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What is Orencia (abatacept)?
Common side effects of Orencia include:
- upper respiratory tract infections,
- and infusion-related reactions (such as dizziness, headache, high or low blood pressure, wheezing, rash, and shortness of breath).
Serious side effects of Orencia include:
- and cancer.
Drug interactions of Orencia include:
- tumor necrosis factor (TNF) blockers [for example, Enbrel (etanercept), Humira (adalimumab) and Remicade (infliximab)]
- and live vaccines.
What are the important side effects of Orencia (abatacept)?
The most common side effects of abatacept are:
Because abatacept depresses the immune system it reduces the body's ability to fight infection. Therefore, existing infections may worsen or new ones may develop.
Other important side effects include infusion-related reactions such as:
The most serious side effects are:
- and cancer.
Orencia (abatacept) side effects list for healthcare profesisonals
- Because clinical trials are conducted under widely varying and controlled conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not predict the rates observed in a broader patient population in clinical practice.
- As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease.
- For these reasons, comparison of the incidence of antibodies to abatacept in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.
Clinical Studies Experience In Adult RA Patients Treated With Intravenous Orencia
- The data described herein reflect exposure to Orencia administered intravenously in patients with active RA in placebo-controlled studies (1955 patients with Orencia, 989 with placebo). The studies had either a double-blind, placebo-controlled period of 6 months (258 patients with Orencia, 133 with placebo) or 1 year (1697 patients with Orencia, 856 with placebo). A subset of these patients received concomitant biologic DMARD therapy, such as a TNF blocking agent (204 patients with Orencia, 134 with placebo).
- The majority of patients in RA clinical studies received one or more of the following concomitant medications with Orencia: methotrexate, nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, TNF blocking agents, azathioprine, chloroquine, gold, hydroxychloroquine, leflunomide, sulfasalazine, and anakinra.
- The most serious adverse reactions were serious infections and malignancies.
- The most commonly reported adverse events (occurring in ≥10% of patients treated with Orencia) were headache, upper respiratory tract infection, nasopharyngitis, and nausea.
- The adverse events most frequently resulting in clinical intervention (interruption or discontinuation of Orencia) were due to infection. The most frequently reported infections resulting in dose interruption were upper respiratory tract infection (1.0%), bronchitis (0.7%), and herpes zoster (0.7%). The most frequent infections resulting in discontinuation were pneumonia (0.2%), localized infection (0.2%), and bronchitis (0.1%).
- In the placebo-controlled trials, infections were reported in 54% of Orencia-treated patients and 48% of placebo-treated patients.
- The most commonly reported infections (reported in 5%-13% of patients) were upper respiratory tract infection, nasopharyngitis, sinusitis, urinary tract infection, influenza, and bronchitis.
- Other infections reported in fewer than 5% of patients at a higher frequency (>0.5%) with Orencia compared to placebo, were rhinitis, herpes simplex, and pneumonia.
- Serious infections were reported in 3.0% of patients treated with Orencia and 1.9% of patients treated with placebo. The most common (0.2%-0.5%) serious infections reported with Orencia were pneumonia, cellulitis, urinary tract infection, bronchitis, diverticulitis, and acute pyelonephritis.
- In the placebo-controlled portions of the clinical trials (1955 patients treated with Orencia for a median of 12 months), the overall frequencies of malignancies were similar in the Orencia-and placebo-treated patients (1.3% and 1.1%, respectively).
- However, more cases of lung cancer were observed in Orencia-treated patients (4, 0.2%) than placebo-treated patients (0). In the cumulative Orencia clinical trials (placebo-controlled and uncontrolled, open-label) a total of 8 cases of lung cancer (0.21 cases per 100 patient-years) and 4 lymphomas (0.10 cases per 100 patient-years) were observed in 2688 patients (3827 patient-years).
- The rate observed for lymphoma is approximately 3.5-fold higher than expected in an age-and gender-matched general population based on the National Cancer Institute’s Surveillance, Epidemiology, and End Results Database.
- Patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. Other malignancies included skin, breast, bile duct, bladder, cervical, endometrial, lymphoma, melanoma, myelodysplastic syndrome, ovarian, prostate, renal, thyroid, and uterine cancers. The potential role of Orencia in the development of malignancies in humans is unknown.
Infusion-Related Reactions And Hypersensitivity Reactions
- Acute infusion-related events (adverse reactions occurring within 1 hour of the start of the infusion) in Studies III, IV, and V were more common in the Orencia-treated patients than the placebo patients (9% for Orencia, 6% for placebo). The most frequently reported events (1%-2%) were dizziness, headache, and hypertension.
- Acute infusion-related events that were reported in >0.1% and ≤1% of patients treated with Orencia included cardiopulmonary symptoms, such as hypotension, increased blood pressure, and dyspnea; other symptoms included nausea, flushing, urticaria, cough, hypersensitivity, pruritus, rash, and wheezing.
- Most of these reactions were mild (68%) to moderate (28%). Fewer than 1% of Orencia-treated patients discontinued due to an acute infusion-related event. In controlled trials, 6 Orencia-treated patients compared to 2 placebo-treated patients discontinued study treatment due to acute infusion-related events.
- In clinical trials of 2688 adult RA patients treated with intravenous Orencia, there were two cases (<0.1%) of anaphylaxis or anaphylactoid reactions. Other reactions potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea, each occurred in less than 0.9% of Orencia-treated patients and generally occurred within 24 hours of Orencia infusion. Appropriate medical support measures for the treatment of hypersensitivity reactions should be available for immediate use in the event of a reaction.
Adverse Reactions In Patients With COPD
- In Study V, there were 37 patients with chronic obstructive pulmonary disease (COPD) who were treated with Orencia and 17 COPD patients who were treated with placebo. The COPD patients treated with Orencia developed adverse events more frequently than those treated with placebo (97% vs 88%, respectively).
- Respiratory disorders occurred more frequently in Orencia-treated patients compared to placebo-treated patients (43% vs 24%, respectively) including COPD exacerbation, cough, rhonchi, and dyspnea. A greater percentage of Orencia-treated patients developed a serious adverse event compared to placebo-treated patients (27% vs 6%), including COPD exacerbation (3 of 37 patients [8%]) and pneumonia (1 of 37 patients [3%]).
Other Adverse Reactions
Adverse events occurring in 3% or more of patients and at least 1% more frequently in Orencia-treated patients during placebo-controlled RA studies are summarized in Table 3.
Table 3: Adverse Events Occurring in 3% or More of Patients and at Least 1% More Frequently in Orencia-Treated Patients During Placebo-Controlled RA Studies
|Adverse Event (Preferred Term)||Orencia|
|Urinary tract infection||6||5|
|Pain in extremit||3||2|
|a Includes 204 patients on concomitant biologic DMARDs (adalimumab, anakinra, etanercept, or infliximab).|
b Includes 134 patients on concomitant biologic DMARDs (adalimumab, anakinra, etanercept, or infliximab).
- Antibodies directed against the entire abatacept molecule or to the CTLA-4 portion of abatacept were assessed by ELISA assays in RA patients for up to 2 years following repeated treatment with Orencia.
- Thirty-four of 1993 (1.7%) patients developed binding antibodies to the entire abatacept molecule or to the CTLA-4 portion of abatacept. Because trough levels of abatacept can interfere with assay results, a subset analysis was performed. In this analysis it was observed that 9 of 154 (5.8%) patients that had discontinued treatment with Orencia for over 56 days developed antibodies.
- Samples with confirmed binding activity to CTLA-4 were assessed for the presence of neutralizing antibodies in a cell-based luciferase reporter assay. Six of 9 (67%) evaluable patients were shown to possess neutralizing antibodies. However, the development of neutralizing antibodies may be underreported due to lack of assay sensitivity.
- No correlation of antibody development to clinical response or adverse events was observed.
- The data reflect the percentage of patients whose test results were positive for antibodies to abatacept in specific assays. The observed incidence of antibody (including neutralizing antibody) positivity in an assay is highly dependent on several factors, including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medication, and underlying disease. For these reasons, comparison of the incidence of antibodies to abatacept with the incidence of antibodies to other products may be misleading.
Clinical Experience In Methotrexate-Naive Patients
- Study VI was an active-controlled clinical trial in methotrexate-naive patients. The safety experience in these patients was consistent with Studies I-V.
Clinical Studies Experience In Adult RA Patients Treated With Subcutaneous Orencia
- Study SC-1 was a randomized, double-blind, double-dummy, non-inferiority study that compared the efficacy and safety of abatacept administered subcutaneously (SC) and intravenously (IV) in 1457 subjects with rheumatoid arthritis, receiving background methotrexate, and experiencing an inadequate response to methotrexate (MTX-IR).
- The safety experience and immunogenicity for Orencia administered subcutaneously was consistent with intravenous Studies I-VI.
- Due to the route of administration, injection site reactions and immunogenicity were evaluated in Study SC-1 and two other smaller studies discussed in the sections below.
Injection Site Reactions In Adult RA Patients Treated With Subcutaneous Orencia
- Study SC-1 compared the safety of abatacept including injection site reactions following subcutaneous or intravenous administration.
- The overall frequency of injection site reactions was 2.6% (19/736) and 2.5% (18/721) for the subcutaneous abatacept group and the intravenous abatacept group (subcutaneous placebo), respectively.
- All these injection site reactions (including hematoma, pruritus, and erythema) were mild (83%) to moderate (17%) in severity, and none necessitated drug discontinuation.
Immunogenicity In Adult RA Patients Treated With Subcutaneous Orencia
- Study SC-1 compared the immunogenicity to abatacept following subcutaneous or intravenous administration.
- The overall immunogenicity frequency to abatacept was 1.1% (8/725) and 2.3% (16/710) for the subcutaneous and intravenous groups, respectively.
- The rate is consistent with previous experience, and there was no correlation of immunogenicity with effects on pharmacokinetics, safety, or efficacy.
Immunogenicity And Safety Of Subcutaneous Orencia Administration As Monotherapy Without An Intravenous Loading Dose
- Study SC-2 was conducted to determine the effect of monotherapy use of Orencia on immunogenicity following subcutaneous administration without an intravenous load in 100 RA patients, who had not previously received abatacept or other CTLA4Ig, who received either subcutaneous Orencia plus methotrexate (n=51) or subcutaneous Orencia monotherapy (n=49).
- No patients in either group developed anti-product antibodies after 4 months of treatment.
- The safety observed in this study was consistent with that observed in the other subcutaneous studies.
Immunogenicity And Safety Of Subcutaneous Orencia Upon Withdrawal (Three Months) And Restart Of Treatment
- Study SC-3 in the subcutaneous program was conducted to investigate the effect of withdrawal (three months) and restart of Orencia subcutaneous treatment on immunogenicity in RA patients treated concomitantly with methotrexate.
- One hundred sixty-seven patients were enrolled in the first 3-month treatment period and responders (n=120) were randomized to either subcutaneous Orencia or placebo for the second 3-month period (withdrawal period). Patients from this period then received open-label Orencia treatment in the final 3-month period of the study (period 3).
- At the end of the withdrawal period, 0/38 patients who continued to receive subcutaneous Orencia developed anti-product antibodies compared to 7/73 (9.6%) of patients who had subcutaneous Orencia withdrawn during this period. Half of the patients receiving subcutaneous placebo during the withdrawal period received a single intravenous infusion of Orencia at the start of period 3 and half received intravenous placebo.
- At the end of period 3, when all patients again received subcutaneous Orencia, the immunogenicity rates were 1/38 (2.6%) in the group receiving subcutaneous Orencia throughout, and 2/73 (2.7%) in the group that had received placebo during the withdrawal period.
- Upon reinitiating therapy, there were no injection reactions and no differences in response to therapy in patients who were withdrawn from subcutaneous therapy for up to 3 months relative to those who remained on subcutaneous therapy, whether therapy was reintroduced with or without an intravenous loading dose.
- The safety observed in this study was consistent with that observed in the other studies.
Clinical Studies Experience In Juvenile Idiopathic Arthritis Patients Treated With Intravenous Orencia
- In general, the adverse events in pediatric patients were similar in frequency and type to those seen in adult patients.
- Study JIA-1 was a three-part study including an open-label extension that assessed the safety and efficacy of intravenous Orencia in 190 pediatric patients, 6 to 17 years of age, with polyarticular juvenile idiopathic arthritis.
- Overall frequency of adverse events in the 4-month, lead-in, open-label period of the study was 70%; infections occurred at a frequency of 36%.
- The most common infections were upper respiratory tract infection and nasopharyngitis. The infections resolved without sequelae, and the types of infections were consistent with those commonly seen in outpatient pediatric populations.
- Other events that occurred at a prevalence of at least 5% were headache, nausea, diarrhea, cough, pyrexia, and abdominal pain.
- A total of 6 serious adverse events (acute lymphocytic leukemia, ovarian cyst, varicella infection, disease flare , and joint wear) were reported during the initial 4 months of treatment with Orencia.
- Of the 190 patients with juvenile idiopathic arthritis treated with Orencia in clinical trials, there was one case of a hypersensitivity reaction (0.5%). During Periods A, B, and C, acute infusion-related reactions occurred at a frequency of 4%, 2%, and 3%, respectively, and were consistent with the types of events reported in adults.
- Upon continued treatment in the open-label extension period, the types of adverse events were similar in frequency and type to those seen in adult patients, except for a single patient diagnosed with multiple sclerosis while on open-label treatment.
- Antibodies directed against the entire abatacept molecule or to the CTLA-4 portion of abatacept were assessed by ELISA assays in patients with juvenile idiopathic arthritis following repeated treatment with Orencia throughout the open-label period.
- For patients who were withdrawn from therapy for up to 6 months during the double-blind period, the rate of antibody formation to the CTLA-4 portion of the molecule was 41% (22/54), while for those who remained on therapy the rate was 13% (7/54).
- Twenty of these patients had samples that could be tested for antibodies with neutralizing activity; of these, 8 (40%) patients were shown to possess neutralizing antibodies.
- The presence of antibodies was generally transient and titers were low. The presence of antibodies was not associated with adverse events, changes in efficacy, or an effect on serum concentrations of abatacept.
- For patients who were withdrawn from Orencia during the double-blind period for up to 6 months, no serious acute infusion-related events were observed upon re-initiation of Orencia therapy.
Clinical Studies Experience In Juvenile Idiopathic Arthritis Patients Treated With Subcutaneous Orencia
- Study JIA-2 was an open-label study with a 4-month short-term period and a long-term extension period that assessed the pharmacokinetics (PK), safety, and efficacy of subcutaneous Orencia in 205 pediatric patients, 2 to 17 years of age with juvenile idiopathic arthritis.
- The safety experience and immunogenicity for Orencia administered subcutaneously were consistent with the intravenous Study JIA-1.
- There were no reported cases of hypersensitivity reactions. Local injection-site reactions occurred at a frequency of 4.4%.
Clinical Studies Experience In Adult PsA Patients
- The safety of Orencia was evaluated in 594 patients with psoriatic arthritis (341 patients on Orencia and 253 patients on placebo), in two randomized, double-blind, placebo-controlled trials.
- Of the 341 patients who received Orencia, 128 patients received intravenous Orencia (PsA-I) and 213 patients received subcutaneous Orencia (PsA-II).
- The safety profile was comparable between studies PsA-I and PsA-II and consistent with the safety profile in rheumatoid arthritis.
- Adverse reactions have been reported during the postapproval use of Orencia. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Orencia.
- Based on the postmarketing experience in adult RA patients, the following adverse reaction has been identified during postapproval use with Orencia.
What drugs interact with Orencia (abatacept)?
- Concurrent administration of a TNF antagonist with Orencia has been associated with an increased risk of serious infections and no significant additional efficacy overuse of the TNF antagonists alone.
- Concurrent therapy with Orencia and TNF antagonists is not recommended.
Other Biologic RA Therapy
- There is insufficient experience to assess the safety and efficacy of Orencia administered concurrently with other biologic RA therapy, such as anakinra, and therefore such use is not recommended.
Blood Glucose Testing
- Parenteral drug products containing maltose can interfere with the readings of blood glucose monitors that use test strips with glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ).
- The GDH-PQQ based glucose monitoring systems may react with the maltose present in Orencia for intravenous administration, resulting in falsely elevated blood glucose readings on the day of infusion.
- When receiving Orencia through intravenous administration, patients that require blood glucose monitoring should be advised to consider methods that do not react with maltose, such as those based on glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), glucose oxidase, or glucose hexokinase test methods.
- Orencia for subcutaneous administration does not contain maltose; therefore, patients do not need to alter their glucose monitoring.
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Related Disease Conditions
Buildup of uric acid crystals in a joint causes gouty arthritis. Symptoms and signs include joint pain, swelling, heat, and redness, typically of a single joint. Gout may be treated with diet and lifestyle changes, as well as medication.
Rheumatoid Arthritis (RA)
Rheumatoid arthritis (RA) is an autoimmune disease that causes chronic inflammation of the joints, the tissue around the joints, as well as other organs in the body. Because it can affect multiple other organs of the body, rheumatoid arthritis is referred to as a systemic illness and is sometimes called rheumatoid disease. The 16 characteristic early RA signs and symptoms include the following. Anemia Both sides of the body affected (symmetric) Depression Fatigue Fever Joint deformity Joint pain Joint redness Joint stiffness Joint swelling Joint tenderness Joint warmth Limping Loss of joint function Loss of joint range of motion Many joints affected (polyarthritis)
16 Early Rheumatoid Arthritis (RA) Symptoms and Signs
Early RA symptoms and signs vary differently from person to person. The most common body parts that are initially affected by RA include the small joints of the hands, wrists, and feet, and the knees and hip joints. Joint inflammation causes stiffness. Warmth, redness, and pain may vary in degree.
Arthritis (Joint Inflammation)
Arthritis is inflammation of one or more joints. When joints are inflamed they can develop stiffness, warmth, swelling, redness and pain. There are over 100 types of arthritis, including osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, lupus, gout, and pseudogout.
Osteoarthritis is a type of arthritis caused by inflammation, breakdown, and eventual loss of cartilage in the joints. Also known as degenerative arthritis, osteoarthritis can be caused by aging, heredity, and injury from trauma or disease.
Septic arthritis, or infectious arthritis, is infection of one or more joints by bacteria, viruses, or fungi. Symptoms and signs of septic arthritis include fever, joint pain, chills, swelling, redness, warmth, and stiffness. Treatment involves antibiotics and the drainage of the infected joint.
Psoriatic arthritis is a disease that causes skin and joint inflammation. Symptoms and signs include painful, stiff, and swollen joints, tendinitis, and organ inflammation. Treatment involves anti-inflammatory medications and exercise.
Second Source article from Government
Reactive arthritis is a chronic, systemic rheumatic disease characterized by three conditions, including conjunctivitis, joint inflammation, and genital, urinary, or gastrointestinal system inflammation. Inflammation leads to pain, swelling, warmth, redness, and stiffness of the affected joints. Non-joint areas may experience irritation and pain. Treatment for reactive arthritis depends on which area of the body is affected. Joint inflammation is treated with anti-inflammatory medications.
Rheumatoid Arthritis vs. Fibromyalgia
Though rheumatoid arthritis (RA) and fibromyalgia have similar symptoms, RA is an autoimmune disease and fibromyalgia is a chronic pain syndrome. RA symptoms include joint redness, swelling, and pain that lasts more than six weeks. Fibromyalgia symptoms include widespread pain, tingling feet or hands, depression, and bowel irritability. Home remedies for both include stress reduction, exercise, and getting enough sleep.
Pain Management and Rheumatoid Arthritis
Second Source article from WebMD
Second Source article from Government
Fungal arthritis is inflammation of a joint by a fungus that has invaded the body and is growing in the normally sterile joint. Fungal arthritis symptoms and signs include pain, redness, loss of range of motion, and swelling. Fungal arthritis treatment includes antibiotics, adequate drainage of the joint, and sometimes surgery.
Osteoarthritis vs. Osteoporosis Differences and Similarities
Arthritis is defined as painful inflammation and joint stiffness. Osteoarthritis is a type of arthritis and the most common cause of chronic joint pain, affecting over 25 million Americans. Osteoarthritis is a type of arthritis that involves the entire joint. Osteoporosis is not a type of arthritis. It is a disease that mainly is caused by a loss of bone tissue that is not limited to the joint areas. It is possible for one person to have both osteoarthritis and osteoporosis. The differences in the signs and symptoms of osteoarthritis and osteoporosis include; pain, stiffness, and joint swelling, joint deformity, crackle sounds when the joint is moving, and walking with a limp. Osteoporosis is called the "silent disease" because it can progress for years without signs and symptoms before it is diagnosed, severe back pain, bone fractures, height loss, and difficulty or inability to walk. The differences in the causes of osteoarthritis and osteoporosis are that osteoarthritis usually is caused by wear and tear on the joints. Osteoporosis usually is caused by one or more underlying problems, for example, calcium and vitamin D deficiencies. Treatment for osteoarthritis and osteoporosis are not the same. There is no cure for osteoarthritis or osteoporosis.
Rheumatoid Arthritis vs. Arthritis
Arthritis is a general term used to describe joint disease. Rheumatoid arthritis (RA) is a type of arthritis in which the body’s immune system mistakenly attacks the joints, causing chronic inflammation.
Juvenile Rheumatoid Arthritis (JRA)
Juvenile rheumatoid arthritis (JRA) annually affects one child in every thousand. There are six types of JRA. Treatment of juvenile arthritis depends upon the type the child has and should focus on treating the symptoms that manifest.
Non-Radiographic Axial Spondyloarthritis (nr-axSpA)
Non-radiographic spondyloarthritis (nr-axSpA) is an inflammatory arthritis that mainly affects the joints of the spine. Morning stiffness and back pain are the usual symptoms of nr-axSpA. Nonsteroidal anti-inflammatory drugs, exercise, and biologics are treatments for nr-axSpA.
Osteoarthritis vs. Rheumatoid Arthritis
Osteoarthritis (OA) and rheumatoid arthritis (RA) are chronic joint disorders. RA is also an autoimmune disease. OA and RA symptoms and signs include joint pain, warmth, and tenderness. Over-the-counter pain relievers treat both diseases. There are several prescription medications that treat RA.
Quackery of Arthritis
Arthritis patients are sometimes vulnerable to quackery (the business of promoting unproven remedies). These "quick fix" treatments are promoted as cure-alls, but they really have no right to such claims. Consumers should be wary of products that have marketing claims like "will cure," "ancient remedy," "has no side effects," and "revolutionary new scientific breakthrough." Read about arthritis remedies and tests that have no scientific proof of benefits.
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- Lupus: 2005 Arthritis Conference Highlights
- Osteoporosis: 2005 Arthritis Conference Highlights
- Osteoarthritis Update: 2005 Arthritis Conference
- Rheumatoid Arthritis Update: 2005 Arthritis Conference
- Gout: 2005 Arthritis Conference Highlights
- Osteoarthritis and Weight Loss Audio Podcast
- Rheumatoid Arthritis - Checking Your Pulse Audio Segment
Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.