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Enbrel (Etanercept) - 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.

See all Enbrel indications & dosage >>


Published Studies Related to Enbrel (Etanercept)

Remission induction comparing infliximab and high-dose intravenous steroid, followed by treat-to-target: a double-blind, randomised, controlled trial in new-onset, treatment-naive, rheumatoid arthritis (the IDEA study). [2014]
infliximab (IFX) with MTX and intravenous corticosteroid for remission induction... CONCLUSIONS: In DMARD-naive early RA patients, initial therapy with MTX+high-dose

Rates of serious infections, opportunistic infections, inflammatory bowel disease, and malignancies in subjects receiving etanercept vs. controls from clinical trials in ankylosing spondylitis: a pooled analysis. [2014]
CONCLUSIONS: These data suggest that etanercept is well tolerated in subjects

Etanercept (Enbrel) in the treatment of juvenile idiopathic arthritis. [2013]
INTRODUCTION: Juvenile idiopathic arthritis (JIA) is a relatively common multidimensional and heterogeneous chronic disease of childhood. Children with JIA are at risk for significant morbidity in terms of joint damage, impairments in physical function and health-related quality of life... Further, identification of potential clinical or laboratory markers allowing for prediction of response and timing of starting and cessation of this biologic therapy are urgently required.

Etanercept in the treatment of ankylosing spondylitis: a meta-analysis of randomized, double-blind, placebo-controlled clinical trials, and the comparison of the Caucasian and Chinese population. [2013]
systematic analysis for its efficacy and safety... INTERPRETATION: Our preliminary analysis provided that the Caucasian population

High-dose etanercept in ankylosing spondylitis: results of a 12-week randomized, double blind, controlled multicentre study (LOADET study). [2011.10]
OBJECTIVES: Etanercept 50 mg a week is approved in the treatment of AS. Increasing the etanercept dose to 100 mg/week improves efficacy in cutaneous psoriasis, a clinical manifestation related to the spondylarthritis family, while maintaining its safety profile. The purpose of this study was to evaluate the efficacy and safety of etanercept 100 vs 50 mg/week in patients with AS... CONCLUSIONS: High-dose (100 mg/week) etanercept in the treatment of AS for 12 weeks is as safe as the standard dose (50 mg/week). However, it does not significantly increase its efficacy. Trial Registration. Clinicaltrials.gov, http://clinicaltrials.gov/, NCT00873730.

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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 EnbrelŪ (Etanercept) Auto-Injector Versus EnbrelŪ Pre-Filled Syringes [Completed]
The purpose of this study is to determine the preference of RA patients for the new EnbrelŪ (etanercept) pre-filled syringe in patients who are already taking EnbrelŪ.

Safety and Efficacy Study of Etanercept (EnbrelŪ) 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]

more trials >>

Reports of Suspected Enbrel (Etanercept) Side Effects

Injection Site Pain (6662)Injection Site Erythema (5633)Injection Site Swelling (3183)Rheumatoid Arthritis (3001)Injection Site Pruritus (2899)Psoriasis (2632)Arthralgia (2574)Injection Site Reaction (2480)Drug Ineffective (2422)Injection Site Haematoma (2251)more >>


Based on a total of 14 ratings/reviews, Enbrel has an overall score of 8.43. The effectiveness score is 9.57 and the side effect score is 8.14. 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

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


Enbrel review by 54 year old male patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
Treatment Info
Condition / reason:   rheumatoid arthritis
Dosage & duration:   50 ml (dosage frequency: once per week) for the period of 10 months
Other conditions:   depression
Other drugs taken:   meloxicam, trazodone
Reported Results
Benefits:   There was a complete halt of pain in the foot, which was the most affected area with arthritis, within 3 weeks of use. Swelling of the foot was gone within 5 weeks.
Side effects:   I have not experienced any side effects.
Comments:   I feel that it is definitely easy to contract a bad cold and then very difficult to overcome it, with the use of Enbrel. However, the benefit outweighs the liability. I would also recommend that the patient have good insurance. This medication is very expensive.


Enbrel review by 47 year old male patient

Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Extremely Severe Side Effects
Treatment Info
Condition / reason:   RA
Dosage & duration:   50mg taken once for the period of Once
Other conditions:   None
Other drugs taken:   Methotrexate
Reported Results
Benefits:   Reduced swelling and pain after about two days. Then on the third day, started to get stomach cramps that settled into lower right abdomen. Initial injection on Monday night, cramps by Thursday noon, emergency room Thursday night, appendix removed Saturday morning.
Side effects:   By fourth day, diagnosed with appendicitis - nice trip to the emergency room for removal of appendix 4 days after injection. Stopped drug now. Apparently, this is a reported, low level side effect. http://www.druglib.com/druginfo/enbrel/side-effects/ Other infrequent serious adverse events observed in RA, psoriatic arthritis, ankylosing spondylitis, or plaque psoriasis clinical trials are listed by body system below: Digestive:cholecystitis, pancreatitis, gastrointestinal hemorrhage, appendicitis
Comments:   50mg pen injection. Of course did not continue with Enbrel treatment.

See all Enbrel reviews / ratings >>

Page last updated: 2014-11-30

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