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Enbrel (Etanercept) - Summary

 
 



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.


See all Enbrel indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Enbrel (Etanercept)

Treatment of RA With Etanercept With Reference to DMARDs
Source: Medscape Rheumatology Headlines [2014.04.09]
This study compares the long-term safety of etanercept with conventional DMARDs.
Rheumatology

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Published Studies Related to Enbrel (Etanercept)

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.

Cost utility analysis based on a head-to-head Phase 3 trial comparing ustekinumab and etanercept in patients with moderate-to-severe plaque psoriasis: a Canadian perspective. [2011.07]
OBJECTIVE: A head-to-head comparator study has shown that the clinical efficacy of ustekinumab is superior to that of etanercept over a 12-week period in patients with psoriasis. Economic models are often hindered by the lack of trials directly comparing outcomes between relevant alternative therapies. The aim of this analysis was to evaluate the cost-effectiveness of ustekinumab versus etanercept among adults with moderate-to-severe plaque psoriasis based on a Phase 3 head-to-head trial... CONCLUSIONS: This model highlights the advantage of having head-to-head comparative trial data relevant to the at-risk population. Our model shows that ustekinumab is more cost-effective than etanercept for patients with moderate-to-severe plaque psoriasis. Copyright (c) 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Clinical efficacy and safety of etanercept versus sulfasalazine in patients with ankylosing spondylitis: a randomized, double-blind trial. [2011.06]
OBJECTIVE: Etanercept, a fully human tumor necrosis factor (TNF) receptor, is an effective treatment in patients with ankylosing spondylitis (AS). Sulfasalazine is frequently used for the treatment of both axial symptoms and peripheral symptoms of AS, and it has been the recommended therapy before the use of an anti-TNF agent when peripheral arthritis is present. Until now, no clinical trial has compared the efficacy and safety of a TNF blocker with that of sulfasalazine. This study was undertaken to compare the efficacy and safety of etanercept with that of sulfasalazine after 16 weeks of treatment in patients with axial and peripheral manifestations of AS... CONCLUSION: In this population of patients with AS, etanercept was significantly more effective than sulfasalazine in improving the signs and symptoms of AS in the axial skeleton and peripheral joints. Copyright (c) 2011 by the American College of Rheumatology.

Etanercept compared to intraarticular corticosteroid injection in rheumatoid arthritis: double-blind, randomized pilot study. [2011.06]
OBJECTIVE: To compare etanercept (anti-tumor necrosis factor-alpha) with intraarticular (IA) corticosteroid injections to treat rheumatoid arthritis (RA)... CONCLUSION: Etanercept and IA steroid injections resulted in significant improvement at Week 4 that persisted to Week 24. There was no significant difference in outcome between the groups.

Efficacy and safety of etanercept in moderate-to-severe asthma: a randomised, controlled trial. [2011.06]
Increased tumour necrosis factor-alpha levels have been observed in bronchial biopsies and induced sputum from subjects with severe asthma... Studies in specific subsets of patients with asthma with longer-term follow-up may be needed to fully evaluate the clinical efficacy of ETN in this population.

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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]

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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 >>


PATIENT REVIEWS / RATINGS / COMMENTS

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

  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

 

Enbrel review by 54 year old male patient

  Rating
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

  Rating
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: 2014-04-09

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