Background Anti-tumour necrosis monoclonal antibodies are being used increasingly in both gastroenterology and rheumatology services at Southampton Children's Hospital. Concern has been raised that initiation may be outside the boundaries of the relevant National Institute for Health and Clinical Excellence (NICE) technology assessments or licensed indications. In addition, patients should be investigated for latent or active tuberculosis prior to starting treatment, usually with a Quantiferon Gold test and, if this is positive, then a chest x-ray should be requested.
Aim To review the use of infliximab and adalimumab at Southampton Children's Hospital.
Objectives Determine whether infliximab and adalimumab are being used according to NICE guidelines for IBD.
Determine whether adalimumab is being used within its licensed indications for juvenile idiopathic arthritis (JIA).
Establish whether all patients have a Quantiferon Gold test and/or a chest x-ray prior to starting treatment.
Method A retrospective review of electronic records for all patients administered infliximab and adalimumab between April 1st 2013 and March 31st 2014. A modified NICE audit tool was used to collect the data. Electronic records accessed included clinic letters, microbiology and radiology reports and pharmacy dispensing records.
Results Sixty two children met the criteria for inclusion in the audit. Fifty four received infliximab, 16 received adalimumab and 12 children received both. Forty-five children had a diagnosis of Crohn's disease, 12 had Juvenile Idiopathic Arthritis (JIA) and five had another diagnosis.
Fifty seven children had not responded to conventional immunosuppression, six were intolerant of first-line therapy and seven had another rationale for treatment e.g. severity of disease at diagnosis.
All the patients prescribed infliximab or adalimumab for an inflammatory bowel disease met the relevant NICE criteria for initiation of therapy. Use for JIA was within the licence.
Prior to starting treatment 15 (24%) patients had a Quantiferon Gold test, two of which were positive,
49 (79%) of patients had a chest x-ray and 15 (24%) patients had neither.
Conclusion Whilst, there are no NICE technology assessments for JIA, adalimumab is licensed for this indication, whereas infliximab is not. Six of the children who received infliximab for JIA had not responded to or had had an adverse reaction to adalimumab.
It is of significant concern that 15 children received either infliximab or adalimumab without apparently being assessed for tuberculosis (TB). There is confusion about the most appropriate test to perform to investigate a patient's TB status, with some having a chest x-ray and others a Quantiferon Gold. We are instigating a “No negative test – No Dispensing” rule, where clinical pharmacists will confirm a negative test result prior to ordering therapy.
The gastroenterologists, rheumatologists and infectious diseases clinicians are writing a guideline to improve the safe use of these treatments and clarify the most appropriate testing procedure prior to starting therapy.
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