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Stuttgart Mühlhausen, Germany

Schmeling H.,University of Calgary | Minden K.,Childrens University Hospital Charite | Foeldvari I.,Hamburg Center for Paediatrics and Adolescence Rheumatology | Ganser G.,North Western German Center for Rheumatology and Orthopaedics | Hospach T.,Olgahospital
Arthritis and Rheumatology | Year: 2014

Objective. To evaluate the efficacy and safety of adalimumab in patients with juvenile idiopathic arthritis (JIA). Methods. Baseline demographic and clinical characteristics and disease activity parameters were prospectively documented in the German Biologics JIA Registry. Efficacy was determined using the American College of Rheumatology (ACR) Pediatric (Pedi) response criteria and the Juvenile Arthritis Disease Activity Score based on a 10-joint count (JADAS-10). Safety assessments were based on adverse event reports from the responsible physician. Results. Two hundred eighty-nine patients with a total of 1,046 visits were identified (435.7 patient-years). A high proportion of patients demonstrated a significant response to treatment, with a marked decrease in the JADAS-10 score in both the biologics-naive group (which consisted of patients who had not received therapy with a biologic agent prior to initiation of adalimumab) and the biologic-switcher group (which consisted of patients who had been treated with a different biologic agent prior to initiation of adalimumab). The median JADAS-10 score at treatment start was significantly higher in the biologics-naive group than in the biologic-switcher group (12.9 versus 8.5; P = 0.00044), although the score in the biologics-naive group was lower over the course of adalimumab treatment. ACR Pedi 30, 50, 70, and 90 scores were achieved in 63.4%, 61.0%, 48.8%, and 34.2% of biologics-naive patients, respectively, at 6 months of treatment, while ACR Pedi 30, 50, 70, and 90 scores were achieved in 47.6%, 38.1%, 21.9%, and 15.2% of biologic-switcher patients, respectively. Forty-eight patients experienced 222 adverse events (50.9 per 100 patient-years). Eleven were reported as serious (2.5 per 100 patient-years). No malignancies were observed during adalimumab exposure. There were 16 uveitis flares in 11 patients. Treatment was discontinued in 58 patients for the following reasons: inefficacy 11.1%, adverse events 5.2%, remission 4.5%, patient request 11.8%, and other reasons 7.9%. Conclusion. Adalimumab appears to be highly effective in children and adolescents with JIA who have been previously treated with biologic agents and in children and adolescents who switched biologic agents. The treatment is safe and its efficacy is similar to that of other biologic agents used to treat JIA. Few patients discontinued therapy due to intolerance or inefficacy. © 2014, American College of Rheumatology.

Gopel W.,University of Lubeck | Kribs A.,University of Cologne | Ziegler A.,University of Lubeck | Laux R.,Asklepios Klinik Barmbek | And 13 more authors.
The Lancet | Year: 2011

Surfactant is usually given to mechanically ventilated preterm infants via an endotracheal tube to treat respiratory distress syndrome. We tested a new method of surfactant application to spontaneously breathing preterm infants to avoid mechanical ventilation. In a parallel-group, randomised controlled trial, 220 preterm infants with a gestational age between 26 and 28 weeks and a birthweight less than 1·5 kg were enrolled in 12 German neonatal intensive care units. Infants were independently randomised in a 1:1 ratio with variable block sizes, to standard treatment or intervention, and randomisation was stratified according to centre and multiple birth status. Masking was not possible. Infants were stabilised with continuous positive airway pressure and received rescue intubation if necessary. In the intervention group, infants received surfactant treatment during spontaneous breathing via a thin catheter inserted into the trachea by laryngoscopy if they needed a fraction of inspired oxygen more than 0·30. The primary endpoint was need for any mechanical ventilation, or being not ventilated but having a partial pressure of carbon dioxide more than 65 mm Hg (8·6 kPa) or a fraction of inspired oxygen more than 0·60, or both, for more than 2 h between 25 h and 72 h of age. Analysis was by intention to treat. This study is registered, number ISRCTN05025922. 108 infants were assigned to the intervention group and 112 infants to the standard treatment group. All infants were analysed. On day 2 or 3 after birth, 30 (28) infants in the intervention group were mechanically ventilated versus 51 (46) in the standard treatment group (number needed to treat 6, 95 CI 3-20, absolute risk reduction 0·18, 95 CI 0·30-0·05, p=0·008). 36 (33) infants in the intervention group were mechanically ventilated during their stay in the hospital compared with 82 (73) in the standard treatment group (number needed to treat: 3, 95 CI 2-4, p<0·0001). The intervention group had significantly fewer median days on mechanical ventilation, (0 days. IQR 0-3 vs 2 days, 0-5) and a lower need for oxygen therapy at 28 days (30 infants [30] vs 49 infants [45], p=0·032) compared with the standard treatment group. We recorded no differences between groups for mortality (seven deaths in the intervention group vs five in the standard treatment group) and serious adverse events (21 vs 28). The application of surfactant via a thin catheter to spontaneously breathing preterm infants receiving continuous positive airway pressure reduces the need for mechanical ventilation. German Ministry of Research and Technology, University of Lübeck, and Chiesi Pharmaceuticals. © 2011 Elsevier Ltd.

Holder M.,Olgahospital | Lilientha E.,Ruhr University Bochum
Monatsschrift fur Kinderheilkunde | Year: 2012

Intensive insulin treatment has continuously increased in the last 15 years for the treatment of type-1 diabetes in children and adolescents. Especially continuous subcutaneous insulin infusion (CSII) is now an established treatment option in all pediatric age groups. In very young children (<6 years), more than two-thirds of patients are using CSII. With CSII better glycemic control and quality of life, but less severe hypoglycemia appeared compared with multiple daily injection (MDI) therapy. The use of continuous glucose monitoring (CGM) is also increasing in pediatric patients. CGM is mostly applied for several days for diagnostic reasons and to optimize therapy. Sensor augmented pump ther-apy is recommended when used on a nearly daily basis. CGM can be an additional tool to optimize glycemic control and maintaining target HbA1c levels, while limiting the risk of hypoglycemic events. © Springer-Verlag 2012.

Mainz J.G.,Jena University Hospital | Schien C.,Jena University Hospital | Schiller I.,Jena University Hospital | Schadlich K.,Jena University Hospital | And 6 more authors.
Journal of Cystic Fibrosis | Year: 2014

Background: Chronic rhinosinusitis significantly impairs CF patients' quality of life and overall health. The Pari-Sinus™ device delivers vibrating aerosol effectively to paranasal sinuses. After a small pilot study to assess sinonasal inhalation of dornase alfa and placebo (isotonic saline) on potential sinonasal outcome measures, we present the subsequent prospective double-blind placebo-controlled crossover-trial. Methods: 23 CF patients were randomised to inhale either dornase alfa or isotonic saline for 28. days with the Pari-Sinus™ and after 28. days (wash-out) crossed over to the alternative treatment. The primary outcome parameter was primary nasal symptom score in the disease-specific quality of life Sino-Nasal Outcome-Test-20 (SNOT-20: nasal obstruction/sneezing/runny nose/thick nasal discharge/reduced smelling). Results: Primary nasal symptoms improved significantly with dornase alfa compared with no treatment, while small improvements with isotonic saline did not reach significance. SNOT-20 overall scores improved significantly after dornase alfa compared with isotonic saline (p=0.017). Additionally, sinonasal dornase alfa but not isotonic saline significantly improved pulmonary function (FEF75-25: p=0.021). Conclusion: Vibrating sinonasal inhalation of dornase alfa reduces rhinosinusitis symptoms in CF. © 2014 European Cystic Fibrosis Society.

Hirschfeld G.,German Paediatric Pain Center | Von Glischinski M.,German Paediatric Pain Center | Blankenburg M.,Olgahospital | Zernikow B.,German Paediatric Pain Center
Pediatrics | Year: 2014

BACKGROUND AND OBJECTIVE: Although guidelines for the management of children with type 1 diabetes include recommendations to screen for diabetic peripheral neuropathies (DPN), the research into the diagnostic utility of screening methods has not been systematically reviewed. The goal of this study was to summarize the findings with regard to the diagnostic accuracy of the Semmes-Weinstein monofilament and the Rydel-Seiffer tuning fork in detecting DPN in children and adolescents compared with the gold standard nerve conduction studies. METHODS: Based on a PubMed search (conducted on April 26, 2013) and secondary searching, we identified 72 articles for review. We included studies that: (1) assessed DPN with the gold standard nerve conduction studies; (2) used noninvasive screening for DPN (monofilament, tuning fork, or biothesiometer); and (3) were performed in the relevant population (children with diabetes). Five articles met these criteria. Study quality was assessed by using the revised Quality Assessment of Diagnostic Accuracy Studies criteria. Heterogeneous methods precluded a formal meta-analysis of effects. RESULTS: Diagnostic accuracies were heterogeneous for the different screening methods. Sensitivities ranged from 1% to 19% for the tuning fork (3 studies); from 61% to 80% for the biothesiometer (2 studies); and from 19% to 73% for the monofilament (2 studies). CONCLUSIONS: Data show extremely low diagnostic utility for standard screening methods (tuning fork and 10-g monofilament) but acceptable utilities for biothesiometry and finer (1 g) monofilaments. Data on the diagnostic utility should be used to inform national and international guidelines on diabetes management. Copyright © 2014 by the American Academy of Pediatrics.

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