Search

Background: Concern about post-CAR T-cell lymphomas has recently emerged. Analysis of pharmacovigilance data contributes to continuous safety monitoring, especially for newly authorized medicines, like CAR-T therapies., Research Design and Methods: Individual case safety reports (ICSRs) reporting at least one CAR T-cell therapy as a suspect drug were extracted from the Food and Drug Administration Adverse Event Reporting System database up to 6 February 2024. Descriptive and disproportionality analysis were performed., Results: Seventeen ICSRs reported T-cell malignancies associated with CAR T-cell therapy. Gender distribution was similar between females and males, and adult patients accounted for 41.2% of ICSRs. All cases were serious, with 41.2% resulting in death. The most reported Preferred Terms (PTs) for T-cell malignancies was 'T-cell lymphoma' (70.6%). Over 70% of ICSRs reported at least one other adverse event, predominantly gastrointestinal disorders (14.3%). Axicabtagene ciloleucel and tisagenlecleucel were associated with a statistically higher reporting frequency of T-cell lymphoma compared to all other drugs (p-value <0.001, for both). Statistically higher reporting frequencies of 'Haematological malignant tumors' and 'Malignant lymphomas' SMQs emerged when tisagenlecleucel was compared with axicabtagene ciloleucel (p-value <0.001, for both)., Conclusions: Axicabtagene ciloleucel and tisagenlecleucel may be associated with a higher reporting frequency of T-cell lymphoma than other drugs.

Objectives : Human papillomavirus (HPV) vaccines have proved to be effective in preventing cervical carcinoma. Although their safety profile resembled those of any other vaccine, few clinical studies showed that HPV vaccines might also induce severe adverse events. Methods : The authors aimed to investigate the safety profile of HPV vaccines, by analyzing the individual case safety reports (ICSRs) of a suspected adverse event following immunization (AEFI) concerning HPV vaccines that were sent to the Italian Pharmacovigilance Spontaneous Reporting System (RNF) in the Campania Region from January 2007 to September 2018. Results : During the study period, 82 ICSRs, covering 181 AEFIs, related to HPV vaccines were sent to the RNF in the Campania Region. The mean age of patients who experienced an AEFI after HPV vaccinations was 13 ± 4.5 years. The majority of ICSRs reported AEFIs that were considered as not serious (82%) and that had a favorable outcome (93%). Conclusion : The overall results of the study demonstrated that, except for a few cases, AEFIs related to HPV vaccines reflect those already reported in the summary of product characteristics. The authors did not identify any new safety issues or serious, rare or unexpected AEFIs that were medically confirmed to be related to HPV vaccines.

Background: Statin treatment is often associated with poor adherence, which may be due to the onset of adverse drug reactions (ADRs). We investigated on potential risk factors related to preventable cases of statin-induced ADRs and to the discontinuation of statin therapy., Methods: We performed a study using the database of Italian spontaneous reporting. The target population for the preventability assessment was all patients with suspected statin-induced ADRs deriving from Campania Region (a territory of Southern Italy) between 2012 and 2017. Additionally, a local sentinel surveillance site involving General Practitioners was selected to countercheck in routine clinical practice the role of ADRs for statin discontinuation., Results: In total, 34 of 655 (5.19%) regional cases were preventable and among detected risk factors 90.0% was related to healthcare professionals' practices and 10.0% to patient behaviour. In 81.4% (533/655) of cases, statin therapy was discontinued due to ADRs, mainly classified as not serious and associated with a positive prognosis. These results were also confirmed in the active sentinel site., Conclusions: Our findings suggest an inappropriate use of statins among the identified preventable cases and a potential inappropriate statin discontinuation due to ADRs. These factors may be useful for targeting interventions to improve statin adherence.

Introduction: Multiple sclerosis (MS) is a chronic immune-mediated inflammatory disorder of the brain and spinal cord characterized by inflammation, demyelination, and axonal degeneration. Area covered: Even though the pharmacological armamentarium for MS treatment is considerably improved in the last 20 years, safety data especially for the second-line and innovative treatments are lacking. In order to analyze the safety profile of drugs used for the treatment of MS, a literature review of pre-marketing, post-marketing studies and case reports was performed. Expert opinion: Nowadays, the numerous drugs approved in the last years for the treatment of MS allow a better control of the disease and a better patient compliance. The main advantages of the new disease-modifying agents for MS (DMTs), in fact, derive from the new oral administration and the prolonged half-life with consequent improvement in compliance compared to first-line therapy which required subcutaneous administrations. However, DMTs can cause serious, sometimes life-threatening or fatal, drug adverse reactions. Due to the lack of safety data and given the recent marketing approval of the last DMTs for MS, observational studies and post-marketing surveillance activities will be necessary in order to improve the knowledge about the safety profile of these drugs and the improvement of their use in clinical practice.