Subcutaneous Abatacept in Patients Aged 2–17 Years with Juvenile Idiopathic Arthritis and Inadequate Response to Biologic or Non-Biologic Disease-Modifying Antirheumatic Drugs: Results over 24 Months By Juvenile Idiopathic Arthritis Disease Category

Nicola Ruperto¹, Hermine I. Brunner², Gabriel Vega-Cornejo³, Alberto Berman⁴, Rubén J. Cuttica⁵, Francisco Ávila-Zapata⁶, Michael Henrickson⁷, Daniel J Kingsbury⁸, John F. Bohnsack⁹, Thomas Lutz¹⁰, Nadina E Rubio-Pérez¹¹, Valeria Gerloni¹², Xiaohui Li¹³, Marleen Nys¹⁴, Robert Wong¹³, Alberto Martini¹⁵ and Daniel J Lovell¹⁶, ¹Istituto Giannina Gaslini - Clinica Pediatrica e Reumatologia, Genoa, Italy, ²Division of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, ³Clinica de Reumatología y Enfermedades Autoinmunes (CREA), Hospital México Americano, Guadalajara Jalisco, Mexico, ⁴Centro Médico Privado de Reumatología, Tucumán, Argentina, ⁵Hospital General de Niños Pedro de Elizalde, Buenos Aires, Argentina, ⁶Star Medica Hospital, Merida, Yucatán, Mexico, ⁷Cincinnati Children’s Medical Center, Cincinnati, OH, ⁸Randall Children’s Hospital at Legacy Emanuel, Portland, OR, ⁹University of Utah School of Medicine, Salt Lake City, UT, ¹⁰Pediatric Rheumatology, University Hospital, Center for Pediatric and Adolescent Medicine / Clinic 1, Heidelberg, Germany, ¹¹Universidad Autónoma de Nuevo León, Monterrey Nuevo León, Mexico, ¹²Istituto Gaetano Pini, Milan, Italy, ¹³Bristol-Myers Squibb, Princeton, NJ, ¹⁴Bristol-Myers Squibb, Braine L’Alleud, Belgium, ¹⁵Istituto G. Gaslini Pediatria II Reumatologia and University of Genova, Genova, Italy, ¹⁶Cincinnati Children's Hospital Medical Center, Cincinnati, OH

Meeting: ACR/ARHP Annual Meeting 2018

Keywords: Abatacept, Clinical research, juvenile idiopathic arthritis (JIA), pediatrics and polyarthritis

Session Information

Date: Tuesday, October 23, 2018

Title: Pediatric Rheumatology – Clinical Poster III: Juvenile Idiopathic Arthritis and Uveitis

Session Type: ACR Poster Session C

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

Background/Purpose: The effect of biologic DMARDs on different juvenile idiopathic arthritis (JIA) categories is poorly understood. In patients (pts) with JIA aged 2–17 years (y), SC abatacept (ABA) was effective and well tolerated.¹ Here, effectiveness and HRQoL of SC ABA in pts aged 2–17 y by JIA categories over 24 months (M) are presented. Methods: The design of this single-arm, two-cohort, open-label Phase III study (ClinicalTrials.gov, NCT01844518) has been described.¹ Eligible pts with JIA received SC ABA (50, 87.5 or 125 mg by body-weight tier) weekly for 4M; JIA-ACR criteria 30% improvement (JIA-ACR30) responders at 4M could receive ABA for another 20M. Pre-specified analyses included JIA-ACR30, 50, 70, 90 and 100 responses and inactive disease (modified criteria)² status. Post hoc analyses included Juvenile Arthritis Disease Activity Score on 27 joints (JADAS27-CRP) and proportion of pts with minimal clinically important difference (MCID) in Childhood HAQ-DI (CHAQ-DI; MCID −0.188)³ by JIA category (polyarticular [PA] RF positive (+), PA RF negative (−), extended oligoarthritis [EOA], systemic [SA], psoriatic [PsA], enthesitis-related [ERA], persistent oligoarthritis [POA] and undifferentiated [UA] JIA) and overall safety. Due to low pt numbers, separate data for SA, PsA, ERA, POA and UA were not interpreted; data were pooled for JADAS27-CRP. Results: In 219 treated pts, median (min, max) age was 11.0 (2.0, 17.0) y and disease duration was 1.0 (0.0, 15.0) y. Overall, 19.6% of pts discontinued over 24M with 10.0% discontinuing due to lack of efficacy. Data for SA, PsA, ERA, POA and UA are provided for completeness (Figs 1, 2). In PA RF+, PA RF− and EOA, pts responded early to SC ABA and showed robust JIA-ACR30 responses over time (4M: 80.5–96.6%). More stringent JIA-ACR50 (Fig 1), 70, 90 and 100 responses, inactive disease status and JADAS27-CRP (Fig 2) improved across these categories up to M4 and were sustained to M24; similar results were observed in a JADAS27-CRP pooled analysis of other categories. A trend for improvement in CHAQ-DI MCID was evident across categories (24M: 50.0–61.2%). No new/unexpected AEs were observed; a safety summary per age cohort over 24M was reported previously.¹

Conclusion: In this analysis of pts aged 2–17 yrs with JIA, SC abatacept was effective and well tolerated and improved HRQoL across JIA categories over 24M.

References: 1. Brunner HI, et al. Arthritis Rheumatol 2018; doi: 10.1002/art.40466. 2. Wallace CA, et al. Arthritis Care Res (Hoboken) 2011;63:929–36. 3. Brunner HI, et al. J Rheumatol 2005;32:150–61. Medical writing assistance provided by Katerina Kumpan, PhD (Caudex), funded by Bristol-Myers Squibb.

Disclosure: N. Ruperto, Abbott, AbbVie, Amgen, Biogenidec, Astellas, Alter, AstraZeneca, Baxalta Biosimilars, Boehringer, Bristol-Myers Squibb, CD-Pharma, Celgene, CrescendoBio, EMD Serono, Hoffman-La Roche, Italfarmaco, Janssen, MedImmune, Medac, Novartis, Novo Nordisk, Pfizer, 8,Abbott, Bristol-Myers Squibb,, 2,Rewind Arms, R-Pharma, Sanofi-Aventis, Servier, Sinergie, Takeda, Vertex, UCB Biosciences GmbH, 8; H. I. Brunner, Novartis, Genentech, Pfizer, UCB, Lilly, Janssen, Ablynx, AbbVie, Bristol-Myers Squibb, EMD Serono, Astrazeneca, 5,Genentech and Novartis, 8; G. Vega-Cornejo, None; A. Berman, None; R. J. Cuttica, Abbvie, Bristol-Myers Squibb, Centocor, GSK, Lilly, Novartis, Pfizer, Roche, 5, 8; F. Ávila-Zapata, None; M. Henrickson, None; D. J. Kingsbury, None; J. F. Bohnsack, None; T. Lutz, None; N. E. Rubio-Pérez, None; V. Gerloni, None; X. Li, Bristol-Myers Squibb, 1, 3; M. Nys, Bristol-Myers Squibb, 1, 3; R. Wong, Bristol-Myers Squibb, 1, 3; A. Martini, None; D. J. Lovell, AstraZeneca, Bristol-Myers Squibb, AbbVie, Pfizer, Roche, Novartis, UBC, Forest Research Institute, Takeda, GlaxoSmithKline, Boehringer Ingelheim, Celgene, Janssen, Hoffmann-La Roche, Wyeth Pharma, Amgen, Abbott, 5,Wyeth Pharma, 8.

To cite this abstract in AMA style:

Ruperto N, Brunner HI, Vega-Cornejo G, Berman A, Cuttica RJ, Ávila-Zapata F, Henrickson M, Kingsbury DJ, Bohnsack JF, Lutz T, Rubio-Pérez NE, Gerloni V, Li X, Nys M, Wong R, Martini A, Lovell DJ. Subcutaneous Abatacept in Patients Aged 2–17 Years with Juvenile Idiopathic Arthritis and Inadequate Response to Biologic or Non-Biologic Disease-Modifying Antirheumatic Drugs: Results over 24 Months By Juvenile Idiopathic Arthritis Disease Category [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/subcutaneous-abatacept-in-patients-aged-2-17-years-with-juvenile-idiopathic-arthritis-and-inadequate-response-to-biologic-or-non-biologic-disease-modifying-antirheumatic-drugs-results-over-24/. Accessed .

ACR Meeting Abstracts - https://acrabstracts.org/abstract/subcutaneous-abatacept-in-patients-aged-2-17-years-with-juvenile-idiopathic-arthritis-and-inadequate-response-to-biologic-or-non-biologic-disease-modifying-antirheumatic-drugs-results-over-24/