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%).
