Longitudinal effectiveness of abatacept in Juvenile Idiopathic Arthritis (JIA): results from an ongoing JIA registry

Nicolino Ruperto, Daniel J. Lovell, Nikolay Tzaribachev, Esi Morgan, Gabriele Simonini, Thomas Griffin, Ekaterina Alexeeva, John Bohnsack, Andrew Zeft, Gerd Horneff, Richard Vehe, Valda Stanevica, Stacey Tarvin, Maria Trachana, Adam Huber, Ilonka Orban, Jason Dare, Ivan Foeldvari, Pierre Quartier, A. DominiqueTzuyung Douglas Kou, Robert Wong, Alberto Martini, Hermine Brunner

Research output: Contribution to journalMeeting Abstractpeer-review

Abstract

Introduction: Abatacept (ABA) is a selective T-cell co-stimulation
modulator approved for use in JIA. Efficacy and safety of ABA in patients (pts) with JIA has been demonstrated previously in two Phase
III studies.1,2
Objectives: Provide data from a real-world setting for longitudinal effectiveness of IV and SC ABA in pts with JIA.
Methods: By protocol, clinical sites in the Pediatric Rheumatology
Collaborative Study Group and Paediatric Rheumatology
International Trial Organization enrolled pts with JIA currently taking
or starting IV or SC ABA. Planned duration of follow-up (FU) is 10 yrs;
data were collected up to 31 Mar 2018. Effectiveness was assessed at
day of entry into registry (baseline; BL), 3 and 6 mos and 1, 2, 3, 4
and 5 yrs. Safety data were collected at each visit.
Results: 438 were enrolled; 435 were included in the analysis, 346/
435 (80%) were female. At BL, 17 (4%) pts were aged 2–5 yrs and
median age was 13.6 yrs; JIA disease duration was 4.4 yrs; ABA
treatment duration 6.5 mos, number of active joints 1 (mean 2.7). JIA
categories were systemic (2%), oligo (23%), poly RF– (55%), poly RF+
(10%), psoriatic (3%), enthesitis-related (3%) and undifferentiated
(4%). Total ABA exposure was 474.0 pt-yrs. At 1-yr FU, pts had low
MD Global Disease Activity, low Juvenile Arthritis Multidimensional
Assessment Report scores and improved joint assessments (Table 1).
A higher percentage of pts achieved clinically inactive disease after 1
yr FU vs BL (32 vs 45; Table 1). This trend continued despite low
numbers of pts with 4 and 5 yrs of FU. There were 5 serious infections reported (incidence rate [IR] 0.66 /100 pt-yrs of FU, 95% CI:
0.22, 1.55; IR 0.79/100 pt-yrs on treatment, 95% CI: 0.26, 1.84). There
were 15 autoimmune events (9 new onset) in 14 patients (IR 1.98/
100 pt-yrs of FU, 95% CI: 0.66, 4.65; IR 2.37/100 pt-yrs on treatment,
95% CI: 0.78, 5.52). No malignancies or TB 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
pts with JIA.
Original languageEnglish
Pages (from-to)29
JournalPediatric Rheumatology
Volume18
Issue numberSuppl.2
Publication statusPublished - 2020
Externally publishedYes
Event26th European
Paediatric Rheumatology Congress
-
Duration: 23 Oct 202026 Oct 2020
Conference number: 26

Field of Science

  • 3.2 Clinical medicine

Publication Type

  • 3.4. Other publications in conference proceedings (including local)

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