Effectiveness and Safety of Ustekinumab in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis

Honap, Sailish; Meade, Susanna; Ibraheim, Hajir; Irving, Peter M.; Jones, Michael P.; Samaan, Mark A

doi:10.1007/s10620-021-06932-4

Cited by 54 publications

(52 citation statements)

References 94 publications

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“…21 Since we estimated that up to four ultrasonographic parameters would be analysed in the regression model, approximately 100 cases were required assuming a remission rate of 45%. [4][5][6][7] In anticipation of dropouts, 105 cases were set as the required minimum number of cases for this study. This sample size also allowed the detection of a 20% difference in BWT from baseline to week 1 with an alpha risk of 0.05 and beta of 0.2.…”

Section: Statistical Powermentioning

confidence: 99%

“…2,3 In real-world practice, response rates of these treatments range from 60% to 80%, whereas clinical remission can only be achieved in approximately half of these patients. [4][5][6][7] Because it is difficult to thoroughly predict the outcome in advance, response should be closely monitored after treatment initiation. Clinical decision is always a challenge because the onset of response to treatment varies from a few days to months in each patient, and the patient whose condition is deteriorating may require treatment alteration.…”

Section: Introductionmentioning

confidence: 99%

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Early improvement in bowel wall thickness on transperineal ultrasonography predicts treatment success in active ulcerative colitis

Sagami

Aihara

Umeda

et al. 2022

Aliment Pharmacol Ther

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Summary Background Bowel ultrasonography is a non‐invasive imaging tool that can repeatedly monitor ulcerative colitis (UC) activity. Aim This study aimed to determine whether early transabdominal or transperineal ultrasonography changes can predict subsequent clinical response to induction therapy in patients with UC. Methods This single‐centre prospective study explored ultrasonographic predictors for clinical remission (patient‐reported outcome‐2 ≤ 1 with no rectal bleeding subscore) at week 8 in patients with active UC who underwent induction therapy, in comparison with faecal calprotectin and C‐reactive protein (measured at baseline, week 1 and week 8). Predictive factors were assessed using multivariable regression models and receiver‐operating‐characteristic curve analysis. Results A total of 100 patients were analysed, of which 54 achieved remission at week 8. Baseline biomarker and ultrasonographic‐parameter values were not predictive of remission. Contrastingly, change from baseline to week 1 in rectal bowel wall thickness measured using transperineal ultrasonography was an independent predictor of remission by week 8 (adjusted odds ratio is associated with a 1‐mm decrease: 1.90 [95% confidence interval, 1.22–2.95]). In a subgroup analysis of the patients who did not achieve remission in 1 week, the predictive value of change in rectal bowel wall thickness remained high (AUC = 0.77 [95% confidence interval, 0.61–0.88]). Conclusion Improvement in rectal bowel wall thickness measured using transperineal ultrasonography at week 1 predicts treatment success and potentially facilitates decision making during the early course of induction therapy in UC.

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Section: Statistical Powermentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Early improvement in bowel wall thickness on transperineal ultrasonography predicts treatment success in active ulcerative colitis

Sagami

Aihara

Umeda

et al. 2022

Aliment Pharmacol Ther

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“…There were no differences in the rates of congenital anomalies (2%), miscarriages (12%), or healthy live births (74%) compared with that in the general population. [ 16 ] Placental transfer of tofacitinib has not been evaluated, but the medication has shown teratogenicity in animal models and should be discontinued 6 weeks before conception. [ 2 , 17 ]…”

Section: Discussionmentioning

confidence: 99%

Management of inflammatory bowel disease and serum level of infliximab in newborn exposed to anti-TNF therapy during pregnancy

et al. 2021

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Rationale: Heightened inflammatory bowel disease (IBD) activity during pregnancy is associated with higher rates of preterm birth, miscarriage, and low birth weight. Therefore, its adequate treatment is essential, considering the risk–benefit of medication use. Although previous literature has described the management of IBD during pregnancy, few studies have assessed the pharmacokinetics of IBD drugs in the newborn. In this case report, we describe the management of ulcerative colitis during pregnancy and discuss the benefits of checking serum levels of infliximab in newborns exposed to the medication during pregnancy. Patient concern: A 37-year-old patient with ulcerative colitis in clinical and endoscopic remission had been undergoing treated with infliximab since 2008. The patient became pregnant in 2018. Diagnosis and intervention: Infliximab medication was discontinued at the 29th week of pregnancy. Outcomes: The pregnancy was uneventful, and the levels of infliximab in the umbilical cord were >20 μg/dL. Live vaccinations were postponed until the baby was 6 months old, when a new serum drug level proved to be undetectable. Lessons: Our case suggests that the use of infliximab is safe in pregnancy, and drug discontinuation could be considered from the 24th week of pregnancy onward to reduce placental transfer to the newborn in patients at low risk of relapse. Vaccines with live attenuated organisms should be delayed for at least 6 months or until the serum level of the medication is undetectable.

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“…Since then, several real-world studies have confirmed the efficacy and safety profile of ustekinumab 107 – 109 and its efficacy in perianal disease and fistula healing. 110 …”

Section: Recently Developing Biologicsmentioning

confidence: 99%

A review of the therapeutic management of Crohn’s disease

Kumar

Cole

Segal

et al. 2022

Therap Adv Gastroenterol

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Crohn’s disease is a chronic inflammatory, relapsing-remitting, and progressive gastrointestinal disorder with an often-negative impact on the physical, emotional, and psychological well-being. Over the past two decades, the medical compendium for the treatment of Crohn’s disease has increased significantly, enabling treatment beyond symptoms. Indeed, early and timely use of effective medical therapy has been reflected by improved outcomes with reduction in surgery and ability to achieve clinical and endoscopic remission, reduce corticosteroid dependance, and prevent long-term complications in more patients. In this review, we discuss the key milestones in the medical management of Crohn’s disease.

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Effectiveness and Safety of Ustekinumab in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis

Cited by 54 publications

References 94 publications

Early improvement in bowel wall thickness on transperineal ultrasonography predicts treatment success in active ulcerative colitis

Early improvement in bowel wall thickness on transperineal ultrasonography predicts treatment success in active ulcerative colitis

Management of inflammatory bowel disease and serum level of infliximab in newborn exposed to anti-TNF therapy during pregnancy

A review of the therapeutic management of Crohn’s disease

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