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| Name | Class |
|---|---|
| Hospital General Dr. Manuel Gea González | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active pemphigus vulgaris subjects | 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 | 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 | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Level of Th17 cytokines in skin of pemphigus vulgaris subjects | The level of IL-17a, IL-21, IL-22, and IL-23 mRNA from skin biopsies at the time of enrollment and when the subject reaches 75% of PDAI improvement or after a year of follow-up (termination visit). The percentage of change in these two determinations will be calculated. | Enrollment |
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| Measure | Description | Time Frame |
|---|---|---|
| Pemphigus Disease Area Index (PDAI) | PDAI has a total of 0-263 points, 250 are related to activity and 13 to damage. Disease severity is considered as follows: 1) moderate <= 14 points; b) significative 15-44 points; and c) extensive >=45 | Enrollment |
| Disease activity |
Inclusion Criteria:
Exclusion Criteria:
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Subjects with the diagnosis of pemphigus who are 18 or older and who have curent skin activity and will receive treatment with corticosteroids with or without adjuvants. At the moment of enrollment subjects shoould not be pregnant, have concurrent autoimmune diseases with skin lesions (eg cutaneous lupus), cancer or infectious diseases.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luis Guillermo Llorente Peters, MD | Contact | 525554870900 | 2603 | luisllorentepeters57@gmail.com |
| Alba Cicero Casarrubias, MD | Contact | 525554870900 | 2604 | albcicero@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Luis Guillermo Llorente Peters, MD | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Dr. Manuel Gea González | Not yet recruiting | Mexico City | 14080 | Mexico | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19137355 | Background | Agarwal V, Mittal SK, Misra R. Expression of multidrug resistance-1 protein correlates with disease activity rather than the refractoriness to methotrexate therapy in rheumatoid arthritis. Clin Rheumatol. 2009 Apr;28(4):427-33. doi: 10.1007/s10067-008-1071-1. Epub 2009 Jan 10. | |
| 23850258 | Background | Almugairen N, Hospital V, Bedane C, Duvert-Lehembre S, Picard D, Tronquoy AF, Houivet E, D'incan M, Joly P. Assessment of the rate of long-term complete remission off therapy in patients with pemphigus treated with different regimens including medium- and high-dose corticosteroids. J Am Acad Dermatol. 2013 Oct;69(4):583-8. doi: 10.1016/j.jaad.2013.05.016. Epub 2013 Jul 12. |
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| ID | Term |
|---|---|
| D010392 | Pemphigus |
| D012872 | Skin Diseases, Vesiculobullous |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |
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Measured with Pemphigus Disease Area Index (PDAI) and Autoimmune Bullous Skin Disorder Intensity Score (ABSIS). PDAI has a total of 0-263 points, 250 are related to activity and 13 to damage. ABSIS has a total score of 0-206. |
| Enrollment |
| Autoimmune Bullous Skin Disorder Intensity Score (ABSIS) | ABSIS has a total score of 0-206. Disease severity is considered as follows: 1) moderate <= 16 points; b) significative 17-52 points; and c) extensive >=53 | Enrollment |
| Treatment | The medications and doses used since the diagnosis and during the study | Enrollment |
| Proportion of Th17 and Treg populations on skin biopsies | iopsies will be processed for immunohistochemistry for TH17 subsets (CD+IL17a+) and Treg subset (CD25+Foxp3+). The proportion of both subsets will be quantified with specialized software. | Enrollment |
| Level of Th17 cytokines in serum of pemphigus vulgaris subjects | The level of IL-17a, IL-21, IL-22 and IL-23 determined by luminometry | Enrollment |
| Level of Th17 chemokines levels | The level of CCL20 and CXCL8 mRNA from skin biopsies and in serum by luminometry | Enrollment |
| Level of Treg cytokines | Determination in skin (RT-PCR) and serum (luminometry) of CCL20 and CXCL8 | Enrollment |
| Level of Treg chemokines | Determinations at the moment of enrollment and at the termination visit in skin (RT-PCR) and serum (luminometry) | Enrollment |
| P-glycoprotein transporter activity in mononuclear peripheral cells | The activity will be a measure of the percentage of efflux of daunorubicin ar 37°C. | Enrollment |
| Percentage of Th17 peripheral cells with expression of P-glycoprotein on the surface | Cells with the phenotype IL-17a+CCR6+CXR3hiCCR4loCCR10-CD161+PGP+ will be measured with flow cytometry | Enrollment |
| Levels of anti-desmogleins 1 and 3 | Levels will be measures with an ELISA assay | Enrollment |
| Proportion of peripheral cellular subpopulations | Determinations with flow cytometry | Enrollment |
| Level of cytokines in supernatant of cellular culture | Determinations at the moment of enrollment with ELISA | Enrollment |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
| Recruiting |
| Mexico City |
| 14080 |
| Mexico |
|
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