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A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction.
Br J Dermatol. 2005 Jun; 152(6):1304-12.BJ

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+Show Affiliations

Papp KA
Probity Medical Research, Waterloo, Ontario N2J 1C4, Canada. kapapp@probitymedical.com
Tyring S
No affiliation info available
Lahfa M
No affiliation info available
Prinz J
No affiliation info available
Griffiths CE
No affiliation info available
Nakanishi AM
No affiliation info available
Zitnik R
No affiliation info available
van de Kerkhof PC
No affiliation info available
Melvin L
No affiliation info available
Etanercept Psoriasis Study Group
No affiliation info available

MeSH

AdolescentAdultAgedAged, 80 and overDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleEtanerceptFemaleHumansImmunoglobulin GImmunosuppressive AgentsInjections, SubcutaneousMaleMiddle AgedPsoriasisReceptors, Tumor Necrosis FactorRecombinant Fusion ProteinsStatistics as Topic

Pub Type(s)

Clinical Trial
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15948997

Clinical Trial Links

Effect of Adalimumab on Vascular Inflammation in Patients With Moderate to Severe Plaque Psoriasis
Safety and Efficacy Study of Etanercept (Qiangke®) to Treat Moderate to Severe Plaque Psoriasis

Citation

Papp, K A., et al. "A Global Phase III Randomized Controlled Trial of Etanercept in Psoriasis: Safety, Efficacy, and Effect of Dose Reduction." The British Journal of Dermatology, vol. 152, no. 6, 2005, pp. 1304-12.
Papp KA, Tyring S, Lahfa M, et al. A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction. Br J Dermatol. 2005;152(6):1304-12.
Papp, K. A., Tyring, S., Lahfa, M., Prinz, J., Griffiths, C. E., Nakanishi, A. M., Zitnik, R., van de Kerkhof, P. C., & Melvin, L. (2005). A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction. The British Journal of Dermatology, 152(6), 1304-12.
Papp KA, et al. A Global Phase III Randomized Controlled Trial of Etanercept in Psoriasis: Safety, Efficacy, and Effect of Dose Reduction. Br J Dermatol. 2005;152(6):1304-12. PubMed PMID: 15948997.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction. AU - Papp,K A, AU - Tyring,S, AU - Lahfa,M, AU - Prinz,J, AU - Griffiths,C E M, AU - Nakanishi,A M, AU - Zitnik,R, AU - van de Kerkhof,P C M, AU - Melvin,Linda, AU - ,, PY - 2005/6/14/pubmed PY - 2005/8/5/medline PY - 2005/6/14/entrez SP - 1304 EP - 12 JF - The British journal of dermatology JO - Br J Dermatol VL - 152 IS - 6 N2 - 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. SN - 0007-0963 UR - https://www.unboundmedicine.com/medline/citation/15948997/A_global_phase_III_randomized_controlled_trial_of_etanercept_in_psoriasis:_safety_efficacy_and_effect_of_dose_reduction_ DB - PRIME DP - Unbound Medicine ER -