Schön Klinik Hamburg Eilbek

This study assessed sarilumab in treating patients with polyarticular-course juvenile idiopathic arthritis (pcJIA). This phase 2b, open-label study (NCT02776735) consisted of three sequential parts (each with a core-treatment and extension phase). During part 1, three doses were assessed in two weight groups (group A/B: ≥30-60 kg/≥10 to <30 kg) to select the optimal dose with regard to pharmacokinetics, safety and efficacy were evaluated in latter parts. During the extension phase of part 1, patients initially assigned to the selected optimal dose continued on this dose; the remaining patients were switched to this selected dose. Patients in parts 2 and 3 received the selected dose from baseline. The primary endpoint was pharmacokinetic exposure (area under the serum concentration versus time curve during a dose interval Շ of 2 weeks [AUC0-Շ], maximum serum concentration observed [Cmax], and concentrations observed before treatment administration during repeated dosing [Ctrough]). Safety and efficacy were assessed. The mean age of treated patients (N = 101; 76.2% female) was 9.4 years. Of the evaluated doses in part 1, dose 2 (group A/B: 3.0/4.0 mg/kg every 2 weeks [q2w]) was selected. In patients receiving the selected dose from baseline (n = 73), Cmax, AUC0-14 days and Ctrough at steady state in group A/B were 27.1/40.4 mg/L, 276/395-day*mg/L, and 9.57/14.4 mg/L, respectively. At week 48, the JIA-American College of Rheumatology 30%, 50%, 70%, and 90% improvement criteria rates were 100%, 100%, 93.8%, and 76.6%, respectively. Adverse events were reported in 70 of 73 patients (95.9%). Twenty-seven patients (37%) experienced grade 3/4 neutropenia; there were no associated infections. No deaths occurred. In patients with pcJIA receiving the selected dose from baseline, pharmacokinetic exposure was comparable to a dose of 200 mg q2w for adults with rheumatoid arthritis. Clinically relevant improvements were observed in disease activity, with safety being consistent with the known profile of sarilumab.

BackgroundTo evaluate the use of hydroxychloroquine (HCQ) and its impact on the Health Assessment Questionnaire disability index(HAQ-DI) and the Cochin Hand Function Status(CHFS) in a large Systemic Sclerosis (SSc) cohort.MethodsSSc patients from the European Scleroderma Trials and Research (EUSTAR) database treated with HCQ for at least 6 months were evaluated and compared to a matched group of SSc patients not using HCQ. Demographic and clinical data, concomitant drugs, HAQ-DI and CHFS (at least 2 evaluations) were recorded and were the outcome variables of interest. Statistical analysis was performed using propensity score matching for age, gender, disease duration, corticosteroids, immunosuppressives, vasoactive drugs in a 3:1 control: HCQ ratio. Standard descriptive statistics and Student’s t-test and Chi-square test were used to assess the propensity-matched groups.ResultsOut of 17,805 SSc patients evaluated, 468 (2.6%) used HCQ and constituted the HCQ group. Among them, 50 (10.7%) had at least a baseline and follow-up HAQ-DI evaluation and 44 (9.4%) had at least a baseline and follow-up CHFS evaluation.Propensity matching assured that patients were matched for female gender (HCQ vs. control 92.0% vs. 85.3%), mean age (49.8 vs. 50.0 years) disease duration (8.3 vs. 9.1 years), limited disease (55.3 vs. 62.6%) as well as background medications (all P > 0.1). We did not find any significant differences among the two groups in the change of HAQ-DI or CHFS, over up to 365 days (all P > 0.05).ConclusionsResults from the EUSTAR registry showed that HCQ was used by 2.6% of SSc patients. HCQ use did not improve the HAQ-DI, or CHFS when comparing HCQ users to non-HCQ users.

INTRODUCCI&#x00D3;N La fundaci&#x00F3;n de la European Association of Percutaneous Cardiovascular Interventions (EAPCI) por el Grupo de Trabajo en Cardiolog&#x00ED;a Intervencionista de la antigua European Society of Cardiology (ESC) se sit&#x00FA;a en 2006. Dentro de la ESC, y como 1 de las 7 asociaciones de subespecialidades, la misi&#x00F3;n de la EAPCI es, ante todo, reducir la carga de las enfermedades cardiovasculares mediante la realizaci&#x00F3;n de intervenciones cardiovasculares percut&#x00E1;neas. La EAPCI capacita a cardi&#x00F3;logos intervencionistas a trav&#x00E9;s de una s&#x00F3;lida red de recursos dise&#x00F1;ados ad hoc para satisfacer las demandas propias de la pr&#x00E1;ctica cl&#x00ED;nica contempor&#x00E1;nea. En las secciones que se presentan a continuaci&#x00F3;n, esbozaremos los principales beneficios que tiene ser miembro de la EAPCI en materia cient&#x00ED;fica, de contenido, educativa, de defensa, as&#x00ED; como a nivel colaborativo (figura 1). Cada uno de estos pilares conforman un marco que no solo mantiene a sus miembros a la vanguardia de la cardiolog&#x00ED;a intervencionista, sino que tambi&#x00E9;n fomenta la colaboraci&#x00F3;n con grupos y sociedades nacionales para avanzar colectivamente en este campo. Figura 1. &#x00BF;Por qu&#x00E9; ser miembro de la European Association of Percutaneous Cardiovascular Interventions (EAPCI)? Resaltando estas valiosas ventajas, esperamos poder subrayar el verdadero valor que tiene pertenecer a la EAPCI ayudando a los cardi&#x00F3;logos intervencionistas a...

BackgroundPhysical therapy interventions play a crucial role in the daily care of patients recovering from severe stroke. However, the efficacy of these interventions and associated modalities, including duration, intensity, and frequency, have not been fully elucidated. In 2020, a systematic review reported the beneficial effects of physical therapy for patients with severe stroke but did not assess therapeutic modalities. We aim to update the current evidence on the effects of physical therapy interventions and their modalities in relation to the recovery phase in people with severe stroke in a hospital or inpatient rehabilitation facility.MethodsWe searched CENTRAL, MEDLINE, Web of Science, and three other relevant databases between December 2018 and March 2021 and updated the search between April 2021 and March 2023. ClinicalTrials.gov and ICTRP for searching trial registries helped to identify ongoing RCTs since 2023. We included individual and cluster randomized controlled trials in the English and German languages that compared physical therapy interventions to similar or other interventions, usual care, or no intervention in a hospital or rehabilitation inpatient setting. We screened the studies from this recent review for eligibility criteria, especially according to the setting. Critical appraisal was performed according to the Cochrane risk-of-bias tool 2.0. The data were synthesized narratively.ResultsThe update identified 15 new studies, cumulating in a total of 30 studies (n = 2545 participants) meeting the eligibility criteria. These studies reported 54 outcomes and 20 physical therapy interventions. Two studies included participants during the hyperacute phase, 4 during the acute phase,18 during the early subacute phase, and 3 in the late subacute phase. Three studies started in the chronic phase. Summarised evidence has revealed an uncertain effect of physical therapy on patient outcomes (with moderate to low-quality evidence). Most studies showed a high risk of bias and did not reach the optimal sample size. Little was stated about the standard care and their therapy modalities.DiscussionThere is conflicting evidence for the effectiveness of physical therapy interventions in patients with severe stroke. There is a need for additional high-quality studies that also systematically report therapeutic modalities from a multidimensional perspective in motor stroke recovery. Due to the high risk of bias and the generally small sample size of the included studies, the generalizability of the findings to large and heterogeneous volumes of outcome data is limited.Systematic review registrationPROSPERO CRD42021244285.

The goal was to develop and validate classification criteria for axial juvenile spondyloarthritis (SpA; AxJSpA). This international initiative consisted of four phases: (1) item generation, (2) item reduction, (3) criteria development, and (4) validation of the AxJSpA criteria by an independent team of experts in an internationally representative validation cohort. These criteria are intended to be used on youth with a physician diagnosis of juvenile SpA and for whom axial disease is suspected. Item generation consisted of a systematic literature review and a free-listing exercise using input from international physicians, which collectively resulted in 108 items. After the item reduction exercise and expert panel input, 37 items remained for further consideration. The final AxJSpA criteria domains included the following: imaging of active inflammation, imaging of structural lesions, pain chronicity, pain pattern, pain location, stiffness, and genetics. The most heavily weighted domains were active inflammation and structural lesions on imaging. Imaging typical of sacroiliitis was deemed necessary, but not sufficient, to classify a youth with AxJSpA. The threshold for classification of AxJSpA was a score of ≥55 (out of 100). When tested in the validation data set, the final criteria had a specificity of 97.5% (95% confidence interval [CI] 91.4%-99.7%), sensitivity of 64.3% (95% CI 54.9%-73.1%), and area under the receiver operating characteristic curve of 0.81 (95% CI 0.76%-0.86%). The new AxJSpA classification criteria require an entry criterion and a physician diagnosis of juvenile SpA and include seven weighted domains. The AxJSpA classification criteria are validated and designed to identify participants for research studies.

Introduction: Weight bias internalization (WBI) is associated with reduced psychological well-being in individuals with obesity. The aim of this study was to investigate the application of Cohen’s stress-buffering model of social support for WBI on well-being in patients presenting for bariatric surgery. Methods: In N = 804 adult prebariatric patients, WBI, social support, depression severity, health-related quality of life (HRQOL), and self-esteem were assessed by self-report questionnaires. Structural Equation Modeling was applied to test for direct associations between social support and well-being and for a buffering effect of social support on the relationship between WBI and well-being. Results: After controlling for age, sex, and body mass index, greater social support was directly associated with reduced depression severity and increased self-esteem, but not with increased HRQOL. Contrary to Cohen’s stress-buffering model, social support showed no moderating effects on the association between WBI and depression severity, HRQOL, and self-esteem. Conclusion: These cross-sectional results may indicate that greater social support is associated with improved well-being, supporting it as a potential coping resource in bariatric surgery. Given the absence of supporting evidence for the buffering effect in the present study, future prospective research may reevaluate the existence of a moderating effect of social support and investigate whether support-focused interventions improve psychological well-being.

BackgroundPhysical active lifestyles are essential throughout growth and maturation and may offer potential preventive and therapeutic benefit in patients with juvenile idiopathic arthritis (JIA). Insufficient physical activity (PA), in contrast, can lead to aggravation of disease-related symptoms. This study aimed to i) examine PA levels in children and adolescents with JIA compared to general population controls and ii) investigate correlates of pronounced physical inactivity in order to identify risk groups for sedentary behaviour.MethodsData from children and adolescents with JIA and population controls aged 3 to 17 years documented in the National Pediatric Rheumatologic Database (NPRD) and the German Health Interview and Examination Survey for Children and Adolescents (KiGGS) were used. Self-reported PA was collected from parents/guardians of children up to 11 years of age or adolescents 12 years of age and older. To compare PA-related data, age- and sex-specific pairwise analyses were conducted considering NPRD/KiGGS participants' data from 2017. Correlates of physical inactivity among patients were identified using a linear regression model.ResultsData of 6,297 matched-pairs (mean age 11.2 ± 4.2 years, female 67%, patients’ disease duration 4.5 ± 3.7 years, persistent oligoarthritis 43%) were available for evaluation. Almost 36% of patients aged 3–17 years (vs. 20% of controls) achieved the WHO recommended amount of PA, while PA steadily decreased with age (18% of patients aged ≥ 12 years) and varied between JIA categories. Female adolescents and patients with enthesitis-related arthritis were least likely to achieve the minimum recommended level of PA. Physical inactivity was associated with female sex, higher age at disease onset, longer disease duration, more functional disability (C-HAQ) and higher disease activity (cJADAS-10).ConclusionsDepending on JIA category, children and adolescents with JIA were similarly or even more likely to achieve the WHO recommended minimum level of PA compared to general population controls. However, since a large proportion of young JIA patients appear to be insufficiently physically active, engagement in targeted efforts to promote PA is urgently needed.

The term 'sclerosing diseases of the skin' comprises specific dermatological entities, which have fibrotic changes of the skin in common. These diseases mostly manifest in different clinical subtypes according to cutaneous and extracutaneous involvement and can sometimes be difficult to distinguish from each other. The present consensus provides an update to the 2017 European Dermatology Forum Guidelines, focusing on characteristic clinical and histopathological features, diagnostic scores and the serum autoantibodies most useful for differential diagnosis. In addition, updated strategies for the first- and advanced-line therapy of sclerosing skin diseases are addressed in detail. Part 1 of this consensus provides clinicians with an overview of the diagnosis and treatment of localized scleroderma (morphea), and systemic sclerosis including overlap syndromes.

Bariatric surgery candidates (BSC) are a highly vulnerable group for mental health impairments. According to the theoretical model of weight stigma, weight-related experienced stigmatization (ES) negatively influences mental health through weight bias internalization (WBI). This study tested this model among BSC and investigated whether this association depends on a negative body image in terms of weight and shape concern as a potential moderator. As part of a German multicenter study, ES, WBI, weight and shape concern, and depressive symptoms were assessed via self-report questionnaires among n = 854 BSC. Simple and moderated mediation analyses were applied to analyze whether WBI influences the relationship between ES and depressive symptoms, and whether this influence depends on weight and shape concern. WBI significantly mediated the relationship between ES and depressive symptoms by partially reducing the association of ES with depressive symptoms. Weight and shape concern emerged as significant moderators in the overall model and specifically for associations between WBI and depressive symptoms. The results suggest that the association between ES and depressive symptoms among BSC is stronger in those with high WBI. This association is strengthened by weight and shape concern, especially at low and mean levels. Studies evaluating longitudinal associations between weight-related stigmatization and mental health are indicated, as well as intervention studies targeting WBI in order to reduce adverse effects of ES on mental health in BSC.