ORENCIA SIDE EFFECTS

 

 Because clinical trials are conducted under widely varying and controlled conditions, it is impossible to directly compare the adverse reaction rate observed in the drug clinical trial with the incidence in the clinical trial of another drug, and may not be predictable in clinical practice The adverse reaction rate observed in the wider patient population.

Like all therapeutic proteins, it has the potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. In addition, the incidence of positive antibodies (including neutralizing antibodies) observed in the assay may be affected by several factors, including the assay method, sample processing, sample collection time, concomitant medications and underlying diseases. named patient supply For these reasons, comparing the incidence of abatacept antibodies in the studies described below with the incidence of antibodies in other studies or other products may be misleading.

Clinical research experience of Orencia intravenous injection in adult RA patients

The data described in this article reflect the intravenous use of Orencia in patients with active RA in a placebo-controlled study (Orencia patients in 1955, 989 placebo patients).named patient medicines The double-blind placebo-controlled period of the study was 6 months (258 ORENCIA patients, 133 placebo) or 1 year (1697 ORENCIA patients, 856 placebo). Some of these patients received biological DMARD therapy, such as TNF blockers (204 ORENCIA patients and 134 placebo patients).

Most patients in RA clinical studies receive one or more of the following ORENCIA concomitant drugs: methotrexate, non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, TNF blockers, azathioprine, chloroquine, gold, hydroxy Chloroquine, leflunomide, sulfasalazine and anakinra.

The most serious adverse reactions are serious infections and malignant tumors.

The most common adverse events (occurring in ≥10% of patients treated with ORENCIA) were headache, upper respiratory tract infection, nasopharyngitis, and nausea.

The most common adverse event (interruption or discontinuation of ORERNCIA) of clinical intervention is caused by infection. pharmaceutical consulting companies The most frequently reported infections that caused dose interruptions were upper respiratory tract infection (1.0%), bronchitis (0.7%), and herpes zoster (0.7%). The most common infections leading to discontinuation are pneumonia (0.2%), local infection (0.2%) and bronchitis (0.1%).