BPA_immun: Evaluation of the Prevalence of BP180 and BP230 Autoantibodies in the Serum of Patients With Pruritus Under Immunotherapy
Study Details
Study Description
Brief Summary
The aim of the study is to evaluate the prevalence of positive anti BP180 and/or anti BP230 serology in the serum of patients with chronic and diffuse pruritus for at least 1 month under immunotherapy and in the absence of obvious pruritic dermatosis (e.g. scabies, contact eczema...).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Patient with prurit
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Biological: characterisation of immunoglobulin subclasses
For patients with positive anti BP180 and/or anti BP230 serology, a characterisation of the immunoglobulin subclasses will be performed
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Outcome Measures
Primary Outcome Measures
- Number of patients on immunotherapy with chronic diffuse pruritus for at least 1 month with positive anti BP180 and/or anti BP230 serology [1 day]
Secondary Outcome Measures
- Number of anti-BP180 and/or anti-BP230 positive patients who will develop urticarial, eczematous or bullous disease [30 days]
- Number of anti-BP180 and/or anti-BP230 positive patients who will develop urticarial, eczematous or bullous disease [1 year]
- Patient survival [1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient currently receiving immunotherapy (pembrolizumab, nivolumab, atezolizumab, durvalumab) as monotherapy or in combination OR patient who has received immunotherapy (pembrolizumab, nivolumab, atezolizumab, durvalumab) as monotherapy or in combination within the last 6 months.
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Patients with chronic (> 1 month) diffuse pruritus, which started after the start of immunotherapy and in the absence of an obvious pruritic dermatosis.
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Woman of childbearing age with effective contraception (see GTFG) (estrogen-progestin or intrauterine device or tubal ligation) for 1 month (negative urine/blood pregnancy test) or Postmenopausal woman: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit)
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Major patient
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Patient having read and understood the information letter and signed the consent form
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Patient affiliated to a social security scheme
Exclusion Criteria:
Pruritus prior to immunotherapy. Bullous pemphigoid prior to immunotherapy End-stage chronic renal failure (GFR < 15ml/min or dialysis) Clinical jaundice or total bilirubin > 34 µmol/L Hepatic cholestasis Diabetes mellitus complicated by diabetic neuropathy. History of polycythemia vera History of Hodgkin's lymphoma iron deficiency anemia Current treatment including DPP-4 inhibitors (vildagliptin, linagliptin) Treatment with systemic corticosteroids or immunosuppressant for more than one month.
Pregnant or parturient or breastfeeding woman or absence of proven contraception
· Person deprived of liberty by an administrative or judicial decision or person placed under legal safeguard / sub-tutorship or curatorship
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University Hospital, Rouen
Investigators
- Principal Investigator: Vivien HEBERT, MD, Rouen University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020/0429/HP