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OP0058 Improvement in patient-reported outcomes in patients with polyarticular-course juvenile idiopathic arthritis and inadequate response to biologic or non-biologic disease-modifying antirheumatic drugs treated with sc abatacept
  1. N Ruperto1,
  2. H Brunner2,
  3. N Tzaribachev1,
  4. G Vega-Cornejo1,
  5. I Louw1,
  6. J Anton1,
  7. D Viola1,
  8. I Foeldvari1,
  9. V Keltsev1,
  10. D Kingsbury2,
  11. C Wouters1,
  12. B Lauwerys1,
  13. E Alemao3,
  14. R Wong3,
  15. M Nys4,
  16. S Banerjee3,
  17. A Martini1,
  18. D Lovell2
  1. 1PRINTO, Istituto Gaslini, Genoa, Italy
  2. 2PRCSG, CHMC, Cincinnati
  3. 3Bristol-Myers Squibb, Princeton, United States
  4. 4Bristol-Myers Squibb, Braine L'Alleud, Belgium

Abstract

Background In patients (pts) with polyarticular-course juvenile idiopathic arthritis (pJIA), SC abatacept (ABA) 125 mg weekly has a similar pharmacokinetic profile, therapeutically equivalent efficacy and comparable safety to IV ABA 10 mg/kg every 4 weeks.1 Although some data on paediatric pt-reported outcomes (PRO) have been published for IV ABA,2 PRO data following treatment with SC ABA have not.

Objectives This analysis examined the effect of SC ABA treatment on PROs (activities of daily living [ADL] limitation questionnaire of parent/caregiver, childhood HAQ [CHAQ]-DI, and parent global assessment of overall pt well-being [PaGA]) in 6–17-year pts with active pJIA in a Phase III trial (NCT01844518).

Methods Pts with pJIA aged 2–17 years with an inadequate response/intolerance to ≥1 DMARD were enrolled in this single-arm, open-label study and received SC ABA weekly for 4 months based on body weight tier (10–<25 kg [50 mg ABA], 25–50 kg [87.5 mg ABA] and >50 kg [125 mg ABA]). JIA-ACR 30 criteria (ACR Pediatric 30) responders at Month 4 could receive ABA for another 20 months. For the 6–17-year cohort reported here, ADL limitation questionnaire of parent/caregiver (mean [SD] number of days [D] of parental/caregiver missed activity, paid care and missed school [absolute values per month and percentage of D missed per month relative to an assumed average of 20 school D/month]); CHAQ-DI (0–3 scale across 8 domains of disability component); and PaGA (0–100 mm visual analogue scale) were evaluated.

Results Baseline characteristics of the 173 pts with pJIA from the 6–17-year cohort were: median (min, max) age, 13.0 (6.0, 17.0) years; median (min, max) number of active joints, 10.0 (2.0, 42.0); 78.6% of pts used MTX (median dose: 11.6 mg/m2/week); and 26.6% were with prior biologic failure. All ADL limitation components improved from baseline to D113 (Month 4); these improvements were largely maintained at D309 (Figure). Relative percentage D missed from school decreased from 15% (D1) to 5.5% (D309, Figure D). CHAQ-DI and PaGA improved from baseline to D309 (Table). Further 2-year data are pending.

Table 1.

CHAQ-DI and PaGA scores over time in the 6–17-year cohort

Conclusions In this analysis of patients with pJIA aged 6–17 years, SC abatacept demonstrated a beneficial effect on PROs including reductions in activity limitation and disability (CHAQ-DI) and improvement in well-being (PaGA) up to D309.

References

  1. Lovell D, et al. Arthritis Rheumatol 2016;68(suppl 10): Abstract 948.

  2. Ruperto N, et al. Arthritis Care Res 2010;62:1542–51.

References

Disclosure of Interest N. Ruperto Grant/research support from: The G. Gaslini Hospital has received contributions from the following industries for the coordination activity of the PRINTO network: Bristol-Myers Squibb, GlaxoSmithKline, Hoffman-La Roche, Novartis, Pfizer,sanofi-aventis, Schwarz Biosciences, Abbott, Francesco Angelini S.P.A., Sobi, Merck Serono, Consultant for: AbbVie, Amgen, Biogen Idec, Alter, AstraZeneca, Baxalta Biosimilars, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Crescendo Bioscience, EMD Serono, Hoffman-La Roche, Italfarmaco, Janssen, MedImmune, Medac, Novartis, Novo Nordisk, Pfizer, sanofi-aventis, Servier, Takeda, UCB Biosciences GmbH, Speakers bureau: AbbVie, Amgen, Biogen Idec, Alter, AstraZeneca, Baxalta Biosimilars, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Crescendo Bioscience, EMD Serono, Hoffman-La Roche, Italfarmaco, Janssen, MedImmune, Medac, Novartis, Novo Nordisk, Pfizer, sanofi-aventis, Servier, Takeda, UCB Biosciences GmbH, H. Brunner: None declared, N. Tzaribachev: None declared, G. Vega-Cornejo: None declared, I. Louw: None declared, J. Anton Grant/research support from: Bristol-Myers Squibb, Novartis, Pfizer, AbbVie, GSK, Sobi, Roche, Alexion, Sanofi, Genzyme, Consultant for: Novartis, Sobi, Roche, Gebro, Pfizer, AbbVie, Alexion, Speakers bureau: Novartis, AbbVie, Pfizer, Sobi, Roche, Gebro, D. Viola: None declared, I. Foeldvari: None declared, V. Keltsev: None declared, D. Kingsbury: None declared, C. Wouters: None declared, B. Lauwerys: None declared, E. Alemao Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, R. Wong Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, M. Nys Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, S. Banerjee Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, A. Martini: None declared, D. Lovell Grant/research support from: National Institutes of Health, NIAMS, Consultant for: AstraZeneca, Bristol-Myers Squibb, AbbVie, Pfizer, Roche, Novartis, UBC, Forest Research Institute, Horizon, Johnson & Johnson, Biogen, Takeda, Genentech, GlaxoSmithKline, Boehringer Ingelheim, Celgene, Janssen, Speakers bureau: Genentech

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