P1655 - Patients Hospitalized With Acute Severe Ulcerative Colitis Undergoing Colectomy Within Three Months Have Lower Oral Cyclosporine Levels

Joshua M. Steinberg, MD¹, Nathaniel A. Cohen, MBBCh¹, Zaheera Shabbir, PharmD¹, Scott Friedberg, MD¹, Tina G. Rodriguez, BA¹, Cindy Traboulsi, MD¹, Joel Pekow, MD¹, Dejan Micic, MD¹, Russell D. Cohen, MD¹, Atsushi Sakuraba, MD, PhD¹, Sushila R. Dalal, MD¹, David T. Rubin, MD, FACG^2
1University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, IL; ²University of Chicago Medicine, Inflammatory Bowel Disease Center, Chicago, IL

Introduction: Intravenous (IV) cyclosporine (CYS) is a well-established salvage therapy for patients admitted with acute severe ulcerative colitis (ASUC) who are refractory to IV corticosteroids. Responders to IV CYS are discharged on an oral equivalent dose but are challenged by significant variation in serum drug levels. We studied the relationship between PO CYS serum levels and colectomy at 3 months post-discharge in patients admitted to our center with ASUC.

Methods: Baseline characteristics and demographics were obtained from the Electronic Medical Record for patients who had been admitted to our center with ASUC and received IV cyclosporine salvage therapy from May 2013 to December 2017 (Table 1). Group comparisons for categorical variables were performed using the χ2 or Fisher exact test, as appropriate. Group comparisons for continuous variables were performed using the student’s T-test for parametric data; a Mann-Whitney U test was used for non-parametric data. A logistic regression analysis was performed to determine factors associated with 3-month colectomy. P values were considered statistically significant when < 0.05.

Results: 36 patients were included in the initial analysis; baseline disease characteristics are in Table 1. Patients on oral CYS who had a colectomy within 3 months of admission had significantly lower median serum CYS levels [196.5ng/mL (IQR 65.25-232.5) vs 268.5ng/mL (IQR 211.75-298), p=0.03], and trended towards a greater difference in mean IV-PO transition drug levels (252.2±189.4 ng/mL vs 110.3±162.2 ng/mL, p=0.09) when compared with patients who did not have a colectomy. Multivariable analysis was performed and showed that higher CYS levels (when adjusted for age and disease duration) were independently associated with a lower risk of 3-month colectomy [HR 0.98 95%CI (0.96-0.99), p=0.04]. There were no significant differences in CYS serum levels in patients undergoing colectomy at 1 year.

Discussion: Our study demonstrates that patients with ASUC who received CYS salvage therapy but required colectomy within 3 months had lower outpatient PO CYS serum levels compared with those who did not undergo colectomy. This finding highlights the need for a greater understanding of the factors that affect pharmacokinetics of CYS in the outpatient setting, as well as more effective dose monitoring strategies, which may affect outcomes in this challenging patient group.



Disclosures:


Joshua M. Steinberg, MD¹, Nathaniel A. Cohen, MBBCh¹, Zaheera Shabbir, PharmD¹, Scott Friedberg, MD¹, Tina G. Rodriguez, BA¹, Cindy Traboulsi, MD¹, Joel Pekow, MD¹, Dejan Micic, MD¹, Russell D. Cohen, MD¹, Atsushi Sakuraba, MD, PhD¹, Sushila R. Dalal, MD¹, David T. Rubin, MD, FACG². P1655 - Patients Hospitalized With Acute Severe Ulcerative Colitis Undergoing Colectomy Within Three Months Have Lower Oral Cyclosporine Levels, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.