Efficacy and safety of ustekinumab in real clinical practice. Retrospective multicentre study. ARAINF cohort

Deza, Diego Casas; López, Santiago García; Lafuente, Miguel; Lidón, Raquel Vicente; Puerta, J; González, Elena Peña; Nieto, Yolanda Ber; Calvillo, Mara Charro; Escriche, Maria José Alcalá; García, Fernando L. de la Vega; Villarino, M. Arroyo

doi:10.1016/j.gastre.2019.09.010

Cited by 14 publications

(33 citation statements)

References 21 publications

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“…Other heterogeneous predictors found in some previous cohorts included ileocolonic disease, previous intestinal resection, male gender, extra-intestinal manifestations, steroid use and concomitant immunomodulator use [11 , 14 , 20] . Some previous cohorts showed predictors similar to ours, including smoking associated with poorer response to ustekinumab [21] . While in previously published real-life cohorts with vedolizumab in CD, predictors of response were rather consistent, highlighting a worse response in patients with previous anti-TNF failure and higher disease burden [14 , 23] , this seems to be less clear in real-life ustekinumab CD cohorts like in ours.…”

Section: Discussionsupporting

confidence: 87%

Ustekinumab in bio-naïve and bio-failure Crohn's disease patients: Results from a « real-life » monocentric cohort.

Monin

Dubois

Reenaers

et al. 2021

Digestive and Liver Disease

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Section: Discussionsupporting

confidence: 87%

Ustekinumab in bio-naïve and bio-failure Crohn's disease patients: Results from a « real-life » monocentric cohort.

Monin

Dubois

Reenaers

et al. 2021

Digestive and Liver Disease

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“…Family history and a higher CCI at baseline were associated with failure to achieve steroid‐free remission at week 24. Several other predictors of failure or success have been identified in other studies, like body mass index, 11,14 male gender and penetrating disease, 13 colonic disease, 14 age, and tobacco use 21 , together with other indicators of earlier clinical success (e.g. CRP drop, clinical response, or remission at 24 weeks 15 ).…”

Section: Discussionmentioning

confidence: 90%

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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“…The study also has some limitations that should be considered when interpreting the findings. First, similar to other real-world studies that have investigated the effectiveness and safety of ustekinumab in patients with refractory CD, 13 – 17 , 19 , 20 , 22 , 23 , 25 , 28 , 30 our study had a retrospective design, which could have led to overestimation of the positive response rate and underestimation of AEs, especially of the mild intensity. Second, all patients were treated at tertiary referral centres providing care for patients with IBD.…”

Section: Discussionmentioning

confidence: 86%

Effectiveness of ustekinumab in patients with refractory Crohn’s disease: a multicentre real-life study in Italy

Scribano

Aratari

Neri

et al. 2022

Therap Adv Gastroenterol

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Background: The effectiveness of ustekinumab in patients with refractory Crohn’s disease (CD) has been investigated in several real-world studies. However, very few data concerning the real-life experience in Italy have been reported. Therefore, this study assessed the effectiveness of ustekinumab in a large cohort of Italian patients with refractory CD. Methods: All patients who had started on ustekinumab after failure of or intolerance to antitumour necrosis factor-α (TNF-α) treatment at five tertiary centres between November 2018 and February 2020 were retrospectively enrolled. The coprimary outcome was corticosteroid-free clinical remission, defined as a Harvey–Bradshaw Index (HBI) score of ⩽4, at weeks 26 and 52. The secondary outcomes were changes in the HBI and C-reactive protein (CRP) values at weeks 8, 26, and 52 from baseline and the normalization of CRP in patients with initially abnormal values. Results: Totally, 140 patients who had previously received at least one anti-TNF-α agent were enrolled; 40.0% received two anti-TNF-α agents and 20.0% received vedolizumab. At baseline, 108 patients (77.1%) had HBI scores of >4; of these, 56.5% and 58.3% achieved corticosteroid-free clinical remission at weeks 26 and 52, respectively. Significant decreases in HBI and CRP values were observed at weeks 8, 26, and 52 in the entire study cohort (all p < 0.0001). The CRP values were normalized in 34.9%, 37.8%, and 49.3% of the patients by weeks 8, 26, and 52, respectively. The baseline HBI score of ⩾8 was a negative predictor of corticosteroid-free clinical remission at week 52 (odds ratio: 0.21, 95% confidence interval: 0.08–0.56, p = 0.002). The probability of remaining on ustekinumab after 52 weeks was 92.1%. Eleven (7.9%) patients discontinued ustekinumab (three for adverse events). Conclusion: Our study findings confirm the effectiveness and safety of ustekinumab in patients with CD after failure of or intolerance to anti-TNF-α therapy.

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Efficacy and safety of ustekinumab in real clinical practice. Retrospective multicentre study. ARAINF cohort

Cited by 14 publications

References 21 publications

Ustekinumab in bio-naïve and bio-failure Crohn's disease patients: Results from a « real-life » monocentric cohort.

Ustekinumab in bio-naïve and bio-failure Crohn's disease patients: Results from a « real-life » monocentric cohort.

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

Effectiveness of ustekinumab in patients with refractory Crohn’s disease: a multicentre real-life study in Italy

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