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Moderate to severe plaque psoriasis with scalp involvement: a randomized, double-blind, placebo-controlled study of etanercept.
J Am Acad Dermatol. 2012 Jul; 67(1):86-92.JA

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/m(2). 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.

Links

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Authors+Show Affiliations

Bagel J
Psoriasis Treatment Center of Central New Jersey, East Windsor, New Jersey 08520, USA. dreamacres1@aol.com
Lynde C
No affiliation info available
Tyring S
No affiliation info available
Kricorian G
No affiliation info available
Shi Y
No affiliation info available
Klekotka P
No affiliation info available

MeSH

AdultAgedBiological TherapyBody Mass IndexDouble-Blind MethodDrug Administration ScheduleEtanerceptFemaleHumansImmunoglobulin GImmunosuppressive AgentsInjections, SubcutaneousMaleMiddle AgedPsoriasisReceptors, Tumor Necrosis FactorScalp DermatosesYoung Adult

Pub Type(s)

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

Language

eng

PubMed ID

22014541

Clinical Trial Links

Moderate to Severe Plaque Psoriasis With Scalp Involvement

Citation

Bagel, Jerry, et al. "Moderate to Severe Plaque Psoriasis With Scalp Involvement: a Randomized, Double-blind, Placebo-controlled Study of Etanercept." Journal of the American Academy of Dermatology, vol. 67, no. 1, 2012, pp. 86-92.
Bagel J, Lynde C, Tyring S, et al. Moderate to severe plaque psoriasis with scalp involvement: a randomized, double-blind, placebo-controlled study of etanercept. J Am Acad Dermatol. 2012;67(1):86-92.
Bagel, J., Lynde, C., Tyring, S., Kricorian, G., Shi, Y., & Klekotka, P. (2012). Moderate to severe plaque psoriasis with scalp involvement: a randomized, double-blind, placebo-controlled study of etanercept. Journal of the American Academy of Dermatology, 67(1), 86-92. https://doi.org/10.1016/j.jaad.2011.07.034
Bagel J, et al. Moderate to Severe Plaque Psoriasis With Scalp Involvement: a Randomized, Double-blind, Placebo-controlled Study of Etanercept. J Am Acad Dermatol. 2012;67(1):86-92. PubMed PMID: 22014541.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Moderate to severe plaque psoriasis with scalp involvement: a randomized, double-blind, placebo-controlled study of etanercept. AU - Bagel,Jerry, AU - Lynde,Charles, AU - Tyring,Stephen, AU - Kricorian,Gregory, AU - Shi,Yifei, AU - Klekotka,Paul, Y1 - 2011/10/20/ PY - 2010/12/15/received PY - 2011/06/29/revised PY - 2011/07/08/accepted PY - 2011/10/22/entrez PY - 2011/10/22/pubmed PY - 2012/8/21/medline SP - 86 EP - 92 JF - Journal of the American Academy of Dermatology JO - J Am Acad Dermatol VL - 67 IS - 1 N2 - 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/m(2). 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. SN - 1097-6787 UR - https://www.unboundmedicine.com/medline/citation/22014541/Moderate_to_severe_plaque_psoriasis_with_scalp_involvement:_a_randomized_double_blind_placebo_controlled_study_of_etanercept_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0190-9622(11)00832-2 DB - PRIME DP - Unbound Medicine ER -