Clinical characterization of colitis arising from anti-PD-1 based therapy.

Journal Article (Journal Article)

Colitis is a frequent, clinically-significant immune-related adverse event caused by anti-programmed death-1 (PD-1). The clinical features, timing, and management of colitis with anti-PD-1-based regimens are not well-characterized. Patients with advanced melanoma that received either anti-PD-1 monotherapy ("monotherapy") or combined with ipilimumab ("combination therapy") were screened from 8 academic medical centers, to identify those with clinically-relevant colitis (colitis requiring systemic steroids). Of 1261 patients who received anti-PD-1-based therapy, 109 experienced colitis. The incidence was 3.2% (30/937) and 24.4% (79/324) in the monotherapy and combination therapy cohorts, respectively. Patients with colitis from combination therapy had significantly earlier symptom onset (7.2 weeks vs 25.4 weeks, p < 0.0001), received higher steroid doses (median prednisone equivalent 1.5 mg/kg vs 1.0 mg/kg, p = 0.0015) and experienced longer steroid tapers (median 6.0 vs 4.0 weeks, p = 0.0065) compared to monotherapy. Infliximab use and steroid-dose escalation occurred more frequently in the combination therapy cohort compared to monotherapy. Nearly all patients had resolution of their symptoms although one patient died from complications. Anti-PD-1 associated colitis has a variable clinical presentation, and is more frequent and severe when associated with combination therapy. This variability in checkpoint-inhibitor associated colitis suggests that further optimization of treatment algorithms is needed.

Full Text

Duke Authors

Cited Authors

  • Wang, DY; Mooradian, MJ; Kim, D; Shah, NJ; Fenton, SE; Conry, RM; Mehta, R; Silk, AW; Zhou, A; Compton, ML; Al-Rohil, RN; Lee, S; Voorhees, AL; Ha, L; McKee, S; Norrell, JT; Mehnert, J; Puzanov, I; Sosman, JA; Chandra, S; Gibney, GT; Rapisuwon, S; Eroglu, Z; Sullivan, R; Johnson, DB

Published Date

  • 2019

Published In

Volume / Issue

  • 8 / 1

Start / End Page

  • e1524695 -

PubMed ID

  • 30546965

Pubmed Central ID

  • PMC6287774

International Standard Serial Number (ISSN)

  • 2162-4011

Digital Object Identifier (DOI)

  • 10.1080/2162402X.2018.1524695


  • eng

Conference Location

  • United States