Background/Purpose: There continues to be uncertainty regarding when to start biologic medications for polyarticular juvenile idiopathic arthritis (P-JIA). The Childhood Arthritis and Rheumatology Research Alliance (CARRA) developed consensus treatment plans (CTPs) that reflect the most commonly-used strategies for starting biologic treatment in untreated P-JIA patients.  The CARRA STOP-JIA study compares the effectiveness of the CARRA CTPs in achieving clinical inactive disease (CID) at 12 months using a prospective, observational study design. Enrollment was completed in August 2018.

Methods: Untreated P-JIA patients with ≥ 5 active joints were enrolled into the CARRA Registry. One of the CARRA P-JIA CTPs was chosen by the physician and patient/family to follow without randomization or blinding: 1) Step-Up (begin with non-biologic DMARD and add biologic after 3 months if needed); 2) Early Combination (begin both DMARD and biologic at baseline); and 3) Biologic First (biologic monotherapy). Providers prescribed glucocorticoids per their usual practice.  Patient Reported Outcomes (PROs) included the CHAQ, Patient/Parent Global Assessment, PROMIS® Pain Interference and Mobility measures.

Results: Four hundred and one patients were enrolled at 44 sites in the US and Canada between 11/2015 and 8/2018. Table 1 shows the baseline data. The most commonly chosen CTPs were Step-Up (n=257; 64%) and Early Combination (n=100; 25%). At baseline, 343 (86%) of patients were started on a non-biologic DMARD (methotrexate). 147 (37%) were started on a biologic DMARD, most commonly etanercept (n=103, 26%) and adalimumab (49, 13%). To date, 320 patients have completed 12-months follow up. 278 patients completed at least one PRO measure at baseline. Table 2 shows mean PROMIS® Pain Interference and Mobiity scores for each treatment group. Table 3 shows the clinical Juvenile Arthritis Disease Activity Scores based on 10 joints (cJADAS-10) and the percentage of participants in each disease activity score category (inactive, low, moderate and high) over time.

Conclusion: STOP-JIA has successfully completed enrollment. Patients enrolled into all CTP choices; however, the Step-Up CTP was most common. There are differences between the treatment groups at baseline, including in PROMIS® measures, which will require statistical adjustment to reduce bias. Overall, disease activity reduced across all treatment groups over time. Once all patients have completed 12-month follow-up, analyses comparing the effectiveness of the different CTP strategies will be performed.

Table 1

Table 2

Table 3

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