Abstract
ObjectiveIn patients with postoperative recurrence of Crohn’s disease endoscopic and clinical remission can be maintained for up to 1 year with low infliximab doses (3 mg/Kg). However, in theory low-dose infliximab treated patients could develop subtherapeutic trough levels, infiximab antibodies, and might loose response to therapy. To verify this hypothesis infliximab pharmacokinetics and clinical/endoscopic response were checked in a group of patients treated in the long term with low infliximab doses.DesignInfliximab antibodies, infliximab levels, highly-sensitive CRP and fecal calprotectin were measured during the 8-week interval in 5 consecutive patients in clinical (Crohn’s Disease Activity Index < 150) and endoscopic (Rutgeerts scores 0–1) remission after one year of therapy with infliximab 3 mg/Kg. For comparison with reported standards, infliximab pharmacokinetics and inflammatory parameters were also tested in 6 Crohn’s disease patients who did not undergo surgery and who were in clinical remission while on infliximab 5 mg/Kg. Patients on low infliximab dose also underwent colonoscopy after 18 additional months of therapy.ResultsHighly sensitive CRP and fecal calprotectin increased in all patients during the 8-week interval. Infliximab trough levels were lower in patients treated with the low dose compared to controls (mean±SE: 2.0±0.3 vs 4.75±0.83 μg/mL respectively p<0.05). Infliximab antibodies were present in two of the subjects treated with low infliximab dose and in none of the controls. However, in low dose-treated patients after 18 additional months of therapy endoscopy continued to show mucosal remission and none of them developed clinical recurrence or side effects.ConclusionsPatients treated with low infliximab doses had lower trough levels compared to patients treated with 5 mg/Kg and some developed antibodies to infliximab. However, low infliximab doses sustained clinical and endoscopic remission for a total of 30 months of treatment.
Highlights
Since 2006, the monoclonal anti-TNF-α antibodies infliximab and adalimumab have been shown in several studies to be highly effective in preventing post-operative recurrence [POR] of Crohn’s disease [CD] [1]
Infliximab trough levels were lower in patients treated with the low dose compared to controls
Low Dose Infliximab for Postsurgical Crohn's Disease Relapse authors have no conflicts of interest to disclose
Summary
Since 2006, the monoclonal anti-TNF-α antibodies infliximab and adalimumab have been shown in several studies to be highly effective in preventing post-operative recurrence [POR] of Crohn’s disease [CD] [1]. Initial studies from our group showed that maintenance infliximab is effective in preventing POR in the long term [2]–a finding recently confirmed by others [3]. Stopping infliximab has been proposed by some authors [10,11] this is followed by prompt endoscopic disease relapse [2], eventually leading to clinical recurrence [3]. To address this issue, we proposed in a pilot study a dose titration strategy, with the goal of finding the minimal effective dose of infliximab in patients with endoscopic recurrence after surgery [2]. We showed that a dose of 3 mg/Kg was capable of inducing and maintaining endoscopic and clinical remission for up to 1 year in all patients [2]
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