Session Information
Date: Tuesday, November 7, 2017
Title: Pediatric Rheumatology – Clinical and Therapeutic Aspects Poster III: Juvenile Arthritis
Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose: Despite the many available new and effective treatments for polyarticular JIA (P-JIA), there is significant variation in the timing of when biologic medications are started. Three consensus treatment plans (CTPs) reflecting the currently most commonly-used strategies for starting biologic treatment were developed by the Childhood Arthritis and Rheumatology Research Alliance (CARRA) using consensus methodology. The CARRA Start Time Optimization of Biologic Therapy in Polyarticular JIA (STOP-JIA) study aims to compare the effectiveness of the 3 CARRA P-JIA CTPs using a prospective, observational study design. This abstract describes interim baseline characteristics and CTP choices for the patients enrolled in STOP-JIA.
Methods: Untreated P-JIA patients were enrolled into the CARRA Registry. Providers and patients together chose one of the CTPs to follow: 1) Step-Up treatment (initial therapy with DMARD and biologic added after 3 months if needed); 2) Early Combination (initial therapy with both DMARD and biologic); and 3) Biologic First (initial treatment with biologic monotherapy). Providers had the option of prescribing glucocorticoids at baseline per their usual practice and were provided with tapering options. There is no randomization or blinding in this observational study.
Results: One hundred and eighty two patients were enrolled at 37 sites in the US and Canada between 1 Nov 15 and 31 May 17. Patient characteristics are summarized in Table 1. The most commonly chosen CTP was Step-Up (n=116; 64%). Early Combination CTP was the next most common choice (n=44; 24%). Forty eight (26%) of patients received oral steroids at baseline. To date, 491 follow up visits have been entered and 30 patients have completed their 12 month visit. Of the patients who have completed their 3 month visit, 10 patients were reported to have changed CTP. There were 9 Serious Adverse Events (SAE) or Important Medical Events (IME): 1 each of septic shock (CTCAE Grade 3), influenza A (Grade 2), new onset uveitis (Grade 2), shingles (Grade 2), seizure (Grade 1), hepatitis (Grade 1), and 3 infections treated with IV antibiotics (Grades 1 , 2, and 3).
Conclusion: To date, patients have been enrolled into all 3 CTP choices, with the Step-Up CTP being the most common. Ongoing, prospective data collection from these patients will allow for a comparison of the effectiveness of the strategies.
Table 1. Baseline Patient Characteristics
|
|
Total Cohort (n=182) |
Step up (n=116) |
Early Combination (n=44) |
Biologic First (n=22) |
|
Female N (%) |
134 (74%) |
85 (76%) |
31 (71%) |
15 (68%) |
|
White N (%) |
118 (69%) |
85 (73%) |
28 (64%) |
13 (59%) |
|
Age in yrs – median (IQR)* |
11 (6, 14) |
11 (6, 14) |
11 (8, 14) |
13 (7, 15) |
|
JIA Category N (%) |
|
|
|
|
|
Extended Oligoarticular |
2 (1) |
2 (2) |
— |
— |
|
Polyarticular (RF-) |
121 (67) |
88 (76) |
23 (52) |
10 (46) |
|
Polyarticular (RF+) |
27 (15) |
14 (12) |
12 (27) |
1 (5) |
|
Psoriatic |
9 (5) |
4 (3) |
2 (5) |
3 (14) |
|
Enthesitis-related |
19 (10) |
8 (7) |
5 (11) |
6 (27) |
|
Undifferentiated |
4 (2) |
— |
2 (5) |
2 (9) |
|
Number of Active joints – median (IQR) |
9 (6, 17) |
14 (8, 22) |
8 (6, 13)) |
8 (6, 15) |
|
Physician Global Assessment of Disease Activity – median (IQR) |
5 (4, 7) |
5 (4, 7) |
7 (5, 8) |
6 (5, 8) |
|
Juvenile Arthritis Disease Activity Score – median (IQR) |
18 (15, 22) |
17 (14, 20) |
21 (17, 23) |
19 (17, 22) |
|
CHAQ Score – median (IQR) |
1 (0, 1.5) |
0.6 (0.2, 1.2) |
1 (0.6, 2.5) |
0.9 (0.6, 2.1) |
|
Oral steroids prescribed at baseline – N (%) |
48 (26%) |
31 (27) |
15 (34) |
2 (9) |
* IQR: Interquartile Range
To cite this abstract in AMA style:
Ringold S, Tomlinson GA, Weiss PF, Schanberg LE, Feldman BM, Riordan ME, Dennos AC, Del Gaizo V, Murphy K, Kimura Y. The Childhood Arthritis and Rheumatology Research Alliance Start Time Optimization of Biologic Therapy in Polyarticular JIA Study: Interim Report of Baseline Patient Characteristics and Treatment Choices [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/the-childhood-arthritis-and-rheumatology-research-alliance-start-time-optimization-of-biologic-therapy-in-polyarticular-jia-study-interim-report-of-baseline-patient-characteristics-and-treatment-choi/. Accessed .« Back to 2017 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/the-childhood-arthritis-and-rheumatology-research-alliance-start-time-optimization-of-biologic-therapy-in-polyarticular-jia-study-interim-report-of-baseline-patient-characteristics-and-treatment-choi/