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  1. Article: ABP 501 (adalimumab-atto) in the treatment of inflammatory bowel disease: an example of evidence-based extrapolation.

    Muñoz Núñez, Fernando / Taxonera, Carlos / Marrón, Jordi

    Revista espanola de enfermedades digestivas : organo oficial de la Sociedad Espanola de Patologia Digestiva

    2021  Volume 113, Issue 10, Page(s) 737–738

    Abstract: 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 ... ...

    Abstract 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.
    MeSH term(s) Adalimumab/therapeutic use ; Biosimilar Pharmaceuticals/therapeutic use ; Colitis, Ulcerative ; Crohn Disease/drug therapy ; Humans ; Inflammatory Bowel Diseases/drug therapy
    Chemical Substances ABP 501 ; Biosimilar Pharmaceuticals ; Adalimumab (FYS6T7F842)
    Language English
    Publishing date 2021-02-06
    Publishing country Spain
    Document type Letter
    ZDB-ID 1070381-0
    ISSN 1130-0108 ; 0212-7512
    ISSN 1130-0108 ; 0212-7512
    DOI 10.17235/reed.2021.7921/2021
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: Therapeutic drug monitoring in inflammatory bowel diseases. Position statement of the Spanish Working Group on Crohn's Disease and Ulcerative Colitis.

    Rodríguez-Moranta, Francisco / Argüelles-Arias, Federico / Hinojosa Del Val, Joaquín / Iborra Colomino, Marisa / Martín-Arranz, M Dolores / Menchén Viso, Luis / Muñoz Núñez, Fernando / Ricart Gómez, Elena / Sánchez-Hernández, José Germán / Valdés-Delgado, Teresa / Guardiola Capón, Jordi / Barreiro-de Acosta, Manuel / Mañosa Ciria, Míriam / Zabana Abdo, Yamile / Gutiérrez Casbas, Ana

    Gastroenterologia y hepatologia

    2024  Volume 47, Issue 5, Page(s) 522–552

    Abstract: 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, ... ...

    Title translation Monitorización terapéutica de los fármacos biológicos en la enfermedad inflamatoria intestinal. Documento de Posicionamiento del Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU).
    Abstract 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.
    MeSH term(s) Humans ; Drug Monitoring ; Colitis, Ulcerative/drug therapy ; Crohn Disease/drug therapy ; Biological Products/therapeutic use ; Biological Products/pharmacokinetics ; Inflammatory Bowel Diseases/drug therapy
    Chemical Substances Biological Products
    Language Spanish
    Publishing date 2024-02-02
    Publishing country Spain
    Document type Journal Article ; Practice Guideline
    ZDB-ID 632502-6
    ISSN 0210-5705
    ISSN 0210-5705
    DOI 10.1016/j.gastrohep.2024.01.007
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article: Predictive factors for post-ERCP bleeding. Influence of direct oral anticoagulants.

    Parras Castañera, Ernesto / Rodríguez López, Pelayo / Álvarez, Alberto / Muñoz Núñez, Fernando / Geijo Martínez, Fernando / Velasco Guardado, Antonio

    Revista espanola de enfermedades digestivas : organo oficial de la Sociedad Espanola de Patologia Digestiva

    2020  Volume 113, Issue 8, Page(s) 591–596

    Abstract: 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 ... ...

    Abstract 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).
    MeSH term(s) Anticoagulants/adverse effects ; Cholangiopancreatography, Endoscopic Retrograde/adverse effects ; Hemorrhage ; Heparin, Low-Molecular-Weight ; Humans ; Retrospective Studies ; Risk Factors ; Stents
    Chemical Substances Anticoagulants ; Heparin, Low-Molecular-Weight
    Language English
    Publishing date 2020-12-28
    Publishing country Spain
    Document type Journal Article
    ZDB-ID 1070381-0
    ISSN 1130-0108 ; 0212-7512
    ISSN 1130-0108 ; 0212-7512
    DOI 10.17235/reed.2020.7547/2020
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: The Risk of Developing Disabling Crohn's Disease: Validation of a Clinical Prediction Rule to Improve Treatment Decision Making.

    Bastida Paz, Guillermo / Merino Ochoa, Olga / Aguas Peris, Mariam / Barreiro-de Acosta, Manuel / Zabana, Yamile / Ginard Vicens, Daniel / Ceballos Santos, Daniel / Muñoz Núñez, Fernando / Monfort I Miquel, David / Catalán-Serra, Ignacio / García Sánchez, Valle / Loras Alastruey, Carmen / Lucendo Villarín, Alfredo / Huguet, Jose Maria / de la Coba Ortiz, Cristóbal / Aldeguer Manté, Xavier / Palau Canós, Antonio / Domènech Morral, Eugeni / Nos, Pilar

    Digestive diseases (Basel, Switzerland)

    2023  Volume 41, Issue 6, Page(s) 879–889

    Abstract: 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 ... ...

    Abstract 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.
    MeSH term(s) Humans ; Adult ; Crohn Disease/diagnosis ; Crohn Disease/epidemiology ; Crohn Disease/complications ; Retrospective Studies ; Clinical Decision Rules ; Risk Factors ; Steroids/therapeutic use ; Decision Making
    Chemical Substances Steroids
    Language English
    Publishing date 2023-08-23
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 632798-9
    ISSN 1421-9875 ; 0257-2753
    ISSN (online) 1421-9875
    ISSN 0257-2753
    DOI 10.1159/000531789
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article: Pericarditis aguda secundaria al tratamiento con mesalazina.

    Sierra Ausín, Mónica / Rascarachi, Gabriela / Díez Rodríguez, Rubén / Arias Rodríguez, Laura / Del Pozo Maroto, Elvira / Muñoz Núñez, Fernando

    Gastroenterologia y hepatologia

    2010  Volume 33, Issue 4, Page(s) 338–339

    Title translation Mesalazine-induced acute pericarditis.
    MeSH term(s) Anti-Inflammatory Agents, Non-Steroidal/adverse effects ; Anti-Inflammatory Agents, Non-Steroidal/therapeutic use ; Chest Pain/etiology ; Colitis, Ulcerative/drug therapy ; Diagnosis, Differential ; Humans ; Male ; Mesalamine/adverse effects ; Mesalamine/therapeutic use ; Middle Aged ; Pericarditis/chemically induced ; Pericarditis/diagnosis ; Pericarditis/drug therapy ; Phytotherapy ; Plantago
    Chemical Substances Anti-Inflammatory Agents, Non-Steroidal ; Mesalamine (4Q81I59GXC)
    Language Spanish
    Publishing date 2010-04
    Publishing country Spain
    Document type Case Reports ; Letter
    ZDB-ID 632502-6
    ISSN 0210-5705
    ISSN 0210-5705
    DOI 10.1016/j.gastrohep.2009.10.006
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article: Uso del ustekinumab en la enfermedad inflamatoria intestinal: a propósito de tres casos.

    Pisabarros Blanco, Cristina / Alvarez Cuenllas, Begoña / Garcia Alvarado, Maria / Vaquero, Luis / del Pozo Maroto, Elvira / de Miguel, Aleida / Sierra Ausin, Mónica / Muñoz Nuñez, Fernando

    Gastroenterologia y hepatologia

    2012  Volume 35, Issue 6, Page(s) 451–452

    Title translation Use of ustekinumab in inflammatory bowel disease: apropos of three cases.
    MeSH term(s) Adult ; Antibodies, Monoclonal/administration & dosage ; Antibodies, Monoclonal/pharmacology ; Antibodies, Monoclonal/therapeutic use ; Antibodies, Monoclonal, Humanized ; Crohn Disease/drug therapy ; Drug Resistance ; Female ; Humans ; Immunosuppressive Agents/therapeutic use ; Interleukin-12 Subunit p40/antagonists & inhibitors ; Interleukin-12 Subunit p40/immunology ; Male ; Middle Aged ; Remission Induction ; Ustekinumab
    Chemical Substances Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; Immunosuppressive Agents ; Interleukin-12 Subunit p40 ; Ustekinumab (FU77B4U5Z0)
    Language Spanish
    Publishing date 2012-06
    Publishing country Spain
    Document type Case Reports ; Letter
    ZDB-ID 632502-6
    ISSN 0210-5705
    ISSN 0210-5705
    DOI 10.1016/j.gastrohep.2011.12.001
    Database MEDical Literature Analysis and Retrieval System OnLINE

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