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

NCT07529236 — Not applicable, Recruiting, 40 participants, Centre Hospitalier Universitaire de Nice

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Digestive Evolution of Children With Crohn's Disease or Ulcerative Colitis Whose Anti-TNFα Was Switched to Ustekinumab Due to Paradoxical Psoriasis: Real Life Data

Registry	NCT07529236, acronym INFLISWITCH
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, other
Enrollment	40 (Estimated)
Sponsor	Centre Hospitalier Universitaire de Nice (Other)
Conditions	Chronic Inflammatory Bowel Diseases
Interventions	switch of anti TNF for ustekinumab for paradoxical psoriasis. (Drug)
Dates	start 2026-04-20, primary completion 2027-10-01 (estimated), completion 2027-10-01 (estimated), first posted 2026-04-14, last updated 2026-06-25
Locations	1 site in France

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
ustekinumab	Other	Drug: switch of anti TNF for ustekinumab for paradoxical psoriasis.	switch of anti TNF for ustekinumab for paradoxical psoriasis.

switch of anti TNF for ustekinumab for paradoxical psoriasis. (Drug): 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

+Outcome measures

Primary outcomes

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).

Secondary outcomes

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
Specify the dermatological evolution of patients with IBD after stopping anti-TNFα and introduction of ustekinumab for paradoxical psoriasis resistant to usual treatments. [at Month 6]: The digestive status of patients will be assessed by disease-specific severity scales, Pediatric Ulcerative Colitis Activity Index (PUCAI) (from 0 to 85) for children with UC.
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, Pediatric Ulcerative Colitis Activity Index : PUCAI (from 0 to 85) for children with UC.
Specify the dermatological evolution of patients with IBD after stopping anti-TNFα and introduction of ustekinumab for paradoxical psoriasis resistant to usual treatments. [at Month 6]: 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

+Eligibility

Sex: All, ages: 6 Years to 17 Years

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

+Locations (1)

Facility	City	Country	Status
CHU de Nice	Nice, France	France	Recruiting

+Investigators

Christine CHIAVERINI, Principal investigator, Centre Hospitalier Universitaire de Nice