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INTRODUCTION: Identifying novel treatment strategies for patients with ulcerative colitis (UC) and at risk of relapse is critical. The objective of this study was to assess the efficacy of beclomethasone dipropionate (BDP) in lowering fecal calprotectin (FC) levels in UC patients in clinical remission and at risk of relapse. METHODS: This multicenter study comprised a double-blind, randomized, placebo-controlled phase (part I) and an open-label, non-randomized phase (part II). Eligible participants with UC in clinical remission, treated with 5-aminosalicylic acid and with FC levels ≥250 µg/g were randomized to receive 5 mg/day of BDP or placebo for 4 weeks (part I). At week 5, patients with FC ≥100 µg/g were treated with 5 mg/day of BDP for 4 weeks (part II), and FC levels were tested at week 9. RESULTS: Forty-three patients were randomized: 22 received BDP (group A) and 21 placebo (group B). At week 4, 13 patients (59.1%) in group A and 3 (17.6%) in group B had FC levels <100 µg/g (p-value = 0.010). In the double-blind phase of the study, no patient relapsed in group A and 4 in group B (p-value = 0.049). Both treatment groups showed a favorable safety profile, with most common adverse events being gastrointestinal disorders. CONCLUSION: In this multicenter, randomized clinical trial including patients with UC in clinical remission but with elevated FC, BDP was efficacious in reducing FC and well-tolerated.
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The treatment of inflammatory bowel disease has undergone a significant transformation following the introduction of biologic drugs. Thanks to these drugs, treatment goals have evolved from clinical response and remission to more ambitious objectives, such as endoscopic or radiologic remission. However, even though biologics are highly effective, a significant percentage of patients will not achieve an initial response or may lose it over time. We know that there is a direct relationship between the trough concentrations of the biologic and its therapeutic efficacy, with more demanding therapeutic goals requiring higher drug levels, and inadequate exposure being common. Therapeutic drug monitoring of biologic medications, along with pharmacokinetic models, provides us with the possibility of offering a personalized approach to treatment for patients with IBD. Over the past few years, relevant information has accumulated regarding its utility during or after induction, as well as in the maintenance of biologic treatment, in reactive or proactive strategies, and prior to withdrawal or treatment de-escalation. The aim of this document is to establish recommendations regarding the utility of therapeutic drug monitoring of biologics in patients with inflammatory bowel disease, in different clinical practice scenarios, and to identify areas where its utility is evident, promising, or controversial.
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Produtos Biológicos , Colite Ulcerativa , Doença de Crohn , Monitoramento de Medicamentos , Humanos , Colite Ulcerativa/tratamento farmacológico , Doença de Crohn/tratamento farmacológico , Produtos Biológicos/uso terapêutico , Produtos Biológicos/farmacocinética , Doenças Inflamatórias Intestinais/tratamento farmacológicoRESUMO
BACKGROUND: Crohn's disease (CD) is characterized by the development of complications over the course of the disease. It is crucial to identify predictive factors of disabling disease, in order to target patients for early intervention. We evaluated risk factors of disabling CD and developed a prognostic model. METHODS: In total, 511 CD patients were retrospectively analyzed. Univariate and multivariate logistic regression analyses were used to identify demographic, clinical, and biological risk factors. A predictive nomogram model was developed in a subgroup of patients with noncomplicated CD (inflammatory pattern and no perianal disease). RESULTS: The rate of disabling CD within 5 years after diagnosis was 74.6%. Disabling disease was associated with gender, location of disease, requirement of steroids for the first flare, and perianal lesions. In the subgroup of patients (310) with noncomplicated CD, the rate of disabling CD was 80%. In the multivariate analysis age at onset <40 years (OR = 3.46, 95% confidence interval [CI] = 1.52-7.90), extensive disease (L3/L4) (OR = 2.67, 95% CI = 1.18-6.06), smoking habit (OR = 2.09, 95% CI = 1.03-4.27), requirement of steroids at the first flare (OR = 2.20, 95% CI = 1.09-4.45), and albumin (OR = 0.59, 95% CI = 0.36-0.96) were associated with development of disabling disease. The developed predictive nomogram based on these factors presented good discrimination, with an area under the receiver operating characteristic curve of 0.723 (95% CI: 0.670-0.830). CONCLUSION: We identified predictive factors of disabling CD and developed an easy-to-use prognostic model that may be used in clinical practice to help identify patients at high risk and address treatment effectively.
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Doença de Crohn , Humanos , Adulto , Doença de Crohn/diagnóstico , Doença de Crohn/epidemiologia , Doença de Crohn/complicações , Estudos Retrospectivos , Regras de Decisão Clínica , Fatores de Risco , Esteroides/uso terapêutico , Tomada de DecisõesRESUMO
We report the available evidence demonstrating the biosimilarity of ABP 501 (AMGEVITA®, adalimumab-atto) to its reference product (RP) (Humira®, adalimumab), and the rationale for the extrapolation of the results obtained with the RP in inflammatory bowel disease (IBD) to ABP 501. Based on its preclinical and clinical data, ABP 501 has been authorized for use in Europe in all the indications approved for the RP, including Crohn's disease and ulcerative colitis.
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Medicamentos Biossimilares , Colite Ulcerativa , Doença de Crohn , Doenças Inflamatórias Intestinais , Adalimumab/uso terapêutico , Medicamentos Biossimilares/uso terapêutico , Doença de Crohn/tratamento farmacológico , Humanos , Doenças Inflamatórias Intestinais/tratamento farmacológicoRESUMO
INTRODUCTION: there is a rising number of patients receiving antiplatelet and anticoagulation therapy who require endoscopic retrograde cholangiopancreatography (ERCP), probably due to the increased morbidity of older patients. Considering the increasing use of direct oral anticoagulants (DOACs), this study aimed to determine the influence of these factors on the possibility of hemorrhage after ERCP in our center. MATERIAL AND METHODS: data were collected from all the examinations carried out in 2017 and 2018, which included 797 examinations on 588 patients. Collected data included personal history of the patients, results of the test and follow-up. RESULTS: the percentage of post-ERCP bleeding was 4.6 % (n = 37). With regard to the severity, the bleeding was mild in 21.6 % (n = 8) of the cases, moderate in 59.5 % (n = 22) and severe in 18.9 % (n = 7). Previous cardiopathy antiplatelet therapy, anticoagulation therapy, treatment with DOACs, having a pancreatic stent and lithiasis removal doubled the risk of bleeding after ERCP. Having a sphincterotomy increased the risk by over five-fold. CONCLUSION: according to the multivariate analysis, a statistically significant increase of bleeding among patients treated with DOACs was observed compared to patients who received anticoagulation with acenocoumarol or low-molecular-weight heparins (LMWH).