Correlation Between RISANKIZUMAB's Trough Levels, Clinical and Biological Remission in Moderate to Severe Crohn's Disease: a Retrospective Multicentric Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Clinical and biological remission without corticosteroids 12 months after introduction of RISANKIZUMAB treatment.
Study Overview
Brief Summary
The goal of this observational study is to determine if, as with other therapeutics such as anti-TNF, trough levels of Risankizumab are correlated with clinical and biological remission in patients with moderate to severe Crohn's disease. As part of their regular biological surveillance, trough levels of Risankizumab were mesured and clinical and biological data were collected to determine if biological and clinical remission criteria were met.
Detailed Description
The treatment of chronic inflammatory bowel disease has undergone a number of therapeutic revolutions in recent years, with the emergence of new biotherapies. These include RISANKIZUMAB, an anti-IL23 p19, whose ADVANCE , MOTIVATE and FORTIFY studies have demonstrated its efficacy in the induction and maintenance phases of Crohn's disease. Reimbursement in France for this indication is expected in the final quarter of 2024.
While for first-line molecules such as anti-TNF alpha, the relationship between serum levels and clinical remission is accepted and allows to guide the therapeutic strategy for patients, it has yet to be demonstrated for new molecules of interest.
We enrolled patients with moderate to severe Crohn's disease on Risankizumab in four centers. Trough levels of Risankizumab were mesured as a part of their regular medical surveillance routine. For each consultation, biological and clinical data were collected to determine wether patients were in remission (according to our primary outcome) or not. Data were collected up to 18 months since the introduction of Risankizumab.
The objectives of this study were also to identify factors of primary or secondary failure of treatment, to determine clinical reponse rate, to evaluate tolerance and persistence of treatment.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18 years
- •Patients with moderate to severe Crohn's disease
- •Failure of at least one immunosuppressant and one anti-TNF alpha agent
- •Patients on Risankizumab
- •No opposition to study participation
Exclusion Criteria
- •Age < 18 years
- •Unclassified colitis
- •Risankizumab prescribed to prevent post-operative relapse
- •Any contraindication to Risankizumab
- •Refusal to participate in study
Outcomes
Primary Outcomes
Clinical and biological remission without corticosteroids 12 months after introduction of RISANKIZUMAB treatment.
Time Frame: 12 months
Defined by Harvey-Bradshaw score (HBI \< 4) and CRP \< 5 mg/L and/or calprotectin \< 250 µg/g.
Secondary Outcomes
- Predictive factors for primary or secondary treatment failure(18 months)
- Risk factors for immunisation(18 months)
- Risk factors for sub-therapeutics trough levels(18 months)
- Clinical response rates(6 months, 12 months and 18 months)
- Clinical and biological remission rates(6 months and 18 months)
- Drug discontinuation rates(18 months)