evaluation of the effectiveness of kits promonitor-ifx/adl and promonitor-anti-ifx/adl in patients with ibd

Conditions: Crohn Disease and Ulcerative Colitis

Summary: 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.

Eligibility criteria:
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.

Keywords: ibd, anti-tnfα, promonitor-ifx/adl, promonitor-anti-ifx/adl