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BACKGROUND: Ulcerative proctitis (UP) can have a milder, less aggressive course than left-sided colitis or extensive colitis. Therefore, immunosuppressants tend to be used less in patients with this condition. Evidence, however, is scarce because these patients are excluded from randomised controlled clinical trials. Our aim was to describe the characteristics of patients with refractory UP and their disease-related complications, and to identify the need for immunosuppressive therapies. METHODS: We identified patients with UP from the prospective ENEIDA registry sponsored by the GETECCU. We evaluated socio-demographic data and complications associated with immunosuppression. We defined immunosuppression as the use of immunomodulators, biologics and/or small molecules. We used logistic regression to identify factors associated with immunosuppressive therapy. RESULTS: From a total of 34,716 patients with ulcerative colitis, we identified 6281 (18.1%) with UP; mean ± SD age 53 ± 15 years, average disease duration of 12 ± 9 years. Immunosuppression was prescribed in 11% of patients, 4.2% needed one biologic agent and 1% needed two; 2% of patients required hospitalisation, and 0.5% underwent panproctocolectomy or subtotal colectomy. We identified 0.2% colorectal tumours and 5% extracolonic tumours. Patients with polyarthritis (OR 3.56, 95% CI 1.86-6.69; p < 0.001) required immunosuppressants. CONCLUSIONS: Among patients with refractory UP, 11% required immunosuppressant therapy, and 4.2% required at least one biologic agent.
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Colite Ulcerativa , Imunossupressores , Proctite , Sistema de Registros , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Adulto , Idoso , Proctite/tratamento farmacológico , Colite Ulcerativa/tratamento farmacológico , Imunossupressores/uso terapêutico , Estudos ProspectivosRESUMO
Crohn's disease is a chronic inflammatory disorder which involves mainly the gut. It poses a continuous challenge for health care due to the lack of effective medical therapies. Given the situation of this refractory disease, surgery is indicated. However, the optimal moment to perform it stills unknown. Data from 38 patients who underwent elective ileal resection because of Crohn's disease between years 2019 and 2022 were collected. Early postoperative morbimortality, ileostomy rates, postoperative complications rates and postoperative recurrence rates were retrieved.
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BACKGROUND: Both vedolizumab and ustekinumab are approved for the management of Crohn's disease [CD]. Data on which one would be the most beneficial option when anti-tumour necrosis factor [anti-TNF] agents fail are limited. AIMS: To compare the durability, effectiveness, and safety of vedolizumab and ustekinumab after anti-TNF failure or intolerance in CD. METHODS: CD patients from the ENEIDA registry who received vedolizumab or ustekinumab after anti-TNF failure or intolerance were included. Durability and effectiveness were evaluated in both the short and the long term. Effectiveness was defined according to the Harvey-Bradshaw index [HBI]. The safety profile was compared between the two treatments. The propensity score was calculated by the inverse probability weighting method to balance confounder factors. RESULTS: A total of 835 patients from 30 centres were included, 207 treated with vedolizumab and 628 with ustekinumab. Dose intensification was performed in 295 patients. Vedolizumab [vs ustekinumab] was associated with a higher risk of treatment discontinuation (hazard ratio [HR] 2.55, 95% confidence interval [CI]: 2.02-3.21), adjusted by corticosteroids at baseline [HR 1.27; 95% CI: 1.00-1.62], moderate-severe activity in HBI [HR 1.79; 95% CI: 1.20-2.48], and high levels of C-reactive protein at baseline [HR 1.06; 95% CI: 1.02-1.10]. The inverse probability weighting method confirmed these results. Clinical response, remission, and corticosteroid-free clinical remission were higher with ustekinumab than with vedolizumab. Both drugs had a low risk of adverse events with no differences between them. CONCLUSION: In CD patients who have failed anti-TNF agents, ustekinumab seems to be superior to vedolizumab in terms of durability and effectiveness in clinical practice. The safety profile is good and similar for both treatments.
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Anticorpos Monoclonais Humanizados , Doença de Crohn , Ustekinumab , Humanos , Ustekinumab/uso terapêutico , Doença de Crohn/tratamento farmacológico , Inibidores do Fator de Necrose Tumoral/uso terapêutico , Indução de Remissão , Fator de Necrose Tumoral alfa , Sistema de Registros , Resultado do Tratamento , Estudos RetrospectivosRESUMO
Crohn's disease is a chronic multifactorial disease for which therapeutic options have expanded in the last decades. However there are still patients who lack or lose response to current standard treatment strategies. A unicentric, retrospective, study was performed in order to evaluate the clinical and biochemical response to intravenous ustekinumab manteinance therapy (IVUMT) in patients with refractory CD. We included 12 patients from our centre who started IVUMT between September 2018 and November 2021. 75% started IV treatment after previous subcutaneous (SC) treatment. At week 8 (n=8), 63% had clinical response, with 25% in clinical remission. At week 16 (n=10), 60% had clinical response, with 50% in clinical remission. At week 26 (n=10), 90% had clinical response, with 60% in clinical remission. At week 52 (n=11), 91% had clinical response, with 64% in clinical remission (Fig. 2). Basal faecal calprotectin (FCP) median level was 684µg/g, with a significant reduction at 52 weeks, with median FCP 97µg/g (p=0,017). Basal C-reactive protein (CRP) median level was 11,6mg/L. A significant reduction was observed at week 26, with median CRP 2,8mg/L (p=0,008); and 52 weeks, with median CRP 2,7 (p=0,013). Average follow-up was 117,1 weeks, average treatment survival was 105,9 weeks. There were no severe adverse events. Our results suggest IVUMT is a safe and effective treatment for most patients with refractory and complex CD and should be considered as an option in selected patients.
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Doença de Crohn , Ustekinumab , Humanos , Ustekinumab/efeitos adversos , Doença de Crohn/metabolismo , Estudos Retrospectivos , Indução de Remissão , Administração Intravenosa , Resultado do TratamentoRESUMO
(1) Aims: To assess the incidence of inflammatory bowel disease (IBD) in Spain, to describe the main epidemiological and clinical characteristics at diagnosis and the evolution of the disease, and to explore the use of drug treatments. (2) Methods: Prospective, population-based nationwide registry. Adult patients diagnosed with IBD-Crohn's disease (CD), ulcerative colitis (UC) or IBD unclassified (IBD-U)-during 2017 in Spain were included and were followed-up for 1 year. (3) Results: We identified 3611 incident cases of IBD diagnosed during 2017 in 108 hospitals covering over 22 million inhabitants. The overall incidence (cases/100,000 person-years) was 16 for IBD, 7.5 for CD, 8 for UC, and 0.5 for IBD-U; 53% of patients were male and median age was 43 years (interquartile range = 31-56 years). During a median 12-month follow-up, 34% of patients were treated with systemic steroids, 25% with immunomodulators, 15% with biologics and 5.6% underwent surgery. The percentage of patients under these treatments was significantly higher in CD than UC and IBD-U. Use of systemic steroids and biologics was significantly higher in hospitals with high resources. In total, 28% of patients were hospitalized (35% CD and 22% UC patients, p < 0.01). (4) Conclusion: The incidence of IBD in Spain is rather high and similar to that reported in Northern Europe. IBD patients require substantial therapeutic resources, which are greater in CD and in hospitals with high resources, and much higher than previously reported. One third of patients are hospitalized in the first year after diagnosis and a relevant proportion undergo surgery.
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It has been demonstrated that ustekinumab (UST) is effective as an induction and maintenance therapy in patients with Crohn's disease (CD). However, a significant number of patients experience an insufficient response or a secondary non-response. We report six cases from our center that underwent a rescue treatment by changing maintenance treatment to weight-adjusted intravenous UST, obtaining a subsequent clinical improvement.
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Doença de Crohn , Ustekinumab , Administração Intravenosa , Doença de Crohn/tratamento farmacológico , Humanos , Quimioterapia de Indução , Indução de Remissão , Ustekinumab/uso terapêuticoRESUMO
Lymphomatoid granulomatosis is a rare lymphoproliferative disorder associated with immunosuppressive therapy in inflammatory bowel disease. We present the case of a patient with Crohn's disease and treated azathioprine that develops lymphomatoid granulomatosis, as well as its diagnostic process and the chosen treatment. Lymphomatoid granulomatosis is a serious disease barely described and whose suspicion is essential for its prognosis.