Related Experiment Video
Updated: Jan 25, 2026
The Goeckerman Regimen for the Treatment of Moderate to Severe Psoriasis
Published on: July 11, 2013
Sustained long-term efficacy and safety of adalimumab in paediatric patients with severe chronic plaque psoriasis
1Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Ratzeburger Allee 160, 23435, Lübeck, Germany.
Insights
Long-term adalimumab treatment effectively reduced and maintained disease severity in children with severe plaque psoriasis over 52 weeks, with no new safety concerns identified. This study provides crucial data on adalimumab
Area of Science:
- Pediatric Dermatology
- Immunology
- Clinical Trials
Background:
- Adalimumab (ADA) is approved for severe plaque psoriasis in children aged four and older.
- Previous trial phases indicated ADA's efficacy and safety in this pediatric population.
Purpose of the Study:
- To assess the long-term efficacy and safety of adalimumab in children with severe plaque psoriasis.
- To evaluate treatment outcomes over a 52-week period.
Main Methods:
- A 52-week long-term extension of a Phase III trial.
- Pediatric patients (4-18 years) received adalimumab (0.8 or 0.4 mg/kg) or methotrexate (MTX).
- Patients transitioned between treatment arms or continued/discontinued treatment during the extension phase.
Main Results:
- Efficacy, measured by Psoriasis Area and Severity Index (PASI) improvement, was maintained or improved from entry to the end of the long-term extension.
- Specific PASI 75% improvement rates varied by treatment group (e.g., 31-86% for MTX(IT)/ADA 0.8(LTE)).
- No serious infections were reported during the long-term extension phase.
Conclusions:
- Adalimumab treatment over 52 weeks reduced and maintained disease severity in children with severe plaque psoriasis.
- No new safety risks were identified with long-term adalimumab use in this population.
- This study is the first to evaluate long-term adalimumab treatment and MTX-to-ADA switching in pediatric severe psoriasis.
Background:
Adalimumab (ADA) (Humira® , AbbVie Inc., U.S.A.) is approved by the European Medicines Agency for children aged ≥ 4 years with severe plaque psoriasis.
Objectives:
To evaluate the long-term efficacy and safety of ADA in children with severe plaque psoriasis.
Methods:
Results are presented from the 52-week long-term extension (LTE) of the randomized, double-blind, double-dummy, phase III trial, in children with severe plaque psoriasis (results from prior periods have been published). Patients aged ≥ 4 and < 18 years were randomized 1 : 1 : 1 to ADA 0·8 mg kg-1 (40 mg maximum) or 0·4 mg kg-1 (20 mg maximum) every other week or to methotrexate (MTX) 0·1-0·4 mg kg-1 (25 mg maximum) weekly. The 16-week initial treatment (IT) period was followed by a 36-week withdrawal period and a 16-week retreatment period. Patients could enter the LTE at prespecified time points to receive ADA 0·8 mg kg-1 (blinded or open label) or ADA 0·4 mg kg-1 (blinded), or to remain off treatment. Efficacy is reported for patient groups according to doses received in the IT and LTE periods.
Results:
Of the 114 patients randomized in the IT period, 108 entered the LTE (n = 36 in each group); 93 received ADA 0·8 mg kg-1 . Efficacy (≥ 75% improvement from baseline in Psoriasis Area and Severity Index) was maintained or improved from entry to the end of the LTE: MTX(IT)/ADA 0·8(LTE) 31-86% of patients; ADA 0·4(IT)/0·4 or 0·8(LTE) 28-47%; ADA 0·8(IT)/0·8(LTE) 50-72%. No serious infections occurred in the LTE.
Conclusions:
After 52 weeks of long-term ADA treatment in children aged 4-18 years with severe plaque psoriasis, disease severity was reduced and maintained or further improved, as demonstrated by efficacy outcomes. No new safety risks were identified. What's already known about this topic? The results from the first three periods of this phase III trial in children aged 4-18 years with severe plaque psoriasis suggest that adalimumab is a safe and efficacious treatment option in this population. What does this study add? This is the first study to evaluate long-term treatment of adalimumab in children with severe psoriasis, and the first to evaluate switching from methotrexate to adalimumab in this population.
More Related Videos
Related Concept Videos
02:07Blind Procedures
01:43Sustainable Development
01:11Blinding
01:20Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs
01:28Chronic Kidney Disease III: Interprofessional Care
01:25Chronic Obstructive Pulmonary Disease-III: Symptoms and Complications.
Symptoms of COPD can be classified as primary or systemic. Primary symptoms relate to reduced airflow, while systemic or extrapulmonary symptoms relate to COPD's broader impact on the body.
Primary Symptoms of COPD: