A randomized study to evaluate the efficacy and safety of adding topical therapy to etanercept in patients with moderate to severe plaque psoriasis - 17/08/13
, John Koo, MD fAbstract |
Background |
Few clinical trials have evaluated the combination of topical corticosteroids plus systemic therapies for psoriasis.
Objective |
We sought to evaluate efficacy and safety of etanercept plus topical clobetasol propionate (CP) foam versus etanercept monotherapy for treatment of moderate to severe plaque psoriasis.
Methods |
Adults with Psoriasis Area and Severity Index (PASI) score greater than or equal to 10 and psoriasis-affected body surface area greater than or equal to 10% were randomized to etanercept with CP as needed to clear (2 up-to-2-week courses, weeks 11-12 and 23-24) or etanercept alone (each arm at 50 mg twice weekly for 12 weeks followed by 50 mg once weekly for 12 weeks).
Results |
A total of 592 patients enrolled (295 etanercept + CP arm; 297 etanercept arm). At week 12, significant differences were observed for response of 75% improvement in PASI score (primary end point, 65.2% vs 48.3% in the etanercept + CP vs etanercept arms, respectively; P < .001), response of 90% improvement in PASI score (29.7% vs 19.4%; P = .009), percentage PASI score improvement (76.5% vs 68.2%; P < .001), static physician global assessment of clear/almost clear (63.1% vs 47.3%; P < .001), and patient satisfaction with treatment (P = .006). Response of 75% improvement in PASI score and static physician global assessment of clear/almost clear were not significantly different between arms at week 24. Patient satisfaction with treatment (P = .001) and percentage improvement in PASI score (P = .031) were also greater in the etanercept + CP arm compared with etanercept only at week 24. Comparable numbers of adverse events occurred in each arm.
Limitations |
No placebo for CP foam was provided in the etanercept arm.
Conclusions |
Addition of CP to etanercept yielded increased efficacy compared with etanercept alone at week 12 without an increase in treatment-related adverse events.
Il testo completo di questo articolo è disponibile in PDF.Key words : clobetasol propionate, combination therapy, efficacy, etanercept, plaque psoriasis, safety
Abbreviations used : BSA, CP, PASI, PASI 50, PASI 75, PASI 90, PASI 100, sPGA, TNF
Mappa
| Funded by Amgen Inc and by Wyeth, which was acquired by Pfizer Inc in October 2009. |
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| Disclosure: Dr Lebwohl is a consultant and/or investigator for Abbott Laboratories, Amgen Inc, Anacor Pharmaceuticals Inc, BioLineRX Ltd, Celgene Corp, Coronado Biosciences, Dermipsor, Eli Lilly and Co, Galderma, Stiefel a GSK company, Janssen Ortho Biotech, LEO Pharma Inc, Maruho Co Ltd, Novartis, Pfizer, Ranbaxy, and Valeant. Dr Lebwohl serves as principal investigator for Celgene and LEO Pharma Inc and is a subinvestigator for Can-Fite Biopharma Ltd and Centocor. Dr Lebwohl is a course director for the annual Fall and Winter Clinical Dermatology Conferences and the annual Mount Sinai Winter Symposium, which receive support from numerous dermatology companies. Dr Kircik is a consultant, investigator, speaker, and/or advisory board member for Abbott Laboratories, Amgen Inc, Celgene Corp, Centocor Inc, Galderma, GlaxoSmithKline PLC, Idera, LEO Pharma Inc, Merck, Novartis, and Pfizer. Dr Callis Duffin is a consultant, investigator, and/or advisory board member for Abbott Laboratories, Amgen, ApoPharma, Eli Lilly and Co, Janssen Biotech, Pfizer, and Vascular Biogenics. Dr Pariser is a consultant, investigator, and/or advisory board member for Abbott Laboratories, Amgen Inc, Astellas Pharma US Inc, Basliea, Celgene Corp, Dow Pharmaceutical Sciences Inc, DUSA Pharmaceuticals Inc, Eli Lilly and Co, Galderma, Genentech Inc, Graceway Pharmaceuticals LLC, Intendis Inc, Janssen-Ortho Inc, Johnson & Johnson Consumer Products Co, LEO Pharma Inc, Medicis Pharmaceutical Corp, MelaSciences, Novartis, Novo Nordisk A/S, Ortho Dermatologics, Peplin Inc, Pfizer, Photocure ASA, Procter & Gamble Co, Stiefel a GSK company, and Valeant Pharmaceuticals International. Drs Hooper, Wenkert, Thompson, and Kricorian and Ms Yang are employees and shareholders of Amgen Inc. Dr Koo is an investigator and/or speaker for Abbott Laboratories, Amgen Inc, Galderma, LEO Pharma Inc, Novartis, Pfizer, and Photomedex. |
Vol 69 - N° 3
P. 385-392 - settembre 2013 Ritorno al numero
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