Trial discontinuation: lessons for future trial design?

Background: The current therapeutic arsenal still does not fulfill the therapeutic needs of inflammatory bowel disease patients. Although new drugs are constantly being developed, many will never reach the market. In this review we will search for reasons for discontinuing promising clinical trials and offer recommendation for future trials. Methods: The website clinicaltrials.gov was searched for interventional trials on novel inflammatory bowel disease therapies. Included were discontinued ‘Crohn’s disease’ and/or ‘colitis, ulcerative’ trials, started between July 1996 and October 2011 and discontinued. Pubmed was searched for publications to elucidate reasons for discontinuation. Results: One hundred and ninety one novel drug trials were published on clinicaltrials. gov, of which 24 (12.6%) were interrupted. The most common reason for discontinuation was lack of efficacy. Conclusion: Translation from bench to bedside is not always feasible, animal models come with restrictions. For better treatments, personalized medicine will be the future

Effect of biologicals and JAK inhibitors during pregnancy on health-related outcomes in children of women with inflammatory bowel disease

Current guidelines advise to maintain immunomodulators and biologicals in pregnant patients because relapse of inflammatory bowel is associated with unfavourable pregnancy outcome. With the exception of Methotrexate, IBD therapy seems not to be related to an increase of congenital malformations or infections requiring hospitalisation of the babies, although the effect the on the developing immune system of the exposed infants remains unknown. In this review we will focus on the effect of IBD drugs on health-related outcomes in children taking into account possible long-term effects of biologicals and immunomodulators, which are transferred across the placenta

Immunogenicity negatively influences the outcome of adalimumab treatment in Crohn's disease

Background: Adalimumab is an effective treatment in patients with Crohn's disease; as it is a humanized anti-tumour necrosis factor monoclonal antibody, immunogenicity is thought not to be of any significance. Aim: To assess whether antibodies to adalimumab (ATAs) affect adalimumab treatment outcome in patients with Crohn's disease previously treated with infliximab. Methods: A retrospective study was p

Peripheral neutrophil functions and cell signalling in crohn's disease

The role of the innate immunity in the pathogenesis of Crohn's disease (CD), an inflammatory bowel disease, is a subject of increasing interest. Neutrophils (PMN) are key members of the innate immune system which migrate to sites of bacteria

Self-efficacy did not predict the outcome of the transition to adult care in adolescents with inflammatory bowel disease

Aim: It can be difficult for adolescents with inflammatory bowel disease (IBD) to make the transition from paediatric to adult care. We studied the outcomes of this process and defined what constituted a successful transition. Methods: In 2008, 50 adolescents who attended our IBD transition clinic completed IBD-yourself, a self-efficacy questionnaire that we had previously developed and validated. We approached the subjects in 2014, two to six years after they transferred to adult care, and 35 agreed to take part in the current study. The outcome of transition was assessed by our newly developed Transition Yourself Score. In addition, the relationship between self-efficacy and the outcome of the transition was measured. Results: The mean age of the patients was 21.8 years, and 69% suffered from Crohn's disease. The transition process was successful in 63% of cases, moderately successful in 31% and failed in 6%. A successful transition was associated with effective use of medication and clinical remission at the time of transfer, but could not be predicted by self-efficacy. The Transition Yourself Score will be validated in future studies. Conclusion: Nearly two-thirds (63%) of the adolescents who attended the IBD transition clinic had a successful transition to adult care