Melanoma patients with preexisting autoimmune disease have similar efficacy and toxicity rates from immune checkpoint inhibition: Netherlands’ experience.

Citation: van der Kooij MK, Suijkerbuijk KPM, Aarts MJB, et al.  Ann Intern Med 2021 February. Online ahead of print

There remains hesitancy to treat patients with preexisting autoimmune disease (PAD) with immune checkpoint inhibitors (ICI) due the exclusion of these patients from major clinical trials for these drugs due to the theoretical risk of increased toxicity in these patients.

In this nationwide cohort study out of the Netherlands, out of 4367 patients with melanoma, 415 patients (9.5%) had PAD, including rheumatologic, endocrine and inflammatory bowel disease (IBD).  228 of these patients were treated with ICI.  Compared with the 2546 patients without PAD treated with ICI, rates of grade 3 or higher immune related adverse events (irAE) were similar: 30% in both patients with and without PAD treated with anti-CTLA-4, 17% in patients with PAD vs 13% in patients without PAD treated with anti-PD-1, and 44% in patients with PAD vs 48% in patients without PAD treated with combination therapy.

Patients with PAD were more likely to discontinue anti-PD-1 treatment due to irAE than patients without PAD and patients with pre-existing IBD were more likely to develop colitis from anti-PD-1 treatment than patients with other PAD.

Reassuringly, objective response rate and overall survival (median 13-14 months) was similar between patients with PAD compared with patients without PAD.  Unfortunately there was limited information on severity or disease activity of patients’ PAD at the time of ICI initiation nor their immunosuppressive therapies.

This study adds to the growing body of literature supporting the use of ICI in patients with PAD, although further research is required regarding selection of patients based on specific type of PAD and disease activity and management of immunosuppression during ICI therapy.

Article summary by:  Dr. Carrie Ye