P1022 One-year safety and effectiveness of ustekinumab in patients with Crohn’s disease: The K-STAR study

Abstract

Abstract Background We aimed to investigate the safety and effectiveness of ustekinumab (UST) for Korean patients with Crohn’s disease (CD). Methods Adult patients with CD treated with UST were prospectively enrolled in the K-STAR (Post-MarKeting Surveillance for Crohn’s Disease patients treated with STelARa) study from April 2018 to April 2022. After single intravenous infusion of UST ~6 mg/kg, UST 90 mg subcutaneous injection was followed at week 8 and then maintenance treatment with subcutaneous UST 90 mg every 8 or 12 weeks were given, following up to week 52 to 66. Both adverse events and clinical effectiveness of UST therapy were analyzed (ClinicalTrials.gov Identifier: NCT03942120). Results Of the 464 patients enrolled from 44 medical centers across South Korea, 457 and 428 patients (Crohn’s disease activity index 150 or over) were included in the safety analysis and effectiveness analysis set, respectively (Table 1). At week 16–20 after starting UST, rates of clinical response, clinical remission and corticosteroid-free remission were 75.0% (321/428), 64.0% (274/428), and 61.9% (265/428), respectively (Figure 1A). At week 52–66, rates of clinical response, clinical remission and corticosteroid-free remission were 62.4% (267/428), 52.6% (225/428), and 50.0% (214/428), respectively (Figure 1B). Combined effectiveness (clinical response + biochemical response) was achieved in 40.0% (171/428) and 41.6% (178/428) of patients at week 16–20 and week 52–66, respectively. Bio-naïve patients exhibited significantly higher rates of combined effectiveness than bio-experienced patients (50.3% vs. 30.7% at week 16–20, p<0.001; 47.7% vs. 36.0% at week 52–66, p=0.014) (Figure 1A;1B). No additional benefits were observed with the concomitant use of immunomodulators. Using a multivariable analysis using backward selection, colonic involvement (vs. ileal involvement, odds ratio [OR], 0.32; 95% confidence interval [CI], 0.12–0.89; p=0.028), ileocolonic involvement (vs. ileal involvement, OR, 0.45; 95% CI, 0.23–0.89; p=0.021), baseline C-reactive protein levels (OR, 0.90; 95% CI, 0.84–0.97; p=0.009), and the exposure to two or more biologics (vs. bio-naïve, OR, 0.38; 95% CI, 0.20–0.73; p=0.003) were inversely associated with achieving clinical remission at week 52–66. Any adverse events and serious adverse events were observed in 28.2% (129/457) and in 12.7% (58/457), respectively with no new safety signal associated with UST treatment. Conclusion UST was well-tolerated, effective, and safe as induction and maintenance therapy for patients with CD in Korea. The results from this study enhance our understanding of the role of UST in managing CD patients with diverse characteristics and may help inform clinical decisions.