Safety of Upadacitinib in Older Patients With Ulcerative Colitis: A Real-World Experience

Background: Upadacitinib is a selective Janus kinase inhibitor approved by the FDA in March 2022 for the treatment of moderate to severe ulcerative colitis (UC) patients who had an inadequate response or intolerance to one or more anti-TNF agents. Aims: Our goal is to describe our experience with upadacitinib use in adults over the age of 60 years with UC. Methods: This is a multicenter retrospective cohort study of adult patients with moderate to severe UC treated with Upadacitinib after failing at least one biologic. IRB approval was obtained. We collected information from electronic medical records on demographics, clinical and laboratory response as well as any adverse effects. All patients were enrolled in a laboratory monitoring program for upadacitinib followed at our institution. Results: A total of 26 UC patients over the age of 60 years received upadacitinib. The median age at treatment was 66 years, (range 60-80 years). There were 14 males and 12 females. All the patients were White. Every patient had used steroids, anti- TNF agents or other biologic medications prior to upadacitinib. There were 19 patients (73%) with pancolitis and 7 (27%) with limited colitis. There were 6 patients with Mayo endoscopic subscore 2 and 16 patients with Mayo endoscopic subscore 3 noted on colonoscopy prior to upadacitinib use. The median pretreatment fecal calprotectin was 1403 mcg/gram (range, 113-4130). The median pretreatment C reactive protein was 18 mg/L (range, 3-82). The median duration of treatment was 36 weeks (range, 4-208). Twenty-one patients (80%) reported improvement in symptoms and are continuing Upadacitinib. Five patients did not improve, out of which four have required colectomy. Colectomy was performed for refractory disease in three and colon neoplasia in one patient. Adverse effects included hyperlipidemia in 6 patients, acne or rash in 2 patients, and severe oral ulcerations in one patient. Upadacitinib was only discontinued in one patient because of adverse effects. Conclusions: In this cohort of refractory UC patients over the age of 60 years, Upadacitinib was effective and well tolerated. The safety profile in older adults is similar to that reported in the general population.