Background. The risk of herpes zoster reactivation is increased in immunocompromised patients, especially in those with immune-mediated inflammatory diseases (IMIDs) on Janus kinase inhibitor (JAKi) treatment. The recombinant subunit herpes zoster vaccine (RZV) is a non-live vaccine, recently approved for this subgroup of patients, which shows high rates of vaccine effectiveness, with few adverse effects reported in clinical trials. Purpose. The aim of this real-world study was to determine the immunogenicity and safety of RZV in IMID patients on JAKi treatment. Methods. The increase in the concentration of anti-gE antibody for varicella zoster virus post-vaccination, compared to the pre-vaccination concentration, was analyzed to test the humoral immune response. Adverse effects after the first and second vaccine doses were registered. Results. In total, 49 patients were analyzed, and a fourfold increase in antibody concentration was achieved in almost 40% of subjects, with only one serious local adverse effect. Discussion. The resulting immunogenicity was lower than that observed in clinical trials, probably due to the presence of immune disease and immunosuppressive treatment, and to the fact that this was a real-world study. No differences in response according to age, previous virus zoster reactivation, or concomitant treatments were found. Conclusions. RZV was well tolerated and reached the immune response objective in 40% of patients. These results reinforce the importance of including RZV vaccination for immunosuppressed patients. Real-world studies regarding vaccine effectiveness are still needed in order to gain a full understanding of the response to RZV in this group of patients.
Background/Objectives: Janus kinase inhibitors (JAKi) have revolutionized the treatment of various inflammatory and immune disorders. Concerns about the potential increased risk of major adverse cardiovascular events (MACEs) associated with JAKi use led to a European Medicines Agency (EMA) health alert recommending restricting the use of JAKi in high-risk populations. Methods: This study aims to determine the proportion of patients who developed any cardiovascular, ischemic, neoplastic, or thrombotic adverse event in a cohort of patients receiving, or who have received, JAKi treatment between January 2017 and September 2023. In addition, we studied the impact of the alert in the clinical practice of our Rheumatology department. Results: In this retrospective, observational study, 101 patients were analysed, predominantly women (72.3%), with a mean age of 57.6 years. The most common diagnoses were rheumatoid arthritis (60.4%) and psoriatic arthritis (18.8%). The most frequent adverse events were infections (5.9%) and neoplasms (2.9%). Deep vein thrombosis and haemorrhagic stroke each occurred in 1% of patients, with no cases of ischemic stroke or ischemic heart disease. When the health alert was published, 75 patients were on treatment with JAKi, and 33 met the alert criteria. Of these, 12.1% changed treatment due to the alert, 9% had no other therapeutic options, 57.5% were in clinical remission or had low disease activity, and 9% maintained treatment at their own request. Conclusions: These findings suggest that, in this patient cohort, JAKi use did not result in new MACE cases. The alert concerning the use of JAKi has had a limited impact in our clinical practice.
Since the development of vaccines for coronavirus disease 2019 (COVID-19), the course of infections has changed significantly. Over the past 4 years of coexisting with the virus, a marked improvement in disease outcomes has been observed, especially in patients with rheumatological diseases; this is largely attributable to widespread immunization. This study aimed to evaluate the perception of COVID-19 vaccine protection and to describe the incidence and severity of COVID-19 in the pre- and post-vaccination periods among different patient typologies and immunosuppressive treatments in rheumatology patients. This study used observational, descriptive–analytical, ambispective, and cross-sectional methods. We administered a questionnaire in the rheumatology department to patients with immune-mediated inflammatory diseases (IMID), with or without disease-modifying antirheumatic drugs, including conventional synthetic drugs, biological drugs, and targeted synthetic drugs, and to patients with musculoskeletal conditions (non-autoimmune patients). All patients received at least 2 doses of the COVID-19 vaccine. A total of 407 patients, with a mean age and standard deviation 59.1 ± 13.6 and 66.1% female, were studied. Most patients (78.1%) reported feeling protected or very protected by the COVID-19 vaccine, with the perception of safety ranging from 66.9% to 87.5% across different patient typologies. The proportion of patients who felt protected or very protected was significantly lower in the non-autoimmune group (63.9%) than in the IMID patients treated with conventional synthetic drugs (87.5%) or biological drugs [excluding CD-20 inhibitors (rituximab)] and targeted synthetic drugs (82.1%) (P < .001 and P = .011, respectively). There were no significant differences in the incidence of COVID-19 infection or in the severity of its clinical presentation (in both the pre- and post-vaccination stages) among the different typologies of patients, or in relation to the immunosuppressive therapy they received. Patients with IMID who received immunosuppressive treatment reported higher levels of perceived protection after COVID-19 vaccination. However, the incidence and severity of COVID-19 were similar between patients with and without IMIDs. This study supports the importance of infection prevention in these patients and emphasizes the need for closely monitored vaccination programs.