Safety and effectiveness of ustekinumab for induction of remission in patients with Crohn’s disease: A multicenter Israeli study

Shitrit, Ariella Bar-Gil; Ben-Ya'acov, Ami; Siterman, Matan; Waterman, Matti; Hirsh, A.T; Schwartz, Doron; Zittan, Eran; Adler, Yael D.; Koslowsky, Benjamin; Avni-Biron, Irit; Chowers, Yehuda; Ron, Yulia; Israeli, Eran; Ungar, Bella; Yanai, Henit; Maharshak, Nitsan; Ben‐Horin, Shomron; Eliakim, Rami; Dotan, Iris; Goldin, Eran; Kopylov, Uri

doi:10.1177/2050640620902956

Cited by 28 publications

(40 citation statements)

References 24 publications

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“…With regard to the data obtained at 24 weeks with obviously more consistent patient's numbers in all studies, 11,[18][19][20] percentages of steroid-free remission are more homogenous, with 40% in the present study and 38.3%, 11 38.4%, 19 35.1% in other studies, 19 with only one exception of 15%. 18 In the present study, disease severity at baseline in terms of HBI score was the only factor independently associated with failure to achieve steroid-free remission, both at weeks 24 and 52. Family history and a higher CCI at baseline were associated with failure to achieve steroid-free remission at week 24.…”

Section: Discussionsupporting

confidence: 78%

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: 78%

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

et al. 2021

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“…This is a considerably higher proportion likely due to a more diseaserefractory patient population when compared to the patients of IM-UNITI trial where only 23% needed dose adjustment from q12w to q8w [21]. Our data on dosing patterns support the findings of other real-world registry studies of ustekinumab maintenance treatment where the majority or all the patients commenced their ustekinumab maintenance therapy with q8w dosing [6,10,12,13,22]. Interestingly, data on recapturing or improvement of ustekinumab response in CD patients with q4w dosing is emerging [11,[22][23][24][25].…”

Section: Discussionsupporting

confidence: 74%

“…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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“…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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Safety and effectiveness of ustekinumab for induction of remission in patients with Crohn’s disease: A multicenter Israeli study

Cited by 28 publications

References 24 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

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

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

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