Infliximab: Dosing interval lengthening from 8 to 12 weeks
Adalimumab: Dosing interval lengthening from 2 to 3 weeks
Study summary
BACKGROUND/RATIONALE:
Treatment outcomes of patients with inflammatory bowel disease (IBD) have improved enormously during the past decade due to the use of anti-tumour necrosis factor (anti-TNF) therapy. As a result, 67 to 91% of paediatric patients and 66% of adult patients is still in sustained remission two years after the initiation of anti-TNF therapy. Prolonged use of anti-TNFs comes with disadvantages such as dose dependent susceptibility to infections and dermatological adverse effects. Preliminary, mostly uncontrolled studies suggest that dose reduction by dosing interval lengthening is a realistic option in a relevant proportion of patients with IBD, provided that intensive follow-up is applied.
OBJECTIVE:
To evaluate whether a faecal calprotectin (FC) guided strategy of anti-TNF dosing interval lengthening is non-inferior in maintaining remission in patients with IBD, compared with an unchanged dosing interval.
Eligibility
Sex
ALL
Min age
12 Years
Max age
25 Years
Healthy volunteers
No
Inclusion Criteria:
* Aged 12-25 years
* Diagnosed with luminal Crohn's disease or ulcerative colitis
* Treated with either 8-weekly infliximab or 2-weekly adalimumab
* Current anti-TNF agent as first ever anti-TNF agent or prior anti-TNF agent discontinued for reason other than primary non-response or secondary loss-of-response
* No previous attempts to lengthen the dosing interval
* Three consecutive faecal calprotectin (FC) results in the target range (i.e. \<250 μg/g for CD patients; \<150 μg/g for UC patients) in the previous 6 months or confirmed endoscopic remission within 2 months before study entry (i.e. simple endoscopic score for Crohn's disease (SES-CD) \<3 points for CD patients; ulcerative colitis endoscopic index of severity (UCEIS) ≤1 point for UC patients)
* Absence of symptoms associated with active IBD (judged by the local IBD-team)
* Written informed consent granted
Exclusion Criteria:
* Perianal fistula
* Presence of ileostomy or ileoanal pouch (as FC cut-off is not validated for small bowel faeces)
* Any inflammatory comorbidity, such as rheumatoid arthritis
* Current treatment with corticosteroids (prednisone or budesonide)
* Current pregnancy
Primary outcome measure(s)
cumulative incidence of out-of-range fecal calprotectin results at 48 weeks follow-up — 48 weeks Out-of-range FC results are defined as fecal calprotectin above the target range (i.e. \>250 μg/g for CD patients; \>150 μg/g for UC patients) and at least 100 μg/g increase compared with the previous result, unless the previous result was already above the target range.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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