In this article, we will discuss Abatacept (Adverse Effects). So, let’s get started.
The most serious adverse reactions were serious infections and malignancies. The most commonly reported adverse events (occuring in 10% of patients treated with ORENCIA® (abatacept)) 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
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.
The data described herein reflect exposure to ORENCIA® (abatacept) 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® (abatacept), 134 with placebo).
In the placebo-controlled trials, infections were reported in 54% of ORENCIA® (abatacept)-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® (abatacept) compared to placebo, were rhinitis, herpes simplex, and pneumonia
Serious infections were reported in 3.0% of patients treated with ORENCIA® (abatacept) 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 for a median of 12 months), the overall frequencies of malignancies were similar in the ORENCIA® (abatacept)- and placebo-treated patients (1.3% and 1.1%, respectively). However, more cases of lung cancer were observed in ORENCIA® (abatacept)-treated patients (4, 0.2%) than placebo-treated patients. In the cumulative ORENCIA® (abatacept) 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 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® (abatacept) 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 to moderate. 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.
Of 2688 patients treated with ORENCIA in clinical trials, there were two cases of anaphylaxis or anaphylactoid reactions. Other events 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%]).