N/A
N=72
Study Evaluating the Safety and Effectiveness of Etanercept for the Treatment of Pediatric Psoriasis
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT01100034 ↗Enrolled (actual)
72
Serious AEs
15.3%
Results posted
Oct 2019
Primary outcome: Primary: Number of Participants With Serious Infections, Opportunistic Infections of Interest and Malignancies: Prospective Participants — 0; 0; 0 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Etanercept (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serious Infections, Opportunistic Infections of Interest and Malignancies: Prospective Participants |
0; 0; 0 | — |
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Prospective Participants |
26; 3 | — |
| PRIMARY Number of Participants Who Discontinued From Etanercept During Initial Treatment Period: Prospective Participants |
3 | — |
| PRIMARY Number of Participants Who Discontinued From Etanercept After Initial Treatment Period: Prospective Participants |
4 | — |
| PRIMARY Percentage of Participants Who Required Subsequent Treatment With Etanercept or Other Systemic Therapies After Completion of Initial Treatment Period: Prospective Participants |
17.9; 26.7 | — |
| SECONDARY Duration of Subsequent Etanercept Treatment After Completion of Initial Treatment Period |
146.3 | — |
Summary
Psoriasis is a chronic, often severe, autoimmune condition that affects approximately 2% of the world's population. The epidemiology of pediatric psoriasis has not been well documented and no treatment guidelines exist for pediatric psoriasis.
Etanercept is a biologic drug and has been licensed for the treatment of chronic severe plaque psoriasis in children and adolescents (6-17 years of age) who are inadequately controlled by or are intolerant to, other systemic therapies or phototherapies. Although the long-term safety and efficacy of etanercept in children with juvenile idiopathic arthritis (JIA) has been studied and the short-term safety profile of etanercept in both JIA and pediatric psoriasis appears similar, there is limited data available about the long-term effects of etanercept in pediatric psoriasis, especially with respect to malignancy. The aim of this study is to assess the safety and effectiveness of etanercept for the treatment of pediatric psoriasis in Europe. Patients aged <=17 with plaque psoriasis diagnosed by a dermatologist will be invited to participate in the registry only after a clinical decision has been made to prescribe etanercept. The safety of the drug and how well the drug works will be evaluated during the follow-up period. The follow-up period will last 5 years and patients will be followed up every 3 months for the first 2 years and every 6 months for the next 3 years or until the end of study.
Eligibility Criteria
Inclusion Criteria
- 17 years of age or younger
- Diagnosed with plaque psoriasis by a dermatologist.
- Prior to enrollment, there must be a clinical decision to initiate etanercept for the treatment of plaque psoriasis and etanercept must then be initiated.
- Actively being treated with etanercept, regardless of length of treatment prior to enrollment
- Willing to provide written informed consent
Exclusion Criteria
- Prior therapy with any biologic agent other than etanercept
- History of malignancy
Data sourced from ClinicalTrials.gov (NCT01100034). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.