ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 0713

Longitudinal Effectiveness of Abatacept in JIA: Results from an Ongoing JIA Registry

Daniel J Lovell1, Hermine Brunner2, Nikolay Tzaribachev3, Esi Morgan2, Gabriele Simonini4, Thomas Griffin5, Ekaterina Alexeeva6, John Bohnsack7, Andrew Zeft8, Gerd Horneff9, Richard Vehe10, Valda Stanevicha11, Stacey Tarvin12, Maria Trachana13, Adam Huber14, Ilonka Orban15, Jason Dare16, Ivan Foeldvari17, Pierre Quartier18, Alyssa Dominique19, Tzuyung Douglas Kou19, Robert Wong19, Alberto Martini20 and Nicolino Ruperto20, 1PRCSG, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, 2Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, 3Pediatric Rheumatology Research Institute, Bad Bramstedt, Germany, 4Anna Meyer Children's Hospital, Firenze, Italy, 5Levine Children's Hospital, Charlotte, NC, 6Scientific Center of Children’s Health of RAMS, Moscow, Russia, 7University of Utah and Primary Children's Hospital, Cincinnati, OH, 8Cleveland Clinic, Cleveland, OH, 9Asklepios Clinic Sankt Augustin, Sankt Augustin, Germany, 10University of Minnesota, Minneapolis, MN, 11Riga Stradins University, Riga, Latvia, 12Riley Children’s Health, Indianapolis, IN, 13Aristotle University of Thessaloniki, Thessaloníki, Greece, 14Dalhousie University, Halifax, NS, Canada, 15National Institute of Rheumatology and Physiotherapy, Budapest, Hungary, 16University of Arkansas for Medical Sciences, Little Rock, AR, 17Hamburg Centre for Pediatric and Adolescent Rheumatology, Hamburg, Germany, 18Necker-Enfants Malades University Hospital, Assistance Publique-Hopitaux de Paris, Paris, France, 19Bristol-Myers Squibb Company, Princeton, NJ, 20PRINTO, Istituto Giannina Gaslini, Genova, Italy

Meeting: ACR Convergence 2020

Keywords: , , , ,

Session Information

Date: Saturday, November 7, 2020

Title: Pediatric Rheumatology – Clinical Poster II: JIA

Session Type: Poster Session B

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

Background/Purpose: Abatacept is a selective T-cell co-stimulation modulator approved for use in JIA. Efficacy and safety of abatacept in patients with JIA has been demonstrated previously in two Phase III studies.1,2 The objective of this analysis was to provide data from a real-world setting for longitudinal effectiveness of IV and SC abatacept in patients with JIA.

Methods: By protocol, clinical sites in the Pediatric Rheumatology Collaborative Study Group and Paediatric Rheumatology International Trial Organization enrolled patients meeting the ILAR criteria for one of the categories of JIA3 currently taking or starting IV or SC abatacept. Planned duration of follow-up (FU) is 10 years; data were collected up to March 31, 2018. Effectiveness was assessed at day of entry into registry (baseline [BL]), 3 and 6 months and 1, 2, 3, 4 and 5 years. Safety data were collected at each visit.

Results: Of the 438 patients enrolled, 435 were included in the analysis; 346/435 (80%) were female. At BL, 17 (4%) patients were aged 2–5 years, median age was 13.6 years, JIA disease duration was 4.4 years, abatacept treatment duration was 6.5 months and number of active joints was 1 (mean 2.7). JIA categories were systemic (2%), oligo (23%), polyarticular RF– (55%), polyarticular RF+ (10%), psoriatic (3%), enthesitis-related (3%) and undifferentiated (4%). Total abatacept exposure was 474.0 patient-years. At 1-year FU, patients had low Physician Global Disease Activity, low Juvenile Arthritis Multidimensional Assessment Report scores and improved joint assessments (Table 1). A higher percentage of patients achieved clinically inactive disease after 1 year of FU vs BL (32 vs 45; Table 1). This trend continued despite low numbers of patients with 4 and 5 years of FU. There were 5 serious infections reported (incidence rate [IR] 0.66 /100 patient-years of FU, 95% CI: 0.22, 1.55; IR 0.79/100 patient-years on treatment, 95% CI: 0.26, 1.84). There were 15 autoimmune events (9 new onset) in 14 patients (IR 1.98/100 patient-years of FU, 95% CI: 0.66, 4.65; IR 2.37/100 patient-years on treatment, 95% CI: 0.78, 5.52). No malignancies or tuberculosis were reported. There was 1 death (unrelated pre-existing cardiac problems).

Conclusion: In this real-world JIA cohort, abatacept was safe and well-tolerated with no new safety risks identified. This longitudinal analysis further supports the persistent effectiveness of abatacept in patients with JIA.

References

  1. Brunner HI, et al. Arthritis Rheumatol. 2018:70;1144-54.
  2. Ruperto N, et al. Lancet. 2008;372:383-91.
  3. Petty RE, et al. J Rheumatol 2004;31:390–392.

Disclosure: D. Lovell, AstraZeneca, 5, Boehringer Ingelheim, 5, Bristol-Myers Squibb, 2, Forest Research, 5, GlaxoSmithKline, 5, Janssen, 2, Novartis, 2, 5, Roche, 2, 5, UBC, 2, 5, AbbVie, 2, Pfizer Inc, 2, 5, Abbott, 5, Amgen, 5, Celgene, 5, Takeda, 5, Wyeth, 5; H. Brunner, Abbott, 5, Amgen, 5, AstraZeneca, 5, Boehringer Ingelheim, 5, Celgene, 5, GlaxoSmithKline, 5, 8, F Hoffman-La Roche, 5, 8, Novartis, 5, 8, Pfizer, 5, Takeda, 5, UBC, 5, Wyeth, 5; N. Tzaribachev, None; E. Morgan, None; G. Simonini, Novartis, 5, 8, AbbVie, 5, 8; T. Griffin, None; E. Alexeeva, Novartis, 2, 5, 8, Roche, 2, 5, 8, Pfizer, 2, 5, 8, AbbVie, 2, 5, 8; J. Bohnsack, AbbVie, 2, Bristol-Myers Squibb, 2, Janssen, 2, Pfizer Inc, 2, Roche, 2; A. Zeft, Merck, 4, Teva, 4, Opko Health, 4; G. Horneff, Pfizer, 5, 8, AbbVie, 5, 8, Novartis, 5, 8, Sanofi, 5, 8; R. Vehe, None; V. Stanevicha, None; S. Tarvin, None; M. Trachana, AbbVie, 2, Bristol Myers Squibb, 2, Novartis Hellas, 2, 8, Pfizer, 8, Roche, 8; A. Huber, None; I. Orban, None; J. Dare, AbbVie, 2, Bristol Myers Squibb, 2, Pfizer, 2, Roche, 2, UCB, 2, Centene Corporation, 3, 4; I. Foeldvari, Novartis, 5, Amgen, 5, Pfizer, 5, Bristol Myers Squibb, 5, Sanofi, 5, Eli Lilly, 5; P. Quartier, AbbVie, 1, Bristol-Myers Squibb, 1, Chugai-Roche, 1, Lilly, 1, Novartis, 1, Novimmune, 1, Sanofi, 1, Sobi, 1; A. Dominique, Bristol-Myers Squibb Company, 1, 3, 4; T. Kou, Bristol-Myers Squibb Company, 1, 3; R. Wong, Bristol-Myers Squibb Company, 1, 3, 4; A. Martini, AbbVie, 8, Eli Lilly, 8, EMD Serono, 8, Janssen, 5, 8, Pfizer Inc, 5, 8, Novartis, 5, 8; N. Ruperto, AstraZeneca-MedImmune, 5, 8, Biogen, 5, 8, Eli Lilly, 2, 5, 8, EMD Serono, 5, 8, Janssen, 2, 5, 8, Novartis, 2, 5, 8, Pfizer Inc, 2, 5, Sobi, 2, 5, Bristol-Myers Squibb, 2, 5, 8, GlaxoSmithKline, 2, 5, 8, Roche, 2, 5, 8, AbbVie, 5, 8, Ablynx, 5, 8, Merck, 5, 8, R-Pharm, 5, Sanofi, 5, Servier, 5, Sinergie, 5, Takeda, 5, Boehringer Ingelheim, 5, 8.

To cite this abstract in AMA style:

Lovell D, Brunner H, Tzaribachev N, Morgan E, Simonini G, Griffin T, Alexeeva E, Bohnsack J, Zeft A, Horneff G, Vehe R, Stanevicha V, Tarvin S, Trachana M, Huber A, Orban I, Dare J, Foeldvari I, Quartier P, Dominique A, Kou T, Wong R, Martini A, Ruperto N. Longitudinal Effectiveness of Abatacept in JIA: Results from an Ongoing JIA Registry [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/longitudinal-effectiveness-of-abatacept-in-jia-results-from-an-ongoing-jia-registry/. Accessed .

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