CROHN’S DISEASE REAL-WORLD EVIDENCE ON UPADACITINIB: INSIGHTS ON PATIENT CHARACTERISTICS AND EARLY TREATMENT PATTERN OUTCOMES

Abstract Upadacitinib (UPA) has demonstrated efficacy in clinical trials and was approved in 2023 for treating adults with moderately to severely active Crohn’s disease (CD) in the United States (US). Understanding real-world patient characteristics and treatment patterns is important to support clinical decision-making. This study evaluated the characteristics and early treatment patterns in patients with CD initiating treatment with UPA using real-world evidence. This retrospective cohort study was conducted from May 2023 to December 2024 using US healthcare claims data from the Merative™ MarketScan Research database. Patients ≥18 years initiating UPA 45 mg once daily induction treatment were included if they had ≥1 inpatient or 2 outpatient claims with a CD diagnosis (≥1 claim in the baseline period) and were continuously enrolled for ≥6 months before and ≥6 months after the index date. Patient demographics and baseline characteristics were summarized using descriptive analyses. Treatment patterns such as adherence (proportion of days covered [PDC], defined by percentage of available UPA days’ supply in the follow-up period), persistence (time on UPA [days] until a gap of 60 days was observed in the follow-up period), dose escalation and de-escalation were evaluated. Outcomes were described at 6 months and were stratified by prior line of advanced therapy (LOT). A total of 704 patients were identified with ≥6 months of follow-up data. Mean age was 41 years, 48% were female, 70% were tumor-necrosis factor inhibitor (TNFi)-experienced, 23% were non-TNFi biologic-experienced, 61% had prior exposure to 1 or 2 LOT and 32% had prior exposure to 3+ LOT. Overall, 87% (n = 611) of patients moved from UPA 45 mg induction to maintenance. Of these patients, 21% received UPA 15 mg and 79% received UPA 30 mg (Figure). At 6 months, mean (standard deviation [SD]) PDC was 0.81 (0.25) and 82% of patients demonstrated treatment persistence with UPA (Table). In TNFi-experienced versus non-TNFi-biologic experienced patients, mean PDC and the proportion of patients persisting on treatment were similar. Overall, 19% of patients escalated their dose from 15 to 30 mg and 2% de-escalated from 30 to 15 mg (Table). Patients who used UPA in earlier LOT (1 or 2) compared with later LOT (3+) had higher adherence (0.83 [0.23] or 0.84 [0.23] vs 0.78 [0.27]), higher persistence (85% or 86% vs 77%), and lower dose escalation (17% or 22% vs 25%). This real-world US claims analysis showed approximately 85% of patients remained on UPA from induction to maintenance. Overall, the outcome journeys of patients were better when UPA was used in earlier lines of therapy. Findings were consistent with the observations in the UPA clinical trials in patients with CD. Future analyses will evaluate outcomes with a longer follow-up period. Figure 1:Table 1: