Benjamin L. Cohen, MD1, Helena Chang, MS1, Jason Rogers, BA1, Shashank Garg, MS1, Debra Lawrence, PhD2, Farah Fasihuddin, MPH1, Trevor Lissoos, MBBCh, FACG2, Ashish Atreja, MD, MPH1
1Icahn School of Medicine at Mount Sinai, New York, NY; 2Takeda Pharmaceuticals U.S.A., Inc., Deerfield, IL
Introduction: Ulcerative colitis (UC) and Crohn’s disease (CD) are chronic disorders of the gastrointestinal tract associated with high morbidity and decreased quality of life (QOL). The objectives were to assess health resource use, inflammatory biomarkers, and QOL in a cohort of inflammatory bowel disease (IBD) patients initiating vedolizumab therapy by analyzing existing data from both electronic health records (EHR) and the patient-focused application HealthPROMISE.
Methods: A retrospective cohort of adult IBD patients initiating vedolizumab between June 2014 and April 2019 at the Mount Sinai Medical Center (MSMC) infusion center was analyzed. Baseline data from the 1-year period prior to first vedolizumab infusion are reported. Health resource use and inflammatory biomarkers were extracted from EHR. IBD symptoms and QOL (Short Inflammatory Bowel Disease Questionnaire [SIBDQ]) were collected from the HealthPROMISE application. Descriptive analyses were conducted using SAS® v9.4.
Results: A total of 877 patients (502 with UC and 368 with CD, with a mean age of 39.6 years [SD = 16.2] and 51.8% female) was included. At baseline, mean levels of C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and hemoglobin were as follows: 22.4 mg/L (SD = 54.0), 27.3 mm/h (SD = 21.5), 12.4 g/dL (SD = 1.7), respectively. Baseline SIBDQ scores and IBD symptom scores were 34.2 (SD = 13.0) and 4.8 (SD = 2.7), respectively. The proportion of patients with IBD-related hospitalizations, office visits, emergency room (ER) visits, procedures (surgical and nonsurgical), and medication use prior to initiating vedolizumab therapy are presented in Table 1.
Discussion: Baseline data collected from the HealthPROMISE application are limited; however, the scores reported are consistent with larger cohorts, suggesting that the HealthPROMISE application may be used to track QOL and patient-reported outcomes in IBD patients.
Citation: Benjamin L. Cohen, MD; Helena Chang, MS; Jason Rogers, BA; Shashank Garg, MS; Debra Lawrence, PhD; Farah Fasihuddin, MPH; Trevor Lissoos, MBBCh, FACG; Ashish Atreja, MD, MPH. P0489 - BASELINE CHARACTERISTICS OF A RETROSPECTIVE COHORT OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE INITIATING VEDOLIZUMAB THERAPY: DATA FROM A PATIENT-FOCUSED APPLICATION (HEALTHPROMISE). Program No. P0489. ACG 2019 Annual Scientific Meeting Abstracts. San Antonio, Texas: American College of Gastroenterology.