Guidelines for the administration of biological therapy in patients with Crohn´s disease and ulcerative colitis: third updated edition

Bortlík, Martin; Ďuricová, Dana; Kohout, Pavel; Konečný, M; Koželuhová, Jana; Novotný, Aleš; Zbořil, Vladimír; Prokopová, Lucie; Douda, Tomáš; Stehlík, J; Shonová, Olga; Mareš, Karel; Hrdlička, Luděk; Matějková, Petra; Šerclová, Zuzana; Nedbalová, Lenka; Tomanová, Marie; Liberda, Martin; Bronský, Jiří; Mitrová, Katarína; Drastich, Pavel; Ryska, O; Falt, Přemysl; Březina, Jan; Vaňásek, Tomáš; Kalvach, J; Kolář, Martin; Lukáš, Milan

doi:10.14735/amgh201611

Cited by 9 publications

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“…In the five included countries, biologics were indicated for patients with a Mayo Score > 6. Failure (or intolerance) to both corticosteroids and immunomodulators is a requirement to initiate biologic treatment in Poland, Latvia, the United Kingdom, and France ( [40][41][42] for Czech Republic, The National Health Service of the Republic of Latvia 43 for Latvia, National Health Insurance Fund 44 for Bulgaria, Directorate-General for Health, 45 Diário da República Eletrónico, 46 and Government Directive 47 for Portugal, National Institute for Health and Care Excellence 48 for UK, and Légifrance and Agence Nationale de Sécurité du Médicament et des Produits de Santé 49-51 for France. Modified and updated from Péntek and colleagues.…”

Section: Discussionmentioning

confidence: 99%

Characteristics of patients with moderate-to-severe ulcerative colitis treated with vedolizumab: results from a Polish multicenter, prospective, observational real-life study (the POLONEZ study)

Cichoż‐Lach

Michalak

Kopertowska-Majchrzak³

et al. 2021

Therap Adv Gastroenterol

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Background: Vedolizumab, a humanized antibody targeting the α4β7 integrin, was proven to be effective in the treatment of moderate-to-severe ulcerative colitis (UC) in randomized clinical trials. The aim of the POLONEZ study is to determine the demographic and clinical characteristics of the patients with UC treated with vedolizumab within the scope of the National Drug Program in Poland and to assess the real-world effectiveness and safety of vedolizumab in the study population. Here we report the demographic and clinical characteristics of these patients. Methods: This prospective study included adult patients eligible for UC treatment with vedolizumab who were recruited from 12 centers in Poland between February and November 2019. Collected data included sex, age, disease duration, presence of extraintestinal manifestations or comorbidities, status of previous biologic treatment, and current concomitant treatment. Disease extent was determined according to the Montreal classification, and disease activity was measured with the Mayo Score. Results: A total of 100 (55 biologic-naïve and 45 biologic-exposed) patients were enrolled in the study (51% female, median age 35 years). Among biologic-exposed patients (mostly infliximab-treated), 57% had failed to respond to the therapy. The disease duration was significantly shorter in biologic-naïve (median 5 years) than in biologic-exposed (8 years, p = 0.004) or biofailure patients (7 years, p = 0.04). In the overall population the median Total Mayo Score was 10. Disease extent and activity were similar between the subgroups. Conclusions: Our study indicates that patients treated with vedolizumab in Poland receive the drug relatively early after UC diagnosis, but their disease is advanced. More than half of the patients had not been treated with biologic drugs before initiating vedolizumab. The study was registered in ENCePP database (EUPAS34119). Lay summary Characteristics of patients treated for ulcerative colitis with vedolizumab in Poland Treatment of moderate-to-severe ulcerative colitis (UC) with the integrin antagonist vedolizumab became available within the Polish National Drug Program (NDP) in 2018. In this study, for the first time, we provide detailed demographic and clinical characteristics of 100 patients (median age 35 years, 51% female) treated with vedolizumab in Poland, of whom 55 were biologic-naïve and 45 biologic-exposed. The median duration of disease was 6 years. The disease duration was shorter in biologic-naïve than in biologic-exposed patients. Most patients were affected by extensive colitis (52%) or left-sided colitis (42%). Median disease activity was 10 according to the Total Mayo Score. Sixty-eight patients received concomitant systemic corticosteroids and 45 patients received immunomodulators. Our findings indicate that Polish patients receiving vedolizumab have a high disease activity and are treated relatively early after UC diagnosis. This might be due to the criteria for inclusion of a patient in the NDP.

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Section: Discussionmentioning

confidence: 99%

Characteristics of patients with moderate-to-severe ulcerative colitis treated with vedolizumab: results from a Polish multicenter, prospective, observational real-life study (the POLONEZ study)

Cichoż‐Lach

Michalak

Kopertowska-Majchrzak³

et al. 2021

Therap Adv Gastroenterol

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“…time to delivery negatively cor related with cord blood IFX levels (r S = -0.6759; p = 0.0069). This fact is reflected in both the ECCO guidelines [14] and the guidelines of Czech Society of Gastroenterology [15], which both recom mend the discontinuation of anti-TNF at the end of the 2 nd trimester if there is no need to continue due to dis ease activity or high relapse risk.…”

Section: Ifx Ther Apymentioning

confidence: 99%

Pregnancy outcomes in women with inflammatory bowel disease treated with biosimilar infliximab

Kolář¹,

Bortlík²,

Ďuricová³

et al. 2018

Gastroent Hepatol

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Sum mary: Background: In pregnant women with inflammatory bowel disease (IBD), exposure to biologic therapy, especially anti-TNF antibodies, has not been associated with adverse events. However, data on the efficacy and safety of biosimilar infliximab (IFX) in this particular population of IBD patients are lacking. Methods: This retrospective study included 20 women treated with biosimilar IFX (CT-P13) during pregnancy for whom information about pregnancy outcome was available. Data on disease activity, treatment, and pregnancy and newborn outcome were recorded. Cord blood levels of anti-TNF were measured by ELISA. Results: Twenty pregnant women (16 with Crohn's disease and 4 with ulcerative colitis) with a mean age of 28.7 ± 4.1 years were included, 55% of whom were primigravidae. The mean disease duration at the time of pregnancy was 6.0 ± 5.3 years, and 70% of the women had a history of perianal disease. At the time of conception, 30% had active disease and 65% were in remission; one of the women was newly diagnosed with acute severe colitis after conception. Besides this patient, to whom IFX rescue therapy was administered during the first trimester, all women had already been treated with IFX before becoming pregnant, with a mean treatment duration of 2.3 ± 2.7 years. There were 19 live births (mean weight, 3,305 ± 493 g), 18 at term and 1 pre-term (with a low birth weight). One pregnancy ended in spontaneous abortion. Disease activity at conception was associated with lower birth weight (3,549 ± 392 g for those in remission vs. 2,921 ± 390 g for those with active disease; p = 0.0043). Cesarean section was performed in 70% of the women, 79% of whom had a history of perianal disease. No perinatal complications and birth defects were reported, except for a single case of cleft palate. Conclusion: To our knowledge, this is the first report of pregnancy outcomes in women exposed to biosimilar IFX. Under the constraints inherent in the limited sample size, no new safety concerns have so far arisen. Souhrn: Úvod: Biologická terapie těhotných pa cientek s idiopatickými střevními záněty (IBD -inflam matory bowel dis ease) nemá negativní vliv na výsledek těhotenství ani na vývoj plodu. Stále však chybí data o efektivitě a bezpečnosti bio similárního infliximabu (IFX) v této situaci. Metody:Retrospektivní observační studie zahrnovala 20 žen s IBD léčených v průběhu těhotenství bio similárním IFX (CT-P13), u kterých byly k dispozici informace o výsledku těhotenství. Sledovány byly údaje o aktivitě choroby, léčbě, výsledcích těhotenství a data o novorozenci. Hladiny IFX z pupečníkové krve byly měřeny pomocí metody ELISA. Výsledky: Do studie bylo zařazeno 20 těhotných žen (16 s Crohnovou nemocí, 4 s ulcerózní kolitidou) průměrného věku 28,7 ± 4,1 let, z nich 55 % (11) bylo prvorodiček. Střední doba trvání onemocnění k počátku těhotenství byla 6,0 ± 5,3 let, 70 % (14) žen mělo anamnézu perianálního postižení. V období početí trpělo 30 % (6) žen aktivní chorobou, 65 % (13) bylo v remisi a u jedné pa cientky byla nově dia g...

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“…Pro tuto strategii je používán termín akcelerovaná stepup léčba a jde o racionální kompromis mezi stan dardní léčbou založenou na postupném navyšování te rapie (stepup) a postupem opačným, při němž je bio logikum podáno na samém počátku léčby (topdown). Za prediktory nepříznivého průběhu CD považujeme především časný začátek nemoci (diagnóza CD před 17. rokem života), perianální chorobu, extenzivní po stižení tenkého střeva a rychlou progresi onemocnění do stadia penetrujících komplikací (intraabdominální abscesy a píštěle) [41]. Součástí akcelerované stepup léčby je obvykle i souběžné podávání imunosupresivní terapie (thiopuriny, metotrexát, combo terapie).…”

Section: Akcelerovaná Step-up Terapie a Koncept Treat-to-targetunclassified

Conventional and biological therapy for inflammatory bowel disease

Bortlík¹

2018

Vnitr Lek

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SouhrnCrohnova choroba a ulcerózní kolitida jsou chronická, medikamentózně a chirurgicky nevyléčitelná onemocnění trávicí trubice, která postihují zejména mladou populaci ekonomicky vyspělých zemí. Medikamentózní léčba za hrnuje podávání konvenčních preparátů -aminosalicylátů, kortikosteroidů, imunosupresiv, antibiotik a výjimečně i probiotik u pacientů neodpovídajících na konvenční léčbu nebo je u nich ve vyšším riziku nepříznivého prů běhu indikována léčba biologická. Nejčastěji podávanými biologiky jsou protilátky proti tumor nekrozujícímu fak toru α, které jsou vysoce efektivní, délka jejich aplikace je však limitována ztrátou účinnosti a výskytem nežádou cích účinků. Nová, selektivněji působící biologika zahrnují antiintegrinové protilátky a protilátky proti interleukinu 12/23. Klíčová slova: biologická léčba -Crohnova choroba -idiopatické střevní záněty -medikamentózní léčba -ulce rózní kolitida Conventional and biological therapy for inflammatory bowel disease SummaryCrohn's disease and ulcerative colitis are chronic digestive conditions incurable by medication or surgery, which affect mainly young populations in economically developed countries. A medical treatment includes conven tional preparations: aminosalicylates, corticosteroids, immunosuppressive drugs, antibiotics and exceptionally also probiotics, while in not responding patients or those at higher risk of an adverse course a biological treat ment is indicated. The most frequently administered biologics are antibodies directed against the tumournecro sis factor α, which are highly effective, but the length of their application is limited by a loss of efficiency and incidence of adverse effects. The new, more selectively acting biologics include antiintegrin antibodies and interleukin 12/23 antibodies.

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Guidelines for the administration of biological therapy in patients with Crohn´s disease and ulcerative colitis: third updated edition

Cited by 9 publications

References 0 publications

Characteristics of patients with moderate-to-severe ulcerative colitis treated with vedolizumab: results from a Polish multicenter, prospective, observational real-life study (the POLONEZ study)

Characteristics of patients with moderate-to-severe ulcerative colitis treated with vedolizumab: results from a Polish multicenter, prospective, observational real-life study (the POLONEZ study)

Pregnancy outcomes in women with inflammatory bowel disease treated with biosimilar infliximab

Conventional and biological therapy for inflammatory bowel disease

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