Abstract INTRODUCTION Upadacitinib is a JAKi currently approved as second line advanced therapy for moderate to severe ulcerative colitis (UC) and Crohn’s disease (CD) after anti-TNF exposure. Fast onset of action, short half-life, and high efficacy rates invite investigation into steroid-sparing utilization strategies for severe, refractory phenotypes. Here, we assess our utilization of Upadacitinib samples to manage refractory Inflammatory Bowel Disease (IBD). METHODS This study is a single institution retrospective review of Upadacitinib pharmaceutical sample utilization. We included patients with severe Ulcerative Colitis (UC), Crohn’s Disease (CD) or indeterminate colitis, who received Upadacitinib samples (45mg, 30mg, and 15mg dosing options available) from our clinic between 1/2024-8/2025. Primary outcomes collected were: 1) Utilization patterns, 2) safety outcomes/adverse events, 3) Clinical outcomes. RESULTS There were 58 patients meeting inclusion criteria. Most patients were male (n = 33; 57%). There were 26 patients with CD (45%), 28 patients with UC (48%), and 4 patients with unspecified colitis (7%). These patients were previously exposed to an average of 2.7 advanced therapy options. Samples were utilized for: 1) Quick starts/Bridging to insurance approval for induction (n = 28); 2) Bridging insurance lapses to prevent gaps in therapy (n = 7); 3) Bridge to alternative biologic therapies (n = 3); 4) Bridge to dual therapy with upadacitinib + biologic (n = 2); 5) Reinduction after flare on maintenance therapy (n = 9); 6) Escalated maintenance dosing with either 45mg alternating with 30mg daily dosing (n = 7) or kept at 45mg dose (n = 1). There were no drug related serious adverse events in our sample. There were 3 patients with minor cutaneous reactions (acne, HSV), and 1 unrelated death (motor vehicle accident). Despite salvage therapy efforts, 7.7% (n = 4) patients did require colectomy. Remarkably, of our total sample we found 86.5% of evaluated patients reported clinical improvement and most of these patients (72.5%) reported subjective clinical remission. Similar improvements were noted in patients receiving escalated off-label dosing regimens/escalated maintenance, with 80.3% reporting subjective improvement and 60.8% reporting clinical remission. There were no unplanned re-hospitalizations. Patients receiving Upadacitinib samples were largely able to avoid corticosteroid use, with only 13 (22%) requiring abbreviated corticosteroid tapers. CONCLUSION Our institution’s use of Upadacitinib samples highlight benefit and safety of Upadacitinib as a steroid-sparing agent as well as clinical benefit for reinduction and escalated maintenance strategies for patients with refractory disease. Further investigation into these alternative use strategies is warranted to further explore safety and efficacy for patients with refractory disease.
Shay et al. (Thu,) studied this question.