Ipilimumab Feasible In Autoimmune Disease Patients

Ipilimumab may be used with close monitoring in patients with advanced melanoma and pre-existing autoimmune disease

medwireNews: Autoimmune disease is not a contraindication to ipilimumab treatment for advanced melanoma, suggests research published in JAMA Oncology.

Chart review showed that just 27% of the 30 patients treated with the cytotoxic T-lymphocyte antigen 4 (CTLA-4) inhibitor experienced recurrence or exacerbation of autoimmune disorder symptoms that required systemic therapy, most commonly within 2–6 weeks of treatment. And all were successfully treated with corticosteroids or the tumour necrosis factor-alpha inhibitor infliximab.

A further 33% of patients experienced conventional autoimmune-related grade 3–5 adverse events – distinct from baseline autoimmune symptoms – and again most patients’ symptoms were reversed with corticosteroids or infliximab. One patient died from immune-related colitis after a 1-week delay in reporting diarrhoea symptoms.

Thus, 50% of the patients given ipilimumab did not experience autoimmune flare or immune-related adverse events, say Douglas Johnson, from Vanderbilt University Medical Center in Nashville, Tennessee, USA, and co-authors.

Ipilimumab was associated with a median progression-free survival of 3.0 months and median overall survival of 12.5 months. A fifth of patients responded to treatment, including one complete response in a patient with rheumatoid arthritis who had a mild flare of joint pain and hypophysitis after their third dose, and five partial responses.

The team notes that the patients had a range of autoimmune disorders including rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, systemic lupus erythematosus and thyroiditis. Forty-three percent of patients were using systemic treatments, such as low-dose steroids or hydroxychloroquine sulphate, when ipilimumab treatment began.

“Therefore, clinicians may judiciously consider ipilimumab therapy in patients with advanced melanoma and baseline autoimmunity with close monitoring and adherence to [immune-related adverse event] treatment algorithms”, the researchers write.

“These insights are also important for other T-cell checkpoint inhibitors, which are now achieving regulatory approval in melanoma and other types of cancer.”


Johnson DB, Sullivan RJ, Ott PA, et al. Ipilimumab therapy in patients with advanced melanoma and preexisting autoimmune disorders. JAMA Oncol 2015; Advance online publication 3 December.doi:10.1001/jamaoncol.2015.4368

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