Guidelines for the management of ulcerative colitis. Recommendations of the Working Group of the Polish National Consultant in Gastroenterology and the Polish Society of Gastroenterology

Eder, Piotr; Łodyga, Michał; Łykowska‐Szuber, Liliana; Bartnik, W; Durlik, Marek; Gonciarz, Maciej; Kłopocka, Maria; Linke, Krzysztof; Małecka‐Panas, Ewa; Radwan, Piotr; Rydzewska, Grażyna

doi:10.5114/pg.2013.34176

Cited by 14 publications

(70 citation statements)

References 126 publications

(234 reference statements)

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“…However, advances made in recent years have allowed the introduction into clinical practice of some novel products characterised by better efficacy and more favourable safety profiles. This study complements the previously published Guidelines of the Working Group of the Polish Society of Gastroenterology and former National Consultant in Gastroenterology regarding the management of patients with Crohn's disease and ulcerative colitis [ 1 , 2 ].…”

Section: Introductionsupporting

confidence: 55%

New pharmaceuticals in inflammatory bowel disease

Łodyga

Eder

Bartnik

et al. 2015

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Section: Introductionsupporting

confidence: 55%

New pharmaceuticals in inflammatory bowel disease

Łodyga

Eder

Bartnik

et al. 2015

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“…Ulcerative colitis (UC) is classified as an inflammatory bowel disease (IBD) together with Crohn’s disease and indeterminate colitis. This group of diseases is characterised by multifactorial etiopathogenesis – including genetic predisposition, immunological disorders, and environmental factors; however, the relationships between them are still unknown [ 1 , 2 ]. Ulcerative colitis incidence in Europe is about 10 new cases per 100 thousand people annually and still rising, especially in young adults [ 1 – 3 ].…”

Section: Introductionmentioning

confidence: 99%

The efficacy and safety of the biosimilar product (Inflectra®) compared to the reference drug (Remicade®) in rescue therapy in adult patients with ulcerative colitis

Kaniewska¹,

Moniuszko²,

Rydzewska³

2017

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IntroductionThe biosimilar product Inflectra® has been approved by the European Medicine Agency (EMA) for the same indications as its reference drug, infliximab, based on studies in patients with rheumatic diseases. Thus far, there have not been enough data regarding its efficacy and safety in ulcerative colitis (UC).AimTo assess the efficacy and safety of the biosimilar product Inflectra® in comparison with its reference biological agent (Remicade®) in rescue therapy in adult patients presenting with severe exacerbation of UC, as well as to evaluate recurrence rate during a 6-month observation after finish of treatment.Material and methodsIn a single-centre retrospective study, a cohort of 83 adult patients with severe UC treated at the Department of Gastroenterology with Inflammatory Bowel Diseases Subdivision of the Central Clinical Hospital of MSWiA, Warsaw was investigated. All patients received three induction doses of Remicade® (28 individuals) or Inflectra® (55 individuals) based on the same criteria of the National Health Fund (NFZ) Therapeutic Program (total Mayo score > 6). Activity of the disease was evaluated on the Mayo scale at qualification, after finishing the rescue treatment (after 14 weeks), and after a 6-month observation period. In all patients, sigmoidoscopy was performed at qualification and after induction (after three doses).ResultsThe studied groups were similar with respect to age and sex distribution, duration of the disease, extent of the disease (left-sided type, pancolitis), additional pharmacotherapy, and smoking. Clinical response following three induction doses was noted in 81% of patients receiving Remicade® compared to 77% receiving the biosimilar product, Inflectra® (NS); while clinical remission was observed in 42% receiving Remicade® and 32% receiving Inflectra® (NS), respectively. Endoscopic remission assessed as 0 on the Mayo scale was achieved in 4 (15%) patients on Remicade® and in 7 (13%) patients on Inflectra® (p = 0.45). Relapse occurred in 68% of all patients, while 51% presented with exacerbation of the disease 3 months after finishing biological treatment. In 93%, exacerbation occurred within 12 months. The recurrence rate was similar in both groups (75% with Remicade®, 64% with Inflectra®, respectively). Side effects occurred with similar frequency in both groups.ConclusionsIn the study, it was established that the biosimilar drug (Inflectra®) has a similar efficacy and safety as the reference biological agent (Remicade®), not only in rescue therapy, but also during a 6-month observation period in adult patients with severe UC. Low mucosal healing rate in both groups and high recurrence rate of the disease soon after finishing induction treatment indicate the need for prolonged therapy with infliximab in patients with severe UC.

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“…Polskie Towarzystwo Gastroenterologiczne w indukcji remisji choroby Crohna rekomenduje leczenie biologiczne pod postacią stosowania infliksimabu lub adalimumabu wraz z lekami immunosupresyjnymi jako leczenie ostatecznego wyboru [9]. Podobnie w indukcji remisji wrzodziejącego zapalenia jelita grubego, rekomenduje się stosowanie inhibitora TNF-α przy nieskuteczności leczenia steroidami i tiopurynami [10].…”

Section: Nieswoiste Choroby Zapalne Jelitunclassified