BARCELONA, Spain, June 15, 2007 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company today announced results regarding the efficacy and safety of ORENCIA(R) (abatacept) from the open-label phase of an ongoing investigational study in children with juvenile idiopathic arthritis (JIA) who have had an inadequate response to one or more disease-modifying anti- rheumatic drugs (DMARDs), such as methotrexate (MTX) or tumor necrosis factor (TNF) antagonists. The results demonstrated that, after a study protocol- mandated withdrawal period of up to six months, the re-introduction of ORENCIA was associated with a re-establishment of clinical improvement as measured by the of Rheumatology's Pediatric (ACR Pedi) criteria for improvement in children with JIA. The data will be presented tomorrow at the Annual Congress of the European League Against Rheumatism.
"Children with JIA can have long periods of inactive disease and clinical remission, which makes it important to study the efficacy and safety of re- starting a treatment after a withdrawal period," said Edward H. Giannini, M.Sc., Dr.P.H., Professor of Pediatrics, Division of Rheumatology, Cincinnati Children's Hospital Medical Center, OH, co-principal investigator of the study. "The results of this investigational study suggest that, in these children with JIA who had disease flares while taking placebo during the mandated withdrawal phase, resuming therapy with ORENCIA was associated with a re-establishment of clinical improvement."
The study, designed to assess the efficacy, safety and tolerability of ORENCIA in children and adolescents (ages 6-17 years) with JIA, consisted of three periods: a four-month open-label lead-in treatment period in which all participants received ORENCIA and both a clinical response and safety were assessed (Period A), a six-month randomized double-blind withdrawal phase where responders received either ORENCIA(R) (abatac ept) or placebo (Period B) and time to disease flare and safety were assessed, and an open-label phase designed to assess efficacy and long-term safety (Period C). Children in periods A and B remained on a stable dose of MTX and children in Period C were permitted one of three DMARDs in addition to ORENCIA. Data from Period C will be presented tomorrow. Results from Periods A and B were presented at the of Rheumatology Annual Scientific Meeting in November 2006.
Fifty-nine children randomized to placebo in Period B participated in Period C to receive open label treatment with ORENCIA. Thirty-three of them experienced a flare while 26 did not.
Everyone in Period C received 10 mg/kg of ORENCIA approximately every 28 days. Of the 33 children who received placebo and experienced disease flares during the Period B protocol-mandated withdrawal phase of up to six months, 80 percent had an ACR Pedi 30 response, 70 percent had an ACR Pedi 50 response, 50 percent had an ACR Pedi 70 Response and 27 percent had an ACR Pedi 90 response after re-introduction of therapy with ORENCIA in Period C.
Of the 26 children who received placebo during Period B who did not experience disease flares and then chose to receive open-label ORENCIA treatment during Period C, 76 percent had an ACR Pedi 30 response, 68 percent had an ACR Pedi 50 response, 60 percent had an ACR Pedi 70 Response and 36 percent had an ACR Pedi 90 response after re-introduction of therapy with ORENCIA in Period C.
Of the children who completed Period C, four (6.7 percent) children previously treated with placebo in Period B reported serious adverse events (SAEs) versus five (5.5 percent) children continuously treated with ORENCIA. All SAEs were considered unrelated to ORENCIA according to the investigator. None of these children discontinued due to an adverse event (AE). In addition, no child previously treated with placebo in Period B had an acute infusion reaction during the first infusion of ORENCIA in Period C. There was one acute infusion reaction (palpebral edema, pruritus and rash) later during Period C. No deaths or malignant neoplasms were reported during this Period. The overall safety profile after re-establishing therapy with ORENCIA was similar to that observed in patients who were continuously treated with ORENCIA and who entered Period C.
Important Safety Information about ORENCIA
Before receiving treatment with ORENCIA individuals should tell their doctor if they are taking a TNF blocker (e.g., Enbrel(R), Humira(R), Remicade(R)) to treat rheumatoid arthritis (RA). ORENCIA(R) (abatacept) should not be taken with these medications because of a higher chance of getting a serious infection. Individuals should also tell their doctor if they are taking Kineret(R) to treat RA. ORENCIA should not be taken with Kineret. People taking ORENCIA should notify their doctor if they are taking any other medications including hormones, over-the-counter medicines, vitamins, supplements or herbal products.
Individuals should let their doctor know if they have any kind of infection including an infection that is in only one place of the body (such as an open cut or sore) or an infection that is in the whole body (such as the flu). Having an infection could increase the risk for serious side effects from ORENCIA. It is also important for individuals to let their doctor know if they have an infection that won't go away or a history of infections that keep coming back.
People who have had tuberculosis (TB), a positive skin test for TB, recent close contact with someone who has had TB or develop any of the symptoms of TB (a dry cough that doesn't go away, weight loss, fever, night sweats) should call their doctor right away. Before starting treatment with ORENCIA, a doctor may examine the individual for TB or perform a skin test.
In addition, individuals should let their doctor know if they are scheduled to have surgery or any vaccination or have recently received a vaccination. People should inform their doctor if they have a history of chronic obstructive pulmonary (lung) disease (COPD). Taking ORENCIA may cause COPD symptoms to get worse.
People who have diabetes and use a blood glucose monitor to check their sugar levels should tell their doctor. The infusion of ORENCIA contains maltose, a sugar that can give falsely high blood glucose readings with some monitors on the day the infusion is received. The doctor may recommend a different monitor.
Women who are pregnant, planning to become pregnant or are thinking about becoming pregnant should tell their doctor. It is not known if ORENCIA can harm an unborn baby. Women who are breast feeding should also inform their doctor. They will need to decide to either breast-feed or receive treatment with ORENCIA, but not both.
Important Information about Side Effects with ORENCIA
Like all medicines that affect your immune system, ORENCIA can cause serious side effects. The possible serious side effects include serious infections and allergic reactions. Also, rare cases of certain kinds of cancers have been reported.
People taking ORENCIA(R) (abatacept) are at increased risk for developing infections including pneumonia, and other infections caused by viruses, bacteria, or fungi. Individuals should call their doctor immediately if they feel sick or get any infection during treatment with ORENCIA.
Allergic reactions are usually mild or moderate, generally occur within the first 24 hours of an infusion, and include hives, swollen face, eyelids, lips, tongue, throat, or trouble breathing. There have been some serious allergic reactions reported after receiving an infusion of ORENCIA.
There have been rare cases of certain kinds of cancer. The role of ORENCIA in the development of cancer is not known.
The more common side effects with ORENCIA are headache, upper respiratory tract infection, sore throat, and nausea.
Dosing and Administration
ORENCIA is administered by a healthcare professional as a 30-minute intravenous infusion at a fixed dose based on body weight range approximating 10 mg/kg at day 0, 2 weeks, 4 weeks, and every 4 weeks thereafter. Acute infusion-related reactions were experienced in nine percent of people treated with ORENCIA and in six percent of people treated with placebo. According to the full prescribing information, the most frequently reported infusion- related adverse events (1 percent to 2 percent) were dizziness, headache, and hypertension. In pivotal studies, premedications were not required. However, appropriate medical support measures for the treatment of hypersensitivity reactions should be available for immediate use in the event of a reaction.
About Juvenile Idiopathic Arthritis
ORENCIA is not FDA-approved for use in children with juvenile idiopathic arthritis (JIA).
JIA - also commonly known as juvenile rheumatoid arthritis (JRA) - is a chronic, autoimmune disease, causing chronic pain, stiffness and swelling of the joints, which may ultimately lead to joint damage and deformities. The disease usually begins before the age of 16 and may affect up to 1 child in every 1,000 in the United States. Despite current therapies, some individuals with JIA experience ongoing disease and many eventually worsen, resulting in severe joint damage and abnormal joint function.
About ORENCIA(R) (abatacept)
ORENCIA is indicated in the United States for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs, such as methotrexate or TNF antagonists. ORENCIA may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists. ORENCIA should not be administered concomitantly with TNF antagonists and is not recommended for use concomitantly with anakinra.
ORENCIA, which was discovered and developed by Bristol-Myers Squibb Company, is a selective modulator of a co-stimulatory signal required for full T-cell activation and works in a fundamentally different way than cytokine antagonists, including TNF antagonists.
Bristol-Myers Squibb Company is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.
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