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Updated: Aug 10, 2026
The Goeckerman Regimen for the Treatment of Moderate to Severe Psoriasis
Published on: July 11, 2013
A multicenter dose-escalation trial with denileukin diftitox (ONTAK, DAB(389)IL-2) in patients with severe psoriasis
A Martin1, E Gutierrez, J Muglia
1Department of Dermatology, Washington University School of Medicine, St Louis, Missouri 63110, USA.
Background:
Denileukin diftitox, a fusion protein targeting both malignant and normal activated lymphocytes, has been shown previously to have antipsoriatic activity. However, the ideal dosing regimen for treating psoriasis was not established.
Objective:
We examined the safety and efficacy of denileukin diftitox in patients with severe plaque-type psoriasis.
Methods:
This was a cohort dose-escalation trial. Patients were administered denileukin diftitox on 3 consecutive days every other week. Patients were evaluated for toxicity, improvement in psoriasis, immunogenicity, and serum levels.
Results:
Thirty-five patients were treated at 3 dose levels. Eight patients had a 50% decrease or more in Psoriasis Area and Severity Index score from baseline (0/10 at 0.5 microg/kg per day, 1/10 at 1.5 microg/kg per day, and 7/15 at 5 microg/kg per day). Adverse events primarily consisted of constitutional events and skin reactions.
Conclusions:
The potential antipsoriatic activity of denileukin diftitox demonstrated in this study was comparable to that observed in other psoriasis studies with this agent. However, this dosing regimen was better tolerated than the dosing regimen used in the last study with denileukin diftitox in psoriasis patients.
Insights
Denileukin diftitox shows antipsoriatic activity in severe plaque psoriasis patients. This new dosing regimen was better tolerated than previous ones, with some patients showing significant Psoriasis Area and Severity Index score improvement.
Area of Science:
- Dermatology
- Immunology
- Pharmacology
Background:
- Denileukin diftitox, a fusion protein, targets activated lymphocytes.
- Previous studies indicated its antipsoriatic potential.
- An optimal dosing regimen for psoriasis remained undefined.
Purpose of the Study:
- To evaluate the safety and efficacy of denileukin diftitox.
- To assess treatment in patients with severe plaque-type psoriasis.
Main Methods:
- A cohort dose-escalation trial was conducted.
- Denileukin diftitox was administered over 3 consecutive days every other week.
- Evaluations included toxicity, psoriasis improvement, immunogenicity, and serum levels.
Main Results:
- 35 patients were treated across 3 dose levels.
- Eight patients achieved ≥50% Psoriasis Area and Severity Index score reduction.
- Adverse events were mainly constitutional and skin-related.
Conclusions:
- Antipsoriatic activity was comparable to previous studies.
- The tested dosing regimen demonstrated improved tolerability.
- Denileukin diftitox shows promise for severe plaque psoriasis treatment.
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