ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2707

Improvement in Patient-Reported Outcomes in Patients Aged 2–5 Years with Polyarticular-Course JIA Treated with Subcutaneous Abatacept: 2-Year Results from a Phase III International Study

Hermine Brunner1, Nikolay Tzaribachev 2, Ingrid Louw 3, Jordi Antón 4, Diego Viola 5, Bernard Lauwerys 6, Rubèn J Cuttica 7, Pierre Quartier 8, Elisabeth Gervais 9, Alexandre Belot 10, Kirsten Minden 11, Thomas Lutz 12, Rolando Cimaz 13, Mahmood M. T. M. Ally 14, Riana van Zyl 15, Inmaculada Calvo Penadés 16, Joe Zhuo 17, Robert Wong 18, Marleen Nys 19, Yedid Elbez 20, Alberto Martini 21, Daniel J. Lovell 22 and Nicolino Ruperto 23, 1Pediatric Rheumatology Collaborative Study Group (PRCSG), Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, 2Pediatric Rheumatology Research Institute, Bad Bramstedt, Germany, 3Panorama Medical Centre, Parow, South Africa, 4Hospital Sant Joan de Déu, Barcelona, Spain, 5CAICI Institute, Rosario City, Santa Fe State, Argentina, 6Rheumatology, Cliniques universitaires Saint-Luc - Université Catholique de Louvain - Institut de Recherche Expérimentale et Clinique (IREC), Brussels, Belgium, Brussels, Belgium, 7Hospital General de Niños Pedro de Elizalde, Buenos Aires, Argentina, 8Necker Hospital, Paris, France, 9CHU de Poitiers, Rheumatology, Poitiers, France, 10Centre Hospitalier Universitaire de Lyon, Lyon, France, 11German Rheumatism Research Center and Charité University Medicine, Berlin, Germany, 12Heidelberg University Hospital, Heidelberg, Germany, 13Meyer Children's Hospital in Florence, Florence, Italy, 14University of Pretoria, Pretoria, South Africa, 15University of the Free State, Bloemfontein, South Africa, 16Hospital Univ. La Fe, Valencia, Spain, 17Bristol-Myers Squibb, Princeton, NJ, 18Bristol-Myers Squibb, Princeton, 19Bristol-Myers Squibb, Braine L’Alleud, Belgium, 20Excelya, Boulogne-Billancourt, France, 21IRCCS Istituto Giannina Gaslini, Università degli Studi di Genova, Genova, Italy, 22Pediatric Rheumatology Collaborative Study Group (PRCSG), Cincinnati Children’s Hospital Medical Center, Cincinnati, 23Paediatric Rheumatology International Trials Organisation (PRINTO), Genoa, Italy

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: , , ,

Session Information

Date: Tuesday, November 12, 2019

Title: Pediatric Rheumatology – ePoster III: Systemic JIA, Fever, & Vasculitis

Session Type: Poster Session (Tuesday)

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

Background/Purpose: Efficacy of SC abatacept in patients with polyarticular-course JIA (pJIA) was shown in a 2-year, open-label, Phase III international study (NCT01844518).1 Pediatric patient-reported outcomes (PROs) were improved with IV and SC abatacept in patients aged 6–17 years.2,3 Here we report the effect of SC abatacept on PROs (Activity Limitation Questionnaire [ALQ], Childhood HAQ-Disability Index [CHAQ-DI], Pain Assessment and Parent Global Assessment of Overall Patient Well-being [PaGA]) in the 2–5-year-old patients with active pJIA over 2 years.

Methods: Patients with pJIA were grouped into two age cohorts (2–5 and 6–17 years) and received weight-tiered SC abatacept (10 to < 25 kg [50 mg], 25 to < 50 kg [87.5 mg], ≥50 kg [125 mg]) weekly for 4 months. JIA-ACR30 criteria responders at Month 4 could receive SC abatacept for another 20 months.1 For the 2–5-year cohort reported here, ALQ (mean [SD] number of days of parental/caregiver missed activity, paid care and missed school [absolute values per month and percentage of days missed per month relative to an assumed average of 20 school days/month]), CHAQ-DI (0–3 scale across 8 domains of disability component), pain (0–100 mm visual analog scale [VAS]) and PaGA (0–100 mm VAS) were evaluated.

Results: Baseline characteristics of the 46 patients with pJIA from the 2–5-year cohort included median (min, max) age of 4.0 (2.0, 5.0) years and median (interquartile range) number of active joints of 7.0 (6.0, 12.0). At baseline, 80.4% of patients received MTX (median dose: 13.3 mg/m2/week) and 21.7% of patients had prior biologic failure. CHAQ-DI, pain and PaGA improved from baseline to Month 24 (Table). Most ALQ components improved from baseline to Month 4 (primary endpoint); these improvements were largely maintained over time to Month 24 (Figure). Relative percentage of days missed from school decreased from 16.2% (baseline) to 2.4% (Month 24, Figure D).

Conclusion: In this analysis of patients with pJIA aged 2–5 years, SC abatacept demonstrated a beneficial effect on PROs including improvement in well-being (PaGA) and reductions in disability (CHAQ-DI), pain and activity limitation (ALQ) over 24 months.

References:

  1. Brunner HI, et al. Arthritis Rheumatol 2018;70:1144–54.
  2. Ruperto N, et al. Arthritis Care Res (Hoboken) 2010;62:1542–51.
  3. Ruperto N, et al. Ann Rheum Dis 2017;76(suppl 2):75.

Professional medical writing assistance was provided by Katerina Kumpan, PhD, at Caudex, funded by Bristol-Myers Squibb.

Disclosure: H. Brunner, ., 2, 5, 8, AbbVie, 5, AstraZeneca, 5, Bayer, 5, Bristol-Myers Squibb, 2, 5, EMD Serono, 5, Genentech, 2, 5, 8, GlaxoSmithKline, 5, Janssen, 5, Lilly, 5, Novartis, 5, 8, Pfizer, 2, 5, R-Pharm, 5, Sanofi, 5, UCB, 5; N. Tzaribachev, None; I. Louw, Amgen, 5, Janssen, 5, Novartis, 5, Pfizer, 5, Pfizer Inc, 5, Roche, 5; J. Antón, AbbVie, 2, Bristol-Myers Squibb, 2, Gebro, 2, GlaxoSmithKline, 2, Novartis, 2, Novimmune, 2, Pfizer, 2, Roche, 2, Sobi, 2; D. Viola, None; B. Lauwerys, None; R. Cuttica, AbbVie, 2, 5, Bristol-Myers Squibb, 2, 5, Lilly, 2, 5, Pfizer, 2, 5, Roche, 2, 5, Sanofi, 2, 5; P. Quartier, AbbVie, 5, 8, Bristol-Myers Squibb, 5, 8, Chugai-Roche, 5, 8, Lilly, 5, Novartis, 5, 8, Novimmune, 5, Pfizer, 5, 8, Sanofi, 9, Swedish Orphan Biovitrum, 5, 8; E. Gervais, None; A. Belot, None; K. Minden, AbbVie, 8, Abbvie, 8, German Arthritis Foundation, 2, GlaxoSmithKline, 5, GSK, 5, Sanofi, 8; T. Lutz, MSD, 8; R. Cimaz, None; M. Ally, None; R. van Zyl, None; I. Calvo Penadés, AbbVie, 2, 5, 8, Bristol-Myers Squibb, 2, Clementia, 2, MSD, 2, Novartis, 2, 5, 8, Pfizer, 2, Roche, 2, 8, Sanofi, 2, SOBI, 8; J. Zhuo, Bristol-Myers Squibb, 1, 3; R. Wong, Bristol-Myers Squibb, 3, 4; M. Nys, Bristol-Myers Squibb, 1, 3; Y. Elbez, None; A. Martini, EMD Serono, 5, 8, EMD-Serono, 5, 8, Janssen, 5, 8, Novartis, 5, 8, Pfizer, 5, 8; D. Lovell, Abbott, 5, 9, AbbVie, 5, 9, Amgen, 5, 9, AstraZeneca, 5, Astra-Zeneca Pharm, 5, Biogen, 5, Boehringer Ingelheim, 5, Boeringher Ingelheim, 5, Bristol-Myers Squibb, 5, 9, Celgene, 5, Forest Research, 9, Forest Research Institute, 5, Genentech, 5, 8, GlaxoSmithKline, 5, Hoffmann-La Roche, 5, 9, Horizon, 5, Jannsen, 5, Janssen, 5, 9, Johnson & Johnson, 5, Novartis, 5, 9, Pfizer, 5, 9, Roche, 5, 9, Takeda, 5, 9, UBC, 5, Wyeth Pharm, 5, 8; N. Ruperto, AbbVie, 5, 8, Abbvie, 8, Ablynx, 5, 8, Ablynx, AbbVie, Astrazeneca-Medimmune, Biogen, Boehringer, Bristol Myers and Squibb, Eli-Lilly, EMD Serono, Glaxo Smith and Kline, 8, AstraZeneca-Medimmune, 8, Astrazeneca-Medimmune, 8, AstraZeneca-MedImmune, 5, 8, Biogen, 5, 8, BMS, Eli-Lilly, GlaxoSmithKline, F Hoffmann-La Roche, Janssen, Novartis, Pfizer, Sobi., 2, Boehringer, 8, Boehringer Ingelheim, 5, 8, Boeringher Ingelheim, 8, Bristol-Myers Squibb, 2, 5, 8, Eli Lilly, 2, 5, 8, Eli-Lilly, 8, EMD Serono, 5, 8, F Hoffmann-La Roche, 2, 5, 8, GlaxoSmithKline, 2, 5, 8, Hoffmann-La Roche, 8, Hoffmann-La Roche, Janssen, Merck, Novartis, Pfizer, R-Pharma, SanofiServier, Sinergie, Sobi and Takeda, 8, Janssen, 2, 5, 8, Merck, 5, 8, Novartis, 2, 5, 8, Pfizer, 2, 5, 8, R-Pharma, 5, 8, SanofiServier, 5, 8, Sinergie, 5, 8, Sobi, 2, 5, 8, 9, Takeda, 5, 8.

To cite this abstract in AMA style:

Brunner H, Tzaribachev N, Louw I, Antón J, Viola D, Lauwerys B, Cuttica R, Quartier P, Gervais E, Belot A, Minden K, Lutz T, Cimaz R, Ally M, van Zyl R, Calvo Penadés I, Zhuo J, Wong R, Nys M, Elbez Y, Martini A, Lovell D, Ruperto N. Improvement in Patient-Reported Outcomes in Patients Aged 2–5 Years with Polyarticular-Course JIA Treated with Subcutaneous Abatacept: 2-Year Results from a Phase III International Study [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/improvement-in-patient-reported-outcomes-in-patients-aged-2-5-years-with-polyarticular-course-jia-treated-with-subcutaneous-abatacept-2-year-results-from-a-phase-iii-international-study/. Accessed .

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