Introduction With the recent NICE guidelines giving clearance for the use of infliximab, golimumab and adalimumab in moderate-severe ulcerative colitis, there is a general fear held by the Clinical Commissioning Groups (CCGs) that the cost of biological therapy is about to rapidly escalate. Cheaper biosimilars will soon join the market place, but already many CCGs have restricted funding to just 1 year and advocate stopping if the patient is in clinical remission. Given these funding restrictions we assess the outcomes seen in those patients stopping biological therapy.
Method A 5 year retrospective review was made of the 94 inflammatory bowel disease (IBD) patients that have been treated with biologics at the Luton and Dunstable University Hospital. Data was obtained from the National IBD Registry, Evolve (the hospital’s electronic note system), and ICE (the hospitals results system). Full remission was defined as asymptomatic patients with near normal inflammatory markers and complete mucosal healing or minimal endoscopic inflammation only.
Results There were 94 IBD patients treated with biological therapy between January 2010 and December 2014. Biologics were stopped in 49 patients, of which 36 were deemed to be in full remission. Biological therapy was also stopped because of treatment failure requiring surgery (eg.colectomy) in 6, 2 were in remission but needed surgery for subsequent colorectal cancer, 3 patients fell pregnant (all initially in clinical remission, although 2 subsequently flared and were restarted), the injection was too painful for 2, 1 was non-compliance and 1 had an infusion reaction. In the group of 36 that achieved full remission (25CrD, 2CrD Fistulae, 9UC), 31 (86%) of them stayed in remission after stopping their biologics, with an average follow up time of 13 months (4–42 months), at the point of writing this abstract. Of the 5 patients in remission that flared, 2 CrD patients flared post-delivery, 1 UC patient flared, and 2 CrD patients flared with the complications of fistulae and/or strictures requiring surgery. Of the 13 patients who weren’t in remission on stopping the biologics, only 2 of them settled into remission using alternative therapies.
Conclusion Provided patients are in a full remission our data supports an efficacy of 86% in stopping biological therapy and then managing patients on traditional immunosuppressor therapies, at least in the first year. Caution must however be observed, as 2 of the unpredictable relapses that did occur on stopping biological therapy resulted in young patients having to undergo surgery. A greater overall success rate may have been achieved with tighter initial case selection by gastroenterologists with a specialist experience in IBD or through open discussions at a Biologics MDT.
Disclosure of interest None Declared.
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