Meta‐analysis: Real‐world effectiveness and safety of ustekinumab in patients with ulcerative colitis

Taxonera, Carlos; Olivares, David; López-García, Olga N.; Alba, Cristina

doi:10.1111/apt.17386

Cited by 17 publications

(10 citation statements)

References 39 publications

(260 reference statements)

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“…A meta-analysis of RW studies included a total of 19 studies, with 3786 patients, of which >92% were previously treated with any biologic, 61.1% with both anti-TNF-α and VDZ, and 16.4% with any biologic and tofacitinib [ 91 ]. Among the UC patients, 45.4% were in clinical remission by weeks 8, 43.8% (38.4–49.2%) by weeks 12–16, 44.6% by month 6, and 50.6% by month 12.…”

Section: Resultsmentioning

confidence: 99%

“…In UC, a systematic review of RW data found that patients with AEs ranged from 2.6% to 32% [ 89 ]. In another recent systematic review with a meta-analysis of RW, the incidence rates (iRs) of colectomy, mild and severe AEs, and serious infections were 4.8, 7.9, 0.8, and 0.3 per 100 patient-years, respectively [ 91 ]. The most common non-infectious AE, except IBD exacerbation, was arthralgia (1.94%), followed by a skin rash (1.55%).…”

Section: Resultsmentioning

confidence: 99%

“…Other treatments are usually recommended for refractory patients or those with specific contraindications to anti-TNF-α drugs [ 108 ]. The real-life data for the use of UST in this setting are still scarce and limited by small sample sizes and large heterogeneity of therapy protocols/outcome definitions [ 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 35 , 45 , 47 , 48 , 55 , 61 , 62 , 63 , 68 , 69 , 70 , 71 , 72 , 74 , 75 , 76 , 77 , 78 , 79 , 80 , 81 , 82 , 83 , 84 , 85 , 86 , 87 , 88 , 89 , 91 , 92 , 93 , 94 , 95 , 96 , 97 , 98 , 99 , 100 , 101 , …”

Section: Resultsmentioning

confidence: 99%

See 2 more Smart Citations

Ustekinumab in the Treatment of Inflammatory Bowel Diseases: Evolving Paradigms

Mocci,

Tursi,

Onidi

et al. 2024

JCM

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Inflammatory bowel diseases, comprising Crohn’s disease (CD) and ulcerative colitis (UC), are chronic, relapsing, and remitting immune-mediated inflammatory diseases affecting the gastrointestinal tract. Ustekinumab (UST) is a monoclonal antibody that blocks the p40 subunit of the anti-interleukin (IL) 12/23. Pivotal trials (CERTIFI and UNITI-IM for CD, UNIFI for UC) established the efficacy of UST for the induction and maintenance of remission in both CD and UC, with the most favorable results in naïve patients to biologics. In recent years, a wealth of ‘real-world’ data has emerged supporting positive clinical, endoscopic, and histological outcomes in patients treated with UST, as well as reassuring safety data. More recently, the results of the first head-to-head trials of UST and tumor necrosis factor (TNF) antagonists were reported. Moreover, a number of studies exploring the role of UST in specific clinical settings, such as perianal CD, postoperative complications and recurrence, extraintestinal manifestations, chronic antibiotic-refractory pouchitis, and pregnancy, were reported. This review explores the results reported to date on UST, including those from pivotal trials, real-world data, and emerging studies regarding therapeutic drug monitoring and immunogenicity. The safety profile of UST was also reviewed.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Ustekinumab in the Treatment of Inflammatory Bowel Diseases: Evolving Paradigms

Mocci,

Tursi,

Onidi

et al. 2024

JCM

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“…No adverse events were observed in our cohort. In a systematic review of real-world data [ 15 ] and results from randomized clinical trials [ 5 , 16 ], an acceptable safety profile of UST in patients with UC was reported. The results of our real-world safety data validate these results, although the number of patients included in our study was small.…”

Section: Discussionmentioning

confidence: 99%

Real-World Effectiveness and Risk Factors for Discontinuation of Ustekinumab in Ulcerative Colitis

Uchida¹,

Nakamura²,

Yamamura³

et al. 2023

Inflamm Intest Dis

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Introduction Ustekinumab (UST) has been approved for the treatment of moderate to severe ulcerative colitis (UC). Real-world data showing the effectiveness and safety of UST are necessary to confirm the results of clinical trials for applicability in daily clinical practice. Although some studies have reported real-world evidence of UST, only few studies have confirmed its effectiveness in the real world. The aim of this study was to assess the short- and long-term effectiveness, durability, safety, and risk factors for discontinuation of UST in UC in clinical practice. Methods This was a retrospective, single-center, observational study. From March 2020 to January 2023, all consecutive patients with active UC who were treated with UST at Nagoya University Hospital were included. The primary outcome was the clinical remission rate at weeks 2–8 and weeks 24–48. The secondary outcomes included clinical response, persistence of UST therapy, endoscopic changes during follow-up, risk factors for UST discontinuation, and occurrence of any adverse events. The clinical effectiveness was evaluated using the Lichtiger score. Results A total of 31 patients were included in this study. The clinical remission rates were 9.7%, 29.0%, 54.8%, and 64.5% at weeks 2, 8, 24, and 48, respectively. Twelve (38.7%) patients discontinued UST during the follow-up period. The probability of continuing UST was 93.5%, 80.6%, 77%, and 70% at weeks 2, 8, 24, and 48, respectively. The major reason for discontinuation of UST was primary failure (75.0%). A high baseline C-reactive protein (CRP) level was a significant risk factor for the discontinuation of UST. No adverse events were observed in this study. Discussion/Conclusion UST is effective for patients with UC. High CRP levels were identified as a risk factor for UST discontinuation. The findings of this study would help clinicians to select appropriate treatment options for patients with UC by identifying the risk factors for treatment discontinuation.

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“…Ustekinumab (UST, marketed as Stelara; Janssen Biotech, Inc, Horsham, PA, USA) represents a fully human IgG1 monoclonal antibody designed to target the shared p40 subunit of interleukin 12 (IL12) and 23 (IL23) and effectively inhibit the T-helper 1 (Th1) and T-helper 17 (Th17) pathways, which play crucial roles in CD [ 8 , 10 , 11 , 12 , 13 , 14 ]. UST has shown favourable results in real-life studies [ 15 , 16 , 17 , 18 ] and a good safety profile [ 19 , 20 , 21 , 22 , 23 , 24 , 25 ].…”

Section: Introductionmentioning

confidence: 99%

Association between Ustekinumab Trough Levels, Serum IL-22, and Oncostatin M Levels and Clinical and Biochemical Outcomes in Patients with Crohn’s Disease

Bertin,

Barberio,

Gubbiotti

et al. 2024

JCM

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Background: Ustekinumab (UST) has demonstrated effectiveness in treating patients with Crohn’s disease. Monitoring treatment response can improve disease management and reduce healthcare costs. We investigated whether UST trough levels (TLs), serum IL22, and Oncostatin M (OSM) levels could be early indicators of non-response by analysing their correlation with clinical and biochemical outcomes in CD. Methods: Patients with CD initiating UST treatment from October 2018 to September 2020 were enrolled at six Italian centres for inflammatory bowel disease (IBD). Clinical and biochemical data were collected at four time points: baseline, second subcutaneous (SC) dose, fourth SC dose, and 52 weeks. TLs were measured during maintenance, at the second SC dose, and at the fourth SC dose. IL-22 and OSM serum levels were assessed at baseline and the second SC dose. We analysed whether TLs, IL22 levels, and OSM serum levels were associated with clinical response, clinical remission, biochemical remission, and endoscopic remission using the appropriate statistical tests. Results: Out of eighty-four initially enrolled patients, five were lost to follow-up, and eleven discontinued the drug before 52 weeks. At the 52-week time point, 47% achieved biochemical remission based on faecal calprotectin levels, and 61.8% achieved clinical remission. TLs at the second SC dose significantly correlated with biochemical remission at the same time point (p = 0.011). However, TLs did not correlate with clinical remission. Baseline OSM levels did not correlate with biochemical or clinical remission or response. IL22 levels notably decreased during UST therapy (p = 0.000), but its values did not correlate with biochemical or clinical remission. Conclusions: UST is an effective therapy for patients with CD. TLs measured at the second SC dose significantly correlated with biochemical remission, emphasising their potential role in treatment monitoring. Levels of OSM and IL-22, despite a significant decrease in the latter during therapy, did not exhibit correlations with clinical or biochemical outcomes in our study. Further studies are needed to confirm these findings.

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Meta‐analysis: Real‐world effectiveness and safety of ustekinumab in patients with ulcerative colitis

Cited by 17 publications

References 39 publications

Ustekinumab in the Treatment of Inflammatory Bowel Diseases: Evolving Paradigms

Ustekinumab in the Treatment of Inflammatory Bowel Diseases: Evolving Paradigms

Real-World Effectiveness and Risk Factors for Discontinuation of Ustekinumab in Ulcerative Colitis

Association between Ustekinumab Trough Levels, Serum IL-22, and Oncostatin M Levels and Clinical and Biochemical Outcomes in Patients with Crohn’s Disease

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