Devin B. Patel, MD, Erica Cohen, MD, Christina Ha, MD
Cedars-Sinai Medical Center, Los Angeles, CA
Introduction: Evaluating the safety and efficacy of therapeutics for older patients with moderate to severe IBD is challenging as they are often excluded from clinical trials. Medication recommendations have primarily focused on risks of adverse effects, thus vedolizumab has emerged as the preferred first line therapy for these patients. However, there is a paucity of data regarding its clinical and endoscopic efficacy for the older population compared to other biologics. The aim of this study was to characterize the response rates and adverse effects to vedolizumab in older IBD patients based on prior medication and/or biologic exposure.
Methods: A retrospective cohort study of 55 consecutive older IBD patients, > 60 years, treated at a tertiary care referral center from 1/2016 to 12/2018 with exposure to vedolizumab during the study period was performed. The primary outcome of interest was clinical response rates (defined as > 50% improvement in abdominal pain and stool frequency) to vedolizumab induction in biologic-exposed vs biologic-naïve older patients. The secondary outcome was to compare adverse effects to vedolizumab in biologic-exposed vs biologic-naïve older patients within 1 year of initiation of therapy.
Results: Patients with prior biologic exposure were younger in age (69.1 ± 6.2 vs 74.6 ± 8.4 yrs, p=0.01) and more likely to have also been treated with immunomodulators (76.2%) than naïve (30.8%) patients, p = 0.006. More bio-exposed patients had stricturing disease (60.0% vs 0%, p = 0.04) and were treated with combination therapy at induction (29.3% vs 0%, p = 0.05) compared to bio-naïve patients (Table). There were no differences in clinical response to induction (p=0.76), vedolizumab dose escalation (p=1.0), steroid use after induction (p=0.36), and adverse effects (p=1.0) between bio-exposed and naïve older patients (Figure). The addition of immunomodulators did not yield better outcomes for the older bio-exposed patients 50.0% combination therapy vs 55.2% monotherapy response rates, p=1.0.
Discussion: These results suggest similar efficacy and safety of vedolizumab for older IBD patients regardless of prior biologic exposure based on clinical symptom assessment. Combination therapy did not add incremental benefit for this higher-risk age group or complications associated with additive immunosuppression. Further studies are needed to determine appropriate positioning of vedolizumab prior to or after anti-TNF agents or ustekinumab.
Citation: Devin B. Patel, MD, Erica Cohen, MD, Christina Ha, MD. P1431 - EFFICACY OF VEDOLIZUMAB IN OLDER IBD PATIENTS BASED ON PRIOR BIOLOGIC EXPOSURE. Program No. P1431. ACG 2019 Annual Scientific Meeting Abstracts. San Antonio, Texas: American College of Gastroenterology.