Clinical Experience

Study Design

Learn about the study designs of the pivotal clinical studies demonstrating the efficacy and safety profile of ENBREL in patients with moderate to severe plaque psoriasis and psoriatic arthritis.

Adult Chronic Moderate to Severe Plaque Psoriasis Study Overviews

ENBREL global psoriasis pivotal trial1-3
(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
ENBREL US psoriasis pivotal trial1,4,5
(Leonardi CL, Gordon KB)
  • Multicenter, double-blind, US phase 3 trial
  • 672 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 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
ENBREL psoriasis phase 3 trial1,6
(Tyring S)
  • Multicenter, double-blind, phase 3 trial
  • 620 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 administered BIW or placebo for the first 12 weeks
ENBREL phase 2 psoriasis trial1,7
(Gottlieb AB)
  • Multicenter, double-blind, phase 2 trial
  • 112 adult patients with active but clinically stable plaque psoriasis involving at least 10% of body surface were randomized to receive subcutaneous injections of ENBREL 25 mg or placebo administered BIW for 24 weeks

Psoriatic Arthritis Study Overview

ENBREL psoriatic arthritis pivotal trial1,8
(Mease PJ)
  • Multicenter, double-blind, phase 3 trial
  • 205 patients with active psoriatic arthritis randomized to receive subcutaneous injections of ENBREL 25 mg or placebo BIW for 24 weeks (a subset of patients with BSA ≥ 3% were evaluable for PASI)
  • After 24 weeks, patients continued therapy in a maintenance period for up to 24 weeks until all patients discontinued or completed double-blind therapy, after which all patients were eligible to enroll in an open-label period in which they received ENBREL 25 mg BIW for a period of 48 weeks
  • Of the 205 patients in the blinded study, 169 patients (81 originally receiving placebo, 88 originally receiving ENBREL) entered the open-label extension
  • The data were stratified by absence or presence of concurrent MTX
  • Linear extrapolation was utilized for the radiographic data; NRI analysis was conducted during the double-blind portion for ACR response while parameters assessed during the open-label period were analyzed based on the observed population at each time point

 
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.

Supportive data

Moderate to Severe Plaque Psoriasis
In medical studies, nearly half of patients saw 75% skin clearance in their moderate to severe plaque psoriasis in 3 months with ENBREL. Overall, 3 out of 4 patients saw 50% skin clearance in 3 months. ENBREL can work fast; many patients saw improvement within 2 months. Your results may vary.

Psoriatic Arthritis
In a medical study, ENBREL was shown to be effective in about 50% of psoriatic arthritis patients who used it at 6 months. Clinical responses were apparent at the time of the first visit (4 weeks) and were maintained through 6 months of therapy.

Steve's psoriasis used to be a huge interference in his life.

Today, Steve uses ENBREL and is relieved that his symptoms have improved.

"I cannot believe how effective ENBREL is for me."