Ipilimumab administration for advanced melanoma in patients with pre-existing Hepatitis B or C infection: A multicenter, retrospective case series

Sowmya Ravi, Kristen Spencer, Mary Ruisi, Nageatte Ibrahim, Jason J. Luke, John A. Thompson, Keisuke Shirai, David Lawson, Heddy Bartell, Ragini Kudchadkar, Ngoc Thi Gunter, Janice M. Mehnert, Evan J. Lipson

Research output: Contribution to journalArticle

22 Citations (Scopus)

Abstract

Ipilimumab is a fully human, monoclonal antibody directed against Cytotoxic T Lymphocyte Antigen-4 (CTLA-4) that has demonstrated a survival benefit and durable disease control in patients with advanced melanoma. Ipilimumab is associated with potentially serious immune-related adverse events, including autoimmune hepatitis. Because clinical trials of ipilimumab excluded patients with pre-existing hepatitis B or C infection, there is a paucity of data on the safety of ipilimumab administration to that patient population. Here, we report the largest case series to date of patients with hepatitis B or C who received ipilimumab for advanced melanoma. Two of the nine patients described in this case series experienced fluctuations in their liver function tests (LFTs) and were subsequently treated with corticosteroids. Although this is a small series, the rate of hepatotoxicity appears similar to what has been seen in the general population treated with ipilimumab, and the ability to administer ipilimumab did not appear to be affected by concomitant hepatitis B or C infection. The use of ipilimumab in patients with metastatic melanoma who have pre-existing hepatitis can be considered among other therapeutic options.

Original languageEnglish (US)
Article number33
JournalJournal for ImmunoTherapy of Cancer
Volume2
Issue number1
DOIs
StatePublished - Oct 14 2014

Fingerprint

Hepatitis C
Hepatitis B
Melanoma
Infection
CTLA-4 Antigen
Autoimmune Hepatitis
ipilimumab
Liver Function Tests
Hepatitis
Population
Adrenal Cortex Hormones
Monoclonal Antibodies
Clinical Trials
Safety
Survival

All Science Journal Classification (ASJC) codes

  • Molecular Medicine
  • Oncology
  • Cancer Research
  • Immunology and Allergy
  • Pharmacology
  • Immunology

Keywords

  • Hepatitis B
  • Hepatitis C
  • Ipilimumab
  • Melanoma

Cite this

Ravi, Sowmya ; Spencer, Kristen ; Ruisi, Mary ; Ibrahim, Nageatte ; Luke, Jason J. ; Thompson, John A. ; Shirai, Keisuke ; Lawson, David ; Bartell, Heddy ; Kudchadkar, Ragini ; Gunter, Ngoc Thi ; Mehnert, Janice M. ; Lipson, Evan J. / Ipilimumab administration for advanced melanoma in patients with pre-existing Hepatitis B or C infection : A multicenter, retrospective case series. In: Journal for ImmunoTherapy of Cancer. 2014 ; Vol. 2, No. 1.
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abstract = "Ipilimumab is a fully human, monoclonal antibody directed against Cytotoxic T Lymphocyte Antigen-4 (CTLA-4) that has demonstrated a survival benefit and durable disease control in patients with advanced melanoma. Ipilimumab is associated with potentially serious immune-related adverse events, including autoimmune hepatitis. Because clinical trials of ipilimumab excluded patients with pre-existing hepatitis B or C infection, there is a paucity of data on the safety of ipilimumab administration to that patient population. Here, we report the largest case series to date of patients with hepatitis B or C who received ipilimumab for advanced melanoma. Two of the nine patients described in this case series experienced fluctuations in their liver function tests (LFTs) and were subsequently treated with corticosteroids. Although this is a small series, the rate of hepatotoxicity appears similar to what has been seen in the general population treated with ipilimumab, and the ability to administer ipilimumab did not appear to be affected by concomitant hepatitis B or C infection. The use of ipilimumab in patients with metastatic melanoma who have pre-existing hepatitis can be considered among other therapeutic options.",
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Ravi, S, Spencer, K, Ruisi, M, Ibrahim, N, Luke, JJ, Thompson, JA, Shirai, K, Lawson, D, Bartell, H, Kudchadkar, R, Gunter, NT, Mehnert, JM & Lipson, EJ 2014, 'Ipilimumab administration for advanced melanoma in patients with pre-existing Hepatitis B or C infection: A multicenter, retrospective case series', Journal for ImmunoTherapy of Cancer, vol. 2, no. 1, 33. https://doi.org/10.1186/s40425-014-0033-1

Ipilimumab administration for advanced melanoma in patients with pre-existing Hepatitis B or C infection : A multicenter, retrospective case series. / Ravi, Sowmya; Spencer, Kristen; Ruisi, Mary; Ibrahim, Nageatte; Luke, Jason J.; Thompson, John A.; Shirai, Keisuke; Lawson, David; Bartell, Heddy; Kudchadkar, Ragini; Gunter, Ngoc Thi; Mehnert, Janice M.; Lipson, Evan J.

In: Journal for ImmunoTherapy of Cancer, Vol. 2, No. 1, 33, 14.10.2014.

Research output: Contribution to journalArticle

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T1 - Ipilimumab administration for advanced melanoma in patients with pre-existing Hepatitis B or C infection

T2 - A multicenter, retrospective case series

AU - Ravi, Sowmya

AU - Spencer, Kristen

AU - Ruisi, Mary

AU - Ibrahim, Nageatte

AU - Luke, Jason J.

AU - Thompson, John A.

AU - Shirai, Keisuke

AU - Lawson, David

AU - Bartell, Heddy

AU - Kudchadkar, Ragini

AU - Gunter, Ngoc Thi

AU - Mehnert, Janice M.

AU - Lipson, Evan J.

PY - 2014/10/14

Y1 - 2014/10/14

N2 - Ipilimumab is a fully human, monoclonal antibody directed against Cytotoxic T Lymphocyte Antigen-4 (CTLA-4) that has demonstrated a survival benefit and durable disease control in patients with advanced melanoma. Ipilimumab is associated with potentially serious immune-related adverse events, including autoimmune hepatitis. Because clinical trials of ipilimumab excluded patients with pre-existing hepatitis B or C infection, there is a paucity of data on the safety of ipilimumab administration to that patient population. Here, we report the largest case series to date of patients with hepatitis B or C who received ipilimumab for advanced melanoma. Two of the nine patients described in this case series experienced fluctuations in their liver function tests (LFTs) and were subsequently treated with corticosteroids. Although this is a small series, the rate of hepatotoxicity appears similar to what has been seen in the general population treated with ipilimumab, and the ability to administer ipilimumab did not appear to be affected by concomitant hepatitis B or C infection. The use of ipilimumab in patients with metastatic melanoma who have pre-existing hepatitis can be considered among other therapeutic options.

AB - Ipilimumab is a fully human, monoclonal antibody directed against Cytotoxic T Lymphocyte Antigen-4 (CTLA-4) that has demonstrated a survival benefit and durable disease control in patients with advanced melanoma. Ipilimumab is associated with potentially serious immune-related adverse events, including autoimmune hepatitis. Because clinical trials of ipilimumab excluded patients with pre-existing hepatitis B or C infection, there is a paucity of data on the safety of ipilimumab administration to that patient population. Here, we report the largest case series to date of patients with hepatitis B or C who received ipilimumab for advanced melanoma. Two of the nine patients described in this case series experienced fluctuations in their liver function tests (LFTs) and were subsequently treated with corticosteroids. Although this is a small series, the rate of hepatotoxicity appears similar to what has been seen in the general population treated with ipilimumab, and the ability to administer ipilimumab did not appear to be affected by concomitant hepatitis B or C infection. The use of ipilimumab in patients with metastatic melanoma who have pre-existing hepatitis can be considered among other therapeutic options.

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KW - Hepatitis C

KW - Ipilimumab

KW - Melanoma

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