WARNINGS: SERIOUS INFECTIONS AND MALIGNANCIES
SERIOUS INFECTIONS
Patients treated with Enbrel are at increased risk for developing serious infections that may le
ad to hospitalization or death [see Warnings and Precautions and Adverse Reactions (6)]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Enbrel should be discontinued if a patient develops a serious infection or sepsis.
Reported infections include:
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Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before Enbrel use and during therapy. Treatment for latent infection should be initiated prior to Enbrel use.
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Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
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Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.
The risks and benefits of treatment with Enbrel should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Enbrel, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
MALIGNANCIES
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including Enbrel.
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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 CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system.
Rheumatoid Arthritis
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 (RA). Enbrel can be initiated in combination with methotrexate (MTX) or used alone.
Polyarticular Juvenile Idiopathic Arthritis
Enbrel is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients ages 2 and older.
Psoriatic Arthritis
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 (PsA). Enbrel can be used in combination with methotrexate (MTX) in patients who do not respond adequately to MTX alone.
Ankylosing Spondylitis
Enbrel is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis (AS).
Plaque Psoriasis
Enbrel is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.
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NEWS HIGHLIGHTS
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.
Clinical Trials Related to Enbrel (Etanercept)
Enbrel-Juvenile Idiopathic Arthritis (JIA) Use Results Survey [All-Case Surveillance] [Completed]
This surveillance is conducted to survey the followings under the post marketed drug
utilization on the patients who are administrated ENBREL as a treatment for active
polyarticular JIA.
1. Primary Occurrence status of Adverse Events; incidence of all adverse events, serious
adverse events
2. Secondary Factors affecting safety and to confirm the efficacy such as DAS28.
Etanercept (Enbrel) in Undifferentiated Spondyloarthritis [Active, not recruiting]
The study has the aim to investigate the efficacy and safety of etanercept in patients with
active undifferentiated spondyloarthritis (uSpA) over the period of 520 weeks.
ASIS for Enbrel in Plaque Psoriasis [Not yet recruiting]
AUTOMATIC SUBDERMAL INJECTOR SYSTEM (ASIS) Corporation has developed and patented the only
automatic injection system for delivery of injectable products to the optimum spot, just
outside of the fascia, which exists subdermally (between the skin and muscle) or
interfascial (between the deeper muscles). ASIS device creates that bloodless space,
enhancing Enbrel's efficacy and preventing unnecessary distant spread and adverse reactions.
This space remains bloodless as long as the skin is lifted up or filled with an injectable
product. Although ASIS device was initially designed to best administer BOTOX for such
muscular conditions as Upper limb Spasticity, Cervical Dystonia, Chronic Migraine,
Strabismus, Blepharospasm, and Primary Axillary Hyperhidrosis, the technology will also
benefit other injectable products, including: GAMMAGARD for Primary Immunodeficiency (PI)
and Insulin for Diabetics, etc.
Etanercept (Enbrel) in Ankylosing Spondylitis [Active, not recruiting]
The study has the aim to investigate the efficacy and safety of etanercept in patients with
active ankylosing spondylitis (AS) over 520 weeks.
Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis [Recruiting]
The purpose of this study is to learn more about the role of etanercept alone or in
combination with methotrexate on disease activity in subjects with psoriatic arthritis.
To do this, etanercept alone will be compared to methotrexate alone or to combination
etanercept and methotrexate. This study will last approximately 1 year (52 weeks) for an
individual subject.
Subjects will be randomized into 1 of 3 groups. Subjects will have a 1 in 3 chance of
receiving etanercept plus methotrexate, etanercept alone or methotrexate alone. Neither the
subject nor the study doctor can choose the group to which the subject will be randomized
into. Subjects will take one study medication by injection under their skin and a second
medication taken by mouth. After the first 24 weeks of the study, if the doctor evaluates
the subject and determines that their condition has not improved, the subject may qualify to
receive etanercept plus methotrexate.
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 >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased 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 |
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| | 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. |
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| | 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. |
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Page last updated: 2014-11-30
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