Abstract

Introduction: A primary goal of Crohn’s disease (CD) treatment is to induce and maintain long-lasting disease remission. Ustekinumab (UST) is a biologic approved for treating adult moderate-severe CD patients since 2016, but real-world effectiveness data remain limited. To describe clinical characteristics of CD patients currently on UST and investigate their disease status since UST initiation in the real world in the US. Methods: This was a cross sectional study of gastroenterologists and their CD patients in the US (Jan 2020–Mar 2021) using the Adelphi Inflammatory Bowel Disease Specific Programme. Physicians completed patient record forms for their next 5 to 10 consecutively consulting CD patients, recording clinical status, disease duration and location, Harvey Bradshaw Index (HBI) components to derive a patient score, symptoms (from a list of 24), treatment history and current treatment use and dosage. Data were reported for patients receiving UST for >1 day at time of consultation. Comparisons between prevalence of symptoms were made using McNemar’s test. Results: 197 patients on UST were included if they had received ≥1 UST dose. On average, patients had been diagnosed with CD for 4.0 years; mean age was 42.9 years and 58% of patients were male. UST was the first biologic therapy for 50% of the cohort, second biologic for 34% and third biologic for 16%. Mean time on treatment was 11.8 months, with 81% of patients receiving UST for ≥ 3 months and 19% receiving it for < 3 months. Most patients (77%) were receiving UST as a monotherapy at the time of consultation, while 11% were also on corticosteroids, 8% also on immunomodulators, and 5% on both. Amongst patients currently in maintenance, 68% were on UST US labeled dose, 21% were receiving higher and 11% lower than labeled dose. According to HBI, 84% of patients were in remission or had mild disease at last consultation, while 16% of patients had moderate or severe disease (Table 1). The proportion of patients reporting symptoms decreased from treatment initiation to the most recent consultation in patients currently receiving UST (Figure 1). Conclusion: Real-world effectiveness of UST in CD patients was demonstrated, with physicians reporting that most patients were currently in remission or with mild disease and experiencing improvement of symptoms following UST initiation.Figure 1.: Impact of Tofacitinib on Disease Activity Scores.Table 1.: Results of the logistic regression analysis of variables associated with an increased risk of hospitalization among IBD patients and patients with other immune-mediated inflammatory disorders (IMIDs).

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