Digestive Evolution of Children With Crohn's Disease or Ulcerative Colitis Whose Anti-TNFα Treatment Was Switched to Ustekinumab Due to Paradoxical Psoriasis,

Condition(s) studied

Investigational drug(s) / intervention(s)

switch 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

Study 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.

Eligibility

Primary outcome measure(s)

• 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)
• Proportion of patients maintaining UC or CD control between anti-TNF-α discontinuation (M0) and 3-6 months of ustekinumab treatment (M3-M6) — at Month 6
  Severity scores for ulcerative colitis (PUCAI: Pediatric Ulcerative Colitis Activity Index 0 to 65).
• 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 0 to 100)
• 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 ulcerative colitis (PUCAI: Pediatric Ulcerative Colitis Activity Index0 to 65).

Trial sites (1)

More Centre Hospitalier Universitaire de Nice trials in France