Post-marketing surveillance activities are essential to detect the risk/benefit profile of biologic disease-modifying antirheumatic drugs (bDMARDs) in inflammatory arthritis. The aim of this study was to evaluate adverse events (AEs) in patients treated with bDMARDs in rheumatology during a prospective pharmacovigilance study from 2016 to 2018. Descriptive statistical analyses were performed to evaluate bDMARDs-related variables of patients without AEs/failures vs patients with AEs and failures. The risk profile among biologics was assessed by comparing patients treated with each bDMARD to patients treated with etanercept. A total of 1155 patients were enrolled, mostly affected by rheumatoid arthritis (46.0%). AEs and failures were experienced by 8.7% and 23.3%, respectively. The number of comorbidities significantly influenced the onset of AEs, while anxiety-depressive, gastrointestinal disease, and fibromyalgia influenced onset of failures. The probability of developing an AE was significantly lower in patients treated with secukinumab, while the probability of developing treatment failure was significantly lower in patients treated with golimumab, secukinumab and tocilizumab. A total of 216 AEs were reported (25.5% serious), mostly regarding infections (21.8%), musculoskeletal (17.6%) and skin (16.2%) disorders. Serious AEs included neutropenia (12.7%), lymphocytosis (9.1%) and uveitis (7.3%). The obtained results revealed known AEs but real-world data should be endorsed for undetected safety concerns.

Background: The introduction of biological agents into the clinical armamentarium has modified the management of moderate-severe inflammatory arthritis (IA). However, these drugs can lead to serious adverse events (SAEs) and unpredictable adverse events (AEs) that are difficult to detect in pre-marketing clinical trials. This pharmacovigilance project aimed to study the AEs associated with biologics use in rheumatology. Methods: The current investigation is a multicenter, prospective, observational cohort study based on the Calabria Biologics Pharmacovigilance Program. Patients treated with one biologic agent from January 2016 to January 2022 were enrolled. Results: Overall, 729 (86.3%) of a total of 872 patients did not develop AEs or SAEs, whereas 143 (16.4%) patients experienced at least one AE, of which 16 (1.8%) had at least one SAE. The most common AEs were administration site conditions followed by gastrointestinal, nervous system and skin disorders. We reported a total of 173 switches and 156 swaps. Switches mainly occurred for inefficacy (136; 77.7%), whereas only 39 (22.3%) were due to the onset of an AE. Primary/secondary failure was the most frequent reason for swaps (124, 79%), while AEs onset led to 33 (21%) swaps. Conclusions: This study supports the validity of our program in monitoring and detecting AEs in the rheumatological area, confirming the positive beneficial/risk ratio of biologics.

Whether the primary Hepatitis B vaccination confers lifelong protection is debated. The aim of the study was to assess the effectiveness of booster doses in mounting a protective HBV immune response in subjects vaccinated 18–20 years earlier. The study population consisted of vaccinated students attending medical and healthcare professions schools. A booster dose was offered to subjects with a <10 mIU/mL anti-HBs titer. The post-booster anti-HBs titer was evaluated after four weeks. The subjects with a <10 mIU/mL post-booster anti-HBs titer, received a second and third dose of the vaccine and after one month they were retested. A <10 mIU/mL anti-HBs titer was found in 35.1% of the participants and 92.2% of subjects that were boosted had a ≥10 mIU/mL post-booster anti-HBs titer, whereas 7.8% did not mount an anamnestic response. A low post-booster response (10–100 mIU/mL anti-HBs) was significantly more likely in subjects with a <2.00 mIU/mL pre-booster titer compared to those with a 2.00–9.99 mIU/mL pre-booster titer. The anamnestic response was significantly related to the baseline anti-HBs levels. A booster dose of the HBV vaccine may be insufficient to induce an immunological response in subjects with undetectable anti-HBs titers. A booster dose might be implemented when an anamnestic response is still present.

Background: Study aim was to investigate the vaccination status against vaccine-preventable diseases (VPD) of frail adults during the SARS-CoV-2 pandemic and, for those subjects eligible for at least one vaccine, with respect to the recommended vaccination in line with the Italian National Vaccination Prevention Plane (NPVP), to explore the willingness to be vaccinated. Methods: A cross-sectional study was carried out among adults aged ≥ 60, immunocompromised or subjects affected by chronic conditions. Results: Among the 427 participants, a vaccination coverage rate lower than the targets for all the vaccines considered was found. Of those, 72.6% of subjects stated their willingness to receive recommended vaccinations, and 75.2% of the respondents stated that the advice to undergo vaccinations was received by the General Practitioner (GP). In a multivariable logistic regression model, higher odds of recommended VPD vaccination uptake (defined as having two or more of the recommended vaccinations) were associated with the willingness towards recommended VPD vaccination (Odds Ratio = 3.55, 95% Confidence Interval: 1.39 to 9.07), university education (OR = 2.03, 95% CI: 1.03 to 3.97), but having another person in the household (OR = 0.52, 95% CI: 0.28 to 0.97), and history of oncological disease (OR = 0.39, 95% CI: 0.18 to 0.87) were predictive of lower odds of vaccination uptake. In another multivariable model, higher odds of willingness to receive vaccines were associated with kidney disease (OR = 3.3, 95% CI: 1.01 to 10.5), perceived risk of VPD (OR = 1.9, 95% CI: 1.02 to 3.3), previous influenza vaccination (OR = 3.4, 95% CI: 1.8 to 6.5), and previous pneumococcal vaccination (OR = 3.1, 95% CI: 1.3 to 7.7), but increasing age (OR = 0.93 per year, 95% CI: 0.91 to 0.97), working (OR = 0.40, 95% CI: 0.20 to 0.78), and fear of vaccine side effects (OR = 0.38, 95% CI: 0.21 to 0.68) were predictive of lower odds of willingness to receive vaccines. Conclusions: Despite specific recommendations, vaccination coverage rates are far below international targets for frail subjects. Reducing missed opportunities for vaccination could be a useful strategy to increase vaccination coverage in frail patients during the routine checks performed by GPs and specialists.

Underreporting is the main limitation of spontaneous reporting systems. This cohort-event monitoring study aims to examine the potential of short message service (SMS)-based surveillance compared to traditional surveillance systems. Using VigiVax software, parents of vaccinated children aged two years or younger, in the period March 2021–May 2022, received a single SMS inquiry about adverse events following immunization (AEFI). Responses were collected, validated by health operators and integrated with the information on electronic immunization registries. AEFI reports were automatically submitted to the Italian Pharmacovigilance system. Among 254,160 SMS messages sent, corresponding to 451,656 administered doses (AD), 71,643 responses were collected (28.2% response rate), and 21,231 of them (8.3%) reported AEFI. After a seriousness assessment based on clinical criteria, 50 reports (0.24%) were classified as serious. Among these, a causality assessment identified 31 reports at least potentially related to the vaccination (RR: 6.86/100,000 AD). Febrile seizures following MMRV (measles, mumps, rubella, varicella) vaccination accounted for 11 of these 31 cases, with an incidence of 32 per 100,000 AD. No fatal outcomes were reported. Our findings support the highly favorable risk profile of pediatric vaccinations and the possibility to improve spontaneous reporting through the integration of digital technologies.

Background: The use of immune-modifying biological agents has markedly changed the clinical course and the management of Inflammatory bowel diseases (IBDs). Active post-marketing surveillance programs are fundamental to early recognize expected and unexpected adverse events (AEs), representing a powerful tool to better determine the safety profiles of biologics in a real-world setting. Methods: This study aimed to identify the occurrence of AEs and therapeutic failures linked to biological drugs used in gastroenterology units during a prospective pharmacovigilance program in Southern Italy. Patients affected by IBDs and treated with a biologic agent, from 1 January 2019, to 31 December 2021 (study period) in three gastroenterology units were enrolled. Results: Overall, 358 patients with a diagnosis of active Crohn’s disease or ulcerative colitis satisfying inclusion criteria have been enrolled. Infliximab (IFX) was the most administered drug at the index date (214; 59.8%), followed by Adalimumab (ADA; 89; 24.9%), Golimumab (GOL; 37; 10.3%), Vedolizumab (VDZ; 17; 4.7%) and Ustekimumab (UST; 1; 0.3%). Seventy-three patients (20.4%) experienced at least one AE, while 62 patients (17.3%) had therapeutic ineffectiveness. No serious AEs were reported in the follow-up period in the enrolled patients. AEs have been described with IFX (50/214; p = 0.47), GOL (7/37; p = 0.78), ADA (13/89; p = 0.18), and VDZ (3/17; p = 0.52), no AEs have been noticed with UST (0/1). Conclusions: Based on the low rate of AEs observed and withdrawal from treatment, our data seem to corroborate the favorable beneficial/risk profile of biologics for IBDs.