Alternative Biologic Therapy in Children Failing Conventional TNFα Inhibitors for Refractory, Noninfectious, Chronic Anterior Uveitis.

PURPOSE: A significant number of children with noninfectious, chronic anterior uveitis (CAU) fail to respond to conventional therapy; however, successful alternative biologic treatments (ABT) have not been well described. This study aims to review the clinical and treatment characteristics of children with CAU who require ABT. DESIGN: Retrospective, nonrandomized clinical study. METHODS: Setting: Tertiary center. STUDY POPULATION: Children with noninfectious CAU. OBSERVATION PROCEDURES: Clinical characteristics, uveitis course, complications, and treatment were compared among patients treated with methotrexate (MTX) monotherapy, conventional TNFα inhibitors (cTNFi), and ABT for >3 months. MAIN OUTCOME MEASURE: Success of ABT (abatacept, tocilizumab, and/or golimumab) in children failing conventional treatment. RESULTS: Of the 52 children with CAU, 75% had juvenile idiopathic arthritis. CAU was controlled in 15 children receiving MTX monotherapy, 28 receiving cTNFi, and 9 receiving ABT (n = 1, abatacept; n = 3, tocilizumab; n = 5, golimumab). Patients in the ABT group had a greater number of total ocular complications per person before ABT than those in the control groups (3.4 vs 0.7 [MTX], P < .001, and 1.5 [cTNFi], P < .001, respectively). In all 9 children on ABT, treatment led to control of CAU and topical glucocorticoids tapered to ≤2 drops/d with no new ocular complications. CONCLUSIONS: In this study, alternative biologics (abatacept, golimumab, and tocilizumab) were useful for treating CAU in children who fail MTX and cTNFi therapy. Patients who were controlled on ABT had more disease activity, ocular complications, and anti-cTNFi neutralizing antibodies (before ABT) than those managed with conventional therapy. Larger studies are required to confirm these findings.

Randomized clinical trial of Fibromyalgia Integrative Training (FIT teens) for adolescents with juvenile fibromyalgia - Study design and protocol.

OBJECTIVE: Juvenile-onset fibromyalgia (JFM) is a chronic debilitating pain condition that negatively impacts physical, social and academic functioning. Cognitive-behavioral therapy (CBT) is beneficial in reducing functional disability among adolescents with JFM but has only a modest impact on pain reduction and does not improve physical exercise participation. This randomized controlled trial (RCT) aims to test whether a novel intervention that combines CBT with specialized neuromuscular exercise training (the Fibromyalgia Integrative Training program for Teens "FIT Teens") is superior to CBT alone or a graded aerobic exercise (GAE) program. DESIGN/METHODS: This 3-arm multi-site RCT will examine the efficacy of the FIT Teens intervention in reducing functional disability (primary outcome) and pain intensity (secondary outcome), relative to CBT or GAE. All interventions are 8-weeks (16 sessions) in duration and are delivered in small groups of 4-6 adolescents with JFM. A total of 420 participants are anticipated to be enrolled across seven sites with approximately equal allocation to each treatment arm. Functional disability and average pain intensity in the past week will be assessed at baseline, post-treatment and at 3-, 6-, 9- and 12-month follow-up. The 3-month follow-up is the primary endpoint to evaluate treatment efficacy; longitudinal assessments will determine maintenance of treatment gains. Changes in coping, fear of movement, biomechanical changes and physical fitness will also be evaluated. CONCLUSIONS: This multi-site RCT is designed to evaluate whether the combined FIT Teens intervention will have significantly greater effects on disability and pain reduction than CBT or GAE alone for youth with JFM. Clinical trials.gov registration: NCT03268421.

Preliminary Outcomes of a Cross-Site Cognitive-Behavioral and Neuromuscular Integrative Training Intervention for Juvenile Fibromyalgia.

OBJECTIVE: Cognitive-behavioral therapy (CBT) is effective in reducing disability among youth with juvenile fibromyalgia (FM); however, engagement in moderate to vigorous physical activity remains poor, even after CBT. The purpose of this study was to evaluate the feasibility and preliminary outcomes of an innovative program combining CBT with specialized neuromuscular exercise: the Fibromyalgia Integrative Training for Teens (FIT Teens) program. METHODS: Adolescents with juvenile FM (n = 22, all female, ages 12-18 years) from 2 urban children's hospitals participated in the 8-week FIT Teens intervention. Participants completed measures of pain intensity, functional disability, depressive symptoms, pain catastrophizing, fear of movement, and readiness to change at baseline and after the intervention. RESULTS: The feasibility of the intervention across 2 sites was documented, including high retention rates (80%). Participants showed significant decreases in functional disability (P < 0.05), depression (P < 0.001), fear of movement (P < 0.01), and pain catastrophizing (P < 0.001) from pre- to postintervention. Results of the readiness to change measure indicated a significant decrease in precontemplation (P < 0.01) and increase in action/maintenance scores (P < 0.001). All results demonstrated medium to large effect sizes. CONCLUSION: Adolescents with juvenile FM reported significant improvements in physical function and reduced fear of movement following the intervention. Improvement in physical function was achieved in a shorter time frame than in a prior trial of CBT without an exercise component. Further work is needed to compare the FIT Teens program with existing approaches and determine whether objective changes in exercise participation are achieved.

A survey of conventional and complementary therapies used by youth with juvenile-onset fibromyalgia.

Little is known regarding treatment choices of youth diagnosed with juvenile-onset fibromyalgia (JFM) as they move into young adulthood. Additionally, there is little empirical evidence to guide youth with FM into appropriate treatment options, leading to a variety of therapies used to manage FM symptoms. The purpose of this descriptive study was to examine all therapies used by individuals with JFM as they entered young adulthood and the perceived effectiveness of these treatments. As part of a larger follow-up study, participants completed a web-based survey of all current and past treatments received for FM symptoms 2 years after their initial presentation and diagnosis at a pediatric rheumatology clinic. One hundred ten out of 118 eligible patients participated in the follow-up assessment as young adults (mean age 18.97 years; 93.6% female). A majority of participants reported use of conventional medications (e.g., antidepressants, anticonvulsants) and nondrug therapies (e.g., psychotherapy). Currently and within the past 2 years, antidepressant medications were the most commonly used to manage FM. Complementary treatments were used less often, with massage being the most popular choice. Although currently used treatments were reported as being effective, past treatments, especially medications, were viewed as being more variably effective. This is a potential reason why young adults with JFM might try more complementary and alternative approaches to managing their symptoms. More controlled studies are needed to investigate the effectiveness of these complementary methods to assist treatment providers in giving evidence-based treatment recommendations.