ABSTRACT
OBJECTIVE To provide a reference for the safe use of abatacept in clinic. METHODS Based on the United States FDA Adverse Event Reporting System （FAERS） database， the generic name of the drug “abatacept” and the trade name “Orencia” were used as the search keywords to retrieve drug adverse event （ADE） signal of abatacept as primary suspected drug. The reported odds ratio method and proportional reporting ratio method in the proportional imbalance method and Excel 2020 software were used to mine and analyze the signals. RESULTS A total of 93 189 abatacept-induced ADE reports were retrieved， mainly female cases （75.98%）， and the age was mainly concentrated in 18-64 years old （35.17%）； main countries reporting data were the United States （47.41%） and Canada （30.59%）， and the number of reports was generally increasing year by year. A total of 3 092 ADE signals were screened， of which the signals associated with the primary disease were similar to those described in the drug instruction of abatacept， such as rheumatoid arthritis， arthralgia， joint swelling， etc.； followed by ADE signals related to infusion reactions， including pain， fatigue， rash， etc. All selected ADE signals involved 27 system organ classes， mainly involved systemic diseases and drug site conditions， musculoskeletal and connective tissue diseases， injury， poisoning and surgical complications， infections and invasive diseases， gastrointestinal diseases， neurological diseases， respiratory， thoracic and mediastinal diseases， heart diseases， benign， malignant and unspecified tumors and reproductive system and breast diseases， etc. A total of 22 ADE signals were not included in the drug instructions of abatacept among the top 50 ADE signals in the number list of reported cases， including fatigue， drug intolerance， abdominal discomfort， swelling， lupus erythematosus， peripheral swelling， cell sores， diarrhea， elevated liver enzymes and lower respiratory tract infection， etc. CONCLUSIONS In the process of clinical use of abatacept， special attention should be paid to infection and its carcinogenicity， while assessing the risk of respiratory and cardiovascular system diseases in patients； when patients suffer from these two underlying diseases， the pros and cons should be weighed carefully before selecting drug； in addition， the drug-induced ADE in the neurological， gastrointestinal and reproductive system cannot be ignored.