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Multicenter Study
. 2023 Jun;21(6):1598-1606.e5.
doi: 10.1016/j.cgh.2023.01.002. Epub 2023 Jan 13.

Comparative Safety of Biologic Agents in Patients With Inflammatory Bowel Disease With Active or Recent Malignancy: A Multi-Center Cohort Study

Ariela K Holmer  1 , Jiyu Luo  2 , Kirk B Russ  3 , Sarah Park  4 , Jeong Yun Yang  4 , Furkan Ertem  5 , Jeffrey Dueker  5 , Vu Nguyen  6 , Simon Hong  7 , Cameron Zenger  8 , Jordan E Axelrad  7 , Anthony Sofia  9 , Jessica C Petrov  10 , Badr Al-Bawardy  10 , David I Fudman  11 , Ernesto Llano  11 , Joseph Dailey  12 , Sushrut Jangi  12 , Nidah Khakoo  13 , Oriana M Damas  13 , Edward L Barnes  14 , Frank I Scott  15 , Ryan C Ungaro  4 , Siddharth Singh  16 ; Rising Educators Academics and Clinicians Helping-IBD (REACH-IBD)
Affiliations
Multicenter Study

Comparative Safety of Biologic Agents in Patients With Inflammatory Bowel Disease With Active or Recent Malignancy: A Multi-Center Cohort Study

Ariela K Holmer et al. Clin Gastroenterol Hepatol. 2023 Jun.

Abstract

Background & aims: Safety of biologic agents is a key consideration in patients with inflammatory bowel disease (IBD) and active or recent cancer. We compared the safety of tumor necrosis factor (TNF)-α antagonists vs non-TNF biologics in patients with IBD with active or recent cancer.

Methods: We conducted a multicenter retrospective cohort study of patients with IBD and either active cancer (cohort A) or recent prior cancer (within ≤5 years; cohort B) who were treated with TNFα antagonists or non-TNF biologics after their cancer diagnosis. Primary outcomes were progression-free survival (cohort A) or recurrence-free survival (cohort B). Safety was compared using inverse probability of treatment weighting with propensity scores.

Results: In cohort A, of 125 patients (483.8 person-years of follow-up evaluation) with active cancer (age, 54 ± 15 y, 75% solid-organ malignancy), 10 of 55 (incidence rate [IR] per 100 py, 4.4) and 9 of 40 (IR, 10.4) patients treated with TNFα antagonists and non-TNF biologics had cancer progression, respectively. There was no difference in the risk of progression-free survival between TNFα antagonists vs non-TNF biologics (hazard ratio, 0.76; 95% CI, 0.25-2.30). In cohort B, of 170 patients (513 person-years of follow-up evaluation) with recent prior cancer (age, 53 ± 15 y, 84% solid-organ malignancy; duration of remission, 19 ± 19 mo), 8 of 78 (IR, 3.4) and 5 of 66 (IR 3.7) patients treated with TNFα antagonists and non-TNF biologics had cancer recurrence, respectively. The risk of recurrence-free survival was similar between both groups (hazard ratio, 0.94; 95% CI, 0.24-3.77).

Conclusions: In patients with IBD with active or recent cancer, TNFα antagonists and non-TNF biologics have comparable safety. The choice of biologic should be dictated by IBD disease severity in collaboration with an oncologist.

Keywords: Colitis; Crohn’s Disease; Immunosuppressive; Malignancy.

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