Performance of the 2016 ACR-EULAR myositis response criteria in juvenile dermatomyositis therapeutic trials and consensus profiles.

OBJECTIVES: The 2016 ACR-EULAR Response Criteria for JDM was developed as a composite measure with differential weights of six core set measures (CSMs) to calculate a Total Improvement Score (TIS). We assessed the contribution of each CSM, representation of muscle-related and patient-reported CSMs towards improvement, and frequency of CSM worsening across myositis response criteria (MRC) categories in validation of MRC. METHODS: Data from JDM patients in the Rituximab in Myositis trial (n = 48), PRINTO JDM trial (n = 139), and consensus patient profiles (n = 273) were included. Observed vs expected CSM contributions were compared using Sign test. Characteristics of MRC categories were compared by Wilcoxon tests with Bonferroni adjustment. Spearman correlation of changes in TIS and individual CSMs were examined. Agreement between physician-assessed change and MRC categories was evaluated by weighted Cohen's kappa. RESULTS: Of 457 JDM patients with IMACS CSMs and 380 with PRINTO CSMs, 9-13% had minimal, 19-23% had moderate and 41-50% had major improvement. The number of improved and absolute percentage change of CSMs increased by MRC improvement level. Patients with minimal improvement by MRC had a median of 0-1 CSM worsened, and those with moderate/major improvement had a median of zero worsening CSMs. Of patients improved by MRC, 94-95% had improvement in muscle strength and 93-95% had improvement in ≥1 patient-reported CSM. IMACS and PRINTO CSMs performed similarly. Physician-rated change and MRC improvement categories had moderate-to-substantial agreement (Kappa 0.5-0.7). CONCLUSION: The ACR-EULAR MRC perform consistently across multiple studies, supporting its further use as an efficacy end point in JDM trials.

Prednisone versus prednisone plus ciclosporin versus prednisone plus methotrexate in new-onset juvenile dermatomyositis: a randomised trial.

BACKGROUND: Most data for treatment of dermatomyositis and juvenile dermatomyositis are from anecdotal, non-randomised case series. We aimed to compare, in a randomised trial, the efficacy and safety of prednisone alone with that of prednisone plus either methotrexate or ciclosporin in children with new-onset juvenile dermatomyositis. METHODS: We did a randomised trial at 54 centres in 22 countries. We enrolled patients aged 18 years or younger with new-onset juvenile dermatomyositis who had received no previous treatment and did not have cutaneous or gastrointestinal ulceration. We randomly allocated 139 patients via a computer-based system to prednisone alone or in combination with either ciclosporin or methotrexate. We did not mask patients or investigators to treatment assignments. Our primary outcomes were the proportion of patients achieving a juvenile dermatomyositis PRINTO 20 level of improvement (20% improvement in three of six core set variables at 6 months), time to clinical remission, and time to treatment failure. We compared the three treatment groups with the Kruskal-Wallis test and Friedman's test, and we analysed survival with Kaplan-Meier curves and the log-rank test. Analysis was by intention to treat. Here, we present results after at least 2 years of treatment (induction and maintenance phases). This trial is registered with ClinicalTrials.gov, number NCT00323960. FINDINGS: Between May 31, 2006, and Nov 12, 2010, 47 patients were randomly assigned prednisone alone, 46 were allocated prednisone plus ciclosporin, and 46 were randomised prednisone plus methotrexate. Median duration of follow-up was 35.5 months. At month 6, 24 (51%) of 47 patients assigned prednisone, 32 (70%) of 46 allocated prednisone plus ciclosporin, and 33 (72%) of 46 administered prednisone plus methotrexate achieved a juvenile dermatomyositis PRINTO 20 improvement (p=0.0228). Median time to clinical remission was 41.9 months in patients assigned prednisone plus methotrexate but was not observable in the other two treatment groups (2.45 fold [95% CI 1.2-5.0] increase with prednisone plus methotrexate; p=0.012). Median time to treatment failure was 16.7 months in patients allocated prednisone, 53.3 months in those assigned prednisone plus ciclosporin, but was not observable in patients randomised to prednisone plus methotrexate (1.95 fold [95% CI 1.20-3.15] increase with prednisone; p=0.009). Median time to prednisone discontinuation was 35.8 months with prednisone alone compared with 29.4-29.7 months in the combination groups (p=0.002). A significantly greater proportion of patients assigned prednisone plus ciclosporin had adverse events, affecting the skin and subcutaneous tissues, gastrointestinal system, and general disorders. Infections and infestations were significantly increased in patients assigned prednisone plus ciclosporin and prednisone plus methotrexate. No patients died during the study. INTERPRETATION: Combined treatment with prednisone and either ciclosporin or methotrexate was more effective than prednisone alone. The safety profile and steroid-sparing effect favoured the combination of prednisone plus methotrexate. FUNDING: Italian Agency of Drug Evaluation, Istituto Giannina Gaslini (Genoa, Italy), Myositis Association (USA).

Recommendations of the Mexican College of Rheumatology for the management of psoriatic arthritis.

Psoriatic arthritis is a chronic systemic inflammatory disease that affects the skin, musculoskeletal structures and other organs and systems compromising functionality, quality of life and reducing the life expectancy of patients. It is a complex disease that requires specialist and timely care and management. The alternatives for treating the manifestations of psoriatic arthritis have increased and the effect of the different agents on specific manifestations has been clarified in recent studies. Therefore, we should incorporate the available evidence to build a strategy for the treatment of these patients. The Mexican College of Rheumatology selected a committee to evaluate these different alternatives and make recommendations. METHODS: The study group included 16 rheumatologists and 3 certified dermatologists, selected from different health institutions and regions of the country. An executive committee was formed to coordinate the meetings and a committee of experts selected the literature search criteria, prepared the research questions, rated the quality of the evidence, and produced the recommendations in the different disease domains based on the GRADE methodology. RESULTS: 24 updated recommendations were generated for the treatment of patients with psoriatic arthritis. The recommendations establish the role of the drugs currently available in our country. The importance of adequate disease control is emphasized, individualizing the level of involvement of each patient in each of the six domains potentially affected by the disease. In addition, the sequence in the choice of treatments available for each domain is established, based on their efficacy, safety profile and accessibility. CONCLUSIONS: With this consensus document, it will be possible to improve the care of patients with psoriatic arthritis. The recommendations were generated based on the best available information and in consideration of the Mexican health system.

Recommendations of the Mexican College of Rheumatology for the management of psoriatic arthritis. / Recomendaciones del Colegio Mexicano de Reumatología para el manejo de la artritis psoriásica.

Psoriatic arthritis is a chronic systemic inflammatory disease that affects the skin, musculoskeletal structures and other organs and systems compromising functionality, quality of life and reducing the life expectancy of patients. It is a complex disease that requires specialist and timely care and management. The alternatives for treating the manifestations of psoriatic arthritis have increased and the effect of the different agents on specific manifestations has been clarified in recent studies. Therefore, we should incorporate the available evidence to build a strategy for the treatment of these patients. The Mexican College of Rheumatology selected a committee to evaluate these different alternatives and make recommendations. METHODS: The study group included 16 rheumatologists and 3 certified dermatologists, selected from different health institutions and regions of the country. An executive committee was formed to coordinate the meetings and a committee of experts selected the literature search criteria, prepared the research questions, rated the quality of the evidence, and produced the recommendations in the different disease domains based on the GRADE methodology. RESULTS: 24 updated recommendations were generated for the treatment of patients with psoriatic arthritis. The recommendations establish the role of the drugs currently available in our country. The importance of adequate disease control is emphasized, individualizing the level of involvement of each patient in each of the six domains potentially affected by the disease. In addition, the sequence in the choice of treatments available for each domain is established, based on their efficacy, safety profile and accessibility. CONCLUSIONS: With this consensus document, it will be possible to improve the care of patients with psoriatic arthritis. The recommendations were generated based on the best available information and in consideration of the Mexican health system.

[Social costs of the most common inflammatory rheumatic diseases in Mexico from the patient's perspective]. / El costo de las principales enfermedades reumáticas inflamatorias desde la perspectiva del paciente en México.

OBJECTIVE: To estimate the social costs of rheumatoid arthritis (RA), ankylosing spondylitis (AS), and gout from the patient's perspective. METHODS: We carried out a cross-sectional analysis of the cost and resource utilization of 690 RA, AS, and gout patients from 10 medical centers and private facilities in five cities of Mexico. The information was obtained from the baseline of a dynamic cohort. We estimated out-of-pocket expenses, institutional direct costs, and direct medical costs. RESULTS: The mean (SD) annual out-of-pocket expense (USD) was $610.0 ($302.2) for RA, $578.6 ($220.5) for AS, and $245.3 ($124.0) for gout. Figures correspond to 15%, 9.6%, and 2.5% of the family income. They also represented 26.1%, 25.3%, and 24.4% of the total annual cost per RA, AS, and gout patients, respectively. The expected direct institutional patient/year costs were 1,724.2 for RA, $1,710.8 for AS, and $760.7 for gout. The total patient annual costs were $2,334.3 for RA, $2,289.4 for AS, and $1,006.1 for gout. Most out-of-pocket expenses were used to purchase drugs, pay for laboratory tests, imaging studies, and alternative therapies. CONCLUSIONS: From the patient's perspective, the cost of RA, AS, and gout represents 25% of direct medical costs. The cost of RA is higher than that for AS and gout.

Coping strategies for health and daily-life stressors in patients with rheumatoid arthritis, ankylosing spondylitis, and gout: STROBE-compliant article.

This article aims to identify the strategies for coping with health and daily-life stressors of Mexican patients with chronic rheumatic disease. We analyzed the baseline data of a cohort of patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), and gout. Their strategies for coping were identified with a validated questionnaire. Comparisons between health and daily-life stressors and between the 3 clinical conditions were made. With regression analyses, we determined the contribution of individual, socioeconomic, educational, and health-related quality-of-life variables to health status and coping strategy. We identified several predominant coping strategies in response to daily-life and health stressors in 261 patients with RA, 226 with AS, and 206 with gout. Evasive and reappraisal strategies were predominant when patients cope with health stressors; emotional/negative and evasive strategies predominated when coping with daily-life stressors. There was a significant association between the evasive pattern and the low short-form health survey (SF-36) scores and health stressors across the 3 diseases. Besides some differences between diagnoses, the most important finding was the predominance of the evasive strategy and its association with low SF-36 score and high level of pain in patients with gout. Patients with rheumatic diseases cope in different ways when confronted with health and daily-life stressors. The strategy of coping differs across diagnoses; emotional/negative and evasive strategies are associated with poor health-related quality of life. The identification of the coping strategies could result in the design of psychosocial interventions to improve self-management.

El costo de las principales enfermedades reumáticas inflamatorias desde la perspectiva del paciente en México / Social costs of the most common inflammatory rheumatic diseases in Mexico from the patient's perspective

Objetivo: Estimar el costo de la artritis reumatoide (AR), la espondilitis anquilosante (EA) y la gota, desde la perspectiva del paciente. Métodos: Análisis transversal de los costos y utilización de recursos de 690 pacientes con AR, EA y gota, de 10 departamentos de centros hospitalarios y consultorios privados de cinco ciudades del país, al momento de ser incluidos en una cohorte dinámica. Se incluye una estimación de los gastos de bolsillo, los costos médicos directos institucionales y el costo médico directo real. Resultados: El gasto de bolsillo promedio (SD) anual (en dólares) en pacientes con AR ascendió a $610.0 ($302.2), en EA a $578.6 ($220.5) y en gota a $245.3 ($124.0), lo que equivalió a 15, 9.6 y 2.5% del ingreso familiar, respectivamente. El gasto de bolsillo representó 26.1% del costo total anual por paciente con AR, 25.3% con EA y 24.4% con gota. Los costos directos institucionales esperados por paciente/año con AR fueron de $1724.2, con EA de $1710.8 y con gota de $760.7. El costo total anual por paciente con AR fue de $2334.3, con EA de $2289.4 y con gota de $1006.1. Los componentes del gasto de bolsillo de mayor cuantía fueron los medicamentos, exámenes de laboratorio y gabinete y las terapias alternativas. Conclusiones: Se concluye que desde la perspectiva del paciente, el costo de la AR, EA y gota equivale a la cuarta parte del costo médico directo. La AR es la enfermedad que mayor gasto implica.

OBJECTIVE: To estimate the social costs of rheumatoid arthritis (RA), ankylosing spondylitis (AS), and gout from the patient's perspective. METHODS: We carried out a cross-sectional analysis of the cost and resource utilization of 690 RA, AS, and gout patients from 10 medical centers and private facilities in five cities of Mexico. The information was obtained from the baseline of a dynamic cohort. We estimated out-of-pocket expenses, institutional direct costs, and direct medical costs. RESULTS: The mean (SD) annual out-of-pocket expense (USD) was $610.0 ($302.2) for RA, $578.6 ($220.5) for AS, and $245.3 ($124.0) for gout. Figures correspond to 15%, 9.6%, and 2.5% of the family income. They also represented 26.1%, 25.3%, and 24.4% of the total annual cost per RA, AS, and gout patients, respectively. The expected direct institutional patient/year costs were 1,724.2 for RA, $1,710.8 for AS, and $760.7 for gout. The total patient annual costs were $2,334.3 for RA, $2,289.4 for AS, and $1,006.1 for gout. Most out-of-pocket expenses were used to purchase drugs, pay for laboratory tests, imaging studies, and alternative therapies. CONCLUSIONS: From the patient's perspective, the cost of RA, AS, and gout represents 25% of direct medical costs. The cost of RA is higher than that for AS and gout.