Effects of TNF Blockade on Human BPH/LUTS

International Prostate Symptom Score

The IPSS is a self-report measure used to assess urinary urgency, frequency, and voiding symptoms, and includes one disease-specific quality of life (QoL) question. IPSS scores ranges from 0 to 35, with higher scores indicating more severe urinary symptoms, and QoL ranges from 0 (delighted) to 6 (terrible).

Safety as measured by Clavien-Dindo grading system

Frequency and severity of treatment related adverse events will be reported using the Clavien-Dindo severity grading system.

LURN Symptom Index 29 (LURN SI-29)

This is a multidimensional 29-item questionnaire that assesses different lower urinary tract symptoms as well as single item about global bother.

The Patient-Reported Outcomes Measurement Information System (PROMIS-29) Profile v2.1

The PROMIS-29 Profile is a 29-item instrument that combines short assessments of eight core constructs of health-related quality of life (HRQoL): physical function (PF), sleep disturbance (SD), pain interference (PI) and pain intensity (PIN), fatigue (FA), anxiety (AN), depression (DE) and ability to participate in social roles and activities (SRAA).

Patient Global Impression of Improvement (PGI-I)

This is a single item that captures how much better or worse the person's condition is relative to when they began treatment. Scale ranges from "Very much worse" to "Very much better".

3-Day Voiding Diary

The diary records the patient's daily fluid intake, frequency of urination throughout the day and night, instances of leakage, and the quantity of lost urine. Analyzing these findings against the standard criteria for regular bladder function could reveal potential issues and help confirm a diagnosis. The definition of normal benchmarks takes into account factors like age, gender, as well as various internal and external variables including fluid consumption and its nature.

Cellular consequences of adalimumab therapy on prostate tissue

We hypothesize that TNF-antagonist treatment will de-repress apoptosis, suppress proliferative pathways, and modify the immune cell profile in the prostate. In this aim we will employ flow cytometry and scRNA-seq analysis with pathway imputation, supplemented with immunohistochemistry and bulk RNA-seq, to characterize these changes at a cellular and tissue level.

Genetic predictors to stratify patients with differential response to adalimumab

We hypothesize that genetic variants in 1) genes involved in the TNF-antagonist targeted pathways, 2) susceptibility to chronic inflammation, and 3) susceptibility to BPH influence the effectiveness of the therapy