Prevalence of endoscopic improvement and remission according to patient‐reported outcomes in ulcerative colitis

Dulai, Parambir S.; Singh, Siddharth; Jairath, Vipul; Ma, Christopher; Narula, Neeraj; Casteele, Niels Vande; Peyrin–Biroulet, Laurent; Vermeire, Séverine; D’Haens, Geert R.; Feagan, Brian G.; Sandborn, William J.

doi:10.1111/apt.15577

Cited by 26 publications

(21 citation statements)

References 27 publications

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“…Because faecal calprotectin was not routinely assessed in our cohort, we were unable to evaluate its association with histologic remission. However, we expect similar findings in this cohort—the majority of patients achieving symptomatic and biochemical remission tend to achieve MES 1, and predictive value of this combination for achieving complete endoscopic remission is low 18 . Finally, and most importantly, our findings do not inform feasibility or outcomes of patients treated‐to‐target of histologic remission, but rather focuses on feasibility and outcomes of patients who achieve histologic remission in the context of conventional treat‐to‐target practices.…”

Section: Discussionmentioning

confidence: 66%

Predictors and outcomes of histological remission in ulcerative colitis treated to endoscopic healing

Jangi

Yoon

Dulai

et al. 2020

Aliment Pharmacol Ther

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Summary Background Clinical remission is the recommended treatment target in ulcerative colitis. The predictors and outcomes of achieving histologic remission within a treat‐to‐target paradigm are not well established. Aim To evaluate the predictors and outcomes of achieving histologic remission in patients with ulcerative colitis treated‐to‐target of endoscopic healing (modified Mayo endoscopy score 0 or 1). Methods We conducted a retrospective cohort study in adults with active ulcerative colitis (modified Mayo endoscopy score 2 or 3), whose treatment was iteratively optimised to achieve endoscopic healing. We identified predictors of achieving histologic remission, and outcomes (risk of symptomatic relapse, and ulcerative colitis‐related hospitalisation and/or surgery) of achieving histologic remission vs persistent histologic activity, using Cox proportional hazard analysis. Results Of the 411 patients with clinically active ulcerative colitis, 270 achieved endoscopic healing. Of the 270 patients, 55% simultaneously achieved histologic remission. Depth of endoscopic healing at final endoscopic assessment was the only independent determinant of histologic remission (modified Mayo endoscopy score 0 vs 1: odds ratio, 0.31 [95% confidence intervals, 0.18‐0.52]). Over 28 months, achieving histologic remission was associated with a lower risk of clinical relapse (1‐year cumulative risk: 18.7% vs 29.5%; adjusted hazard ratio, 0.56 [0.37‐0.85]), and lower risk of hospitalisation (hazard ratio, 0.44 [0.20‐0.94]). The incremental benefit of achieving histologic remission was observed only in patients achieving Mayo endoscopy score 1, but not Mayo endoscopy score 0. Conclusions In patients with active ulcerative colitis treated‐to‐target of endoscopic healing, 55% simultaneously achieved histologic remission. Histologic remission, particularly in patients achieving modified Mayo endoscopy score 1, was associated with favourable outcomes. Treating to a target of histologic remission over endoscopic healing requires prospective evaluation.

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Section: Discussionmentioning

confidence: 66%

Predictors and outcomes of histological remission in ulcerative colitis treated to endoscopic healing

Jangi

Yoon

Dulai

et al. 2020

Aliment Pharmacol Ther

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“…For patients with UC, endoscopic remission was defined as going from baseline Mayo endoscopic subscore 2 (moderate disease) or 3 (severe disease) to postinduction subscore 0 (inactive disease). Endoscopic improvement was defined as going from baseline Mayo endoscopic subscore 2 or 3 to postinduction subscore 0 or 1 25 …”

Section: Methodsmentioning

confidence: 99%

The effect of aging on infliximab exposure and response in patients with inflammatory bowel diseases

Kantasiripitak

Verstockt

Alsoud

et al. 2021

Brit J Clinical Pharma

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Aims Controversies regarding infliximab treatment in elderly patients with inflammatory bowel diseases remain. We evaluated the effect of patient's age on infliximab exposure, efficacy and safety. Methods Retrospective case‐control data of patients receiving infliximab induction treatment were analysed. A population pharmacokinetic model was developed to estimate individual pharmacokinetic parameters. A logistic regression model was used to investigate the effect of exposure on endoscopic remission. Repeated time‐to‐event models were developed to describe the hazard of safety events over time. Results A total of 104 patients (46 elderly, ≥65 years) were included. A two‐compartment population pharmacokinetic model with linear elimination adequately described the data. Infliximab clearance decreased with older age, higher serum albumin, lower fat‐free mass, lower C‐reactive protein and absence of immunogenicity. Yet, infliximab exposure was not significantly different between elderly and nonelderly. Regardless of age, an infliximab trough concentration at week (w)14 of 15.6 mg/L was associated with a 50% probability of attaining endoscopic remission between w6 and w22. Infliximab exposure during induction treatment was not a risk factor of (severe) adverse events. The hazard of severe adverse events and malignancy increased by 2% and 7%, respectively, with increasing year of age. Concomitant immunomodulator use increased the hazard of infection by 958%, regardless of age. Conclusions Elderly patients attained infliximab exposure and endoscopic remission similarly to nonelderly patients. Therefore, the same infliximab trough concentration target can be used in therapeutic drug monitoring. The hazards of severe adverse events and malignancy increased with age, but not with infliximab exposure.

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“…This suggests that continued treatment beyond 5 days might be beneficial for optimising endoscopic response rates in some patients, however, it is noted that we did not perform a day 5 flexible sigmoidsocopy in the current trial. It has been observed that over 80% of patients achieving a RBS of 0 are found to have a Mayo endoscopic sub‐score of 0‐1 with nearly 50% having a Mayo endoscopic sub‐score of 0 7 . With nearly 50% of patients achieving a RBS of 0 after 5 days of hyperbaric oxygen, it is possible that our day 5 endoscopic improvement and remission rates are quite substantial and the lower rate of day 10 endoscopic improvement in the current trial compared to the prior trial are a function of recurrence.…”

Section: Discussionmentioning

confidence: 99%

“…MES were available at study days 0 and 10, with RBS and SFS available at days 3, 5 and 10. Clinical response was assessed using the modified partial Mayo score which included the RBS and SFS specifically, given the subjectivity in the physician global assessment and the strong correlation between the RBS and MES 7 . Clinical response was defined as a reduction in the modified partial Mayo score (SFS+RBS) of 2 or more points with at least a 1 point drop in RBS.…”

Section: Methodsmentioning

confidence: 99%

A phase 2B randomised trial of hyperbaric oxygen therapy for ulcerative colitis patients hospitalised for moderate to severe flares

Dulai

Raffals

Hudesman

et al. 2020

Aliment Pharmacol Ther

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Summary Background Hyperbaric oxygen has been reported to improve disease activity in hospitalised ulcerative colitis (UC) patients. Aim To evaluate dosing strategies with hyperbaric oxygen for hospitalised UC patients. Methods We enrolled UC patients hospitalised for acute flares (Mayo score 6‐12). Initially, all patients received 3 days of hyperbaric oxygen at 2.4 atmospheres (90 minutes with two air breaks) in addition to intravenous steroids. Day 3 responders (reduction of partial Mayo score ≥ 2 points and rectal bleeding score ≥ 1 point) were randomised to receive a total of 5 days vs 3 days of hyperbaric oxygen. Results We treated 20 patients with hyperbaric oxygen (75% prior biologic failure). Day 3 response was achieved in 55% (n = 11/20), with significant reductions in stool frequency, rectal bleeding and CRP (P < 0.01). A more significant reduction in disease activity was observed with 5 days vs 3 days of hyperbaric oxygen (P = 0.03). Infliximab or colectomy was required in only three patients (15%) despite a predicted probability of 80% for second‐line therapy. Day 3 hyperbaric oxygen responders were less likely to require re‐hospitalisation or colectomy by 3 months vs non‐responders (0% vs 66%, P = 0.002). No treatment‐related adverse events were observed. Conclusion Hyperbaric oxygen appears to be effective for optimising response to intravenous steroids in UC patients hospitalised for acute flares, with low rates of re‐hospitalisation or colectomy at 3 months. An optimal clinical response is achieved with 5 days of hyperbaric oxygen. Larger phase 3 trials are needed to confirm efficacy and obtain labelled approval.

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Prevalence of endoscopic improvement and remission according to patient‐reported outcomes in ulcerative colitis

Cited by 26 publications

References 27 publications

Predictors and outcomes of histological remission in ulcerative colitis treated to endoscopic healing

Predictors and outcomes of histological remission in ulcerative colitis treated to endoscopic healing

The effect of aging on infliximab exposure and response in patients with inflammatory bowel diseases

A phase 2B randomised trial of hyperbaric oxygen therapy for ulcerative colitis patients hospitalised for moderate to severe flares

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