1.1 The LISA‑TRACKER, IDKmonitor and Promonitor enzyme‑linked immunosorbent assay (ELISA) kits show promise for therapeutic monitoring of tumour necrosis factor (TNF)‑alpha inhibitors in people with Crohn's disease but there is insufficient evidence to recommend their routine adoption across the NHS.
1.2 Laboratories currently using LISA‑TRACKER, IDKmonitor and Promonitor ELISA kits for therapeutic monitoring of TNF‑alpha inhibitors in people with Crohn's disease whose disease loses response to TNF‑alpha inhibitors should:
have specialist expertise in immunoassay analysis, including an understanding of the technical factors that may affect the results of the ELISA kits
work closely with the treating or referring clinician, in a network, to ensure appropriate use of the tests and interpretation of the results
work with clinicians to collect data through a prospective study, for local audit, or for submission to an existing registry. (The IBD Registry is being adapted to receive data on TNF‑alpha inhibitor levels and antibodies against TNF‑alpha inhibitors. When this facility is available, all data should be entered onto the database; see section 7.2).
1.3 Further research is recommended on the clinical and cost effectiveness of using LISA‑TRACKER, IDKmonitor and Promonitor ELISA kits for therapeutic monitoring of TNF‑alpha inhibitors in people with Crohn's disease whose disease responds to treatment with TNF‑alpha inhibitors (see section 7.3).
This guidance considers ELISA kits for therapeutic monitoring of TNF‑alpha inhibitors in 2 different populations:
people with Crohn's disease, whose disease loses response to treatment with TNF‑alpha inhibitors (that is, people whose disease first responds to treatment, but stops responding over time, so may need a higher dose of TNF‑alpha inhibitor to try to recover a clinical response)
people with Crohn's disease, whose disease responds to treatment with TNF‑alpha inhibitors (that is, people whose disease responds well to treatment and who may continue having the same level of treatment).
People whose disease does not respond to treatment in the induction phase of treatment are not considered in this assessment.
NICE's technology appraisal guidance on vedolizumab for treating moderately to severely active Crohn's disease after prior therapy was published while this guidance was in development. NICE will consider adding vedolizumab into the economic model as a treatment option in the care pathway of people with Crohn's disease when the diagnostics guidance is reviewed for the need to update.