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.
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 language | English |
|---|---|
| Pages (from-to) | 29 |
| Journal | Pediatric Rheumatology |
| Volume | 18 |
| Issue number | Suppl.2 |
| Publication status | Published - 2020 |
| Externally published | Yes |
| Event | 26th European Paediatric Rheumatology Congress - Geneva, Switzerland Duration: 23 Sept 2020 → 26 Sept 2020 Conference number: 26 https://www.pres.eu/pres2020/ https://ped-rheum.biomedcentral.com/articles/supplements/volume-18-supplement-2 |
Field of Science*
- 3.2 Clinical medicine
Publication Type*
- 3.4. Other publications in conference proceedings (including local)