Study Designs and References

Select ENBREL Clinical Study Overviews

ENBREL US psoriasis pivotal trial1-3
(Leonardi CL, Gordon KB)
  • Multicenter, double-blind, US phase 3 trial
  • 672* adult patients with active but clinically stable moderate to severe plaque psoriasis involving at least 10% of body surface and a minimum PASI score of 10
  • Patients randomized to receive subcutaneous injections of ENBREL 50 mg BIW, ENBREL 25 mg BIW, ENBREL 25 mg QW, or placebo for 12 weeks. After 12 weeks, patients in the placebo group began treatment with ENBREL 25 mg BIW in a blinded fashion
  • Patients were limited to low- to moderate-strength topical corticosteroids in the axillary, groin, and scalp regions
  • After 24 weeks, patients were classified as responders (had ≥ 50% improvement from baseline PASI) or incomplete responders (had < 50% improvement from baseline PASI)
  • Responders were entered into the withdraw/retreat portion of the study and were discontinued from treatment and followed until their disease relapsed (loss of ≥ 50% PASI improvement obtained between baseline and week 24), at which time subjects resumed blinded ENBREL therapy at their dose from weeks 13 to 24

*652 of these adult patients received at least one dose of double-blind treatment.

ENBREL global psoriasis pivotal trial1,4,5
(Papp KA)
  • Multicenter, double-blind, global phase 3 trial
  • 611 adult patients with active but clinically stable plaque psoriasis involving at least 10% of body surface and a minimum PASI score of 10
  • Patients randomized to receive subcutaneous injections of ENBREL 50 mg, ENBREL 25 mg, or placebo administered BIW over 12 weeks
  • Patients were limited to low- to moderate-strength topical corticosteroids in the axillary, groin, and scalp regions
  • After 12 weeks, patients received open-label ENBREL 25 mg BIW. However, in the open-label portion, physicians and patients remained blinded to the original randomized dosing arm through 6 months

583 patients received at least one dose of double-blind treatment.

References

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Cohen SN, Baron SE, Archer CB; on behalf of the British Association of Dermatologists and Royal College of General Practitioners. Guidance on the diagnosis and clinical management of psoriasis. Clin Exp Dermatol. 2012;37:13-18.

Data on file, Amgen.

Enbrel® (etanercept) Medication Guide, Immunex Corporation, Thousand Oaks, Calif. November 2013.

Enbrel® (etanercept) Prescribing Information, Immunex Corporation, Thousand Oaks, Calif. November 2013.

Gelfand JM, Kimball AB, Mostow EN, et al. Patient-reported outcomes and health-care resource utilization in patients treated with etanercept: continuous versus interrupted treatment. Value Health. 2008;11:400-407.

Gordon KB, Gottlieb AB, Leonardi CL, et al. Clinical response in psoriasis patients discontinued from and then reinitiated on etanercept therapy. J Dermatolog Treat. 2006;17:9-17.

Gottlieb A, Korman NJ, Gordon KB, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 2: psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on biologics. J Am Acad Dermatol. 2008;58:851-864.

Gottlieb AB, Matheson RT, Lowe N, et al. A randomized trial of etanercept as monotherapy for psoriasis. Arch Dermatol. 2003;139:1627-1632.

Humira® (adalimumab) prescribing information. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails. Accessed January 2, 2013.

Jacobson CC, Kimball AB. Psoriasis. In: Gordon KB, Ruderman EM, eds. Psoriasis and Psoriatic Arthritis: An Integrated Approach. New York, NY: Springer; 2005:47-56.

Kane D, Stafford L, Bresnihan B, et al. A prospective, clinical and radiological study of early psoriatic arthritis: an early synovitis clinic experience. Rheumatology. 2003;42:1460-1468.

Krueger GG. Clinical features of psoriatic arthritis. Am J Manag Care. 2002;8:S160-S170.

Krueger JG. The immunologic basis for the treatment of psoriasis with new biologic agents. J Am Acad Dermatol. 2002;46:1-23.

Kurd SK, Gefland JM. The prevalence of previously diagnosed and undiagnosed psoriasis in US adults: results from NHANES 2003-2004. J Am Acad Dermatol. 2008;60:218-224.

Langley RGB, Krueger GG, Griffiths CEM. Psoriasis: epidemiology, clinical features, and quality of life. Ann Rheum Dis. 2005;64(suppl 2):ii18-ii23.

Last JM, ed. Spasoff RA, Harris SS, Thuriaux MC, assoc eds. A Dictionary of Epidemiology. 4th ed. New York, NY: Oxford University Press, Inc; 2001.

Leonardi CL, Powers JL, Matheson RT, et al, for the Etanercept Psoriasis Study Group. Etanercept as monotherapy in patients with psoriasis. N Engl J Med. 2003;349:2014-2022.

Mease P, Goffe BS. Diagnosis and treatment of psoriatic arthritis. J Am Acad Dermatol. 2005;52:1-19.

Mease PJ. Cytokine blockers in psoriatic arthritis. Ann Rheum Dis. 2001;60:iii37-iii40.

Mease PJ, Kivitz AJ, Burch FX, et al. Etanercept treatment of psoriatic arthritis: safety, efficacy, and effect on disease progression. Arthritis Rheum. 2004;50:2264-2272.

Menter A, Gottlieb A, Feldman SR, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section I: overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008;58:826-850.

Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 5: guidelines of care for the treatment of psoriasis with phototherapy and photochemotherapy. J Am Acad Dermatol. 2010;62:114-135.

Moreland LW, Weinblatt ME, Keystone EC, et al. Etanercept treatment in adults with established rheumatoid arthritis: 7 years of clinical experience. J Rheumatol. 2006;33:854-861.

Naldi L, Gambini D. The clinical spectrum of psoriasis. Clin Dermatol. 2007;25:510-518.

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Papp KA, Tyring S, Lahfa M, et al; for the Etanercept Psoriasis Study Group. A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction. Br J Dermatol. 2005;152:1304-1312.

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Reich K, Krüger K, Mössner R, Augustin M. Epidemiology and clinical pattern of psoriatic arthritis in Germany: a prospective interdisciplinary epidemiological study of 1511 patients with plaque-type psoriasis. Br J Dermatol. 2009;160:1040-1047.

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INDICATIONS

ENBREL is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis. ENBREL can be initiated in combination with methotrexate (MTX) or used alone.

ENBREL is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older.

ENBREL is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis. ENBREL can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.

ENBREL is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.

ENBREL is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Questions?

If you, your staff, or your patients have questions, simply call ENBREL Support™ toll-free at 1-888-4ENBREL
(1-888-436-2735). Representatives are available to assist you 8 AM to 8 PM Eastern time, Monday through Friday, and registered nurses are available 8 AM to 11 PM Eastern time, 7 days a week.