P318 Ustekinumab: early experience and medium-term outcomes from a UK multi-centre real-world cohort

Gadhok, Radha; Rao, Rohit; Honap, Sailish; Samaan, Mark A; Harpham-Lockyer, Louis; Kwok, Heemun; Whitley, L; Ibarra, Ana; Burgess, Natasha; Seward, Edward; Parkes, Gareth; Mehta, Shameer; Vega, Roser; Bloom, Stuart; Irving, Peter M.; Lindsay, James O.; Kok, Klaartje; Rahman, Farooq

doi:10.1093/ecco-jcc/jjy222.442

Cited by 4 publications

(3 citation statements)

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“…To date, several real‐world experience studies have been published 6–10 . In a recent retrospective real‐world British cohort that included 149 patients, 63% response and 39% remission were reported at week 32, along with 50% reduction in C‐reactive protein (CRP) levels 11 . In another prospective study of ustekinumab induction, an endoscopic remission rate at week 24 of 7.1% was demonstrated with concurrent clinical remission rate of 39.5% 12 .…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2020

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Introduction Ustekinumab is an effective treatment of Crohn’s disease (CD). Real-world data addressing the efficacy and safety of ustekinumab are scarce. Aim Our aim was to assess the safety and efficacy of ustekinumab in a large national patient cohort. Methods A prospective multicenter study, in which we followed patients with active CD treated with ustekinumab for 24 weeks. Induction dose was intravenous ranging from 260 to 520 mg, according to body weight, followed by 90 mg doses given subcutaneously every 8 weeks. Clinical response was defined as a reduction of at least 1 severity category, as defined by Harvey–Bradshaw index (HBI). Patients with HBI < 5 were considered to be in clinical remission. Patients who stopped needing steroids at week 24 were defined as being in steroid-free clinical remission. Results A total of 106 CD patients from eight Israeli centers were included. All patients were previously exposed to at least one biological agent. Our cohort consisted of 65 (61.3%) females. Mean age was 41 ± 14 years with an average disease duration of 12.2 ± 8 years. A total of 96 (90.5%) patients continued treatment throughout week 24. Clinical response was observed in 52% of these patients with mean HBI reduction from 8.34 ± 3.8 to 6.8 ± 4.4 at week 24 ( p = 0.001). Clinical remission was achieved in 33 patients (31.1%). Moreover, the number of patients requiring steroid treatment was reduced by 66% at week 24. Out of 106 patients, 11 patients (10.4%) discontinued treatment: 3 due to adverse events (2.8%), 7 due to a lack of response, and 1 who was lost to follow-up. Following 24 weeks of treatment, 15 patients reported minor adverse events. Conclusions In a large real-world Israeli cohort of non-naïve-to-biological-treatment CD patients, ustekinumab was effective and safe in induction of clinical remission with a significant reduction in the number of patients requiring steroid treatment.

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Section: Introductionmentioning

confidence: 99%

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

et al. 2020

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“…In addition to the randomised controlled trial data of ustekinumab’s efficacy demonstrated by the UNITI program, there exists a growing body of observational data of its effectiveness in clinical practice. One such study, carried out as a collaboration between three IBD centres in London, included a cohort of 149 patients and reported week 32 response and remission rates of 63% and 39%, respectively 49 . These are broadly consistent with another large cohort (n = 167) from Canada which described corresponding week 24 rates of 60% and 25% 50 .…”

Section: Newer Mechanisms: Tips and Tricksmentioning

confidence: 99%

“…These are broadly consistent with another large cohort (n = 167) from Canada which described corresponding week 24 rates of 60% and 25% 50 . The London cohort also reported a range of other endpoints, including biological response (50% reduction in CRP) and biological remission (CRP of less than 5 mg/L in patients with a baseline CRP of more than 5 mg/L) ( Figure 2) 49 .…”

Section: Newer Mechanisms: Tips and Tricksmentioning

confidence: 99%

Biologic therapies for Crohn’s disease: optimising the old and maximising the new

et al. 2019

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The era of biologic agents for the treatment of Crohn’s disease has brought about significant benefits for patients, and since the introduction of infliximab at the turn of the century, the entire field has moved on rapidly. Clinicians now have multiple agents at their disposal and a choice between several different anti-inflammatory mechanisms of action. This has allowed unprecedented improvements not only in symptoms and quality of life for patients previously refractory to conventional treatments but also for demonstrated healing of the intestinal mucosa and resolution of perianal fistulation. However, despite the undisputed efficacy of these agents, there remains a significant proportion of patients who fail to gain a meaningful benefit. Through years of studying infliximab and its counterpart anti-tumour necrosis factor (anti-TNF) agent, adalimumab, we now understand that strategies such as combining use with a conventional immunomodulator or measuring serum levels can help to optimise outcomes and reduce the proportion of patients for whom treatment fails. Work is ongoing to understand whether these principles apply to newer biologics such as vedolizumab and ustekinumab. In addition, novel approaches are being investigated in an attempt to maximise the benefit that these agents could offer. In this article, we summarise these new understandings and consider ways in which they could be integrated into clinical practice for the benefit of patients.

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Real-world Comparative Effectiveness of Ustekinumab vs Anti-TNF in Crohn’s Disease With Propensity Score Adjustment: Induction Phase Results From the Prospective, Observational RUN-CD Study

Bokemeyer

Plachta-Danielzik

Giuseppe

et al. 2023

Inflammatory Bowel Diseases

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Background In addition to randomized controlled trials (RCTs), real-world studies on the effectiveness of ustekinumab (UST) in Crohn’s disease (CD) are required inasmuch as RCTs are usually confined to selected patients, which may not represent everyday clinical practice. Within the framework of the prospective real-world RUN-CD registry, a total of approximately 900 CD patients from 44 inflammatory bowel disease centers from all over Germany starting a new therapy with UST or other biologics were screened for a real-world evidence (RWE) comparison of CD patients with UST vs antitumor necrosis factor (TNF). Methods A total of 618 CD patients with a nonrandomized biological therapy were qualified for this induction phase effectiveness RUN-CD study of UST vs anti-TNF. To reduce selection bias in estimations of treatment effects, the propensity score with inverse probability of treatment weighting was implemented. The results were reported as odds ratio (OR) and 95% confidence interval (CI). Results A total of 339 UST and 279 anti-TNF patients were analyzed. The effectiveness of UST vs anti-TNF in terms of clinical remission (UST 65.4% vs anti-TNF 63.0%; OR, 1.11; 95% CI, 0.71-1.74) and steroid-free remission (UST 51.0% vs anti-TNF 53.8%; OR, 0.94; 95% CI, 0.60-1.47) was comparable at the end of induction therapy. Similar results were observed in the bio-naïve and bio-experienced UST vs anti-TNF groups. For both, the remission rates were higher in the bio-naïve than in the bio-experienced groups (P < .05). Conclusions In this prospective, observational RUN-CD study, the RWE head-to-head comparison of UST vs anti-TNF showed similar induction effectiveness in both groups, remarkably higher than those found in prior RCTs.

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P318 Ustekinumab: early experience and medium-term outcomes from a UK multi-centre real-world cohort

Cited by 4 publications

References 0 publications

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

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

Biologic therapies for Crohn’s disease: optimising the old and maximising the new

Real-world Comparative Effectiveness of Ustekinumab vs Anti-TNF in Crohn’s Disease With Propensity Score Adjustment: Induction Phase Results From the Prospective, Observational RUN-CD Study

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