THU0497 MAINTENANCE OF MINIMAL DISEASE ACTIVITY OR INACTIVE DISEASE STATUS AND PATIENT-REPORTED OUTCOMES IN INDIVIDUAL PAEDIATRIC PATIENTS WITH JUVENILE IDIOPATHIC ARTHRITIS TREATED WITH SUBCUTANEOUS ABATACEPT

Background:Maintenance of clinical response over time has been shown in individual patients (pts) with polyarticular-course juvenile idiopathic arthritis (pJIA) treated with SC abatacept (ABA).1It is unknown whether each individual pt with sustained efficacy also consistently maintains the previously reported shorter-term benefits on patient-reported outcomes (PROs)2,3over time.Objectives:Investigate whether combined efficacy and stringent, optimal PRO responses to ABA treatment are maintained by individual pts with pJIA over time.Methods:In this analysis of the intent-to-treat population, pts in two age cohorts (2–5 and 6–17 yrs) who achieved clinical response to weekly SC ABA (10–4) were followed for 2 yrs. Stringent efficacy outcomes (Juvenile Arthritis Disease Activity Score 27 [JADAS27] minimal disease activity [MDA; ≤3.8] and inactive disease [ID; ≤1] status) were combined with optimal PRO endpoints (childhood [C]HAQ-DI=0, Parental Global Assessment [PaGA] ≤1 and Pain visual analogue scale [VAS] Results:219 pts entered the study (46 [21.0%] 2–5 yrs; 173 [79.0%] 6–17 yrs); a subgroup of these pts achieved a clinical response at Mo 4 (Table 1). Many pts who achieved JADAS27 MDA or JADAS27 ID combined with optimal PROs at Mo 4 sustained their response at Mo 13, and at both Mo 13 and Mo 21 in the 2–5-yr and 6–17-yr cohorts (Table 1). Across the cohorts, 33–88% of pts maintained a combined JADAS27 MDA with optimal PRO responses through Mo 21. Where estimable, median times to combined efficacy and specific optimal PRO responses were consistent across the cohorts (Table 2; Figs 1, 2).Table 1.Proportion of pts with combined efficacy and optimal PRO responses at Mos 4, 13 and 21EndpointResponders at Mo 4Responders at Mos 4 and 13*Responders at Mos 4, 13 and 21*2–5 yrs (n=46)6–17 yrs (n=173)2–5 yrs6–17 yrs2–5 yrs6–17 yrsJADAS27 MDA and CHAQ-DI=09 (20)34 (20)5/9 (56)25/34 (74)3/9 (33)16/34 (47)JADAS27 MDA and PaGA ≤18 (17)14 (8)8/8 (100)7/14 (50)7/8 (88)5/14 (36)JADAS27 MDA and Pain VAS 28 (61)70 (41)25/28 (89)58/70 (83)21/28 (75)43/70 (61)JADAS27 ID and CHAQ-DI=07 (15)20 (12)2/7 (29)13/20 (65)1/7 (14)9/20 (45)JADAS27 ID and PaGA ≤16 (13)10 (6)4/6 (67)4/10 (40)4/6 (67)4/10 (40)JADAS27 ID and Pain VAS 17 (37)31 (18)10/17 (59)22/31 (71)8/17 (47)17/31 (55)Data are n (%) or n/N (%). *% based on n of pts who achieved response at Mo 4 (denominator)Table 2.Kaplan–Meier estimates for median (95% CI) times (mos) to achieving combined efficacy and optimal PRO responsesEndpoint2–5 yrs6–17 yrsJADAS27 MDA and CHAQ-DI=021.5 (6.8, NE)21.5 (13.1, 24.4)JADAS27 MDA and PaGA ≤1NE (15.9, NE)24.6 (24.3, NE)JADAS27 MDA and Pain VAS 2.8 (1.9, 2.9)3.8 (3.7, 6.6)JADAS27 ID and CHAQ-DI=0NE (18.4, NE)24.4 (18.7, NE)JADAS27 ID and PaGA ≤1NE (21.3, NE)24.6 (24.3, NE)JADAS27 ID and Pain VAS 3.8 (3.8, 10.3)13.2 (10.3, 15.9)NE=not estimableConclusion:Many individuals with pJIA who achieved stringent efficacy and PRO measures with weekly SC abatacept by Mo 4 sustained them over 2 years. Time to achieve combined efficacy and Pain VAS References:[1]Ruperto N, et al.Ann Rheum Dis2019;78:99–100 (abstr OP0056)[2]Brunner H, et al.Arthritis Rheumatol2019;71(suppl 10):abstr 2707[3]Ruperto N, et al.Ann Rheum Dis2017;76:75 (abstr OP0058)[4]Brunner HI, et al.Arthritis Rheumatol2018;70:1144–54Acknowledgments:Katerina Kumpan, PhD, Caudex; funding: Bristol-Myers SquibbDisclosure of Interests: :Hermine Brunner Consultant of: Hoffman-La Roche, Novartis, Pfizer, Sanofi Aventis, Merck Serono, AbbVie, Amgen, Alter, AstraZeneca, Baxalta Biosimilars, Biogen Idec, Boehringer, Bristol-Myers Squibb, Celgene, EMD Serono, Janssen, MedImmune, Novartis, Pfizer, and UCB Biosciences, Speakers bureau: GSK, Roche, and Novartis, Nikolay Tzaribachev: None declared, Ingrid Louw Consultant of: Amgen, Novartis, Pfizer, Roche (advisory boards), Inmaculada Calvo Grant/research support from: Bristol-Myers Squibb, Clementia, GlaxoSmithKline, Hoffman-La Roche, Merck Sharpe & Dohme, Novartis, Pfizer, Sanofi, Speakers bureau: AbbVie, GlaxoSmithKline, Hoffman-La Roche, Novartis, Francisco Zapata: None declared, Gerd Horneff Grant/research support from: AbbVie, Chugai, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Speakers bureau: AbbVie, Bayer, Chugai, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Ivan Foeldvari Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Chugai, Eli Lilly, Novartis, Pfizer, Daniel Kingsbury: None declared, Maria Gastanaga Grant/research support from: Amgen, Bristol-Myers Squibb, GlaxoSmithKline, Novartis, Pfizer, Roche, Speakers bureau: AbbVie, Roche, Carine Wouters Grant/research support from: GlaxoSmithKline, Pfizer, Roche, Johannes Breedt: None declared, Robert Wong Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, Marleen Nys Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, Margarita Askelson Consultant of: Bristol-Myers Squibb, Joe Zhuo Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, Alberto Martini Consultant of: AbbVie, Eli Lily, EMD Serono, Janssen, Novartis, Pfizer, UCB, Daniel J Lovell Consultant of: Abbott (consulting and PI), AbbVie (PI), Amgen (consultant and DSMC Chairperson), AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb (PI), Celgene, Forest Research (DSMB Chairman), GlaxoSmithKline, Hoffman-La Roche, Janssen (co-PI), Novartis (consultant and PI), Pfizer (consultant and PI), Roche (PI), Takeda, UBC (consultant and PI), Wyeth, Employee of: Cincinnati Children’s Hospital Medical Center, Speakers bureau: Wyeth, Nicolino Ruperto Grant/research support from: Bristol-Myers Squibb, Eli Lily, F Hoffmann-La Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, Sobi (paid to institution), Consultant of: Ablynx, AbbVie, AstraZeneca-Medimmune, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lily, EMD Serono, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Merck, Novartis, Pfizer, R-Pharma, Sanofi, Servier, Sinergie, Sobi, Takeda, Speakers bureau: Ablynx, AbbVie, AstraZeneca-Medimmune, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lily, EMD Serono, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Merck, Novartis, Pfizer, R-Pharma, Sanofi, Servier, Sinergie, Sobi, Takeda