Abstract
SummaryBackgroundInfliximab and adalimumab have established roles in inflammatory bowel disease (IBD) therapy. UK regulators mandate reassessment after 12 months' anti‐TNF therapy for IBD, with consideration of treatment withdrawal. There is a need for more data to establish the relapse rates following treatment cessation.AimTo establish outcomes following anti‐TNF withdrawal for sustained remission using new data from a large UK cohort, and assimilation of all available literature for systematic review and meta‐analysis.MethodsA retrospective observational study was performed on 166 patients with IBD (146 with Crohn's disease (CD) and 20 with ulcerative colitis [UC) and IBD unclassified (IBDU)] withdrawn from anti‐TNF for sustained remission. Meta‐analysis was undertaken of all published studies incorporating 11 further cohorts totalling 746 patients (624 CD, 122 UC).ResultsRelapse rates in the UK cohort were 36% by 1 year and 56% by 2 years for CD, and 42% by 1 year and 47% by 2 years for UC/IBDU. Increased relapse risk in CD was associated with age at diagnosis [hazard ratio (HR) 2.78 for age <22 years], white cell count (HR 3.22 for >5.25 × 109/L) and faecal calprotectin (HR 2.95 for >50 μg/g) at drug withdrawal. Neither continued immunomodulators nor endoscopic remission were predictors. In the meta‐analysis, estimated 1‐year relapse rates were 39% and 35% for CD and UC/IBDU respectively. Retreatment with anti‐TNF was successful in 88% for CD and 76% UC/IBDU.ConclusionsAssimilation of all available data reveals remarkable homogeneity. Approximately one‐third of patients with IBD flare within 12 months of withdrawal of anti‐TNF therapy for sustained remission.
Highlights
Tumour necrosis factor (TNF) antagonists, notably infliximab (IFX) and adalimumab (ADA) are firmly established induction and maintenance agents in Crohn’s disease (CD) and ulcerative colitis (UC).[1,2,3,4] The European Crohn’s and Colitis Organisation (ECCO) recommend their use for CD that is refractory to steroids or relapses after initial therapy, as second-line therapy in patients with acute severe UC and in patients with immunomodulator-refractory UC.[5, 6] despite the advent of biosimilar infliximab, the drugs are expensive[7] and there remain some concerns over long-term safety
Increased relapse risk in CD was associated with age at diagnosis [hazard ratio (HR) 2.78 for age 5.25 9 109/L) and faecal calprotectin (HR 2.95 for >50 lg/g) at drug withdrawal
Retreatment with anti-TNF was successful in 88% for CD and 76% UC/IBD unclassified (IBDU)
Summary
Tumour necrosis factor (TNF) antagonists, notably infliximab (IFX) and adalimumab (ADA) are firmly established induction and maintenance agents in Crohn’s disease (CD) and ulcerative colitis (UC).[1,2,3,4] The European Crohn’s and Colitis Organisation (ECCO) recommend their use for CD that is refractory to steroids or relapses after initial therapy, as second-line therapy in patients with acute severe UC and in patients with immunomodulator-refractory UC.[5, 6] despite the advent of biosimilar infliximab, the drugs are expensive (approximately £6–10 000 per annum)[7] and there remain some concerns over long-term safety. Serious potential adverse effects include immunogenicity, opportunistic infections, melanoma.[8, 9] Once sustained deep remission has been achieved on maintenance anti-TNF therapy clinicians, patients and payers may all have different motivations for a trial of drug withdrawal. In the UK, the National Institute for Clinical Excellence (NICE) and the Scottish Medicines Consortium (SMC) mandate reassessment at 12 monthly intervals with a consideration of drug cessation where patients are in stable remission. We recruited a large retrospective uncontrolled cohort of patients from the UK, all withdrawn from anti-TNF therapy for sustained clinical remission, and assessed possible predictive factors for relapse and the success of drug reintroduction. We performed a systematic review of the published literature and conference abstracts with a meta-analysis of all relevant data
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