Daily Symptom Scores Research Articles

Short‐course subcutaneous treatment with birch pollen allergoids greatly improves symptom and medication scores in birch allergy

AbstractBackgroundSubcutaneous immunotherapy has emerged as an effective option for treating allergic diseases. Here, we assessed the clinical impact of the mannan‐conjugated birch pollen polymerized allergoid T502 in birch pollen‐induced allergic rhinoconjunctivitis.MethodsIn this prospective, randomized, double‐blind placebo‐controlled phase III trial, 298 birch pollen–allergic adult patients were treated across 28 trial sites in Germany. Patients received either placebo or 23,000 mTU T502 subcutaneously over five pre‐seasonal visits. Efficacy was assessed by comparing the combined symptom and medication score (CSMS) between placebo and T502 during the peak birch pollen season 2022. Safety, tolerability and immunologic effects were also analyzed.ResultsDuring the peak birch pollen season, the median CSMS of the T502 group was reduced by 33% (p = 0.002) compared to placebo. The median daily symptom score and daily medication score were reduced by 30.4% (p < 0.001) and 56.3% (p = 0.045), respectively. Health related quality of life improved as reflected by reduction of RQLQ values by 31.5% (p < 0.0001). Production of Bet v 1 sIgG4 and Bet v 1 sIgG increased up to 6.2‐fold and 3‐fold respectively in the T502 group (p < 0.0001). The sIgE/sIgG4 ratio was strongly reduced in the T502 group at V7 (−62.9%, p < 0.0001).No fatalities nor serious adverse events were reported. In total, 16 systemic allergic reactions occurred (Grade I/II).ConclusionsTreatment with T502 significantly reduced symptoms and medication need in rhinoconjunctivitis patients. The treatment is well tolerated and safe.

The SQ tree sublingual immunotherapy tablet is effective and well tolerated in children-A pivotal phase III trial.

Allergic rhinitis and/or conjunctivitis (AR/C) induced by tree pollen is common and negatively impacts quality of life in children and adolescents. This phase III trial investigated the efficacy and safety of the SQ tree SLIT-tablet in a paediatric population (5-17 years) with moderate-to-severe AR/C induced by pollen from birch and trees in the birch homologous group. Nine hundred and fifty-two subjects were randomized (1:1) to daily treatment with SQ tree SLIT-tablet or placebo for up to 52 weeks and had free access to AR/C symptom-relieving medications. The primary endpoint was the average total combined score (TCS); sum of average daily symptom score (DSS) and average daily medication score (DMS) during the birch pollen season (BPS). Key secondary endpoints included average DSS and DMS during BPS and average TCS, DSS and DMS during tree pollen season (TPS). SQ tree SLIT-tablet demonstrated a statistically significant and clinically relevant treatment effect compared with placebo for the TCS during BPS with an absolute treatment difference of 1.29 (95% CI: 0.58, 2.00; p = .0004) and a relative reduction of 21.9% (95% CI: 10.6, 31.9). Results were substantiated by reductions in both DSS and DMS versus placebo during the BPS and in DSS, DMS and TCS during the TPS. Treatment was generally well tolerated. Most treatment-related adverse events were mild or moderate local administration site reactions. This is the first paediatric trial to provide robust evidence of efficacy and safety of the SQ tree SLIT-tablet in tree pollen-induced AR/C in a paediatric population (5-17 years).

Influence of Preexisting Conditions and Concussion History on Postconcussion Symptom Severity and Recovery Time in Collegiate Athletes.

Mental health conditions and concussion history reported by a collegiate athlete may contribute to prolonged recovery and symptom severity after concussion. This work examined the potential associations among concussion history, preexisting conditions, and sex relative to initial symptom severity and recovery duration following sport-related concussion (SRC) in a cohort of Division 1 National Collegiate Athletic Association athletes. This prospective cohort study analyzed symptom severity, recovery, and return-to-play (RTP) times reported post-SRC using data collected as part of the Pac-12 Concussion Assessment, Research and Education Affiliated Program and Health Analytics Program. Health history questionnaires that included self-reported history of preexisting conditions were completed at baseline. When consented athletes were diagnosed with a concussion, daily postconcussion symptom scores were evaluated until an athlete was clinically determined to be asymptomatic. Generalized linear and Cox proportional hazards models were used to determine associations between preexisting conditions and recovery and RTP times. Ninety-two concussions met inclusion criteria. Notable differences in initial symptom severity existed between females and males who had mood disorders (effect size [d] = 0.51) and attention-deficit hyperactivity disorder (ADHD; d = 0.93). The number of previous concussions was a strong predictor of athletes reporting preexisting mood disorders, depression, anxiety, and ADHD (p = 0.008-0.04). Females with ≥2 previous concussions required more days to RTP than males (d = 0.31-0.72). Weekly recovery and RTP probabilities substantially differed between athletes who did or did not have learning disorders (LDs; hazard ratio [HR]Recovery = 0.32, HRRTP = 0.22, d = 1.96-2.30) and ADHD (HRRecovery = 3.38, HRRTP = 2.74, d = 1.71-4.14). Although no association existed between concussion history and acute symptom severity, collegiate athletes with a history of concussion had higher probabilities of reporting depression, mood disorders, anxiety, and ADHD. Having ADHD or LDs likely strongly affects time to recovery and RTP for collegiate athletes.

Classifying Self-Reported Rheumatoid Arthritis Flares Using Daily Patient-Generated Data From a Smartphone App: Exploratory Analysis Applying Machine Learning Approaches.

The ability to predict rheumatoid arthritis (RA) flares between clinic visits based on real-time, longitudinal patient-generated data could potentially allow for timely interventions to avoid disease worsening. This exploratory study aims to investigate the feasibility of using machine learning methods to classify self-reported RA flares based on a small data set of daily symptom data collected on a smartphone app. Daily symptoms and weekly flares reported on the Remote Monitoring of Rheumatoid Arthritis (REMORA) smartphone app from 20 patients with RA over 3 months were used. Predictors were several summary features of the daily symptom scores (eg, pain and fatigue) collected in the week leading up to the flare question. We fitted 3 binary classifiers: logistic regression with and without elastic net regularization, a random forest, and naive Bayes. Performance was evaluated according to the area under the curve (AUC) of the receiver operating characteristic curve. For the best-performing model, we considered sensitivity and specificity for different thresholds in order to illustrate different ways in which the predictive model could behave in a clinical setting. The data comprised an average of 60.6 daily reports and 10.5 weekly reports per participant. Participants reported a median of 2 (IQR 0.75-4.25) flares each over a median follow-up time of 81 (IQR 79-82) days. AUCs were broadly similar between models, but logistic regression with elastic net regularization had the highest AUC of 0.82. At a cutoff requiring specificity to be 0.80, the corresponding sensitivity to detect flares was 0.60 for this model. The positive predictive value (PPV) in this population was 53%, and the negative predictive value (NPV) was 85%. Given the prevalence of flares, the best PPV achieved meant only around 2 of every 3 positive predictions were correct (PPV 0.65). By prioritizing a higher NPV, the model correctly predicted over 9 in every 10 non-flare weeks, but the accuracy of predicted flares fell to only 1 in 2 being correct (NPV and PPV of 0.92 and 0.51, respectively). Predicting self-reported flares based on daily symptom scorings in the preceding week using machine learning methods was feasible. The observed predictive accuracy might improve as we obtain more data, and these exploratory results need to be validated in an external cohort. In the future, analysis of frequently collected patient-generated data may allow us to predict flares before they unfold, opening opportunities for just-in-time adaptative interventions. Depending on the nature and implication of an intervention, different cutoff values for an intervention decision need to be considered, as well as the level of predictive certainty required.

Efficacy and safety of stapokibart (CM310) in uncontrolled seasonal allergic rhinitis (MERAK): an investigator-initiated, placebo-controlled, randomised, double-blind, phase 2 trial

There is no trial to assess the benefits of periodically using biologics during the pollen season in patients with uncontrolled seasonal allergic rhinitis (SAR), who have moderate-to-severe symptoms even after standard-of-care. This trial aimed to evaluate the efficacy and safety of the add-on administration of stapokibart, a humanised monoclonal antibody that targets interleukin-4 receptor alpha, in patients with uncontrolled SAR. In this investigator-initiated, randomised, double-blind, placebo-controlled trial, eligible patients received either stapokibart 600-300mg weekly (QW), every 2 weeks (Q2W), or placebo QW for 4 weeks. All patients were given mometasone furoate nasal spray and loratadine throughout the trial. The primary endpoint was the mean change from baseline in daily reflective total nasal symptom score (rTNSS) during 2-week treatment. Secondary efficacy outcomes included: the mean change from baseline in daily rTNSS during 4-week treatment; the mean changes and the mean percentage changes from baseline during 2-week and 4-week treatment in 1) daily rTNSS and reflective total ocular symptom score (rTOSS), 2) morning (AM)/evening (PM) rTNSS and rTOSS, 3) AM instantaneous total nasal symptom score (iTNSS) and instantaneous total ocular symptom score (iTOSS), 4) individual nasal and ocular symptoms; the change from baseline in Rhinoconjunctivitis Quality of-Life Questionnaire score during 4-week treatment. Exploratory endpoints included the change of prespecified markers related to type 2 inflammation pre- and post-treatment. Safety, immunogenicity, and pharmacokinetics were also evaluated. This study is registered with www.clinicaltrials.gov (NCT05470647). Between August 17, 2022, and December 28, 2022, 92 patients with uncontrolled SAR were enrolled from 4 centres in China and randomly assigned to receive stapokibart 600-300mg QW (n=31), stapokibart 600-300mg Q2W (n=30), or placebo QW (n=31), of whom 86 (93%) completed the study. Both stapokibart Q2W and QW did not significantly improve mean change from baseline in daily rTNSS compared with placebo in 2 weeks. The least-squares (LS) mean differences (97.5% confidence interval [CI]) compared with placebo were-1.0 (-2.3, 0.2) in stapokibart Q2W group (p=0.065) and-0.2 (-1.5, 1.0) in stapokibart QW group (p=0.67). For the secondary outcomes, compared with placebo, stapokibart Q2W presented significant improvements in the mean percentage change from baseline in daily rTNSS in 2 weeks (LS mean difference-12.9%, 95% CI-25.3%,-0.4%, p=0.043), as well as AM iTNSS over 2 weeks (LS mean difference-17.4%, 95% CI-31.0%,-3.8%, p=0.013) and 4 weeks (LS mean difference-15.4%, 95% CI-29.0%,-1.9%, p=0.026). Additionally, the nasal congestion score was significantly lower in stapokibart Q2W than placebo during 2-week (LS mean difference-0.4, 95% CI-0.7,-0.1, p=0.014) and 4-week (LS mean difference-0.4, 95% CI-0.7,-0.04, p=0.028) treatment. Treatment-emergent adverse events (TEAEs) occurred in 48% (15/31), 33% (10/30), and 61% (19/31) of patients receiving stapokibart QW, Q2W, and placebo, respectively. Most reported TEAEs were sinus bradycardia, hyperlipidaemia, and blood uric acid increased. In this phase 2 trial, both stapokibart regimens had an acceptable safety and tolerability profile but did not significantly improve daily rTNSS in patients with uncontrolled SAR. The efficacy of stapokibart in patients with uncontrolled SAR is being further investigated in ongoing phase 3 trials (clinicaltrials.gov, NCT05908032). Ministry of Science and Technology of the People's Republic of China; Ministry of Education of the People's Republic of China; National Natural Science Foundation of China; Chinese Academy of Medical Sciences.

Changes in gut microbiota and lactose intolerance symptoms before and after daily lactose supplementation in individuals with the lactase nonpersistent genotype

BackgroundApproximately 70%–100% of the Asian adult population is lactase nonpersistent (LNP). The literature shows that many individuals with the LNP-genotype can consume ≤12 g of lactose without experiencing gastrointestinal discomfort. Repetitive consumption of lactose may reduce intolerance symptoms via adaptation of the gut microbiota. ObjectiveThis study aimed to assess the effects of daily consumption of incremental lactose doses on microbiota composition and function, and intolerance symptoms. MethodsTwenty-five healthy adults of Asian origin, carrying the LNP-genotype were included in this 12-wk before and after intervention trial. Participants consumed gradually increasing lactose doses from 3 to 6 g to 12 g twice daily, each daily dose of 6 g, 12 g, or 24 g being provided for 4 consecutive weeks. Participants handed-in repeated stool samples and underwent a 25 g lactose challenge hydrogen breath test (HBT) before and after the 12-wk intervention. Daily gastrointestinal symptoms and total symptom scores (TSSs) during the lactose challenge were recorded. ResultsA significant increase from 5.5% ± 7.6% to 10.4% ± 9.6% was observed in Bifidobacterium relative abundance after the intervention (P = 0.009), accompanied by a 2-fold increase (570 ± 269 U/g; P < 0.001) in fecal β-galactosidase activity compared with baseline (272 ± 158 U/g). A 1.5-fold decrease (incremental area under the curve; P = 0.01) in expired hydrogen was observed during the second HBT (38 ± 35 ppm·min), compared with the baseline HBT (57 ± 38 ppm·min). There was a nonsignificant decrease in TSS (10.6 ± 8.3 before compared with 8.1 ± 7.2 after intervention; P = 0.09). Daily consumption of lactose was well tolerated, with mild to no gastrointestinal complaints reported during the intervention. ConclusionsIncreased levels of Bifidobacterium indicate an adaptation of the gut microbiota upon repetitive consumption of incremental doses of lactose, which was well tolerated as demonstrated by reduced expired hydrogen concentrations during the second 25-g lactose HBT. Bifidobacteria metabolize lactose without gas production thereby potentially reducing intestinal gas formation in the gut of individuals with the LNP-genotype. This increased lactose tolerance possibly lifts the necessity to remove nutrient-rich dairy foods completely from the diet.The trial is registered at the International Clinical Trials Registry Platform: NL9516. The effect of dietary lactose in lactase nonpersistent individuals on gut microbiota.

Identifying Children Likely to Benefit From Antibiotics for Acute Sinusitis

The large overlap between symptoms of acute sinusitis and viral upper respiratory tract infection suggests that certain subgroups of children being diagnosed with acute sinusitis, and subsequently treated with antibiotics, derive little benefit from antibiotic use. To assess if antibiotic therapy could be appropriately withheld in prespecified subgroups. Randomized clinical trial including 515 children aged 2 to 11 years diagnosed with acute sinusitis based on clinical criteria. The trial was conducted between February 2016 and April 2022 at primary care offices affiliated with 6 US institutions and was designed to evaluate whether symptom burden differed in subgroups defined by nasopharyngeal Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis on bacterial culture and by the presence of colored nasal discharge. Oral amoxicillin (90 mg/kg/d) and clavulanate (6.4 mg/kg/d) (n = 254) or placebo (n = 256) for 10 days. The primary outcome was symptom burden based on daily symptom scores on a validated scale (range, 0-40) during the 10 days after diagnosis. Secondary outcomes included treatment failure, adverse events including clinically significant diarrhea, and resource use by families. Most of the 510 included children were aged 2 to 5 years (64%), male (54%), White (52%), and not Hispanic (89%). The mean symptom scores were significantly lower in children in the amoxicillin and clavulanate group (9.04 [95% CI, 8.71 to 9.37]) compared with those in the placebo group (10.60 [95% CI, 10.27 to 10.93]) (between-group difference, -1.69 [95% CI, -2.07 to -1.31]). The length of time to symptom resolution was significantly lower for children in the antibiotic group (7.0 days) than in the placebo group (9.0 days) (P = .003). Children without nasopharyngeal pathogens detected did not benefit from antibiotic treatment as much as those with pathogens detected; the between-group difference in mean symptom scores was -0.88 (95% CI, -1.63 to -0.12) in those without pathogens detected compared with -1.95 (95% CI, -2.40 to -1.51) in those with pathogens detected. Efficacy did not differ significantly according to whether colored nasal discharge was present (the between-group difference was -1.62 [95% CI, -2.09 to -1.16] for colored nasal discharge vs -1.70 [95% CI, -2.38 to -1.03] for clear nasal discharge; P = .52 for the interaction between treatment group and the presence of colored nasal discharge). In children with acute sinusitis, antibiotic treatment had minimal benefit for those without nasopharyngeal bacterial pathogens on presentation, and its effects did not depend on the color of nasal discharge. Testing for specific bacteria on presentation may represent a strategy to reduce antibiotic use in this condition. ClinicalTrials.gov Identifier: NCT02554383.

Physiological and Psychological Effects of Medically Supervised Fasting in Young Female Adults: An Observational Study.

Background Large-scale empirical and observational studies confirm the safety and efficacy of short-term intermittent fasting; however, prolonged fasting (fasting for more than two days or more) is not well studied. This study investigated the safety, physiological, and psychological effects of a medically supervised fasting (MSF) regimen on healthy volunteers. Methods In this observational study, 117 female participants with an average age of 21.02 (± 1.45) years underwent 10 days of medically supervised fasting. Daily symptom scores and 24-hour food recalls were collected, along with serum levels of vitamin D and calcium, a complete blood count, anthropometric measurements, quality of life (QoL), and subjective mood, anxiety, and depression scores, at the baseline and at the end of fasting. Results Compared to baseline, significant improvements were observed in vitamin D levels (z = -8.79, p = 0.000), calcium levels (z = -4.08, p = 0.000), red blood cell count (z = -4.61, p = 0.000), and hemoglobin levels (z = -5.57, p = 0.00). Improvements were observed in physical QOL (t (116) = -4.51, p = 0.000); psychological QOL (t (116) = -4.70, p = 0.000); and social QOL (t (116) = -2.68, p = 0.008). We also observed significant reductions inbody weight (55.83 (±11.38), 52.99 (±10.94); p = 0.00) and other anthropometric measures.More than 80% (n = 94) experienced at least one symptom associated with fasting. The symptoms associated with fasting changed significantly (p<0.05), with most symptoms peaking from day 3 to day 7 of fasting with remission from day 8 onwards. Conclusion Our findings suggest that MSF is associated with significant improvements in physiological and psychological variables. The symptoms associated with MSF are to be considered in clinical decision-making, and follow-up of patients on fasting therapy, particularly during the peaking of symptoms, may be warranted.

Efficacy and safety of Artemisia annua sublingual immunotherapy in patients with seasonal allergic rhinoconjunctivitis over two pollen seasons.

This study investigates the efficacy and safety of sublingual immunotherapy (SLIT) with A. annua allergens in patients with seasonal allergic rhinoconjunctivitis over two pollen seasons. Seventy patients with moderate-severe seasonal allergic rhinoconjunctivitis were divided evenly into the SLIT and control groups. The SLIT last from 3months before the summer-autumn pollen season in 2021 till the end of the summer-autumn pollen season in 2022. The daily individual symptom score, total rhinoconjunctivitis symptom score (dTRSS), total medication score (dTMS), combined score of medication and rhinoconjunctivitis symptom (dCSMRS), visual analog scale (VAS) score, and adverse events (AEs) were evaluated. The average pollen concentration in 2022 was twice that previous two-year during the pollen season. Fifty-six patients completed treatments (SLIT group: 29, control group: 27). Compared with baseline, the individual symptoms, dTRSS, dTMS, dCSMRS, and VAS scores of SLIT group declined in 2021. After 16months of SLIT, all efficacy indexes in 2022 were still lower than baseline and equivalent to those in 2021. In control group, the efficacy indexes in 2022 were higher than that in 2020 and 2021. The efficacy indexes of SLIT group were lower than those of control group in 2021 and 2022. SLIT is effective for both mono- and poly-sensitized patients. AEs incidence in SLIT group was 82.7% without severe AEs. The A. annua-SLIT can obtain efficacy and safety over two pollen seasons for patients with moderate-severe seasonal allergic rhinoconjunctivitis.

Differential responses to systemic therapy among patients who are financially fragile and receiving Medicaid: Results from ePRO and biometric monitoring study.

1527 Background: Cancer patients with Medicaid insurance have a 50% higher risk of unplanned ED admissions during systemic chemotherapy compared to commercially insured cancer patients. In a prospective study of an ePRO app and smartwatch to remotely monitor patients receiving anti-cancer therapy, we compared symptoms and biometric data among financially fragile (able vs. not to come up with $2000 in 30 days for an unexpected expense) Medicaid enrollees and commercially insured patients with solid tumor malignancies. Methods: The study was conducted at 3 community oncology practices in WA state. (ML41539, ISRCTN25569053) The ePRO had 15 common treatment-related symptoms from the PRO-CTCAE survey. 30 patients initiating systemic treatment wore a Samsung Galaxy 3 watch and completed the ePRO daily on study provided smartphones for 2 weeks. EPRO app adherence (ratio of completed to expected entries) was 91%. Smartwatch adherence (ratio of days with any biosensor data to number of days expected) was 86%. Composite symptom scores were calculated from ePRO responses using a published mapping algorithm (Range 0-3). Repeat symptoms, number of unique symptoms scores &gt;1, and average heart rate (HR) were compared. Results: Participants’ average age was 60 (68% female; 75% no comorbidity, 45% metastatic, 10% Medicaid, 13% reported financial fragility). Treatments: chemotherapy only (56%); immunotherapy only (11%); combination therapy (33%). Financially fragile patients had significantly higher average HR, unique symptoms, and repeat symptoms (e.g., &gt;1 day with symptoms). The average composite symptom score over 2 weeks was significantly higher for Medicaid enrollees, and trended higher for financially fragile patients. 16% of daily composite symptom scores recorded by Medicaid patients were 2 or greater, versus 7% for non-Medicaid patients (p&lt;0.001). Conclusions: Medicaid-insured and financially fragile patients may have more adverse responses to systemic therapy compared to more advantaged patients. If supported in larger studies, the findings may have profound implications for research aimed at improving clinical management in financially disadvantaged cancer patients.[Table: see text]

Bronchodilator response by interrupter technique to guide management of preschool wheeze

ObjectiveWe examined relationships between clinical features and pulmonary function before and after inhaled corticosteroid (ICS) treatment in wheezy preschool children, and specifically, whether measuring bronchodilator response (BDR) could predict benefit...

MP67-10 CLINICAL FACTORS ASSOCIATED WITH EARLY RETURN OF URINARY CONTROL FOLLOWING RETZIUS-SPARING ROBOTIC-ASSISTED RADICAL PROSTATECTOMY

You have accessJournal of UrologyCME1 Apr 2023MP67-10 CLINICAL FACTORS ASSOCIATED WITH EARLY RETURN OF URINARY CONTROL FOLLOWING RETZIUS-SPARING ROBOTIC-ASSISTED RADICAL PROSTATECTOMY Ruben Blachman-Braun, Dinno F Mendiola, Carole Lahana, Chad R. Ritch, Sanoj Punnen, Bruno Nahar, Dipen J Parekh, and Mark L Gonzalgo Ruben Blachman-BraunRuben Blachman-Braun More articles by this author , Dinno F MendiolaDinno F Mendiola More articles by this author , Carole LahanaCarole Lahana More articles by this author , Chad R. RitchChad R. Ritch More articles by this author , Sanoj PunnenSanoj Punnen More articles by this author , Bruno NaharBruno Nahar More articles by this author , Dipen J ParekhDipen J Parekh More articles by this author , and Mark L GonzalgoMark L Gonzalgo More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003330.10AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: A potential side effect following radical prostatectomy is urinary incontinence. Retzius-sparing robotic-assisted radical prostatectomy (RS-RARP) has been associated with improved urinary control outcomes. We investigated the impact of clinical variables and intraoperative surgical findings on recovery of urinary control following RS-RARP. METHODS: Data was collected from a single-surgeon, single-institution prospective database of patients who underwent RS-RARP from May 2020 to July 2022 with≥3 months of follow up. Those without EPIC-CP (Expanded Prostate Cancer Index Composite for Clinical Practice) or unknown prostate size at baseline were excluded. Daily pad use and EPIC-CP urinary incontinence symptom score domain (EPIC-CP UISS) were used to assess continence status. Multivariable-adjusted logistic regression was performed to assess clinical variables associated with 3-month continence (EPIC-CP UISS≤3) following surgery. RESULTS: A total of 295 men were analyzed, 49 (16.6%) had a median lobe (ML) confirmed intraoperatively, 27 (9.2%) required bladder neck reconstruction (BNR) using a tennis-racket suturing technique, and 139 (47.1%) had bilateral nerve-sparing (BNS). A total of 145 (49.2%) and 224 (76.6%) men reported using 0 or 0-1 pad per day ≤1 week following catheter removal, respectively. At 3-month follow up, 65.4% and 86.1% of men reported using 0 or 0-1 pad per day, respectively; 81.7% of men had EPIC-CP UISS ≤3. Approximately 90% and 97% of men reported using 0 or 0-1 pad per day 12 months following surgery, respectively. Diabetes mellitus (DM) was associated with worse continence (OR=0.403, p=0.027), and BNS was associated with better continence (OR=3.595, p=0.003) at 3 months. Prostate size, presence of a ML, and BNR were not associated with worse urinary control at 3 months (Table 1). CONCLUSIONS: Early continence rates after RS-RARP are encouraging with the majority of men being completely dry or using 0-1 pad per day within 1 week of catheter removal and by 3 months following surgery. DM has a negative impact and BNS has a positive impact on return of early continence. Age, prostate size, presence of ML, and BNR did not have a significant impact on early recovery of urinary control after RS-RARP. Source of Funding: No © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e946 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Ruben Blachman-Braun More articles by this author Dinno F Mendiola More articles by this author Carole Lahana More articles by this author Chad R. Ritch More articles by this author Sanoj Punnen More articles by this author Bruno Nahar More articles by this author Dipen J Parekh More articles by this author Mark L Gonzalgo More articles by this author Expand All Advertisement PDF downloadLoading ...

Safety and Tolerability of Bilastine 0.6% Ophthalmic Solution: An 8-Weeks Phase III Study.

The objective of this study was to assess the safety and tolerability of preservative-free bilastine 0.6% ophthalmic solution after 8 weeks of once-daily administration in patients with allergic conjunctivitis (AC). Multi-center, international, randomized, double blind, placebo-controlled, parallel-group, phase III study of adult patients with seasonal or perennial AC. The study was conducted in 26 centers of 5 European countries. Duration of daily treatment with bilastine 0.6% ophthalmic solution or placebo was 8 weeks. Safety was evaluated by analyzing incidence of ocular treatment-emergent adverse events (TEAEs); additionally, and as secondary parameters, ocular tolerability was assessed, in addition efficacy was also assessed by the average daily total eye symptoms score (TESS). A total of 333 randomized patients with AC were included (bilastine, N=218; placebo, N=115). Mean (SD) age of the patients was 39.9 (13.7) and were 63.7% female. Overall, the percentage of ocular related TEAEs was low, and the percentage of patients with ocular related TEAEs was lower in the bilastine ophthalmic solution group (2.8%) than in the placebo group (4.3%). No severe TEAEs were reported. The ocular symptoms and TESS improved during the trial in both treatment groups. Statistically significant treatment differences were observed at Week 8 for the TESS and all individual ocular symptoms, being significantly better in the bilastine ophthalmic solution group than in placebo group. Bilastine 0.6% ophthalmic solution revealed no safety concerns in patients with AC after 8 weeks of once-daily administration. Bilastine was effective in reducing ocular symptoms associated with AC in response to both seasonal and perennial allergens.

P348 Disease trajectories in ulcerative colitis: Early identification of patients with endoscopic remission at Week 52

Abstract Background Clinical understanding of different disease courses in response to targeted therapies in ulcerative colitis (UC) is lacking. Symptom load over time can help to define different trajectories leading to outcome measures at week 52. This post hoc analysis from the GEMINI 1 study of vedolizumab (VDZ) vs placebo for the treatment of moderately to severely active UC1 aimed to define different clinical patterns of response that led to Week 52 endoscopic remission based on daily collection of symptom data: rectal bleeding (RB) and stool frequency (SF). Methods RB and SF data, each scored 0 to 3, were extracted from the diary cards of patients who were treated with VDZ up to Week 50, had clinical outcome assessed at Week 52 and had sufficient diary data. From the daily scores, six different daily symptom score rules comprising RB alone or various combinations of RB and SF (Table 1) were derived. Each of the six symptom score rules was then accrued over the time to derive cumulative symptom scores (area under the curve [AUC]). The AUCs at Weeks 6, 10, 14 and 22 for each rule were evaluated for sensitivity and specificity to predict endoscopic remission at Week 52, which was defined as Mayo endoscopic subscore of ≤1 point. Results Of the 895 pts included in the GEMINI 1 study, 217 pts were treated with VDZ, had sufficient RB and SF data and Week 52 outcome data. Of these, 157 (72.4%) achieved endoscopic remission at Week 52. Rule 4, with a score of 0 if both RB=0 and SF≤1 or 1 if not, was consistently better at predicting response at Week 52, i.e., had largest area under the receiver-operator characteristic (ROC) curve (Week 10 and Week 14 shown in Table 2). Area under ROC curve for Rule 4 was 0.7317 (0.6578, 0.8057) and 0.7534 (0.6810, 0.8258) at Week 10 and Week 14, respectively (Fig 1). Rule 4 had better predictive performance than the use of RB Mayo score (RB1) alone or the simple dichotomization (RB2, 0 if RB≤1, 1 if RB &amp;gt;1) [Table 2]. AUCs for Rule 4 differed between pts with vs without endoscopic remission at Week 52, with differences evident as early as Week 10: median AUC=41 for pts with endoscopic remission vs 70 for pts without (Fig 2). Conclusion The daily collection of RB and SF symptoms during the first weeks of therapy with VDZ identifies patients with a high likelihood for endoscopic emission at Week 52. Early clinical symptom change is a simple method for tight monitoring of patients with UC. The identification of preferential responder populations in which marked reduction of suffering are combined with hard endpoints could help in establishing treatment optimization algorithms for targeted therapies.

The efficacy of a novel smart watch on medicine adherence and symptom control of allergic rhinitis patients: Pilot study

BackgroundAllergic rhinitis (AR) is a common allergic airway disorder that is often poorly managed. There is an urgent need to enhance medication adherence in order to improve treatment outcomes in patients with AR. The efficacy of wearable smart watches in improving medication adherence is currently unclear. ObjectivesThis study aimed to evaluate the efficacy of a novel smart watch in improving medication adherence and symptom control in patients with AR. The reliability of self-reported medication use was also investigated. MethodsThis randomized, open-label, parallel controlled, pilot study enrolled adult patients with AR caused by cypress pollen. Patients were randomized in a 1:2 ratio to an intervention group and control group. Smart watches were only distributed to patients in the intervention group. During the cypress pollen season, all patients were required to take oral antihistamines daily and use nasal corticosteroids and antihistamine eye drops as needed. Daily AR symptom scores and medication usage were recorded in both groups. The smart watch was able to identify medication-taking behaviors of patients via artificial intelligence (AI) and relay this information to physicians, who sent short message service reminders to patients who forgot to take oral antihistamines for more than 2 days. ResultsDuring the pollen season, the adherence rate to oral antihistamines in the intervention group (n = 17) was significantly higher than that in the control group (n = 38) (63.3% ± 28.5% versus 43.2% ± 30.2%, P = 0.02). The daily symptom score of the intervention group was lower than that of the control group (2.4 ± 1.1 versus 3.9 ± 1.0, P < 0.001). There was no significant difference in the on-demand medication score between the 2 groups (1.3 ± 0.4 versus 1.5 ± 0.5, P = 0.13). The consistency rate between self-reported nasal corticosteroid usage and the gold standard (ie, human observation of medication usage in the videos recorded by the smart watch) was 20.0% (0%, 53.7%), and the consistency rate between self-reported antihistamine eye drop usage and the gold standard was 24.3% (2.1%, 67.1%). ConclusionsThis pilot study showed that the application of smart watches in patients with AR was associated with improved medication adherence and symptom control. Furthermore, the reliability of self-reported medication usage was limited.

High Discovery Rate of Duodenal and Gastric Eosinophilia in Patients With Unexplained Moderate–Severe Abdominal Symptoms: A Prospective US Multisite Study

High Discovery Rate of Duodenal and Gastric Eosinophilia in Patients With Unexplained Moderate–Severe Abdominal Symptoms: A Prospective US Multisite Study

Intranasal Xylitol for the Treatment of COVID-19 in the Outpatient Setting: A Pilot Study.

It is well known that acute COVID-19 infection can present with a variety of symptoms, including fever, cough, rhinitis, loss of taste, and the cardinal sign of loss of smell (anosmia). Recently, nasal irrigations with saline and other agents have shown promise for the treatment of COVID-19. Xylitol has been shown to display virucidal effects against SARS-CoV-2. This study aimed to examine the efficacy of xylitol as an adjunct treatment for COVID-19 in an outpatient setting. In a randomized controlled double-blinded fashion, a total of 50 participants (F=30) consented to participate in this study. It was a population of 18 to 65 years of age, with polymerase chain reaction confirmed for SARS-COV-2 by nasopharyngeal swab, less than three days from the start of symptoms. This study's primary endpoint was time to clinical recovery, defined as the change from baseline to end of treatment in COVID-19 symptoms. Outcome variables were the changes in visual analog scale (VAS) and daily symptoms score (DSS) on Days 1-7, 14, and 28 after the initiation of the 14-day treatment. There were no differences between the treatment groups in any demographic and subject characteristics-related variables, including vaccination status. None of the patients were hospitalized, or required emergency visits in addition to no adverse reactions were reported. There were no statistically significant interactions found for VAS (P=0.124), DSS (P=0.448), and sense of smell (P=0.667). The proportion of patients reporting nasal congestion was higher (X2=5.05; P=0.025) in the xylitol (XYL) group (73.1%) vs. the saline (SAL) group (41.7%) on Day 4, and on Day 7 (X2=5.72; P=0.017) XYL group (50.0%) vs. SAL group (17.4%). During Day 28 a total of two patients in the SAL group had anosmia vs. no patients with anosmia in the XYL group, although this difference did not reach statistical significance (X2=5.72; P=0.133). Results demonstrate that both xylitol and saline were equally effective in decreasing the time of symptom resolution and preventing hospitalizations, yet, persistent anosmia was only seen in the SAL group. Intranasal xylitol might play a pivotal role in preventing persistent olfactory abnormalities in post-COVID-19 patients.

Role of Probiotics in Patients with Allergic Rhinitis: A Systematic Review of Systematic Reviews.

Introduction Allergic rhinitis (AR) is estimated to affect up to 30% of the world population. With the rise in cases, newer treatment modalities have been explored. Probiotics have shown to reduce symptoms of AR and improve quality of life. A few systematic reviews have been published aiming to assess the role of probiotics in AR. Objectives To consolidate the recent evidence with an overview of systematic reviews by extracting data regarding subjective outcomes (from quality of life questionnaires, the Total Nasal Symptom Score, the Total Ocular Symptom Score, the Daily Total Symptom Score, the incidence of AR, and the Rhinitis Total Symptom Score) and objective outcomes (levels of antigen-specific immunoglobulin E [IgE], total IgE, interleukin 10 [IL-10], interferon gamma [IFNG], eosinophil, and the T helper 1/T helper 2 [Th1/Th2] ratio). Data Synthesis We conducted a literature search on the PubMed, EBSCO CINAHL, EBSCO Dentistry & Oral Sciences Source, and Cochrane Library up to April 14, 2020. The qualitative assessment was performed using the Assessing the Methodological Quality of Systematic Reviews (AMSTAR-2) tool. A total of 419 titles were screened, and 3 systematic reviews met our eligibility criteria. Probiotics in the treatment of AR have been shown to improve quality of life, the total nasal and ocular symptom scores, the daily total symptom scores and Th1/Th2 ratio. No difference was ascertained for rhinitis total symptom score, and the rates of antigen-specific IgE, total IgE, IL-10, INFG and eosinophil. Conclusion The present review showed that there is considerable evidence that probiotics are useful in the treatment of AR. Further randomized trials targeting the limitations of the currently-available evidence can help ascertain the usefulness of probiotics in cases of AR.

Mepolizumab improves work productivity, activity limitation, symptoms, and rescue medication use in severe eosinophilic asthma.

Patients with severe eosinophilic asthma experience daily activity limitations and reduced productivity at work. Using anonymized individual patient‐level data from two previously conducted randomized, double‐blind, placebo‐controlled studies (MENSA [GSK ID:115588/NCT01691521]; MUSCA [GSK ID:200862/NCT02281318]), we investigated the effect of mepolizumab on work productivity, activity limitation, symptoms, and rescue medication use. Patient‐reported outcomes including Work Productivity and Activity Impairment–General Health (WPAI‐GH) scores (impairment percentages, 0%–100%), global activity limitation (scale 1–4), and perceived change in activity limitation (Likert scale 1–7) since the start of the study were analyzed. WPAI‐GH scores from MENSA were analyzed post hoc for employed patients using mixed model repeated measures; global activity limitation and perceived change in activity limitation from MUSCA were analyzed by ordinal logistic regression. Mean changes from baseline in daily asthma symptom scores (scale 0–5) and rescue medication use (occasions/day) were also assessed, via a post hoc meta‐analysis of MENSA and MUSCA. At study end, WPAI‐GH scores indicative of overall work impairment, impairment while working, and activity impairment consistently improved with mepolizumab versus placebo. Overall, 76% versus 54% of patients rated their activity as “much better,” “better,” or “slightly better” since the start of the study with mepolizumab versus placebo. Mepolizumab was associated with numerically larger improvements from baseline in asthma symptoms (treatment difference 0.21–0.29 points) and rescue medication use (treatment difference −0.08 to −0.22 occasions/day) versus placebo. Our results indicate that patients with severe eosinophilic asthma may experience improved activity limitation, work productivity, symptoms, and rescue medication use with mepolizumab.

Using patient-reported data from a smartphone app to capture and characterize real-time patient-reported flares in rheumatoid arthritis.

ObjectiveWe aimed to explore the frequency of self-reported flares and their association with preceding symptoms collected through a smartphone app by people with RA.MethodsWe used data from the Remote Monitoring of RA study, in which patients tracked their daily symptoms and weekly flares on an app. We summarized the number of self-reported flare weeks. For each week preceding a flare question, we calculated three summary features for daily symptoms: mean, variability and slope. Mixed effects logistic regression models quantified associations between flare weeks and symptom summary features. Pain was used as an example symptom for multivariate modelling.ResultsTwenty patients tracked their symptoms for a median of 81 days (interquartile range 80, 82). Fifteen of 20 participants reported at least one flare week, adding up to 54 flare weeks out of 198 participant weeks in total. Univariate mixed effects models showed that higher mean and steeper upward slopes in symptom scores in the week preceding the flare increased the likelihood of flare occurrence, but the association with variability was less strong. Multivariate modelling showed that for pain, mean scores and variability were associated with higher odds of flare, with odds ratios 1.83 (95% CI, 1.15, 2.97) and 3.12 (95% CI, 1.07, 9.13), respectively.ConclusionOur study suggests that patient-reported flares are common and are associated with higher daily RA symptom scores in the preceding week. Enabling patients to collect daily symptom data on their smartphones might, ultimately, facilitate prediction and more timely management of imminent flares.