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Once weekly administration of etanercept 50 mg is efficacious and well tolerated in patients with moderate-to-severe plaque psoriasis: a randomized controlled trial with open-label extension.
Br J Dermatol. 2008 Nov; 159(5):1177-85.BJ

Abstract

BACKGROUND

In previous studies, etanercept 25 mg twice weekly (BIW) or 50 mg BIW significantly reduced disease severity in patients with plaque psoriasis and demonstrated a favourable safety profile.

OBJECTIVES

To assess the efficacy and safety of etanercept 50 mg administered once weekly (QW) compared with placebo in patients with moderate-to-severe plaque psoriasis over 24 weeks.

METHODS

This study was conducted in two parts: (i) a 12-week, double-blind, placebo-controlled phase, in which patients received etanercept 50 mg QW or placebo QW; and (ii) a 12-week, open-label extension phase, in which all patients received etanercept 50 mg QW. Primary endpoint was a 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI 75) at week 12. Secondary endpoints included percentage PASI improvement and Physician's Global Assessment (PGA).

RESULTS

One hundred and forty-two patients were analysed in the double-blind phase; 126 patients entered the open-label phase. At week 12, significantly more patients receiving etanercept 50 mg QW (37.5%) achieved PASI 75 response than patients receiving placebo (2.2%; P < 0.0001). At week 24, 71.1% in the etanercept-etanercept group and 44.4% in the placebo-etanercept group achieved PASI 75. Mean percentage of PASI improvement from baseline was 55.4% with etanercept vs. 9.4% worsening with placebo at week 12 (P < 0.0001), with 77.4% and 57.7% improvement in the etanercept-etanercept and placebo-etanercept groups at week 24. A PGA score of 0-1 (clear-almost clear) was achieved by 64% and 42% in the etanercept-etanercept and placebo-etanercept groups at week 24, respectively. Etanercept 50 mg QW was well tolerated. No deaths, serious infections, opportunistic infections (including tuberculosis), demyelinating disorders, malignancies or new safety signals were reported.

CONCLUSIONS

Nearly three-quarters of patients with moderate-to-severe psoriasis receiving etanercept 50 mg QW achieved significant improvement in disease severity over 24 weeks. This study also showed a favourable tolerability and safety profile with etanercept 50 mg QW.

Authors+Show Affiliations

Department of Dermatology, UMC St Radboud, PO Box 9101, 65 HB Nijmegen, The Netherlands. P.vandeKerkhof@derma.umcn.nlNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

18673365

Citation

van de Kerkhof, P C M., et al. "Once Weekly Administration of Etanercept 50 Mg Is Efficacious and Well Tolerated in Patients With Moderate-to-severe Plaque Psoriasis: a Randomized Controlled Trial With Open-label Extension." The British Journal of Dermatology, vol. 159, no. 5, 2008, pp. 1177-85.
van de Kerkhof PC, Segaert S, Lahfa M, et al. Once weekly administration of etanercept 50 mg is efficacious and well tolerated in patients with moderate-to-severe plaque psoriasis: a randomized controlled trial with open-label extension. Br J Dermatol. 2008;159(5):1177-85.
van de Kerkhof, P. C., Segaert, S., Lahfa, M., Luger, T. A., Karolyi, Z., Kaszuba, A., Leigheb, G., Camacho, F. M., Forsea, D., Zang, C., Boussuge, M. P., Paolozzi, L., & Wajdula, J. (2008). Once weekly administration of etanercept 50 mg is efficacious and well tolerated in patients with moderate-to-severe plaque psoriasis: a randomized controlled trial with open-label extension. The British Journal of Dermatology, 159(5), 1177-85. https://doi.org/10.1111/j.1365-2133.2008.08771.x
van de Kerkhof PC, et al. Once Weekly Administration of Etanercept 50 Mg Is Efficacious and Well Tolerated in Patients With Moderate-to-severe Plaque Psoriasis: a Randomized Controlled Trial With Open-label Extension. Br J Dermatol. 2008;159(5):1177-85. PubMed PMID: 18673365.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Once weekly administration of etanercept 50 mg is efficacious and well tolerated in patients with moderate-to-severe plaque psoriasis: a randomized controlled trial with open-label extension. AU - van de Kerkhof,P C M, AU - Segaert,S, AU - Lahfa,M, AU - Luger,T A, AU - Karolyi,Z, AU - Kaszuba,A, AU - Leigheb,G, AU - Camacho,F M, AU - Forsea,D, AU - Zang,C, AU - Boussuge,M P, AU - Paolozzi,L, AU - Wajdula,J, Y1 - 2008/07/31/ PY - 2008/8/5/pubmed PY - 2009/4/7/medline PY - 2008/8/5/entrez SP - 1177 EP - 85 JF - The British journal of dermatology JO - Br J Dermatol VL - 159 IS - 5 N2 - BACKGROUND: In previous studies, etanercept 25 mg twice weekly (BIW) or 50 mg BIW significantly reduced disease severity in patients with plaque psoriasis and demonstrated a favourable safety profile. OBJECTIVES: To assess the efficacy and safety of etanercept 50 mg administered once weekly (QW) compared with placebo in patients with moderate-to-severe plaque psoriasis over 24 weeks. METHODS: This study was conducted in two parts: (i) a 12-week, double-blind, placebo-controlled phase, in which patients received etanercept 50 mg QW or placebo QW; and (ii) a 12-week, open-label extension phase, in which all patients received etanercept 50 mg QW. Primary endpoint was a 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI 75) at week 12. Secondary endpoints included percentage PASI improvement and Physician's Global Assessment (PGA). RESULTS: One hundred and forty-two patients were analysed in the double-blind phase; 126 patients entered the open-label phase. At week 12, significantly more patients receiving etanercept 50 mg QW (37.5%) achieved PASI 75 response than patients receiving placebo (2.2%; P < 0.0001). At week 24, 71.1% in the etanercept-etanercept group and 44.4% in the placebo-etanercept group achieved PASI 75. Mean percentage of PASI improvement from baseline was 55.4% with etanercept vs. 9.4% worsening with placebo at week 12 (P < 0.0001), with 77.4% and 57.7% improvement in the etanercept-etanercept and placebo-etanercept groups at week 24. A PGA score of 0-1 (clear-almost clear) was achieved by 64% and 42% in the etanercept-etanercept and placebo-etanercept groups at week 24, respectively. Etanercept 50 mg QW was well tolerated. No deaths, serious infections, opportunistic infections (including tuberculosis), demyelinating disorders, malignancies or new safety signals were reported. CONCLUSIONS: Nearly three-quarters of patients with moderate-to-severe psoriasis receiving etanercept 50 mg QW achieved significant improvement in disease severity over 24 weeks. This study also showed a favourable tolerability and safety profile with etanercept 50 mg QW. SN - 1365-2133 UR - https://www.unboundmedicine.com/medline/citation/18673365/Once_weekly_administration_of_etanercept_50_mg_is_efficacious_and_well_tolerated_in_patients_with_moderate_to_severe_plaque_psoriasis:_a_randomized_controlled_trial_with_open_label_extension_ L2 - https://doi.org/10.1111/j.1365-2133.2008.08771.x DB - PRIME DP - Unbound Medicine ER -