Hamzah Abu-Sbeih, MD1, David Faleck, MD2, Biagio Ricciuti, MD3, Robin Mendelsohn, MD2, Abdul Rafeh Naqash, MD4, Justine Cohen, DO5, Maclean Sellers, MD5, Aanika Balaji, MD6, Guy Ben-Betzalel, MD7, Ibraheim Hajir, MBChB8, Jiajia Zhang, MD, MPH9, Mark Awad, MD, PhD10, Giulia Leonardi, MD10, Douglas Johnson, MD11, David Pinato, MD, PhD12, Dwight Owen, MD13, Sarah Weiss, MD14, Giuseppe Lamberti, MD15, Mark Lythgoe, MBBS, MPharm12, Lisa Manuzzi, MD15, Christina Arnold, MD13, Jarushka Naidoo, MD9, Gal Merkel, MD7, Nick Powell, MBChB, PhD8, Sai-Ching Yeung, MD16, Elad Sharon, MD, MPH17, Michael Dougan, MD, PhD5, Yinghong Wang, MD, PhD16
1University of Missouri, Kansas City, MO; 2Memorial Sloan-Kettering Cancer Center, New York, NY; 3Dana Farber Cancer Institute, Boston, MA; 4East Carolina University, Greenville, NC; 5Massachusetts General Hospital, Boston, MA; 6Johns Hopkins University, Baltimore, MD; 7Sheba Medical Center, Ramat Gan, HaDarom, Israel; 8King's College London, London, England, United Kingdom; 9Johns Hopkins University Hospital, Baltimore, MD; 10University of Perugia, Perugia, Puglia, Italy; 11Vanderbilt University Medical Center, Nashville, TN; 12Imperial College London, London, England, United Kingdom; 13The Ohio State University, Columbus, OH; 14Yale University, New Haven, CT; 15Bologna University, Bologna, Umbria, Italy; 16MD Anderson Cancer Center, Houston, TX; 17National Cancer Institute, Bethesda, MD
Introduction: We characterized gastrointestinal adverse events in patients with underlying inflammatory bowel disease (IBD) who received immune checkpoint inhibitors.
Methods: We performed a fourteen-center, retrospective study of patients with documented IBD who received immune checkpoint inhibitor therapy between January 2010 and February 2019. Backward selection and multivariate logistic regression were conducted to assess risk of gastrointestinal adverse events.
Results: Of the 102 included patients, 17 received therapy targeting cytotoxic T-lymphocyte antigen-4 and 85 received monotherapy targeting programmed death-1 or its ligand. Half the patients had Crohn’s disease and half had ulcerative colitis. The median time from last active IBD episode to immunotherapy initiation was 5 years (interquartile range, 3-12). Forty-three patients were not receiving treatment for IBD (Table 1). Gastrointestinal adverse events occurred in 42 patients (41%) after a median of 62 days (interquartile range, 33-123), a rate higher than that among similar patients without underlying IBD who were treated at centers participating in the study (11%; P< 0.001). Gastrointestinal events among patients with IBD included grade 3 or 4 diarrhea in 21 patients. Four patients experienced colonic perforation, 2 of whom required surgery. No gastrointestinal adverse event-related deaths were recorded (Table 2). Anti-cytotoxic T-lymphocyte antign-4 therapy was associated with increased risk of gastrointestinal adverse events on univariate but not multivariate analysis (respectively, odds ratio, 3.19; 95%confidence interval, 1.8-9.48; P=0.037 and odds ratio, 4.72; 95% confidence interval, 0.95-23.53; P=0.058).
Discussion: Preexisting IBD increases the risk of severe gastrointestinal adverse events in patients treated with immune checkpoint inhibitors.
Citation: Hamzah Abu-Sbeih, MD; David Faleck, MD; Biagio Ricciuti, MD; Robin Mendelsohn, MD; Abdul Rafeh Naqash, MD; Justine Cohen, DO; Maclean Sellers, MD; Aanika Balaji, MD; Guy Ben-Betzalel, MD; Ibraheim Hajir, MBChB; Jiajia Zhang, MD, MPH; Mark Awad, MD, PhD; Giulia Leonardi, MD; Douglas Johnson, MD; David Pinato, MD, PhD; Dwight Owen, MD; Sarah Weiss, MD; Giuseppe Lamberti, MD; Mark Lythgoe, MBBS, MPharm; Lisa Manuzzi, MD; Christina Arnold, MD; Jarushka Naidoo, MD; Gal Merkel, MD; Nick Powell, MBChB, PhD; Sai-Ching Yeung, MD; Elad Sharon, MD, MPH; Michael Dougan, MD, PhD; Yinghong Wang, MD, PhD. P1420 - IMMUNE CHECKPOINT INHIBITOR THERAPY IN PATIENTS WITH PREEXISTING INFLAMMATORY BOWEL DISEASE. Program No. P1420. ACG 2019 Annual Scientific Meeting Abstracts. San Antonio, Texas: American College of Gastroenterology.