Guidelines for the administration of biological therapy in patients with inflammatory bowel diseases: fourth, updated edition

Bortlík, Martin; Ďuricová, Dana; Douda, Tomáš; Konečný, M; Koželuhová, Jana; Novotný, Aleš; Zbořil, Vladimír; Prokopová, Lucie; Kohout, Pavel; Stehlík, J; Shonová, Olga; Mareš, Karel; Hrdlička, Luděk; Matějková, Petra; Šerclová, Zuzana; Nedbalová, Lenka; Tomanová, Marie; Liberda, Martin; Hradský, Ondřej; Mitrová, Kararína; Drastich, Pavel; Falt, Přemysl; Březina, Jan; Vaňásek, Tomáš; Volfová, Miroslava; Kalvach, J; Pipek, Barbora; Kajzlíková, Ivana Mikovny; Mináriková, Petra; Grega, Tomáš; Poredská, Karolína; Kolář, Martin; Lukáš, Milan

doi:10.14735/amgh201911

Cited by 6 publications

(1 citation statement)

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“…Inclusion criteria for this study: Indication of Biosimilar adalimumab FKB327 (Hulio 1 ) or GP2017 (Hyrimoz 1 ) in naive patients (in terms of biological therapy) with CD or UC if indication criteria for these biological agents (according to the guidelines of the Czech Gastroenterological Society valid at the time of study) were met [18][19][20]. FKB327 and GP2017 were indicated in patients for treatment of:…”

Section: Patientsmentioning

confidence: 99%

Adalimumab biosimilars in the therapy of Crohn´s disease and ulcerative colitis: Prospective multicentric clinical monitoring

et al. 2022

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Objective The adalimumab biosimilars FKB327 and GP2017 were approved for the therapy of patients with inflammatory bowel disease (IBD). Relatively few prospective studies with biosimilar adalimumab in patients with IBD have been published. The aim of this prospective observational study was to evaluate the effectiveness and safety of the biosimilar adalimumab. Material and methods Adalimumab biosimilars FKB327 (Hulio®) and GP2017 (Hyrimoz®) were indicated to 50 naive patients in terms of biological therapy with Crohn’s disease (CD) or ulcerative colitis (UC). Effectiveness of therapy was evaluated via the Crohn’s Disease Activity Index [CDAI] or the Mayo Scoring System [MSS] in patients with CD or UC, respectively, before and after 12 weeks. Additional goals were to evaluate weight changes, laboratory tests and complications or adverse events of this therapy. Results In CD patients, remission (CDAI <150) was achieved in 73.5% of cases, partial response (≥70-point decrease in CDAI score from baseline) in 11.8%, no response in 11.8% and 2.9% patients discontinued therapy. In UC patients, remission (total score on partial Mayo index ≤2 points) was achieved only in 18.8% of cases, partial response (≥2-point decrease in partial Mayo score from baseline) in 43.8%, no response in 25.0% and 12.5% patients discontinued therapy. There were statistically significant improvements in CDAI, MSS, haemoglobin, fecal calprotectin, albumin and CRP serum levels after 12 weeks of therapy. Seven adverse events were identified, three of which resulted in therapy being discontinued. Conclusions This prospective observational study proved the effectiveness of the adalimumab biosimilars FKB327 and GP2017 in IBD.

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Section: Patientsmentioning

confidence: 99%

Adalimumab biosimilars in the therapy of Crohn´s disease and ulcerative colitis: Prospective multicentric clinical monitoring

et al. 2022

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Fecal Microbiome Changes and Specific Anti-Bacterial Response in Patients with IBD during Anti-TNF Therapy

Schierová

Roubalová

Kolář

et al. 2021

Cells

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Inflammatory bowel diseases (IBD) are chronic disorders of the gastrointestinal tract that have been linked to microbiome dysbiosis and immune system dysregulation. We investigated the longitudinal effect of anti-TNF therapy on gut microbiota composition and specific immune response to commensals in IBD patients. The study included 52 patients tracked over 38 weeks of therapy and 37 healthy controls (HC). To characterize the diversity and composition of the gut microbiota, we used amplicon sequencing of the V3V4 region of 16S rRNA for the bacterial community and of the ITS1 region for the fungal community. We measured total antibody levels as well as specific antibodies against assorted gut commensals by ELISA. We found diversity differences between HC, Crohn’s disease, and ulcerative colitis patients. The bacterial community of patients with IBD was more similar to HC at the study endpoint, suggesting a beneficial shift in the microbiome in response to treatment. We identified factors such as disease severity, localization, and surgical intervention that significantly contribute to the observed changes in the gut bacteriome. Furthermore, we revealed increased IgM levels against specific gut commensals after anti-TNF treatment. In summary, this study, with its longitudinal design, brings insights into the course of anti-TNF therapy in patients with IBD and correlates the bacterial diversity with disease severity in patients with ulcerative colitis (UC).

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Pharmacotherapy of inflammatory boweldisease

Dujsíková¹

2018

Klin Farmakol Farm

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Interní gastroenterologická klinika FN Brno a LF Masarykovy univerzity v Brně Pod pojmem idiopatické střevní záněty rozumíme Crohnovu chorobu a ulcerózní kolitidu. Postihují nejčastěji ileocékální oblast, resp. tlusté střevo. Etiologie onemocnění je neznámá, na vzniku onemocnění se podílí více faktorů. Tento fakt neumožňuje léčbu kauzální, léčba je možná pouze symptomatická. Základní skupiny léků, které využíváme k léčbě idiopatických střevních zánětů, jsou aminosalicyláty, kortikoidy, imunosupresiva a biologická léčba. Za doplňkovou léčbu považujeme antibiotika a probiotika, ve specifických případech volíme parenterální nebo enterální výživu. Léčba je pro každého pacienta zvolena individuálně, její efektivitu výrazně zvyšuje pacientova spolupráce na léčbě a dispenzární péči. Klíčová slova: idiopatické střevní záněty, Crohnova choroba, ulcerózní kolitida, farmakoterapie. Pharmacotherapy of inflammatory boweldisease Inflammatory bowel disease means Crohn's disease and ulcerative colitis. Mostly, it affects ileocecal area, resp. large intestine. Ethiology of the disease is unknown. The start of the disease is formed by a number of factors. This fact does not enable causal treatment; treatment is possible only as symptomatic. Basic drug groups that are used for treatment of inflammatory bowel disease are aminosalicylates, corticoids, immunosuppressive therapy and biological therapy. As a supplementary treatment can be considered antibiotics, probiotics; in specific cases parenteral or enteral nourishment is prescribed. Treatment is individually chosen for each patient; its effectiveness is considerably increased by patient's cooperation during the treatment and follow-up.

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Guidelines for the administration of biological therapy in patients with inflammatory bowel diseases: fourth, updated edition

Cited by 6 publications

References 0 publications

Adalimumab biosimilars in the therapy of Crohn´s disease and ulcerative colitis: Prospective multicentric clinical monitoring

Adalimumab biosimilars in the therapy of Crohn´s disease and ulcerative colitis: Prospective multicentric clinical monitoring

Fecal Microbiome Changes and Specific Anti-Bacterial Response in Patients with IBD during Anti-TNF Therapy

Pharmacotherapy of inflammatory boweldisease

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