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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Inflammatory Bowel Diseases
• Intervention / Treatment: Drug: switch of anti TNF for ustekinumab for paradoxical psoriasis.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Christine Chiaverini, Dr; Phone Number: 04 92 03 47 02; Email: chiaverini.c@chu-nice.fr

Study Locations

• France
  • France
    • Nice, France, France, 06000
      • CHU de Nice
      • Contact: Christine CHIAVERINI, Doctor; Phone Number: 0492034702; Email: chiaverini.c@chu-nice.fr
      • Principal Investigator: Christine CHIAVERINI, Doctor
      • Sub-Investigator: Thomas HUBICHE, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

children

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ustekinumab; switch of anti TNF for ustekinumab for paradoxical psoriasis.	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients maintaining UC or CD control between anti-TNF-α discontinuation (M0) and 3-6 months of ustekinumab treatment (M3-M6)	Severity scores for Crohn disease (PCDAI: The Pediatric Crohn's Disease Activity Index 0 to 100)	at baseline Month 0
Proportion of patients maintaining UC or CD control between anti-TNF-α discontinuation (M0) and 3-6 months of ustekinumab treatment (M3-M6)	Severity scores for ulcerative colitis (PUCAI: Pediatric Ulcerative Colitis Activity Index 0 to 65).	at Month 6
Proportion of patients maintaining UC or CD control between anti-TNF-α discontinuation (M0) and 3-6 months of ustekinumab treatment (M3-M6)	Severity scores for Crohn disease (PCDAI: The Pediatric Crohn's Disease Activity 0 to 100)	at baseline Month 0
Proportion of patients maintaining UC or CD control between anti-TNF-α discontinuation (M0) and 3-6 months of ustekinumab treatment (M3-M6)	Severity scores for ulcerative colitis (PUCAI: Pediatric Ulcerative Colitis Activity Index0 to 65).	at baseline Month 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specify the dermatological evolution of patients with IBD after stopping anti-TNFα and introduction of ustekinumab for paradoxical psoriasis resistant to usual treatments.	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	at baseline Month 0
Specify the dermatological evolution of patients with IBD after stopping anti-TNFα and introduction of ustekinumab for paradoxical psoriasis resistant to usual treatments.	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.	at Month 6
Specify the dermatological evolution of patients with IBD after stopping anti-TNFα and introduction of ustekinumab for paradoxical psoriasis resistant to usual treatments.	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.	at baseline Month 0
Specify the dermatological evolution of patients with IBD after stopping anti-TNFα and introduction of ustekinumab for paradoxical psoriasis resistant to usual treatments.	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	at Month 6

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Christine CHIAVERINI, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Estimated): April 19, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Ustekinumab
• Other Study ID Numbers: 25-PP-16; IDRCB (Other Identifier: 2025-A01568-41)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No