American College of Rheumatology Guidance for the Management of Pediatric Rheumatic Disease During the COVID-19 Pandemic: Version 2.

2021

2021 Jun 10

2326-5205

<p><strong>OBJECTIVE: </strong>To provide clinical guidance to rheumatology providers who treat children with pediatric rheumatic disease (PRD) in the context of the coronavirus disease 2019 (COVID-19) pandemic.</p>

<p><strong>METHODS: </strong>The task force, consisting of 7 pediatric rheumatologists, 2 pediatric infectious disease physicians, 1 adult rheumatologist, and 1 pediatric nurse practitioner, was convened on May 21, 2020. Clinical questions and subsequent guidance statements were drafted based on a review of the queries posed by the patients as well as the families and healthcare providers of children with PRD. An evidence report was generated and disseminated to task force members to assist with 3 rounds of asynchronous, anonymous voting by email using a modified Delphi approach. Voting was completed using a 9-point numeric scoring system with predefined levels of agreement (categorized as disagreement, uncertainty, or agreement, with median scores of 1-3, 4-6, and 7-9, respectively) and consensus (categorized as low, moderate, or high). To be approved as a guidance statement, median vote ratings were required to fall into the highest tertile for agreement, with either moderate or high levels of consensus.</p>

<p><strong>RESULTS: </strong>To date, 39 guidance statements have been approved by the task force. Those with similar recommendations were combined to form a total of 33 final guidance statements, all of which received median vote ratings within the highest tertile of agreement and were associated with either moderate consensus (n&nbsp;=&nbsp;5) or high consensus (n&nbsp;=&nbsp;28).</p>

<p><strong>CONCLUSION: </strong>These guidance statements have been generated based on review of the available literature, indicating that children with PRD do not appear to be at increased risk for susceptibility to SARS-CoV-2 infection. This guidance is presented as a "living document," recognizing that the literature on COVID-19 is rapidly evolving, with future updates anticipated.</p>

10.1002/art.41772

Arthritis Rheumatol

34114365

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

2021

2021 Jun 08

2326-5205

<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>

10.1002/art.41888

Arthritis Rheumatol

34105312

American College of Rheumatology Guidance for the Management of Children with Pediatric Rheumatic Disease During the COVID-19 Pandemic: Version 1.

2020

2020 Jul 23

2326-5205

<p><strong>OBJECTIVE: </strong>To provide clinical guidance to rheumatology providers who treat children with PRD in the context of the COVID-19 pandemic.</p>

<p><strong>METHODS: </strong>The task force, consisting of 7 pediatric rheumatologists, 2 pediatric infectious disease physicians, one adult rheumatologist and one pediatric nurse practitioner, was convened on May 21, 2020. Clinical questions and subsequent guidance statements were drafted based on review of queries posed by patients, families and healthcare providers of children with PRD. An evidence report was generated and disseminated to task force members to assist with three rounds of asynchronous, anonymous voting by email using a modified Delphi approach. Voting was completed using a 9-point numeric scoring system with predefined levels of agreement ("disagreement"; "uncertain"; "agreement") and consensus. To be approved as a guidance statement, median votes were required to fall into the highest tertile for agreement with "moderate" (M) or "high" (H) levels of consensus.</p>

<p><strong>RESULTS: </strong>33 guidance statements were drafted and voted upon during rounds two and three of voting. Of these statements, all received median votes within the highest tertile of agreement and were associated with moderate (n=6) or high consensus (n=27). Statements with similar recommendations were combined, resulting in 27 final guidance statements.</p>

<p><strong>CONCLUSION: </strong>These guidance statements have been generated based on review of the available literature, indicating that children with PRD do not appear to be at increased risk for susceptibility to SARS-CoV-2 infection. This guidance is presented as a "living document," recognizing that the literature on COVID-19 is rapidly evolving, with future updates anticipated.</p>

10.1002/art.41455

32705780

The American English version of the Juvenile Arthritis Multidimensional Assessment Report (JAMAR).

2018

35-42

2018 Apr

1437-160X

<p>The Juvenile Arthritis Multidimensional Assessment Report (JAMAR) is a new parent/patient-reported outcome measure that enables a thorough assessment of the disease status in children with juvenile idiopathic arthritis (JIA). We report the results of the cross-cultural adaptation and validation of the parent and patient versions of the JAMAR in the American English language. The reading comprehension of the questionnaire was tested in 10 JIA parents and patients. Each participating centre was asked to collect demographic, clinical data and the JAMAR in 100 consecutive JIA patients or all consecutive patients seen in a 6-month period and to administer the JAMAR to 100 healthy children and their parents. The statistical validation phase explored descriptive statistics and the psychometric issues of the JAMAR: the 3 Likert assumptions, floor/ceiling effects, internal consistency, Cronbach's alpha, interscale correlations, test-retest reliability, and construct validity (convergent and discriminant validity). A total of 315 JIA patients (5.1% systemic, 31.1% oligoarticular, 34% RF negative polyarthritis, 29.8% other categories) and 98 healthy children, were enrolled in three centres. The JAMAR components discriminated well healthy subjects from JIA patients. All JAMAR components revealed good psychometric performances. In conclusion, the American English version of the JAMAR is a valid tool for the assessment of children with JIA and is suitable for use both in routine clinical practice and clinical research.</p>

10.1007/s00296-018-3984-6

29637338

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

2018

2018 Jan 15

2326-5205

<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>

10.1002/art.40395

29333701

Pilot study comparing the Childhood Arthritis & Rheumatology Research Alliance (CARRA) systemic Juvenile Idiopathic Arthritis Consensus Treatment Plans.

2017

23

2017 Apr 11

1546-0096

<p><strong>OBJECTIVES: </strong>To assess the feasibility of studying the comparative effectiveness of the Childhood Arthritis and Rheumatology Research Alliance (CARRA) consensus treatment plans (CTPs) for systemic Juvenile Idiopathic Arthritis (JIA) using an observational registry.</p>

<p><strong>METHODS: </strong>Untreated systemic JIA patients enrolled in the CARRA Registry were begun on one of 4 CTPs chosen by the treating physician and patient/family (glucocorticoid [GC] alone; methotrexate [MTX] ± GC; IL1 inhibitor [IL1i] ± GC; IL6 inhibitor [IL6i] ± GC). The primary outcome of clinical inactive disease (CID) without current GC use was assessed at 9&nbsp;months.</p>

<p><strong>TRIAL REGISTRATION: </strong>clinicaltrials.gov NCT01697254; first registered 9/28/12 (retrospectively enrolled).</p>

<p><strong>RESULTS: </strong>Thirty patients were enrolled at 13 sites; eight patients were started on a non-biologic CTP (2 GC, 6 MTX) and 22 patients on a biologic CTP (12 IL1i, 10 IL6i) at disease onset. Demographic and disease features were similar between CTP groups. CTP choice appeared to segregate by site preference. CID off GC was achieved by 37% (11 of 30) including 11/22 (50%) starting a biologic CTP compared to 0/8 starting a non-biologic CTP (p = 0.014). There were four serious adverse events: two infections, one appendicitis and one macrophage activation syndrome.</p>

<p><strong>CONCLUSIONS: </strong>The CARRA systemic JIA CTP pilot study demonstrated successful implementation of CTPs using the CARRA registry infrastructure. Having demonstrated feasibility, a larger study using CTP response to better determine the relative effectiveness of treatments for new-onset systemic JIA is now underway.</p>

10.1186/s12969-017-0157-1

Pediatr Rheumatol Online J

28399931

Childhood Arthritis and Rheumatology Research Alliance consensus treatment plans for new-onset polyarticular juvenile idiopathic arthritis.

2014

1063-72

2014 Jul

2151-4658

<p><strong>OBJECTIVE: </strong>There is no standardized approach to the initial treatment of polyarticular juvenile idiopathic arthritis (JIA) among pediatric rheumatologists. Understanding the comparative effectiveness of the diverse therapeutic options available will result in better health outcomes for polyarticular JIA. The Childhood Arthritis and Rheumatology Research Alliance (CARRA) developed consensus treatment plans (CTPs) for use in clinical practice to facilitate such studies.</p>

<p><strong>METHODS: </strong>A case-based survey was administered to CARRA members to identify the common treatment approaches for new-onset polyarticular JIA. Two face-to-face consensus conferences employed modified nominal group technique to identify treatment strategies, operational case definition, end points, and data elements to be collected. A core workgroup reviewed the relevant literature, refined plans, and developed medication dosing and monitoring recommendations.</p>

<p><strong>RESULTS: </strong>The initial case-based survey identified significant variability among treatment approaches for new-onset polyarticular JIA. We developed 3 CTPs based on treatment strategies for the first 12 months of therapy, as well as case definitions and clinical and laboratory monitoring schedules. The CTPs include a step-up plan (nonbiologic disease-modifying antirheumatic drug [DMARD] followed by a biologic DMARD), an early combination plan (nonbiologic and biologic DMARD combined within a month of treatment initiation), and a biologic only plan. This approach was approved by 96% of the CARRA JIA Research Committee members attending the 2013 CARRA face-to-face meeting.</p>

<p><strong>CONCLUSION: </strong>Three standardized CTPs were developed for new-onset polyarticular JIA. Coupled with data collection at defined intervals, use of these CTPs will enable the study of their comparative effectiveness in an observational setting to optimize initial management of polyarticular JIA.</p>

10.1002/acr.22259

Arthritis Care Res (Hoboken)

24339215

2013 update of the 2011 American College of Rheumatology recommendations for treatment of juvenile idiopathic arthritis: recommendations for medical therapy of children with systemic JIA and TB screening among children receiving biologic medications.

2013

2499-512

2013 Oct

1529-0131

10.1002/art.38092

Arthritis Rheum.

24092554

Disease-modifying antirheumatic drug use in the treatment of juvenile idiopathic arthritis: a cross-sectional analysis of the CARRA Registry.

2012

1867-74

2012 Sep

0315-162X

<p><strong>OBJECTIVE: </strong>To characterize disease-modifying antirheumatic drug (DMARD) use for children with juvenile idiopathic arthritis (JIA) in the United States and to determine patient factors associated with medication use.</p>

<p><strong>METHODS: </strong>We analyzed cross-sectional baseline enrollment data from the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry from May 2010 through May 2011 for children with JIA. Current and prior medication use was included. We used parsimonious backward stepwise logistic regression models to calculate OR to estimate associations between clinical patient factors and medication use.</p>

<p><strong>RESULTS: </strong>We identified 2748 children with JIA with a median disease duration of 3.9 years from 51 US clinical sites. Overall, 2023 (74%) had ever received a nonbiologic DMARD and 1246 (45%) had ever received a biologic DMARD. Among children without systemic arthritis, methotrexate use was most strongly associated with uveitis (OR 5.2, 95% CI 3.6-7.6), anticitrullinated protein antibodies (OR 4.5, 95% CI 1.7-12), and extended oligoarthritis (OR 4.1, 95% CI 2.5-6.6). Among children without systemic arthritis, biologic DMARD use was most strongly associated with rheumatoid factor (RF)-positive polyarthritis (OR 4.3, 95% CI 2.9-6.6), psoriatic arthritis (PsA; OR 3.0, 95% CI 2.0-4.4), and uveitis (OR 2.8, 95% CI 2.1-3.7). Among children with systemic arthritis, 160 (65%) ever received a biologic DMARD; tumor necrosis factor inhibitor use was associated with polyarthritis (OR 2.5, 95% CI 3.8-16), while interleukin 1 inhibitor use was not.</p>

<p><strong>CONCLUSION: </strong>About three-quarters of all children with JIA in the CARRA Registry received nonbiologic DMARD. Nearly one-half received biologic DMARD, and their use was strongly associated with RF-positive polyarthritis, PsA, uveitis, and systemic arthritis.</p>

10.3899/jrheum.120110

J. Rheumatol.

22859354