ABSTRACT
Background: Improvement in clinical outcomes and normalisation of objective markers of inflammation, high-sensitivity C-reactive protein (hs-CRP) and faecal calprotectin (FCP), are considered treatment targets per STRIDE-II guidelines.1 We evaluated the effect of the oral selective Janus kinase inhibitor upadacitinib (UPA) on changes in hs-CRP, FCP, and clinical outcomes in patients with Crohn's disease (CD). Method(s): In 2 phase 3, randomized, double-blind, placebo-controlled induction studies (U-EXCEL, NCT03345849;U-EXCEED, NCT03345836), patients with moderate-to-severe CD received 12-week treatment with UPA 45 mg (UPA45) once daily (QD) or placebo (PBO). Patients with clinical response to UPA45 were rerandomised in U-ENDURE (NCT03345823) to receive 52-week maintenance treatment with UPA 30 mg QD (UPA30), UPA 15 mg QD (UPA15), or PBO. Endpoints included marker normalisation (hs-CRP <= 5 mg/L, FCP <= 250 mug/g) in patients with elevated baseline marker levels, normal marker and clinical remission by Crohn's Disease Activity Index (CDAI < 150) or very soft/liquid stool frequency (SF)/abdominal pain score (APS) (average daily SF <= 2.8 and average daily APS <= 1, neither greater than baseline), and >= 50% reduction from baseline in marker values with a decrease of at least 100 points in CDAI from baseline. Median changes from baseline in marker levels were also evaluated. Non-responder imputation with no special data handling for missing data due to COVID-19 was used. Result(s): Of 1021 enrolled patients, 645 (63.2%) had elevated hs-CRP (> 5 mg/L) and 750 (73.5%) had elevated FCP (> 250 mug/g) levels at baseline. Significantly greater proportions of patients with elevated baseline marker levels achieved normalisation with UPA compared with PBO at week 12 (Fig 1A/B) and week 52 (Fig 2A/B;nominal P < .001 for all). Decreases in marker levels from baseline with UPA were observed as early as week 2 and were significantly greater than with PBO through week 12 (Fig 1C) and week 52 (Fig 2C;nominal P < .001 for all). Patients achieved clinical endpoints and improvements in markers at significantly higher rates with UPA45 vs PBO at week 12 (Fig 1D-F) and with UPA15 and UPA30 vs PBO at week 52 (Fig 2D-F;P < .001 for all). The safety profile of UPA in CD was previously reported and no new safety concerns were identified. Conclusion(s): Improvements in clinical endpoints and normalisation of objective markers of inflammation were achieved as early as week 2 with UPA45 induction and sustained with UPA15 and UPA30 maintenance therapy in patients with CD. Median changes in hs-CRP and FCP with UPA support continued improvement of inflammation up to week 52 .
ABSTRACT
This patient was a 73-year-old man who initially came to our service with acute respiratory failure secondary to COVID-19. Soon after hospitalization, he was submitted to orotracheal intubation and placed in the prone position to improve hypoxia, due to severe acute respiratory syndrome (SARS). On the third day of hospitalization, he developed acute oliguric kidney injury and volume overload. The nephrology service was activated to obtain deep venous access for renal replacement therapy (RRT). The patient could not be placed in the supine position due to significant hypoxemia. A 50-cm Permcath (MAHURKARTM, Covidien, Massachusetts, USA) was inserted through the left popliteal vein. This case report describes a possible challenging scenario that the interventional nephrologist may encounter when dealing with patients with COVID-19 with respiratory impairment in the prone position.
ABSTRACT
This article aims to evaluate the sleep quality in individuals during the COVID-19 pandemic by Pittsburgh Sleep Quality Index (PSQI). Searches were conducted in the PubMed, Embase, Web of Science, and PEDro databases, on May 22, 2020. In the publications, 208 articles were found and, considering the eligibility criteria, 10 articles were included at the end, showing the effects on sleep quality during the pandemic, in populations hospitalized, quarantined, and in frontline health professionals. The PSQI measured sleep disorders and a higher score indicated poor sleep quality. Nine articles were classified with evidence level IV and one as level III-2. Eight studies present a "serious" risk of bias and two in "moderate". The studies investigated different populations and described the results as "poor" sleep quality, considering the PSQI on quarantined individuals and frontline health professionals as the most committed. A poor sleep quality was found in the populations evaluated in the selected publications, probably, due to the COVID-19 to contribute as a risk factor for mental health. Psychological interventions must be made to minimize the consequences through social support and social capital.