40 research outputs found
Efficacy and Safety of Etanercept Biosimilars Compared With the Originator for Treatment of Juvenile Arthritis: A Prospective Observational Study
No full textObjective Analysis of etanercept biosimilars in pediatric patients with juvenile idiopathic arthritis (JIA) in comparison with the etanercept originator in terms of efficacy and safety. Methods Patients diagnosed with JIA who started treatment with either the etanercept originator or a biosimilar after January 1, 2017, were selected from the German BIKER registry (Biologics in Paediatric Rheumatology Registry). Furthermore, patients who started therapy with the originator and switched to a biosimilar during the course of therapy were identified. For both patient groups, disease activity and safety were examined and compared separately. Results After January 1, 2017, 348 patients started treatment with the etanercept originator (n = 293) or a biosimilar (n = 55). Another 57 patients switched to a biosimilar during the course of therapy. A significant decrease or a stable remission of disease activity was observed in both patient groups. The safety profiles were comparable, and frequencies and types of adverse events (AEs) and serious AEs were similar in patients starting therapy with the originator or a biosimilar. Only injection site reactions occurred slightly more frequently under biosimilar therapy, without having an impact on therapy adherence. In patients who switched therapy, the AE rate per 100 patient‐years was comparable before (26.4) and after (32.1) the switch. Conclusion In patients with JIA who require treatment with etanercept, the originator is still used much more frequently. However, our study highlights the equivalence of etanercept biosimilars for therapy for JIA. Increased use of these biosimilars in pediatric patients can therefore be recommended without hesitation
Toward standardized musculoskeletal ultrasound in pediatric rheumatology: Normal age related ultrasound findings
No full textThe OMERACT Ultrasound Task Force has recently started to work on the validation and standardization of musculoskeletal ultrasound (MSUS) examination in children in order to improve its applicability to joint examination
Anxiety and depression symptoms in adolescents and young adults with juvenile idiopathic arthritis : results of an outpatient screening
No full textPrevious studies have shown that growing up with rheumatic conditions can fuel dissatisfaction and psychological distress, which in turn affects disease self-management and treatment adherence. Primary objective of this study was to estimate the prevalence of anxiety and depression symptoms in adolescents and young adults (AYA) with juvenile idiopathic arthritis (JIA) and to identify correlates of conspicuous screening results. Initiated as part of the COACH multicenter observational study, outpatients aged 12 to 21 years participating in the National Pediatric Rheumatological Database (NPRD) were prospectively screened for mental health using the Patient Health Questionnaire-9 (PHQ-9) and the Generalised Anxiety Disorder Scale-7 (GAD-7). Data from 1,150 adolescents with JIA (mean age 15.6 ± 2.2 years; mean disease duration 7.2 ± 4.9 years, 69% female, 43% oligoarthritis, 26% polyarthritis) were analysed. Overall, 32.7% (n = 316) of AYA showed conspicuous screening results, of whom 30.4% reported clinically relevant suicidal or self-harm thoughts. About 19% of screened patients showed moderate to severe depressive or anxious symptoms. AYA with conspicuous screening results were older (15.8 vs. 15.2 years; p < 0.0001), more often female (81% vs. 64%; p < 0.0001) and more often overweight (25% vs. 17%; p = 0.006). They had higher disease activity (physician global assessment on NRS 0–10; 1.7 vs. 1.2; p < 0.0001), more functional limitations (CHAQ; 0.44 vs. 0.14; <0.0001) and rated their health status worse (NRS 0–10; 3.5 vs. 1.8; p < 0.0001) than AYA with inconspicuous screening results. Females (OR 2.33 [CI 1.53–3.56]; p < 0.0001), older age (OR 1.09 [CI 1.01–1.18]; p = 0.026), patients with more functional limitations (OR 3.36 [CI 1.98–5.72]; p < 0.0001), and patients with worse subjective health status (OR 1.17 [CI 1.07–1.27]; p < 0.0001) were more likely to have a conspicuous screening result. Regular sports participation was associated with a lower likelihood of conspicuous screening result (OR 0.69 [CI 0.49–0.98]; p = 0.039). A large-scale outpatient screening of AYA with JIA in Germany shows a high prevalence of anxiety and depression symptoms. The need for routine screening for early detection of mental health problems became apparent
Doppler Sonography of Blood Flow Velocity in the Vertebral Arteries of Preterm and Term Neonates
No full textPhysical (in)activity and screen-based media use of adolescents with juvenile idiopathic arthritis over time : data from a German inception cohort
No full textBackground:
Regular physical activity (PA) has been proven to help prevent non-communicable diseases and is beneficial for disease management in chronically ill populations. Physical inactivity and recreational screen-based media (SBM) use are related to poor health outcomes and common among youth. This study aimed to (1) investigate PA levels and recreational SBM use of adolescents with JIA over time and (2) compare these behaviours with those of their peers.
Methods:
Data from JIA patients and their peers enrolled in the inception cohort study ICON at 11 German centers were analyzed. Individuals aged 13 and over were followed prospectively with questionnaires concerning PA level, recreational SBM use, and health-related quality of life (HRQoL) at a two-year interval. Group by time interactions were analyzed using linear mixed models.
Results:
Data of 214 patients (mean age at first documentation 14.4 ± 0.9 years, female 63%) and 141 peers could be considered. At first documentation, patients were less physically active compared to their peers (p < 0.001). In contrast to their peers, patients’ PA levels increased over time (OR 3.69; 95% CI: 1.01–13.50, p = 0.048). Mean screen time did not differ significantly between patients and peers (first documentation: 3.5 h vs. 3.0 h, p = 0.556; follow-up: 3.6 h vs. 3.3 h, p = 0. 969). During the observation period, male patients reported higher PA levels than female patients, but also higher screen time levels. While low socioeconomic status (SES) (OR 14.40; 95%-CI: 2.84–73.15) and higher cJADAS-10 score (OR 1.31; 95%-CI: 1.03–1.66) increased the likelihood for high SBM use (≥ 4.5 h/d), higher PedsQL psychosocial health score (OR 0.93; 95%-CI: 0.88–0.99) was associated with a decreased likelihood.
Conclusions:
Adolescents with JIA become more physically active over the disease course and achieve comparable levels of PA and recreational screen time to their peers. However, the vast majority appear to be insufficiently physically active. Future interventions to promote healthy lifestyles should include gender and SES as important determinants to reach most vulnerable groups
POS0170 EXPERIENCES WITH COVID-19 INFECTIONS IN GERMAN PEDIATRIC RHEUMATOLOGY CENTERS
No full textBackgroundAlthough the risk for severe COVID-19 progression in children is low, this may be aggravated by the underlying disease and/or immunosuppressive drugs.ObjectivesWe analyzed clinical data of COVID-19 cases among paediatric patients with rheumatic diseases reported to the BIKER registry.MethodsThe main task of the German BIKER (Biologics in Pediatric Rheumatology) registry is to monitor the safety of biologics therapies in JIA. After the onset of the COVID-19 pandemic, the survey was expanded with a standardized form to proactively interview all participating centers about the occurrence, presentation, and outcome of SARS-CoV-2- infections in children with rheumatic diseases. Interviews were conducted with 68 centers initially weekly and later biweekly.ResultsA total of 68 centres participated in the survey. Clinical data from 194 COVID-19 cases reported to the BIKER registry from 41 German and 1 Austrian pediatric rheumatology institutions between February 2020 and December 2021 were analyzed. Juvenile idiopathic arthritis (JIA, n=144) was the most common diagnosis followed by genetic autoinflammation (n=18; i.e. FMF, TRAPS, CAPS, HIDS, DADA2), systemic autoimmune diseases (n=11; i.e. SLE, dermatomyositis, vasculitis) and 16 with other rheumatic diseases (i.e. CRMO, Uveitis). 5 patients with no rheumatic disease were excluded. 104 (54%) patients were receiving conventional DMARDs, 81 (43%) received biologics, mainly TNF inhibitors (n=66 (35%)).Of the 189 rheumatic patients with SARS-CoV2 infection, 123 (63%) were female. The mean age was 12.4+/-4.4 years in females and 13.2+/-4.1 in males. The duration of SARS-Co2 infection associated symptoms was 13.8+/-15.3 days (max. 113 days), in 35 (43%) patients they lasted for > 12 days. 46 (24%) were asymptomatic. Patients with autoinflammation and systemic autoimmunopathies reported more symptoms such as fever, head and throat ache. 4 patients only complained about dyspnea.Only 3 patients were hospitalized and received Oxygen-supplementation. The only patients admitted to ICU, received ventilation but succumbed. This 3½-year-old patient, initially diagnosed with systemic JIA, developed fatal disease with intracranial edema and respiratory failure, as well as typical pulmonary texture changes. Prior to her SARS-CoV-2 infection, the patient was treated with MTX and low-dose steroids. Genetic testing revealed a so far unrecognized congenital immunodeficiency.In the total JIA cohort, treatment with corticosteroids, conventional DMARDs, biologics or combinations did not influence the number of reported symptoms or the favorable outcome of the cohort. However, the duration of symptoms was lower in the TNF-treated cohort (10.4+/-6.4 days vs. 15.7 +/- 19.7 days). In the cohort with autoinflammation, fever was observed in 11 (61%). Those 6 who received IL-1-inhibitors did not show a different outcome than those 12 who did not. No case of PIMS/MISC in children with rheumatic diseases was reported.ConclusionExcept for one patient with congenital immunodeficiency who died from her COVID-19 infection, no case of severe COVID-19 was reported in our cohort. At the time of infection, over 80% of patients in our cohort had been treated with conventional DMARDs and/or biologics. This did not appear to have a negative impact on the severity or outcome of SARS-CoV2 infection. Interestingly, no case of PIMS/MISC was observed.Disclosure of InterestsGerd Horneff Speakers bureau: Novartis, Pfizer, Janssen, Grant/research support from: Pfizer, Novartis, Roche, MSD, Frank Dressler Speakers bureau: Pfizer, Novartis, Abbvie, Paid instructor for: Advisory boards Novartis, Mylan, Daniel Windschall Speakers bureau: Pfizer, Novartis, Abbvie, MEDAC, Canon, Grant/research support from: Novartis, Pfizer, Sonja Mrusek: None declared, Toni Hospach: None declared, Alexander Kühn: None declared, Maria Haller: None declared, Philipp von Bismarck: None declared, Wolfgang Emminger: None declared, Peggy Ruehmer: None declared, Markus Hufnagel: None declared, Ariane Klein Speakers bureau: Novartis</jats:sec
Age-related vascularization and ossification of joints in children: an international pilot study to test multi-observer ultrasound reliability
No full textObjective: To determine the intra- and interobserver reliability of ultrasound (US)-detected age-related joint vascularization and ossification grading in healthy children. Methods: Following standardized image acquisition and machine setting protocols, 10 international US experts examined 4 joints (wrist, second metacarpophalangeal joint, knee, and ankle) in 12 healthy children (divided into 4 age groups: 2–4, 5–8, 9–12, and 13–16 years). Gray-scale was used to detect the ossification grade, and power Doppler ultrasound (PDUS) was used to detect physiologic vascularization. Ossification was graded from 0 (no ossification) to 3 (complete ossification). A positive PDUS signal was defined as any PDUS signal inside the joint. Kappa statistics were applied for intra- and interobserver reliability. Results: According to the specific joint and age, up to 4 solitary PDUS signals (mean 1.5) were detected within each joint area with predominant localization of the physiologic vascularization in specific anatomic positions: fat pad, epiphysis, physis, and short bone cartilage. The kappa values for ossification grading were 0.87 (range 0.85–0.91) and 0.58 for intra- and interobserver reliability, respectively. The bias-adjusted kappa values for intra- and interobserver reliability were 0.71 (range 0.44–1.00) and 0.69, respectively. Conclusion: Detection of normal findings (i.e., grading of physiologic ossification during skeletal maturation and identification of physiologic vessels) can be highly reliable by using clear definitions and a standardized acquisition protocol. These data will permit development of a reliable and standardized US approach for evaluating pediatric joint pathologies
