ENBREL provides consistent results across body regions
ENBREL Global Psoriasis Pivotal Trial
- The ENBREL Global Psoriasis Pivotal Trial was a 24-week, randomized, multicenter, double-blind, placebo-controlled, phase 3 study that included 611 adult patients with active but clinically stable moderate to severe plaque PsO. Patients were randomized to receive ENBREL 50 mg, ENBREL 25 mg, or placebo administered BIW over 12 weeks, followed by open-label ENBREL 25 mg BIW for an additional 12 weeks2
- Primary Endpoint: Nearly half (46%) of patients saw 75% skin clearance in their moderate to severe plaque PsO in 12 weeks with ENBREL* (n=203) vs. 3% with placebo (n=204) (ITT NRI analysis)1,3
- Select secondary endpoints: Percent improvement from baseline PASI, PASI 50, PASI 90, sPGA† of clear or almost clear at Weeks 12 and 24, PASI 75 at 24 weeks
through 24 weeks from the
Global Psoriasis Pivotal Trial
(50 mg BIW/50 mg QW)4‡§¶
*50 mg BIW.
†sPGA=static Physician's Global Assessment.
‡Rates as observed with no imputation for missing data.4
§Post hoc analysis of the ENBREL Global Psoriasis Pivotal Trial. All patients who received at least one dose of investigational product were included. Patients received ENBREL 50 mg BIW for 12 weeks followed by ENBREL 50 mg QW through Week 24 (as observed).4
¶The efficacy and use of ENBREL are based on involvement across the entire BSA and not from individual body regions.1
Reinitiate ENBREL for recapturable results
ENBREL US Psoriasis Pivotal Trial
- The ENBREL US Psoriasis Pivotal Trial was designed to assess retreatment after withdrawal. Patients with ≥50% PASI improvement from baseline at Week 24 (responders) discontinued ENBREL treatment. Upon relapse (loss of ≥50% PASI improvement obtained before Week 24), patients resumed blinded ENBREL therapy at the dose they received from Weeks 13 to 245-7
- The mean numerical difference for each patient (primary endpoint) between the PASI score at Week 12 of retreatment and the PASI score at Week 12 of initial treatment in the ENBREL 50 mg BIW group was –1.4 (±0.5) and in the ENBREL 25 mg BIW group was –0.3 (±0.5)6
- Primary Endpoint: 49% of patients achieved a PASI 75 score by Week 12 in the ENBREL 50 mg BIW group (n=164; LOCF) vs. 4% with placebo (n=166)5
- Secondary endpoints: PASI 50 and 90 achievement, percent improvement from baseline PASI, static global assessment of psoriasis clear or almost clear, and the patient’s global assessment of psoriasis.
||Patients included in this trial started with placebo, ENBREL 25 mg QW, ENBREL 25 mg BIW, or ENBREL 50 mg BIW for 12 weeks. After 12 weeks, placebo patients were switched to ENBREL 25 mg BIW.
**Patients who completed 12 weeks of retreatment.7
††Only patients with ≥50% PASI improvement from baseline at Week 24 discontinued ENBREL treatment and were enrolled in this part of the study.7
‡‡Last observation carried forward (LOCF).
Many patients struggle with scalp involvement8,9
- An estimated 1.2 million adults aged ≥20 in the US have moderate to severe PsO10
- The scalp is often the first site of presentation9
- In a questionnaire taken by 752 people, as many as 80% of people with plaque PsO may have scalp involvement8,9
- For many patients, plaque PsO of the scalp is the most difficult aspect of their disease owing to the visibility of the lesions9
Plaque PsO involving the scalp remains a difficult-to-treat area of the body9
Photo is from a moderate to severe plaque psoriasis patient. Photos that depict scalp involvement do not represent the patient’s complete skin involvement.
ENBREL offers proven results from head to toe
ENBREL Scalp Involvement Study
- The ENBREL Scalp Involvement Study was a multicenter, double-blind, randomized, placebo-controlled trial of 124 adult patients with active but clinically stable plaque PsO involving at least 10% of BSA and a minimum PASI score of 10. Patients were also required to have ≥30% involvement of the scalp surface area (SSA) and a minimum PSSI score of 15. Patients received ENBREL 50 mg or placebo BIW over 12 weeks. From Weeks 12 to 24, patients received ENBREL 50 mg BIW (if initially randomized to placebo) or ENBREL 50 mg QW (if initially randomized to ENBREL 50 mg BIW)11,12
- Primary Endpoint: 87% mean PSSI improvement in ENBREL patients vs 20% in patients taking placebo at Week 12 (LOCF)11
- Select secondary endpoints: PSSI 75 at Week 12 and percent change in PSSI from Week 12 to Week 24 in subjects switching from placebo to ENBREL at Week 1214,15
- Select exploratory endpoints: Mean percentage improvement in PASI from baseline, PASI 50, PASI 75, PASI 90, PSSI 50, and PSSI 90 at 12 and 24 weeks, and the severity of itch and pain on the scalp14,15
*ITT analysis with LOCF imputation.
†P<0.0001 vs placebo.
- Among PSSI 75 achievers, the median time to PSSI 50 and PSSI 75 was approximately 4 weeks and approximately 8 weeks, respectively13
ENBREL provides scalp results you can see
Actual photos of patients from the ENBREL Scalp Involvement Study14
- These are actual photos from ENBREL clinical trial patients and depict only a select area of the patients' scalp involvement. Included below the photos are the patients' actual PSSI scores at baseline, Week 12, and Week 24
Extensive skin involvement in moderate to severe plaque psoriasis often includes many areas of the body. ENBREL does not treat individual problem areas and efficacy benefits are a result of overall PASI improvements. These are actual photos from ENBREL clinical trial patients that reflect approximately 75% PSSI improvements in the areas shown. Mean PSSI improvement scores were determined by evaluating overall improvement in the entire head/scalp. These photos have not been retouched. Individual results may vary.1
ENBREL demonstrated overall mean PASI improvements
‡ITT analysis with LOCF imputation
ENBREL provides overall results you can see
Actual photos of patients from the ENBREL Scalp Involvement Study14
- These photos depict only a select area of the patients’ skin involvement. Included below the photos are the patients’ actual PASI scores at baseline, Week 12, and Week 24
Extensive skin involvement in moderate to severe plaque psoriasis often includes many areas of the body. ENBREL does not treat individual problem areas and efficacy benefits are a result of overall PASI improvements. Actual photos from ENBREL clinical trial patients that reflect approximately 75% PASI improvements in the areas shown. These photos have not been retouched. Individual results may vary.1
Patients experienced less scalp itch with ENBREL
- The severity of scalp itch was assessed by patients based on a single-item questionnaire§ rating it on a scale of 0 (none) to 5 (severe)12,15
- Scalp itch was assessed as an exploratory endpoint in this study and no statistical conclusions can be drawn15
§ Subjects were asked to rate their scalp itch as a component of a psoriasis clinical trial, so it can be reasonably assumed that the subjects answered this question attributing the scalp itch to their moderate to severe plaque psoriasis.
**ITT analysis with LOCF imputation.
Patients experienced less scalp pain with ENBREL
- The severity of scalp pain was assessed by patients based on a single-item questionnaire†† rating it on a scale of 0 (none) to 10 (severe)12,15
- Scalp pain was assessed as an exploratory endpoint in this study and no statistical conclusions can be drawn15
†† Subjects were asked to rate their scalp pain as a component of a psoriasis clinical trial, so it can be reasonably assumed that the subjects answered this question attributing the scalp pain to their moderate to severe plaque psoriasis.
‡‡ITT analysis with LOCF imputation.
1 out of 3 plaque psoriasis (PsO) patients may develop PsA16
Patients with skin symptoms may have underlying joint damage from PsA17,19
before joint pain and swelling20,21
“PsA can be a very severe disease with significant functional impairment…Therefore, we strongly encourage dermatologists to actively seek signs and symptoms of PsA at every patient’s visit.”22
–American Academy of Dermatology (AAD) 2008 Psoriatic Arthritis Guidelines
*GRAPPA=Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.
Stand up to PsA one step at a time with ENBREL
ENBREL Psoriatic Arthritis Pivotal Trial
- The ENBREL Psoriatic Arthritis Pivotal Trial, a 2-year, multicenter, double-blind, phase 3 study of 205 patients with active PsA24,25
- At Week 12, 59% (n=101) of patients on ENBREL achieved the primary clinical endpoint of an ACR 20 response vs 15% (n=104) of patients on placebo (P<0.0001)25
- The primary radiographic endpoint of mean change from baseline in Total Sharp score (TSS) was –0.03 for ENBREL patients vs 1.0 for placebo patients at Year 1 (P=0.0001)24,25
ENBREL is radiographically proven to inhibit the progression of further joint damage1
Total Sharp Score (TSS)24
Significant improvements in physical function with ENBREL
- At Week 24, 60% of patients on ENBREL (n=101) achieved a HAQ score ≤0.5 vs 29% of patients on placebo (n=104)26†
†HAQ score of ≤0.5 is consistent with the score of the general population.27
Patients achieved clearer skin with ENBREL24
- 47% and 18% of patients achieved PASI 50 at Week 24 in the ENBREL and placebo arms, respectively24‡
- 23% and 3% of patients achieved PASI 75 at Week 24 in the ENBREL and placebo arms, respectively24‡
- 54% and 23% of patients had sPGA of clear or almost clear at Week 24 in the ENBREL and placebo arms, respectively24§
at Week 24 in patients with
BSA ≥1% and <3% at baseline28§
- Material Limitations: At baseline, 20% of patients in both arms had an sPGA of almost clear. These data are based on a post hoc analysis, and therefore the study was not designed to demonstrate definitive rates of clear or almost clear sPGA among the patients in this subgroup. No statistical conclusions can be drawn from this analysis24
(based on data from the CORRONA‡‡ Registry; N=1,688)29
‡Patients had plaque PsO involvement ≥3% BSA at baseline.
§Assessment was determined on a 0 to 5 (clear to severe PsO) scale.
**sPGA=static Physician’s Global Assessment.
††BSA=Body Surface Area
‡‡CORRONA=Consortium of Rheumatology Researchers of North America.
Patients felt less pain after treatment with ENBREL
- Results were similar between ENBREL monotherapy and ENBREL + MTX in a post hoc analysis—patients on ENBREL monotherapy (n=57) experienced a 42% decrease and patients on ENBREL + MTX (n=44) experienced a 50% decrease in pain at Week 2426
- Post hoc analyses are exploratory and no statistical conclusions can be drawn
Start with an established safety profile
The safety profile of ENBREL has been evaluated in 7 PsO trials, which included 4,410 patients, and the PsA pivotal trial, which included 205 patients.24,30