Children and adolescents with Crohn's disease (CD) present often with a more complicated disease course compared to adult patients. In addition, the potential impact of CD on growth, pubertal and emotional development of patients underlines the need for a specific management strategy of pediatric-onset CD. To develop the first evidenced based and consensus driven guidelines for pediatric-onset CD an expert panel of 33 IBD specialists was formed after an open call within the European Crohn's and Colitis Organisation and the European Society of Pediatric Gastroenterolog, Hepatology and Nutrition. The aim was to base on a thorough review of existing evidence a state of the art guidance on the medical treatment and long term management of children and adolescents with CD, with individualized treatment algorithms based on a benefit-risk analysis according to different clinical scenarios. In children and adolescents who did not have finished their growth, exclusive enteral nutrition (EEN) is the induction therapy of first choice due to its excellent safety profile, preferable over corticosteroids, which are equipotential to induce remission. The majority of patients with pediatric-onset CD require immunomodulator based maintenance therapy. The experts discuss several factors potentially predictive for poor disease outcome (such as severe perianal fistulizing disease, severe stricturing/penetrating disease, severe growth retardation, panenteric disease, persistent severe disease despite adequate induction therapy), which may incite to an anti-TNF-based top down approach. These guidelines are intended to give practical (whenever possible evidence-based) answers to (pediatric) gastroenterologists who take care of children and adolescents with CD; they are not meant to be a rule or legal standard, since many different clinical scenario exist requiring treatment strategies not covered by or different from these guidelines.
The goal of this consensus initiated by the European Crohn’s and Colitis Organisation [ECCO] and European Society of Colo-Proctology [ESCP] was to establish European consensus guidelines for the surgical treatment of Crohn’s disease [CD]. The strategy to reach the consensus involved several steps and follows the standard operating procedures for consensus guidelines of ECCO. An open call for chairs and participants for this consensus was made among members of the ESCP, surgeons of ECCO, and ECCO members. Participants were selected by the Guidelines’ Committee of ECCO [GuiCom] and the guideline committee of the ESCP on the basis of their publication record and personal statement. Five working groups [WGs] were formed: WG 1, perioperative management; WG 2, upper gastrointestinal tract and small bowel; WG 3, large bowel; WG 4, perianal CD; and WG 5, special conditions. Participants were asked to answer relevant questions on current practice and areas of controversy related to the surgical treatment of CD based on their experience as well as evidence from the literature [Delphi procedure].1 In parallel, the WG members performed a systematic literature search of their topic with the appropriate key words using Medline/PubMed/ISI/Scopus, and the Cochrane database, as well as their own files. Provisional guideline statements [with supporting text] were then written by the WG chairs based on answers to the questionnaire and were subsequently circulated among the WG members, prompting discussion and exchange of available evidence. The proposed statements and the supporting text were submitted to an online platform for discussion and two online voting rounds were conducted. The first round involved all participants of the consensus development process and, for the second voting round, all national representatives of ECCO and ESCP were invited to participate. The consensus participants finally met in Dublin on September 22, 2015 for face-to-face discussion and voting for consensus on the statements. This was done by projecting the statements and revising them on screen until consensus was reached. Consensus was defined as agreement by more than 80% of participants; the consensus statements were numbered for convenience in the document. The level of evidence was graded according that published by the Oxford Centre for Evidence-based Medicine 2011 [http://www.cebm.net/mod_product/design/files/CEBM-Levels-of-Evidence-2.1.pdf]. The final manuscript was written by the WG chairs [OZ, GS, JW, WB, ZS] in conjunction with the WG members and revised for consistency by WB and AD. Officially, WB is representing the ECCO and AD the ESCP. It was agreed to publish the consensus guideline in JCC and to post links to the original publication in JCC on the websites of ECCO and the ESCP.
Clinically effective therapies now exist for remission maintenance in both ulcerative colitis (UC) and Crohn’s Disease (CD). For each major class of IBD medications (5-aminosalicyclates, immunomodulators and biologic agents), used alone or in combination, there is a risk of relapse following reduction or stopping of treatment. A consensus expert panel convened by the European Crohn’s and Colitis Organisation (ECCO) reviewed the published literature and agreed a series of consensus practice points. The objective of the expert consensus is to provide evidence-based guidance for clinical practice so that physicians can make informed decisions in partnership with their patients. The likelihood of relapse with stopping each class of IBD medication is reviewed. Factors associated with an altered risk of relapse with withdrawal are evaluated and strategies to monitor and allow early identification of relapse are considered. In general, patients in clinical, biochemical and endoscopic remission are more likely to remain well when treatments are stopped. Reintroduction of the same treatment is usually, but not always, successful. The decision to stop a treatment needs to be individualized and shared decision making with the patient should take place.
30 December 2015 in Journal of Crohn's and Colitis
The growing incidence of inflammatory bowel disease (IBD) in children necessitates the use of biological treatments. Recently, an infliximab biosimilar was authorized in the European Union, which may result in switching patients. We present our preliminary experiences with such switches. The prospective study included 32 paediatric patients diagnosed with Crohn's disease (CD) and 7 children with ulcerative colitis (UC) at 3 academic hospitals, who were switched from infliximab originator to its biosimilar (Remsima). Patient characteristics, disease severity, laboratory parameters and adverse events were recorded. Means, medians and ranges were calculated. Mean age at diagnosis of CD and UC was 11.1 (2.7-15.3) and 12.3 years (8.5-14.8), respectively. Mean number of infliximab originator infusions before switching to the biosimilar was 9.9 (median 8, range 4-29) and 5.1 (5, 1-12) for the CD and UC group, respectively. Evaluation efficacy of last biosimilar doses of all patients revealed rates of clinical remission of 88 and 57% for CD and UC patients, respectively. Last follow-up assessment of patients who continued with biosimilar therapy showed that 16/20 (80%) CD patients and all 4 UC individuals were in remission. One infusion reaction to infliximab biosimilar was observed in a CD patient, which led to treatment discontinuation. The incidence of sporadic mild adverse events prior to and after switching did not differ significantly and was consistent with the safety profile of the infliximab molecule. Switching from infliximab originator to its biosimilar seems to be a safe option in children with CD. After the switch the biosimilar was just as effective as the originator.