| Abstract | BACKGROUND: In previous studies, etanercept significantly improved plaque psoriasis and was well tolerated. OBJECTIVES: To examine further the efficacy and safety of etanercept and to assess maintenance of treatment effect after dose reduction of etanercept. METHODS: In this multicentre 24-week study in the U.S.A., Canada and Western Europe, patients were at least 18 years old; had active, clinically stable plaque psoriasis involving at least 10% of body surface area; had a minimum Psoriasis Area and Severity Index (PASI) of 10 at screening; and had received or were a candidate to receive systemic psoriasis therapy or phototherapy. During the first 12 weeks of the study, patients were randomly assigned to receive by subcutaneous injection etanercept twice weekly (BIW) at a dose of 50 mg or 25 mg, or placebo BIW in a double-blind fashion. During the second 12 weeks, all patients received etanercept 25 mg BIW. The primary endpoint was a 75% or greater improvement from baseline in PASI (PASI 75) at 12 weeks. RESULTS: Five hundred and eighty-three subjects were randomized and received at least one dose of study drug. At week 12, a PASI 75 was achieved by 49% of patients in the etanercept 50 mg BIW group, 34% in the 25 mg BIW group, and 3% in the placebo group (P < 0.0001 for each etanercept group compared with placebo). At week 24 (after 12 weeks of open-label 25 mg etanercept BIW), a PASI 75 was achieved by 54% of patients whose dose was reduced from 50 mg BIW to 25 mg BIW, by 45% of patients in the continuous 25 mg BIW group, and by 28% in the group that received placebo followed by etanercept 25 mg BIW. Etanercept was well tolerated throughout the study. CONCLUSIONS: Etanercept provided clinically meaningful benefit to patients with chronic plaque psoriasis, with no apparent decrease in efficacy after dose reduction. |
| Authors | K A Papp, S Tyring, M Lahfa, J Prinz, C E M Griffiths, A M Nakanishi, R Zitnik, P C M van de Kerkhof, Linda Melvin, Etanercept Psoriasis Study Group
(Affiliation: Probity Medical Research, Waterloo, Ontario N2J 1C4, Canada. kapapp at probitymedical.com)
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| Journal | The British journal of dermatology
(Br J Dermatol)
Vol. 152
Issue 6
Pg. 1304-12
(Jun 2005)
ISSN: 0007-0963 England |
| PMID | 15948997
(Publication Type: Clinical Trial, Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
| Chemical References |
- Immunoglobulin G
- Immunosuppressive Agents
- Receptors, Tumor Necrosis Factor
- Recombinant Fusion Proteins
- TNFR-Fc fusion protein
|
| Topics |
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Dose-Response Relationship, Drug
- Double-Blind Method
- Drug Administration Schedule
- Female
- Humans
- Immunoglobulin G
(administration & dosage, therapeutic use)
- Immunosuppressive Agents
(administration & dosage, therapeutic use)
- Injections, Subcutaneous
- Male
- Middle Aged
- Psoriasis
(drug therapy)
- Receptors, Tumor Necrosis Factor
(administration & dosage, therapeutic use)
- Recombinant Fusion Proteins
(administration & dosage, therapeutic use)
- Statistics as Topic
|
