The LISA-TRACKER ELISAs (Theradiag), IDKmonitor ELISAs (Immundiagnostik AG), and Promonitor ELISAs (Proteomika S.L.U) are intended for measuring the levels of drugs called TNF-alpha inhibitors and the levels of antibodies against TNF-alpha inhibitors in the blood of people with Crohn’s disease.

Crohn's disease is an incurable long-term, chronic, relapsing-remitting condition that causes inflammation of the lining of the digestive system (gut). Symptoms include diarrhoea, abdominal pain and cramping, extreme tiredness and unintended weight loss.

The aims of treatment are to induce remission (active treatment of acute disease) and maintain remission (preventing relapse) while reducing symptoms and maintaining or improving quality of life. In some cases, surgery may be needed to remove the inflamed section of the gut.

TNF-alpha inhibitors help to stop the inflammatory responses in the gut characteristic of Crohn’s disease. The TNF-alpha inhibitors adalimumab and infliximab are recommended by NICE as treatment options for adults with severe, active Crohn’s disease that has not responded to conventional treatment with corticosteroids, or who are intolerant to conventional treatment.

Commenting on the draft guidance, Professor Carole Longson, Director of the NICE Health Technology Evaluation Centre, said: “Tests that can accurately measure levels of TNF inhibitors and antibodies to TNF inhibitors could enable people with Crohn’s disease to receive treatment that’s better tailored to their needs to allow treatment optimisation with fewer side effects.

“The tests reviewed in this draft guidance show real promise. But the Committee was concerned that, because of the complexities in interpreting test results there is a risk they could be incorrectly used by clinicians without specialist knowledge of immunoassay analysis. The Committee therefore concluded that in people with Crohn’s disease whose disease loses response to TNF alpha inhibitors, for the time being, these tests should be used only in those laboratories that have specialist expertise in immunoassay analysis. These laboratories should work closely with clinicians who refer samples for testing, to ensure appropriate use of the tests and interpretation of the results. The recommendations highlight that these clinicians and laboratories should work together to collect data on the use of the tests through a relevant registry, audit or prospective study in order to gather more evidence to allow an update of this guidance in the future.”

Although TNF inhibitors can bring benefits to many patients with Crohn’s disease, there are some patients whose disease does not respond to treatment with TNF inhibitors. There are also a large proportion of patients whose disease initially responds to treatment but who find their disease stops responding over time. This can be caused by changes in disease characteristics over time, inflammation unrelated to TNF concentrations, the presence of antibodies to TNF inhibitors, or fluctuations in the drug levels circulating in the body.

Being able to tailor TNF inhibitor treatment to the person with Crohn’s disease can be difficult because at the moment treatment decisions are commonly based on clinical judgement and ‘trial and error’. This can mean that people whose disease responds well to treatment with a TNF inhibitor may continue to receive the same level of treatment even though a decrease in dose or withdrawing it altogether may be possible without any detrimental impact on clinical outcomes. This continued treatment may lead to patients experiencing side-effects of the treatment unnecessarily.

People whose disease loses response to TNF inhibitors are often given a bigger dose in an attempt to bring back the decreasing clinical response. Although this can be successful for some, for others the intensified treatment regimen means continuing to receive an expensive drug from which they do not benefit, and from which they may experience treatment side-effects unnecessarily.

The draft guidance also recommends that, in people with Crohn’s disease whose disease responds to treatment with TNF inhibitor, the tests should only be used in research for monitoring levels of TNF inhibitors and antibodies to TNF inhibitors. 

Ends

For more information call the NICE press office on 0300 323 0142/ pressoffice@nice.org.uk or out of hours on 07775 583 813.

Notes to editors

About the draft guidance

1. The draft diagnostics guidance on tests for therapeutic monitoring of TNF inhibitors is available on the NICE website at http://www.nice.org.uk/guidance/dg18  

About Crohn’s disease

1. There are currently around 115,000 people living with Crohn's disease in the UK. It can affect people of all ages, including children. However, most cases first develop between the ages of 16 and 30. 
2. There is currently no cure for Crohn's disease, so the aim of treatment is to stop the inflammatory process, relieve symptoms (induce and maintain remission) and avoid surgery wherever possible.
3. The first treatment offered to reduce symptoms is usually steroid medication (corticosteroids). If this doesn't help, medication to suppress the immune system (immunosuppressants) and medication to reduce inflammation, including TNF inhibitors, may be used.
4. Once symptoms are under control (in remission), further medication may be needed to help maintain this.

About the NICE Diagnostics Assessment Programme

1. For further information about the NICE diagnostics assessment programme see Developing NICE diagnostic technologies guidance  
   1. Topics to be considered by the Programme are routed through the related Medical Technologies Evaluation Programme. Further information about this can be found at Developing NICE medical technologies guidance