NEW YORK (Reuters Health)—Patients with preexisting autoimmune disease (AIDs) are not at increased risk for immune-related adverse events from immune checkpoint inhibitor (ICI) therapy, although these adverse events may be more likely in patients with inflammatory bowel disease (IBD), new research indicates.
“Therefore, we encourage physicians not to withhold ICI in most common AIDs. However, close monitoring in patients with IBD is advised because the incidence of severe colitis and early discontinuation of treatment due to toxicity was higher in this group,” Ellen Kapiteijn, MD, PhD, with Leiden University Medical Center, the Netherlands, and colleagues advise in Annals of Internal Medicine.1
Because ICIs can cause immune-related adverse events (irAEs) mimicking immunologic diseases, patients with preexisting AIDs were excluded from clinical trials, they explain.
The researchers evaluated the safety and efficacy of ICI therapy in patients with advanced melanoma with and without AID, using the Dutch Melanoma Treatment Registry.
A total of 415 patients (9.5%) had an AID, which was categorized as rheumatologic AID in 227, endocrine AID in 143, IBD in 55) and other in eight. Altogether, 228 of these patients (55%) received ICI therapy versus 2,546 (58%) patients who did not have an AID.
Objective response rates were similar in patients with vs. without AID who received anti-CTLA-4 therapy (10% vs 16%), anti-PD-1 therapy (40% vs. 44%), or the combination (39% vs. 43%). Survival rates were also similar in patients with and without AID (median, 13 months vs. 14 months).
According to the researchers, there was no difference in the incidence of irAEs of grade 3 or higher in patients with and without preexisting AID of rheumatologic or endocrine origin.
The incidences of grade 3 or higher irAEs in patients with AID were 30% with anti-CTLA-4 therapy, 17% with anti-PD-1 therapy and 44% with combination therapy; for patients no AID, the incidences were 30%, 13% and 48%, respectively.
Patients with AID more often discontinued anti-PD-1 therapy due to toxicity than patients without AID (17% vs 9%). Patients with IBD were more prone to anti-PD-1-induced colitis (19%) than patients with other AIDs (3%) and patients without AID (2%).
The researchers say their findings suggest no need to withhold ICI therapy in patients with common AIDs, although close monitoring in cases of IBD is warranted.
Funding for the study was provided by the Netherlands Organization for Health Research and Development.
- van der Kooij MK, Suijkerbuijk KPM, Aarts MJB, et al. Safety and efficacy of checkpoint inhibition in patients with melanoma and preexisting autoimmune disease: A cohort study. Ann Intern Med. 2021 Feb 16. Online ahead of print.