Table 1

Demographic and clinical characteristics of the study population, stratified for response to the first dose of the BNT162b2 mRNA COVID-19 vaccine

All n=140 patientsResponders n=85Non-responders n=55P value
Age, mean (SD), years55.7 (14.4)50.9 (13.9) 63.3 (11.6)<0.001
Females, n (%)95 (67.9)53 (62.4) 42 (76.4)0.12
BMI, mean (SD)25.89 (5.24)25.37 (5.31) 26.69 (5.09)0.19
Smoking, n (%)23 (16.4)14 (16.5) 9 (16.4)0.83
Hypertension, n (%)47 (33.6)23 (27.1) 24 (43.6)0.07
Obesity, n (%)26 (18.6)15 (17.6) 11 (20)0.89
CCI, mean (SD)0.57 (0.92)0.47 (0.91) 0.73 (0.93)0.11
≥1 comorbidity*, n (%)50 (35.7)23 (27.1) 27 (49.1)0.01
Previous COVID-19*, n (%)20 (14.3)19 (22.4) 1 (1.8)0.002
Diagnosis, n (%):
 RA83 (59.3)40 (47.1) 43 (78.2)<0.001
 PsA29 (20.7)20 (23.5) 9 (16.4)0.42
 SpA28 (20)25 (29.4) 3 (5.5)0.001
Disease duration, mean (SD), years13.7 (8.2)12.9 (8.7) 14.9 (7.2)0.15
Active disease†, n (%)34 (24.3)22 (25.9) 12 (21.8)0.73
Glucocorticoids, n (%)53 (37.9)26 (30.6) 27 (49.1)0.04
Prednisone dose, mean (SD), mg/day3.7 (1.8)3.7 (1.5) 3.7 (2.1)0.94
csDMARDs, n (%)80 (57.1)38 (44.7) 42 (76.4)<0.001
 MTX66 (47.1)27 (31.8) 39 (70.9)<0.001
 SSZ12 (8.6)10 (11.8) 2 (3.6)0.17
 LFN5 (3.6)3 (3.5) 2 (3.6)0.67
 CYA1 (0.7)0 (0) 1 (1.8)0.83
MTX dose, mean (SD), mg/week14.7 (5.2)14.6 (5.3) 14.7 (5.2)0.93
Days of MTX withholding, mean (SD)16.4 (3.5)16.1 (3.4) 16.6 (3.6)0.65
Adherence to MTX withholding‡, n (%)33 (50)13 (48.1) 20 (51.3)0.99
b/tsDMARDs, n (%)140 (100)85 (100) 55 (100)
 TNFi61 (43.6)39 (45.9) 22 (40)0.61
 IL-6Ri14 (10)8 (9.4) 6 (10.9)0.99
 IL-17/IL-23i19 (13.6)17 (20) 2 (3.6)0.01
 CTLA4Ig30 (21.4)9 (10.6) 21 (38.2)<0.001
 JAKi12 (8.6)9 (10.6) 3 (5.5)0.46
 PDE4i4 (2.9)3 (3.5) 1 (1.8)0.94
Days of b/tsDMARD withholding, mean (SD)22 (13.2)23.7 (14.7) 19.4 (10.2)0.06
Adherence to b/tsDMARDs withholding‡, n (%)96 (68.6)62 (72.9) 34 (61.8)0.23
  • Bold indicates statistically significant values (p<0.05).

  • *Based on patient-reported history of swab-confirmed SARS-CoV-2 infection and/or on prevaccine anti-S IgG levels >15 AU/mL (LIAISON SARS-CoV-2 S1/S2 IgG; DiaSorin).

  • †Above the threshold of low disease activity according to the appropriate composite index: DAS28 >3.2; DAPSA >14; ASDAS-PCR >2.1.

  • ‡Recommendations for timing of immunomodulatory therapies in relation to vaccination: (1) for all the bDMARDs and MTX, withholding of therapy in the 7 days before and after vaccination; (2) for tsDMARDs, withholding of therapy from the day before until day 7 after vaccination; and (3) for glucocorticoids and csDMARDs other than MTX, no modifications.

  • §Among those listed in the Charlson Comorbidity Index.

  • ASDAS-CRP, Ankylosing Spondylitis Disease Activity Score calculated with C reactive protein; BMI, body mass index; b/ts,biological/targeted synthetic CCI, Charlson Comorbidity Index; cs, conventional synthetic; CTLA4Ig, cytotoxic T lymphocyte associated protein-4 immunoglobulin; CYA, cyclosporine; DAPSA, Disease Activity in Psoriatic Arthritis; DAS28, Disease Activity Score on 28 joints; DMARD, disease-modifying antirheumatic drug; IL-17/IL-23i, interleukin-17/interleukin-23 inhibitor; IL-6Ri, interleukin-6 receptor inhibitor; JAKi, Janus kinase inhibitor; LFN, leflunomide; MTX, methotrexate; PDE4i, phosphodiesterase-4 inhibitor; PsA, psoriatic arthritis; RA, rheumatoid arthritis; SpA, spondyloarthritis; SSZ, sulphasalazine; TNFi, tumour necrosis factor inhibitor.