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.
- Brunner HI, et al. Arthritis Rheumatol. 2018:70;1144-54.
- Ruperto N, et al. Lancet. 2008;372:383-91.
- Petty RE, et al. J Rheumatol 2004;31:390–392.
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 April 16, 2021.
« Back to ACR Convergence 2020
ACR Meeting Abstracts - https://acrabstracts.org/abstract/longitudinal-effectiveness-of-abatacept-in-jia-results-from-an-ongoing-jia-registry/