Safe Administration of Anti-PD-1 Immunotherapy in a Patient with Pre-Existing Primary Biliary Cholangitis

Abstract

A 63-year-old female presented with cholestatic liver function tests in November 2016. Screening tests were negative for other causes and liver biopsy revealed primary biliary cholangitis (PBC) with autoimmune hepatitis (AIH) overlap. Ursodeoxycholic acid and azathioprine was initiated. In September 2018 she was diagnosed with Stage III BRAF wild-type melanoma. Azathioprine was ceased and adjuvant immunotherapy was not recommended due to the risk of worsening PBC/AIH. Surveillance PET revealed metastatic disease and she commenced pembrolizumab. Restaging PET after 4 cycles showed a complete metabolic response, with no hepatitis or other significant toxicity. We believe this is the first reported case of the safe administration of pembrolizumab in a patient with known PBC/AIH. Treatment duration in such high risk patients needs further investigation.

Keywords::

• autoimmune condition
• autoimmune hepatitis
• autoimmunity
• immunotherapy
• metastatic melanoma
• pembrolizumab
• primary biliary cholangitis

Author contributions

P Bhave collated patient data, performed a literature review and wrote the manuscript. A Pham performed histological examination of the liver biopsy and edited the manuscript. A Gordon collated patient data and edited the manuscript. M Moore performed a literature review and was a major contributor in writing the manuscript. All authors read and approved the final manuscript.

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

Availability of data & material

Data sharing is not applicable to this article as no datasets were generated or analyzed during the current study.

Ethical conduct of research

The patient freely consented to her clinical details and results being presented in this case report. Written informed consent was obtained and the ethical guidelines set out by the Declaration of Helsinki were followed. This case report was deemed exempt from ethics board review by our institution. Written informed consent for publication of their clinical details and/or clinical images was obtained from the patient. A copy of the consent form is available for review by the Editor of this journal.