463 results on '"Lakatos PL"'
Search Results
2. 3rd European Evidence-based Consensus on the Diagnosis and Management of Crohn's Disease 2016: Part 2: Surgical Management and Special Situations
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Gionchetti, P, Dignass, A, Danese, S, Dias, FJM, Rogler, G, Lakatos, PL, Adamina, M, Ardizzone, S, Buskens, CJ, Sebastian, S, Laureti, S, Sampietro, GM, Vucelic, B, van der Woude, C.J., Barreiro-de Acosta, M, Maaser, C, Portela, F, Vavricka, S R, Gomollon, F, Ecco, Gastroenterology & Hepatology, Gionchetti, Paolo, Dignass, Axel, Danese, Silvio, Magro Dias, Fernando José, Rogler, Gerhard, Lakatos, Péter Laszlo, Adamina, Michel, Ardizzone, Sandro, Buskens, Christianne J, Sebastian, Shaji, Laureti, Silvio, Sampietro, Gianluca M, Vucelic, Bori, van der Woude, C Janneke, Barreiro-de Acosta, Manuel, Maaser, Christian, Portela, Francisco, Vavricka, Stephan R, Gomollón, Fernando, University of Zurich, Gionchetti, P, Dignass, A, Danese, S, Dias, Fjm, Rogler, G, Lakatos, Pl, Adamina, M, Ardizzone, S, Buskens, Cj, Sebastian, S, Laureti, S, Sampietro, Gm, Vucelic, B, van der Woude, Cj, Barreiro-de Acosta, M, Maaser, C, Portela, F, Vavricka, Sr, Gomollon, F, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, and Surgery
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Budesonide ,Crohn’s disease ,medicine.medical_specialty ,Evidence-based practice ,budesonide ,immunosuppressant ,610 Medicine & health ,Disease ,Biologics ,Investigations ,Management of Crohn's disease ,Gastroenterology ,Anti-integrins ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,thiopurine ,Diagnosis ,medicine ,2715 Gastroenterology ,Colitis ,Intensive care medicine ,Anti-TNFs ,Immunosuppressant ,Crohn's disease ,Thiopurine ,Thiopurine methyltransferase ,biology ,investigation ,treatment ,business.industry ,steroid ,General Medicine ,anti-TNF ,medicine.disease ,Treatment ,diagnosi ,10219 Clinic for Gastroenterology and Hepatology ,anti-integrin ,030220 oncology & carcinogenesis ,biology.protein ,Steroids ,030211 gastroenterology & hepatology ,business ,biologic ,medicine.drug - Abstract
This paper is the second in a series of two publications relating to the European Crohn’s and Colitis Organisation [ECCO] evidence-based consensus on the diagnosis and management of Crohn’s disease [CD] and concerns the surgical management of CD as well as special situations including management of perianal CD and extraintestinal manifestations. Diagnostic approaches and medical management of CD of this ECCO Consensus are covered in the first paper [Gomollon et al. JCC 2016].
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- 2017
3. PRM185 - COMPARISON OF THE MEASUREMENT PROPERTIES OF THE EQ-5D-5L AND EQ-5D-3L IN PATIENTS WITH CROHN’S DISEASE
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Rencz, F, primary, Brodszky, V, additional, Gulácsi, L, additional, Palatka, K, additional, Lakatos, PL, additional, Herszényi, L, additional, Banai, J, additional, and Péntek, M, additional
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- 2018
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4. Development of Red Flags for Early Referral of Adults With Symptoms and Signs Suggestive of Crohn's Disease: An IOIBD Initiative
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Danese S, Fiorino G, Peyrin-Biroulet L, Lakatos PL, Mary JY, D'Haens GR, Moja L, D'Hoore A, Panes J, Reinisch W, Sandborn W, Travis S, Vermeire S, Colombel JF, Danese, S, Fiorino, G, Peyrin-Biroulet, L, Lakatos, Pl, Mary, Jy, D'Haens, Gr, Moja, L, D'Hoore, A, Panes, J, Reinisch, W, Sandborn, W, Travis, S, Vermeire, S, and Colombel, Jf
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- 2014
5. Dose Optimization Is Effective in Patients With Ulcerative Colitis Losing Response to Infliximab: A Collaborative Multicentre Retrospective Study
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Cesarini M, Katsanos K, Ellul P, Lakatos PL, Papamichael K, Caprioli F, Tsianos EV, Mantzaris GJ, Danese S, Fiorino G, Cesarini, M, Katsanos, K, Ellul, P, Lakatos, Pl, Papamichael, K, Caprioli, F, Tsianos, Ev, Mantzaris, Gj, Danese, S, and Fiorino, G
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- 2013
6. Discontinuation of Infliximab in Patients With Ulcerative Colitis Is Associated With Increased Risk of Relapse: A Multinational Retrospective Cohort Study
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Fiorino, G, Cortes, Pn, Ellul, P, Felice, C, Karatzas, P, Silva, M, Lakatos, Pl, Bossa, F, Ungar, B, Sebastian, S, Furfaro, F, Karmiris, K, Katsanos, Kh, Muscat, M, Christodoulou, Dk, Maconi, G, Kopylov, U, Magro, F, Mantzaris, Gj, Armuzzi, Alessandro, Boscà Watts, Mm, Ben Horin, S, Bonovas, S, Danese, S., Armuzzi, Alessandro (ORCID:0000-0003-1572-0118), Fiorino, G, Cortes, Pn, Ellul, P, Felice, C, Karatzas, P, Silva, M, Lakatos, Pl, Bossa, F, Ungar, B, Sebastian, S, Furfaro, F, Karmiris, K, Katsanos, Kh, Muscat, M, Christodoulou, Dk, Maconi, G, Kopylov, U, Magro, F, Mantzaris, Gj, Armuzzi, Alessandro, Boscà Watts, Mm, Ben Horin, S, Bonovas, S, Danese, S., and Armuzzi, Alessandro (ORCID:0000-0003-1572-0118)
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BACKGROUND & AIMS: Infliximab is a safe and effective therapy for ulcerative colitis (UC). We conducted a multicenter retrospective cohort study that included 7 European countries and Israel to examine whether infliximab discontinuation can be considered for patients who achieve sustained remission. METHODS: We performed a retrospective cohort study, collecting medical records from 13 tertiary care referral inflammatory bowel disease centers of all patients with UC treated with infliximab (n = 193). We compared the disease course of patients with at least 12 months of clinical remission who discontinued infliximab (n = 111) with that of patients who continued scheduled treatment (controls, n = 82). We examined the incidence rates of relapse, hospitalization and colectomy, the comparative effectiveness of different therapeutic strategies after discontinuation, and assessed the rates of response, remission, and adverse effects after infliximab re-initiation. Statistical analyses used time-to-event methods. RESULTS: In the entire cohort, 67 patients (34.7%) relapsed during the follow-up period. The incidence rate of relapse was significantly higher after discontinuation (23.3 per 100 person-years) compared with the control group (7.2 per 100 person-years) in univariable analysis (log-rank P < .001; hazard ratio, 3.41; 95% confidence interval, 1.88-6.20) and multivariable analysis (hazard ratio, 3.70; 95% confidence interval, 2.02-6.77). Rates of hospitalization and colectomy did not differ between groups. Thiopurines appeared to be the best treatment option after infliximab discontinuation (incidence of relapse: 15.0 per 100 person-years for thiopurines, 27.4 per 100 person-years for thiopurines plus aminosalicylates, and 31.2 per 100 person-years for aminosalicylates alone; log-rank P = .032). Response was regained in 77.1% of patients and remission in 51.4% of patients who re-initiated infliximab. However, 17.1% had infusion reactions and 17.1% reported other adverse
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- 2016
7. PTU-072 Discontinuation of Infliximab in Patients with Ulcerative Colitis is Associated with Increased Risk of Relapse: A Multinational Retrospective Cohort Study
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Fiorino, G, primary, Cortes, PN, additional, Ellul, P, additional, Felice, C, additional, Karatzas, P, additional, Silva, M, additional, Lakatos, PL, additional, Bossa, F, additional, Sebastian, S, additional, Ungar, B, additional, Furfaro, F, additional, Karmiris, K, additional, Katsanos, KH, additional, Muscat, M, additional, Christodoulou, D, additional, Maconi, G, additional, Kopylov, U, additional, Magro, F, additional, Mantzaris, GJ, additional, Armuzzi, A, additional, Boscà-Watts, MM, additional, Ben-Horin, S, additional, Bonovas, S, additional, and Danese, S, additional
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- 2016
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8. The efficacy of shortening the dosing interval to once every six weeks in Crohn's patients losing response to maintenance dose of infliximab
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Kopylov, U, Mantzaris, Gj, Katsanos, Kh, Reenaers, C, Ellul, P, Rahier, Jf, Israeli, E, Lakatos, Pl, Fiorino, Gionata, Cesarini, M, Tsianos, Ev, Louis, E, and Ben Horin, S.
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Adult ,Male ,Young Adult ,Time Factors ,Treatment Outcome ,Dose-Response Relationship, Drug ,Gastrointestinal Agents/*administration & dosage ,Statistics as Topic ,Crohn Disease/*drug therapy ,Antibodies, Monoclonal/*administration & dosage ,Humans ,Female ,Retrospective Studies - Abstract
BACKGROUND: Patients treated with infliximab for Crohn's disease (CD) frequently require intensified dosage due to loss of response. There are scant data regarding the efficacy of shortening the dosing interval to 6 weeks. AIM: We sought to investigate the efficacy of a once every 6 weeks' strategy compared with dose-doubling. METHODS: This work was a multicentre retrospective study of infliximab-treated CD patients who required dose escalation. The clinical outcome of patients treated by intensification to 5 mg/kg/6 weeks (6-week group) was compared with the outcome of patients whose infliximab was double-dosed (10 mg/kg/8 weeks or 5 mg/kg/4 weeks). RESULTS: Ninety-four patients (mean age: 29.8 years) were included in the study, 55 (59%) in the 6-week group and 39 (41%) in the double-dose group. Demographics and disease characteristics were similar between the two groups, although patients with re-emerging symptoms 5-7 weeks postinfusion were more likely to receive 5 mg/kg/6 weeks dosing (OR: 3.4, 95% CI: 1.4-8.8, P < 0.01). Early response to dose-intensification occurred in 69% of patients in the 6-week group and 67% in the double-dose group (P = N.S.). Regained response was maintained for 12 months in 40% compared with 29% of the patients respectively (P = N.S.). CONCLUSION: In CD patients who lost response to standard infliximab dose, especially when symptoms re-emerge 5-7 weeks postinfusion, shortening the dosing interval to 6 weeks appears to be at least as effective as doubling the dose to 10 mg/kg or halving the infusion intervals to once in 4 weeks. Aliment Pharmacol Ther
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- 2011
9. The ATP-binding cassette transporter ABCG2 (BCRP) and ABCB1 (MDR1) variants are not associated with disease susceptibility and disease phenotype in Hungarian patients with inflammatory bowel diseases
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Fischer, S, primary, Lakatos, L, additional, Kovacs, A, additional, Molnar, T, additional, Altorjay, I, additional, Papp, M, additional, Tulassay, Z, additional, Osztovits, J, additional, Demeter, P, additional, Tordai, A, additional, Andrikovics, H, additional, Papp, J, additional, and Lakatos, PL, additional
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- 2007
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10. Double-balloon enteroscopy for the diagnosis and treatment of obscure bleeding, inflammatory bowel diseases and polyposis syndromes: we see more but do we know more?
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Lakatos, PL, primary, Fuszek, P, additional, Horvath, H, additional, Zubek, L, additional, and Papp, J, additional
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- 2007
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11. Common NOD2/CARD15 variants are not associated with susceptibility or clinicopathologic characteristics of sporadic colorectal cancer in Hungarian patients
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Gemela, O, primary, Hitre, E, additional, Szalay, F, additional, Zinober, K, additional, Fuszek, P, additional, Horvath, H, additional, Lakatos, L, additional, Fischer, S, additional, Osztovits, J, additional, Papp, J, additional, Ferenci, P, additional, and Lakatos, PL, additional
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- 2007
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12. NOD1 gene E266K (G796A) polymorphism is associated with disease susceptibility but not with disease phenotype or NOD2/CARD15 in Hungarian patients with Crohn's disease
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Molnár, T, primary, Hofner, P, additional, Nagy, F, additional, Lakatos, PL, additional, Fischer, S, additional, Lakatos, L, additional, Kovács, Á, additional, Altorjay, I, additional, Palatka, K, additional, Demeter, P, additional, Tulassay, Z, additional, Miheller, P, additional, Papp, J, additional, Mándi, Y, additional, and Lonovics, J, additional
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- 2007
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13. Changes of OPG and RANKL concentrations in Crohn's disease after infliximab therapy
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Miheller, P, primary, Műzes, G, additional, Rácz, K, additional, Blázovits, A, additional, Lakatos, PL, additional, Herszényi, L, additional, and Tulassay, Z, additional
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- 2007
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14. Impairment of cardiovagal autonomic function in patients with chronic hepatitis C
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Osztovits, J, primary, Horváth, T, additional, Visnyei, Z, additional, Csák, T, additional, Lakatos, PL, additional, Ibrányi, E, additional, Tóth, T, additional, Abonyi, M, additional, Bekő, G, additional, Kempler, P, additional, Kollai, M, additional, and Szalay, F, additional
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- 2007
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15. Detection of antineutrophil cytoplasmic antibodies in patients with inflammatory bowel diseases
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Tumpek, J, primary, Papp, M, additional, Lakatos, PL, additional, Lakos, G, additional, Shums, Z, additional, Sipka, S, additional, Altorjay, I, additional, and Norman, G, additional
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- 2007
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16. Relationships between autonomic function and 24-hour blood pressure profile in patients with primary biliary cirrhosis
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Keresztes, K, primary, Istenes, I, additional, Folhoffer, A, additional, Lakatos, PL, additional, Vargha, P, additional, Szalay, F, additional, and Kempler, P, additional
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- 2006
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17. Is there a change in the incidence and prevalence of inflammatory bowel diseases in eastern Europe?
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Lakatos, L, primary and Lakatos, PL, additional
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- 2006
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18. Double-balloon endoscopy for the diagnosis and treatment of small intestinal disease: initial experience in 21 patients
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Papp, J, primary, Fuszek, P, additional, Horvath, H, additional, and Lakatos, PL, additional
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- 2006
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19. The ATP-binding cassette transporter ABCG2 (BCRP) V12M and Q141K variants in Hungarian patients with IBD
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Fuszek, P, primary, Fischer, S, additional, Lakatos, PL, additional, Lakatos, L, additional, Kovacs, A, additional, Molnár, T, additional, Altorjay, I, additional, Papp, M, additional, Szilvás, Á, additional, Demeter, P, additional, Papp, J, additional, Schwab, R, additional, Tordai, A, additional, and Andrikovics, H, additional
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- 2006
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20. Anti-cholesterol antibody levels in chronic hepatitis c. high titers in patients with genotype 3 and 4, but not in genotype 1B
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Szalay, F, primary, Csak, T, additional, Biro, A, additional, Scherzer, T, additional, Folhoffer, A, additional, Horvath, A, additional, Osztovits, J, additional, Lakatos, PL, additional, Karádi, I, additional, Füst, G, additional, and Ferenci, P, additional
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- 2006
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21. DLG5 R30Q is not associated with IBD in Hungarian patients, but predicts clinical response to steroids in Crohn's disease
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Lakatos, PL, primary, Fischer, S, additional, Claes, K, additional, Lakatos, L, additional, Kovacs, A, additional, Molnár, T, additional, Altorjay, I, additional, Demeter, P, additional, Palatka, K, additional, Papp, M, additional, Tulassay, Z, additional, Szalay, F, additional, Vermeire, S, additional, and Papp, J, additional
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- 2006
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22. Mucocele of the appendix: An unusual cause of lower abdominal pain in a patient with ulcerative colitis. A case report
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Győri, G, primary, Fuszek, P, additional, Jaray, B, additional, Halasz, J, additional, Schaff, Z, additional, Lukovich, P, additional, Abonyi, M, additional, and Lakatos, PL, additional
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- 2004
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23. Common NOD2/CARD15 alleles and other EXON4 mutations in 527 hungarian patients with Crohn's disease: Genotype-phenotype associations
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Lakatos, L, primary, Lakatos, PL, additional, Szalay, F, additional, Willheim-Polli, C, additional, Tulassay, Z, additional, Molnar, T, additional, Reinisch, W, additional, Österreicher, C, additional, and Papp, J, additional
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- 2004
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24. Nociceptin in experimentally induced hepatocellular carcinoma
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Horváth, A, primary, Folhoffer, A, additional, Csák, T, additional, Zalatnai, A, additional, Hantos, M, additional, Tekes, K, additional, Lakatos, PL, additional, and Szalay, F, additional
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- 2004
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25. Adie's syndrome and mesenterial lymphangioma in a patient with celiac disease and autoimmune hepatitis
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Csák, T, primary, Folhoffer, A, additional, Horvath, A, additional, Szeli, D, additional, Lakatos, PL, additional, and Szalay, F, additional
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- 2004
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26. Serum leptin levels in patients with primary biliary cirrhosis
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Szalay, F, primary, Folhoffer, A, additional, Horvath, A, additional, Csak, T, additional, Tornai, I, additional, Habior, A, additional, Speer, G, additional, Nagy, Z, additional, Lakatos, P, additional, and Lakatos, PL, additional
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- 2004
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27. Neurofibromatosis, cutan melanoma and hyper-thyroidism in a HCV positive patient treated with interferon
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Folhoffer, A, primary, Horváth, A, additional, Csák, T, additional, Lakatos, PL, additional, and Szalay, F, additional
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- 2004
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28. NOD2/CARD15 SNP8, 12 and 13 and other EXON4 mutations and primary biliary cirrhosis (PBC) in Hungarian and Polish patients
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Lakatos, PL, primary, Willheim-Polli, C, additional, Folhoffer, A, additional, Horvath, A, additional, Csák, T, additional, Österreicher, C, additional, Habior, A, additional, Tornai, I, additional, Ferenci, P, additional, and Szalay, F, additional
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- 2004
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29. Early azathioprine/biological therapy is associated with decreased risk for first surgery and delays time to surgery but not reoperation in both smokers and nonsmokers with Crohn's disease, while smoking decreases the risk of colectomy in ulcerative colitis.
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Szamosi T, Banai J, Lakatos L, Czegledi Z, David G, Zsigmond F, Pandur T, Erdelyi Z, Gemela O, Papp M, Papp J, and Lakatos PL
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- 2010
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30. Anticarbohydrate antibodies as markers of inflammatory bowel disease in a Central European cohort.
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Malickova K, Lakatos PL, Bortlik M, Komarek V, Janatkova I, and Lukas M
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- 2010
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31. Novel mutations of the ATP7B gene among 109 Hungarian patients with Wilson's disease.
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Folhoffer A, Ferenci P, Csak T, Horvath A, Hegedus D, Firneisz G, Osztovits J, Kosa JP, Willheim-Polli C, Szonyi L, Abonyi M, Lakatos PL, Szalay F, Folhoffer, Aniko, Ferenci, Peter, Csak, Timea, Horvath, Andrea, Hegedus, Dalma, Firneisz, Gabor, and Osztovits, Janos
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- 2007
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32. Serum leptin, soluble leptin receptor, free leptin index and bone mineral density in patients with primary biliary cirrhosis.
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Szalay F, Folhoffer A, Horváth A, Csak T, Speer G, Nagy Z, Lakatos P, Horváth C, Habior A, Tornai I, Lakatos PL, Szalay, Ferenc, Folhoffer, Aniko, Horváth, Andrea, Csak, Timea, Speer, Gabor, Nagy, Zsolt, Lakatos, Peter, Horváth, Csaba, and Habior, Andrzej
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- 2005
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33. Effects of the lactase 13910 C/T and calcium-sensor receptor A986S G/T gene polymorphisms on the incidence and recurrence of colorectal cancer in Hungarian population.
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Bácsi K, Hitre E, Kósa JP, Horváth H, Lazáry A, Lakatos PL, Balla B, Budai B, Lakatos P, and Speer G
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Epidemiological studies suggested the chemopreventive role of higher calcium intake in colorectal carcinogenesis. We examined genetic polymorphisms that might influence calcium metabolism: lactase (LCT) gene 13910 C/T polymorphism causing lactose intolerance and calcium-sensing receptor (CaSR) gene A986S polymorphism as a responsible factor for the altered cellular calcium sensation.~Background~Background~538 Hungarian subjects were studied: 278 patients with colorectal cancer and 260 healthy controls. Median follow-up was 17 months. After genotyping, the relationship between LCT 13910 C/T and CaSR A986S polymorphisms as well as tumor incidence/progression was investigated.~Methods~Methods~in patient with colorectal cancer, a significantly higher LCT CC frequency was associated with increased distant disease recurrence (OR = 4.04; 95% CI = 1.71-9.58; p = 0.006). The disease free survival calculated from distant recurrence was reduced for those with LCT CC genotype (log rank test p = 0.008). In case of CaSR A986S polymorphism, the homozygous SS genotype was more frequent in patients than in controls (OR = 4.01; 95% CI = 1.33-12.07; p = 0.014). The number of LCT C and CaSR S risk alleles were correlated with tumor incidence (p = 0.035). The CCSS genotype combination was found only in patients with CRC (p = 0.033).~Results~Results~LCT 13910 C/T and CaSR A986S polymorphisms may have an impact on the progression and/or incidence of CRC.~Conclusion~Conclusions [ABSTRACT FROM AUTHOR]
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- 2008
34. Biosimilars for the management of inflammatory bowel diseases
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Fanni Rencz, Silvio Danese, László Gulácsi, Laurent Peyrin-Biroulet, Krisztina Gecse, Peter L. Lakatos, Petra Baji, Valentin Brodszky, Zsuzsanna Vegh, Márta Péntek, Gulacsi, L, Pentek, M, Rencz, F, Brodszky, V, Baji, P, Vegh, Z, Gecse, Kb, Danese, S, Peyrin-Biroulet, L, Lakatos, Pl, Gastroenterology and Hepatology, and AGEM - Digestive immunity
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Crohn’s disease ,medicine.medical_specialty ,Health Knowledge, Attitudes, Practice ,Cost effectiveness ,Cost-Benefit Analysis ,Alternative medicine ,Access to health services ,Disease ,Pharmacology ,Inflammatory bowel diseases ,Biochemistry ,03 medical and health sciences ,0302 clinical medicine ,Drug Discovery ,medicine ,Humans ,Economics, Pharmaceutical ,Intensive care medicine ,Biosimilar Pharmaceuticals ,health care economics and organizations ,Biosimilars ,Crohn's disease ,business.industry ,030503 health policy & services ,Organic Chemistry ,Anti-Inflammatory Agents, Non-Steroidal ,Biosimilar ,Healthcare costs ,medicine.disease ,Ulcerative colitis ,digestive system diseases ,Infliximab ,Budget impact ,Incentive ,Molecular Medicine ,030211 gastroenterology & hepatology ,Cost-effectiveness ,0305 other medical science ,business ,medicine.drug - Abstract
Biological drugs revolutionized the treatment of inflammatory bowel diseases (IBD) such as Crohn’s disease and ulcerative colitis. However, not all clinically eligible patients have access to biologicals due to significant costs and budget impact. Biosimilars are highly comparable to their originator product in terms of clinical efficacy and safety. Biosimilars are priced 15-75% lower than their reference product, which makes them a less costly alternative and is expected to offer better patients access to biologicals. The total projected cost savings are significant. If the achieved budget savings were used to cover more biological therapy, several additional IBD patients could be treated. Currently, the main barriers to the increasing uptake of biosimilars are the few incentives of the key stakeholders, while physicians’ and patients’ skepticism towards biosimilars seems to be changing. Over the coming years, biosimilars are expected to gain a growing importance in the treatment of IBD, contributing to a better access to treatment, improving population-level health gain and sustainability of health systems. This review summarizes the results of the literature on the economic considerations of biosimilars in IBD and the role of biosimilar infliximab in the treatment of IBD.
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- 2019
35. The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases
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Souzi Makri, Steven Simoens, Ben Parker, JongHyuk Lee, Laurent Peyrin-Biroulet, Jonas Halfvarson, Kay Greveson, Jørgen Jahnsen, Rieke Alten, Rene Westhovens, Peter L. Lakatos, Silvio Danese, Fernando Gomollón, Stefan Schreiber, Peter M. Irving, HoUng Kim, Ji Hoon Jeong, Luisa Avedano, Axel Dignass, Schlosspark Klinik Berlin, Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], Department of Gastroenterology, Hepatology, Oncology and Metabolic Diseases, Agaplesion Markus Krankenhaus = Agaplesion Markus Hospital [Frankfurt], Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd), Liver Unit, Clínica Universitaria, CIBER-EHD, Dept of Medicine, Div of Gastroenterology, Örebro University Hospital [Örebro, Sweden], Gastroenterology, Guy's and St Thomas' Hospital [London], Semmelweis University [Budapest], University of Manchester [Manchester], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Department for Internal Medicine I, Universitätsklinikum Schleswig-Holstein, Université Catholique de Louvain = Catholic University of Louvain (UCL), Humanitas University [Milan] (Hunimed), Celltrion Healthcare Co., Ltd provided funding for medical writing support for this article, Kim, H, Alten, R, Avedano, L, Dignass, A, Gomollon, F, Greveson, K, Halfvarson, J, Irving, Pm, Jahnsen, J, Lakatos, Pl, Lee, J, Makri, S, Parker, B, Peyrin-Biroulet, L, Schreiber, S, Simoens, S, Westhovens, R, Danese, S, and Jeong, Jh
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EARLY BIOLOGIC TREATMENT ,media_common.quotation_subject ,Supply chain ,[SDV]Life Sciences [q-bio] ,PEDIATRIC CROHNS-DISEASE ,NECROSIS FACTOR THERAPY ,Leading Article ,Toxicology ,ECONOMIC-IMPACT ,CT-P13 INDUCTION THERAPY ,03 medical and health sciences ,0302 clinical medicine ,EVIDENCE-BASED CONSENSUS ,Pharmacovigilance ,Medicine ,Pharmacology (medical) ,Quality (business) ,ddc:610 ,Pharmacology & Pharmacy ,BOWEL-DISEASE ,Reimbursement ,media_common ,Science & Technology ,Market competition ,business.industry ,Information sharing ,RHEUMATOID-ARTHRITIS PATIENTS ,Biosimilar ,[SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology ,medicine.disease ,3. Good health ,ULCERATIVE-COLITIS ,Risk analysis (engineering) ,[SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system ,030220 oncology & carcinogenesis ,Immune-mediated inflammatory diseases ,CLINICAL-PRACTICE GUIDELINES ,business ,Life Sciences & Biomedicine ,030217 neurology & neurosurgery ,[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology - Abstract
Biologics have transformed the treatment of immune-mediated inflammatory diseases such as rheumatoid arthritis (RA) and inflammatory bowel disease (IBD). Biosimilars—biologic medicines with no clinically meaningful differences in safety or efficacy from licensed originators—can stimulate market competition and have the potential to expand patient access to biologics within the parameters of treatment recommendations. However, maximizing the benefits of biosimilars requires cooperation between multiple stakeholders. Regulators and developers should collaborate to ensure biosimilars reach patients rapidly without compromising stringent quality, safety, or efficacy standards. Pharmacoeconomic evaluations and payer policies should be updated following biosimilar market entry, minimizing the risk of imposing nonmedical barriers to biologic treatment. In RA, disparities between treatment guidelines and national reimbursement criteria could be addressed to ensure more uniform patient access to biologics and enable rheumatologists to effectively implement treat-to-target strategies. In IBD, the cost-effectiveness of biologic treatment earlier in the disease course is likely to improve when biosimilars are incorporated into pharmacoeconomic analyses. Patient understanding of biosimilars is crucial for treatment success and avoiding nocebo effects. Full understanding of biosimilars by physicians and carefully considered communication strategies can help support patients initiating or switching to biosimilars. Developers must operate efficiently to be sustainable, without undermining product quality, the reliability of the supply chain, or pharmacovigilance. Developers should also facilitate information sharing to meet the needs of other stakeholders. Such collaboration will help to ensure a sustainable future for both the biosimilar market and healthcare systems, supporting the availability of effective treatments for patients. Electronic supplementary material The online version of this article (10.1007/s40265-020-01256-5) contains supplementary material, which is available to authorized users.
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- 2020
36. Aortic Stiffening Is an Extraintestinal Manifestation of Inflammatory Bowel Disease: Review of the Literature and Expert Panel Statement
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Luca Zanoli, Konstantinos H. Katsanos, Ioannis E. Koutroubakis, Pierre Boutouyrie, Peter L. Lakatos, Dimitri P. Mikhailidis, Stephan R. Vavricka, Julien Kirchgesner, Rosa Maria Bruno, Geoffrey C. Nguyen, Silvio Danese, Ian B. Wilkinson, Alfredo Papa, Maria T. Abreu, Rami Eliakim, Paolo Gionchetti, Torsten Kucharzik, Zanoli, Luca, Mikhailidis, Dimitri P, Bruno, Rosa Maria, Abreu, Maria T, Danese, Silvio, Eliakim, Rami, Gionchetti, Paolo, Katsanos, Konstantinos H, Kirchgesner, Julien, Koutroubakis, Ioannis E, Kucharzik, Torsten, Lakatos, Peter L, Nguyen, Geoffrey C, Papa, Alfredo, Vavricka, Stephan R, Wilkinson, Ian B, Boutouyrie, Pierre, and Zanoli L, Mikhailidis DP, Bruno RM, Abreu MT, Danese S, Eliakim R, Gionchetti P, Katsanos KH, Kirchgesner J, Koutroubakis IE, Kucharzik T, Lakatos PL, Nguyen GC, Papa A, Vavricka SR, Wilkinson IB, Boutouyrie P.
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medicine.medical_specialty ,pulse wave velocity ,Anti-Inflammatory Agents ,030204 cardiovascular system & hematology ,Systemic inflammation ,Gastroenterology ,Inflammatory bowel disease ,arterial stiffness ,biomarkers ,extraintestinal manifestation ,inflammation ,inflammatory bowel disease ,03 medical and health sciences ,0302 clinical medicine ,Vascular Stiffness ,Risk Factors ,arterial stiffne ,Internal medicine ,medicine ,Animals ,Humans ,Endothelial dysfunction ,Risk factor ,Pulse wave velocity ,business.industry ,medicine.disease ,Inflammatory Bowel Diseases ,digestive system diseases ,Treatment Outcome ,Cardiovascular Diseases ,Arterial stiffness ,biomarker ,Biomarker (medicine) ,030211 gastroenterology & hepatology ,Aortic stiffness ,Tumor Necrosis Factor Inhibitors ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business ,Immunosuppressive Agents - Abstract
Current guidelines state that systemic inflammation, together with endothelial dysfunction, calcification, and hypercoagulability, predispose to premature atherosclerosis in patients with inflammatory bowel disease (IBD). We assessed whether IBD can affect aortic stiffness, a well-recognized vascular biomarker and an independent risk factor for cardiovascular (CV) disease (CVD) in several populations. Recent studies reported that aortic stiffness is increased in adults with IBD compared with matched controls. This association is dependent on inflammatory burden and disease duration, and is reduced by antitumor necrosis factor therapy. Considered together, current findings suggest that increased aortic stiffness is an extraintestinal manifestation of IBD. This is clinically relevant since measuring aortic stiffness in patients with IBD could improve risk assessment, especially in those without established CVD. Moreover, effective control of inflammation could lower CV risk in patients with IBD by reducing aortic stiffness. Further longitudinal studies are needed to better clarify (i) the relationship between disease duration and irreversible changes of the arterial wall, (ii) the clinical characteristics of patients with IBD that have an increased arterial stiffness at least in part reversible, and (iii) whether arterial stiffness is useful to evaluate the efficacy of immunosuppressive therapy.
- Published
- 2020
37. Antigenic response to CT-P13 and infliximab originator in inflammatory bowel disease patients shows similar epitope recognition
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Gionata Fiorino, Myrna Serapião dos Santos, John J. Carey, Fernando Magro, D. Trabuco, G. D'Haens, Isabel Ferreira Barbosa, C. Lima Vieira, Thomas Dörner, L Correia, J. Galvao, J. Eurico Fonseca, Marco Cavaco, Ana Barbas, P Matos de Brito, Peter L. Lakatos, M. Cardoso, Rita C. Acúrcio, Luís F. Gouveia, Armando Alcobia, Miri Yavzori, Silvio Danese, Isabel Rosa, J. Delgado Alves, A. Catarina Cunha-Santos, Inês Iria, Carolina Palmela, A. Strik, João Paulo N. Torres, Shomron Ben-Horin, João Gonçalves, F. Aires da Silva, Goncalves, J, Santos, M, Acurcio, R, Iria, I, Gouveia, L, Brito, Pm, Cunha-Santos, Ac, Barbas, A, Galvao, J, Barbosa, I, da Silva, Fa, Alcobia, A, Cavaco, M, Cardoso, M, Alves, Jd, Carey, Jj, Dorner, T, Fonseca, Je, Palmela, C, Torres, J, Vieira, Cl, Trabuco, D, Fiorino, G, Strik, A, Yavzori, M, Rosa, I, Correia, L, Magro, F, D'Haens, G, Ben-Horin, S, Lakatos, Pl, and Danese, S
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musculoskeletal diseases ,0301 basic medicine ,congenital, hereditary, and neonatal diseases and abnormalities ,Antigenicity ,medicine.drug_class ,Enzyme-Linked Immunosorbent Assay ,Cross Reactions ,Monoclonal antibody ,Inflammatory bowel disease ,Epitope ,Epitopes ,03 medical and health sciences ,0302 clinical medicine ,Antigen ,Peptide Library ,immune system diseases ,Humans ,Medicine ,Pharmacology (medical) ,skin and connective tissue diseases ,Biosimilar Pharmaceuticals ,Hepatology ,biology ,business.industry ,Gastroenterology ,Antibodies, Monoclonal ,Inflammatory Bowel Diseases ,medicine.disease ,Infliximab ,stomatognathic diseases ,030104 developmental biology ,Case-Control Studies ,Immunoglobulin G ,Immunology ,biology.protein ,030211 gastroenterology & hepatology ,Tumor necrosis factor alpha ,Antibody ,business ,medicine.drug - Abstract
AIM To test the cross-immunogenicity of anti-CT-P13 IBD patients' sera to CT-P13/infliximab originator and the comparative antigenicity evoked by CT-P13/infliximab originator sera. METHODS Sera of patients with IBD with measurable anti-CT-P13 antibodies were tested for their cross-reactivity to 5 batches of infliximab originator and CT-P13. Anti-drug antibody positive sera from treated patients were used to compare antigenic epitopes. RESULTS All 42 anti-CT-P13 and 37 anti-infliximab originator IBD sera were cross-reactive with infliximab originator and CT-P13 respectively. Concentration of anti-drug antibodies against infliximab originator or CT-P13 were strongly correlated both for IgG1 and IgG4 (P
- Published
- 2018
38. Cost‐effectiveness of biological treatment sequences for fistulising Crohn’s disease across Europe
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Fanni Rencz, Petra Baji, László Gulácsi, Peter M. Irving, Laurent Peyrin-Biroulet, Valentin Brodszky, Zsuzsanna Vegh, Silvio Danese, Peter L. Lakatos, Márta Péntek, Stefan Schreiber, Baji, P, Gulacsi, L, Brodszky, V, Vegh, Z, Danese, S, Irving, Pm, Peyrin-Biroulet, L, Schreiber, S, Rencz, F, Lakatos, Pl, and Pentek, M
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Actuarial science ,business.industry ,Cost effectiveness ,Gastroenterology ,MEDLINE ,Time horizon ,Biosimilar ,Original Articles ,Markov model ,Infliximab ,Quality-adjusted life year ,Vedolizumab ,03 medical and health sciences ,0302 clinical medicine ,Oncology ,030220 oncology & carcinogenesis ,medicine ,030211 gastroenterology & hepatology ,business ,medicine.drug - Abstract
In clinical practice, treatment sequences of biologicals are applied for active fistulising Crohn's disease, however underlying health economic analyses are lacking.The purpose of this study was to analyse the cost-effectiveness of different biological sequences including infliximab, biosimilar-infliximab, adalimumab and vedolizumab in nine European countries.A Markov model was developed to compare treatment sequences of one, two and three biologicals from the payer's perspective on a five-year time horizon. Data on effectiveness and health state utilities were obtained from the literature. Country-specific costs were considered. Calculations were performed with both official list prices and estimated real prices of biologicals.Biosimilar-infliximab is the most cost-effective treatment against standard care across the countries (with list prices: €34684-€72551/quality adjusted life year; with estimated real prices: €24364-€56086/quality adjusted life year). The most cost-effective two-agent sequence, except for Germany, is the biosimilar-infliximab-adalimumab therapy compared with single biosimilar-infliximab (with list prices: €58533-€133831/quality adjusted life year; with estimated prices: €45513-€105875/quality adjusted life year). The cost-effectiveness of the biosimilar-infliximab-adalimumab-vedolizumab three-agent sequence compared wit biosimilar-infliximab -adalimumab is €87214-€152901/quality adjusted life year.The suggested first-choice biological treatment is biosimilar-infliximab. In case of treatment failure, switching to adalimumab then to vedolizumab provides meaningful additional health gains but at increased costs. Inter-country differences in cost-effectiveness are remarkable due to significant differences in costs.
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- 2018
39. ECCO Position Statement on the Use of Biosimilars for Inflammatory Bowel Disease—An Update
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Gionata Fiorino, Jaroslaw Kierkus, Marc Ferrante, Silvio Danese, Julián Panés, Peter L. Lakatos, Laurent Peyrin-Biroulet, Tim Raine, Janneke van der Woude, Karen Kemp, Gerassimos J. Mantzaris, Danese, S, Fiorino, G, Raine, T, Ferrante, M, Kemp, K, Kierkus, J, Lakatos, Pl, Mantzaris, G, van der Woude, J, Panes, J, Peyrin-Biroulet, L, and Gastroenterology & Hepatology
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medicine.medical_specialty ,Pathology ,Inflammatory bowel disease ,law.invention ,03 medical and health sciences ,Psoriatic arthritis ,0302 clinical medicine ,Gastrointestinal Agents ,Randomized controlled trial ,law ,Psoriasis ,Humans ,Medicine ,Intensive care medicine ,Biosimilar Pharmaceuticals ,Drug Substitution ,business.industry ,Gastroenterology ,Biosimilar ,General Medicine ,Inflammatory Bowel Diseases ,medicine.disease ,Ulcerative colitis ,Infliximab ,Treatment Outcome ,030220 oncology & carcinogenesis ,030211 gastroenterology & hepatology ,business ,medicine.drug ,Cohort study - Abstract
Biosimilars of infliximab were first approved by the European Medicine Agency in 2013,1 , 2 based on pre-clinical studies on biosimilarity and on clinical data coming from two randomised controlled trials conducted in rheumatoid arthritis [RA] and ankylosing spondylitis [AS].3 , 4 Initially the European Crohn’s Colitis Organisation [ECCO] raised some caution on the use of biosimilars.5 This cautious approach was also supported by several national inflammatory bowel disease [IBD] societies5–12 [Table 1]. An insufficient understanding of the characteristics and use of biosimilars became evident in a web survey among ECCO members in the same period.13 View this table: Table 1. Available society guidelines. Since biosimilars were introduced in the EU market in early 2015, more data from IBD patients14–19 have supported the biosimilarity of biosimilar infliximab CT-P13 and the reference product, with no significant differences in terms of efficacy or safety, in either naive or switched patients in cohort studies. Importantly, a study showed clear cross-reactivity between the infliximab originator and CT-P13.20 Recently, a large nationwide Norwegian randomised controlled trial [NOR-SWITCH] on patients with immune-mediated diseases [Crohn’s disease; ulcerative colitis; psoriasis; psoriatic arthritis; RA and AS] found no differences in terms of clinical response, maintenance of remission, or adverse events in patients receiving CT-P13 compared with those receiving originator infliximab.21 Consideration of these findings22 together with a better understanding of the process of biosimilar development and regulatory approval, have contributed to a change in the perception of IBD experts, who now prescribe biosimilars with significantly more confidence.23 A task-force including Governing Board representatives and one representative from pertinent ECCO Committees performed a literature search and made relevant statements to summarise their shared position. The proposed statements were then discussed, agreed and approved in a Consensus meeting. The licensing of any biosimilar medication …
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- 2016
40. Unmet Medical Needs in Ulcerative Colitis: An Expert Group Consensus
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Matthieu Allez, Silvio Danese, Severine Vermeire, Ailsa Hart, Stephan R. Vavricka, Javier P. Gisbert, Stefan Schreiber, Ad A. van Bodegraven, Fernando Magro, Laurent Peyrin-Biroulet, Jonas Halfvarson, Peter L. Lakatos, Iris Dotan, Dino Tarabar, Danese, S, Allez, M, van Bodegraven, Aa, Dotan, I, Gisbert, Jp, Hart, A, Lakatos, Pl, Magro, F, Peyrin-Biroulet, L, Schreiber, S, Tarabar, D, Vavricka, S, Halfvarson, J, Vermeire, S, University of Zurich, and Vermeire, Séverine
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medicine.medical_specialty ,MAINTENANCE THERAPY ,Consensus ,Delphi method ,610 Medicine & health ,Disease ,Cochrane Library ,DECISION-MAKING ,Unmet needs ,03 medical and health sciences ,0302 clinical medicine ,NECROSIS FACTOR-ALPHA ,QUALITY-OF-LIFE ,Surveys and Questionnaires ,Medicine ,Humans ,In patient ,2715 Gastroenterology ,Practice Patterns, Physicians' ,Health Services Needs and Demand ,Science & Technology ,Gastroenterology & Hepatology ,Consensus panel ,business.industry ,Systematic literature review ,Gastroenterology ,CLINICAL-RESPONSE ,General Medicine ,ANTI-TNF THERAPY ,medicine.disease ,Expert group ,Ulcerative colitis ,CROHNS-DISEASE ,COMBINATION THERAPY ,Systematic review ,10219 Clinic for Gastroenterology and Hepatology ,030220 oncology & carcinogenesis ,Family medicine ,RISK-FACTORS ,030211 gastroenterology & hepatology ,Delphi process ,Colitis, Ulcerative ,business ,Life Sciences & Biomedicine ,INFLAMMATORY-BOWEL-DISEASE - Abstract
Background: The authors aimed to conduct an extensive literature review and consensus meeting to identify unmet needs in ulcerative colitis (UC) and ways to overcome them. UC is a relapsing and remitting inflammatory bowel disease with varied, and changing, incidence rates worldwide. UC has an unpredictable disease course and is associated with a high health economic burden. During 2016 and 2017, a panel of experts was convened to identify, discuss and address areas of unmet need in UC. Methods: PubMed and Cochrane Library databases were searched for relevant articles describing studies performed in patients with UC. These findings were used to generate a set of statements relating to unmet needs in UC. Consensus on these statements was then sought from a panel of 9 expert gastroenterologists using a modified Delphi review process that consisted of anonymous surveys followed by live meetings. Results: In 2 literature reviews, over 5,000 unique records were identified and a total of 138 articles were fully reviewed. These were used to consider 26 areas of unmet need, which were explored in 2 face-to-face meetings, in which the statements were debated and amended, resulting in consensus on 30 final statements. The unmet needs identified were categorised into 7 areas: impact of UC on patients’ daily life; importance of early diagnosis and treatment; drawbacks of existing treatments; urgent need for new treatments; and disease-, practice- or patient-focused unmet needs. Conclusions: These expert group meetings found a number of areas of unmet needs in UC, which is an important first step in tackling them in the future. Future research and development should be focused in these areas for the management of patients with UC.
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- 2019
41. Development of an index to define overall disease severity in IBD
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Richard B. Gearry, Julián Panés, Remo Panaccione, Gerassimos J. Mantzaris, Curt Tysk, Charles N. Bernstein, Stefan Schreiber, Anne M. Griffiths, Edward V. Loftus, Siew C. Ng, Ioannis E. Koutroubakis, Cynthia B. Whitman, Simon Travis, Mark S. Silverberg, Laurent Peyrin-Biroulet, Brian G. Feagan, William J. Sandborn, Gerhard Rogler, Bruce E. Sands, Silvio Danese, Geert R. D'Haens, Balfour R. Sartor, Jean-Frederic Colombel, Stephen B. Hanauer, Corey A. Siegel, Francesco Pallone, Walter Reinisch, Jonas Halfvarson, Dermot P.B. McGovern, Bjørn Moum, Peter L. Lakatos, Colm O'Morain, Brennan Spiegel, Robert H. Riddell, Christoph Gasche, Wolfgang Kruis, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Gastroenterology and Hepatology, Siegel, Ca, Whitman, Cb, Spiegel, Bmr, Feagan, B, Sands, B, Loftus, Ev, Panaccione, R, D'Haens, G, Bernstein, Cn, Gearry, R, Ng, Sc, Mantzaris, Gj, Sartor, B, Silverberg, M, Riddell, R, Koutroubakis, Ie, O'Morain, C, Lakatos, Pl, Mcgovern, Dpb, Halfvarson, J, Reinisch, W, Rogler, G, Kruis, W, Tysk, C, Schreiber, S, Danese, S, Sandborn, W, Griffiths, A, Moum, B, Gasche, C, Pallone, F, Travis, S, Panes, J, Colombel, Jf, Hanauer, S, and Peyrin-Biroulet, L
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Adult ,Male ,medicine.medical_specialty ,Abdominal Abscess ,Activities of daily living ,Delphi Technique ,Disease ,Severity of Illness Index ,03 medical and health sciences ,0302 clinical medicine ,Crohn Disease ,Disease severity ,Internal medicine ,Activities of Daily Living ,Intestinal Fistula ,Humans ,Medicine ,In patient ,Intestinal Mucosa ,Abscess ,Aged ,Biological Products ,Crohn's disease ,biology ,business.industry ,C-reactive protein ,Gastroenterology ,Middle Aged ,medicine.disease ,Ulcerative colitis ,Surgery ,C-Reactive Protein ,030220 oncology & carcinogenesis ,biology.protein ,Colitis, Ulcerative ,Female ,030211 gastroenterology & hepatology ,Symptom Assessment ,business - Abstract
Background and aimDisease activity for Crohn's disease (CD) and UC is typically defined based on symptoms at a moment in time, and ignores the long-term burden of disease. The aims of this study were to select the attributes determining overall disease severity, to rank the importance of and to score these individual attributes for both CD and UC.MethodsUsing a modified Delphi panel, 14 members of the International Organization for the Study of Inflammatory Bowel Diseases (IOIBD) selected the most important attributes related to IBD. Eighteen IOIBD members then completed a statistical exercise (conjoint analysis) to create a relative ranking of these attributes. Adjusted utilities were developed by creating proportions for each level within an attribute.ResultsFor CD, 15.8% of overall disease severity was attributed to the presence of mucosal lesions, 10.9% to history of a fistula, 9.7% to history of abscess and 7.4% to history of intestinal resection. For UC, 18.1% of overall disease severity was attributed to mucosal lesions, followed by 14.0% for impact on daily activities, 11.2% C reactive protein and 10.1% for prior experience with biologics. Overall disease severity indices were created on a 100-point scale by applying each attribute's average importance to the adjusted utilities.ConclusionsBased on specialist opinion, overall CD severity was associated more with intestinal damage, in contrast to overall UC disease severity, which was more dependent on symptoms and impact on daily life. Once validated, disease severity indices may provide a useful tool for consistent assessment of overall disease severity in patients with IBD.
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- 2016
42. Editorial: antigenic response to CT-P13 and infliximab originator in IBD shows similar epitope recognition-evidence from basic science supports safe switching to biosimilars. Authors’ reply
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Fernando Magro, Silvio Danese, Shomron Ben-Horin, Peter L. Lakatos, João Gonçalves, Goncalves, J, Magro, F, Danese, S, Lakatos, Pl, and Ben-Horin, S
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Hepatology ,Basic science ,business.industry ,Gastroenterology ,Antibodies, Monoclonal ,Biosimilar ,Computational biology ,Inflammatory Bowel Diseases ,Infliximab ,Epitope ,Epitopes ,03 medical and health sciences ,0302 clinical medicine ,Antigen ,030220 oncology & carcinogenesis ,medicine ,Humans ,030211 gastroenterology & hepatology ,Pharmacology (medical) ,business ,Biosimilar Pharmaceuticals ,medicine.drug - Published
- 2018
43. The management of iron deficiency in inflammatory bowel disease – an online tool developed by the RAND/UCLA appropriateness method
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O. Haagen Nielsen, Milan Lukas, Gerassimos J. Mantzaris, Axel Dignass, Yehuda Chowers, Peter L. Lakatos, Silvio Danese, H. Stoevelaar, Bjørn Moum, Murat Törüner, Pierre Michetti, Günter Weiss, Fernando Gomollón, Walter Reinisch, Stefan Lindgren, J. van der Woude, Laurent Peyrin-Biroulet, Charlie W. Lees, Department Internal Medicine III [Medizinische Universität Wien], Medizinische Universität Wien = Medical University of Vienna, Rambam Health Care Campus, Department of Gastroenterology [Humanitas Research Hospital], Humanitas Research Hospital, Department of Gastroenterology, Oncology, Infectious Diseases and Metabolism [Agaplesion Markus Hospital], Agaplesion Markus Krankenhaus = Agaplesion Markus Hospital [Frankfurt], Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd), Liver Unit, Clínica Universitaria, CIBER-EHD, Herlev and Gentofte Hospital, Semmelweis University [Budapest], Western General Hospital, Edinburgh, Skane University Hospital [Lund], Charles University in Prague, First Faculty of Medicine, Department of Gastroenterology [Evangelismos Athens General Hospital], Evangelismos Athens General Hospital, Division of Gastroenterology and Hepatology [CHU Vaudois], Centre Hospitalier Universitaire Vaudois [Lausanne] (CHUV), Oslo University Hospital [Oslo], Nutrition-Génétique et Exposition aux Risques Environnementaux (NGERE), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Service d'Hépato-gastro-entérologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Ankara University School of Medicine [Turkey], Erasmus University Medical Center [Rotterdam] (Erasmus MC), Department of Internal Medicine III (Dep Med Int - INNSBRUCK), Innsbruck Medical University [Austria] (IMU), Ismar Healthcare NV, Charles University [Prague] (CU), Innsbruck Medical University = Medizinische Universität Innsbruck (IMU), UL, NGERE, Reinisch, W, Chowers, Y, Danese, S, Dignass, A, Gomollon, F, Nielsen, Oh, Lakatos, Pl, Lees, Cw, Lindgren, S, Lukas, M, Mantzaris, Gj, Michetti, P, Moum, B, Peyrin-Biroulet, L, Toruner, M, van der Woude, J, Weiss, G, and Stoevelaar, H
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medicine.medical_specialty ,Blood transfusion ,Anemia ,[SDV]Life Sciences [q-bio] ,medicine.medical_treatment ,Iron ,Alternative medicine ,MEDLINE ,Inflammatory bowel disease ,03 medical and health sciences ,0302 clinical medicine ,Pharmacotherapy ,Internal medicine ,medicine ,Humans ,Pharmacology (medical) ,Blood Transfusion ,Hematinic ,Practice Patterns, Physicians' ,Internet ,Hepatology ,Anemia, Iron-Deficiency ,Dose-Response Relationship, Drug ,business.industry ,Gastroenterology ,Iron deficiency ,Iron Deficiencies ,medicine.disease ,Decision Support Systems, Clinical ,Inflammatory Bowel Diseases ,3. Good health ,Surgery ,[SDV] Life Sciences [q-bio] ,030220 oncology & carcinogenesis ,Practice Guidelines as Topic ,Hematinics ,030211 gastroenterology & hepatology ,Administration, Intravenous ,Drug Therapy, Combination ,Iron Deficiency Anaemia and Ibd ,business - Abstract
BackgroundIron deficiency is a common and undertreated problem in inflammatory bowel disease (IBD).AimTo develop an online tool to support treatment choice at the patient-specific level.MethodsUsing the RAND/UCLA Appropriateness Method (RUAM), a European expert panel assessed the appropriateness of treatment regimens for a variety of clinical scenarios in patients with non-anaemic iron deficiency (NAID) and iron deficiency anaemia (IDA). Treatment options included adjustment of IBD medication only, oral iron supplementation, high-/low-dose intravenous (IV) regimens, IV iron plus erythropoietin-stimulating agent (ESA), and blood transfusion. The panel process consisted of two individual rating rounds (1148 treatment indications; 9-point scale) and three plenary discussion meetings.ResultsThe panel reached agreement on 71% of treatment indications. ‘No treatment’ was never considered appropriate, and repeat treatment after previous failure was generally discouraged. For 98% of scenarios, at least one treatment was appropriate. Adjustment of IBD medication was deemed appropriate in all patients with active disease. Use of oral iron was mainly considered an option in NAID and mildly anaemic patients without disease activity. IV regimens were often judged appropriate, with high-dose IV iron being the preferred option in 77% of IDA scenarios. Blood transfusion and IV+ESA were indicated in exceptional cases only.ConclusionsThe RUAM revealed high agreement amongst experts on the management of iron deficiency in patients with IBD. High-dose IV iron was more often considered appropriate than other options. To facilitate dissemination of the recommendations, panel outcomes were embedded in an online tool, accessible via http://ferroscope.com/.
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- 2013
44. Development of Red Flags Index for Early Referral of Adults with Symptoms and Signs Suggestive of Crohn’s Disease: An IOIBD Initiative
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Severine Vermeire, Gionata Fiorino, Jean Yves Mary, Simon Travis, Laurent Peyrin-Biroulet, Jean-Frederic Colombel, André D'Hoore, Silvio Danese, Geert R. D'Haens, Julián Panés, Walter Reinisch, Lorenzo Moja, William J. Sandborn, Peter L. Lakatos, Gastroenterology, Istituto Clinico Humanitas [Milan] (IRCCS Milan), Humanitas University [Milan] (Hunimed)-Humanitas University [Milan] (Hunimed), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC), Semmelweis University [Budapest], Academic Medical Center - Academisch Medisch Centrum [Amsterdam] (AMC), University of Amsterdam [Amsterdam] (UvA), Istituto Ortopedico Galeazzi-IRCCS, Abdominal Surgery and Radiology University Hospital Leuven, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona (UB), Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd), Liver Unit, Clínica Universitaria, CIBER-EHD, Medizinische Universität Wien = Medical University of Vienna, University of California [San Diego] (UC San Diego), University of California, John Radcliffe Hospital [Oxford University Hospital], Division of Gastroenterology [University Hospitals Leuven], University Hospitals Leuven [Leuven], Nutrition-Génétique et Exposition aux Risques Environnementaux (NGERE), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Service d'Hépato-gastro-entérologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Icahn Medical Institute-Mount Sinai School of Medicine, Department of Gene and Cell Medicine and Institute for Immunology, Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Gastroenterology and Hepatology, Danese, S, Fiorino, G, Mary, Jy, Lakatos, Pl, D'Haens, G, Moja, L, D'Hoore, A, Panes, J, Reinisch, W, Sandborn, Wj, Travis, Sp, Vermeire, S, Peyrin-Biroulet, L, and Colombel, Jf
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Adult ,Crohn’s disease ,Pediatrics ,medicine.medical_specialty ,Delayed Diagnosis ,Multivariate analysis ,Red Flags ,[SDV]Life Sciences [q-bio] ,Disease ,Logistic regression ,Risk Assessment ,Sensitivity and Specificity ,Decision Support Techniques ,Crohn Disease ,Surveys and Questionnaires ,Health Status Indicators ,Humans ,Medicine ,Referral and Consultation ,Irritable bowel syndrome ,Crohn's disease ,Receiver operating characteristic ,business.industry ,Gastroenterology ,General Medicine ,Odds ratio ,medicine.disease ,diagnostic delay ,Confidence interval ,3. Good health ,Cross-Sectional Studies ,Early Diagnosis ,business - Abstract
International audience; BACKGROUND AND AIMS:Diagnostic delay is frequent in patients with Crohn's disease (CD). We developed a tool to predict early diagnosis.METHODS:A systematic literature review and 12 CD specialists identified 'Red Flags', i.e. symptoms or signs suggestive of CD. A 21-item questionnaire was administered to 36 healthy subjects, 80 patients with irritable bowel syndrome (non-CD group) and 85 patients with recently diagnosed (
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- 2015
45. Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE): Determining Therapeutic Goals for Treat-to-Target
- Author
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Mark S. Silverberg, Mark A Samaan, Silvio Danese, Marla Dubinsky, G. Van Assche, Jaap Stoker, Iris Dotan, Sarah O’Donnell, Robert H. Riddell, Laurent Peyrin-Biroulet, Travis B. Murdoch, Brian G. Feagan, P. Marteau, Stephen B. Hanauer, Edward V. Loftus, Stefan Schreiber, Benjamin Pariente, David T. Rubin, S. Winer, Bruce E. Sands, Robert V Bryant, G R D’Haens, J.-F. Colombel, Simon Travis, S. Krishnareddy, Peter L. Lakatos, Walter Reinisch, Willem A. Bemelman, Gionata Fiorino, Richard B. Gearry, William J. Sandborn, Pia Munkholm, Guillaume Bouguen, Ingrid Ordás, J. Ruel, Julián Panés, Corey A. Siegel, Remo Panaccione, Nutrition-Génétique et Exposition aux Risques Environnementaux (NGERE), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Clinic of Internal Medicine IV, Department of Gastroenterology and Hepathology, Universität Wien, AP-HP, Hôpital Lariboisière, Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Foie, métabolismes et cancer, Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Service des Maladies de l'Appareil Digestif [CHU Rennes], CHU Pontchaillou [Rennes], Hôpital Claude Huriez [Lille], CHU Lille, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Service des Maladies de l'Appareil Digestif, Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-CHU Pontchaillou [Rennes], AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Surgery, Gastroenterology and Hepatology, Other departments, CCA -Cancer Center Amsterdam, Radiology and Nuclear Medicine, Peyrin-Biroulet, L, Sandborn, W, Sands, Be, Reinisch, W, Bemelman, W, Bryant, Rv, D'Haens, G, Dotan, I, Dubinsky, M, Feagan, B, Fiorino, G, Gearry, R, Krishnareddy, S, Lakatos, Pl, Loftus, Ev, Marteau, P, Munkholm, P, Murdoch, Tb, Ordas, I, Panaccione, R, Riddell, Rh, Ruel, J, Rubin, Dt, Samaan, M, Siegel, Ca, Silverberg, M, Stoker, J, Schreiber, S, Travis, S, Van Assche, G, Danese, S, Panes, J, Bouguen, G, O'Donnell, S, Pariente, B, Winer, S, Hanauer, S, and Colombel, Jf
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medicine.medical_specialty ,Abdominal pain ,[SDV]Life Sciences [q-bio] ,Disease ,Inflammatory bowel disease ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,Humans ,Prospective cohort study ,Hepatology ,business.industry ,Remission Induction ,Gastroenterology ,Disease Management ,medicine.disease ,Inflammatory Bowel Diseases ,Ulcerative colitis ,3. Good health ,Diarrhea ,030220 oncology & carcinogenesis ,Practice Guidelines as Topic ,Physical therapy ,Biomarker (medicine) ,030211 gastroenterology & hepatology ,medicine.symptom ,Calprotectin ,business - Abstract
International audience; OBJECTIVES: The Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) program was initiated by the International Organization for the Study of Inflammatory Bowel Diseases (IOIBD). It examined potential treatment targets for inflammatory bowel disease (IBD) to be used for a "treat-to-target" clinical management strategy using an evidence-based expert consensus process. METHODS: A Steering Committee of 28 IBD specialists developed recommendations based on a systematic literature review and expert opinion. Consensus was gained if ≥75% of participants scored the recommendation as 7-10 on a 10-point rating scale (where 10=agree completely). RESULTS: The group agreed upon 12 recommendations for ulcerative colitis (UC) and Crohn's disease (CD). The agreed target for UC was clinical/patient-reported outcome (PRO) remission (defined as resolution of rectal bleeding and diarrhea/altered bowel habit) and endoscopic remission (defined as a Mayo endoscopic subscore of 0-1). Histological remission was considered as an adjunctive goal. Clinical/PRO remission was also agreed upon as a target for CD and defined as resolution of abdominal pain and diarrhea/altered bowel habit; and endoscopic remission, defined as resolution of ulceration at ileocolonoscopy, or resolution of findings of inflammation on cross-sectional imaging in patients who cannot be adequately assessed with ileocolonoscopy. Biomarker remission (normal C-reactive protein (CRP) and calprotectin) was considered as an adjunctive target. CONCLUSIONS: Evidence- and consensus-based recommendations for selecting the goals for treat-to-target strategies in patients with IBD are made available. Prospective studies are needed to determine how these targets will change disease course and patients' quality of life.Am J Gastroenterol advance online publication, 25 August 2015; doi:10.1038/ajg.2015.233
- Published
- 2014
46. Letter: European Medicines Agency recommendations for allergic reactions to intravenous iron-containing medicines
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Axel Dignass, O. Haagen Nielsen, Milan Lukas, Günter Weiss, H. Stoevelaar, Bjørn Moum, Laurent Peyrin-Biroulet, Gerassimos J. Mantzaris, Silvio Danese, Yehuda Chowers, Peter L. Lakatos, Murat Törüner, Pierre Michetti, Fernando Gomollón, Walter Reinisch, Stefan Lindgren, J. van der Woude, Charlie W. Lees, Gomollon, F, Chowers, Y, Danese, S, Dignass, A, Nielsen, Oh, Lakatos, Pl, Lees, Cw, Lindgren, S, Lukas, M, Mantzaris, Gj, Michetti, P, Moum, B, Peyrin-Biroulet, L, Toruner, M, van der Woude, J, Weiss, G, Stoevelaar, H, Reinisch, W, Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd), Liver Unit, Clínica Universitaria, CIBER-EHD, Rambam Health Care Campus, Istituto Clinico Humanitas [Milan] (IRCCS Milan), Humanitas University [Milan] (Hunimed), Agaplesion Markus Krankenhaus = Agaplesion Markus Hospital [Frankfurt], Herlev and Gentofte Hospital, Semmelweis University [Budapest], Western General Hospital, Edinburgh, Skane University Hospital [Lund], Charles University in Prague, First Faculty of Medicine, ISCARE, Evangelismos Athens General Hospital, Centre Hospitalier Universitaire Vaudois [Lausanne] (CHUV), Oslo University Hospital [Oslo], Nutrition-Génétique et Exposition aux Risques Environnementaux (NGERE), Université de Lorraine (UL)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Ankara University School of Medicine [Turkey], Erasmus University Medical Center [Rotterdam] (Erasmus MC), Clinical Immunology and Infectious Diseases [IMU], Innsbruck Medical University [Austria] (IMU), Ismar Healthcare NV, Department Internal Medicine III [Medizinische Universität Wien], Medizinische Universität Wien = Medical University of Vienna, and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL)
- Subjects
medicine.medical_specialty ,[SDV]Life Sciences [q-bio] ,Iron ,Intravenous iron ,Federal Government ,Drug Hypersensitivity ,Irritable Bowel Syndrome ,03 medical and health sciences ,0302 clinical medicine ,Health care ,Agency (sociology) ,medicine ,Humans ,Pharmacology (medical) ,University medical ,General hospital ,Erasmus+ ,ComputingMilieux_MISCELLANEOUS ,Hepatology ,Traditional medicine ,Anemia, Iron-Deficiency ,business.industry ,Gastroenterology ,University hospital ,3. Good health ,Europe ,030220 oncology & carcinogenesis ,Family medicine ,030211 gastroenterology & hepatology ,Administration, Intravenous ,business ,Research center - Abstract
*CIBEREHD, Hospital Cl inico Universitario Lozano Blesa, Zaragoza, Spain. Rambam Health Care Campus, Haifa, Israel. Humanitas Clinical and Research Center, Milan, Italy. Agaplesion Markus Hospital, Frankfurt, Germany. Herlev Hospital, University of Copenhagen, Copenhagen, Denmark. **Semmelweis University, Budapest, Hungary. Western General Hospital, Edinburgh, UK. University Hospital Skane, University of Lund, Malm€o, Sweden. ISCARE Lighthouse and 1st Medical Faculty, Charles University, Prague, Czech Republic. Evangelismos Hospital, Athens, Greece. ***Lausanne University Medical Center, Lausanne, Switzerland. Oslo University Hospital, University of Oslo, Oslo, Norway. University Hospital of Nancy, Universit e Henri Poincar e 1, Vandoeuvre-l es-Nancy, France. Ankara University School of Medicine, Ankara, Turkey. Erasmus University Medical Center, Rotterdam, The Netherlands. ****Clinical Immunology and Infectious Diseases, Medical University of Innsbruck, Innsbruck, Austria. Ismar Healthcare, Lier, Belgium. Department Internal Medicine III, Medical University of Vienna, Vienna, Austria. E-mails: fgomollon@gmail.com, fgomollon@me.com
- Published
- 2014
47. Discontinuation of Infliximab in Patients With Ulcerative Colitis Is Associated With Increased Risk of Relapse: A Multinational Retrospective Cohort Study
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Federica Furfaro, Giovanni Maconi, Pantelis Karatzas, Shaji Sebastian, Bella Ungar, Martina Muscat, Carla Felice, Konstantinos Karmiris, Stefanos Bonovas, Silvio Danese, Peter L. Lakatos, Gionata Fiorino, Konstantinos H. Katsanos, Marco Silva, Pierre Ellul, Dimitrios K. Christodoulou, Alessandro Armuzzi, Gerassimos J. Mantzaris, Fernando Magro, Marta Maia Bosca-Watts, Shomron Ben-Horin, Uri Kopylov, Fabrizio Bossa, Pablo Navarro Cortes, Fiorino, G, Cortes, Pn, Ellul, P, Felice, C, Karatzas, P, Silva, M, Lakatos, Pl, Bossa, F, Ungar, B, Sebastian, S, Furfaro, F, Karmiris, K, Katsanos, Kh, Muscat, M, Christodoulou, Dk, Maconi, G, Kopylov, U, Magro, F, Mantzaris, Gj, Armuzzi, A, Bosca-Watts, Mm, Ben-Horin, S, Bonovas, S, and Danese, S
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Adult ,Male ,medicine.medical_specialty ,Adolescent ,Settore MED/12 - GASTROENTEROLOGIA ,IBD ,Anti-TNF Agent ,Discontinuation ,Risk Assessment ,Inflammatory bowel disease ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Gastrointestinal Agents ,Recurrence ,Internal medicine ,Humans ,Medicine ,Israel ,Adverse effect ,ulcerative colitis ,Aged ,Retrospective Studies ,Aged, 80 and over ,Gastrointestinal agent ,Hepatology ,business.industry ,Gastroenterology ,Retrospective cohort study ,Middle Aged ,medicine.disease ,Ulcerative colitis ,Infliximab ,Management ,Surgery ,Europe ,Withholding Treatment ,030220 oncology & carcinogenesis ,Cohort ,Colitis, Ulcerative ,Female ,030211 gastroenterology & hepatology ,business ,medicine.drug - Abstract
BACKGROUND & AIMS: Infliximab is a safe and effective therapy for ulcerative colitis (UC). We conducted a multicenter retrospective cohort study that included 7 European countries and Israel to examine whether infliximab discontinuation can be considered for patients who achieve sustained remission. METHODS: We performed a retrospective cohort study, collecting medical records from 13 tertiary care referral inflammatory bowel disease centers of all patients with UC treated with infliximab (n = 193). We compared the disease course of patients with at least 12 months of clinical remission who discontinued infliximab (n = 111) with that of patients who continued scheduled treatment (controls, n = 82). We examined the incidence rates of relapse, hospitalization and colectomy, the comparative effectiveness of different therapeutic strategies after discontinuation, and assessed the rates of response, remission, and adverse effects after infliximab reinitiation. Statistical analyses used time-to-event methods. RESULTS: In the entire cohort, 67 patients (34.7%) relapsed during the follow-up period. The incidence rate of relapse was significantly higher after discontinuation (23.3 per 100 person-years) compared with the control group (7.2 per 100 person-years) in univariable analysis (logrank P < .001 hazard ratio, 3.41 95% confidence interval, 1.88-6.20) and multivariable analysis (hazard ratio, 3.70 95% confidence interval, 2.02-6.77). Rates of hospitalization and colectomy did not differ between groups. Thiopurines appeared to be the best treatment option after infliximab discontinuation (incidence of relapse: 15.0 per 100 person-years for thiopurines, 27.4 per 100 person-years for thiopurines plus aminosalicylates, and 31.2 per 100 person-years for aminosalicylates alone log-rank P = .032). Response was regained in 77.1% of patients and remission in 51.4% of patients who re-initiated infliximab. However, 17.1% had infusion reactions and 17.1% reported other adverse events. CONCLUSIONS: In a multinational retrospective cohort study of patients with UC in sustained clinical remission, we associated discontinuation of infliximab with an increased risk of relapse. Treatment reinitiation is effective and safe.
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- 2016
48. Infliximab discontinuation is associated with a higher risk for relapse in patients with ulcerative colitis in remission: a multinational collaborative retrospective study
- Author
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Fiorino, G., Ellul, P., Muscat, M., Karatzas, P., Silva, M., Peixoto, A., Felice, C., Bossa, F., Lakatos, P. L., Sebastian, S., Ungar, B., Furfaro, F., Karmiris, K., Katsanos, K., Navarro Pablo, Bosca-Watts, M. M., Christodoulou, D. K., Maconi, G., Kopylov, U., Armuzzi, A., Magro, F., Mantzaris, G. J., Ben-Horin, S., Danese, S., Fiorino, G, Ellul, P, Muscat, M, Karatzas, P, Silva, M, Peixoto, A, Felice, C, Bossa, F, Lakatos, Pl, Sebastian, S, Ungar, B, Furfaro, F, Karmiris, K, Katsanos, Kh, Cortes, Pn, Watts, Mmb, Christodoulou, Dk, Maconi, G, Kopylov, U, Armuzzi, A, Magro, F, Mantzaris, G, Ben-Horin, S, Danese, S, Katsanos, K, Navarro, P, Bosca-Watts, Mm, and Mantzaris, Gj
49. Improving access to inflammatory bowel disease care in Canada: The patient experience.
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Lalani S, Mathias H, Heisler C, Rohatinsky N, Mirza RM, Kits O, Zelinsky S, Nguyen G, Lakatos PL, Fowler S, Rioux K, and Jones JL
- Abstract
Objectives: Canada has one of the highest age-adjusted incidence and prevalence rates of inflammatory bowel disease (IBD). Large patient volumes and limited resources have created challenges concerning the quality of IBD care, but little is known about patients' experiences. This paper aimed to better understand patient-perceived barriers to IBD care., Methods: An exploratory qualitative approach was used for this study. Fourteen focus groups (with 63 total participants) were co-facilitated by a researcher and patient research partner across eight Canadian provinces in 2018. Patients diagnosed with IBD (>18 years of age) and their caregivers were purposefully recruited through Crohn's and Colitis Canada, gastroenterology clinics and communities, and national social media campaigns. Focus group sessions were recorded, transcribed, and analyzed using thematic analysis., Results: Most participants self-identified as being white and women. The analysis generated four key themes regarding patient-perceived barriers and gaps in access to IBD care: (1) gatekeepers and their lack of IBD knowledge, (2) expenses and time, (3) lack of holistic care, and (4) care that is not patient-centered. An additional four themes were generated on the topic of patient-perceived areas of health system improvement for IBD care: (1) direct access to care, (2) good care providers, (3) electronic records and passports, and (4) multidisciplinary care or an 'IBD dream team'., Conclusions: This research contributes to the limited global knowledge on patients' experiences accessing IBD care. It is valuable for the development of care plans and policies to target gaps in care. Patients have identified system-level barriers and ideas for improvement, which should be taken into consideration when implementing system redesign and policy change., Competing Interests: Declaration of conflicting interestsThe authors declare that there are no conflicts of interest.
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- 2024
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50. The added value of the cognition, dining, gastrointestinal problems, sleep and tiredness bolt-on dimensions to the EQ-5D-5L in patients with coeliac disease.
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Angyal MM, Janssen MF, Lakatos PL, Brodszky V, and Rencz F
- Abstract
Objectives: Multiple studies suggest that the EQ-5D may overestimate health-related quality of life (HRQoL) in patients with coeliac disease (CD). We aimed to develop and psychometrically test potentially relevant bolt-on dimensions to improve the measurement performance of the EQ-5D-5L in CD patients., Methods: The development and selection of bolt-ons were informed by a literature review on HRQoL in CD, expert and patient input. A cross-sectional online survey was conducted amongst 312 adult CD patients. Respondents completed the EQ-5D-5L, two condition-specific bolt-ons newly-developed for the present study [dining (DI) and gastrointestinal problems (GI)] and three existing bolt-ons [cognition (CO), sleep (SL) and tiredness (TI)]. The following psychometric properties were tested: ceiling, informativity, convergent and known-group validity, and dimensionality (confirmatory factor analysis)., Results: Adding the TI, SL, GI, DI and CO individual bolt-ons reduced the ceiling of the EQ-5D-5L (39%) to 17%, 23%, 24%, 26% and 37%, respectively. GI excelled with strong convergent validity with the Gastrointestinal Symptom Rating Scale total score (r
s =0.71) and improved the discriminatory power for all known-groups. GI was the only bolt-on loading on a different factor from the five core dimensions, whereas the other four bolt-ons loaded onto the same 'psychosocial health' factor as the EQ-5D-5L anxiety/depression dimension., Conclusion: The DI, GI, SL and TI bolt-ons, especially the GI, enhance the validity of EQ-5D-5L in patients with CD, suggesting their value in capturing important HRQoL aspects potentially missed by the five core dimensions. These bolt-ons can be used in sensitivity analyses supporting health technology assessments and subsequent resource allocation decisions., (© 2024. The Author(s).)- Published
- 2024
- Full Text
- View/download PDF
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