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Efficacy of etanercept in an integrated multistudy database of patients with psoriasis.
J Am Acad Dermatol. 2006 Mar; 54(3 Suppl 2):S101-11.JA

Abstract

BACKGROUND

The tumor necrosis factor (TNF) inhibitor etanercept has been demonstrated to be safe and effective for treating chronic plaque psoriasis in 3 clinical trials.

OBJECTIVES

To refine efficacy results for etanercept on the basis of a larger population size through the integration of the 3 studies, and to determine if the efficacy profile across all 3 studies is consistent with efficacy profiles observed for individual trials.

METHODS

In these integrated analyses, data for 1187 patients from 3 blinded treatment groups were pooled to compare efficacy at 12 weeks: etanercept 50 mg weekly (equivalent to 25 mg twice weekly) subcutaneously, etanercept 50 mg twice weekly subcutaneously, and placebo. The primary efficacy end point in all 3 studies was at least a 75% improvement in the Psoriasis Area and Severity Index (PASI 75). Other measurements included PASI 50, PASI 90, patient's and dermatologist's global assessments, and Dermatology Life Quality Index.

RESULTS

In the integrated analyses, statistically significant, dose-dependent improvements in PASI 75 at 12 weeks were observed in patients treated with etanercept 50 mg weekly (33%) and 50 mg twice weekly (49%), compared with the placebo group (3%; P < .05). Significant improvements also were seen in all secondary end points (PASI 50 and PASI 90 responses, patient's and dermatologist's global assessments, and Dermatology Life Quality Index) at 12 weeks. Subgroup analyses of baseline patient characteristics demonstrated that there were no statistically significant treatment-by-covariate interactions.

LIMITATIONS

A limitation of these integrated analyses is the relatively short (12-week) time frame.

CONCLUSION

The efficacy profile of etanercept in patients with psoriasis was consistent across multiple studies as shown in the integrated analyses of the primary and secondary end points. Etanercept demonstrated rapid, dose-dependent improvements in disease severity and quality of life consistently over all studies.

Authors+Show Affiliations

Gordon K
Loyola University Medical Center, Maywood, Illinois, USA. kgordon@enh.org
Korman N
No affiliation info available
Frankel E
No affiliation info available
Wang H
No affiliation info available
Jahreis A
No affiliation info available
Zitnik R
No affiliation info available
Chang T
No affiliation info available

MeSH

AdultDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleEtanerceptFemaleHumansImmunoglobulin GImmunosuppressive AgentsLogistic ModelsMaleMiddle AgedMulticenter Studies as TopicPsoriasisRandomized Controlled Trials as TopicReceptors, Tumor Necrosis FactorTreatment Outcome

Pub Type(s)

Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16488320

Citation

Gordon, Kenneth, et al. "Efficacy of Etanercept in an Integrated Multistudy Database of Patients With Psoriasis." Journal of the American Academy of Dermatology, vol. 54, no. 3 Suppl 2, 2006, pp. S101-11.
Gordon K, Korman N, Frankel E, et al. Efficacy of etanercept in an integrated multistudy database of patients with psoriasis. J Am Acad Dermatol. 2006;54(3 Suppl 2):S101-11.
Gordon, K., Korman, N., Frankel, E., Wang, H., Jahreis, A., Zitnik, R., & Chang, T. (2006). Efficacy of etanercept in an integrated multistudy database of patients with psoriasis. Journal of the American Academy of Dermatology, 54(3 Suppl 2), S101-11.
Gordon K, et al. Efficacy of Etanercept in an Integrated Multistudy Database of Patients With Psoriasis. J Am Acad Dermatol. 2006;54(3 Suppl 2):S101-11. PubMed PMID: 16488320.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of etanercept in an integrated multistudy database of patients with psoriasis. AU - Gordon,Kenneth, AU - Korman,Neil, AU - Frankel,Ellen, AU - Wang,Huei, AU - Jahreis,Angelika, AU - Zitnik,Ralph, AU - Chang,Ting, PY - 2005/06/01/received PY - 2005/11/16/revised PY - 2005/11/27/accepted PY - 2006/2/21/pubmed PY - 2006/3/8/medline PY - 2006/2/21/entrez SP - S101 EP - 11 JF - Journal of the American Academy of Dermatology JO - J Am Acad Dermatol VL - 54 IS - 3 Suppl 2 N2 - BACKGROUND: The tumor necrosis factor (TNF) inhibitor etanercept has been demonstrated to be safe and effective for treating chronic plaque psoriasis in 3 clinical trials. OBJECTIVES: To refine efficacy results for etanercept on the basis of a larger population size through the integration of the 3 studies, and to determine if the efficacy profile across all 3 studies is consistent with efficacy profiles observed for individual trials. METHODS: In these integrated analyses, data for 1187 patients from 3 blinded treatment groups were pooled to compare efficacy at 12 weeks: etanercept 50 mg weekly (equivalent to 25 mg twice weekly) subcutaneously, etanercept 50 mg twice weekly subcutaneously, and placebo. The primary efficacy end point in all 3 studies was at least a 75% improvement in the Psoriasis Area and Severity Index (PASI 75). Other measurements included PASI 50, PASI 90, patient's and dermatologist's global assessments, and Dermatology Life Quality Index. RESULTS: In the integrated analyses, statistically significant, dose-dependent improvements in PASI 75 at 12 weeks were observed in patients treated with etanercept 50 mg weekly (33%) and 50 mg twice weekly (49%), compared with the placebo group (3%; P < .05). Significant improvements also were seen in all secondary end points (PASI 50 and PASI 90 responses, patient's and dermatologist's global assessments, and Dermatology Life Quality Index) at 12 weeks. Subgroup analyses of baseline patient characteristics demonstrated that there were no statistically significant treatment-by-covariate interactions. LIMITATIONS: A limitation of these integrated analyses is the relatively short (12-week) time frame. CONCLUSION: The efficacy profile of etanercept in patients with psoriasis was consistent across multiple studies as shown in the integrated analyses of the primary and secondary end points. Etanercept demonstrated rapid, dose-dependent improvements in disease severity and quality of life consistently over all studies. SN - 1097-6787 UR - https://www.unboundmedicine.com/medline/citation/16488320/Efficacy_of_etanercept_in_an_integrated_multistudy_database_of_patients_with_psoriasis_ DB - PRIME DP - Unbound Medicine ER -