Elective switching from infliximab to adalimumab in stable Crohn's disease. 2013

Frank Hoentjen, and Bertram J T Haarhuis, and Joost P H Drenth, and Dirk J de Jong
Inflammatory Bowel Disease Center , Radboud University Medical Center, Nijmegen, The Netherlands. frankhoentjen@gmail.com

BACKGROUND Elective switching of biological therapy in patients with Crohn's disease (CD) in remission is generally discouraged, given the theoretical risk of antibody formation and loss of response. The aim of this study was to assess efficacy and tolerability of adalimumab (ADA) therapy after an elective switch from infliximab (IFX) in patients with stable CD. METHODS Patients with CD with stable disease for >6 months (Harvey-Bradshaw Index ≤ 8) on IFX were eligible for this prospective, open-label single-center study. The primary endpoint was termination of ADA therapy. Disease activity (Harvey-Bradshaw Index, laboratory results) and adverse events were documented during the follow-up. RESULTS We enrolled 29 patients with CD (19 women, mean age, 39 years; interquartile range, 23-58 years) who switched from IFX to ADA. At the end of the 54-week follow-up period, 72% of patients continued ADA therapy. Eight patients discontinued ADA therapy due to disease activity (n = 3), side effects (n = 4), or general symptoms (n = 1). After discontinuation of ADA, 4 patients switched back to IFX, and no infusion reactions occurred. No significant changes were observed in Harvey-Bradshaw Index scores, C-reactive protein, and leukocyte counts at 0 versus 54 weeks. Half of the patients who discontinued ADA showed an elevated baseline C-reactive protein. CONCLUSIONS The majority of patients with CD (72%) continued therapy and maintained remission after an elective switch from IFX to ADA, although switching back to IFX, if required, was well tolerated. However, elective switching of anti-tumor necrosis factor therapy in stable CD should be carefully considered, given the risk of loss of response and the limited options for alternative maintenance therapies.

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D011446 Prospective Studies Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group. Prospective Study,Studies, Prospective,Study, Prospective
D012074 Remission Induction Therapeutic act or process that initiates a response to a complete or partial remission level. Induction of Remission,Induction, Remission,Inductions, Remission,Remission Inductions
D002097 C-Reactive Protein A plasma protein that circulates in increased amounts during inflammation and after tissue damage. C-Reactive Protein measured by more sensitive methods often for coronary heart disease risk assessment is referred to as High Sensitivity C-Reactive Protein (hs-CRP). High Sensitivity C-Reactive Protein,hs-CRP,hsCRP,C Reactive Protein,High Sensitivity C Reactive Protein
D003424 Crohn Disease A chronic transmural inflammation that may involve any part of the DIGESTIVE TRACT from MOUTH to ANUS, mostly found in the ILEUM, the CECUM, and the COLON. In Crohn disease, the inflammation, extending through the intestinal wall from the MUCOSA to the serosa, is characteristically asymmetric and segmental. Epithelioid GRANULOMAS may be seen in some patients. Colitis, Granulomatous,Enteritis, Granulomatous,Enteritis, Regional,Ileitis, Regional,Ileitis, Terminal,Ileocolitis,Crohn's Disease,Crohn's Enteritis,Inflammatory Bowel Disease 1,Regional Enteritis,Crohns Disease,Granulomatous Colitis,Granulomatous Enteritis,Regional Ileitides,Regional Ileitis,Terminal Ileitis
D005260 Female Females
D005500 Follow-Up Studies Studies in which individuals or populations are followed to assess the outcome of exposures, procedures, or effects of a characteristic, e.g., occurrence of disease. Followup Studies,Follow Up Studies,Follow-Up Study,Followup Study,Studies, Follow-Up,Studies, Followup,Study, Follow-Up,Study, Followup
D005765 Gastrointestinal Agents Drugs used for their effects on the gastrointestinal system, as to control gastric acidity, regulate gastrointestinal motility and water flow, and improve digestion. Digestants,Gastric Agents,Gastric Drugs,Gastrointestinal Drugs,Agents, Gastric,Agents, Gastrointestinal,Drugs, Gastric,Drugs, Gastrointestinal
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man

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