Skin adverse events in melanoma patients treated with ipilimumab

The authors examined the safety of ipilimumab (Yervoy) and the associated skin-related adverse events in the treatment of melanoma.

In advanced melanoma, cancer spreads from deep within the skin to other parts of the body. Ipilimumab, an immunotherapy (treatment that uses body’s own immune system to fight cancer), is an approved drug for the treatment of advanced melanoma or melanoma that cannot be treated with surgery.  The most common adverse events after ipilimumab are known as immune-related adverse events (irAE). These irAEs can include bowel effects (such as diarrhea), liver inflammation, and most commonly skin effects. Understanding the occurrences and types of these skin-related side effects is critical since they may reduce patients’ quality of life.

The aim of this study was to examine the safety of ipilimumab. The authors discussed the side effects associated ipilimumab and ways to manage them.

Treatment with ipilimumab resulted in longer survival and slower disease progression in patients with advanced stage melanoma (stage III, IV) that could not be removed by surgery. Based on several studies with ipilimumab, the most frequently reported irAEs were skin rash, itching, diarrhea and inflammation in colon. The majority of these side events were of mild or moderate severity. 

Based on 1498 patients treated with ipilimumab for metastatic melanoma (melanoma that had spread from the skin to other parts of the body), 64.2% of patients experienced irAEs. Most irAEs started during the first 12 weeks of treatment. Skin-related adverse events (such as itching or rashes) were the most common adverse events (44.9%). 17.8% of patients had severe irAEs.

Based on 19 studies (760 patients), 24.3% patients treated with ipilimumab developed a skin rash. Both 3 mg/kg and 10 mg/kg doses of ipilimumab resulted in similar severity of skin rash. 2.4% of patients developed severe skin rashes.

The symptoms of skin rashes were treated with antihistamine tablets (such as Vistaril, Atarax, or Benadryl). Skin inflammation was usually treated with corticosteroids (steroid hormones; anti-inflammatory drugs). Of 63 patients who were treated with corticosteroids (51%; tablets or creams) or nothing (49%) for moderate skin rashes, 81% improved to ‘mild’ or no skin reactions. Of 7 patients with severe skin reactions who were treated with a high-dose of corticosteroids (such as 60 mg of Deltasone), 6 were cured of the skin reaction within 15.6 weeks.

The authors concluded that ipilimumab therapy was associated mostly with mild and moderate skin-related adverse events. Severe skin-related adverse events required stopping ipilimumab or treatment with corticosteroids.