Iranian psoriasis registry: Research protocol and preliminary results of a pilot study

Psoriasis as a common cutaneous inflammatory disease affect many aspects of patients' life. Disease registries render it possible to collect valuable data regarding a disease prevalence and burden as well as long‐term observations concerning possible therapeutic regimens.


| INTRODUC TI ON
Psoriasis is a common cutaneous inflammatory disease affecting 2%-3% of people in the United States, with an estimated prevalence of 0.5%-8% in different countries worldwide.3][4] Many aspects of patients' life, quality of life, are influenced remarkably by this chronic disorder.Considering the rising trend in the rate of years lived with disability (YLDs) and disability-adjusted life years (DALYs) over the last three decades, prompt action should be taken to manage the disease comprehensively. 5e National Committee on Vital and Health Statistics defines a patient or a disease registry as a categorized system for gathering, storing, extracting, analyzing, and assessing data employed in medicine globally. 6There is an essential demand to attain epidemiological, clinical, and therapeutic data on common diseases, such as psoriasis, to improve public health. 7Disease registries render it possible to collect valuable data regarding a disease's prevalence and burden, associated risk factors, and therapeutic modalities. 6,7With the development of registries, clinicians, and researchers can design clinical guidelines and encourage patients to participate in clinical trials, leading to improvements in public health. 7,8Such registries also facilitate long-term observations concerning possible therapeutic regimens. 8Another appealing capability is providing drug safety data in patients omitted from clinical trials due to comorbidities, concurrent medications, or other exclusion criteria. 9 managing psoriasis, diverse treatment regimens have been used with the goal of optimal outcomes and minimal adverse effects.
Therapeutic options for managing psoriasis are topical agents, phototherapy, and systemic medications, including biologics. 10Compared to other studies such as clinical trials, disease registration centers aim to enable long-term investigation of the adverse events related to diverse therapeutic modalities, the efficacy of different combined treatments in each sub-type of the diseases, the optimal stepwise therapeutic recommendation in different stages and severity of the disease, and the optimal means and timing of tapering or discontinuing medications. 8nsidering the indications above, we aimed to design and establish a registry system for evaluating psoriatic patients in Iran.The excellent experience of others with psoriasis registries worldwide encouraged us to set up this registry for Iranian psoriatic patients.The main aims of the study were:

| Conception of the registry
1. To determine the sociodemographic profile, therapeutic modalities, and treatment regimens of patients with psoriasis; 2. To determine the disease burden; 3. To specify and recommend combination treatment for disease management; 4. To facilitate further research and studies on psoriasis and its treatment modalities.

| Study design
This study was a community-based participatory investigation carried out at two referral dermatology centers for patients with psoriasis, namely Shohada-e-Tajrish and Loghman Hakim hospitals in Tehran, Iran.The pilot phase of the registry was used to identify possible obstacles in the application and execution of systematic registration.

| Patients
Patients with psoriasis of any age group referred to our dermatology centers with or without arthritis were included in the study.
Written informed consent was taken from each patient.Patients were included in the study regardless of associated comorbidities or medication history, allowing us to collect data on the population of patients with psoriasis seeking health care in society.

| Documentation
All demographic information, clinical manifestations, paraclinical data, and treatment regimens were recorded during the first clinical visit.Additional data for clinical assessment were also recorded, including the Psoriasis Area and Severity Index (PASI) score and affected body surface area (BSA).
During the follow-up session, clinical, and paraclinical data were collected regarding the plan and period of the therapeutic regimen.
The treating dermatologist recorded all the mentioned data.A centralized web database was developed, and each dermatologist had a private account to access the online form for registering each patient and adding their data.

| Statistical method
Data were analyzed with SPSS (version 26).Quantitative and qualitative data were reported with mean ± standard deviation (SD) and frequency (percent), respectively.The independent sample t-test, Mann-Whitney test, and chi-squared test were used to compare data between groups.p-values less than 0.05 were considered significant.The patients' parents were relatives in 18.5% (n = 50) of cases.

| RE SULTS
First-degree relatives of 77 patients (27.4%) and second-degree relatives of 38 patients (13.5%) were affected by psoriasis.Notably, 167 patients had children.Among them, 13 had children with psoriasis; 5 patients (3 females, 2 males) had affected girls, and 8 patients (6 females, 2 males) had affected boys.The gender of the affected parent did not affect the possibility of psoriasis transmission to the child, and no significant difference was seen between the two sexes (P = 0.569).
Smoking was noted in 24% of patients (n = 68), while 11.4% (n = 31) were alcohol consumers.The habitual history of alcohol consumption in eight patients and smoking in six patients was not recorded.Only 11.2% of patients (n = 31) had a history of hospitalization, and the mean number of hospitalizations was 0.86 ± 3.86.
Roughly a third of patients (n = 91) had previously suffered from systemic diseases (Table 1), while 3.3% of patients (n = 9) had another skin disease besides psoriasis (Table 2).
The disease duration was reported in 120 patients, generating a mean of 12.06 ± 10.90 years.
The clinical presentations of psoriasis among the patients are summarized in Table 3.
The number of sessions was not recorded in 21 patients, though the median in the remaining patients was 30 (range: 1-250).

| DISCUSS ION
Psoriasis is an inflammatory dermatologic disease that affects people of all ages, with a slight predilection for women.Psoriasis presents with different clinical manifestations involving the skin, nails, joints, and scalp. 11The incidence rate of psoriasis increased over the last three decades from 92.3 individuals per 100 000 in 1990-99.5 in 2017. 5According to a recent systematic review, psoriasis is associated with some comorbidities including cardiovascular disease, mental health, type 2 diabetes mellitus, stroke, non-Hodgkin's TA B L E 1 Systemic diseases that patients had before or during registration.

Systematic disease Frequency Percentage (%)
Gastrointestinal a 1 0. lymphoma, Hodgkin's lymphoma, nonmelanoma skin cancer, and inflammatory bowel disease. 12Due to the higher rate of comorbidities than the general population, psoriasis-related morbidity, and mortality are prominent. 13oriasis is a chronic disease with a substantial psychological burden.For instance, the rate of depression in psoriatic patients is roughly 10%, and among dermatologic diseases, only psoriasis is associated with suicidal ideas. 14,15Furthermore, psoriasis is linked with the highest burden of depression and anxiety among dermatologic diseases. 15In light of these issues, further studies should be conducted to evaluate and address this condition.
Clinical trials report the efficacy and safety data regarding limited study populations in a restricted time window, and the results may differ from the general population.This highlights the importance of registry-based studies for collecting and analyzing longitudinal information about the natural course of a disease, its associated risk factors, and the realistic efficacy of different treatments and their therapeutic combinations. 16Psoriasis registries have been developed in the United Kingdom and Ireland (BADBIR), Spain (Biobadaderm), the Netherlands (Bio-Capture, Child-Capture), Denmark (DermBio), Germany (PsoBest), Italy (PsoCare), Austria (PsoRA), Malaysia (MPR), Sweden (PsoReg), Netherlands (Amsterdam), and Spain (La Coruna), along with two international registries (PSOLAR and Psonet). 17veral registry-based studies reported the efficacy, superiority, and adverse events of each treatment modality compared to others.The SDNTT, as a noninterventional observational registry, reported that therapeutic goals of PASI75 and PASI90 after 1 year of treatment were achieved in 58% and 36% of their patients, respectively, compared to PASI decreased by 70% following 1 year of treatment reported in psoriasis therapeutic guidelines. 18This emphasizes the significance of real-world registry-based investigations for detailing the efficacy and potency of each treatment modality.
Registry-based studies have reported some surprising outcomes that may affect dermatologists' clinical judgment.In a multi-center registry-based analysis of psoriasis patients, women experienced more benefits from systemic therapy than men, as measured by changes in the PASI. 19Also, some studies confirm the psoriasis-related risk factors and associations in real-world populations.In the Czech national BIOREP registry, 41.0% of patients with psoriasis reported a history of psoriatic arthritis, and psoriasis-related risk factors were hypertension, hyperlipidemia, diabetes mellitus, coronary heart disease, and obesity. 20

| CON CLUS ION
In terms of long-term disease complications such as malignancies, cardiovascular events, and serious adverse events, registry-based studies will help physicians better recognize and manage each disease.Also, registries provide valuable details regarding each therapeutic modality's efficacy and post-marketing safety data.

FU N D I N G I N FO R M ATI O N
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

CO N FLI C T O F I NTER E S T S TATEM ENT
The authors declare no conflict of interest.
TA B L E 4 Drugs patients had received since the beginning of their disease.
This registry was designed for the ongoing systematic data collection on patients with psoriasis at Shohada-e-Tajrish and Loghman Hakim Hospitals, Shahid Beheshti University of Medical Sciences, Tehran, Iran.For each patient, the registering dermatologist confirmed the diagnosis of psoriasis using clinical and paraclinical findings.Histopathological confirmation was optional.Patients with an equivocal diagnosis were excluded.

A
total of 281 patients were registered in this program from May 2022 to March 2023.The mean age of patients was 42.02 years (range: 4-86 years); 48% (n = 135) were females, and 52% (n = 146) were males.The mean age of patients at the time of disease onset was 26.9 ± 16.41 years.There was no significant difference between males and females in the age of disease onset (p = 0.53).
Abdollahimajd and Reza M. Robati contributed to the conception and design of the work.Fahimeh Abdollahimajd, Reza M. Robati, Zahra Sadeghi, Ghazal Mardani, Hamideh Moravvej, Soheila Nasiri, Nastaran Namazi, Sahar Dadkhahfar, Mehdi Gheisari, Mohammad Shahidi Dadras and Fariba Ghalamkarpour performed the research.Saba Hasanzadeh analyzed the data.Mohammad Reza Pourani drafted the manuscript.Fahimeh Abdollahimajd and Reza M. Robati critically revised the manuscript.All authors gave final approval and agreed to be accountable for all aspects of the work ensuring integrity and accuracy.
4Clinical presentations of registered patients.