Chronic Inflammatory Bowel Diseases
Conditions
Brief summary
Inflammatory bowel diseases (IBD) include Crohn's disease (CD) and ulcerative colitis (UC). They cause abdominal pain and chronic diarrhea and/or rectal bleeding, which can lead to weight loss and malnutrition. IBD affects people of all ages but usually appears before the age of 30, most often between the ages of 14 and 24. Childhood IBD is generally considered to be more progressive than adult IBD. Although there is no cure for IBD, many medications can help reduce inflammation and relieve IBD symptoms. Anti-TNF drugs (infliximab and adalimumab) are used early in high-risk patients or when standard treatments have failed. Cutaneous side effects are common in pediatrics (\>10%), primarily psoriasiform eruptions (41%), often exudative, affecting skin folds and scalp, recurrent skin infections (20%), and eczematous eruptions (10%). Only 5% of patients need to discontinue treatment due to these side effects. In such cases, the recommended treatment is ustekinumab (European guidelines). While this treatment has been described as effective in patients who have failed anti-TNFα therapy, little data is available on the gastrointestinal and dermatological outcomes of patients on anti-TNFα therapy who switch to ustekinumab for dermatological reasons.
Interventions
DRUGswitch of anti TNF for ustekinumab for paradoxical psoriasis.
After traitement 6 months of ustekinumab the patients are inclued in the study and the Medical file are used to complete the CRF. no specific intervention in the study
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
retrospective and case only
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Patients capable of giving their non-opposition 2. Patient \<19 years 3. Diagnosis of IBD established 4. Having received an anti-TNFα for IBD for at least 3 months 5. Having stopped the anti-TNFα for a severe paradoxical psoriasis resistant to usual treatments (topical or systemic) diagnosed by a dermatologist 6. Having received Ustekinumab in relay of the anti-TNFα
Exclusion criteria
1. Patient \> 18 years 2. Diagnosis of IBD not confirmed 3. Discontinuation of anti-TNFα for a cause other than psoriasis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients maintaining UC or CD control between anti-TNF-α discontinuation (M0) and 3-6 months of ustekinumab treatment (M3-M6) | at baseline Month 0 | Severity scores for Crohn disease (PCDAI: The Pediatric Crohn's Disease Activity Index 0 to 100) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specify the dermatological evolution of patients with IBD after stopping anti-TNFα and introduction of ustekinumab for paradoxical psoriasis resistant to usual treatments. | at baseline Month 0 | The digestive status of patients will be assessed by disease-specific severity scales, namely the Pediatric Crohn's Disease Activity (PCDAI)(from 0 to 100) for patients with Crohn's disease |
Countries
France
Contacts
CONTACTChristine Chiaverini, Dr
PRINCIPAL_INVESTIGATORChristine CHIAVERINI
Centre Hospitalier Universitaire de Nice
Outcome results
None listed