Patients with preexisting autoimmune diseases are at an increased risk of developing immune-related adverse events (irAEs) when treated with anti-programmed death-1 (PD-1) agents, according to study findings published in The Oncologist.

This also proved to be true regardless of primary tumor type, gender, and ECOG performance status. However, the researchers pointed out that this doesn’t mean these patients shouldn’t be treated with anti-PD-1 immunotherapy.

In the study of 751 patients, 85 (11.3%) had preexisting autoimmune disorders that were further differentiated as clinically active (17.6%) and inactive (82.4%). Types of autoimmune disorders included thyroid (60%), dermatologic (16.4%), rheumatologic (11.8%), gastrointestinal/hepatic (4.7%), neurologic (1.2%), nephrologic (1.2%), and multiple site (4.7%).

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Median age of participants was 69 years, and the male/female ratio was 499/252. Four primary tumor types were represented in the patient population: non-small cell lung cancer (65.5%), melanoma (21.2%), kidney cancer (12.5%), and others (0.8%). All patients had advanced cancer.

In addition, all patients had received treatment with a single-agent anti-PD1 therapy at 1 of 15 medical centers in Italy from September 2013 to May 2018: 75.8% received nivolumab and 24.2% received pembrolizumab. Thirty-one patients with melanoma had received prior treatment with ipilimumab.

In the overall population, irAEs of any grade occurred in 42.9% of patients and grade 3/4 irAEs occurred in 8.9%. For those with preexisting autoimmune disorders, any grade and grade 3/4 irAEs were seen in 65.9% and 9.4% of patients, respectively. Of 56 patients with an autoimmune disorder who experienced an irAE, 40 also experienced a flare of the underling disorder. The flare rates with any grade irAE were 66.6% in patients with thyroid disorders, 50% in patients with dermatologic disorders, 10% in patients with rheumatologic disorders, and 100% in those with gastrointestinal/hepatic disorders.

Compared with patients who didn’t have a preexisting autoimmune disorder, incidence of irAEs of any grade were significantly higher in those with preexisting autoimmune disorders (39.9% vs 65.9%, respectively; P <.0001).

In the overall population, the median time to grade 3/4 irAEs was 3.6 months. In patients with preexisting inactive autoimmune disorders, median time to grade 3/4 irAEs was 1.9 months, and in those with active autoimmune disorders it was 3.5 months.

Treatment was discontinued due to irAEs in 54 patients (7% in patients with preexisting autoimmune disorders and 7.2% in those without).

When examining irAEs of any grade in men and women, the researchers saw a greater incidence in female patients with the risk of developing toxicities 1.4-fold higher than male patients. However, the researchers noted that this finding requires additional investigation.

Disclosure: Some authors declared affiliations with or received funding from the pharmaceutical industry. Please refer to the original article for a full list of disclosures.


Cotellini A, Buti S, Santini D, et al. Clinical outcomes of patients with advanced cancer and pre-existing autoimmune diseases treated with anti-programmed death-1 immunotherapy: a real-world transverse study. The Oncologist. 2019;24:e327-e337. doi:10.1634/theoncologist.2018-0618

This article originally appeared on Oncology Nurse Advisor