Ustekinumab Is Effective for the Treatment of Crohn’s Disease of the Pouch in a Multicenter Cohort

Weaver, Kimberly N.; Gregory, Martin; Syal, Gaurav; Hoversten, Patrick; Hicks, Stephen B.; Patel, Dhairya; Christophi, George P.; Beniwal-Patel, Poonam; Isaacs, Kim L.; Raffals, Laura E.; Deepak, Parakkal; Herfarth, Hans H; Barnes, Edward L.

doi:10.1093/ibd/izy302

Cited by 62 publications

(55 citation statements)

References 27 publications

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“…Previous studies have reported endoscopic remission with the use of biologic agents for the management of chronic antibiotic refractory pouchitis, however the true definition of endoscopic remission is not well established. [20][21][22][23][24] Prospective studies are needed to confirm our observations, delineate the meaning of endoscopic remission in the pouch, and assess the feasibility of achieving endoscopic remission in the pouch.…”

Section: Discussionmentioning

confidence: 70%

Endoscopic activity in asymptomatic patients with an ileal pouch is associated with an increased risk of pouchitis

Kayal

Plietz

Radcliffe

et al. 2019

Aliment Pharmacol Ther

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Summary Background The significance of endoscopic activity in asymptomatic ulcerative colitis (UC) patients with an ileal pouch is unknown. Aim To investigate the association of endoscopic pouch activity in asymptomatic patients with the subsequent development of pouchitis. Methods We analyzed a retrospective cohort of patients with UC or IBD‐unspecified who underwent a total proctocolectomy with ileal pouch anal anastomosis (IPAA). Asymptomatic patients with a Pouchitis Disease Activity Index (PDAI) symptom sub‐score of zero who underwent an index surveillance pouchoscopy were included. Endoscopic pouch body activity was graded as 0: normal, 1: mucosal inflammation, or 2: mucosal breaks (ulcers and/or erosions). The primary outcome was primary acute idiopathic pouchitis defined as PDAI score ≥ 7 with symptoms lasting less than four weeks and responsive to standard antibiotics, not otherwise meeting criteria for secondary pouchitis. The secondary outcome was chronic idiopathic pouchitis defined as PDAI score ≥ 7 with symptoms lasting greater than four weeks despite standard antibiotics. Predictors of pouchitis were analyzed using Kaplan‐Meier and Cox regression methods with hazard ratios (HR) and 95% confidence intervals (CI) reported. Results 143 asymptomatic pouch patients were included. Index endoscopic pouch body activity was 0 in 86 (60.1%) patients, 1 in 26 (18.2%) and 2 in 31 (21.7%). The median length of follow‐up after index surveillance pouchoscopy was 3.03 [IQR 1.24‐4.60] years. Primary acute idiopathic pouchitis occurred in 44 (31%) patients and chronic idiopathic pouchitis in 12 (8.4%). Grade 2 endoscopic pouch activity was associated with the development of acute pouchitis (HR 2.39, 95% CI 1.23‐4.67), although not chronic pouchitis (HR 1.76, 95% CI 0.53‐5.87). Histologic inflammation in endoscopically normal pouch mucosa was not associated with acute or chronic pouchitis. Conclusions Mucosal breaks are present in nearly a quarter of asymptomatic patients with IPAA and are associated with an increased risk of acute pouchitis.

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Section: Discussionmentioning

confidence: 70%

Endoscopic activity in asymptomatic patients with an ileal pouch is associated with an increased risk of pouchitis

Kayal

Plietz

Radcliffe

et al. 2019

Aliment Pharmacol Ther

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“…The reason for this result is unclear but similar observations have been reported. Male sex has been associated with a lesser response to ustekinumab in patients with refractory CD or pouchitis in two studies 41,42 whereas female sex has been associated with termination because of vedolizumab intolerance 43 …”

Section: Discussionmentioning

confidence: 99%

The effectiveness of either ustekinumab or vedolizumab in 239 patients with Crohn's disease refractory to anti‐tumour necrosis factor

Alric

Amiot

Kirchgesner

et al. 2020

Aliment Pharmacol Ther

105

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Background:There is no head-to-head trial comparing ustekinumab and vedolizumab in patients with Crohn's disease (CD) refractory to anti-tumour necrosis factor (anti-TNF). Aim:To compare the effectiveness and safety of ustekinumab and vedolizumab in patients with CD refractory to anti-TNF in a multicentre retrospective observational cohort.Methods: All consecutive patients with CD refractory or intolerant to anti-TNF who initiated either vedolizumab or ustekinumab were included between May 2014 and August 2018. Clinical remission, steroid-free clinical remission (SFCR) and treatment persistence were assessed at week 48 with intention-to-treat analysis and propensity scores weighted comparison.Results: A total of 239 patients were included, 107 received ustekinumab and 132 received vedolizumab. At week 48, ustekinumab was associated with a higher clinical remission rate (54.4% vs 38.3%; odds ratios, OR = 1.92, 95% CI [1.09-3.39]) and treatment persistence (71.5% vs 49.7%; OR = 2.54, 95% CI [1.40-4.62]) than vedolizumab.The rate of SFCR did not differ significantly between ustekinumab and vedolizumab (44.7% vs 34.0%; OR = 1.57, 95% CI [0.88-2.79]). Subgroup analyses showed that ustekinumab was associated with a higher clinical remission rates at week 48 in patients with ileal location (OR = 3.49, 95% CI [1.33-9.17) and penetrating behaviour (OR = 6.58, 95% CI [1. 91-22.68]). Regardless of the treatment group, combination therapy at initiation was associated with a higher clinical remission rate at week 48 (OR = 1.93, 95% CI [1.09-3.43]). Conclusion:This study suggests that ustekinumab is associated with a higher rate of clinical remission and treatment persistence than vedolizumab after 48 weeks of follow-up, in patients with CD refractory or intolerant to anti-TNF. The rate of SFCR was not significantly different. | 949 ALRIC et AL.

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“…Over 50% of patients with a chronic pouch-related condition (chronic pouchitis or CD of the pouch) in this cohort required treatment with a biologic therapy. While recent retrospective studies have demonstrated the potential utility of ustekinumab 5 and vedolizumab 4 in treating chronic antibiotic refractory pouchitis and CD of the pouch, the prospects regarding the long-term efficacy of biologic therapies in this population is still relatively concerning. A systematic review and meta-analysis demonstrated a long-term efficacy of only 37% for anti-TNF therapy in the treatment of chronic pouchitis 6 and in a more recent evaluation by Kayal et al, biologic use was associated with endoscopic remission in only 40% of patients with CD of the pouch at 12 months after initiation.…”

Section: Discussionmentioning

confidence: 99%

Disease and Treatment Patterns Among Patients With Pouch-related Conditions in a Cohort of Large Tertiary Care Inflammatory Bowel Disease Centers in the United States

Barnes

Raffals

Long

et al. 2020

Crohn's &Amp; Colitis 360

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Background Gaps exist in our understanding of the clinical course of pouch-related disorders. Methods We evaluated baseline disease activity and longitudinal treatment patterns among patients with inflammatory conditions of the pouch. Results Among 468 patients with an ileal pouch-anal anastomosis (IPAA), 94 (20%) had acute pouchitis, 96 (21%) had chronic pouchitis, and 192 (41%) had Crohn disease of the pouch. Following an IPAA, 38% of patients were treated with a biologic and 11% underwent inflammatory bowel disease- or bowel-related surgery. Conclusions Treatment patterns after IPAA indicate that pouch-related disorders have a significant impact on individual patients and the healthcare system.

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Ustekinumab Is Effective for the Treatment of Crohn’s Disease of the Pouch in a Multicenter Cohort

Cited by 62 publications

References 27 publications

Endoscopic activity in asymptomatic patients with an ileal pouch is associated with an increased risk of pouchitis

Endoscopic activity in asymptomatic patients with an ileal pouch is associated with an increased risk of pouchitis

The effectiveness of either ustekinumab or vedolizumab in 239 patients with Crohn's disease refractory to anti‐tumour necrosis factor

Disease and Treatment Patterns Among Patients With Pouch-related Conditions in a Cohort of Large Tertiary Care Inflammatory Bowel Disease Centers in the United States

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