Ustekinumab for the treatment of moderate to severe ulcerative colitis: a multicentre UK cohort study

Honap, Sailish; Al‐Hillawi, Lulia; Baillie, Samantha; Bancil, Aaron; Matini, Lawrence; Lau, Rebecca; Kok, Klaartje; Patel, Kamal; Walsh, Alissa J.; Irving, Peter M; Samaan, Mark A

doi:10.1136/flgastro-2022-102168

Cited by 13 publications

(25 citation statements)

References 24 publications

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“…In all, 11 studies [6][7][8][9]16,19,20,[22][23][24]26 Between-study heterogeneity was considerable at week 8 (I 2 = 87%) and month 12 (I 2 = 82%), might be not important at weeks 12-16 (I 2 = 26%), and was substantial at month 6 (I 2 = 65%) (Figure 1).…”

Section: Primary Endpoint: Clinical Remissionmentioning

confidence: 98%

“…Of the 254 citations identified, 19 studies including 3786 patients with UC were eligible for inclusion in this systematic review (Table S2). [5][6][7][8][9][15][16][17][18][19][20][21][22][23][24][25][26][27][28] In all, 13 studies were reported as full-text articles, and 6 were conference proceedings. According to JBI criteria for quality assessment, 14 studies showed low risk of bias, and 5 articles showed moderate risk (Table S3).…”

Section: Re Sultsmentioning

confidence: 99%

“…In all, 12 studies [5][6][7][8][9][15][16][17][18]20,22,23 reported CS-free clinical remission rates (n = 978; Table S3). CS-free remission was achieved in 18.7% of patients at week 8 (95% CI: 13.7-23.6) (260 patients; 4 studies 5, 18, 20, 23) and in 36.8% of patients at weeks 12-16 (95% CI: 32.1-41.5) (409 patients; 8 studies 6, 8, 15-18, 20, 22) (Figure S2).…”

Section: Cs-free Clinical Remissionmentioning

confidence: 99%

“…Nine studies [5][6][7][8]18,20,23,24 assessed endoscopic improvement in 236 patients (Figure 3). At weeks 12-16, the pooled rate of endoscopic improvement was 29.9% (95% CI: 21.1-38.7) (91 patients; 2 studies: 6, 18).…”

Section: Endoscopic Improvement (Mayo Endoscopic Subscore ≤1)mentioning

confidence: 99%

“…Dose escalation rates were reported in 10 studies [7][8][9][15][16][17]20,21,24,27 (n = 629). During follow-up, dose escalation was required in 28.4% of patients (95% CI: 14.7-44.3; range 0%-63.1%) (Figure S3A).…”

Section: Dose Escalation Rates and Outcomes Of Escalationmentioning

confidence: 99%

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Meta‐analysis: Real‐world effectiveness and safety of ustekinumab in patients with ulcerative colitis

Taxonera

Olivares

López-García

et al. 2023

Aliment Pharmacol Ther

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Summary Background Evidence on real‐world outcomes of ustekinumab for ulcerative colitis (UC) patients is needed. Aims To summarise evidence on the real‐world outcomes of ustekinumab for UC and conduct a meta‐analysis of effectiveness and safety data. Methods A systematic search was conducted through September 2022 in electronic databases for observational studies evaluating ustekinumab for UC. A random‐effects meta‐analysis model was used to calculate the pooled effect sizes (percentages or incidence rates [IRs]) of effectiveness and safety outcomes. Results In all, 19 studies were included with 3786 patients. More than 92% of patients were previously treated with any biologic, 61.1% with both anti‐TNF and vedolizumab and 16.4% with any biologic and tofacitinib. Clinical remission was achieved in 45.4% at week 8 (95% CI: 30.1%–60.6%), 43.8% (38.4%–49.2%) at weeks 12–16, 44.6% (35.9%–53.3%) at month 6, and 50.6% (36.3%–64.8%) at month 12. Response was achieved in 61.2%, 59.4%, 65.2% and 76.8% at weeks 8, 12–16, month 6 and 12, respectively. CS‐free remission was achieved in 18.7%, 36.8%, 34.5% and 39% at weeks 8, 12–16, month 6 and 12, respectively. Overall, 58.2% of patients had endoscopic improvement at month 12. Almost 30% of the patients needed dose escalation, which was effective in 40% of these patients. The IRs of colectomy, adverse events (AEs), serious AEs and serious infections were 4.8, 7.9, 0.8 and 0.3 per 100 patient‐years, respectively. Conclusions This meta‐analysis confirms the effectiveness and safety of ustekinumab in a highly treatment‐refractory population of UC patients.

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Section: Primary Endpoint: Clinical Remissionmentioning

confidence: 98%

Section: Re Sultsmentioning

confidence: 99%

Section: Cs-free Clinical Remissionmentioning

confidence: 99%

Section: Endoscopic Improvement (Mayo Endoscopic Subscore ≤1)mentioning

confidence: 99%

Section: Dose Escalation Rates and Outcomes Of Escalationmentioning

confidence: 99%

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Meta‐analysis: Real‐world effectiveness and safety of ustekinumab in patients with ulcerative colitis

Taxonera

Olivares

López-García

et al. 2023

Aliment Pharmacol Ther

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Effectiveness and Safety of Ustekinumab in Pediatric Ulcerative Colitis: A Multi-center Retrospective Study from the Pediatric IBD Porto Group of ESPGHAN

Cohen,

Rolandsdotter,

Kolho

et al. 2024

Pediatr Drugs

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Background and Objectives Current data on ustekinumab therapy in children with ulcerative colitis (UC) or unclassified inflammatory bowel disease (IBDU) are limited. We aimed to evaluate the effectiveness and safety of ustekinumab in pediatric UC and IBDU. Methods This multicenter retrospective study included 16 centers affiliated with the IBD Interest and Porto groups of ESPGHAN. Children with UC or IBDU treated with ustekinumab were enrolled. Demographic, clinical, laboratory, endoscopic, and imaging data as well as adverse events were recorded. Analyses were all based on the intention-to-treat principle. Results Fifty-eight children (39 UC and 19 IBDU, median age 14.5 .5] years) were included. All had failed biologic therapies, and 38 (66%) had failed two or more biologics. Corticosteroid-free clinical remission (CFR) was observed in 27 (47%), 33 (57%), and 37 (64%) children at 16, 26, and 52 weeks, respectively. Normalization of C-reactive protein and calprotectin < 150 μg/g were achieved in 60% and 52%, respectively, by 52 weeks. Endoscopic and radiologic remissions were reached in 8% and 23%, respectively. The main predictors of CFR were diagnosis of UC compared with IBDU (hazard ratio [HR] 2.2, 95% CI 1.03-4.85; p = 0.041) and no prior vedolizumab therapy (HR 2.1, 95% CI 1.11-4.27; p = 0.023). Ustekinumab serum levels were not associated with disease activity. Adverse events were recorded in six (10%) children, leading to discontinuation of the drug in three. Conclusion Based on these findings, ustekinumab appears as an effective therapy for pediatric refractory UC and IBDU. The potential efficacy should be weighed against the risks of serious adverse events.

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Selection strategy of second-line biologic therapies in adult patients with ulcerative colitis following prior biologic treatment failure: Systematic review and meta-analysis

Zhang,

Mu,

et al. 2024

Pharmacological Research

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Ustekinumab for the treatment of moderate to severe ulcerative colitis: a multicentre UK cohort study

Cited by 13 publications

References 24 publications

Meta‐analysis: Real‐world effectiveness and safety of ustekinumab in patients with ulcerative colitis

Meta‐analysis: Real‐world effectiveness and safety of ustekinumab in patients with ulcerative colitis

Effectiveness and Safety of Ustekinumab in Pediatric Ulcerative Colitis: A Multi-center Retrospective Study from the Pediatric IBD Porto Group of ESPGHAN

Selection strategy of second-line biologic therapies in adult patients with ulcerative colitis following prior biologic treatment failure: Systematic review and meta-analysis

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