ABSTRACT
Background: Soon after the Italian Medicine Agency (AIFA) authorized the first mRNA COVID-19 vaccine, BNT162b2 (ComirnatyR), the Italian Ministry of Health launched a national vaccination campaign. Giving the high risk of mortality from COVID-19, cancer patients were considered a priority group. However, data about BNT162b2 safety in this population are still lacking and the impact on patients' psychological state and social life was not studied. Herein we describe the adverse events (AE) related to the vaccine and the subjective experience of cancer patients treated and vaccinated at San Luigi Gonzaga University Hospital. Materials and methods: All cancer patients who accepted to participate in our campaign were vaccinated with BNT162b2 and included in the descriptive analysis. Patients who tested positive for COVID-19 after January 1st, 2021 were not recruited. An anonymous questionnaire about AE and psycho-social impact of the vaccination was administered to the study population 21 days after the first dose. The short-term AE reported after the second dose were investigated via a telephone questionnaire. Results: A total of 997 patients were included in the study, of whom 618 were affected by advanced cancer. At the time of the vaccination, 223 patients were receiving chemotherapy and/or immunotherapy. 49 patients have been infected and recovered from COVID-19. AE were reported in 37.3% cases after the first dose and in 48.5% cases after the second dose. The most common AE were muscle pain (26.7% and 27.4%, after the first and second dose respectively) and fatigue (10.4% and 16.8%). No severe AE had been reported. Before receiving the vaccine, 18% patients felt fearful and/or insecure about the vaccination, while 76.4% felt hopeful and/or enthusiast. After the first dose, 57.5% patients changed their feelings positively and 79.5% patients stated to feel much more confident in their social life. Patients' opinion about the vaccination was mainly influenced by the specialist/family doctor (38.7%) and by mass-media (25.8%), and the information they were given was considered adequate by 86% patients. Conclusions: Our data support the short-term safety of BNT162b2 in cancer patients, regardless of the disease staging and the concurrent treatment. Before the vaccination, most of our patients consulted the specialist or the family doctor receiving adequate information and being reassured. Moreover, the vaccination showed a positive psychological and social impact.
ABSTRACT
Background: Tocilizumab is a monoclonal antibody against IL-6 that has been used to treat Neuromyelitis Optica spectrum disorders (NMOSD), generally intravenous. The evidence about its subcutaneous formulation to treat these diseases is scarce, but its efficacy seems to be similar. During SARS-CoV-2 pandemic, decreasing hospital attendance became a priority. According to this, subcutaneous formulations may represent a good therapeutic option in this context. Objectives: We present 3 cases of NMSOD who initiated subcutaneous tocilizumab during SARS-CoV-2 pandemic, with very good tolerability in all the cases. Methods: Retrospective and observational study. We reviewed clinical charts, patients' outcomes and available bibliography. Results: Patient 1: 74 year-old male, diagnosed with Neuromyelitis Optica (NMO) in 2010. He was started on rituximab in 2012. In 2018, he suffered from two optic neuritis (despite the absence of CD19+ and CD27+ cells in peripheral blood). Because of that, in 2019, rituximab was switched to intravenous tocilizumab, with good response and tolerability. In April 2020, due to SARS-CoV-2 pandemic, it was switched to subcutaneous tocilizumab in order to avoid hospital attendance, with very good tolerability. Patient 2: 40 year-old female, diagnosed with NMOSD vs CRION (chronic relapsing inflammatory optic neuropathy). Positive anti-NMO antibodies and negative anti-MOG antibodies were found. She was started on rituximab in 2015. In December 2019, she suffered from an optic neuritis despite having no CD19+ cells in peripheral blood. Hence, rituximab was switched to intravenous tocilizumab without any incidence. In March 2020, she was started on subcutaneous tocilizumab once a week because of the pandemic, with very good tolerability. Patient 3: 28 year-old female, diagnosed with seropositive NMO in 2012, treated with rituximab since 2014, free of relapses since them. In May 2020, we decided to switch to tocilizumab (subcutaneous to decrease hospital visits due to SARS-CoV-2 pandemic) because of hypogammaglobulinemia and repeated respiratory tract infections. Conclusions: Tocilizumab may be an option to treat NMOSD patients. Subcutaneous form decreases hospital visits and, according to our experience, is very well tolerated. Therefore, we postulate it can be a good alternative in the current situation.