Early real-world effectiveness of ustekinumab for Crohn’s disease

Harris, Richard; McDonnell, Martin; Young, David; Bettey, Marion; Downey, Louise; Pigott, Lucinda; Felwick, Richard; Gwiggner, Markus; Cummings, Fraser

doi:10.1136/flgastro-2019-101237

Cited by 32 publications

(49 citation statements)

References 20 publications

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“…Other above-mentioned studies also included patients with a mild disease at baseline, for example, the work by Alric et al (median HBI = 6) or by Biemans et al (HBI = 7), but the percentage of patients on steroids was lower compared to our cohort (28% and 15.8%, respectively). 11,12 Concerning treatment persistence, our patients showed a very high persistence, with 89% at 52 weeks, but similar high rates when reported were achieved with 83.6%, 17 80%, 15 and 71.5%. 12 In all the aforementioned studies, including the present one, an 8-week interval regimen was followed in the majority of patients.…”

Section: Discussionsupporting

confidence: 87%

“…In the present study, 15 patients discontinued treatment mainly because of primary or secondary failure, and only 2 patients, excluding temporary stopping due to surgery, terminated treatment because of AEs. Similarly, in previous studies, the overall discontinuation rate was very low 11‐15 …”

Section: Discussionsupporting

confidence: 73%

“…Other reports indicated 44.7%, 12 26.9%, 13 24.3%, 14 and 14% 15 at 48-52 weeks, differences that may be explained by higher HBI scores at the start, 14 more patients exposed to more than one anti-TNF, 14 or low numbers of included patients. 15 A very recent Finnish study assessed ustekinumab effectiveness in 155 patients in terms of clinical benefit (defined as the sum of patients in clinical response and clinical remission) and biomarker response (reduction of fecal calprotectin and CRP) together with endoscopic evaluation. A significant reduction of biomarkers and Simple Endoscopic Score for Crohn's disease (SES-CD) score from baseline up to 1 year was observed, together with a decrease of clinical active disease.…”

Section: Discussionmentioning

confidence: 99%

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Ustekinumab in Crohn's disease: Real‐world outcomes from the Sicilian network for inflammatory bowel diseases

et al. 2021

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Background and Aim Ustekinumab is approved in Europe for the treatment of moderate to severe Crohn's disease (CD). Italian real‐life data are scarce, so the aim of this study was to assess the effectiveness and safety of ustekinumab in an Italian cohort of CD patients. Methods Data of patients with CD who started using ustekinumab were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Disease. Primary end‐points were steroid‐free clinical remission at 8, 24, and 52 weeks of therapy and reduction of C‐reactive protein. Secondary end‐points were treatment response, treatment persistence at 12 months, and safety. Results A total of 131 patients (males 56%; mean age 46 years ±15) were included. All patients were biologics experienced except for one. At 24 and 52 weeks, 40% and 43% of patients achieved steroid‐free clinical remission, and 64% and 62% had clinical response, respectively. At the end of follow‐up, there was a significant reduction of steroid use (P = 0.012) and of the Harvey‐Bradshaw Index (P = 0.001). The probability of persistence in therapy with ustekinumab after 12 months of treatment was 89%. The only factor associated with discontinuation was older age. Conclusions Data from our real‐life cohort of treatment‐refractory CD patients suggest the satisfactory effectiveness and safety profile of ustekinumab.

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Section: Discussionsupporting

confidence: 87%

Section: Discussionsupporting

confidence: 73%

Section: Discussionmentioning

confidence: 99%

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Ustekinumab in Crohn's disease: Real‐world outcomes from the Sicilian network for inflammatory bowel diseases

et al. 2021

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“…UST is effective for treatment of Crohn's disease (CD) and ulcerative colitis 1‐4 . In addition to randomised controlled trials, multiple real‐world studies corroborated the effectiveness of UST in the treatment of CD 5‐19 . However, the risk of primary and secondary loss of response to UST has not been extensively reported.…”

Section: Introductionmentioning

confidence: 99%

Effectiveness of ustekinumab dose escalation in Crohn’s disease patients with insufficient response to standard‐dose subcutaneous maintenance therapy

Kopylov¹,

Hanžel²,

Liefferinckx³

et al. 2020

Aliment Pharmacol Ther

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Summary Background Ustekinumab is effective in Crohn's disease. However, a substantial proportion of patients will not respond or lose response to ustekinumab. The current evidence to support the effectiveness of dose‐optimisation for ustekinumab nonresponse is limited. Aim To assess the effectiveness of dose escalation of ustekinumab. Methods This was a multicentre retrospective cohort study. We included active Crohn's disease patients who received a standard‐dose intravenous induction and at least one subcutaneous ustekinumab 90 mg dose. All enrolled patients received dose escalation by either shortening the interval between the doses to every 4 or 6 weeks, intravenous reinduction or a combination of strategies. The primary outcome of the study was clinical response at week 16 after dose escalation. Results A total of 142 patients (22 centres/14 countries) were included. The patients were dose‐escalated after a median treatment duration of 30 weeks. At week 16 from escalation, 73/142 (51.4%) responded to treatment, including 55/142 (38.7%) in clinical remission. Corticosteroid‐free remission was achieved in 6/34 (17.6%) patients on corticosteroids at the time of escalation; 118/142 (83%) continued treatment beyond week 16. Follow‐up data beyond week 16 were available for 74/118 (62.7%) patients. On the last follow‐up, 51/98 (52%) patients with available data responded to treatment, including 41/98 (42%) in clinical remission. Conclusions Intensification of ustekinumab maintenance dosage was effective in over 50% of the patients. This strategy should be considered in patients who are nonresponsive to every 8 weeks ustekinumab maintenance dosing.

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“…Furthermore, the patients have typically experienced several drug switches due to primary or secondary loss of response or intolerance [2]. While ustekinumab real-world studies have shown clinical benefit even in treatment-refractory CD patient cohorts, data on dosing patterns and dose optimization remain limited [6][7][8][9][10][11][12][13].…”

mentioning

confidence: 99%

A nationwide real-world study on dynamic ustekinumab dosing and concomitant medication use among Crohn’s disease patients in Finland

Sipponen

Björkesten

Hallinen

et al. 2021

Scandinavian Journal of Gastroenterology

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Background: Real-world evidence to support optimal ustekinumab dosing for refractory Crohn's disease (CD) patients remains limited. Data from a retrospective nationwide chart review study was utilized to explore ustekinumab dosing dynamics and optimization, identify possible clinical predictors of dose intensification, and to evaluate ustekinumab trough concentrations (TCs) and concomitant medication use in Finland. Methods: Information gathered from17 Finnish hospitals included clinical chart data from 155 adult CD patients who received intravenous ustekinumab induction during 2017-2018. Data on ustekinumab dosing and TCs, concomitant corticosteroid and immunosuppressant use, and antiustekinumab antibodies were analyzed in a two-year follow-up, subject to availability. Results: Among 140 patients onustekinumab maintenance therapy, dose optimization was required in 55(39%) of the patients, and 41/47 dose-intensified patients (87%) persisted on ustekinumab. At baseline, dose-intensified patient group had significantly higher C-reactive protein (CRP) levels, and at week 16, significantly lower ustekinumab TCs than in patients without dose intensification. Irrespective of dose optimization, a statistically significant reduction in the use of corticosteroids was observed at both 16 weeks and one year, coupled with an increased proportion of patients on ustekinumab monotherapy. Antiustekinumab antibodies were undetectable in all 28 samples from 25 patients collected throughout the study period. Conclusions: Nearly a third of all CD patients on ustekinumab maintenance therapy, with a history of treatment-refractory and long-standing disease, required dose intensification. These patients persisted on ustekinumab and had significant reduction of corticosteroid use. Increased baseline CRP was identified as the sole indicator of dose intensification.

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Early real-world effectiveness of ustekinumab for Crohn’s disease

Cited by 32 publications

References 20 publications

Ustekinumab in Crohn's disease: Real‐world outcomes from the Sicilian network for inflammatory bowel diseases

Ustekinumab in Crohn's disease: Real‐world outcomes from the Sicilian network for inflammatory bowel diseases

Effectiveness of ustekinumab dose escalation in Crohn’s disease patients with insufficient response to standard‐dose subcutaneous maintenance therapy

A nationwide real-world study on dynamic ustekinumab dosing and concomitant medication use among Crohn’s disease patients in Finland

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