Our daughter, age 13 was dignosed in Jan 07. She has Uveitis and only her elbow joint is involved at this time. Methotrexate is not doing the job - Rheumatologist has added 50 mg Embrel once a week. I have asked several times if this is an appropriate dosage for a young girl and have been assured yes it is. She only weighs 83 lbs and this dosage concerns me. I have never used a message board so bear with me. Anything to offer on this???
I looked on a website that said 0.8mg of Enbrel per kilogram for JRA patients. My son is on Enbrel. He weighs about 38 pounds and he takes 12.5mg once a week. According to my calculations....83 pounds is roughly 37.65 kilograms. Following the 0.8mg per kg formula that would be around 30mg of Enbrel each week. The website I looked at also suggested that the dose be broken up into two shots for JRA patients. My son's dose is not given in two shots, but he is a might smaller than your daughter...as is his dose. It is a difficult thing when you can't get a straight answer from a doctor but you are really concerned for your child's welfare. I'm no doctor, but that is the information I found.Hope this is helpful:
FDA Approves Enbrel For Juvenile Rheumatoid Arthritis
SEATTLE, WA -- May 28, 1999 -- The United States Food and Drug Administration has approved Immunex Corp.'s and Wyeth-Ayerst Pharmaceuticals' Enbrel(R) (etanercept) for the treatment of moderately to severely active polyarticular-course juvenile rheumatoid arthritis (JRA) in patients who have had an inadequate response to one or more disease modifying medicines.
JRA is an autoimmune system disease that strikes children before age 16 and can cause painful joint swelling, deformity, stunted growth and increased mortality. According to the Arthritis Foundation, JRA affects approximately 50,000 children in the United States. The disease can impair a child's ability to take part in physical activities, make daily activities such as schoolwork more difficult and affect a child's physical appearance.
"Children with JRA face the possibility of a lifetime of pain and disability," said Daniel Lovell, M.D., M.P.H., a pediatric rheumatologist at Children's Hospital Medical Center of Cincinnati and principal investigator of the clinical study on which the JRA indication was based. "Rheumatologists have had limited options to treat children with moderate to severe arthritis. The approval of Enbrel for JRA opens a new era of hope for these children, teen-agers and their families."
Prior to this approval, Enbrel was already approved by the FDA for the treatment of moderately to severely active rheumatoid arthritis in adults. Enbrel has been granted orphan drug designation by the FDA for the treatment of JRA. Orphan drug designations are given to drugs for the treatment of medical conditions affecting 200,000 people or less in the United States.
Enbrel has been studied in more than 1,000 people with RA, including 69 JRA patients from ages four to 17 years. Seventy-four percent of the 69 study participants demonstrated a clinical response to Enbrel, measured by the JRA Definition of Improvement. The JRA Definition of Improvement includes a physician's assessment, a count of joints with active arthritis, a count of joints with loss of motion, a patient's or parent's global assessment, a functional ability test and a blood test to assess inflammation (ESR). Enbrel has not been studied in children younger than four years old.
The tolerability profile of Enbrel in JRA patients was similar to that seen in adult RA patients treated with the drug. Enbrel should not be started in patients who have an active or serious infection or are allergic to the drug or its ingredients. If a patient develops a new infection while on Enbrel, they should tell their doctor right away. In adult medical studies some patients experienced injection site reactions (37 percent), infections (35 percent), headache (17 percent) and malignancies (less than one percent).
With the exception of injection site reactions, the adverse event rate over time was similar for patients receiving Enbrel or placebo. In children, infections (62 percent), headache (19 percent), abdominal pain (19 percent), vomiting (13 percent) and nausea (nine percent) occurred more frequently than in adults. The types of infections reported in JRA patients were generally mild and consistent with those commonly seen in out patient pediatric populations.
The long-term effects of Enbrel treatment on infection, malignancy or autoimmune disease are unknown. Since the introduction of Enbrel, there have been some reports of infection that have led to serious problems, including fatalities. Many of these reports have been in people with other diseases, like diabetes, which make them more likely to get serious infections.
The dosage of Enbrel for JRA patients is 0.4 mg/kg (maximum dose of 25 mg) given twice weekly as a subcutaneous injection 72 to 96 hours apart. A two-part clinical trial was conducted in patients ranging from four to 17 years of age with active polyarticular course JRA who were refractory to or intolerant of methotrexate therapy.
In part one of the study, which lasted three months, all patients received Enbrel. Fifty-one of 69, or 74 percent, of these patients demonstrated a positive clinical response and entered part two of the study, which lasted an additional four months. In part two of the study, patients were randomised to receive either Enbrel or placebo. Only six of the 25 patients remaining on Enbrel experienced a disease flare (24 percent) compared to 20 of 26 of placebo patients who experienced a disease flare (77 percent).
Enbrel acts by binding tumour necrosis factor (TNF). TNF is one of the dominant cytokines or proteins that play an important role in the cascade of reactions that cause the inflammatory process of RA. Enbrel competitively inhibits the binding of TNF molecules to the TNF receptor (TNFR) sites. The binding of Enbrel to TNF renders the bound TNF biologically inactive, resulting in significant reduction in inflammatory activity.
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