ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 47

Baseline characteristics of the first 123 patients enrolled in the Childhood Arthritis and Rheumatology Research Alliance Start Time Optimization of Biologic Therapy in Polyarticular JIA comparative effectiveness study

Sarah Ringold1, George A. Tomlinson2, Pamela F. Weiss3, Laura E. Schanberg4, Brian M. Feldman5, Mary Ellen Riordan6, Anne C. Dennos7, Vincent Del Gaizo8, Kate Murphy9, Yukiko Kimura6 and the CARRA Registry Investigators, 1Seattle Children's Hospital, Seattle, WA, 2Medicine, Mount Sinai Hospital, Toronto, ON, Canada, 3Division of Rheumatology, Center for Pediatric Clincial Effectiveness, Children's Hospital of Philadelphia, Philadelphia, PA, 4Pediatrics, Duke Medical Center, Durham, NC, 5Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada, 6Hackensack University Medical Center, Hackensack, NJ, 7Duke Clinical Research Institute, Durham, NC, 8Parent Partner, Whitehouse Station, NJ, 9Patient Partner, San Francisco, CA

Meeting: 2017 Pediatric Rheumatology Symposium

Keywords: , , ,

Session Information

Date: Thursday, May 18, 2017

Title: Clinical and Therapeutic Poster Session

Session Type: Abstract Submissions

Session Time: 5:30PM-7:00PM

Background/Purpose: Many new effective treatments for polyarticular JIA (p-JIA) are available, but there is significant variation among pediatric rheumatologists in the timing of when biologic medications are started. Three consensus treatment plans (CTPs), reflecting the most commonly used current treatment strategies, 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 different CTPs in 400 patients using a prospective, observational study design. This abstract describes baseline characteristics, CTP choices, and reasons for CTP choice for the initial patients enrolled in STOP-JIA.

Methods: P-JIA patients who had not yet received systemic glucocorticoid, DMARD or biologic therapies were enrolled into the CARRA Registry. Providers and patients chose one of the CTPs to follow: 1) Step-Up treatment (initial therapy with DMARD and biologic added later 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.

Results: One hundred and twenty three patients were enrolled at 37 sites in the US and Canada between 11/1/15 and 1/27/17. Patient characteristics are summarized in Table 1. The most commonly chosen CTP was Step-Up (n=79; 64%). Early combination was the next most common choice (n=27; 22%). Thirty (24%) of patients received oral steroids at baseline. Providers indicated physician preference (89%) as the most common reason for choosing a specific CTP. Six adverse events were reported: influenza A (CTCAE Grade 2), septic shock (CTCAE Grade 3), other infection (CTCAE Grade 1), new onset uveitis (CTCAE Grade 2), hepatitis (CTCAE Grade 1), and seizure (CTCAE Grade 1).

Conclusion: Patients were enrolled into all 3 CTP choices during the first 14 months of enrollment, with the Step-Up option 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

Characteristic

Total Cohort (n=123)

Step-Up

(n=79)

Early Combination

(n=27)

Biologic First

(n=17)

Female N (%)

88 (72)

58 (73)

19 (70)

11 (65)

White N (%)

80 (65)

58 (73)

12 (44)

10 (59)

Age in yrs – mean (range)

10 (1-18)

9 (1-18)

11 (1-17)

12 (2-18)

JIA Category N (%)

 

 

 

 

Extended Oligoarticular

1 (1)

1 (1)

—

—

Polyarthritis (RF-)                                                

83 (68)

61 (78)

13 (48)

9 (53)

Polyarthritis (RF+)

17 (14)

7 (9)

10 (37)

—

Psoriatic

7 (6)

4 (4)

1 (4)

2 (12)

Enthesitis-related

11 (9)

5 (6)

1 (4)

5 (30)

Undifferentiated

3 (2)

—

2 (7)

1 (6)

Number of Active joints – mean (range)

13 (5-49)

12 (5-35)

17 (5-49)

9 (5-16)

Physician Global Assessment of Disease Activity – mean (range)

6 (0-10)

5 (0-10)

7 (3-10)

6 (1-10)

Juvenile Arthritis Disease Activity Score – mean (range)

18 (7-29)

17 (7-29)

21 (9-28)

19 (14-25)

CHAQ score- mean (range)

1 (0-3)

1 (0-3)

1 (0-2)

1 (0-2)

Oral steroids prescribed at baseline – N (%)

30 (24)

17 (22)

12 (44)

1 (6)

 

Disclosure: S. Ringold, None; G. A. Tomlinson, None; P. F. Weiss, None; L. E. Schanberg, 9,9,9; B. M. Feldman, None; M. E. Riordan, None; A. C. Dennos, None; V. Del Gaizo, None; K. Murphy, None; Y. Kimura, None.

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. Baseline characteristics of the first 123 patients enrolled in the Childhood Arthritis and Rheumatology Research Alliance Start Time Optimization of Biologic Therapy in Polyarticular JIA comparative effectiveness study [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 4). https://acrabstracts.org/abstract/baseline-characteristics-of-the-first-123-patients-enrolled-in-the-childhood-arthritis-and-rheumatology-research-alliance-start-time-optimization-of-biologic-therapy-in-polyarticular-jia-comparative-e/. Accessed .

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