Bullous Pemphigoid Induced by antiPD-1/PDL-1 Therapy

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Brief Title

Bullous Pemphigoid Induced by antiPD-1/PDL-1 Therapy

Official Title

Clinical, Biological and Histological Characteristics of Bullous Pemphigoid Induced by antiPD-1/PDL-1 Therapy: A National Retrospective Cohort Study

Brief Summary

      Immune checkpoint inhibitors (monoclonal antibodies targeting cytotoxic T
      lymphocyte-associated antigen-4 (CTLA-4), programmed cell death protein 1 (PD-1) or
      programmed death ligand 1 (PD- L1)) have revolutionized the treatment of many cancers. The
      widespread use of these treatments has triggered a new spectrum of immune related adverse
      events (irAE). Several cases of bullous pemphigoid (BP) triggered by antiPD-1/PDL-1 therapy
      have been reported, and their characteristics are currently poorly described in the
      literature. The investigators sought to collect the French cases of BP triggered by
      antiPD-1/PDL-1 therapy, and to describe their clinical, biological and histological
      characteristics.

      In this national, retrospective, observational study, investigators included patients treated
      with antiPD-1/PDL-1 therapy, with a diagnosis of bullous pemphigoid occurring during
      treatment or up to 12 months after its discontinuation. Diagnosis of BP was made by the
      dermatologist and was based on the following criteria: compatible clinical presentation,
      compatible histopathology findings, positive direct immunofluorescence (DIF) studies,
      positive enzyme-linked immunosorbent assay BP180/enzyme-linked immunosorbent assay BP230.
    

Detailed Description

      All members of French study Group on Autoimmune Bullous Skin Diseases and French group of
      Onco-dermatology were asked to report cases of bullous pemphigoid induced by antiPD-1/PDL-1
      therapy from 2014 to 2019. In this retrospective, observational cohort study, investigators
      included patients treated with PD-1 or PD-L1 inhibitor, with a diagnosis of bullous
      pemphigoid occurring during treatment or up to 12 months after its discontinuation. Diagnosis
      of BP was made by the dermatologist and was based on the following criteria developed by the
      French Bullous Study Group : compatible clinical presentation (absence of atrophic scars,
      absence of mucosal involvement and absence of predominant bullous lesions on the neck and
      head), compatible histopathology findings (subepidermal blister on skin biopsy; and linear
      deposits of IgG and C3 along the basement-membrane zone), positive DIF studies, positive
      enzyme-linked immunosorbent assay BP180/enzyme-linked immunosorbent assay BP230. For each
      case, collected data were : sex, type of tumor, type of checkpoint inhibitor, age at the
      onset of the checkpoint inhibitor, time from the onset of BP compared to the onset of the
      PD-1 inhibitor, clinical presentation of BP, results of complementary exams (skin biopsies,
      enzyme-linked immunosorbent assay for BP180 and BP230 and indirect immunofluorescence studies
      if available); treatment of BP used, consequence on antiPD-1/PD-L1 therapy, course of the
      tumor, other irAEs. Overall tumor response was determined by the treating oncologist and
      classified using RECIST 1.1 (Response Evaluation Criteria in Solid Tumors).
    


Study Type

Observational


Primary Outcome

Clinical situation of the patient features

Secondary Outcome

 BP treatments

Condition

Bullous Pemphigoid

Intervention

Not concerned


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

85

Start Date

April 1, 2020

Completion Date

April 1, 2021

Primary Completion Date

April 1, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Adult patients treated with PD-1 or PD-L1 inhibitor, with a diagnosis of bullous
             pemphigoid occurring during treatment or up to 12 months after its discontinuation.

          -  Diagnosis of the BP based on the following criteria: compatible clinical presentation
             (absence of atrophic scars, absence of mucosal involvement and absence of predominant
             bullous lesions on the neck and head), compatible histopathology findings
             (subepidermal blister on skin biopsy; and linear deposits of IgG and C3 along the
             basement-membrane zone)

          -  Positive direct immunofluorescence studies, positive enzyme-linked immunosorbent assay
             BP180/enzyme-linked immunosorbent assay BP230.

        Exclusion Criteria:

          -  Pregnant women

          -  BP occurring more than 12 months after antiPD-1/PDL-1 therapy
      

Gender

All

Ages

50 Years - 93 Years


Contacts

, 33253482835, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT04641884

Organization ID

Bullous pemphigoid


Responsible Party

Sponsor

Study Sponsor

Nantes University Hospital


Study Sponsor

, , 


Verification Date

October 2020