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Biologic Treatment in Combination with Lifestyle Intervention in Moderate to Severe Plaque Psoriasis and Concomitant Metabolic Syndrome: Rationale and Methodology of the METABOLyx Randomized Controlled Clinical Trial.
Pinter, A, Schwarz, P, Gerdes, S, Simon, JC, Saalbach, A, Rush, J, Melzer, N, Kramps, T, Häberle, B, Reinhardt, M
Nutrients. 2021;(9)
Abstract
Inflammatory diseases including psoriasis are associated with metabolic and cardiovascular comorbidities, including obesity and metabolic syndrome. Obesity is associated with greater psoriasis disease severity and reduced response to treatment. Therefore, targeting metabolic comorbidities could improve patients' health status and psoriasis-specific outcomes. METABOLyx is a randomized controlled trial evaluating the combination of a lifestyle intervention program with secukinumab treatment in psoriasis. Here, the rationale, methodology and baseline patient characteristics of METABOLyx are presented. A total of 768 patients with concomitant moderate to severe plaque psoriasis and metabolic syndrome were randomized to secukinumab 300 mg, or secukinumab 300 mg plus a tailored lifestyle intervention program, over 24 weeks. A substudy of immunologic and metabolic biomarkers is ongoing. The primary endpoint of METABOLyx is PASI90 response at week 24. Other endpoints include patient-reported outcomes and safety. METABOLyx represents the first large scale clinical trial of an immunomodulatory biologic in combination with a standardized lifestyle intervention.
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Impact of biological therapy on work outcomes in patients with axial spondyloarthritis: results from the British Society for Rheumatology Biologics Register (BSRBR-AS) and meta-analysis.
Shim, J, Jones, GT, Pathan, EMI, Macfarlane, GJ
Annals of the rheumatic diseases. 2018;(11):1578-1584
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Abstract
OBJECTIVES To quantify, among patients with axial spondyloarthritis (axSpA), the benefit on work outcomes associated with commencing biologic therapy. METHODS The British Society for Rheumatology Biologics Register in Axial Spondyloarthritis (BSRBRAS) recruited patients meeting Assessment of SpondyloArthritis International Society criteria for axSpA naïve to biological therapy across 83 centres in Great Britain. Work outcomes (measured using the Work Productivity and Activity Impairment Index) were compared between those starting biological therapy at the time of recruitment and those not. Differences between treatment groups were adjusted using propensity score matching. Results from BSRBR-AS were combined with other studies in a meta-analysis to calculate pooled estimates. RESULTS Of the 577 participants in this analysis who were in employment, 27.9% were starting biological therapy at the time of recruitment. After propensity score adjustment, patients undergoing biological therapy, at 12-month follow-up, experienced significantly greater improvements (relative to non-biological therapy) in presenteeism (-9.4%, 95% CI -15.3% to -3.5%), overall work impairment (-13.9%, 95% CI -21.1% to -6.7%) and overall activity impairment (-19.2%, 95% CI -26.3% to -12.2%). There was no difference in absenteeism (-1.5%, 95% CI -8.0 to 4.9). Despite these improvements, impact on work was still greater in the biological treated cohort at follow-up. In the meta-analysis including 1109 subjects across observational studies and trials, treatment with biological therapy was associated with significantly greater improvements in presenteeism, work impairment and activity impairment, but there was no difference in absenteeism. CONCLUSIONS There is consistent evidence that treatment with biological therapy significantly improves work productivity and activity impairment in people with axSpA. However, there remain substantial unmet needs in relation to work.
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Evaluation of Benefit and Tolerability of IQP-CL-101 (Xanthofen) in the Symptomatic Improvement of Irritable Bowel Syndrome: A Double-Blinded, Randomised, Placebo-Controlled Clinical Trial.
Alt, F, Chong, PW, Teng, E, Uebelhack, R
Phytotherapy research : PTR. 2017;(7):1056-1062
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Abstract
Irritable bowel syndrome (IBS) is a functional bowel disorder of unknown aetiology. There is currently no known cure, and pharmacological interventions are usually targeting symptomatic relief, where natural and herbal remedies also play a role. This study aimed to evaluate the benefit and tolerability of IQP-CL-101 in symptomatic IBS relief. A double-blinded, randomised, placebo-controlled trial was conducted over 8 weeks. A total of 99 subjects fulfilling ROME-III criteria for IBS were randomised into two groups, given either two IQP-CL-101 softgels or matching placebo twice daily before main meals. The primary endpoint was the difference in change of IBS Symptom Severity Score (IBS-SSS) after an 8-week intake of IQP-CL-101 compared to placebo. After 8 weeks, subjects on IQP-CL-101 showed a significant reduction in IBS-SSS (113.0 ± 64.9-point reduction) compared to subjects on placebo (38.7 ± 64.5-point reduction) (p < 0.001). A significant improvement could be seen as early as 4 weeks. No serious adverse events were reported throughout. IQP-CL-101 can be considered beneficial in the improvement of IBS symptom severity, regardless of IBS type, and therefore able to improve quality of life in patients suffering from abdominal pain and discomfort. © 2017 The Authors. Phytotherapy Research published by John Wiley & Sons Ltd.
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Comparison of Three Different Administration Positions for Intratracheal Beractant in Preterm Newborns with Respiratory Distress Syndrome.
Karadag, A, Ozdemir, R, Degirmencioglu, H, Uras, N, Dilmen, U, Bilgili, G, Erdeve, O, Cakir, U, Atasay, B
Pediatrics and neonatology. 2016;(2):105-12
Abstract
BACKGROUND The aim of this study was to compare the efficacy and adverse effects of various intratracheal beractant administration positions in preterm newborns with respiratory distress syndrome. METHODS This study was performed on preterm newborns with respiratory distress syndrome. The inclusion criteria were being between 26 weeks and 32 weeks of gestational age, having a birth weight between 600 g and 1500 g, having received clinical and radiological confirmation for the diagnosis of respiratory distress syndrome (RDS) within 3 hours of life, having been born in one of the centers where the study was carried out, and having fractions of inspired oxygen (FiO2) ≥ 0.40 to maintain oxygen saturation by pulse oximeter at 88-96%. Beractant was administered in four positions to Group I newborns, in two positions to Group II, and in neutral position to Group III. RESULTS Groups I and II consisted of 42 preterm infants in each whereas Group III included 41 preterm infants. No significant differences were detected among the groups with regards to maternal and neonatal risk factors. Groups were also similar in terms of the following complications: patent ductus arteriosus (PDA), pneumothorax, intraventricular hemorrhage (IVH), chronic lung disease (CLD), retinopathy of prematurity (ROP), necrotising enterocolitis (NEC), death within the first 3 days of life, death within the first 28 days of life, and rehospitalization within 1 month after discharge. Neither any statistically significant differences among the parameters related with surfactant administration, nor any significant statistical differences among the FiO2 levels and the saturation levels before and after the first surfactant administration among the groups were determined. CONCLUSION In terms of efficacy and side effects, no important difference was observed between the recommended four position beractant application, the two position administration, and the neutral position.