Effect of Gender on Clinical Presentation of SLE ِAt Assiut University Hospitals

The investigators aim to compare the clinical characteristics and outcomes of SLE between male and female Egyptian patients at Assuit University Hospital.

Study Overview

• Status: Unknown
• Conditions: SLE

Detailed Description

Systemic lupus erythematosus (SLE) is an autoimmune disease of unknown etiology and is characterized by a multifaceted clinical presentation and disease course. Female predominance is a well-known characteristic of SLE, particularly during the reproductive years. Sex differences are another peculiarity of SLE with respect to clinical manifestations and outcomes. Previous studies have recognized male patients with lupus as a distinct minority; such patients often exhibit a poorer prognosis, especially involving the renal, cardiovascular, and neurologic systems. Higher mortality rates in male than in female patients with SLE have also been reported. Andrade et al reported that multiple conditions (for example, severe skin lesions, serositis, thrombotic events, and seizures) are more frequent in males than females.

Lu et al investigated the frequency of renal failure and end-stage renal disease among both genders and found out that these conditions were more prevalent among males. Another study shows no difference in complications and prognosis between both genders.

The results of these previous studies may not be applicable to all ethnic groups. For example, Mok et al studied the males in the local Chinese population had different disease features in term of clinical features at diagnosis, rate, and severity of relapse, organ damage and cumulative damage score. They found through a retrospective review that at the time of diagnosis, there was a trend, however not statistically significant, that males had less Raynaud's, alopecia, arthritis, anti-Ro antibody, but more thrombocytopenia and discoid lesions. Also, a significantly higher number of males had impaired renal functions.

There are few studies that have assessed the differences between male and female Egyptian patients with SLE according to the presentation, complication, prognosis, and mortality. One of these studies shows a more aggressive disease detected in male patients. This was evident by a higher prevalence of nephritis, fever, cutaneous vasculitis in male patients. on the other hand, alopecia and arthritis were significantly higher in females.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Ahmed Aeltaih, MBBch; Phone Number: +201159486891; Email: a.safwat.4842@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any SLE patients between 18and 40 years old will be eligible to be included in our study.

Description

Inclusion Criteria:

• Any SLE patients between 18and 40 years old will be eligible to be included in our study.

Exclusion Criteria:

• Patients below the age of 18 or above 40.
• Any other autoimmune disease.
• Cardiovascular, neurological, renal complications due to other co-morbidity such as DM and HTN.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
SLE patients; Any SLE patients between 18 and 40 years old.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presentation, complication, and mortality among males and female patients with SLE	Using percentages, we will track the number of patients that develop certain clinical conditions (such as arthritis, malar rash, .... ), complications (such as nephritis), and mortality rates. These numbers and percentages will be used to compare males with females (incidence rates for each event will be calculated).	2 years

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Ahmed Aeltaih, MBBch, Assuit University hospitals

Publications and helpful links

General Publications

• Mok CC, Lau CS, Chan TM, Wong RW. Clinical characteristics and outcome of southern Chinese males with systemic lupus erythematosus. Lupus. 1999;8(3):188-96. doi: 10.1191/096120399678847605.
• Soto ME, Vallejo M, Guillen F, Simon JA, Arena E, Reyes PA. Gender impact in systemic lupus erythematosus. Clin Exp Rheumatol. 2004 Nov-Dec;22(6):713-21.
• El Hadidi KT, Medhat BM, Abdel Baki NM, Abdel Kafy H, Abdelrahaman W, Yousri AY, Attia DH, Eissa M, El Dessouki D, Elgazzar I, Elgengehy FT, El Ghobashy N, El Hadary H, El Mardenly G, El Naggar H, El Nahas AM, El Refai RM, El Rwiny HA, Elsman RM, Galal M, Ghoniem S, Maged LA, Sally SM, Naji H, Saad S, Shaaban M, Sharaf M, Sobhy N, Soliman RM, El Hadidi TS. Characteristics of systemic lupus erythematosus in a sample of the Egyptian population: a retrospective cohort of 1109 patients from a single center. Lupus. 2018 May;27(6):1030-1038. doi: 10.1177/0961203317751856. Epub 2018 Feb 10.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2020
• Primary Completion (ANTICIPATED): March 1, 2022
• Study Completion (ANTICIPATED): March 1, 2022

Study Registration Dates

• First Submitted: January 11, 2020
• First Submitted That Met QC Criteria: January 16, 2020
• First Posted (ACTUAL): January 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 21, 2020
• Last Update Submitted That Met QC Criteria: January 16, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: A44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: No data will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No