-Enfants Malades University Hospital, Assistance Publique-Hopitaux de Paris, Paris, France, 20Bristol-Myers Squibb Company, Princeton, NJ, 21PRINTO, Istituto Giannina Gaslini, Genova, Italy, 22Istituto Giannina Gaslini, Genova, Italy

Meeting: ACR Convergence 2020

Keywords: , , ,

Session Information

Date: Saturday, November 7, 2020

Title: Pediatric Rheumatology – Clinical Poster II: JIA

Session Type: Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose: Abatacept, a selective T-cell co-stimulation modulator, has been demonstrated to be well tolerated and effective in JIA in 2 Phase III studies.1,2 The ongoing Phase IV Pediatric Rheumatology Collaborative Study Group and Paediatric Rheumatology International Trial Organization (PRCSG/PRINTO) registry aims to provide monitoring data from a real-world setting regarding longitudinal effectiveness and safety of abatacept in JIA. Here we assess the effectiveness of abatacept in JIA categories in patients who enrolled ≤1 month after starting abatacept treatment.

Methods: Using a standardized protocol and data collection process, clinical sites enroll patients with JIA currently receiving/starting IV/SC abatacept and follow them for up to 10 years. Patients are assessed at baseline and at 3, 6, 9, 12, and 24 months. Disease-related quality of life and physical function were quantified using the Juvenile Arthritis Multidimensional Assessment Report scale.3 Proportions of patients with JIA-ACR 30, 50, 70, and 90 level of responses were determined using validated definitions based on 5/6 JIA core set measures (CRP/ESR not included).4 The clinical 10-joint Juvenile Arthritis Disease Activity Score (cJADAS10) used validated cut-offs for low disease (LD) and inactive disease (ID) activity.5 Disease remission was defined as cJADAS10-validated ID for ≥6 months. As-observed analysis is presented.

Results: As of March 31, 2018, 115 patients were included. Of these, 93 (80.9%) were female, the baseline mean (median) age at enrollment was 12.8 (13.1) years, and disease duration was 60.0 (42.1) months. The JIA categories identified were: polyarticular RF–, 52 (45.2%); oligoarticular, 36 (31.3%); polyarticular RF+, 11 (9.6%); enthesitis-related arthritis (ERA), 9 (7.8%); psoriatic and undifferentiated, 3 (2.6%) each; systemic, 1 (< 1%) (Table 1; patient with systemic JIA excluded). The proportions of patients achieving JIA-ACR responses, cJADAS10 LD, cJADAS10 ID and cJADAS10 remission are shown in Figure 1 (patient with systemic JIA excluded).

Conclusion: Abatacept treatment resulted in rapid, clinically important and sustained JIA-ACR responses in all JIA categories with polyarticular or oligoarticular disease course and few achieved cJADAS10 ID and cJADAS10 remission status. Quality of life was also improved across JIA categories over time, as per JAMAR QoL scores. Limitations of the study include a low number of patients with ERA, psoriatic, undifferentiated, and systemic JIA.

References:

  1. Brunner HI, et al. Arthritis Rheumatol 2018;70:1144–1154.
  2. Ruperto N, et al. Lancet 2008;372:383–391.
  3. Solari N, et al. Pediatr Rheumatol Online J 2008;6(Suppl 1):P106.
  4. Giannini EH, et al. Arthritis Rheum 1997;40:1202–1209.
  5. Consolaro A, et al. Arthritis Care Res (Hoboken) 2014;66:1703–1709.

Medical writing: Katerina Kumpan, PhD (Caudex).

Disclosure: D. Lovell, AstraZeneca, 5, Boehringer Ingelheim, 5, Bristol-Myers Squibb, 2, Forest Research, 5, GlaxoSmithKline, 5, Janssen, 2, Novartis, 2, 5, Roche, 2, 5, UBC, 2, 5, AbbVie, 2, Pfizer Inc, 2, 5, Abbott, 5, Amgen, 5, Celgene, 5, Takeda, 5, Wyeth, 5; N. Tzaribachev, None; E. Morgan, None; G. Simonini, Novartis, 5, 8, AbbVie, 5, 8; T. Griffin, None; E. Alexeeva, Novartis, 2, 5, 8, Roche, 2, 5, 8, Pfizer, 2, 5, 8, AbbVie, 2, 5, 8; J. Bohnsack, AbbVie, 2, Bristol-Myers Squibb, 2, Janssen, 2, Pfizer Inc, 2, Roche, 2; A. Zeft, Merck, 4, Teva, 4, Opko Health, 4; G. Horneff, Pfizer, 5, 8, AbbVie, 5, 8, Novartis, 5, 8, Sanofi, 5, 8; R. Vehe, None; V. Stanevicha, None; S. Tarvin, None; M. Trachana, AbbVie, 2, Bristol Myers Squibb, 2, Novartis Hellas, 2, 8, Pfizer, 8, Roche, 8; A. Huber, None; D. Kietz, None; I. Orban, None; J. Dare, AbbVie, 2, Bristol Myers Squibb, 2, Pfizer, 2, Roche, 2, UCB, 2, Centene Corporation, 3, 4; I. Foeldvari, Novartis, 5, Amgen, 5, Pfizer, 5, Bristol Myers Squibb, 5, Sanofi, 5, Eli Lilly, 5; P. Quartier, AbbVie, 1, Bristol-Myers Squibb, 1, Chugai-Roche, 1, Lilly, 1, Novartis, 1, Novimmune, 1, Sanofi, 1, Sobi, 1; A. Dominique, Bristol-Myers Squibb Company, 1, 3, 4; T. Kou, Bristol-Myers Squibb Company, 1, 3; R. Wong, Bristol-Myers Squibb Company, 1, 3, 4; A. Martini, AbbVie, 8, Eli Lilly, 8, EMD Serono, 8, Janssen, 5, 8, Pfizer Inc, 5, 8, Novartis, 5, 8; H. Brunner, Abbott, 5, Amgen, 5, AstraZeneca, 5, Boehringer Ingelheim, 5, Celgene, 5, GlaxoSmithKline, 5, 8, F Hoffman-La Roche, 5, 8, Novartis, 5, 8, Pfizer, 5, Takeda, 5, UBC, 5, Wyeth, 5; N. Ruperto, Ablynx, 5, 8, Astrazeneca-Medimmune, 5, 8, Biogen, 5, 8, Boehringer, 5, 8, Bristol Myers Squibb, 2, 5, 8, 9, Eli Lilly, 2, 5, 8, 9, EMD Serono, 5, 8, GlaxoSmithKline, 2, 5, 8, 9, F Hoffmann-La Roche, 2, 5, 8, 9, Janssen, 2, 5, 8, 9, Merck, 5, 8, Novartis, 2, 5, 8, 9, Pfizer, 2, 5, 8, 9, R-Pharma, 5, 8, Sanofi, 5, 8, Servier, 5, 8, Sinergie, 5, 8, Sobi, 2, 5, 8, 9, AbbVie, 5, 8, Takeda, 5, 8.

To cite this abstract in AMA style:

Lovell D, Tzaribachev N, Morgan E, Simonini G, Griffin T, Alexeeva E, Bohnsack J, Zeft A, Horneff G, Vehe R, Stanevicha V, Tarvin S, Trachana M, Huber A, Kietz D, Orban I, Dare J, Foeldvari I, Quartier P, Dominique A, Kou T, Wong R, Martini A, Brunner H, Ruperto N. Response to Abatacept in JIA Categories: Results from the PRCSG/PRINTO JIA Abatacept Phase IV Registry [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/response-to-abatacept-in-jia-categories-results-from-the-prcsg-printo-jia-abatacept-phase-iv-registry/. Accessed .

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