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1.
Reumatol Clin (Engl Ed) ; 20(1): 43-44, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-38129251

RESUMO

Hematogenous spread of Neisseria gonorrhoeae, a sexually transmitted pathogen, results in disseminated gonococcal disease (DGD), also known as arthritis-dermatitis syndrome, due to the development of skin lesions, tenosynovitis, and arthritis. The most frequently affected population is young adults. We describe the case of an adolescent female who acutely developed skin lesions, arthritis, tenosynovitis, and constitutional symptoms. The causal agent was identified by a culture of vaginal secretion and treated with ceftriaxone for 7 days with complete recovery. It is important to differentiate this clinical picture from other types of arthritis developed in adolescence.


Assuntos
Artrite Infecciosa , Gonorreia , Tenossinovite , Adolescente , Adulto Jovem , Humanos , Feminino , Criança , Tenossinovite/complicações , Antibacterianos/uso terapêutico , Gonorreia/complicações , Gonorreia/diagnóstico , Gonorreia/tratamento farmacológico , Neisseria gonorrhoeae , Artrite Infecciosa/diagnóstico
2.
J Rheumatol ; 50(11): 1471-1480, 2023 11.
Artigo em Inglês | MEDLINE | ID: mdl-37453737

RESUMO

OBJECTIVE: To describe the efficacy and safety data of children with polyarticular-course juvenile idiopathic arthritis (pcJIA) treated with abatacept (ABA) + methotrexate (MTX) or ABA monotherapy when prior MTX use was either ineffective or not tolerated. METHODS: Posthoc analysis of 2 phase III trials of subcutaneous (SC) and intravenous (IV) ABA over 2 years in patients with pcJIA (aged 2-17 years). Patients were stratified by treatment with ABA + MTX or ABA monotherapy and further by prior biologic use. Efficacy outcomes included JIA-American College of Rheumatology (JIA-ACR) responses, Juvenile Arthritis Disease Activity Score in 27 joints using C-reactive protein (JADAS27-CRP), and safety. Descriptive pharmacokinetic analyses were also performed. RESULTS: Efficacy responses (JIA-ACR and JADAS27-CRP) were similar between patients receiving ABA + MTX (n = 310) or ABA monotherapy (n = 99) and persisted over 2 years. Clinical response rates were similar in biologic-naïve patients and prior biologic users; this was independent of MTX use. Across both studies, ABA + MTX and ABA monotherapy displayed similar safety profiles. Pharmacokinetic results revealed similar minimum steady-state trough ABA concentrations between studies. Further, baseline MTX did not influence ABA clearance and was not a significant predictor of JIA-ACR responses. CONCLUSION: ABA monotherapy (SC and IV) was effective and well tolerated in children with pcJIA when prior MTX use was ineffective or not tolerated. Treatment effects of ABA appear to be independent of MTX coadministration. Consequently, ABA monotherapy can be considered for those with prior biologic therapy if MTX use is inappropriate. (ClinicalTrials.gov: NCT01844518 and NCT00095173).


Assuntos
Antirreumáticos , Artrite Juvenil , Produtos Biológicos , Criança , Humanos , Metotrexato/uso terapêutico , Abatacepte/uso terapêutico , Artrite Juvenil/tratamento farmacológico , Artrite Juvenil/induzido quimicamente , Antirreumáticos/efeitos adversos , Quimioterapia Combinada , Produtos Biológicos/uso terapêutico , Resultado do Tratamento
3.
Reumatol Clin (Engl Ed) ; 19(7): 379-385, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37156651

RESUMO

OBJECTIVE: Describe the distribution of adult and pediatric rheumatologists with current certification in Mexico and the factors associated with this distribution. METHODS: The databases of the Mexican Council of Rheumatology and the Mexican College of Rheumatology for 2020 were reviewed. The rate of rheumatologists per 100,000 inhabitants by state of the Mexican Republic was calculated. To find out the number of inhabitants by state, the results of the 2020 population census of the National Institute of Statistics and Geography were consulted. The number of rheumatologists with current certification by state, age, and sex was analyzed. RESULTS: In Mexico, there are 1002 registered adult rheumatologists with a mean age of 48.12 ±â€¯13 years. The male gender prevailed with a ratio of 1.18:1. Ninety-four pediatric rheumatologists were identified with a mean age of 42.25 ±â€¯10.4 years, with a predominance of the female gender with a ratio of 2.2:1. In Mexico City and Jalisco, more than one rheumatologist/100,000 inhabitants were reported in the specialty of adults and only in Mexico City in pediatrics. The current certification is 65%-70% on average and the factors associated with a higher prevalence were younger age, female gender and geographic location. CONCLUSIONS: There is a shortage of rheumatologists in Mexico and in the pediatric area there are underserved regions. It is important that health policies apply measures that allow a more balanced and efficient regionalization of this specialty. Although most rheumatologists have current certification, it is necessary to establish strategies to increase this proportion.


Assuntos
Reumatologistas , Reumatologia , Adulto , Humanos , Masculino , Feminino , Criança , Pessoa de Meia-Idade , México , Certificação , Bases de Dados Factuais
4.
Indian J Pediatr ; 90(1): 29-37, 2023 01.
Artigo em Inglês | MEDLINE | ID: mdl-35476251

RESUMO

OBJECTIVES: To describe the design process of a medical care program for adolescents with pediatric onset rheumatic diseases (PRD) during the transition from pediatric to adult care in a resource-constrained hospital. METHODS: The model of attention was developed in three steps: 1) the selection of a multidisciplinary team, 2) the evaluation of the state of readiness of patients and caregivers for the transition, and 3) the design of a strategy of attention according to local needs. The results of the first two steps were used in order to develop the strategy of attention. RESULTS: The transition process was structured in three stages: pretransition (at pediatric rheumatology clinic), Transition Clinic for Adolescents with Rheumatic Diseases (TCARD, the main intervention), and post-transition (at adult rheumatology clinic). Each stage was divided, in turn, into a variable number of phases (8 in total), which included activities and goals that patients and caregivers were to accomplish during the process. A multidisciplinary approach was planned by pediatric and adult rheumatologists, nutritionists, physiatrists, psychiatrist, psychologist, nurse, and social worker. During TCARD, counseling, education, nutritional, physical, and mental health interventions were considered. CONCLUSIONS: The proposed transition model for patients with rheumatic diseases can be a useful tool in developing countries.


Assuntos
Doenças Reumáticas , Reumatologia , Transição para Assistência do Adulto , Adulto , Adolescente , Humanos , Criança , Reumatologia/métodos , Doenças Reumáticas/terapia , Instituições de Assistência Ambulatorial
5.
Pediatr Rheumatol Online J ; 20(1): 96, 2022 Nov 14.
Artigo em Inglês | MEDLINE | ID: mdl-36376976

RESUMO

BACKGROUND: Etanercept (ETN) and adalimumab (ADA) are considered equally effective biologicals in the treatment of arthritis in juvenile idiopathic arthritis (JIA) but no studies have compared their impact on patient-reported well-being. The objective of this study was to determine whether ETN and ADA have a differential effect on patient-reported well-being in non-systemic JIA using real-world data. METHODS: Biological-naive patients without a history of uveitis were selected from the international Pharmachild registry. Patients starting ETN were matched to patients starting ADA based on propensity score and outcomes were collected at time of therapy initiation and 3-12 months afterwards. Primary outcome at follow-up was the improvement in Juvenile Arthritis Multidimensional Assessment Report (JAMAR) visual analogue scale (VAS) well-being score from baseline. Secondary outcomes at follow-up were decrease in active joint count, adverse events and uveitis events. Outcomes were analyzed using linear and logistic mixed effects models. RESULTS: Out of 158 eligible patients, 45 ETN starters and 45 ADA starters could be propensity score matched resulting in similar VAS well-being scores at baseline. At follow-up, the median improvement in VAS well-being was 2 (interquartile range (IQR): 0.0 - 4.0) and scores were significantly better (P = 0.01) for ETN starters (median 0.0, IQR: 0.0 - 1.0) compared to ADA starters (median 1.0, IQR: 0.0 - 3.5). The estimated mean difference in VAS well-being improvement from baseline for ETN versus ADA was 0.89 (95% CI: -0.01 - 1.78; P = 0.06). The estimated mean difference in active joint count decrease was -0.36 (95% CI: -1.02 - 0.30; P = 0.28) and odds ratio for adverse events was 0.48 (95% CI: 0.16 -1.44; P = 0.19). One uveitis event was observed in the ETN group. CONCLUSIONS: Both ETN and ADA improve well-being in non-systemic JIA. Our data might indicate a trend towards a slightly stronger effect for ETN, but larger studies are needed to confirm this given the lack of statistical significance.


Assuntos
Antirreumáticos , Artrite Juvenil , Uveíte , Humanos , Etanercepte/efeitos adversos , Adalimumab/uso terapêutico , Artrite Juvenil/tratamento farmacológico , Estudos de Coortes , Pontuação de Propensão , Uveíte/tratamento farmacológico , Uveíte/etiologia , Resultado do Tratamento
7.
Pediatr Rheumatol Online J ; 20(1): 15, 2022 Feb 17.
Artigo em Inglês | MEDLINE | ID: mdl-35177101

RESUMO

BACKGROUND: Patients with juvenile chronic inflammatory systemic diseases (jCID) are vulnerable to many circumstances when transitioning to adult-centered healthcare; this increases the burden of disease and worsen their quality of life. METHODS: MEDLINE, Embase, Web of Science and Scopus were searched from inception to March 16th, 2021. We included observational, randomized controlled trials and quasi-experimental studies that evaluated a transitional care program for adolescents and young adults with jCIDs. We extracted information regarding health-related quality of life, disease activity, drop-out rates, clinical attendance rates, hospital admission rates, disease-related knowledge, surgeries performed, drug toxicity and satisfaction rates. RESULTS: Fifteen studies met our inclusion criteria. The implementation of transition programs showed a reduction on hospital admission rates for those with transition program (OR 0.28; 95% CI 0.13 to 0.61; I 2 = 0%; p = 0.97), rates of surgeries performed (OR 0.26; 95% CI 0.12 to 0.59; I 2 = 0%; p = 0.50) and drop-out rates from the adult clinic (OR 0.23; 95% CI 0.12 to 0.46; I 2 = 0%; p = 0.88). No differences were found in other outcomes. CONCLUSION: The available body of evidence supports the implementation of transition programs as it could be a determining factor to prevent hospital admission rates, surgeries needed and adult clinic attendance rates.


Assuntos
Doenças Autoimunes/terapia , Efeitos Psicossociais da Doença , Qualidade de Vida , Doenças Reumáticas/terapia , Cuidado Transicional , Adolescente , Adulto , Criança , Doença Crônica/terapia , Fibrose Cística/terapia , Diabetes Mellitus/terapia , Humanos , Síndrome do Intestino Irritável/terapia , Adulto Jovem
8.
Rheumatology (Oxford) ; 61(5): 2104-2112, 2022 05 05.
Artigo em Inglês | MEDLINE | ID: mdl-34508559

RESUMO

OBJECTIVE: To describe risk factors for IBD development in a cohort of children with JIA. METHODS: JIA patients who developed IBD were identified from the international Pharmachild register. Characteristics were compared between IBD and non-IBD patients and predictors of IBD were determined using multivariable logistic regression analysis. Incidence rates of IBD events on different DMARDs were calculated, and differences between therapies were expressed as relative risks (RR). RESULTS: Out of 8942 patients, 48 (0.54% ) developed IBD. These were more often male (47.9% vs 32.0%) and HLA-B27 positive (38.2% vs 21.0%) and older at JIA onset (median 8.94 vs 5.33 years) than patients without IBD development. They also had more often a family history of autoimmune disease (42.6% vs 24.4%) and enthesitis-related arthritis (39.6% vs 10.8%). The strongest predictors of IBD on multivariable analysis were enthesitis-related arthritis [odds ratio (OR): 3.68, 95% CI: 1.41, 9.40] and a family history of autoimmune disease (OR: 2.27, 95% CI: 1.12, 4.54). Compared with methotrexate monotherapy, the incidence of IBD on etanercept monotherapy (RR: 7.69, 95% CI: 1.99, 29.74), etanercept with methotrexate (RR: 5.70, 95% CI: 1.42, 22.77) and infliximab (RR: 7.61, 95% CI: 1.27, 45.57) therapy was significantly higher. Incidence on adalimumab was not significantly different (RR: 1.45, 95% CI: 0.15, 13.89). CONCLUSION: IBD in JIA was associated with enthesitis-related arthritis and a family history of autoimmune disease. An increased IBD incidence was observed for etanercept therapy regardless of concomitant methotrexate use.


Assuntos
Antirreumáticos , Artrite Juvenil , Doenças Inflamatórias Intestinais , Antirreumáticos/efeitos adversos , Artrite Juvenil/tratamento farmacológico , Artrite Juvenil/epidemiologia , Criança , Etanercepte/efeitos adversos , Humanos , Incidência , Doenças Inflamatórias Intestinais/tratamento farmacológico , Doenças Inflamatórias Intestinais/epidemiologia , Masculino , Metotrexato/uso terapêutico , Sistema de Registros
9.
Pediatr Rheumatol Online J ; 19(1): 152, 2021 Oct 09.
Artigo em Inglês | MEDLINE | ID: mdl-34627296

RESUMO

BACKGROUND: Juvenile Idiopathic Arthritis (JIA) requires complex care that generate elevated costs, which results in a high economic impact for the family. The aim of this systematic review was to collect and cluster the information currently available on healthcare costs associated with JIA after the introduction of biological therapies. METHODS: We comprehensively searched in MEDLINE, EMBASE, Web of Science, Scopus, and Cochrane Databases for studies from January 2000 to March 2021. Reviewers working independently and in duplicate appraised the quality and included primary studies that report total, direct and/or indirect costs related to JIA for at least one year. The costs were converted to United States dollars and an inflationary adjustment was made. RESULTS: We found 18 eligible studies including data from 6,540 patients. Total costs were reported in 10 articles, ranging from $310 USD to $44,832 USD annually. Direct costs were reported in 16 articles ($193 USD to $32,446 USD), showing a proportion of 55 to 98 % of total costs. Those costs were mostly related to medications and medical appointments. Six studies reported indirect costs ($117 USD to $12,385 USD). Four studies reported costs according to JIA category observing the highest in polyarticular JIA. Total and direct costs increased up to three times after biological therapy initiation. A high risk of reporting bias and inconsistency of the methodology used were found. CONCLUSION: The costs of JIA are substantial, and the highest are derived from medication and medical appointments. Indirect costs of JIA are underrepresented in costs analysis.


Assuntos
Artrite Juvenil/economia , Efeitos Psicossociais da Doença , Custos de Cuidados de Saúde , Análise Custo-Benefício , Humanos
10.
Pediatr Rheumatol Online J ; 19(1): 30, 2021 Mar 17.
Artigo em Inglês | MEDLINE | ID: mdl-33731150

RESUMO

BACKGROUND: Pediatric rheumatic disease (PRD) patients and their caregivers face a number of challenges, including the consequences of the PRD in patients and the impact on multiple dimensions of the caregivers' daily lives. The objective of this study is to measure the economic, psychological and social impact that PRD has on the caregivers of Mexican children. METHODS: This is a multicenter, cross-sectional study including primary caregivers of children and adolescents with PRD (JIA, JDM and JSLE) during April and November, 2019. A trained interviewer conducted the CAREGIVERS questionnaire, a specific, 28-item multidimensional tool validated to measure the impact on different dimensions of the lives of caregivers. Sociodemographic, clinical, and healthcare system data were collected for further analysis. RESULTS: Two hundred participants were recruited (women 169, 84.5%, aged 38 [IQR 33-44] years); 109 (54.5%) cared for patients with JIA, 28 (14%) JDM and 63 (31.5%) JSLE. The healthcare system was found to be determinant on the impact of the disease. The emotional impact was higher in all the participants, regardless of the specific diagnoses. The social dimension showed significant differences regarding PRD, healthcare system, time to reach the center, presence of disability, active disease, cutaneous and systemic manifestations, treatment and partner. Financial and work impacts were more frequent in those caring for JSLE and less so in those with a partner. Family relationships changed in 81 caregivers (25 [12.5%] worsened and 56 [28%] improved). No variables affecting spirituality were found. For caregivers without a partner, the social networks impact increased. CONCLUSION: The influence of sociodemographic factors can be devastating on families with children with a PRD. These data will help physicians to identify the areas with the greatest need for intervention to achieve comprehensive care for caregivers and their patients.


Assuntos
Cuidadores/economia , Cuidadores/psicologia , Efeitos Psicossociais da Doença , Doenças Reumáticas , Adulto , Criança , Estudos Transversais , Feminino , Humanos , Masculino , México , Autorrelato
11.
Pediatr Infect Dis J ; 40(3): e113-e115, 2021 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-33565816

RESUMO

Multisystem inflammatory syndrome in children (MIS-C) is an emerging entity during the coronavirus disease 2019 pandemic. Medium- and large-vessel changes are present in MIS-C; however, microcirculatory impairment has not been documented. We report a case of MIS-C in a toddler that presented with persistent fever, gastrointestinal symptoms and rash. Nailfold videocapillaroscopy was abnormal, suggesting microcirculatory disease in the setting of MIS-C.


Assuntos
COVID-19/diagnóstico , Gastroenteropatias/diagnóstico , SARS-CoV-2/isolamento & purificação , Síndrome de Resposta Inflamatória Sistêmica/diagnóstico , COVID-19/fisiopatologia , COVID-19/virologia , Exantema , Febre , Gastroenteropatias/fisiopatologia , Gastroenteropatias/virologia , Humanos , Lactente , Masculino , México , Microcirculação , Angioscopia Microscópica , Síndrome de Resposta Inflamatória Sistêmica/fisiopatologia , Síndrome de Resposta Inflamatória Sistêmica/virologia
12.
Rheumatology (Oxford) ; 60(10): 4568-4580, 2021 10 02.
Artigo em Inglês | MEDLINE | ID: mdl-33506875

RESUMO

OBJECTIVES: To determine s.c. tocilizumab (s.c.-TCZ) dosing regimens for systemic JIA (sJIA) and polyarticular JIA (pJIA). METHODS: In two 52-week phase 1 b trials, s.c.-TCZ (162 mg/dose) was administered to sJIA patients every week or every 2 weeks (every 10 days before interim analysis) and to pJIA patients every 2 weeks or every 3 weeks with body weight ≥30 kg or <30 kg, respectively. Primary end points were pharmacokinetics, pharmacodynamics and safety; efficacy was exploratory. Comparisons were made to data from phase 3 trials with i.v. tocilizumab (i.v.-TCZ) in sJIA and pJIA. RESULTS: Study participants were 51 sJIA patients and 52 pJIA patients aged 1-17 years who received s.c.-TCZ. Steady-state minimum TCZ concentration (Ctrough) >5th percentile of that achieved with i.v.-TCZ was achieved by 49 (96%) sJIA and 52 (100%) pJIA patients. In both populations, pharmacodynamic markers of disease were similar between body weight groups. Improvements in Juvenile Arthritis DAS-71 were comparable between s.c.-TCZ and i.v.-TCZ. By week 52, 53% of sJIA patients and 31% of pJIA patients achieved clinical remission on treatment. Safety was consistent with that of i.v.-TCZ except for injection site reactions, reported by 41.2% and 28.8% of sJIA and pJIA patients, respectively. Infections were reported in 78.4% and 69.2% of patients, respectively. Two sJIA patients died; both deaths were considered to be related to TCZ. CONCLUSION: s.c.-TCZ provides exposure and risk/benefit profiles similar to those of i.v.-TCZ. S.c. administration provides an alternative administration route that is more convenient for patients and caregivers and that has potential for in-home use. TRIAL REGISTRATION: ClinicalTrials.gov, http://clinicaltrials.gov, NCT01904292 and NCT01904279.


Assuntos
Anticorpos Monoclonais Humanizados/administração & dosagem , Antirreumáticos/administração & dosagem , Artrite Juvenil/tratamento farmacológico , Artrite/tratamento farmacológico , Adolescente , Criança , Pré-Escolar , Relação Dose-Resposta a Droga , Esquema de Medicação , Feminino , Humanos , Lactente , Injeções Subcutâneas , Masculino , Resultado do Tratamento
13.
Pediatr Rheumatol Online J ; 18(1): 3, 2020 Jan 14.
Artigo em Inglês | MEDLINE | ID: mdl-31937332

RESUMO

BACKGROUND: The primary caregiver is an important person in the life of patients with JIA. Their reactions depend on social, emotional and economic factors that affect the therapeutic alliance. Some generic instruments have been used to evaluate burden, anxiety, or quality of life of caregivers. This study aims to develop a specific instrument to measure the psychosocial and economic impacts on primary caregivers of patients with JIA. METHODOLOGY: This is a mixed methods research, that includes qualitative and quantitative data, and was carried out in two phases. First phase: a pragmatic qualitative study (questionnaire construction) was conducted in two parts, a non-systematic literature review followed by interviews with primary caregivers. Second phase: a cross-sectional study (questionnaire validation) to complete validation and estimate Cronbach's alphas based on tetrachoric correlation coefficients, correlation matrix and Cohen's kappa coefficient test. RESULTS: There were 38 articles found related to the experience of caregivers. 15 primary caregivers were interviewed (female 93%, median age 45 years). Thematic analysis identified 9 important topics from the perspective of participants (economic impact, coping, family roles, impact of diagnosis, mental health, couple/mate relationships, impact at work, religion, and knowledge of the disease). These topics were combined to create the interview questionnaire (56 items). Later, it was modified to 62 items that were divided into five dimensions: impact of the disease (psychosocial, economic, family, and relationships), knowledge of the disease, alternative medicine, future, and religion. The interview questionnaire was applied to 32 primary caregivers (female 93%, median age 37 years), results identify depression on 29 (90%), 18 (56%) feel sadness at diagnosis, 20 (63%) mentioned that JIA has influenced in their financial situation, 23 (72%) feel anxiety about the future, and 11 (37%) considered that their family relationships have changed. Statistical analysis identified inconsistencies during convergent and divergent validity of the construct. Consequently, 11 items were eliminated, 3 relocated, 6 modified, and 39 compacted obtaining the "Impact of Pediatric Rheumatic Diseases on Caregivers Multi-assessment Questionnaire" (CAREGIVERS questionnaire). This final version resulted on an eight-dimension (28 items) instrument. CONCLUSIONS: The CAREGIVERS questionnaire captures perspectives of both the participants and clinicians. It will be helpful to measure the impact of the disease and thus, to improve the quality of care of children with JIA and their families.


Assuntos
Artrite Juvenil/terapia , Cuidadores/psicologia , Adolescente , Adulto , Artrite Juvenil/psicologia , Cuidadores/estatística & dados numéricos , Criança , Humanos , Entrevistas como Assunto , Masculino , Pessoa de Meia-Idade , Psicologia , Reprodutibilidade dos Testes , Fatores Socioeconômicos , Inquéritos e Questionários
14.
J Rheumatol ; 45(8): 1173-1179, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-29961686

RESUMO

OBJECTIVE: Evaluate growth in patients with polyarticular-course juvenile idiopathic arthritis (pcJIA) treated with tocilizumab (TCZ) for up to 2 years in a phase III trial. METHODS: Patients with pcJIA lasting at least 6 months and inadequate response to methotrexate received open-label TCZ intravenously every 4 weeks (randomly assigned to 8 or 10 mg/kg if they weighed < 30 kg; received 8 mg/kg if they weighed ≥ 30 kg) for 16 weeks. Patients with JIA American College of Rheumatology 30 response at Week 16 were randomly assigned to TCZ or placebo for 24 weeks, with an open-label extension through Week 104. Mean ± SD height velocity (cm/yr) and World Health Organization (WHO) height SD score (SDS) were measured in patients receiving ≥ 1 dose of TCZ who did not receive growth hormone and in patients whose baseline Tanner stage was ≤ 3. RESULTS: The study included 187 of 188 patients (99.5%) with mean WHO height SDS -0.5 ± 1.2, which was unrelated to age or disease duration (Spearman rank correlations r = 0.08 and r = -0.12, respectively). There were 123 patients at Tanner stage ≤ 3 at baseline, among whom 103 completed the study with 2 years of height SDS data. Mean height SDS increased from baseline to year 2 (+0.40, p < 0.0001). In 74 of 103 patients (72%), height SDS was greater than at baseline, and mean height velocity was 6.7 ± 2.0 cm/year. CONCLUSION: Among patients with pcJIA at Tanner stage ≤ 3 at baseline, 72% (74/103) had increased height SDS at the end of the study.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Antirreumáticos/uso terapêutico , Artrite Juvenil/tratamento farmacológico , Estatura/efeitos dos fármacos , Desenvolvimento Infantil/efeitos dos fármacos , Adolescente , Anticorpos Monoclonais Humanizados/administração & dosagem , Antirreumáticos/administração & dosagem , Artrite Juvenil/fisiopatologia , Criança , Pré-Escolar , Método Duplo-Cego , Feminino , Humanos , Masculino , Resultado do Tratamento
15.
Arthritis Rheumatol ; 70(7): 1144-1154, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29481737

RESUMO

OBJECTIVE: To investigate the pharmacokinetics, effectiveness, and safety of subcutaneous (SC) abatacept treatment over 24 months in patients with polyarticular-course juvenile idiopathic arthritis (JIA). METHODS: In this phase III, open-label, international, multicenter, single-arm study, patients with polyarticular JIA (cohort 1, ages 6-17 years and cohort 2, ages 2-5 years) in whom treatment with ≥1 disease-modifying antirheumatic drug was unsuccessful received weight-tiered SC abatacept weekly: 10 to <25 kg (50 mg), 25 to <50 kg (87.5 mg), ≥50 kg (125 mg). Patients who had met the JIA-American College of Rheumatology 30% improvement criteria (achieved a JIA-ACR 30 response) at month 4 were given the option to continue SC abatacept to month 24. The primary end point was the abatacept steady-state serum trough concentration (Cminss ) in cohort 1 at month 4. Other outcome measures included JIA-ACR 30, 50, 70, 90, 100, and inactive disease status, the median Juvenile Arthritis Disease Activity Score in 71 joints using the C-reactive protein level (JADAS-71-CRP) over time, safety, and immunogenicity. RESULTS: The median abatacept Cminss at month 4 (primary end point) and at month 24 was above the target therapeutic exposure (10 µg/ml) in both cohorts. The percentage of patients who had achieved JIA-ACR 30, 50, 70, 90, or 100 responses or had inactive disease responses at month 4 (intent-to-treat population) was 83.2%, 72.8%, 52.6%, 28.3%, 14.5%, and 30.1%, respectively, in cohort 1 (n = 173) and 89.1%, 84.8%, 73.9%, 58.7%, 41.3%, and 50.0%, respectively, in cohort 2 (n = 46); the responses were maintained to month 24. The median (interquartile range) JADAS-71-CRP improved from baseline to month 4: cohort 1, from 21.0 (13.5, 30.3) to 4.6 (2.1, 9.4); cohort 2, from 18.1 (14.0, 23.1) to 2.1 (0.3, 4.4). Improvements were sustained to month 24, at which time 27 of 173 patients (cohort 1) and 11 of 22 patients (cohort 2) had achieved JADAS-71-CRP remission. No unexpected adverse events were reported; 4 of 172 patients (2.3%) in cohort 1 and 4 of 46 (8.7%) in cohort 2 developed anti-abatacept antibodies, with no clinical effects. CONCLUSION: Weight-stratified SC abatacept yielded target therapeutic exposures across age and weight groups, was well tolerated, and improved polyarticular JIA symptoms over 24 months.


Assuntos
Abatacepte/administração & dosagem , Artrite Juvenil/tratamento farmacológico , Imunossupressores/administração & dosagem , Adolescente , Artrite Juvenil/imunologia , Criança , Pré-Escolar , Estudos de Coortes , Feminino , Humanos , Injeções Subcutâneas , Masculino , Resultado do Tratamento
16.
Ann Rheum Dis ; 77(1): 21-29, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-28507219

RESUMO

OBJECTIVE: This report aims to determine the safety, pharmacokinetics (PK) and efficacy of subcutaneous golimumab in active polyarticular-course juvenile idiopathic arthritis (polyJIA). METHODS: In this three-part randomised double-blinded placebo-controlled withdrawal trial, all patients received open-label golimumab (30 mg/m2 of body surface area; maximum: 50 mg/dose) every 4 weeks together with weekly methotrexate during Part 1 (weeks 0-16). Patients with at least 30% improvement per American College of Rheumatology Criteria for JIA (JIA ACR30) in Part 1 entered the double-blinded Part 2 (weeks 16-48) after 1:1 randomisation to continue golimumab or start placebo. In Part 3, golimumab was continued or could be restarted as in Part 1. The primary outcome was JIA flares in Part 2; secondary outcomes included JIA ACR50/70/90 responses, clinical remission, PK and safety. RESULTS: Among 173 patients with polyJIA enrolled, 89.0% (154/173) had a JIA ACR30 response and 79.2%/65.9%/36.4% demonstrated JIA ACR50/70/90 responses in Part 1. At week 48, the primary endpoint was not met as treatment groups had comparable JIA flare rates (golimumab vs placebo: 32/78=41% vs 36/76=47%; p=0.41), and rates of clinical remission were comparable (golimumab vs placebo: 10/78=12.8% vs 9/76=11.8%). Adverse event and serious adverse event rates were similar in the treatment groups during Part 2. Injection site reactions occurred with <1% of all injections. PK analysis confirmed adequate golimumab dosing for polyJIA. CONCLUSION: Although the primary endpoint was not met, golimumab resulted in rapid, clinically meaningful, improvement in children with active polyJIA. Golimumab was well tolerated, and no unexpected safety events occurred. CLINICAL TRIAL REGISTRATION: NCT01230827; Results.


Assuntos
Anticorpos Monoclonais/administração & dosagem , Antirreumáticos/administração & dosagem , Artrite Juvenil/tratamento farmacológico , Artrite/tratamento farmacológico , Metotrexato/administração & dosagem , Adolescente , Artrite/patologia , Artrite Juvenil/patologia , Criança , Pré-Escolar , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Humanos , Injeções Subcutâneas , Masculino , Indução de Remissão , Exacerbação dos Sintomas , Resultado do Tratamento
17.
Rheumatol Int ; 36(4): 495-503, 2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-26521081

RESUMO

The aim of this study was to validate the paediatric Gait, Arms, Legs, Spine (pGALS) tool for Mexican Spanish to screen Mexican paediatric population for musculoskeletal (MSK) disorders. A cross-sectional study was performed in the Paediatric Hospital of the Mexican Social Security Institute in Guadalajara, Jalisco. The validation included children and adolescents aged 6-16 years, 87 patients with musculoskeletal disorders and 88 controls without musculoskeletal disorders. The cross-cultural validation followed the current published guidelines. The average pGALS administration time was 2.9 min (SD 0.54). The internal consistency score (Cronbach's α) was 0.90 (0.89 for inflammatory and 0.77 for non-inflammatory disorders) for MSK disorders, with a sensitivity of 97 % (95 % CI 92-99 %), a specificity of 93 % (95 % CI 86-97 %), a LR+ of 14.3, and a ROC curve of 0.95 (95 % CI 0.92-0.98 %). The inflammatory disorders group had a sensitivity of 97 % (95 % CI 86-99 %), a specificity of 93 % (95 % CI 86-97 %), a LR+ of 14.2, and a ROC curve of 0.95 % (95 % CI 0.91-0.99 %). The non-inflammatory disorders group had a sensitivity of 98 % (95 % CI 89-99 %), a specificity of 93 % (95 % CI 86-97 %), and a LR+ of 14.37, with a ROC curve of 0.95 % (95 % CI 0.92-0.98 %). pGALS is a valid screening tool, fast, easy to administer, and useful for detecting musculoskeletal disorders in Mexican children and adolescents.


Assuntos
Características Culturais , Marcha , Extremidade Inferior/fisiopatologia , Doenças Musculoesqueléticas/diagnóstico , Coluna Vertebral/fisiopatologia , Inquéritos e Questionários , Extremidade Superior/fisiopatologia , Adolescente , Fatores Etários , Área Sob a Curva , Estudos de Casos e Controles , Criança , Estudos Transversais , Feminino , Humanos , Masculino , México/epidemiologia , Doenças Musculoesqueléticas/etnologia , Doenças Musculoesqueléticas/fisiopatologia , Valor Preditivo dos Testes , Curva ROC , Reprodutibilidade dos Testes , Tradução
18.
Gac Med Mex ; 151(6): 741-8, 2015.
Artigo em Espanhol | MEDLINE | ID: mdl-26581532

RESUMO

OBJECTIVE: To determine the noise levels of different areas responsible for newborn care, develop intervention strategies to decrease the noise, and evaluate its effectiveness. METHODS: Prospective, observational and longitudinal study carried out using a sonometer, measuring sound levels for three weeks in the neonatal intensive care unit (NICU), neonatal intermediate care unit (UCIREN), delivery (TOCO QX) and nursery (CUNERO) units. We implemented an intervention program and subsequent measurements were performed under the same initial conditions. RESULTS: When comparing the decibel levels in different areas during the three weeks, pre- and post-intervention, we found at the neonatal intensive care unit 59.9±4.8 vs. 56.4±4.7 dB (p<0.001), neonatal intermediate care unit 55.3±3.9 vs. 51.3±4.4 dB (p<0.001), delivery unit 57.3±4.6 vs. 57.3±5.5 dB (NS), and nursery unit 57.6±5.8 vs. 53.9±5.8 dB (p<0.001). CONCLUSIONS: There was a significant reduction in noise levels of 3.5 dB at the NICU, 4 dB at UCIREN and 3.7 dB at TOCO QX, so the intervention program was effective in these areas; however, the decibel levels registered continue above those recommended by international standards.


Assuntos
Exposição Ambiental/prevenção & controle , Monitoramento Ambiental/métodos , Ruído/prevenção & controle , Exposição Ambiental/análise , Ambiente de Instituições de Saúde , Humanos , Recém-Nascido , Unidades de Terapia Intensiva Neonatal , Estudos Longitudinais , Estudos Prospectivos , Centros de Atenção Terciária
19.
Arthritis Rheumatol ; 67(10): 2759-70, 2015 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-26097215

RESUMO

OBJECTIVE: The efficacy and safety of abatacept in patients with juvenile idiopathic arthritis (JIA) who experienced an inadequate response to disease-modifying antirheumatic drugs were previously established in a phase III study that included a 4-month open-label lead-in period, a 6-month double-blind withdrawal period, and a long-term extension (LTE) phase. The aim of this study was to present the safety, efficacy, and patient-reported outcomes of abatacept treatment (10 mg/kg every 4 weeks) during the LTE phase, for up to 7 years of followup. METHODS: Patients enrolled in the phase III trial could enter the open-label LTE phase if they had not achieved a response to treatment at month 4 or if they had received abatacept or placebo during the double-blind period. RESULTS: One hundred fifty-three (80.5%) of 190 patients entered the LTE phase, and 69 patients (36.3%) completed it. The overall incidence rate (events per 100 patient-years) of adverse events decreased during the LTE phase (433.61 events during the short-term phase [combined lead-in and double-blind periods] versus 132.39 events during the LTE phase). Similar results were observed for serious adverse events (6.82 versus 5.60), serious infections (1.13 versus 1.72), malignancies (1.12 versus 0), and autoimmune events (2.26 versus 1.18). American College of Rheumatology (ACR) Pediatric 30 (Pedi 30) responses, Pedi 70 responses, and clinically inactive disease status were maintained throughout the LTE phase in patients who continued to receive therapy. Improvements in the Child Health Questionnaire physical and psychosocial summary scores were maintained over time. CONCLUSION: Long-term abatacept treatment for up to 7 years was associated with consistent safety, sustained efficacy, and quality-of-life benefits in patients with JIA.


Assuntos
Abatacepte/efeitos adversos , Abatacepte/uso terapêutico , Artrite Juvenil/tratamento farmacológico , Artrite Juvenil/psicologia , Qualidade de Vida/psicologia , Atividades Cotidianas/psicologia , Adolescente , Antirreumáticos/efeitos adversos , Antirreumáticos/uso terapêutico , Criança , Método Duplo-Cego , Feminino , Humanos , Estudos Longitudinais , Masculino , Psicologia , Autorrelato , Inquéritos e Questionários , Fatores de Tempo , Resultado do Tratamento
20.
Int J Infect Dis ; 33: 106-8, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25449228

RESUMO

The incidences of infection with Mycobacterium tuberculosis and Cryptococcus neoformans in immunocompromised patients have increased, but there are few documented cases of their coexistence. We present the case of a 9-year-old female with systemic lupus erythematosus (SLE), treated with prednisone and cyclophosphamide, who was admitted to the emergency department with a 2-week history of fever, headache, malaise, fatigue, and diplopia 3 years after diagnosis. Physical examination showed limitation of abduction of the right eye, Kernig and Brudzinski signs, and hyporeflexia. Magnetic resonance imaging showed hyperdense lesions located in the caudate nucleus, and lumbar puncture showed pleocytosis, a low glucose level, and increased protein level. Cerebrospinal fluid culture identified C. neoformans and PCR detect M. tuberculosis. Treatment was started with isoniazid, rifampin, pyrazinamide, ethambutol, and amphotericin B. We found two similar reports in adults, but no data were found for either pediatric or SLE patients.


Assuntos
Coinfecção/complicações , Criptococose/complicações , Hospedeiro Imunocomprometido , Lúpus Eritematoso Sistêmico/complicações , Meningoencefalite/complicações , Anfotericina B/uso terapêutico , Antituberculosos/uso terapêutico , Criança , Coinfecção/líquido cefalorraquidiano , Coinfecção/tratamento farmacológico , Criptococose/líquido cefalorraquidiano , Criptococose/tratamento farmacológico , Cryptococcus neoformans/isolamento & purificação , Etambutol/uso terapêutico , Feminino , Humanos , Isoniazida/uso terapêutico , Lúpus Eritematoso Sistêmico/tratamento farmacológico , Meningoencefalite/tratamento farmacológico , Meningoencefalite/microbiologia , Mycobacterium tuberculosis/isolamento & purificação , Pirazinamida/uso terapêutico , Rifampina/uso terapêutico
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