A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction
| Autor: | Papp, K.A., Tyring, S., Lahfa, M., Prinz, J.C., Griffiths, C.E., Nakanishi, A.M., Zitnik, R., Kerkhof, P.C.M. van de, Melvin, L. |
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| Rok vydání: | 2005 |
| Předmět: |
Adult
Male musculoskeletal diseases medicine.medical_specialty Adolescent Injections Subcutaneous Recombinant Fusion Proteins Statistics as Topic Tildrakizumab Dermatology Placebo Auto-immunity transplantation and immunotherapy [N4i 4] Drug Administration Schedule Receptors Tumor Necrosis Factor Etanercept law.invention Double-Blind Method Randomized controlled trial Psoriasis Area and Severity Index law Psoriasis Internal medicine medicine Humans Aged Aged 80 and over Chronic inflammation and autoimmunity [UMCN 4.2] Dose-Response Relationship Drug business.industry Middle Aged medicine.disease Alefacept Surgery Guselkumab Immunoglobulin G Female business Immunosuppressive Agents medicine.drug |
| Zdroj: | British Journal of Dermatology, 152, 1304-12 British Journal of Dermatology, 152, 6, pp. 1304-12 |
| ISSN: | 0007-0963 |
| Popis: | Item does not contain fulltext 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. |
| Databáze: | OpenAIRE |
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