For a study, researchers sought to assess the safety of programmed death 1 inhibitors in individuals with autoimmune disease.
Adults with solid tumor malignancies who received ≥1 dose of pembrolizumab or nivolumab at Emory Healthcare between September 4, 2014, and December 31, 2019, were the subjects of a medical records review research. The nonautoimmune patients were randomized, and the first 156 individuals were included in a 2:1 ratio to autoimmune patients, whereas all autoimmune patients (n = 77) were included. The main goal was to compare the frequency of immune-related adverse events (irAEs) in individuals with and without pre-existing autoimmune diseases. The secondary goals were to characterize irAE, irAE therapy, and survival analyses.
Before beginning immunotherapy, all autoimmune patients had preexisting autoimmune diseases under control. In the autoimmune group, the rate of irAE was 42.9%, compared to 32.7% in the nonautoimmune group (odds ratio: 0.65; 95% CI: 0.37-1.14; P=0.130). 23.81% of irAEs in patients with rheumatologic autoimmune diseases were thought to represent a flare-up of their preexisting autoimmune condition. Fewer patients in the autoimmune group got systemic corticosteroids (54.55% vs. 67.35%, P=0.241) for the treatment of irAE and suffered a grade ≥3 irAE (21.21% vs. 37.25%, P=0.379).
According to the findings, it was safe to deliver pembrolizumab and nivolumab to patients with well-controlled autoimmune disorders without significantly raising their risk of developing irAE compared to those without autoimmune diseases. It was necessary to include people who already have autoimmune disorders in prospective clinical studies.
