We sought to evaluate COVID-19 clinical course in patients with IBD treated with different medication classes and combinations.
Surveillance Epidemiology of Coronavirus Under Research Exclusion for ...Inflammatory Bowel Disease (SECURE-IBD) is a large, international registry created to monitor outcomes of IBD patients with confirmed COVID-19. We used multivariable regression with a generalised estimating equation accounting for country as a random effect to analyse the association of different medication classes with severe COVID-19, defined as intensive care unit admission, ventilator use and/or death.
1439 cases from 47 countries were included (mean age 44.1 years, 51.4% men) of whom 112 patients (7.8%) had severe COVID-19. Compared with tumour necrosis factor (TNF) antagonist monotherapy, thiopurine monotherapy (adjusted OR (aOR) 4.08, 95% CI 1.73 to 9.61) and combination therapy with TNF antagonist and thiopurine (aOR 4.01, 95% CI 1.65 to 9.78) were associated with an increased risk of severe COVID-19. Any mesalamine/sulfasalazine compared with no mesalamine/sulfasalazine use was associated with an increased risk (aOR 1.70, 95% CI 1.26 to 2.29). This risk estimate increased when using TNF antagonist monotherapy as a reference group (aOR 3.52, 95% CI 1.93 to 6.45). Interleukin-12/23 and integrin antagonists were not associated with significantly different risk than TNF antagonist monotherapy (aOR 0.98, 95% CI 0.12 to 8.06 and aOR 2.42, 95% CI 0.59 to 9.96, respectively).
Combination therapy and thiopurines may be associated with an increased risk of severe COVID-19. No significant differences were observed when comparing classes of biologicals. These findings warrant confirmation in large population-based cohorts.MKH should be changed to MDK for co-last author line.
Abstract
Background
Severe acute respiratory syndrome coronavirus 2 vaccination is recommended for all individuals with inflammatory bowel disease (IBD), including those on immunosuppressive ...therapies; however, little is known about vaccine safety and efficacy in these patients or the impact of vaccination on IBD disease course.
Methods
We evaluated coronavirus disease 2019 (COVID-19) vaccine–related adverse events (AEs) and the effect of vaccination on IBD disease course among participants in the PREVENT-COVID (Partnership to Report Effectiveness of Vaccination in populations Excluded from iNitial Trials of COVID) study, a prospective, observational cohort study. Localized and systemic reactions were assessed via questionnaire. Disease flare was defined by worsening IBD symptoms and change in IBD medications. Outcomes were stratified by vaccine type and IBD medication classes.
Results
A total of 3316 individuals with IBD received at least 1 COVID-19 vaccine. Injection site tenderness (68%) and fatigue (46% dose 1, 68% dose 2) were the most commonly reported localized and systemic AEs after vaccination. Severe localized and systemic vaccine-related AEs were rare. The mRNA-1273 vaccine was associated with significantly greater severe AEs at dose 2 (localized 4% vs 2%, systemic 15% vs 10%; P < .001 for both). Prior COVID-19 infection, female sex, and vaccine type were associated with severe systemic reactions to dose 1, while age <50 years, female sex, vaccine type, and antitumor necrosis factor and vedolizumab use were associated with severe systemic reactions to dose 2. Overall rates (2%) of IBD flare were low following vaccination.
Conclusions
Our findings provide reassurance that the severe acute respiratory syndrome coronavirus 2 vaccine is safe and well tolerated among individuals with IBD, which may help to combat vaccine hesitancy and increase vaccine confidence.
Lay Summary
The severe acute respiratory syndrome coronavirus 2 vaccine is safe and well tolerated among individuals with inflammatory bowel disease (IBD). Severe localized and systemic vaccine-related adverse events were rare, and rates of IBD flare were low (2%) following severe acute respiratory syndrome coronavirus 2 vaccination in a cohort of 3316 participants with IBD.
Abstract
Background
Total proctocolectomy (TPC) with ileal pouch anal anastomosis (IPAA) is the gold standard surgery for ulcerative colitis (UC) patients with medically refractory disease. The aim ...of this study was to report the rates and risk factors of inflammatory pouch conditions.
Methods
This was a retrospective review of UC or IBD unspecified (IBDU) patients who underwent TPC with IPAA for refractory disease or dysplasia between 2008 and 2017. Pouchoscopy data were used to calculate rates of inflammatory pouch conditions. Factors associated with outcomes in univariable analysis were investigated in multivariable analysis.
Results
Of the 621 patients more than 18 years of age who underwent TPC with IPAA between January 2008 and December 2017, pouchoscopy data were available for 386 patients during a median follow-up period of 4 years. Acute pouchitis occurred in 205 patients (53%), 60 of whom (30%) progressed to chronic pouchitis. Cuffitis and Crohn's disease–like condition (CDLC) of the pouch occurred in 119 (30%) patients and 46 (12%) patients, respectively. In multivariable analysis, female sex was associated with a decreased risk of acute pouchitis, and pre-operative steroid use and medically refractory disease were associated with an increased risk; IBDU was associated with chronic pouchitis; rectal cuff length ≥2 cm and medically refractory disease were associated with cuffitis; age 45–54 at colectomy was associated with CDLC. Rates of pouch failure were similar in chronic pouchitis and CDLC patients treated with biologics and those who were not.
Conclusions
Inflammatory pouch conditions are common. Biologic use for chronic pouchitis and CDLC does not impact the rate of pouch failure.
Inflammatory pouch conditions are common after ileal pouch anal anastomosis in ulcerative colitis patients. Biologics used to manage chronic inflammatory pouch conditions such as chronic pouchitis and Crohn's disease–like condition, however, may not impact the rate of pouch failure.
Managing IBD in the COVID-19 era Scalzo, Nicholas; Ungaro, Ryan C.
Therapeutic Advances in Gastroenterology,
01/2023, Letnik:
16
Book Review, Journal Article
Recenzirano
Odprti dostop
Over the last 2 years the lives of millions have changed because of the emergence of Coronavirus disease 2019 (COVID-19). Patients living with inflammatory bowel disease (IBD) represent a sizable ...population with their own sets of challenges to providers in the wake of so much uncertainty. The Centers for Disease Control considers immunocompromised individuals at higher risk of infection and complications from COVID-19. Early in the pandemic, the specific risks for IBD patients were unclear as guidance was based on expert opinion regarding the management of IBD during a COVID-19 era. Fortunately, after considerable work in the field, the overwhelming evidence suggests that IBD patients as a whole do not appear to be at increased risk for more severe disease from COVID-19. Certain risk factors such as age, steroids, comorbidities, combination immunomodulatory therapy, and IBD disease activity have been associated with worse outcomes. Most IBD medications are low risk, with the exception of immunomodulator monotherapy and combination therapy with thiopurine and anti-TNF. Vaccination remains safe and effective for all IBD patients, although additional booster doses may be necessary, particularly in patients taking anti-TNF agents.
Background
Early initiation of biologics in moderate-to-severe Crohn’s disease (CD) may significantly alter disease progression, resulting in better patient outcomes. Limited real-world data exist on ...the impact of early biologic use in patients with CD in the United States.
Aims
We aimed to characterize biologic initiation and subsequent healthcare resource utilization (HCRU) in adults with recently diagnosed CD.
Methods
Patients with CD who initiated biologic treatment within 2 years of diagnosis (index date) were identified from medical and pharmacy claims (Merative L.P. MarketScan Database from 2010 to 2016) and classified as early (≤ 12 months post-index) or late (> 12–24 months post-index) biologic initiators. Propensity score matching balanced patient characteristics up to 1 year post-index. Differences in HCRU frequency and costs 1–2 years post-index were compared between the matched groups.
Results
After propensity score matching, 672 pairs of early and late biologic initiators were identified. Patients who initiated biologics early had fewer outpatient visits (15.5 vs 19.8, 95% confidence interval CI for difference: 2.7, 6.1) and lower total medical costs ($13,646.20 vs $22,180.70, 95% CI for difference: 4748.9, 12,320.1) 1–2 years post-index than late biologic initiators. Early biologic initiators had higher medication costs 1–2 years post-index ($33,766.30 vs $30,580.70, 95% CI: 546.1, 5825.1) but lower combined medical and medication costs ($47,412.50 vs $52,761.50, 95% CI: 801.5, 9896.40).
Conclusions
While biologic treatments are costly, patients initiating biologics sooner after diagnosis appear to have better HCRU outcomes and require fewer healthcare resources at 1–2 years post-index, potentially leading to overall cost savings.
Inflammatory bowel diseases (IBDs), including Crohn’s disease and ulcerative colitis, are chronic, progressive, immune-mediated diseases of adults and children that have no cure. IBD can cause ...significant morbidity and lead to complications such as strictures, fistulas, infections, and cancer. In children, IBD can also result in growth impairment and pubertal delays. IBD is highly heterogenous, with severity ranging from mild to severe and symptoms ranging from mild to debilitating. Delay in IBD diagnosis, especially in Crohn’s disease, is common and associated with adverse outcomes. Early diagnosis and prompt institution of treatment are the cornerstones for improving outcomes and maximizing health. Early diagnosis requires a low threshold of suspicion and red flags to guide early specialist referral at the primary provider level. Although the armamentarium of IBD medications is growing, many patients will not respond to treatment, and the selection of first-line therapy is critical. Risk stratification of disease severity, based on clinical, demographic, and serologic markers, can help guide selection of first-line therapy. Clinical decision support tools, genomics, and other biomarkers of response to therapy and risk of adverse events are the future of personalized medicine. After starting appropriate therapy, it is important to confirm remission using objective end points (treat to target) with continued control of inflammation with adjustment of therapy using surrogate biomarkers (tight control). Lastly, IBD therapy extends far beyond medications, and other aspects of the overall health and wellbeing of the patient are critical. These include preventive health, nutrition, and psychobehavioral support addressing patients’ concerns around complementary therapy and medication adherence, prevention of disability, and ensuring open communication.
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