Effectiveness and Safety of Ustekinumab in Elderly Patients with Crohn’s Disease: Real World Evidence From the ENEIDA Registry

Casas-Deza, D; Calvo, Luis Javier Lamuela; Gomollón, Fernando; Mainar, J.M. Arbones; Caballol, Berta; Gisbert, Javier P.; Rivero, Montserrat; Rodríguez, Eugenia Sánchez; García, Lara Arias; Casbas, Ana Gutiérrez; Merino, Olga; Márquez, Lucía; Laredo, Viviana; Martín-Arranz, María Dolores; Serrano, Pilar López; Menéndez, S. Riestra; González‐Muñoza, Carlos; Parga, L De Castro; Moya, Marta Calvo; Fuentes-Valenzuela, Esteban; Esteve, María; Iborra, Marisa; Gil, Miguel Durá; Acosta, Manuel Barreiro‐de; Poyatos, Rufo Humberto Lorente; Manceñido, Noemí; Calafat, Margalida; Rodríguez‐Lago, Iago; Capo, Jordi Guardiola; Payeras, Maria Antonia; Alvarado, Víctor Jair Morales; Tardillo, Carlos; Bujanda, Luís; Núñez, José Fernando Muñoz; Nieto, Yolanda Ber; Bermejo, Fernando; Almela, Pedro; Navarro-Llavat, M; Montiel, P Martínez; Gutiérrez, Cristina Rodríguez; Domselaar, Manuel Van; Sesé, E; Pérez, Teresa Martínez; Ricart, Elena; Chaparro, María; García, Maria José; López-Sanromán, Antonio; Sicilia, B; Orts, Beatriz; García, Alicia López; Martín-Larraz, Eduardo; Calle, José Lázaro Pérez; Francisco, Ruth de; García‐Planella, Esther; Domènech, Eugeni; García-López, y Santiago

doi:10.1093/ecco-jcc/jjac108

Cited by 25 publications

(17 citation statements)

References 40 publications

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“…Among the 63 publications, 10‐72 58 were journal articles and 5 were international conference abstracts. Two conference abstracts 71,72 were replaced by subsequent published articles found in our search.…”

Section: Resultsmentioning

confidence: 99%

Meta‐analysis: Persistence of advanced therapies in the treatment of inflammatory bowel disease

Yiu,

Ko,

Pudipeddi

et al. 2024

Aliment Pharmacol Ther

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SummaryBackgroundThe expanding options in advanced therapies for ulcerative colitis (UC) and Crohn's disease (CD) present challenges in treatment selection. Persistence analysis assesses drug durability in real‐world settings, acting as a surrogate marker for medication efficacy and tolerance. Unlike traditional comparative studies, persistence analysis provides insights extending beyond the initial year of treatment.AimTo provide real‐world evidence on treatment effectiveness, tolerability and preferences of physicians and patients regarding various advanced therapies for IBD.MethodsWe conducted a systematic review of observational studies up to March 2023 assessing advanced therapies' persistence in UC and CD. Advanced therapies under examination included infliximab, adalimumab, vedolizumab, ustekinumab, golimumab, certolizumab and tofacitinib. We pooled the persistence of each agent and conducted a meta‐analysis to compare the persistence of newer agents with traditional TNF inhibitors (TNFi)—specifically infliximab and adalimumab.ResultsAmong 63 observational studies, vedolizumab had the highest 1‐year persistence in UC (73.8%, 95% CI: 70.0%–77.6%) and ustekinumab in CD (77.5%, 95% CI: 72.9%–82.1%). Compared to TNFi, vedolizumab demonstrated increased persistence with a relative risk (RR) of 1.30 (95% CI: 1.19–1.41) for UC and 1.14 (95% CI: 1.09–1.20) for CD at 1 year, while ustekinumab demonstrated a RR of 1.15 (95% CI: 1.07–1.23) for CD at 1 year. Vedolizumab exhibited sustained increased persistence in UC over 2 years compared to TNFi (RR: 1.33, 95% CI 1.14–1.54).ConclusionThis meta‐analysis highlights the superior persistence of ustekinumab and vedolizumab over TNFi, and offers valuable insights for clinicians navigating the challenging landscape of UC and CD therapeutic choices.

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Section: Resultsmentioning

confidence: 99%

Meta‐analysis: Persistence of advanced therapies in the treatment of inflammatory bowel disease

Yiu,

Ko,

Pudipeddi

et al. 2024

Aliment Pharmacol Ther

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“…Real-world data suggest VDL and UST to be equally safe and effective in young and elderly patients with CD who are biologics naïve 49 50. Taking account of the increased risk of infection on using anti-TNF drugs, especially when given along with concomitant IMMs,39 UST or VDL could be prescribed as first-line biological therapy, at least in frail patients with CD 49 50. However, it should be noted that comparative safety data between UST and VDL and anti-TNF drugs are still scarce.…”

Section: Resultsmentioning

confidence: 99%

“…In addition, an SLR also revealed that UST was an effective option for treating EIMs, especially dermatological and rheumatological manifestations 105. In frail patients with CD, VDL would be preferred by the experts,106 107 whereas UST could also be a reasonable option according to available data in this patient subgroup 49 50 108. Promising results have been reported on using UST in patients with CD and skin manifestations 109 110…”

Section: Resultsmentioning

confidence: 99%

Controversies in the management of anti-TNF therapy in patients with Crohn’s disease: a Delphi consensus

González-Lama,

Ricart,

Carpio

et al. 2024

BMJ Open Gastroenterol

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BackgroundDespite research, there are still controversial areas in the management of Crohn’s disease (CD).ObjectiveTo establish practical recommendations on using anti-tumour necrosis factor (TNF) drugs in patients with moderate-to-severe CD.MethodsClinical controversies in the management of CD using anti-TNF therapies were identified. A comprehensive literature review was performed, and a national survey was launched to examine current clinical practices when using anti-TNF therapies. Their results were discussed by expert gastroenterologists within a nominal group meeting, and a set of statements was proposed and tested in a Delphi process.ResultsQualitative study. The survey and Delphi process were sent to 244 CD-treating physicians (response rate: 58%). A total of 14 statements were generated. All but two achieved agreement. These statements cover: (1) use of first-line non-anti-TNF biological therapy; (2) role of HLA-DQA1*05 in daily practice; (3) attitudes in primary non-response and loss of response to anti-TNF therapy due to immunogenicity; (4) use of ustekinumab or vedolizumab if a change in action mechanism is warranted; (5) anti-TNF drug level monitoring; (6) combined therapy with an immunomodulator.ConclusionThis document sought to pull together the best evidence, experts’ opinions, and treating physicians’ attitudes when using anti-TNF therapies in patients with CD.

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“…These results are clearly different to ours, perhaps, because our population is bio-naïve. In another Spanish study from the ENEIDA registry by Casas-Deza et al 26 Safety is one of the main attributes of ustekinumab. In our study, only 10 adverse events were reported during follow-up, and only four of them led to treatment discontinuation.…”

Section: Discussionmentioning

confidence: 96%

“…These results are clearly different to ours, perhaps, because our population is bio-naïve. In another Spanish study from the ENEIDA registry by Casas-Deza et al 26 published in 2022 and including a considerable number of patients, the effectiveness and safety of ustekinumab were assessed in elderly (>60 years, n = 212) versus young (<60 years, n = 436) patients. Every elderly patient was matched with two young controls under 60 years of age, according to anti-TNF use and smoking habit; however, comorbidities and rate of complicated disease (structuring or fistulizing) were more common in elderly patients.…”

Section: Discussionmentioning

confidence: 99%

Effectiveness and safety of ustekinumab in bio-naïve Crohn’s disease patients: a multicentre observational retrospective study

Delgado

Rául

Iborra

et al. 2023

Therap Adv Gastroenterol

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Background: Clinical trials have demonstrated the efficacy and safety of ustekinumab in Crohn’s disease (CD). However, more data are necessary on the effectiveness of ustekinumab in bio-naïve patients in real-life studies. Objectives: The aim of our study was to evaluate the effectiveness and safety of ustekinumab in patients with CD refractory or intolerant to conventional therapy and without previous exposure to biological drugs. Design: We performed a nationwide, observational, retrospective, multicentre study including patients with CD, in which ustekinumab was used as the first biological drug. Methods: The corticosteroid-free clinical and biological response and remission were analysed at weeks 16, 24, 52 and 72. Clinical remission was defined as Harvey–Bradshaw index ⩽ 4 and biological remission as a faecal calprotectin (FC) <250 mg/g and C-reactive protein (CRP) <5 mg/L. Moreover, the persistence of the treatment and any adverse events were assessed. Results: In all, 84 patients were included in the study, males and females were equally distributed, with a median age of 63 years [interquartile range (IQR): 51–75] and a median disease duration of 6.8 years [IQR: 3.6–17.0]. The majority (86.9%) of patients were treated with ustekinumab as monotherapy, without concomitant immunosuppressive medication. The proportion of patients in corticosteroid-free clinical remission or response at weeks 16, 24, 52 and 72 was 93.3% (56/60), 86.8% (46/53), 82.2% (37/45) and 71.4% (30/42), respectively. CRP returned to normal values in 47.6%, 43.2%, 50% and 52.4% of patients at weeks 16, 24, 52 and 72, respectively. Similarly, FC was normalized in 45.5%, 45.5%, 48.6% and 50% of patients at weeks 16, 24, 52 and 72, respectively. The cumulative probability of remaining on ustekinumab treatment was 84.8% (95% confidence interval: 73.3–91.6) after 72 weeks. Ustekinumab was discontinued in 10 patients (11.9%) within 72 weeks of follow-up. Reasons for discontinuing treatment were lack of response ( n = 4), adverse events ( n = 4) and death ( n = 2). There were no discontinuations because of stable remission. Conclusions: Ustekinumab was effective and safe in Spanish bio-naïve CD patients, showing a quicker and more durable response than obtained in patients with previous biological treatment. In this cohort of bio-naïve patients starting on ustekinumab, the average age was high. Plain language summary Effectiveness and safety of ustekinumab in Crohn’s disease patients not previously exposed to other biological therapies Evidence on the use of ustekinumab in biological naïve real-world patients is scarce. Here, we present real-world data evaluating the effectiveness and safety of ustekinumab in 84 bio-naïve patients from 17 Spanish hospitals. We report high rates of both clinical and biological remission. Moreover, after 1 year, 90.4% of patients remained being treated with ustekinumab. The safety profile of ustekinumab in these patient population was favourable. In conclusion, our results show that in patients with CD, ustekinumab could be considered as first-line therapy.

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Effectiveness and Safety of Ustekinumab in Elderly Patients with Crohn’s Disease: Real World Evidence From the ENEIDA Registry

Cited by 25 publications

References 40 publications

Meta‐analysis: Persistence of advanced therapies in the treatment of inflammatory bowel disease

Meta‐analysis: Persistence of advanced therapies in the treatment of inflammatory bowel disease

Controversies in the management of anti-TNF therapy in patients with Crohn’s disease: a Delphi consensus

Effectiveness and safety of ustekinumab in bio-naïve Crohn’s disease patients: a multicentre observational retrospective study

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