Background Large real-world-evidence studies are required to confirm the durability of response, effectiveness, and safety of ustekinumab in Crohn’s disease (CD) patients in real-world clinical practice. Methods A retrospective, multicentre study was conducted in Spain in patients with active CD who had received ≥1 intravenous dose of ustekinumab for ≥6 months. Primary outcome was ustekinumab retention rate; secondary outcomes were to identify predictive factors for drug retention, short-term remission (week 16), loss of response and predictive factors for short-term efficacy and loss of response, and ustekinumab safety. Results A total of 463 patients were included. Mean baseline Harvey-Bradshaw Index was 8.4. A total of 447 (96.5%) patients had received prior biologic therapy, 141 (30.5%) of whom had received ≥3 agents. In addition, 35.2% received concomitant immunosuppressants, and 47.1% had ≥1 abdominal surgery. At week 16, 56% had remission, 70% had response, and 26.1% required dose escalation or intensification; of these, 24.8% did not subsequently reduce dose. After a median follow-up of 15 months, 356 (77%) patients continued treatment. The incidence rate of ustekinumab discontinuation was 18% per patient-year of follow-up. Previous intestinal surgery and concomitant steroid treatment were associated with higher risk of ustekinumab discontinuation, while a maintenance schedule every 12 weeks had a lower risk; neither concomitant immunosuppressants nor the number of previous biologics were associated with ustekinumab discontinuation risk. Fifty adverse events were reported in 39 (8.4%) patients; 4 of them were severe (2 infections, 1 malignancy, and 1 fever). Conclusions Ustekinumab is effective and safe as short- and long-term treatment in a refractory cohort of CD patients in real-world clinical practice.
Ustekinumab has shown efficacy in Crohn’s Disease (CD) patients. To identify patient profiles of those who benefit the most from this treatment would help to position this drug in the therapeutic paradigm of CD and generate hypotheses for future trials. The objective of this analysis was to determine whether baseline patient characteristics are predictive of remission and the drug durability of ustekinumab, and whether its positioning with respect to prior use of biologics has a significant effect after correcting for disease severity and phenotype at baseline using interpretable machine learning. Patients’ data from SUSTAIN, a retrospective multicenter single-arm cohort study, were used. Disease phenotype, baseline laboratory data, and prior treatment characteristics were documented. Clinical remission was defined as the Harvey Bradshaw Index ≤ 4 and was tracked longitudinally. Drug durability was defined as the time until a patient discontinued treatment. A total of 439 participants from 60 centers were included and a total of 20 baseline covariates considered. Less exposure to previous biologics had a positive effect on remission, even after controlling for baseline disease severity using a non-linear, additive, multivariable model. Additionally, age, body mass index, and fecal calprotectin at baseline were found to be statistically significant as independent negative risk factors for both remission and drug survival, with further risk factors identified for remission.
Background A significant percentage of patients with inflammatory bowel disease (IBD) will require surgical treatment at some point in their disease. Preoperative optimization (PO) intends to ensure that the patient arrives in optimal condition to surgery and to minimize the risk of complications. The aim of this study was to assess whether optimization criteria were met in patients with IBD undergoing elective surgery and to describe the percentage of post-surgical complications based on exposure to any of these risk factors. Methods IBD patients undergoing intra-abdominal surgery between 1st January 2013 and 30st September of 2021 were retrospectively selected. Data collection included clinical characteristic of IBD, nutritional biochemical parameters and surgical aspects. In addition, risk factors associated with a worse prognosis were collected. Among them, anemia, risk of malnutrition (using the Malnutrition Universal Screening Tool, MUST), smoking, presence of intra-abdominal sepsis and treatment received for IBD in the 30 days prior to surgery, especially the use of corticosteroids. Postsurgical complications were defined as those occurring within 30 days after surgery. Results A total of 212 surgeries performed in 5 centres from northwest of Spain were included: 87% in Crohn’s disease, 11% in ulcerative colitis and 2% in unclassified-IBD patients. Patients' clinical and demographic characteristics are summarized in Table 1. Postoperative complications were reported in 20.1% (n=62) of the patients, including suture dehiscence, infection, obstruction, bleeding and thrombosis. The most frequent complication was surgical site infection (10.8% of all the cases). Up to 35.6% of the patients were at risk of malnutrition at the time of surgery (MUST>=1), only half of these patients received some type of nutritional therapy. 20% of patients received at least 20 mg daily of prednisone or equivalent four weeks prior to surgery. Risk factors of post-surgical complications are presented in Table 2. Corticosteroid therapy (> 20 mg daily prednisone or equivalent) (OR 3.52 [95% CI: 1.05–12.6] (p=0.042) and the absence of nutritional support (OR 2.34 [95% CI:1.17-4.65] (p=0.016) were associated with postoperative complications. Multivariate and univariate analysis for postoperative complications are shown in Table 3 and Table 4. Conclusion The absence of a PO model increases the risk of postoperative complications. Inadequate preoperative nutritional care and corticosteroid therapy are risk factors for complications in our study. Protocols of PO in IBD patients are recommended.
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