ENBREL SUMMARY
ENBREL® (etanercept) is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH 2 domain, the CH 3 domain and hinge region, but not the CH 1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system.
ENBREL® is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid 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 of moderately to severely active polyarticular-course juvenile rheumatoid arthritis in patients who have had an inadequate response to one or more DMARDs.
ENBREL® is indicated for reducing signs and symptoms and inhibiting the progression of structural damage of active arthritis 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.
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NEWS HIGHLIGHTSMedia Articles Related to Enbrel (Etanercept)
EADV: Agent Clears Lesions, Lessens Psoriatic Arthritis (CME/CE)
Source: MedPage Today Dermatology [2009.10.14]
BERLIN (MedPage Today) -- In patients with psoriasis and concomitant psoriatic arthritis, treatment with etanercept (Enbrel) improved skin lesions, enthesitis, and dactylitis in a majority of patients, data from a randomized clinical trial showed.
Anti-Tumor Necrosis Factor Treatment Does Not Increase Cancer Risk In RA Patients
Source: Arthritis / Rheumatology News From Medical News Today [2009.10.30]
A recent study by Swedish researchers found that rheumatoid arthritis (RA) patients did not experience an elevated cancer risk in the first 6 years after starting anti-tumor necrosis factor (TNF) therapy. The research team, led by Johan Askling, M.D., Ph.D., from Karolinska University Hospital in Stockholm, Sweden assessed the short-term and medium-term cancer risk for RA patients using anti-TNF therapies: infliximab, adalimumab, and etanercept.
Published Studies Related to Enbrel (Etanercept)
Sustained improvement in joint pain and nail symptoms with etanercept therapy in patients with moderate-to-severe psoriasis. [2009.08]
BACKGROUND: To determine the prevalence of joint and nail symptoms, impact of these symptoms on health-related quality of life (HR-QoL), and the effects of etanercept on them in patients with moderate-to-severe plaque psoriasis... CONCLUSION: In this study of moderate-to-severe plaque psoriasis, joint and nail symptoms were prevalent and patients with these symptoms had significantly greater HR-QoL impairment at baseline than unaffected patients. Etanercept provided significant improvement in symptom severity and HR-QoL.
Etanercept, mycophenolate, denileukin, or pentostatin plus corticosteroids for acute graft-versus-host disease: a randomized phase 2 trial from the Blood and Marrow Transplant Clinical Trials Network. [2009.07.16]
Acute graft-versus-host disease (aGVHD) is the primary limitation of allogeneic hematopoietic cell transplantation...
Etanercept treatment in children with new-onset type 1 diabetes: pilot randomized, placebo-controlled, double-blind study. [2009.07]
CONCLUSIONS: In this small pilot study, treatment of pediatric patients newly diagnosed with type 1 diabetes with etanercept resulted in lower A1C and increased endogenous insulin production, suggesting preservation of beta-cell function. A larger study is needed to further explore safety and efficacy.
Efficacy, safety and patient-reported outcomes of combination etanercept and sulfasalazine versus etanercept alone in patients with rheumatoid arthritis: a double-blind randomised 2-year study. [2009.07]
OBJECTIVE: To determine the efficacy and safety of etanercept and etanercept plus sulfasalazine versus sulfasalazine in patients with rheumatoid arthritis (RA) despite sulfasalazine therapy... CONCLUSION: Etanercept and etanercept plus sulfasalazine are efficacious for the long-term management of patients with RA. The addition of etanercept or substitution with etanercept should be considered as treatment options for patients not adequately responding to sulfasalazine.
Inhibition of radiographic progression with combination etanercept and methotrexate in patients with moderately active rheumatoid arthritis previously treated with monotherapy. [2009.07]
OBJECTIVE: To determine the effect of changing from etanercept or methotrexate monotherapy to etanercept plus methotrexate combination therapy on radiographic progression in rheumatoid arthritis (RA) patients... CONCLUSION: In these RA patients with on average moderate disease activity despite previous methotrexate monotherapy, combination treatment with etanercept and methotrexate inhibited radiographic progression and improved radiographic outcomes. These data, in conjunction with the previously published clinical data, support the use of combination therapy in RA patients with moderate disease activity.
Clinical Trials Related to Enbrel (Etanercept)
Study Comparing Enbrel (Etanercept) Plus Methotrexate Versus Enbrel Alone in Active Rheumatoid Arthritis Despite Current Methotrexate Therapy [Completed]
To investigate the changes in MRI-derived markers of joint inflammation and destruction and
in biochemical markers of connective tissue metabolism and angiogenesis in rheumatoid
arthritis patients treated with Enbrel and Enbrel+methotrexate.
Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant [Active, not recruiting]
The purpose of this study is to determine the effectiveness of etanercept in the treatment of
patients with sub-acute lung injury following a bone marrow transplant. This study will also
examine the toxicity of treatment with etanercept as well as whether there is an improved
quality of life in these patients.
Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (Etanercept) Auto-Injector Versus Enbrel® Pre-Filled Syringes [Completed]
The purpose of this study is to determine the preference of RA patients for the new EnbrelĀ®
(etanercept) pre-filled syringe in patients who are already taking EnbrelĀ®.
Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis [Terminated]
Rationale: etanercept inhibits the effects of tumor necrosis factor, which plays an important
role in the progression of rheumatoid arthritis. A study of children with polyarticular
course juvenile rheumatoid arthritis showed that Enbrel had efficacy and was generally well
tolerated in children ages 4-17 who had moderately to severely active disease and who failed
treatment with one or more disease modifying antiarthritic drugs. The children in the study
may have had arthritis onset of pauciarticular, polyarticular, or systemic nature. Systemic
onset juvenile rheumatoid arthritis (SOJRA) may result in approximately one-third of patients
having significant long-term disability. Purpose: the Phase 4 study is designed to further
define the safety and efficacy of etanercept in those children with SOJRA.
Study of Etanercept (Enbrel) in the Treatment of Pemphigus Vulgaris [Completed]
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 6 ratings/reviews, Enbrel has an overall score of 9.33. The effectiveness score is 9.67 and the side effect score is 8.67. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Enbrel review by 58 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | rheumatiod arthritis |
| Dosage & duration: | | 2 standard injections per week (dosage frequency: 2 times per week) for the period of 6 y ears |
| Other conditions: | | none |
| Other drugs taken: | | Arava 10 mg. per day | | |
Reported Results |
| Benefits: | | Major decrease in joint pain , major increase in mobility. Everything else improved as well; my energy, ability to do everyday small tasks, my state of mind, and sleeping. I had always been a very active person. After starting the Enbrel, I could jog again, ride horses, bike, play tennis, etc. |
| Side effects: | | Occassionally, a slight itch at the injection site. The manufacturer also warns about more susecptibility to infections. |
| Comments: | | Self injection twice per week |
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| | Enbrel review by 29 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | Ankylosing Spondylitis |
| Dosage & duration: | | 50mg / week taken weekly for the period of ongoing (3 months so far) |
| Other conditions: | | None |
| Other drugs taken: | | Was taking DMARDs (Etoricoxib, Diclofenac Sodium) | | |
Reported Results |
| Benefits: | | Little improvement for first week or so but then incredible turnaround. Went from regularly not being able to walk properly due to inflamed sacroiliac joints and general back pain and flu-like aches across whole body most days to a new woman! After 3 months have noticed the last couple of weeks some of the aches and pains starting to come back slightly towards end of the week but overall extremely positive. |
| Side effects: | | Discomfort at injection side, seen little increased infection (i.e colds, flu etc) however only been taking for 3 months so far |
| Comments: | | Enbrel weekly - self injected subcutaneously, 50mg |
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| | Enbrel review by 46 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Considerably Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | Psoriasis |
| Dosage & duration: | | 3x's daily (dosage frequency: 3 x's daily) for the period of 6 months |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | getting rid of plaque and the redness and itchiness and the ugly sight of it. being able to wear short sleeve shirts in the summer |
| Side effects: | | there were none basically. maybe a little soreness but it's like that anyway. it's only when applied and only for a moment |
| Comments: | | just the application |
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Page last updated: 2009-10-30
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