Participants
perianal, perianal fistulae, intra-abdominal fistulae
REMISSION, RECRUITMENT, CROHN'S DISEASE, INFUSION REACTION
To be eligible, all of the following criteria had to be met at recruitment: an established diagnosis of Crohn's disease, age 18 years or older, treatment with combination therapy with scheduled infliximab (5 mg/kg every 8 weeks over the past 4 months at least) and immunosuppressant therapy (stable dose for the past 3 months) for at least 8 months for luminal Crohn's disease, steroid-free clinical remission for at least 6 months according to retrospective assessment of the patients' medical files, Crohn's Disease Activity Index (CDAI) of less than 150 at baseline,Patients were eligible provided that immunosuppressant therapy doses were stable for the past 3 months or more at at least 1 mg/kg for mercaptopurine or 2 mg/kg for azathioprine, or the highest tolerated dose if intolerance to these standard doses; lower doses were also allowed if 6-thioguanine nucleotides (6-TGN) were higher than 235 pmol per 8 × 10Key exclusion criteria included previous severe acute or delayed infusion reaction to infliximab, perianal fistulae as the main indication for infliximab treatment, active perianal or intra-abdominal fistulae at inclusion defined by active drainage, steroid use within 6 months before screening, and ongoing treatment with steroids, immunosuppressive drugs (other than thiopurines or methotrexate), biologics (other than infliximab), or thalidomide.