Issue 02

Clinical Question

Will an “on demand” infliximab (IFX) treatment algorithm achieve similar efficacy to continuous maintenance therapy in patients with ulcerative colitis (UC)? (On demand = induce to remission then discontinue then re-start at relapse.)

Editor’s Bottom Line

An “on demand” IFX treatment regimen, in the presence of ongoing immunosuppressive therapy, achieves remission rates close to continuous maintenance therapy. HOWEVER, in this study the surgical rates and patient dropout rates were high.

Editorial Comment

While this study is intriguing and does confirm what we already know, that is, IFX can be re-started to gain remission after being discontinued, this treatment regimen should not replace continuous maintenance therapy until further randomized controlled trials are completed.

Reference

Johnsen KM, Goll R, Hansen V, et al. Repeated intensified infliximab induction – results from an 11-year prospective study of ulcerative colitis using a novel treatment algorithm. Eur J Gastroenterol Hepatol. 2017 Jan;29(1):98–104. https://www.ncbi.nlm.nih.gov/pubmed/27749779

Synopsis

This study examined the ability to stop and then re-start infliximab after a successful induction. Hospitalized patients with steroid refractory or dependent UC were prospectively recruited and followed from 2004–2015.

IFX (5 mg/kg) as induction therapy was administered at 0, 2, and 6 weeks, and then every 4 weeks thereafter until clinical remission + (3 x normal fecal calprotectin or normal endoscopy) was achieved. All patients received concurrent immunosuppressant and 5-ASA therapy.

IFX was discontinued once patients were in remission. Following IFX discontinuation, patients were assessed (clinically + fecal calprotectin) monthly for 3 months, then once every 3 months. If relapse was suspected, endoscopy was performed to confirm disease recurrence. Relapsers repeated the IFX induction regimen.

Of 116 enrolled patients (intention to treat, ITT), the median time of follow-up was 47 months. Long-term remission without IFX infusions was achieved in 48 (41%) patients over 48 months (Table 1). Surgery was required for 24 patients. Over 5 years, this IFX induction-discontinuation algorithm successfully maintained remission in 66%.

Table 1

Details

Study Design: Prospective, open-label cohort
Funding: Northern Norwegian Regional Health Authority
Allocation: n/a
Setting: Norway
Level of Evidence: 2b (Oxford Levels of Evidence)

The summary and conclusion in this issue of E-mentoring in IBD pertains to the manuscript(s) being reviewed, and should be considered in the context of what is already known surrounding the topic and incorporated into practice as deemed appropriate by the individual learner.