Three Childhood Arthritis and Rheumatology Research Alliance (CARRA) Consensus Treatment Plans (CTPs) evaluated under the CARRA Start Time Optimization of Biologics in Polyarticular Juvenile Idiopathic Arthritis (STOP-JIA) study showed an increased percentage of patients achieving clinical inactive disease (CID) and improved disease activity scores and patient-reported outcomes (PROs) at 24 months. Study results were presented at the American College of Rheumatology (ACR) Convergence 2021, held virtually from November 3 to 10, 2021.

The current analysis was a follow-up to the CARRA-STOP JIA study (ClinicalTrials.gov Identifier: NCT02593006) that compared the effectiveness of 3 CARRA CTPs among children with polyarticular JIA.

Treatment plans included Step Up: starting conventional disease-modifying antirheumatic drug (csDMARD) and adding a biologic (b)DMARD if needed after at least 3 months; Early Combination: a csDMARD and bDMARD started together; and Biologic First: starting a bDMARD and adding a csDMARD if needed after at least 3 months. Treatment plans were determined by patient choice.


Continue Reading

The primary outcome was the percentage of patients achieving CID at 24 months. Secondary outcomes included the clinical Juvenile Arthritis Disease Activity Score based on 10 joints (cJADAS10), the pediatric ACR70 score (pACR70), and PROs.

Researchers followed up with patients every 3 months for the first 12 months and every 6 months thereafter.

A total of 291 patients with 24 months of follow-up were included in the study (188 Step Up, 76 Early Combination, and 27 Biologic First). At 12 and 24 months, the percentage of patients achieving CID were 32% and 42% for Step Up, 37% and 52% for Early Combination, and 24% and 44% for Biologic First, respectively.

Propensity score analysis showed that patients in the Early Combination group were significantly more likely to achieve CID than the Step Up group (P =.006).

There were no significant differences in secondary outcomes (cJADAS10 and pACR70) between the CTP groups and all groups showed continued improvement between 12 and 24 months. The cJADAS10 scores at 12 and 24 months were 45% and 59% for Step Up, 60% and 66% for Early Combination, and 48% and 57% for Biologic First, respectively. The pACR70 scores at 12 and 24 months were 47% and 74% for Step Up, 59% and 83% for Early Combination, and 44% and 74% for Biologic First, respectively.

A total of 17 serious adverse events, primarily infections, were observed among study participants.

Researchers concluded, “While there was a significant difference in CID favoring Early Combination versus Step Up at 24 months, there were no significant differences between CTPs for other study outcomes. All groups did continue to improve in cJADAS10 and PRO measures.”

They added, “Additional analyses will include comparison of remission on medications (CID for 12 months) and patients ever achieving CID between CTPs.”

Disclosure: Several study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of the disclosures.

Reference

Kimura Y, Ringold S, Tomlinson G, et al; The STOP-JIA CARRA Registry Investigators. The Childhood Arthritis and Rheumatology Research Alliance Start Time Optimization of Biologic Therapy in Polyarticular JIA (STOP-JIA) Study: 24-month outcomes. Presented at: ACR Convergence 2021; November 3-10, 2021. Abstract 0960.