Correspondence on ‘immunogenicity and Safety of Anti-Sars-cov-2 Mrna Vaccines in Patients with Chronic Inflammatory Conditions and Immunosuppressive Therapy in a Monocentric Cohort’

We read with interest the recent report by Geisen et al, who describe the immunogenicity and safety profile of two mRNAbased antiSARSCoV-2 vaccines in a cohort of 26 patients with chronic arthritides, psoriasis and other inflammatory diseases, compared with 42 healthy controls. The majority of subjects were health professionals, which makes the 14day postvaccinal observations provided by the authors particularly informative for highrisk settings, such as hospitals. Extensive data about the impact of antiSARSCoV-2 vaccines in patients with immunemediated disorders are eagerly awaited, since people living with these diseases were excluded from registration trials, despite constituting a risk group for severe SARSCoV-2realated disease (COVID-19) and, potentially, for adverse immunemediated postvaccinal events. To contribute in filling this knowledge gap, we studied 55 consecutive patients (54 health professionals) with rheumatic diseases and primary immunodeficiencies, for a median (IQR) of 66 (42–75) days from the first and 45 (20–52) days from the second dose of the BNT162b2 vaccine (detailed methods: online supplemental material 1). Thirtyeight patients (69%) had one or more comorbidities, including allergy in 22 cases (table 1). At time of vaccination, 42/55 patients had been in remission for 20 (5–29) months. The median disease duration was 11 (5–18) years. Fiftyone patients (93%) were taking one or more immunosuppressive/immunomodulating drugs beside other treatments (online supplemental tables 1 and 2). No patient had evidence of SARSCoV-2 infection during followup. Thirtyeight patients (69%) reported at least one symptom after the first (47%), the second (56%) or both doses (35%; online supplemental table 3) with a median timing of 24 hours for onset and 48 hours for resolution. Symptoms after the first dose predicted having symptoms after the second one (OR=3.85, 95% CI 1.23 to 12.01; p=0.020). All events were mild and included more frequently constitutional symptoms (49%) and local pain at injection site (38%). Constitutional symptoms were more frequent after the second than after the first dose (38 vs 18%; p=0.033; online supplemental table 4). Adverse events were more frequent in women than in men (78% vs 30%; p=0.006) and less frequent in IgG4related disease (IgG4RD, 29%) than in other patients (75%; p=0.024). The median age was lower in patient with (49 (39–55) years) than in those without adverse events (58 (46–66); p=0.021). No association was found with disease duration, remission, duration of remission or previous COVID-19. All four patients with inflammatory spondyloarthropathies had adverse events after the first (χ=4.81; p=0.044 compared with other diseases) and second dose, with symptom severity slightly increasing across the two doses (online supplemental table 5). No other factors were associated to adverse events after the first dose. Adverse events after the second dose were more frequent in women (67% vs 10% in men; p=0.001), patients with allergy history (77% vs 42% in patients with no allergy; p=0.014), especially to drugs (82% vs 45% in patients with no history of drug allergy; p=0.017), connective tissue diseases (80% vs 48% in patients with other disorders; p=0.037) and patients without IgG4RD (65% vs 0% in IgG4RD; p=0.002). Constitutional symptoms were more frequent in patients with arthritis than in other patients (84% vs 31%; p<0.001). Specifically, these patients showed higher frequencies of fever (47% vs 11%; p=0.006), and arthralgia/myalgia (47% vs 17%; p=0.025). Constitutional symptoms were particularly frequent in patients with Correspondence