Ustekinumab Does Not Increase Risk of Adverse Events: A Meta-Analysis of Randomized Controlled Trials

Rolston, Vineet S.; Kimmel, Jessica; Popov, Violeta; Bosworth, Brian; Hudesman, David; Malter, Lisa; Hong, Simon; Chang, Shannon

doi:10.1007/s10620-020-06344-w

Cited by 14 publications

(8 citation statements)

References 31 publications

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“…Finally, two recently published systematic review and meta-analyses evaluated the safety of ustekinumab in clinical trials [ 8 , 80 ]. Rolston et al compared rates of AEs in randomised controlled trials of ustekinumab compared to placebo among a spectrum of autoimmune diseases.…”

Section: Discussionmentioning

confidence: 99%

“…Of the 30 studies included, 5 were conducted in IBD patients. In this subgroup, there were no differences in the rates of serious or mild/moderate AEs for ustekinumab vs. placebo or in the rates of AEs for low vs. high-dose ustekinumab [ 80 ]. Likewise, Sandborn et al reported that safety events were similar in the placebo and in the ustekinumab groups for all AEs, serious AEs, infections, and serious infections [ 8 ].…”

Section: Discussionmentioning

confidence: 99%

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Real-World Evidence of the Effectiveness and Safety of Ustekinumab for the Treatment of Crohn’s Disease: Systematic Review and Meta-Analysis of Observational Studies

Célix

Chaparro

Gisbert

2022

JCM

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(1) Background: Evidence on the outcomes of ustekinumab treatment in real-world Crohn’s disease (CD) patients is needed. Our aim was to evaluate the effectiveness and safety of ustekinumab in CD, reported by observational studies. (2) Methods: bibliographical searches were performed (PubMed, EMBASE). Selection: observational studies assessing the effectiveness and safety of ustekinumab in CD. Exclusion criteria: studies using ustekinumab as a prophylaxis for postoperative recurrence or perianal disease. Data synthesis: effectiveness by intention-to-treat (random-effects model). Data were stratified by study design, population included, administered dose, and prior biologic exposure. (3) Results: A total of 63 studies (8529 patients) were included. Response was achieved in 60% (95% CI, 54–67%) in the short term (8–14 weeks); 64% (57–71%) in the medium term (16–24 weeks); and 64% (52–74%) in the long term (48–52 weeks). Remission was achieved in 37% (28–46%) in the short term; 42% (36–49%) in the medium term; and 45% (37–53%) in the long term. The endoscopic remission rate was 33% (25–40%) in the long term. Eighteen percent of patients lost response during follow-up. Nearly one-third of the patients needed dose optimisation, and in 59% of them it was effective. Twenty-five percent of patients developed adverse events, leading to treatment withdrawal in seven percent of the cases. (4) Conclusions: Ustekinumab is an effective and safe therapy in real-world refractory CD patients. Dose optimisation is frequently required, being effective in a high percentage of cases.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Real-World Evidence of the Effectiveness and Safety of Ustekinumab for the Treatment of Crohn’s Disease: Systematic Review and Meta-Analysis of Observational Studies

Célix

Chaparro

Gisbert

2022

JCM

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“…108,109 A recent meta-analysis of 30 ustekinumab randomized control trials (for IBD and non-IBD indications) noted no increase in serious or mild/moderate adverse events compared with placebo. 110 Although this data suggests that ustekinumab has an overall favorable safety profile, more studies are needed to determine its effectiveness and safety in elderly IBD patients.…”

Section: Ustekinumabmentioning

confidence: 99%

The elderly IBD patient in the modern era: changing paradigms in risk stratification and therapeutic management

Hong

Katz

2021

Therap Adv Gastroenterol

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The incidence and prevalence of inflammatory bowel disease (IBD) is rising in the elderly population. Compared with patients with onset during their younger years, patients with elderly onset IBD have a distinct clinical presentation, disease phenotype, and natural history. Genetics contribute less to pathogenesis of disease, whereas biological changes associated with aging including immunosenescence, dysbiosis, and frailty have a greater impact on disease outcomes. With the advent of an increasingly wider array of biologic and small-molecule therapeutic options, data regarding efficacy and safety of these agents in elderly IBD patients specifically are paramount, given the unique characteristics of this population.

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“…54 Although targeting two major cytokine pathways, AEs associated with ustekinumab use were generally nonserious, occasional, and did not lead to drug discontinuation. 55 Thus, IL17 is essential for host defense against bacterial and fungal pathogens. However, despite a decrease in IL17 signaling due to ustekinumab treatment, the infectious risk due to ustekinumab seems to be low in clinical trials.…”

Section: Adverse Events Observed With Ustekinumabmentioning

confidence: 99%

Ustekinumab in Pediatric Dermatology: An Updated Review

Chehad¹,

Boutrid²,

Rahmoune³

2022

J Explor Res Pharmacol

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Managing chronic pediatric skin disorders is challenging due to a lack of approved medication and the relative weakness of research studies for this age group. Ustekinumab is a human monoclonal antibody that targets the p40 subunit shared by IL12 and IL23 and thereby modulates the inflammatory reaction triggered by the Th1 and Th17 pathways, respectively. Currently, in dermatology, ustekinumab is the only IL12/IL23 inhibitor approved by regulatory authorities to treat moderate to severe psoriasis in adults, adolescents, and children of age six years and older. Although off-label and not supported by strong evidence, the therapeutic use of ustekinumab has been gradually extended to various other dermatoses. The reported adverse events of this biologic in pediatric patients were generally consistent with those in adults. However, its long-term safety remains to be confirmed. In this review, we discuss the existing evidence on the mechanisms of ustekinumab action, the current regulatory authority-approved indications, off-label use in pediatric cutaneous disorders, and the most reported adverse events related to this drug.

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Ustekinumab Does Not Increase Risk of Adverse Events: A Meta-Analysis of Randomized Controlled Trials

Cited by 14 publications

References 31 publications

Real-World Evidence of the Effectiveness and Safety of Ustekinumab for the Treatment of Crohn’s Disease: Systematic Review and Meta-Analysis of Observational Studies

Real-World Evidence of the Effectiveness and Safety of Ustekinumab for the Treatment of Crohn’s Disease: Systematic Review and Meta-Analysis of Observational Studies

The elderly IBD patient in the modern era: changing paradigms in risk stratification and therapeutic management

Ustekinumab in Pediatric Dermatology: An Updated Review

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