P0535 - Cytomegalovirus Colitis Is Rarely Observed After Initiation of Infliximab, Adalimumab, or Vedolizumab in Biologic-Naïve Patients With Ulcerative Colitis

Rahul S. Dalal, MD¹, Emma L. McClure, BA¹, Jordan C. Pruce, BS¹, Jessica R. Allegretti, MD, MPH, FACG^2
1Brigham & Women's Hospital, Boston, MA; ²Brigham & Women’s Hospital, Harvard Medical School, Boston, MA

Introduction: Cytomegalovirus (CMV) reactivation may occur in patients with severe ulcerative colitis (UC). It remains unclear whether CMV colitis (CMVC) is a bystander of severe UC or a complication of immunosuppressive therapy. Some providers may delay escalation of immune suppression until colonic biopsy results exclude CMVC. We therefore sought to compare the incidence of CMVC among biologic-naïve patients with UC who initiate infliximab (IFX), adalimumab (ADA), or vedolizumab (VDZ).

Methods: This was a retrospective cohort study of adult, biologic-naïve UC patients initiating IFX, ADA, or VDZ between 6/1/14-11/30/20 at a large academic medical center. Electronic health records were reviewed for demographic, clinical, endoscopic, and pathology data and prior history of CMVC. Patients were followed through 2/1/21 or until biologic discontinuation, colectomy, death, or loss to follow-up, whichever occurred first. The primary outcome was CMVC after initiation of biologic therapy, which was defined as documented histologic evidence of CMV inclusions followed by appropriate antiviral therapy. Secondary outcomes were colectomy or death within 30 days of CMVC diagnosis. Patient characteristics and outcomes were compared by biologic therapy using the Kruskal-Wallis test for continuous data and Fisher’s exact test for categorical data. P< 0.05 was considered significant.

Results: We included 503 UC patients who initiated IFX (n=194), ADA (n=169), or VDZ (n=140) 6/1/14-11/30/20 with 893 patient-years of available follow-up for the cohort. There was a documented history of CMVC prior to biologic initiation in 2/194 (1.0%) patients in the IFX group, 3/169 (1.8%) in the ADA group, and 0/140 in the VDZ group (p=0.4). Baseline characteristics and follow-up time compared by biologic are presented in Table 1. After biologic initiation, 1/194 (0.5%) IFX patients, 1/169 (0.6%) ADA patients, and 0/140 VDZ patients developed CMVC (p=1.0). These 2 patients developed CMV colitis 9 days after IFX initiation and 382 days after ADA initiation. Neither had prior history of CMVC and neither required colectomy or died within 30 days after CMVC diagnosis.

Discussion: Two cases of CMVC were identified over 893 patient-years of follow-up in our cohort of UC patients initiating first-line biologics. Due to the few outcomes, no differences were observed between biologics. While larger studies are needed to confirm these findings, providers should consider the rarity of CMVC in this population before delaying escalation of therapy.

Table: Table 1. Baseline characteristics compared by biologic therapy.
*Calculated using Kruskal-Wallis test for continuous data and Fisher’s exact test for categorical data.
¥Follow-up is defined as time from biologic initiation until discontinuation, colectomy, death, or loss of follow-up
†The most recent values for continuous variables documented within 3 months prior to biologic initiation were used. Older values were excluded. Reduced sample sizes are noted.
‡Dose escalation refers to dose increase or dosing interval reduction of biologic agent at any point after treatment initiation.
Abbreviations: IQR=interquartile range, CMV=cytomegalovirus, BMI=body mass index, SCCAI=simple clinical colitis activity index


Disclosures:
Rahul Dalal indicated no relevant financial relationships.
Emma McClure indicated no relevant financial relationships.
Jordan Pruce indicated no relevant financial relationships.
Jessica Allegretti: Artugen – Consultant. Finch Therapeutics – Consultant. Iterative Scopes – Consultant. Janssen – Consultant. Merck – Grant/Research Support. Pandion – Consultant. Pfizer – Consultant. Servatus – Consultant. Takeda – Consultant.


Rahul S. Dalal, MD¹, Emma L. McClure, BA¹, Jordan C. Pruce, BS¹, Jessica R. Allegretti, MD, MPH, FACG². P0535 - Cytomegalovirus Colitis Is Rarely Observed After Initiation of Infliximab, Adalimumab, or Vedolizumab in Biologic-Naïve Patients With Ulcerative Colitis, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.