AI Article Synopsis
- The study assessed the safety and effectiveness of ustekinumab (UST) in treating Korean patients with Crohn's disease over a four-year period, gathering data from 464 patients across 44 hospitals.
- Results showed that clinical response rates were high at first (75% by week 20) but decreased by week 66 (62.4%), with higher success rates in patients who had not previously used biologics.
- Adverse events occurred in 28.2% of patients, but no new safety concerns were identified, suggesting UST is generally safe and beneficial for this demographic.
Article Abstract
Background: This study investigated the safety and effectiveness of ustekinumab (UST) in 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 between April 2018 and April 2022. Both the clinical effectiveness and adverse effects of UST therapy were analyzed. Missing data were handled using nonresponder imputation (ClinicalTrials.gov Identifier: NCT03942120).
Results: Of the 464 patients enrolled from 44 hospitals across Korea, 457 and 428 patients (Crohn's disease activity index ≥150) were included in the safety analysis and effectiveness analysis sets, respectively. At weeks 16 to 20 after initiating UST, clinical response, clinical remission, and corticosteroid-free remission rates were 75.0% (321 of 428), 64.0% (274 of 428), and 61.9% (265 of 428), respectively. At week 52 to 66, clinical response, clinical remission, and corticosteroid-free remission rates were 62.4% (267 of 428), 52.6% (225 of 428), and 50.0% (214 of 428), respectively. Combined effectiveness (clinical response + biochemical response) was achieved in 40.0% (171 of 428) and 41.6% (178 of 428) at week 16 to 20 and week 52 to 66, respectively. Biologic-naïve patients exhibited significantly higher rates of combined effectiveness than biologic-experienced patients (50.3% vs 30.7% at week 16-20, P < .001; 47.7% vs 36.0% at week 52-66, P = .014). No additional benefits were observed with the concomitant use of immunomodulators. Ileal location was independently associated with a higher probability of clinical remission compared with colonic or ileocolonic location at week 52 to 66. Adverse and serious adverse events were observed in 28.2% (129 of 457) and 12.7% (58 of 457), respectively, with no new safety signal associated with UST treatment.
Conclusions: Ustekinumab was well-tolerated, effective, and safe as induction and maintenance therapy for CD in Korea.
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| http://dx.doi.org/10.1093/ibd/izae171 | DOI Listing |
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