First name
George
Middle name
A
Last name
Tomlinson

Title

The Childhood Arthritis & Rheumatology Research Alliance Start Time Optimization of Biologics in Polyarticular Juvenile Idiopathic Arthritis Study

Year of Publication

2021

Date Published

2021 Jun 08

ISSN Number

2326-5205

Abstract

<p><strong>BACKGROUND: </strong>The optimal time to start biologics for polyarticular JIA (pJIA) remains uncertain. The Childhood Arthritis and Rheumatology Research Alliance (CARRA) developed 3 consensus treatment plans (CTPs) for untreated pJIA to compare strategies for starting biologics.</p>

<p><strong>METHODS: </strong>Start Time Optimization of biologics in PJIA (STOP-JIA) was a prospective, observational, CARRA Registry study comparing the effectiveness of: 1) Step Up (SU)- initial non-biologic disease modifying anti-rheumatic drug (DMARD) monotherapy, adding biologic if needed; 2) Early Combination (EC)- DMARD and biologic started together; 3) Biologic First (BF)- biologic monotherapy. The primary outcome was clinically inactive disease (CID) (Wallace) off glucocorticoids at 12 months. Secondary outcomes included PROMIS® pain interference and mobility, inactive disease defined by the clinical Juvenile Arthritis Disease Activity Score (cJADAS10 ID) and pediatric ACR70 (pACR70).</p>

<p><strong>RESULTS: </strong>Of 400 patients enrolled, 257 (64%) began SU, 100 (25%) EC and 43 (11%) BF. After propensity score weighting and multiple imputation, 37% of EC, 32% SU and 24% BF achieved ACR CID (p=0.17). cJADAS10 ID (score ≤2.5) also favored EC over SU (59% versus 43%; p=0.03) as did pACR70 results (80% versus 64%; p=0.008) but generalizability is limited by missing data. PROMIS® measures improved in all groups, but without significant differences. Seventeen serious adverse events were reported (mostly infections).</p>

<p><strong>CONCLUSIONS: </strong>Achievement of CID off GC did not significantly differ between groups at 12 months. While there was a statistically significant higher likelihood of EC achieving cJADAS10 ID and pACR70, these results require further exploration.</p>

DOI

10.1002/art.41888

Alternate Title

Arthritis Rheumatol

PMID

34105312

Title

The Childhood Arthritis & Rheumatology Research Alliance Consensus Treatment Plans: Towards Comparative Effectiveness in the Pediatric Rheumatic Diseases.

Year of Publication

2018

Date Published

2018 Jan 15

ISSN Number

2326-5205

Abstract

<p>The pediatric rheumatic diseases are a heterogeneous group of rare diseases, posing a number of challenges for the use of traditional clinical and translational research approaches. Innovative comparative effectiveness approaches are needed to efficiently study treatment approaches and disease outcomes. The Childhood Arthritis and Rheumatology Research Alliance (CARRA) developed the consensus treatment plan (CTP) approach as a comparative effectiveness tool for research in pediatric rheumatology. CTPs are treatment strategies, developed by consensus methods among CARRA members, intended to reduce variation in treatment approaches, standardize outcome measurements, and allow for comparison of the effectiveness of different approaches with the goal of improving disease outcomes. To date, CTPs have been published for 7 different diseases and disease manifestations. The approach has been successfully piloted for juvenile localized scleroderma, systemic onset juvenile idiopathic arthritis (JIA), polyarticular JIA, dermatomyositis, and lupus nephritis. Large-scale studies are underway for systemic JIA and polyarticular JIA, with the CARRA patient registry serving as the data collection platform. These studies have been designed with stakeholder involvement, including active input from CARRA providers, patients, and parents, with the goal of increasing the feasibility and ensuring the relevance of the outcomes. These studies include ancillary biospecimen collection intended to support additional translational and mechanistic studies. Data from these ongoing CTP studies will provide more information on the ability of this approach to identify effective treatment strategies and improve outcomes for the pediatric rheumatic diseases. This article is protected by copyright. All rights reserved.</p>

DOI

10.1002/art.40395

PMID

29333701

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