Mirikizumab pharmacokinetics and exposure-response in pediatric patients with moderate-to-severe ulcerative colitis.

Mirikizumab is a p19-directed anti-interleukin-23 antibody approved for the treatment of adults with moderate-to-severe ulcerative colitis (UC). Here, we report the first data of mirikizumab pharmacokinetics (PK) and exposure-response (E/R) relationships in pediatric participants (aged 2 to <18 years weighing >10 kg) with moderate-to-severe UC from the phase II, open-label study SHINE-1 (NCT04004611). PK parameters were analyzed using a model developed previously in adults with fixed-exponent allometry for body weight.

Three-Year Efficacy and Safety of Mirikizumab Following 152 Weeks of Continuous Treatment for Ulcerative Colitis: Results From the LUCENT-3 Open-Label Extension Study.

Background: Mirikizumab, a p19-directed interleukin-23 monoclonal antibody, has demonstrated induction of clinical remission at week 12 with maintenance through week 104 in patients with moderately-to-severely active ulcerative colitis (UC). Results are presented from the LUCENT-3 open-label extension study through week 152.

Methods: Of 868 LUCENT clinical trial program mirikizumab-treated induction patients, 544 were responders of whom 365 were rerandomized to mirikizumab maintenance.

Day-Night Activity in Hospitalized Children after Major Surgery: An Analysis of 2271 Hospital Days.

Objectives: To characterize the day-night activity patterns of children after major surgery and describe differences in children's activity patterns between the pediatric intensive care unit (PICU) and inpatient floor setting.

Study Design: In this prospective observational study, we characterized the daytime activity ratio estimate (DARE; ratio between mean daytime activity [08:00-20:00] and mean 24-hour activity [00:00-24:00]) for children admitted to the hospital after major surgery. The study sample included 221 infants and children ages 1 day to 17 years admitted to the PICU at a tertiary, academic children's hospital.

Fragmentation as a novel measure of stability in normalized trajectories of mood and attention measured by ecological momentary assessment.

Electronic diary data, such as that acquired through Ecological Momentary Assessments (EMA), has historically provided novel insights into diverse psychological processes. Analyses of these data typically focus on modeling participant-specific means, variability, and stability. We propose a novel statistical framework to determine participant stability by quantifying fragmentation of standardized trajectories using the following 2-step approach: (1) participant-level EMA scores are normalized, and (2) normalized scores are dichotomized into 2 states, inside and outside a range of 1 standard deviation.

Mood reactivity and affective dynamics in mood and anxiety disorders.

The application of ecological momentary assessment (EMA) in community settings provides a powerful opportunity to obtain measures of emotional reactivity to daily life events, as well as emotional dynamics in real time. This investigation examines the association between emotional reactivity to daily events and emotional experience in mood and anxiety disorders in a large community-based sample. Two-hundred and 87 participants with a lifetime history of bipolar I disorder (BPI; n = 33), bipolar II disorder (BPII; n = 37), major depression (MDD; n = 116), anxiety disorders without a mood disorder (ANX; n = 36), and controls without a lifetime history of mood, anxiety, or substance use disorder (n = 65) completed a 2-week EMA evaluation period concerning mood states and daily events.

Altered cortical brain activity in end stage liver disease assessed by multi-channel near-infrared spectroscopy: Associations with delirium.

Delirium is a common and serious psychiatric syndrome caused by an underlying medical condition. It is associated with significant mortality and increased healthcare resource utilization. There are few biological markers of delirium, perhaps related to the etiologic heterogeneity of the syndrome.