Secukinumab, an interleukin (IL)-17A antagonist, was associated with disease exacerbations in Crohn’s disease, and de novo cases of inflammatory bowel disease (IBD) have been reported in studies of rheumatoid diseases. However, there has been no detailed report demonstrating the linkage between secukinumab therapy and new-onset IBD. We present a unique case of rapid-onset fulminant colitis after receiving 1 dose of secukinumab infusion followed by improvement with combination antibiotics, corticosteroids, and calcineurin inhibition. Health care providers should be aware of the possible association between IL-17 antagonist therapy and the risk of developing new-onset fulminant IBD.
Background
Chronic antibiotic-refractory pouchitis (CARP) occurs in up to 15% of patients with ulcerative colitis (UC) following proctocolectomy with ileal pouch-anal anastomosis (IPAA).
Aim
To investigate the effectiveness of ustekinumab in the treatment of CARP.
Methods
This was a retrospective single-center study of UC patients with an IPAA, who subsequently developed CARP and received ustekinumab with standard Crohn’s disease (CD) dosing between 2016 and 2018. Patients with CD of the pouch were excluded. Demographic, clinical, and endoscopic data were collected. Outcomes included a change in the endoscopic subscore of the Pouchitis Disease Activity Index (PDAI), change in the ulcerated surface area, clinical response, and the number of bowel movements per 24 h.
Results
Twenty-four patients with CARP were included for analysis. Median follow-up time was 12.9 months (IQR 7.9–16). Twelve patients (50%) had a clinical response with the median number of bowel movements within 24 h decreasing from 8 (IQR, 5–12) to 6 (IQR, 5–8) P = 0.002. Thirteen patients had pouchoscopies available post-ustekinumab treatment. In these patients, the median endoscopic subscore of the PDAI decreased from 5 (IQR, 3–6) to 4 (IQR, 2–5), P = 0.016. Likewise, among these thirteen patients, nine (69%) had an ulcerated surface area > 10% before ustekinumab treatment; after treatment with ustekinumab, only four patients (31%) still had an ulcerated surface area of > 10%.
Conclusions
This is the largest study of ustekinumab treatment for patients with chronic antibiotic-refractory pouchitis. We found that ustekinumab therapy led to the improvement in clinical and endoscopic endpoints.
Background
Ustekinumab has been recently approved for the treatment of moderately to severely active ulcerative colitis (UC). The registry trials for ustekinumab in UC demonstrated efficacy and safety, but data on real world outcomes are limited. We describe the effectiveness and safety of ustekinumab in patients with UC from two US tertiary IBD centers.
Methods
Patients with moderately to severely active UC treated with ustekinumab at ______________ and ______________ between January 2016 and March 2020 were retrospectively included. The primary outcome was clinical remission at 3 and 12 months, defined as a partial Mayo score of ≤2, with a combined rectal bleeding and stool frequency subscore of ≤1.
Results
Sixty-six UC patients were included. 92% of patients had prior exposure to biologics or tofacitinib. 43% and 45% of patients achieved clinical remission by 3 and 12 months, respectively. Anti-TNF non-response and endoscopic Mayo score of 3 were negative predictors of clinical remission. 33% of those followed for a year achieved concurrent endoscopic and histologic healing, which was significantly associated with lower partial Mayo score (P<0.01) and lower stool frequency (P=0.02). Serious adverse events occurred in 4 (6%) patients (3 UC exacerbations, 1 vasculitis).
Conclusion
In this cohort of mostly biologic-refractory UC patients, treatment with ustekinumab achieved remission in nearly half of them at 12 months, and was associated with an overall favorable safety profile. These results are modestly better than the pivotal trials.
Patients with UC and PSC who are in clinical remission are significantly more likely to have endoscopic and histologic inflammation in the right colon than patients with UC without PSC. Our findings provide insight into cause of colorectal cancer in UC patients with PSC.
A significant number of our IBD patients lack immunity to measles, and a majority of our IBD patients do not have detectable immunity to pertussis. Importantly, the majority of the measles non-immune patients are on ISS therapy and therefore unable to receive a booster.
The doctor-patient relationship (DPR) in inflammatory bowel disease (IBD) has been facing new challenges, in part due to the substantial progress in medical and surgical management and also due to the rapid expansion of patient access to medical information. Not surprisingly, the complexity of IBD care and heterogeneity of the disease types may lead to conflict between a physician's therapeutic recommendations and the patient's wishes. In this commentary, we propose that the so-called "treat-to-target" approach of objective targets of disease control and serial adjustments to therapies can also strengthen the DPR in IBD by enabling defined trials of alternative approaches, followed by a more objective assessment and reconsideration of treatments. We contend that such respect for patient autonomy and the use of objective markers of disease activity improves the DPR by fostering trust and both engaging and empowering patients and physicians with the information necessary to make shared decisions about therapies.
Penetrating phenotype, the use of narcotics before surgery, and loop ostomies are associated with major complications in CD patients undergoing ostomy creation. These findings may influence risk management of CD patients needing ostomies.
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