S1003 Early Real-World Effectiveness and Safety of Upadacitinib in Crohn’s Disease: A Single-Center Study

Introduction: The real-world effectiveness and safety of upadacitinib (UPA), an oral selective Janus kinase 1 inhibitor, in patients with Crohn’s disease (CD) have not been well characterized. We assessed the effectiveness, reported adverse effects, and clinical outcomes of UPA as induction and maintenance therapy as mono- or combination therapy for CD. Methods: This was a single-center retrospective cohort study including patients with a CD diagnosis based on clinical/endoscopic criteria. CD patients receiving UPA as monotherapy or combination biologic therapy were included. Baseline variables were abstracted within 3 months prior to UPA initiation, and outcome variables were determined at the most recent GI follow-up on therapy. Baseline clinical activity was determined by using a composite patient-reported outcome (PRO2) score, composed of stool frequency (SF) and abdominal pain (AP) scores (PRO2=2*SF+5*AP). Clinical remission was defined as a PRO2 score < 8. Comparisons of pre-/post-treatment outcomes were determined using 2-sample Wilcoxon rank-sum (Mann-Whitney) test. Results: 40 CD patients receiving UPA were included; 28 (70%) were on UPA monotherapy, and 30% were on combination therapy. In the total cohort, 21 patients had baseline clinical activity; 33% achieved clinical remission. 19 patients did not have baseline activity (safety population). Prior to UPA, the median PRO-2 was 21 (IQR: 14, 28), decreasing to 11 (5, 17) after treatment (P=0.02). Median SF score was 6 (4, 7.75) before UPA, decreasing to 3.5 (2, 6) (P=0.04), and median AP score decreased from 2 (1, 2.25) to 1 (0.75, 1) (P=0.003). Of 13 patients with baseline activity and steroid use, 23% achieved steroid-free clinical remission (SFCR). While groups receiving mono-/combination therapy lacked sufficient size to detect differences in outcomes, numerical trends by subgroup were similar. 45% of patients on UPA reported an adverse event. 25% of patients reported a CD-related hospitalization, 15% underwent CD-related surgery, 7.5% reported a serious infection, 10% reported acne, and 2.5% reported herpes zoster. Conclusion: UPA therapy was associated with clinical remission, improvements in SF and AP scores, and SFCR in this early real-world tertiary CD cohort. Adverse effects were reported in similar rates to registration trials. There was heterogeneity of dose and induction regimen reflecting off-label use during the treatment period. UPA therapy demonstrated a positive efficacy and expected safety for CD in routine practice (Table 1). Table 1 - Baseline (before UPA) Follow-up (after starting UPA) P-value All patients (n=40) Median PRO-2 (with IQR) 21 (14, 28) 11 (5, 17) 0.02 Median SF (with IQR) 6 (4, 7.75) 3.5 (2, 6) 0.04 Median AP (with IQR) 2 (1, 2.25) 1 (0.75, 1) 0.003 Presence of clinical activity 21 (52.5%) - Clinical remission* - 7 (33%) Steroid-free clinical remission** - 3 (23%) *Of n=21 with baseline clinical activity **Of n=13 with baseline clinical activity and steroid use PRO-2: patient-reported outcome SF: stool frequency AP: abdominal pain UPA: upadacitinib.

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