Epidemiology, treatment patterns and healthcare resource use associated with prurigo nodularis in the UK: a retrospective analysis using the Clinical Practice Research Datalink

Study type
Protocol
Date of Approval
Study reference ID
20_166
Lay Summary

Prurigo nodularis is a condition which causes itchy lumps to appear over the skin, particularly on the limbs and shoulders although it can occur on other areas as well. The itching it causes can have a serious effect on the patientÂ’s quality of life but little is known about how many people have prurigo nodularis or the impact the condition has on healthcare services. In this study we wish to use the CPRD AURUM database to estimate how many people in England have prurigo nodularis and how many are newly diagnosed with the condition each year. We then wish to describe patients with prurigo nodularis by their age and gender, what other conditions they have and what therapies are currently used to treat the condition. We also wish to see how often these patients access general practice and hospital services and the cost of these contacts. We will then compare these patients to controls, that is patients from the same general practice of the same age and gender who do not have prurigo nodularis to see if they access these services more frequently. We will also compare death rates between prurigo nodularis patients and their controls. This study will provide useful information about the condition which may inform treatment and management decisions for this debilitating condition.

Technical Summary

This study aims to describe the prevalence and incidence of prurigo nodularis and treatment and resource utilisation associated with the condition from an England perspective. The study will comprise both cross-sectional and longitudinal designs and include non-exposed control subjects. Patients with prurigo nodularis of acceptable research quality and eligible for HES linkage will be selected by medcode or ICD-10 code in the CPRD AURUM (Clinical and Referral tables) and HES admitted patient care table respectively. For the cross-sectional analysis, period prevalence will be calculated for 2018 with index date set as 1st January 2018 or first diagnosis date for those cases diagnosed during 2018. Age, gender and current treatment will be described at index date. For the longitudinal analysis the incidence of prurigo nodularis will be described from 2008-18. Index date will be set as date of first diagnosis. Demographic characteristics, baseline comorbidity and baseline medications at index date will be summarised. Time from index date to first therapy for prurigo nodularis will be reported. First line, second line and third line therapies following index date for the prurigo nodularis exposed cohort will be described by class and whether mono- or combination therapy. Time between each line of therapy will be shown in Kaplan-Meier curves and summary statistics. Controls will be selected by primary care practice, age, gender and current practice registration. Inpatient, outpatient and A&E department contacts will be aggregated and compared between cases and controls. Rates will be compared with controls using Poisson Regression and costs will be compared using the negative binomial distribution. Crude mortality rates and Kaplan-Meier curves will be presented for prurigo nodularis exposed and non-exposed cohorts and mortality compared using a Cox Proportional Hazards model.

Health Outcomes to be Measured

Prevalence; incidence; baseline characteristics; treatment pathways; health resource utilisation; comorbidity; survival

Collaborators

Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Melissa Perry - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Thomas Berni - Collaborator - Pharmatelligence Limited t/a Human Data Sciences

Former Collaborators

Melissa Perry - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Thomas Berni - Collaborator - Pharmatelligence Limited t/a Human Data Sciences

Linkages

HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation