Comparative Analysis of the Th17 Cellular Response in Active and Inactive Pemphigus Vulgaris Patients

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status: Unknown

Conditions: Pemphigus Vulgaris; Bullous Dermatoses; Autoimmune Diseases

Study type: Observational

Funder types: Other

Identifiers

NCT04096222

3012

Details and patient eligibility

About

This study will compare the pattern of Th17 immune response in active and inactive pemphigus subjects. Skin and serum samples will be taken at the moment of enrollment.

Full description

Pemphigus is an autoimmune disease characterized by production of autoantibodies against desmogleins 1 and 3, which are part of the epidermis desmosomes. The first line of treatment are corticosteroids with or without the use of adjuvants (e.g. azathioprine, mycophenolate or rituximab). T lymphocytes are responsible for the initiation and maturation of the humoral response and the B cell activation required for the production of autoantibodies. In the last decade, the Th17 immune response has been implicated in the pathogenesis of pemphigus. Recently, the existence of tertiary lymphoid organ-like structures within the skin lesions was suggested. This structures contain T lymphocytes, B lymphocytes and plasma cells; these cells interact and create a local microenvironment for the production of autoantibodies. Most of the T cells in this structures are T helper CD4+ and express IL-21, and half of them produce IL-17.

In this study the investigators aim to evaluate comparatively the Th17 and T regulatory immune response in the lesional skin and serum of active and inactive pemphigus subjects that are treated with corticosteroids with or without adjuvants and a third group of healthy subjects. The investigators will study skin and serum due to the difference of lymphocytes and cytokines in both tissues. The primary hypothesis is: active pemphigus vulgaris subjects will have different levels of TH17 response in comparison to inactive patients.

The investigators will use descriptive statistics, association and correlation test of hypothesis.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Current cutaneous activity of pemphigus
2. Subjects will be treated with corticosteroids with or without adjuvants
3. Accept and sign the informed consent

Exclusion criteria

1. Pregnancy
2. Concurrent autoimmune diseases with skin lesions
3. Concurrent diagnosis of cancer
4. Concurrent active infectious disease

Trial design

42 participants in 3 patient groups

Active pemphigus vulgaris subjects

Description:

Subjects with the diagnosis of pemphigus and with active or inactive disease in the skin will be invited to participate. After informed consent, at the enrollment visit the following interventions will be done: 1) two 4 mm punch biopsies in a target lesion, 2) A 34 ml blood sample will be taken, 3) photographs of the subject, 4) demographic, disease, comorbidity and treatment data will be documented, 5) PDAI and ABSIS, 6) Biometric data

Inactive pemphigus vulgaris subjects

Description:

Subjects with the diagnosis of pemphigus and with active or inactive disease in the skin will be invited to participate. After informed consent, at the enrollment visit the following interventions will be done: 1) two 4 mm punch biopsies in a target lesion, 2) A 34 ml blood sample will be taken, 3) photographs of the subject, 4) demographic, disease, comorbidity and treatment data will be documented, 5) PDAI and ABSIS, 6) Biometric data

Healthy subjects

Description:

Healthy subjects will be invited to participate. After informed consent, at the enrollment visit the following interventions will be done: 1) Demographic data will be documented, 2) biometric data, 3) A 34 ml blood sample will be taken