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Open-label, multicentre, dose-escalating phase II clinical trial on the safety and efficacy of tadekinig alfa (IL-18BP) in adult-onset Still’s disease
ObjectivesAdult-onset Still’s disease (AOSD) is a rare systemic autoinflammatory disease; its management is largely empirical. This is the first clinical study to determine if interleukin (IL)-18 inhibition, using the recombinant human IL-18 binding protein, tadekinig alfa, is a therapeutic option in AOSD.MethodsIn this phase II, open-label study, patients were ≥18 years with active AOSD plus fever or C reactive protein (CRP) levels ≥10 mg/L despite treatment with prednisone and/or conventional synthetic disease-modifying antirheumatic drugs (DMARDs). Previous biological DMARD treatment was permitted. Patients received tadekinig alfa 80 mg or 160 mg subcutaneously three times per week for 12 weeks; those receiving 80 mg not achieving early predicted response criteria (reduction of ≥50% CRP values from baseline and fever resolution) were up-titrated to 160 mg for a further 12 weeks. The primary endpoint was the occurrence of adverse events (AEs) throughout the study.ResultsTen patients were assigned to receive 80 mg tadekinig alfa and 13 patients to the 160 mg dose. One hundred and fifty-five treatment-emerging AEs were recorded, and 47 were considered related to the study drug. Most AEs were mild and resolved after drug discontinuation. Three serious AEs occurred, one possibly related to treatment (toxic optic neuropathy). At week 3, 5 of 10 patients receiving 80 mg and 6 of 12 patients receiving 160 mg achieved the predefined response criteria.ConclusionsOur results indicate that tadekinig alfa appears to have a favourable safety profile and is associated with early signs of efficacy in patients with AOSD.Trial registration numberNCT02398435.
Journal Article
Redefining post-traditional learning : emerging research and opportunities
\"\"This book explores changing student demographics and offers recommendations to current teaching methodologies through the lens of andragogy\"--Provided by publisher\"-- Provided by publisher.
Book
Emerging adults\ in Deutschland: Differentielle Unterschiede in Bezug auf Identität, Beruf und Partnerschaft und deren Zusammenhänge mit internalisierenden Symptomen
\"Emerging adults\" in Germany: Differences in Identity, Work and Partnership and their Associations with Internalizing Symptoms Young adults are an increasingly common clientele in outpatient and inpatient psychotherapy facilities, many of them with internalizing disorders such as anxiety and depression. Objective: The present study examines associations between identity, workand relationshiprelated variables and internalizing symptoms in a sample of young adults with different professional and relationship status. Methods: In a cross-sectional study with 3,267 young adults (M = 23.61 years, SD = 2.94, 59 % female), sociodemographic characteristics, health-related variables, and workand relationship-related variables are analyzed. Genderand professional group-specific differences are examined using MANOVAs. Associations with internalizing symptoms are analyzed through multiple regression models. Results: The sample shows a high diversity in professional status, with occupation-specific differences in many of the variables examined. Compared to men, women report more somatic complaints, higher levels of internalizing symptoms, and greater work impairment. Overall, the professional domain is perceived as more burdensome than the relationship domain; however, self-efficacy regarding the problems of reconciling work and relationships is relatively high. Work-related stress, ruminative exploration in the domains of work and relationships, dependency in relationships, and work-family conflicts predict depressive symptoms (all p < 0.001). Discussion: Difficulties in realizing one's own identity, as well as work and relationships-related challenges, are associated with internalizing symptoms in young adults. In a clinical context, it is therefore useful to consider for this age group developmentally relevant, age-specific variables in the sense of developmental psychopathology.
Journal Article
Correction: Development and validation of the Continuous Traumatic Stress Response scale (CTSR) among adults exposed to ongoing security threats
[This corrects the article DOI: 10.1371/journal.pone.0251724.].[This corrects the article DOI: 10.1371/journal.pone.0251724.].
Journal Article
The persons in relation perspective : in counselling, psychotherapy and community adult learning
People are constituted by their relationships, past and present, inner and outer, conscious and unconscious. People are agents who experience, know and act on the world. At the heart of your agency is your self: positive, puzzling, and problematic. Colin Kirkwood explores these and other ideas of John Macmurray, Ian Suttie, Ronald Fairbairn, John D Sutherland and Paulo Freire, and shows how they apply in counselling and psychotherapy, adult education, community and society. In today's world, a set of ideas, attitudes and practices has taken hold, which emphasise the individual, self-centredness, pleasure-seeking, consumption, success and the accumulation of wealth and power. They are deeply harmful and need to be tackled. Colin demonstrates how these ideas affect us, and how they can be taken on and defeated, in a dialogical narrative of psychotherapy with a girl suffering from severe anorexia, written by the girl herself, her psychotherapist and one of her doctors.
Book
Correction: Sustained functional benefits after a single set of injections with abobotulinumtoxinA using a 2-mL injection volume in adults with cervical dystonia: 12-week results from a randomized, double-blind, placebo-controlled phase 3b study
[This corrects the article DOI: 10.1371/journal.pone.0245827.].
Journal Article
Effects of Heat-Killed ILacticaseibacillus paracasei/I MCC1849 on the Maintenance of Physical Condition in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study
We previously reported that the intake of heat-killed Lacticaseibacillus paracasei MCC1849 suppressed the onset of cold-like symptoms in healthy young women who were susceptible to colds. This study aimed to investigate the effects of MCC1849 on subjective symptoms of physical condition in healthy adults of a wide age range. In this randomized, double-blind, placebo-controlled, parallel-group study, 200 healthy adults were randomly divided into the MCC1849 group or placebo group. The participants received test powder with 50 billion MCC1849 cells or placebo powder without MCC1849 for 24 weeks. Subjective symptoms were assessed by diary scores. Analysis was performed on 183 participants (MCC1849 group; n = 91, placebo group; n = 92) in the per-protocol set. The number of days of stuffy nose and cold-like symptoms was significantly reduced in the MCC1849 group compared with the placebo group. In addition, the duration of stuffy nose, sore throat and cold-like symptoms was significantly lower in the MCC1849 group. No side effects were observed. Therefore, oral intake of MCC1849 suppressed subjective symptoms in healthy adults of a wide age range. These data suggest that MCC1849 may help maintain physical condition.
Journal Article