OP0056 MAINTENANCE OF CLINICAL RESPONSE IN INDIVIDUAL CHILDREN WITH JUVENILE IDIOPATHIC ARTHRITIS TREATED WITH SUBCUTANEOUS ABATACEPT. (June 2019)

• Record Type: Journal Article
• Authors: Ruperto, Nicolino; Brunner, Hermine; Tzaribachev, Nikolay; Louw, Ingrid; Calvo, Inmaculada; Zapata, Francisco; Horneff, Gerd; Foeldvari, Ivan; Kingsbury, Daniel; Joos, Rik; Gastanaga, Maria; Wouters, Carine; Breedt, Johannes; Lutz, Thomas; Miraval, Tatiana; Rubio, Nadina; Elbez, Yedid; Nys, Marleen; Wong, Robert; Martini, Alberto; Lovell, Daniel J
• Is Part Of: Annals of the rheumatic diseases. Volume 78(2019)Supplement 2
• Page Start: 99
• Page End: 100
• Publication Date: 2019-06
• Subjects: Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2019-eular.236
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : Background: The efficacy of SC abatacept (ABA) in patients (pts) with polyarticular-course juvenile idiopathic arthritis (pJIA) was shown in a 2-year (yr), Phase III, open-label international study (NCT01844518 ). 1 However, it is unknown whether each individual pt within a treatment group consistently achieves the same efficacy endpoint at all time points. Objectives: To investigate whether ABA efficacy is maintained by individual pts with pJIA over time. Methods: In this subgroup analysis, pts in two age cohorts (2–5 yrs and 6–17 yrs) who achieved clinical response to weekly SC ABA (10 to <25 kg [50 mg], 25 to <50 kg [87.5 mg], ≥50 kg [125 mg]) at Day 113 (time point of primary pharmacokinetics endpoint 1 ) were followed for 2 yrs. Stringent efficacy outcomes selected for analysis included JIA-ACR70, JIA-ACR100, Juvenile Arthritis Disease Activity Score 71 (JADAS71) minimal disease activity (MDA; ≤3.8) and JADAS71 inactive disease (ID; ≤1) rates. Prognostic factors for sustained response were investigated using logistic regression. Results: A total of 219 pts entered the study (46 [21.0%] 2–5 yrs; 173 [79.0%] 6–17 yrs) and a subgroup of these pts achieved a clinical response at Day 113 (Table). Most pts who achieved JIA-ACR70, JIA-ACR100, JADAS71 MDA and JADAS71 ID at Day 113 sustained their response at Day 393 and at Days 393 and 645 in the 2–5-yr and 6–17-yr cohorts (Figure). Across cohorts, more than 75% and 60% of pts maintained a JIA-ACR 70 and JADAS71 MDA response through Day 645, respectively. Prior biologic (b)DMARD use was an important prognostic factor. In pts aged 6–17 yrs, sustained JIA-ACR70 response rate at Days 393 and 645 was 81% (57/70) in pts who did not have prior bDMARDs vs 57% (12/21) in pts who had prior bDMARDs (p=0.0715); sustained JADAS71 MDA response rate was 71% (37/52) vs 37% (7/19; p=0.0320). Prognostic factors for JIA-ACR100 response and JADAS71 ID in pts aged 6–17 yrs and for all outcomes in pts aged 2–5 yrs could not be determined due to low pt numbers. Conclusion: The majority of individuals with pJIA who achieved stringent efficacy endpoints with weekly SC abatacept by Day 113 sustained that clinical endpoint over time. Prior bDMARD use may be a prognostic factor for sustained response over 2 yrs. Reference: [1] Brunner HI, et al. Arthritis Rheumatol2018;70:1144–54. Acknowledgement: Professional medical writing: Stacey Reeber, PhD, Caudex; funding: Bristol-Myers Squibb Disclosure of Interests: Nicolino Ruperto Grant/research support from: The Gaslini Hospital, where NR works as full-time public employee, has received contributions (> 10.000 USD each) from the following industries in the last 3 years: BMS, Eli-Lilly, GlaxoSmithKline, F Hoffmann-La Roche, Janssen, Novartis, Pfizer, Sobi. This funding has been reinvested for the research activities of the hospital in a fully independent manner, without any commitment with third parties., Consultant for: Received honoraria for consultancies or speaker bureaus (< 10.000 USD each) from the following pharmaceutical companies in the past 3 years: Ablynx, AbbVie, Astrazeneca-Medimmune, Biogen, Boehringer, Bristol-Myers Squibb, Eli-Lilly, EMD Serono, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Merck, Novartis, Pfizer, R-Pharma, SanofiServier, Sinergie, Sobi and Takeda., Speakers bureau: Received honoraria for consultancies or speaker bureaus (< 10.000 USD each) from the following pharmaceutical companies in the past 3 years: Ablynx, AbbVie, Astrazeneca-Medimmune, Biogen, Boehringer, Bristol-Myers Squibb, Eli-Lilly, EMD Serono, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Merck, Novartis, Pfizer, R-Pharma, SanofiServier, Sinergie, Sobi and Takeda., Hermine Brunner Grant/research support from: Bristol-Myers Squibb, Pfizer, Consultant for: Pfizer, Bristol-Myers Squibb, Janssen, Novartis, Lilly, Roche, GlaxoSmithKline, Sanofi, Speakers bureau: Novartis, Roche, Nikolay Tzaribachev: None declared, Ingrid Louw Consultant for: Advisory committee: Roche, Novartis, Pfizer, Inmaculada Calvo Grant/research support from: received research grants from Pfizer, Roche, Novartis, Clementia, Sanofi, MSD, BMS and GSK, Consultant for: Advisory boards: Novartis, AbbVie, Speakers bureau: AbbVie, Roche, Novartis, SOBI, Francisco Zapata Grant/research support from: Bristol-Myers Squibb, Pfizer, AstraZeneca, Sanofi, Gilead, Gerd Horneff: None declared, Ivan Foeldvari Consultant for: Bayer, Lilly, Genentech, Bristol-Myers Squibb, Novartis, Daniel Kingsbury Grant/research support from: Clinical trial support from Bristol-Myers Squibb, Rik Joos Grant/research support from: Bristol-Myers Squibb, Celgene, Pfizer, Consultant for: Bristol-Myers Squibb, Celgene, Sandoz, Maria Gastanaga: None declared, Carine Wouters Grant/research support from: Grant/research support to Istituto Gaslini from GlaxoSmithKline immune-inflammation: unrestricted grant to study Blau syndrome; Roche: unrestricted research grant; Pfizer: grant for psychological care of patients with JIA, Grant/research support from: GSK, Roche, Pfizer, Johannes Breedt: None declared, Thomas Lutz Speakers bureau: MSD, Tatiana Miraval: None declared, Nadina Rubio: None declared, Yedid Elbez Employee of: Employee of Excelya which received funding from Bristol-Myers Squibb as contract research organization., Marleen Nys Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, Robert Wong Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, Alberto Martini Consultant for: I do not have any conflict of interest to declare since starting from 1 March 2016 I became the Scientific Director of the G. Gaslini Hospital; therefore, my role does not allow me to render private consultancies resulting in personal income. I perform consultancy activities on behalf of the Gaslini Institute for the companies listed below: AbbVie, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, EMD Serono, Janssen, Novartis, Pfizer, R-Pharm. The money received for these activities are directly transferred to the Gaslini Institute's bank account. Before March 2016, I was the head of the Pediatric Rheumatology Department at the G. Gaslini Hospital, where the PRINTO Coordinating Centre is located. For the coordination activity of the PRINTO network, the Gaslini Hospital received contributions from the industries listed in this section. This money has been reinvested for the research activities of the hospital in fully independent manners besides any commitment with third parties., Daniel J Lovell Consultant for: Consulting fees and/or honoraria from Astra Zeneca, Wyeth Pharma, Amgen, Abbott, Pfizer, F. Hoffmann-La Roche, Novartis, UBC, Takeda, GSK, Boehringer, and Celgene