To analyze potential adverse drug events(ADEs) associated with ustekinumab and upadacitinib in the treatment of inflammatory bowel disease(IBD) based on an international authoritative database, thereby providing evidence for clinical medication safety.

Data were extracted from the Food and Drug Administration Adverse Event Reporting System(FAERS) database using OpenVigil 2.1. ADE reports were collected for ustekinumab(from Q3 2017 to Q1 2025) and upadacitinib(from Q3 2019 to Q1 2025), where each drug was identified as the primary suspected medication for IBD. Signal detection and statistical analysis were performed using the reporting odds ratio(ROR) and proportional reporting ratio(PRR) methods.

A total of 3648 ADE reports for ustekinumab and 3812 for upadacitinib, with each as the primary suspected drug in IBD treatment, were retrieved. Using the ROR-PRR combined detection method, relevant ADE signals were identified. High-frequency ADEs associated with ustekinumab included hypersensitivity reactions, various infections, and brain fog, while those associated with upadacitinib included acne, flatulence, and herpes zoster. System organ class(SOC) analysis of positive signals indicated that both drugs commonly caused ADEs in categories such as Infections and infestations, Gastrointestinal disorders, Nervous system disorders, Skin and subcutaneous tissue disorders, and Respiratory, thoracic, and mediastinal disorders. Among these, Infections and infestations were the most frequent SOC, involving preferred terms such as Escherichia sepsis and Pneumococcal pneumonia.

Ustekinumab and upadacitinib exhibit distinct safety profiles in the treatment of IBD. In addition to known ADEs described in the prescribing information, ustekinumab requires close monitoring for hypersensitivity reactions, opportunistic infections, and potential neurological risks. For upadacitinib, attention should be paid to risks of acne, herpes zoster, hypercholesterolemia, and thrombotic events. These findings provide important safety information to support individualized clinical decision-making in IBD management.

To evaluate the clinical safety of four CD19-targeted and two BCMA-targeted chimeric antigen receptor T-cell (CAR-T) therapies.

Adverse drug reaction (ADR) reports for six CAR-T products (Breyanzi, Kymriah, Tecartus, Yescarta, Abecma, Carvykti) from the US FDA Adverse Event Reporting System (FAERS) database between January 2004 and March 2025 were retrieved. The basic characteristics of the reports were analyzed. ADRs were categorized by System Organ Class (SOC) and coded into corresponding preferred term(PT) using MedDRA (Version 27.1). The reporting odds ratio (ROR) and proportional reporting ratio (PRR) methods were used to detect association signals between the six drugs and the PT.

A total of 54 833 ADR reports were included in this study: Breyanzi (1511, 2.76%), Kymriah (18 087, 32.99%), Tecartus (4408, 8.04%), Yescarta (23 937, 43.65%), Abecma (2762, 5.04%), and Carvykti (4128, 7.53%). These reports corresponded to 15 210 unique patients, comprising 7136 males (46.92%), 4483 females (29.47%), and 3591 (23.61%) with missing gender information. Regarding age distribution, all patients in the Abecma and Carvykti groups were ≥18 years old, while 22.52% of patients in the Kymriah group were < 18 years old. The proportion of male patients was higher than that of females across all six drug groups. The top seven ADRs by report count were, in order: various nervous system disorders; immune system disorders; general disorders and administration site conditions; various investigations; infections and infestations; various neoplasms; and blood and lymphatic system disorders. The top ten PTs by report count included cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), pyrexia, neurotoxicity, death, hypotension, disease progression, fatigue, platelet count decreased, and malignant neoplasm progression. Among the six CAR-T therapies, the BCMA-targeted Abecma showed the strongest association with CRS [ROR 2412.12(95% CI: 2093.06-2779.83), PRR 891.75(χ²=449 083.34)]. The CD19-targeted Tecartus showed the strongest association with ICANS [ROR 2604.50 (95% CI: 2317.29-2927.30), PRR 1775.36 (χ²=705 195.47)] and neurotoxicity [ROR 762.84(95% CI: 685.77-848.56), PRR 439.88 (χ²=254 246.08)].All drugs except Tecartus were associated with decreased platelet count. Furthermore, both Breyanzi and Kymriah were associated with malignant neoplasm progression.

Clinicians should implement rigorous safety monitoring for patients receiving CAR-T therapy, paying particular attention to the early symptoms of CRS and neurotoxicity, and enhance surveillance for malignant neoplasm progression.

To evaluate the occurrence of rheumatological immune-related adverse events (irAEs) induced by immune checkpoint inhibitors (ICIs) using real-world database data.

By searching the Food and Drug Administration Adverse Event Reporting System (FAERS) database, adverseevent data from January 1, 2011, to March 31, 2025, were screened. Signal detection for potential adverse events was performed employing the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS) methods.

A total of 2643 reports of rheumatological irAEs directly induced by ICIs were retrieved from the database. The proportion of male patients experiencing rheumatological irAEs was higher than that of female patients. The age group of 45-74 years accounted for the largest proportion (49.80%, 1316/2643). Physicians (47.26%, 1249/2643) and patients (19.11%, 505/2643) were the primary reporters. Among the drugs causing rheumatological irAEs, nivolumab was the most frequently reported (42.41%, 1121/2643), followed by pembrolizumab (35.04%, 926/2643). In terms of the distribution of rheumatological irAE types, arthritis (39.86%, 1106/2775) and rheumatoid arthritis (24.58%, 682/2775) were the most common. Four signal detection methods indicated associations between rheumatological irAEs and the use of six ICIs: nivolumab, pembrolizumab, cemiplimab, dostarlimab, avelumab, and relatlimab. Among the 819 reports with clear timing of onset, 69.72% (571/819) of adverse events occurred within 120 days after drug administration. Among the 2433 reports with clear outcomes of adverse events, 6.45% (157/2433) of patients died, 5.55% (135/2433) experienced disability, 2.47% (60/2433) had life-threatening conditions, 31.98% (778/2433) required hospitalization, and 90.59% (2204/2433) experienced other serious medical events.

Severe rheumatological irAEs induced by ICIs and the corresponding detection signals warrant clinical attention. This study provides new evidence for the clinical monitoring and management of rheumatological irAEs, offering valuable insights for enhancing the safety of ICIs in clinical practice.

To investigate the clinical value of cardiac magnetic resonance feature tracking (CMR-FT) technology in the assessment of the right ventricle function in patients with immune checkpoint inhibitor (ICIs)-related myocarditis.

Patients who visited Peking Union Medical College Hospital from April 2022 to April 2024, were diagnosed as ICIs-related myocarditis by cardiologists, and had normal right ventricular ejection fraction (RVEF) were enrolled in myocarditis group. Meanwhile, healthy individuals without cardiovascular diseases were selected as healthy control group. All subjects underwent cardiac magnetic resonance (CMR) examinations. Cardiac function parameters of the left and right ventricles were measured in the subjects, including left ventricular ejection fraction (LVEF), RVEF, left ventricular end-systolic volume index (LVESVI), left ventricular end-diastolic volume index (LVEDVI), right ventricular end-systolic volume index (RVESVI), and right ventricular end-diastolic volume index (RVEDVI). Additionally, myocardial strain of the left and right ventricles were recorded, encompassing left ventricular global longitudinal strain (LV-GLS), left ventricular global circumferential strain (LV-GCS), left ventricular global radial strain (LV-GRS), right ventricular global longitudinal strain (RV-GLS), right ventricular global circumferential strain (RV-GCS), and right ventricular global radial strain (RV-GRS).

A total of 30 patients were induded in the myocarditis group and 20 in the healthy control group. The LVEF in the myocarditis group was was lower than that in the control group [(58.0±6.9)% vs. (65.4±6.6)%, P < 0.001)].The RVEF was (57.2±5.2)% in the myocarditis group, and (59.6±4.4)% in the healthy control group, showing no statistically significant difference (P > 0.05). LV-GLS, LV-GCS, LV-GRS, RV-GLS, RV-GCS, and RV-GRS in the myocarditis group were all lower than those in the healthy control group, with statistically significant differences (all P < 0.001).

Right ventricular myocardial strain obtained through CMR-FT technology can reveal early right ventricular cardiac dysfunction in patients with ICIs-related myocarditis, providing crucial evidence for early clinical prevention and timely intervention.