One-year effectiveness and safety of ustekinumab in ulcerative colitis: a multicenter real-world study from Italy

Chiappetta, Michele Francesco; Viola, Anna; Mastronardi, Mauro; Turchini, Laura; Carparelli, Sonia; Orlando, A.; Biscaglia, Giuseppe; Miranda, Agnese; Guida, Laura; Costantino, Giuseppe; Scaldaferri, Franco; Bossa, Fabrizio; Renna, Sara; Cappello, Maria; Alibrandi, Angela; Orlando, Ambrogio; Armuzzi, Alessandro; Fries, Walter

doi:10.1080/14712598.2021.1981855

Cited by 27 publications

(48 citation statements)

References 18 publications

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“…The finding that one-third of our patients were in CSFR following induction is consistent with recently published real world studies, though we acknowledge missing clinical data 5–8 14. Chaparro et al evaluated 95 patients from the Spanish ENEIDA registry and found CSFR rates of 30% and 32% at weeks 24 and 52, respectively 5.…”

Section: Discussionsupporting

confidence: 90%

“…Similarly, the French GETAID study of 103 patients demonstrated CSFR rates of 35% between weeks 12–16% and 32% at 12 months 7 14. Two smaller cohorts from Italy and the USA had similar outcomes, with a higher 12-month CSFR rate of 53% in the latter 6 8. It is worth noting that due to prescribing restrictions, only 3.6% (n=4) of our cohort were escalated to 4-weekly therapy, compared with 63% and 44% of the respective GETAID and US cohorts who received 4-weekly ustekinumab 7 8.…”

Section: Discussionsupporting

confidence: 59%

“…This may be because the GETAID cohort was more treatment refractory; 85% had failed two classes of biologics compared with only 33% in this cohort who had failed both anti-TNF and anti-integrin therapy 7. The Italian cohort had the highest persistence rates at week 52, however, the study only included patients receiving both the intravenous induction dose and the first subcutaneous dose 6. Therefore, those ceasing treatment in the first 8 weeks due to treatment failure or AEs, would not have been included.…”

Section: Discussionmentioning

confidence: 94%

“…Ustekinumab treatment persistence at week 52, either actual or estimated (for cohorts with a shorter follow-up), varied between 58% to 87% across real-world studies, including our own 5–8. The variability in persistence, which is often used as a proxy for assessing sustained effectiveness, may reflect the heterogeneity of included cohorts, varying treatment regimens, and study designs.…”

Section: Discussionmentioning

confidence: 96%

“…However, RCTs may not be suitable for effectiveness research due to poor external validity, a consequence of, among other things, strict inclusion criteria 4. Therefore, real-life data of ustekinumab in UC are needed, and remain very limited 5–8. The aim of this study was to supplement the body of observational research by describing the effectiveness and safety of ustekinumab in UC patients in everyday clinical practice.…”

Section: Introductionmentioning

confidence: 99%

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

Honap

Al‐Hillawi

Baillie

et al. 2022

Frontline Gastroenterol

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ObjectiveUstekinumab is an interleukin-12/interleukin-23 receptor antagonist licensed for the treatment of ulcerative colitis (UC). Clinical trial data were promising; however, real-world data are limited. We assessed the safety and effectiveness of ustekinumab in UC in a real-world setting.Design/methodThis was a multicentre, retrospective, observational cohort study between February 2020 and January 2022. Disease activity was assessed using the Simple Clinical Colitis Activity Index (SCCAI). Clinical remission was defined as a SCCAI≤2. The primary endpoints were rates of corticosteroid-free remission (CSFR) at week 16 and at week 26. Objective outcomes, including faecal calprotectin (FCAL), were also collected.Results110 patients with UC (65% male; median age 40 (IQR range 29–59); 96% with prior biologic and/or tofacitinib exposure) had a median follow-up of 28 weeks (IQR 17–47). CSFR was 36% (18/50) at week 16% and 33% (13/39) at week 26, corresponding with a significant fall in SCCAI from 6 (IQR 4–8) at baseline to 3 (IQR 0–5) at week 26, p<0.001. By week 16, there was improvement of median FCAL measurements, which fell from a baseline of 610 µg/g (IQR 333–1100) to 102 µg/g (IQR 54–674) at week 16. At the end of follow-up, 15% (17/110) had discontinued treatment; 13 patients due to primary non-response or loss of response, and 1 patient for family planning. Treatment was discontinued in three patients due to adverse events.ConclusionIn the largest real-world study to date, ustekinumab was effective with a reassuring safety profile in a refractory cohort of patients.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionsupporting

confidence: 59%

Section: Discussionmentioning

confidence: 94%

Section: Discussionmentioning

confidence: 96%

Section: Introductionmentioning

confidence: 99%

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

Honap

Al‐Hillawi

Baillie

et al. 2022

Frontline Gastroenterol

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Ustekinumab treatment in ulcerative colitis: Real‐world data from the Swedish inflammatory bowel disease quality register

et al. 2022

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Background Real‐world data on clinical outcomes of ustekinumab in ulcerative colitis are lacking. Objective To assess short‐ and long‐term clinical outcomes of ustekinumab in ulcerative colitis. Methods Adult ulcerative colitis patients without previous colectomy starting ustekinumab treatment up until 11 December 2020 were identified through the Swedish Inflammatory Bowel Disease Register (SWIBREG). Prospectively recorded data were extracted from the SWIBREG. The primary outcome was persistence to ustekinumab 16 weeks after treatment initiation. Secondary outcomes included drug persistence beyond week 16, clinical remission (defined as a patient‐reported Mayo rectal bleeding subscore = 0 and stool frequency subscore ≤1), biochemical remission (defined as faecal‐calprotectin <250 μg/g) and changes in health‐related quality of life (HRQoL), as measured by the Short Health Scale (SHS). Logistic regression was used to identify potential predictors of ustekinumab persistence at 16 weeks. Results Of the 133 patients with ulcerative colitis, only three were naïve to biologics and tofacitinib. The persistence rates of ustekinumab were 115/133 (86%) at 16 weeks and 89/133 (67%) at last follow‐up, that is, after a median follow‐up of 32 (interquartile range 19–56) weeks. The clinical remission rates were 17% at 16 weeks and 32% at the last follow‐up. The corresponding rates for biochemical remission were 14% and 23%. The median faecal‐calprotectin concentration decreased from 740 μg/g at baseline to 98 μg/g at the last follow‐up (p < 0.01, n = 37). Improvement was seen in each dimension of the SHS between baseline and last follow‐up (p < 0.01 for each dimension, n = 46). Male sex was associated with ustekinumab persistence at 16 weeks (adjusted odds ratio = 4.00, 95% confidence interval: 1.35–11.83). Conclusion In this nationwide real‐world cohort of ulcerative colitis patients with prior drug failures, including other biologics and tofacitinib, ustekinumab was associated with high drug persistence rates and improvements in clinical, biochemical and HRQoL measures.

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Rapidly achieving clinical remission in ulcerative colitis indicates better endoscopic and histological outcomes

Chen,

Tie,

Huang

et al. 2023

UEG Journal

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BackgroundClinical remission (CR) is the principal short‐term treatment target in patients with ulcerative colitis (UC). However, whether rapidly achieving CR indicates better outcomes remains unclear.ObjectivesWe aimed to explore the associations between the timing of CR and therapeutic outcomes in UC.MethodsThis study included UC patients from the UNIFI trial. Week‐2 CR and time to CR were the major variables of interest. Endoscopic remission (ER) at week 52 was the primary outcome. Multivariate logistic regression was performed to evaluate the association between variables and outcomes.ResultsWeek‐2 CR was associated with ER (aOR: 2.37 [95% CI: 1.28, 4.37], p = 0.006) and Histological remission (HR) (aOR: 2.87 [95% CI: 1.42, 5.72], p = 0.003) at week 52. Moreover, C‐reactive protein (CRP) remission could further stratify patients without CR and predict week‐52 outcomes. Patients with clinical activity + CRP remission (aOR: 0.49 [95% CI: 0.26, 0.93], p = 0.039) and clinical activity + CRP activity (aOR: 0.24 [95% CI: 0.11, 0.52], p < 0.001) had gradually decreased likelihood of achieving ER, when compared to those with CR. For time to CR, we found that the earlier to CR, the better endoscopic and histological outcomes patients would attain. Patients achieving CR at weeks 2, 4/8, 12/16 and >16 had gradually reduced proportions of ER (51.9% vs. 40.8% vs. 31.6% vs. 8.8%, p < 0.001) and HR (37.0% vs. 19.8% vs. 17.1% vs. 6.1%, p < 0.001) at week 52. Compared with week 2, achieving CR at weeks 4/8, 12/16 and >16 had 39%, 55% and 92% lower likelihoods of week‐52 ER, respectively.ConclusionsWeek‐2 CR indicates better outcomes in UC patients receiving ustekinumab. Moreover, achieving CR more rapidly is associated with higher probability of ER and HR.

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One-year effectiveness and safety of ustekinumab in ulcerative colitis: a multicenter real-world study from Italy

Cited by 27 publications

References 18 publications

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

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

Ustekinumab treatment in ulcerative colitis: Real‐world data from the Swedish inflammatory bowel disease quality register

Rapidly achieving clinical remission in ulcerative colitis indicates better endoscopic and histological outcomes

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