Moderate to severe plaque psoriasis with scalp involvement: A randomized, double-blind, placebo-controlled study of etanercept - 14/06/12
, Charles Lynde, MD b, c, Stephen Tyring, MD, PhD d, Gregory Kricorian, MD e, Yifei Shi, MS e, Paul Klekotka, MD, PhD e
Reprint requests: Jerry Bagel, MD, Psoriasis Treatment Center of Central New Jersey, East Windsor Professional Park – Suite G, 59 One Mile Road Extension, East Windsor, NJ 08520.Abstract |
Background |
Biologic therapies are used to treat moderate to severe psoriasis, but evidence from randomized, controlled studies is lacking regarding scalp-related effectiveness.
Objective |
To evaluate the efficacy and safety of etanercept for scalp symptoms (erythema, induration, scale, and percentage of scalp involvement) in patients with moderate to severe plaque psoriasis and scalp involvement.
Methods |
In this randomized, placebo-controlled study, adult patients with stable plaque psoriasis and significant scalp symptoms received etanercept 50 mg twice weekly (BIW) by subcutaneous injection (SC) for 12 weeks, followed by etanercept 50 mg once weekly (QW) and placebo QW (Group A, n = 62) or SC placebo BIW for 12 weeks, followed by etanercept 50 mg BIW for 12 weeks (Group B, n = 62). The primary end point was percentage change in Psoriasis Scalp Severity Index (PSSI) at week 12.
Results |
Demographics and disease characteristics were balanced: 56% men, 73% white, median age 41 years, median BMI 30.2 kg/m2. At week 12, mean PSSI improvement was 86.8% (standard deviation [SD], 18.0%) in Group A and 20.4% (SD, 39.3%) in Group B (P < .0001). At week 24, mean PSSI improvements were as follows: Group A, 90.6% (SD 13.1%); Group B, 79.1% (SD 33.6%). At week 12, 51 of 59 (86%) Group A patients and 7 of 61 (11%) Group B patients achieved PSSI 75 (P <.0001). Three patients (2.7%) reported 5 serious adverse events: cholecystitis/cholelithiasis, fall/rib fracture, and metastatic malignant melanoma.
Limitations |
The study was insufficiently powered to detect rare adverse events potentially associated with etanercept.
Conclusions |
Etanercept is an effective, well-tolerated treatment for plaque psoriasis involving the scalp.
Le texte complet de cet article est disponible en PDF.Key words : biologic therapy, etanercept, PASI, plaque psoriasis, PSSI, randomized controlled trial, scalp symptoms, tumor necrosis factor antagonist
Abbreviations used : AE, BIW, BMI, BSA, IL, ITT, LOCF, PASI, PSSI, QW, SD, sPGA, SSA, TNF
Plan
| Funding source: Immunex Corporation, a wholly owned subsidiary of Amgen Inc., Thousand Oaks, California. |
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| Disclosures: (past 5 years): Dr Bagel receives a salary as founder of the Psoriasis Treatment Center of Central New Jersey. He has received speaker honoraria from Leo Pharma, Galderma, Centocor, Abbott, and Amgen. He has also been compensated as a consultant for Galderma and has served as an investigator for Centocor, Abbott, and Amgen. Dr Lynde has received research grants and honoraria from Amgen, Abbott, Merck, Ortho Biotech, Leo Pharma, and Galderma, for whom he has served as an advisory board member, consultant, and speaker. He has also served as an investigator for Amgen, Abbott, Merck, Ortho Biotech, and Leo Pharma. Dr Tyring has received a research grant and honoraria from Amgen, for whom he has served as a consultant, investigator, and speaker. He has also served as an investigator and/or speaker for Abbott, Leo Pharma, Galderma, GSK, Novartis, Merck, Epiphany, Inhibitex, AiCuris, and Pfizer. Dr Kricorian, Yifei Shi, and Dr Klekotka are employees of Amgen Inc. and have received Amgen stock/stock options. |
Vol 67 - N° 1
P. 86-92 - juillet 2012 Retour au numéro
Article précédent
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