P1577 - Real World Experience With Off-Label Upadacitinib in Crohn’s Disease at a Tertiary Care Center

Manuel Bonfim Braga Neto, MD, Shayla Schoenoff, PA-C, Michelle Becker, PharmD, Edward V. Loftus, MD, FACG, Sunanda V. Kane, MD, MSPH, FACG
Mayo Clinic, Rochester, MN

Introduction: Despite advances in the treatment of Crohn’s disease (CD) with the development of biologics with different mechanisms of action, a significant proportion of patients still experience active disease. Upadacitinib (UPA), a selective JAK-1 inhibitor FDA-approved for rheumatoid arthritis, demonstrated efficacy for the treatment of CD in a phase 2 clinical trial, although it is yet to be approved by the FDA for CD. We aimed to describe a series of patients with CD who were treated with off-label UPA.

Methods: Electronic medical records from January 2019 to June 2021 were reviewed using a bioinformatics search tool at a single institution to identify patients with ICD code for CD and UPA in their medical administration record. Data on demographics, CD phenotype, location, medication record, laboratory, endoscopic and radiographic findings. Patients who were participating in a clinical trial of UPA were excluded.



Results: A total of 36 patients with diagnosis of Crohn’s disease and UPA were identified with the initial search tool. After record review, 23 patients were excluded (Figure 1) and 13 included. Median age was 35 years (median age at time of CD diagnosis was 20 years) and 69% of patients were female. Median follow up from initiation of upadacitinib was 60 days (IQR, 43 - 118) (Table 1). The most common disease location was ileocolonic (92.3%), while the most common disease behavior was penetrating (69.2%). All patients had previously failed at least one anti-TNF, an anti-integrin, and anti-IL-23/12 therapy prior to initiation of UPA. The most common dose of UPA was 30 mg daily (53.8%). Medication discontinuation due to side effects occurred in 2 patients (headache/myalgias or abdominal pain). Outcomes were assessed in patients who had ≥ 6 months of follow-up (n=4). Response to therapy occurred in 50% of cases as measured by Physician’s Global Assessment, endoscopic findings and decrease dose requirement of steroids.



Discussion: We describe the largest case series of off-label use of upadacitinib in patients with Crohn’s disease. Insurance approval was a significant barrier for use of upadacitinib in a proportion of patients with clearly refractory disease. Access to novel agents is important for treatment of this refractory population of patients.




Disclosures:


Manuel Bonfim Braga Neto, MD, Shayla Schoenoff, PA-C, Michelle Becker, PharmD, Edward V. Loftus, MD, FACG, Sunanda V. Kane, MD, MSPH, FACG. P1577 - Real World Experience With Off-Label Upadacitinib in Crohn’s Disease at a Tertiary Care Center, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.