Global Assessment Score Research Articles

The dietary risk factors on cancer patients receiving chemotherapy and correlation between serum vitamin D and B12 levels, depression and anxiety status.

Objective: the aim of this study is to evaluate the relationship between serum vitamin D and B12 levels, nutritional levels, depression, and anxiety in adult cancer patients before and after chemotherapy. Methods: a case-controlled study was carried out on 44 patients who were diagnosed with cancer and applied to the Chemotherapy Unit for treatment (patient group, PG) and 44 volunteer individuals (control group, CG) with similar characteristics to the age and gender-matched patient group but with no diagnosis of cancer. Results: the average age of individuals in PG is 52.50 ± 12.21 years and for those in CG is 52.84 ± 10.98 years. Serum D and B12 levels in the first cure in individuals in PG are higher than in the last treatment (p > 0.05). It was determined that vitamin C taken with a daily diet reduces the risk of cancer (OR: 0.920, 95 % CI: 0.899-0.942, p = 0.042). No correlation was found between depression and anxiety scores of both groups and serum vitamin D and B12 levels (p > 0.05). It was determined that the Beck Anxiety Inventory (BAI) score increased with decrease in body mass index (BMI) (β = 0.311, p = 0.040) and serum vitamin B12 level (β = -0.406, p = 0.006). In addition, it was found that the increase in the Patient-Generated Subjective Global Assessment (PG-SGA) score, which reflects the nutritional status of cancer patients, worsened the level of anxiety (β = 0.389, p = 0.009). Conclusions: as stated in the findings of the study, chemotherapy treatment mediated the development of anxiety in cancer patients by changing the vitamin B12 levels and anthropometric characteristics with its negative effect on nutritional status. It should be ensured that cancer patients treated with chemotherapy follow a healthy and balanced diet plan that is suitable for their needs and has adequate vitamin and mineral content.

Sacral neuromodulation treatment for urinary voiding dysfunctions: results of treatment with the largest single-center series in a tertiary referral center in Turkey

Sacral neuromodulation (SNM) is a minimally invasive treatment that modulates spinal reflexes to regulate bladder, urinary sphincter, and pelvic floor and has successfully been used in the treatment of refractory voiding dysfunctions. The aim of this study was to present our experience with SNM in a tertiary referral center with the largest number of patients and review the safety and efficacy of the procedure. A total of 42 patients with refractory lower urinary tract symptoms were included into the study. After an initial test period, patients who showed more than 50% improvement in their symptoms underwent the second stage of SNM. Twelve patients had overactive bladder (OAB), bladder pain syndrome/interstitial cystitis (BPS/IC) and 17 had urinary retention. The clinical success was examined during follow-up by voiding diary, urodynamics, and global response assessment. Between February 2015 and December 2020, a total of 29 patients underwent stages I&II SNM procedures. The mean ages of patients in OAB/BPS group and retention group were 40 (37-57 years) and 35 (27-44 years), respectively. Mean follow-up time was at least 1 year. Overall, 58.5% success rate was observed in OAB, BPS/IC, and urinary retention groups. Global response assessment score in both groups increased significantly (p = 0.001). No statistically significant difference was found between success or failure rates when sex and age were variable parameters (p > 0.05). SNM appears to be an effective and safe treatment option in restoring voiding dysfunctions in patients with refractory idiopathic and neurogenic voiding dysfunctions. Our initial series revealed favorable results; however, further studies with larger series and longer follow-up are needed.

An Open-Label Non-Randomized Preliminary Noninferiority Study Comparing Home-Based Handheld Narrow-Band UVB Comb Device with Standard Hospital-Based Whole-Body Narrow-Band UVB Therapy in Localized Vitiligo.

Narrow-band ultraviolet B (NB-UVB) is the standard therapy for vitiligo. The objective of this study is to compare the safety and clinical efficacy of a handheld NB-UVB comb device with the standard whole-body NB-UVB therapy in localized stable vitiligo. Thirty-one vitiligo patients were allocated to either daily therapy with a home-based handheld comb device (group A, n = 17) or thrice-weekly hospital-based whole-body NB-UVB therapy (group B, n = 14) for 4 months, based on their preference. The primary and secondary outcomes were assessed at each follow-up, and appropriate statistical tools were used for analysis. Of the 31 patients enrolled, 26 patients (study groups A/B: 15/11) completed the study. Primary outcome: Median percentage repigmentation of the representative patch in groups A and B were 51.35% and 63.85%, respectively (P = 0.64). The median size reduction of the representative patch in both groups was statistically significant (P < 0.05). The mean difference between "per protocol analysis" and "intention to treat" showed noninferiority. Secondary outcomes: Both groups were comparable on Lund and Browder score, patient global assessment and investigator global assessment scores, adverse events, color match, and change in the quality of life. The comparison group had a significantly greater number of missed sessions (P = 0.02). The majority of patients had a "good" response in both groups. Handheld NB-UVB comb device daily with a fixed dose of fluence was found to be noninferior with better compliance to standard whole-body NB-UVB therapy.

The Combination of Serum Total IgE and Blood Eosinophil Levels as a Predictor of Response to Phototherapy Treatment in Patients with Atopic Dermatitis

Atopic dermatitis (AD) is the most common chronic inflammatory skin disease affecting approximately 25% of all people worldwide at some point during their lifetime. Although total serum immunoglobulin E (IgE) and blood eosinophil levels are not elevated in all patients with AD, they have been shown associated with AD severity. This study aimed to investigate whether IgE and blood eosinophil levels correlate with the response to phototherapy treatment, which is a second‐line treatment for moderate‐to‐severe AD, and therefore could be considered a readily available and reliable biomarker that could guide patient management. Eighty‐two patients with AD who received phototherapy at the Sheba Medical Center were retrospectively evaluated for the following: demographic characteristics, serum IgE levels, blood eosinophils count, hospitalization duration, response to phototherapy, and requirement for systemic treatment. Response to phototherapy treatment was assessed by comparing the pre‐ and post‐treatment Investigator’s Global Assessment score for each patient in relation to the aforementioned factors. The total IgE and eosinophil levels were found to be significantly higher in patients who did not respond to phototherapy (p = 0.018 and p = 0.002, accordingly). Serum values of 1780 IU/mL for IgE and 225.0 cells/μL for eosinophils showed maximum sensitivity and specificity as predictive values for treatment response. In conclusion, this study found that high total serum IgE levels and eosinophilia were correlated with a low response to phototherapy. These results suggest that escalating treatment is recommended for patients presenting these clinical features.

Bimekizumab for the treatment of moderate-to-severe plaque psoriasis: a meta-analysis of randomized clinical trials

Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits both interleukin (IL)-17A and IL-17F, and is a promising drug for patients with moderate-to-severe plaque psoriasis. This study aimed to assess the efficacy and safety of bimekizumab in treating patients with psoriasis and to determine the optimal maintenance dosing schedules of bimekizumab. Eligible trials were identified from PubMed, Cochrane Controlled Register of Trials, Embase, ClinicalTrials.gov, and Chinese medical databases. Only double-blind, randomized, active comparator, or placebo-controlled trials of bimekizumab treatment on patients with psoriasis were included in this study. Five studies were identified, which included 2473 patients with moderate-to-severe plaque psoriasis. The results indicated that bimekizumab had better efficacy than placebo or active comparator for Psoriasis Area and Severity Index (PASI) 90 [risk ratio (RR) = 29.29, 1.52; 95% confidence interval (CI) = 10.30-83.30, 1.06-2.19], PASI 100 (RR = 59.87, 2.06; 95% CI = 15.06-237.99, 1.12-3.79), and Investigator's Global Assessment scores of 0 or 1 (IGA 0/1) (RR = 21.55, 1.36; 95% CI = 9.25-50.19, 1.02-1.81). Faster onset of clinically meaningful responses was observed with bimekizumab compared with both active comparators (RR = 2.59; 95% CI = 1.32-5.10) and placebo (RR = 40.46; 95% CI = 13.19-124.13), with PASI 75 response observed at week 4 after one dose. Subgroup analysis showed no significant difference in the reduction of PASI scores between 320 mg q4w dosage and q8w dosage (RR = 1.00; 95% CI = 0.96-1.03). Rates of patients with adverse events (AEs) were comparable in the bimekizumab and active comparator groups (RR = 1.13; 95% CI = 1.01-1.26), and oral candidiasis was one of the most common treatment-emergent AEs. The results of this meta-analysis suggest that bimekizumab is more efficacious and has a rapid onset of action than active comparators and placebo in the treatment of moderate-to-severe plaque psoriasis. After 16 weeks of initial maintenance treatment, both bimekizumab maintenance dosing schedules (320 mg every 4 and 8 weeks) had similar efficacy.

Efficacy and Safety of Autologous Serum Therapy in Chronic Spontaneous Urticaria in the Pediatric Population: A Prospective Pilot Study.

Chronic spontaneous urticaria (CSU) in children is mostly spontaneous in onset (57%). Treatment comprises long-term antihistaminic therapy without need for elaborate investigations. A subset of such patients don't respond to conventional treatment and novel therapies to help reduce pill burden is the need of the hour. To determine the efficacy and safety of autologous serum therapy (AST) in pediatric patients with chronic spontaneous urticaria. All pediatric patients, aged between 6-16 years, attended to our OPD from March 2019 to March 2020 were recruited. Clinico-demographic data and baseline investigations of all patients were performed. Two-weekly AST therapy was given for 8 visits with levocetrizine tablet 5mg on an on-demand basis. Urticaria activity score (UAS) sheet was provided to record and return every 2 weeks. Statistical analysis was done using the IBM SPSS 26 software package. Autologous serum skin test (ASST) was positive in 63% patients. Both the ASST positive and ASST negative group showed significant reduction in UAS7 score at week 14 compared to baseline. The reduction in mean UAS7 score was associated with a decreased pill burden and positive response in the patient and physician global assessment scale. No statistically significant difference between the two groups in terms of mean UAS7 reduction was found. This study has explored the efficacy and safety of autologous serum therapy in the pediatric CSU patients. Both ASST positive and ASST negative group respond to AST therapy.

Real-World Effectiveness of 9-12Months of Guselkumab Therapy among Patients with Moderate-to-Severe Plaque Psoriasis in the CorEvitas Psoriasis Registry.

Guselkumab, an anti-interleukin-23 biologic therapy, has been shown to significantly reduce disease activity and improve patient-reported outcome measures (PROMs) among patients with moderate-to-severe plaque psoriasis in clinical trials. However, characterization of the real-world effectiveness of guselkumab among patients living in the USA and Canada is warranted. Patients who participated in the CorEvitas Psoriasis Registry between 18 July 2017 and 10 March 2020 were included if they met the following criteria: Investigator's Global Assessment (IGA) score ≥ 3 and body surface area (BSA) ≥ 10% (moderate-to-severe psoriasis), initiated guselkumab at a registry (index) visit, and had a registry follow-up visit after 9-12months of persistent guselkumab therapy. Data were retrieved for baseline patient demographics and disease characteristics, treatment history, disease activity, and PROMs. Outcomes were assessed at index and follow-up visits; response rates and mean changes were calculated. Among 113 patients, mean age was 49.7years, mean psoriasis duration was 17.5years, and 65.5% of patients were biologic experienced. At baseline, mean IGA score was 3.3, Psoriasis Area Severity Index (PASI) score was 13.6, and Dermatology Life Quality Index (DLQI) score was 9.6. At follow-up, IGA0/1, PASI 90, and DLQI 0/1 were achieved by 62.2%, 56.8%, and 54.7% of patients, respectively. Statistically significant improvements were observed in all disease activity scores and PROMs, including the EuroQoL Visual Analogue Scale, Work Productivity and Activity Impairment, Patient Global Assessment, fatigue, skin pain, and itch (p < 0.05). This real-world study showed that patients with moderate-to-severe psoriasis who received 9-12months of persistent guselkumab therapy experienced improvements in disease severity and PROMs.

Safety, pharmacokinetics, and efficacy of ruxolitinib cream in children and adolescents with atopic dermatitis

BackgroundTherapies for children with atopic dermatitis (AD) have safety and tolerability concerns that may limit long-term use. Ruxolitinib cream, a Janus kinase (JAK) inhibitor, is effective and well tolerated in adolescents and adults with AD. ObjectiveTo analyze the safety and tolerability of ruxolitinib cream in pediatric patients. Pharmacokinetics and efficacy were also evaluated in this phase 1 study (NCT03257644). MethodsPatients aged 2 to 17 years with AD (affected body surface area 8%-20%; Investigator's Global Assessment score ≥2) were enrolled stepwise in 6 age-descending, strength-increasing cohorts to apply 0.5%, 0.75%, or 1.5% ruxolitinib cream twice daily for 28 days. Safety, pharmacokinetics, and efficacy were analyzed at baseline, week 2 (day 10), and week 4 (day 29). ResultsAmong 71 patients, 44 (62.0%) had a baseline Investigator's Global Assessment score of 3; median (range) body surface area affected at baseline was 12.2% (1.7%-20.4%). Ruxolitinib cream was well tolerated, with 4 patients (5.6%) experiencing treatment-related adverse events (all grades 1/2). No clinically meaningful changes in mean chemistry or hematology values were observed, and no consistent pattern of change in bone biomarkers was detected. Mean plasma ruxolitinib levels within each cohort (range, 23.1-97.9 nM) were well below the half-maximal inhibitory concentration for thrombopoietin phosphorylation of STAT3 (281 nM). All cohorts experienced improvements in exploratory efficacy end points. ConclusionRuxolitinib cream was well tolerated in pediatric patients with AD, with no effect on blood counts or bone biomarkers. Mean plasma concentration was low. Efficacy was consistent with data from previous studies in adolescents and adults. Clinical Trial RegistrationClinicalTrials.gov Identifier: NCT03257644

Stem cell-derived exosomes in the treatment of melasma and its percutaneous penetration.

Melasma is a refractory skin disease due to its complex pathogenesis and difficult treatment. Studies have found that human umbilical cord mesenchymal stem cell-derived exosomes (hUCMSC-Exos) could serve as a novel cell-free therapeutic strategy in regenerative and esthetic medicine. It could potentially treat melasma, but the skin barrier is a challenge. In this study, we aim to explore the safety and efficacy of hUCMSC-Exos in the treatment of melasma and the means to promote its percutaneous penetration. In the animal study about the effect of penetration, percutaneous penetration of PKH67-labeled hUCMSC-Exos was studied under microneedles, 1565 nm nonablative fractional laser (NAFL), and a plasma named Peninsula Blue Aurora Shumin Master (PBASM) treatments, observed by confocal laser scanning microscopy. In the clinical application study, 60 patients with melasma treated in our department were divided into four groups. NAFL combined with normal saline treatment was used for Group A. Microneedles, NAFL, and PBASM combined with hUCMSC-Exos treatments were used for Groups B, C, and D, respectively. Each patient received four treatments at 1-month intervals. Assessments were done using the degree of pain posttreatment, melasma area and severity score, improvement rate, physician global assessment score, satisfaction, and complications. In the animal study about the effect of penetration, hUCMSC-Exos can penetrate the deep dermis under microneedles, NAFL, and PBASM treatments. In the clinical application study, compared with Group A, Groups B, C, and D showed significantly improved therapeutic effect and patient satisfaction (p < 0.05), and there was no significant difference among Groups B, C, and D.(p > 0.05). Patients in Group B reported higher pain levels than those in the other three groups (p < 0.05); the treatment experience of patients in Group D was better. hUCMSC-Exos can improve the symptoms of melasma safely and effectively. Compared with microneedles, NAFL and PBASM can also achieve a good effect toward promoting penetration. These findings are worthy of exploration and clinical application.

Association of Circulating Trimethylamine-N Oxide With Malnutrition and the Risk of Coronary Artery Disease in Patients With Maintenance Hemodialysis

Malnutrition is a serious complication frequently observed in dialysis patients. Therefore, nutrition status evaluation and the early identification of malnutrition are clinically important. Trimethylamine N-oxide (TMAO) is reportedly associated with deteriorating metabolic profiles and cardiovascular diseases. The aim of our study was to investigate correlations between circulating TMAO levels and malnutrition and the risk of major adverse cardiovascular events in patients on maintenance hemodialysis. This retrospective observational study involved 228 subjects. Fasting plasma TMAO levels were detected using liquid chromatography-tandem mass spectrometry. TMAO levels were significantly elevated in patients with malnutrition (8728.78±704.12ng/mL) when compared with those without (6532.1±570.41ng/mL, P<.01). TMAO levels were positively correlated with Subjective Global Assessment scores (ρ=0.56, P=.02) and were independent risk factors for malnutrition after adjustment for multiple traditional risk factors (odds ratio=2.07, 95% confidence interval: 1.41-3.62, P<.01). Furthermore, TMAO levels were good predictors of major adverse cardiovascular events in a 2-year follow-up period (area under the curve=0.68, P<.01) and accuracy was increased to 74% when TMAO levels were combined with Subjective Global Assessment scores (area under the curve=0.74, P=.02). Elevated TMAO levels were independently associated with a risk of malnutrition and cardiovascular disease, and could be a useful predictive biomarker for risk stratification and cardiovascular disease management for patients on dialysis.

Insurance Status and Tumor Necrosis Factor Inhibitor Initiation Among Children With Juvenile Idiopathic Arthritis in the CARRA Registry.

Prompt escalation to tumor necrosis factor inhibitors (TNFis) is recommended for children with juvenile idiopathic arthritis (JIA) and ongoing disease activity despite treatment with conventional disease-modifying antirheumatic drugs (cDMARDs). It is unknown whether these recommendations are equitably followed for children with different insurance types. We assessed the association of insurance coverage on the odds and timing of TNFi use. We conducted a retrospective study of children with newly diagnosed JIA in the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry. We compared the odds of starting a TNFi in the first year and time from cDMARD to TNFi initiation between those with public and private insurance. We identified 1086 children with new JIA diagnoses. Publicly insured children had significantly higher active joint counts and parent/patient global assessment scores at the enrollment visit. They were also more likely to have polyarticular arthritis compared to those with private insurance. Odds of any TNFi use in the first year did not differ between publicly and privately insured children. Publicly insured children were escalated from cDMARD to TNFi more quickly than privately insured children. Children who were publicly insured had more severe disease and polyarticular involvement at registry enrollment compared to those who were privately insured. Whereas overall TNFi use did not differ between children with different insurance types, publicly insured children were escalated more quickly, consistent with their increased disease severity. Further research is needed to determine why insurance coverage type is associated with disease severity, including how other socioeconomic factors affect presentation to care.

Parallel, component training in robotic total mesorectal excision.

There has been widespread adoption of robotic total mesorectal excision (TME) for rectal cancer in recent years. There is now increasing interest in training robotic novice surgeons in robotic TME surgery using the principles of component-based learning. The aims of our study were to assess the feasibility of delivering a structured, parallel, component-based, training curriculum to surgical trainees and fellows. A prospective pilot study was undertaken between January 2021 and May 2021. A dedicated robotic training pathway was designed with two trainees trained in parallel per each robotic case based on prior experience, training grade and skill set. Component parts of each operation were allocated by the robotic trainer prior to the start of each case. Robotic proficiency was assessed using the Global Evaluative Assessment of Robotic Skills (GEARS) and the EARCS Global Assessment Score (GAS). Three trainees participated in this pilot study, performing a combined number of 52 TME resections. Key components of all 52 TME operations were performed by the trainees. GEARS scores improved throughout the study, with a mean overall baseline score of 17.3 (95% CI 15.1-1.4) compared to an overall final assessment mean score of 23.8 (95% CI 21.6-25.9), p = 0.003. The GAS component improved incrementally for all trainees at each candidate assessment (p < 0.001). Employing a parallel, component-based approach to training in robotic TME surgery is safe and feasible and can be used to train multiple trainees of differing grades simultaneously, whilst maintaining high-quality clinical outcomes.

Efficacy and safety of belimumab for the treatment of refractory childhood-onset systemic lupus erythematosus: A single-center, real-world, retrospective study.

This study aimed to investigate the efficacy and safety of belimumab for treating children with refractory childhood-onset systemic lupus erythematosus (cSLE). Twenty-six cSLE patients who received belimumab treatment in our hospital from January 2020 to September 2021 (23 of them for more than 52 weeks) were enrolled in this study. Their clinical and laboratory data, assessment of disease activity, glucocorticoid dosage, and treatment-emergent adverse events (TEAEs) were retrieved for analysis. The paired samples t-test and the nonparametric test were used to compare the baseline and post-treatment data. The mean age of onset was 10.3 ± 2.4 years old; the mean disease duration was 41.6 ± 37.4 months; the median Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score was 10 (P 25, P 75: 3, 17); and the mean Physician's Global Assessment (PGA) score at baseline was 1.9 ± 1.0. Compared with the baseline values, there was a significant decrease in the 24-h urine protein quantifications at 24 and 52 weeks of treatment (P<0.05) as well as an elevated complement (C) 3 and C4 levels at 4, 12, 24, and 52 weeks of treatment. In addition, the SLEDAI-2K and PGA scores as well as the percentage of CD19+ B cells were significantly decreased at 12, 24, and 52 weeks of treatment compared with the baseline values (P<0.05). The dosage of glucocorticoid at 4, 12, 24, and 52 weeks of treatment was significantly less than that at baseline or the previous follow-up (P<0.05). At 52 weeks, 14 subjects (53.8%) achieved Lupus Low Disease Activity State (LLDAS), and 4 subjects (15.4%) reached clinical remission (CR). At the last follow-up, 16 subjects (61.5%) achieved LLDAS, and 10 subjects (38.5%) reached CR. Belimumab treatment can significantly improve laboratory indicators, reduce disease activity, and decrease the dosage of glucocorticoid required in children with cSLE. Moreover, it has a good safety profile.

Association of Serum Prealbumin With Nutritional Status of End-Stage Renal Disease Patients Under Maintenance Hemodialysis

Background: End-stage renal disease (ESRD) patients undergoing maintenance hemodialysis often suffer from malnutrition. The primary objective of the study was to measure the level of serum prealbumin, assess the correlation of serum prealbumin with modified subjective global assessment score and determine a cut-off value for prealbumin that can estimate the nutritional status of the study population with highest accuracy, among ESRD patients under maintenance hemodialysis. Methods: A one year long cross-sectional study from July 2016 to June 2017 was conducted at hemodialysis unit of SSMC &amp; MH, BSMMU, BIRDEM hospital and NIKDU, Dhaka, among 80 maintenance hemodialysis patients. Adult patients over the age of 18 years and on regular (≥2 sessions per week) hemodialysis for more than 3 months without any acute infection were enrolled. Nutritional status of the patients was evaluated using modified subjective global assessment score. Serum prealbumin level was compared with both anthropometric and biochemical parameters, as well as with modified SGA score. Using modified SGA score as gold standard, receiver operating characteristic curve was used to estimate best fitting cut-off value for serum prealbumin for nutritional assessment among ESRD patients under maintenance hemodialysis. Results: Mean age of study population was 52.3 years and 66.3% respondents were male. Most prominent primary renal diseases were diabetic nephropathy (48.8%). According to modified SGA score, 10% of the study population had normal nutritional status and 90% had mild to moderate malnutrition. Mean serum prealbumin was 27.8 mg/dl. Serum prealbumin showed significant negative correlation with age, modified SGA score and triglyceride; significant positive correlation was shown with BMI, serum creatinine and serum albumin. Using receiver operating characteristic curve, 32.6 mg/dl was found to be the best fitting cut-off value for nutritional assessment with 73.6% sensitivity, 62.5% specificity and 72.5% accuracy. Conclusion: Data obtained from this study strongly indicates that serum prealbumin can be used as a marker for nutritional assessment among ESRD patients undergoing maintenance hemodialysis. JOPSOM 2021; 40(2):9-15

PP08 Evaluation Of Nutritional Status In Diabetic And Non-Diabetic Chronic Kidney Disease Patients Using A Web Tool

IntroductionPoor nutritional status, a complex consequence of numerous interrelated factors, is poorly characterized in patients with chronic kidney disease (CKD) before they commence dialysis. This study aimed to characterize the risk factors and prevalence of malnutrition among patients with CKD, with or without diabetes mellitus, before they underwent dialysis at a tertiary care public teaching hospital.MethodsThis longitudinal observational study utilized a Pt-Global web tool© to assess the nutritional status of patients based on their Subjective Global Assessment score as follows: a score of two to three indicates that patient and family education is required; scores of four to eight mean that intervention is required as indicated by symptoms; and a score of nine or more indicates a critical need for intervention. Glomerular filtration rate calculated using the Chronic Kidney Disease Epidemiology Collaboration equation was used as the measure of kidney function. Multinomial regression analyses were used to ascertain the predictors of poor nutritional status.ResultsA total of 450 patients (265 men and 185 women) who had CKD, with or without diabetes, and were not on dialysis were recruited during the period of study. The average age of the patients was 53.9 years (standard deviation 14.2). ‘Severe’ malnutrition was present in 152 (33.8%) patients, while 140 (31.1%) were ‘mildly or moderately’ malnourished, and 158 (35.1%) were ‘well-nourished’. Patients with CKD and diabetes were more severely malnourished: 68 were rated as mild or moderate (15.1%) and 91 were rated as severe (20.2%). The prevalence of malnutrition increased with the decline of residual renal function. Fatigue, loss of appetite, pain anywhere in the body, constipation, dry mouth, feeling full quickly, and physical and functional inactivity were the most common risk factors for poor nutritional status.ConclusionsThis study presents real-world evidence of poor nutritional status in patients with CKD and confirms that it is more common in individuals who are diabetic and have poor kidney function and hypoalbuminemia. Emphasis on nutrition in patients with CKD is important for improving their health.

Evaluation of Skindex-16 construct validity in routinely collected psoriasis data: a retrospective analysis of the relationship between overall physician global assessment scores and Skindex-16 and measure discordance.

Patient-reported outcome measures (PROMs) capture disease severity metrics from the patient's perspective, including health-related quality of life (HRQL). Disease-specific validation of PROMs improves their clinical utility. We evaluated construct validity (HRQL) for Skindex-16 in routinely seen psoriasis patients and characterized instances of discordance between Skindex-16 scores and clinician-reported outcome measure of disease severity. We retrospectively studied psoriasis patients seen by University of Utah Dermatology from 2016 to 2020. Cross-sectional construct validity was assessed using quantile regression and Spearman correlation between overall physician global assessment (OPGA) score and Skindex-16 scores. Longitudinal within-subject correlation was performed using linear mixed models. Discordance (10th percentile or lower OPGA and 90th percentile or higher Skindex-16 score [clear skin, poor HRQL; cspHRQL] or the reverse [severe skin, good HRQL; ssgHRQL]) was characterized descriptively. 681 first-visit patients with psoriasis were included. Median overall Skindex-16 score varied by ≥ 10 points across all levels of OPGA scores. OPGA and Skindex-16 domain scores were moderately correlated (emotions ρ = 0.54, functioning ρ = 0.47, and symptoms ρ = 53). Longitudinal correlations were similar (emotion ρxy = 0.54, functioning ρxy = 0.65, symptoms ρxy = 0.47). Visits with cspHRQL discordance occurred for each Skindex-16 domain (emotions = 7, functioning = 13, symptoms = 12). The ssgHRQL group was observed within the emotions (n = 1) and functioning (n = 23) domains. Median Skindex-16 scores are different between different levels of OPGA and show moderate cross-sectional and longitudinal correlation. This supports construct validity in patients with psoriasis. Severe discordance was rare and most often for those with clear skin but poor HRQL. These discordances can prompt further patient-clinician conversation.

Bimekizumab efficacy and safety in patients with moderate-to-severe plaque psoriasis who switched from adalimumab, ustekinumab or secukinumab: results from phase III/IIIb trials.

Discontinuation of biologics is common among patients with psoriasis due to treatment failure or adverse events. To achieve improvements in disease management, patients and clinicians may choose to switch biologics. To evaluate the efficacy and safety of switching to bimekizumab from adalimumab, ustekinumab and secukinumab. Data are reported for up to 80 weeks after patients switched to bimekizumab from adalimumab at week 24 in BE SURE, ustekinumab at week 52 in BE VIVID [upon entry into the BE BRIGHT open-label extension (OLE)] and secukinumab at week 48 in BE RADIANT (upon entry into the BE RADIANT OLE). Efficacy outcomes are reported by number of weeks after switching to bimekizumab and were split based on whether patients had achieved a ≥90% improvement from baseline in Psoriasis Area and Severity Index (PASI 90) at the time of switch. Treatment-emergent adverse events (TEAEs) are reported using exposure-adjusted incidence rates (EAIRs) per 100 patient-years. Trial registration: BE SURE (NCT03412747), BE VIVID (NCT03370133), BE BRIGHT (NCT03598790), BE RADIANT (NCT03536884). Rapid and durable improvements in clinical responses and benefits in health-related quality of life were observed among PASI 90 nonresponders who switched to bimekizumab. Most PASI 90 nonresponders achieved PASI 90 4 weeks after switching to bimekizumab from adalimumab (67%), ustekinumab (79%) and secukinumab (53%). After 48 weeks of bimekizumab, 91%, 90% and 79% of PASI 90 nonresponders had achieved PASI 90 after switching from adalimumab, ustekinumab or secukinumab, respectively. Durable improvements were also observed for PASI 100, Investigator's Global Assessment score 0/1, body surface area affected by psoriasis ≤ 1%, absolute PASI ≤ 2, and Dermatology Life Quality Index 0/1. Among PASI 90 responders, existing treatment responses were maintained or improved after switching to bimekizumab. The majority of TEAEs were mild or moderate. EAIRs were generally similar between active-comparator treatment periods and after switching to bimekizumab. EAIRs typically decreased with a longer duration of bimekizumab exposure. High proportions of patients who did not adequately respond to adalimumab, ustekinumab or secukinumab achieved high levels of skin clearance after switching to bimekizumab. Bimekizumab was well tolerated and there were no new safety findings.

Long-term safety and disease control with ruxolitinib cream in atopic dermatitis: Results from two phase 3 studies

Ruxolitinib cream demonstrated safety and efficacy over 8weeks in 2 double-blind phase 3 atopic dermatitis studies (NCT03745638/NCT03745651). To evaluate long-term safety (LTS) and disease control with ruxolitinib cream. Patients initially randomized to twice-daily 0.75%/1.5% ruxolitinib cream maintained their regimen during the 44-week LTS period (as-needed treatment). Patients on vehicle were rerandomized (1:1) at week 8 to either ruxolitinib cream strength. Safety and disease control (Investigator's Global Assessment score 0/1 and affected body surface area) were assessed. Over 52weeks, adverse events were reported in 67.4%/62.6%/53.5%/57.6% of patients in 0.75%/1.5% ruxolitinib cream/vehicle to 0.75% ruxolitinib cream/vehicle to 1.5% ruxolitinib cream groups (n=426/446/101/99). Most common adverse events were upper respiratory tract infection (10.3%/11.4%/5.9%/7.1%) and nasopharyngitis (8.9%/9.9%/7.9%/14.1%). Most adverse events were considered unrelated to treatment. Application site reactions were infrequent (3.8%/1.8%/1.0%/1.0%). Disease control was achieved throughout the LTS; 74.1% to 77.8% of patients had Investigator's Global Assessment 0/1 at week 52, and mean affected body surface area was low (1.4%-1.8%). LTS had no control treatment. During 44weeks of as-needed treatment, ruxolitinib cream demonstrated effective disease control and tolerability; low ruxolitinib plasma concentrations alongside safety findings reflecting known risk factors suggest physiologically meaningful systemic Janus kinase inhibition is highly unlikely.

A nomogram model based on clinical markers for predicting malignancy of ovarian tumors.

The aim of this study was to build a nomogram based on clinical markers for predicting the malignancy of ovarian tumors (OTs). A total of 1,268 patients diagnosed with OTs that were surgically removed between October 2017 and May 2019 were enrolled. Clinical markers such as post-menopausal status, body mass index (BMI), serum human epididymis protein 4 (HE4) value, cancer antigen 125 (CA125) value, Risk of Ovarian Malignancy Algorithm (ROMA) index, course of disease, patient-generated subjective global assessment (PG-SGA) score, ascites, and locations and features of masses were recorded and analyzed (p 0.05). Significant variables were further selected using multivariate logistic regression analysis and were included in the decision curve analysis (DCA) used to assess the value of the nomogram model for predicting OT malignancy. The significant variables included post-menopausal status, BMI, HE4 value, CA125 value, ROMA index, course of disease, PG-SGA score, ascites, and features and locations of masses (p 0.05). The ROMA index, BMI (≥ 26), unclear/blurred mass boundary (on magnetic resonance imaging [MRI]/computed tomography [CT]), mass detection (on MRI/CT), and mass size and features (on type B ultrasound [BUS]) were screened out for multivariate logistic regression analysis to assess the value of the nomogram model for predicting OT malignant risk (p 0.05). The DCA revealed that the net benefit of the nomogram's calculation model was superior to that of the CA125 value, HE4 value, and ROMA index for predicting OT malignancy. We successfully tailored a nomogram model based on selected clinical markers which showed superior prognostic predictive accuracy compared with the use of the CA125, HE4, or ROMA index (that combines both HE and CA125 values) for predicting the malignancy of OT patients.

Impact of fluid overload on blood pressure variability in patients on peritoneal dialysis

Fluid overload is a common complication in patients who are on continuous ambulatory peritoneal dialysis (CAPD). Blood pressure is the traditional indicator of fluid status in these patients. However, it has poor sensitivity. Blood pressure variability (BPV) can detect fluctuations in blood pressure sooner and more accurately and be useful for the assessment of fluid volume in hemodialysis patient. However, there are limited relevant studies involving patients on CAPD. This retrospective study included 175 patients on CAPD who underwent regular assessment of the peritoneal dialysis adequacy at 2–3-month intervals at our center from January 2018 to December 2020. The overhydration (OH) value was measured using a body composition monitor. Blood pressure measurements obtained in each visit over one-year follow-up were used to determine each patient’s BPV under peritoneal dialysis. The patients were divided into the normal volume (OH ≤2 L), mild volume overload (OH 2–4 L), and severe volume overload groups (OH ≥4 L). There was no significant between-group difference in the mean blood pressure (p > 0.05). However, the systolic and diastolic BPV values were significantly higher in the severe volume overload group than in the other groups (p < 0.05). Further correlation and regression analysis showed volume overload severity and BPV existed positive association, and BPV was also significantly associated with PD volume related indexes, including diabetes mellitus, blood parathyroid hormone levels, Kt/V and subjective global assessment scores in the volume overloaded group (p < 0.05). All these results suggested BPV may be a useful indicator for fluid status in PD patients.