Impact of Bivalent BA.4/5 BNT162b2 COVID-19 Vaccine on Acute Symptoms, Quality of Life, Work Productivity and Activity Levels among Symptomatic US Adults Testing Positive for SARS-CoV-2 at a National Retail Pharmacy.

Evidence on the impact of COVID-19 vaccination on symptoms, Health-Related Quality of Life (HRQoL) and Work Productivity and Activity Impairment (WPAI) is scarce. We analyzed associations between bivalent BA.4/5 BNT162b2 (BNT162b2) and these patient-reported outcomes (PROs). Symptomatic US adults testing positive for SARS-CoV-2 were recruited between 2 March and 18 May 2023 (CT.gov NCT05160636). PROs were assessed using four questionnaires measuring symptoms, HRQoL and WPAI (a CDC-based symptom survey, PROMIS Fatigue, EQ-5D-5L, WPAI-GH), from pre-COVID to Week 4 following infection. Multivariable analysis using mixed models for repeated measures was conducted, adjusting for several covariates. The study included 643 participants: 316 vaccinated with BNT162b2 and 327 unvaccinated/not up-to-date. Mean (SD) age was 46.5 years (15.9), 71.2% were female, 44.2% reported prior infection, 25.7% had ≥1 comorbidity. The BNT162b2 cohort reported fewer acute symptoms through Week 4, especially systemic and respiratory symptoms. All PROs were adversely affected, especially at Week 1; however, at that time point, the BNT162b2 cohort reported better work performance, driven by less absenteeism, and fewer work hours lost. No significant differences were observed for HRQoL COVID-19 negatively impacted patient outcomes. Compared with unvaccinated/not up-to-date participants, those vaccinated with bivalent BA.4/5 BNT162b2 reported fewer and less persistent symptoms and improved work performance.

Impact of COVID-19 Infection on Health-Related Quality of Life, Work Productivity and Activity Impairment by Symptom-Based Long COVID Status and Age in the US.

COVID-19 infection adversely impacts patients' wellbeing and daily lives. This survey-based study examined differences in patient-reported COVID-19 symptoms, Health-Related Quality of Life (HRQoL) and Work Productivity and Activity Impairment (WPAI) among groups of patients defined based on age and symptom-based long COVID status. Symptomatic, COVID-19-positive US outpatients were recruited from 31 January-30 April 2022. Outcomes were collected via validated instruments at pre-COVID, Day 3, Week 1, Week 4, Month 3 and Month 6 following infection, with changes assessed from pre-COVID and between groups, adjusting for covariates. EQ-5D-5L HRQoL and WPAI scores declined in all groups, especially during the first week. Long COVID patients reported significantly higher symptoms burden and larger drops in HRQoL and WPAI scores than patients without long COVID. Their HRQoL and WPAI scores did not return to levels comparable to pre-COVID through Month 6, except for absenteeism. Patients without long COVID generally recovered between Week 4 and Month 3. Older (>50) and younger adults generally reported comparable symptoms burden and drops in HRQoL and WPAI scores. During the first week of infection, COVID-19-related health issues caused loss of 14 to 26 work hours across the groups. These data further knowledge regarding the differential impacts of COVID-19 on clinically relevant patient groups.

Drug survival of ixekizumab, TNF inhibitors, and other IL-17 inhibitors in real-world patients with psoriasis: The Corrona Psoriasis Registry.

To compare drug survival of ixekizumab to other IL-17 inhibitors (IL-17i) and TNF inhibitors (TNFi) among patients with psoriasis (PsO) in a real-world setting. Participants included adult PsO patients enrolled in the Corrona Psoriasis Registry who initiated ixekizumab, TNFi, or other IL-17i between 16 March 2016 to 10 August 2019 and completed ≥1 follow-up visit. Multivariable adjusted hazard ratios (HR) were calculated to estimate the risk for drug discontinuation in the ixekizumab group relative to the other drugs. Among the 1604 drug initiations, 552 initiated ixekizumab, 450 initiated TNFi, and 602 initiated other IL-17i. Mean age was 51 years, 49% were women, and 52% were obese (BMI > 30). Ixekizumab patients had a higher proportion of patients with PASI >12 at drug initiation (24%) than TNFi (15%) and other IL-17i (19%). Over a median of 11 months of follow-up, 723/1604 (45%) drug discontinuations occurred. Persistence of ixekizumab, TNFi, and other IL-17i at 24-months were 68%, 33%, and 46%, among biologic-naïve patients (n = 543), and 46%, 23%, and 36%, for biologic-experienced patients (n = 1061), respectively. Ixekizumab patients had a 64% lower risk of discontinuation vs TNFi (HR = 0.36; 95% CI 0.27-0.47) and a 31% lower risk vs other IL-17i (HR = 0.69, 95% CI 0.55-0.87) after adjustment for biologic experience and other covariates. HRs were similar when limited to patients with moderate-to-severe PsO (BSA > 3, PASI > 3, and IGA > 1, n = 1076) at initiation. In our study of real-world patients with PsO, initiators of ixekizumab had more prolonged drug survival than both initiators of TNFi and other IL-17i up to 2 years of follow-up.

Sexual orientation and salivary alpha-amylase diurnal rhythms in a cohort of U.S. young adults.

Sexual minorities in the United States are at elevated risk of prejudice, discrimination, and violence victimization due to stigma associated with their sexual orientation. These stressors may contribute to physiological stress responses and changes in the regulation of the sympathetic nervous system (SNS). To date, no studies have examined the associations among minority sexual orientation, recent stressful events, and diurnal salivary alpha-amylase (sAA) patterns. The present study included 1663 young adults ages 18-32 years (31% men, 69% women) from the Growing Up Today Study, a prospective cohort of U.S. youth. Participants provided five saliva samples over the course of one day to estimate diurnal sAA patterns. Sexual orientation groups included completely heterosexual with no same-sex partners (CH; referent), mostly heterosexual/completely heterosexual with same-sex partners, and gay/lesbian/bisexual (LB or GB). Sex-stratified multilevel models were fit to evaluate the association of sexual orientation with diurnal patterns of log sAA. The association of recent stressful events was also evaluated. Among women, sexual minorities scored significantly higher than CH on perceived stress and number of stressful events in the past month (p < 0.05). Among men, sexual minorities scored higher than CH on perceived stress but not recent stressful events. In multivariable models, recent stressful events were not associated with sAA patterns, but significant sexual orientation group differences in sAA diurnal rhythm were observed among women though not among men. Compared to CH women, LB showed a blunted awakening response and elevated sAA levels across the day, both indicators consistent with SNS dysregulation. Findings suggest dysregulation of stress physiology in LB women, but not other sexual minority women or men, relative to same-sex heterosexuals. Observed dysregulation may relate to exposure among LB women to chronic stressors associated with sexual orientation stigma, although these relations and differences by sex warrant further study.

Sexual orientation and diurnal cortisol patterns in a cohort of U.S. young adults.

Sexual minorities in the United States are at elevated risk of bullying, discrimination, and violence victimization, all stressors that have been linked to psychological and behavioral stress responses including depressive and anxious symptoms and substance use. Acute and chronic stressors may also elicit physiologic stress responses, including changes in the regulation of the hypothalamic-pituitary-adrenocortical (HPA) axis. Few studies, however, have examined the relationship between minority sexual orientation and diurnal cortisol patterns. The present study included 1670 young adults ages 18-32 years (69% female, 31% male) from the Growing Up Today Study, a prospective cohort of U.S. youth. Participants provided five saliva samples over one day to estimate diurnal cortisol patterns. Sexual orientation groups included: completely heterosexual with no same-sex partners (referent), completely heterosexual with same-sex partners/mostly heterosexual, and gay/lesbian/bisexual. Covariates included perceived stress and stressful life events in the past month. Sex-stratified multilevel models of log-transformed cortisol values were used to model diurnal cortisol patterns, and generalized estimating equations were used to model area under the curve (AUC), both with respect to ground (AUCg) and increase (AUCi). Among females, sexual minorities reported significantly more stressful life events in the past month than their heterosexual counterparts. In adjusted multilevel models, sexual orientation was not significantly associated with diurnal cortisol patterns or with AUCg or AUCi in either females or males. There were no significant interactions between sexual orientation and stressful life events. Time-varying negative mood was significantly associated with higher cortisol levels across the day for both female and male participants, after adjusting for all covariates. This study from a large cohort of U.S. young adults did not detect a relationship between sexual orientation and diurnal cortisol patterns. Despite consistent evidence indicating that, compared to heterosexuals, sexual minorities experience elevated exposure to multiple forms of stressors and adversity across the life course, we did not find differences in diurnal cortisol rhythms by sexual orientation. One possible explanation is that sexual minority participants in the study exhibited physiologic resilience.