Subcutaneous rather than intravenous ustekinumab induction is associated with comparable circulating drug levels and early clinical response: a pilot study

Rowan, Catherine; Keegan, Denise; Byrne, Kathryn R.; Cullen, Garret; Mulcahy, Hugh; Sheridan, Juliette; Ryan, Elizabeth J.; Vries, Annick de; D’Haens, G; Doherty, Glen

doi:10.1111/apt.14834

Cited by 15 publications

(14 citation statements)

References 39 publications

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“…10 The trough levels we observed at Week 8 did not show correlation with clinical outcomes, in contrast with the findings of others. 25,26 This may be for two possible reasons: First, trough levels were performed in our study in a subgroup of 82 patients, which may impact the statistical power. Second, in Battat et al's and Adedokun et al's studies, UST trough levels were better correlated to objective end points such as CRP or endoscopy than clinical end points.…”

Section: Discussionmentioning

confidence: 99%

Long-term Clinical Effectiveness of Ustekinumab in Patients with Crohn’s Disease Who Failed Biologic Therapies: A National Cohort Study

Liefferinckx

Verstockt

Gils

et al. 2019

Journal of Crohn's and Colitis

103

133

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Background Ustekinumab [UST] was recently approved in Europe for the treatment of moderate to severe Crohn’s disease [CD]. Long-term real-world data are currently scarce for CD patients previously exposed to several biologics. Methods This is an observational, national, retrospective multicentre study. Patients received intravenous UST ~6 mg/kg at baseline, with 90 mg subcutaneously thereafter every 8 weeks. Response and remission rates were assessed at Weeks 8, 16, and 52. Results Data from 152 patients were analysed. All patients were exposed to at least one anti-TNFα agent, with 69.7% were exposed to even two anti-TNFα and vedolizumab. After 1 year, 42.1% and 25.7% of patients had experienced clinical response and clinical remission, respectively, and 38.8% and 24.3% had achieved steroid-free clinical response and remission, respectively; 38.8% of patients discontinued therapy during the 12 months of follow-up. Colonic location was predictive of clinical response at 1 year, and low body mass index [BMI] at baseline was a negative predictor of clinical remission. Resolution of arthralgia was associated with clinical response over time. De novo arthralgia was reported by 17.9% of patients at Week 8 and 13.5% of patients at Week 52. No impact of UST on arthralgia was observed in patients with concomitant ankylosing spondylitis [n = 17]. Others adverse events were reported in 7.2% of patients. Conclusions This real-world cohort study confirms the effectiveness of UST in CD patients previously exposed to several biologics. Ustekinumab was well tolerated with respect to adverse events. Podcast This article has an associated podcast which can be accessed at https://academic.oup.com/ecco-jcc/pages/podcast

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Section: Discussionmentioning

confidence: 99%

Long-term Clinical Effectiveness of Ustekinumab in Patients with Crohn’s Disease Who Failed Biologic Therapies: A National Cohort Study

Liefferinckx

Verstockt

Gils

et al. 2019

Journal of Crohn's and Colitis

103

133

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“…The total study population was of 4,487 patients. The majority of the included studies was observational cohort studies with 2,260 patients, 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 and 4 of the included studies were RCTs with 2,227 patients. 13 17 50 51 We have presented data on age, gender, location of CD disease, disease phenotype, route of administration, and drug dose.…”

Section: Methodsmentioning

confidence: 99%

“…Only one study showed good quality. 40 Fifteen studies were rated to have fair quality, 23 24 26 27 29 31 34 35 37 38 39 41 42 44 47 and the remaining 10 trials were of poor quality. 25 28 30 32 33 36 43 46 48 49…”

Section: Methodsmentioning

confidence: 99%

Safety and Efficacy of Ustekinumab in the Treatment of Crohn Disease: A Systematic Review and Meta-analysis

Khorshid¹,

Cordie

2022

Journal of Coloproctology

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Background and Aims The present systematic review and meta-analysis was designed to estimate the safety and effectiveness of ustekinumab in the treatment of Crohn disease (CD) in clinical trials and observational studies. Methods We retrieved all the related publications from the PubMed, Cochrane, EBSCO, Google Scholar and EMBASE databases using a systematic search strategy. We only included clinical trials and observational studies that were published in English. Results Only 31 studies that met the eligibility criteria out of the 733 identified studies were included. The overall clinical response rate in the cohort studies was of 0.539 (95% confidence interval [95%CI]: 0.419–0.659), and in the clinical trials it was of 0.428 (95%CI: 0.356–0.501). The pooled clinical remission rate was of 0.399 (95%CI: 0.295–0.503) in randomized control trials (RCTs,) and of 0.440 (95%CI: 0.339–0.542) in cohort studies. The rate of adverse effects was of 0.158 (95%CI: 0.109–0.207) in cohort studies and of 0.690 (95%CI: 0.633–0.748) in RCTs. Conclusion Ustekinumab is effective in the treatment of CD. However, more research is required on the safety profiles because there was considerable variation among the included studies.

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“…4 For ustekinumab, a pilot study recently evaluated induction therapy with the SC (rather than IV) formulation in patients with CD, establishing comparability of PK and acceptability of the approach. 136 …”

Section: Delivering the Benefits Of Innovative Biologics To Patientsmentioning

confidence: 99%

Innovative approaches to biologic development on the trail of CT-P13: biosimilars, value-added medicines, and biobetters

Kim

Alten

Cummings

et al. 2021

mAbs

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The biosimilar concept is now well established. Clinical data accumulated pre- and post-approval have supported biosimilar uptake, in turn stimulating competition in the biologics market and increasing patient access to biologics. Following technological advances, other innovative biologics, such as “biobetters” or “value-added medicines,” are now reaching the market. These innovative biologics differ from the reference product by offering additional clinical or non-clinical benefits. We discuss these innovative biologics with reference to CT-P13, initially available as an intravenous (IV) biosimilar of reference infliximab. A subcutaneous (SC) formulation, CT-P13 SC, has now been developed. Relative to CT-P13 IV, CT-P13 SC offers clinical benefits in terms of pharmacokinetics, with comparable efficacy, safety, and immunogenicity, as well as increased convenience for patients and reduced demands on healthcare system resources. As was once the case for biosimilars, nomenclature and regulatory pathways for innovative biologics require clarification to support their uptake and ultimately benefit patients.

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Subcutaneous rather than intravenous ustekinumab induction is associated with comparable circulating drug levels and early clinical response: a pilot study

Cited by 15 publications

References 39 publications

Long-term Clinical Effectiveness of Ustekinumab in Patients with Crohn’s Disease Who Failed Biologic Therapies: A National Cohort Study

Long-term Clinical Effectiveness of Ustekinumab in Patients with Crohn’s Disease Who Failed Biologic Therapies: A National Cohort Study

Safety and Efficacy of Ustekinumab in the Treatment of Crohn Disease: A Systematic Review and Meta-analysis

Innovative approaches to biologic development on the trail of CT-P13: biosimilars, value-added medicines, and biobetters

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