Evaluation of the Effectiveness of Kits Promonitor-IFX/ADL and Promonitor-Anti-IFX/ADL in Patients With IBD

Evaluation of the Effectiveness of Kits Promonitor-IFX/ADL and Promonitor-Anti-IFX/ADL to Assist in Taking Clinical Decisions in Patients With IBD Treated With IFX or ADA

To establish the efficacy, safety, effectiveness and efficiency of monitoring the levels of anti-TNFα drugs and the levels of antibodies generated against these drugs in the treatment of patients with moderate or severe IBD (CD/CU).

An analysis will be made of the economic impact on the Health System of monitoring treatment with anti-TNFα drugs in CD/CU.

As a result of this specific objective, a standardized procedure will be established for the evaluation of the response to treatment with anti-TNFα drugs for CD/CU that includes the new trials and the new devices developed.

• To evaluate whether a dose and plasma level optimization strategy based on the use of Promonitor-IFX, Promonitor-Anti-IFX, Promonitor-ADL, and Promonitor-Anti-ADL kits in CD/CU patients on IFX/ADL treatment is superior in terms of the percentage of patients in clinical remission at 12 months compared to standard practice.
• To evaluate whether a dose and plasma level optimization strategy based on the use of Promonitor-IFX, Promonitor-Anti-IFX, Promonitor-ADL, and Promonitor-Anti-ADL kits in CD/CU patients on IFX/ADL treatment is superior in terms of the percentage of patients in deep remission at 12 months compared to standard practice.
• To analyze the influence of the use of the IFX/ADL antibody detection test in moderate to severe CD/CU patients on the annual direct cost to the health system of these patients, compared to the non-use of the tests.
• To evaluate the effectiveness of IFX/ADL antibody testing in moderate to severe CD/CU patients on the increase in quality-adjusted life-years compared to non-use of the tests.
• To evaluate the effectiveness of testing for antibodies to IFX/ADL in moderate to severe CD/CU patients in reducing the number of flares, compared to not using the tests.

Exploratory objective - To conduct a cost-effectiveness (utility) analysis of a strategy for the management of stable moderate to severe CD/CU patients based on treatment monitoring.

Page 10 of 83 anti-TNFα with the introduction of screening tests for plasma levels/antibodies to IFX/ADL with respect to standard practice based on clinical signs/symptoms.

Main operational objective

- To assess whether the prevalence of 1-year remission in moderate to severe CD/CU patients whose anti-TNFα treatment has been managed using Promonitor IFX/ADL kits is at least 16% higher compared to the group of patients in whom this technique has not been employed.

Inclusion criteria:

• patients of both sexes
• over 18 years of age
• diagnosis of CD/CU confirmed by endoscopy
• stable clinical status (remission) for at least 12 weeks prior to inclusion in the study
• on treatment with IFX/ADL for at least 3 months with stabilized dosage and outside the induction period
• negative for tuberculosis at the start of treatment
• who sign the informed consent form

Exclusion criteria:

• severe concomitant pathology preventing adequate follow-up of patients.
• continued corticosteroid therapy at prednisone equivalent doses higher than 40 mg/day
• patients with positive antibody levels at baseline
• there is treatment with immunomodulators and/or corticoids, when it is at high doses and with variations in time
• Patients with intestinal resection and Crohn's disease in prophylactic treatment with anti-TNF, but without recurrence.
• who are participating in a clinical trial or interventional study. Participation in the study will be offered to all patients who meet the above criteria, and in a consecutive manner, without a prior selection process. The comparison group will consist of a cohort of patients belonging to the same Digestive Services and meeting the same selection criteria.