Key messages
Background
Methods
Study design and participants
Study procedures
Data collection
Serological analyses
Outcomes
Statistical analyses
Multivariable linear regression
Results
Population characteristics
Controls (n=134) | Patients (n=1108) | Rheumatoid arthritis (n=403) | Psoriatic arthritis (n=195) | Spondyloarthritis (n=195) | Ulcerative colitis (n=124) | Crohn’s disease (n=191) | |
---|---|---|---|---|---|---|---|
Demographics | |||||||
Age (years), median (IQR) | 45.6 (34.9–56.1) | 54.3 (43.2–64.1) | 61.2 (51.3–69.1) | 57.9 (48.3–64.7) | 50.5 (42.0–59.2) | 45.7 (33.4–54.6) | 43.0 (29.6–53.9) |
Female, n (%) | 111 (83) | 617 (56) | 308 (76) | 104 (53) | 75 (38) | 53 (43) | 77 (40) |
Male, n (%) | 23 (17) | 491 (44) | 95 (24) | 91 (47) | 120 (62) | 71 (57) | 114 (60) |
Patient reported disease activity, median (IQR)ab | 20 (10–40) | 20 (10–41) | 25 (11–40) | 21 (10–40) | 15 (5–35) | 20 (10–30) | |
Vaccines,n(%) | |||||||
BNT162b2 × 2 | 11 (8) | 780 (70) | 282 (70) | 135 (69) | 125 (64) | 94 (76) | 144 (75) |
mRNA-1273 × 2 | 43 (32) | 285 (26) | 108 (26.8) | 52 (27) | 60 (31) | 25 (20) | 40 (21) |
Mixedc | 80 (60) | 37 (3) | 12 (3) | 7 (3.5) | 10 (5) | 3 (2.4) | 5 (3) |
COVID-19 infection and one vaccine dose | 0 | 6 (1) | 1 (0.2) | 1 (0.5) | 0 | 2 (1.6) | 2 (1) |
Medication,n(% of the total number of patients) | |||||||
Rituximab | 31 (3) | 31 (8) | |||||
Tumor necrosis factor inhibitors | |||||||
- Monotherapy | 464 (42) | 51 (12.5) | 60 (31) | 163 (83.5) | 67 (54) | 123 (64) | |
- Combination therapyd | 261 (23.5) | 106 (26) | 64 (32) | 25 (13) | 24 (19) | 43 (23) | |
Interleukin inhibitors | |||||||
- Tocilizumab | 19 (2) | 17 (4) | 2 (1) | ||||
- Other interleukin inhibitorse | 25 (2) | 6 (3) | 2 (1) | 3 (2) | 14 (7) | ||
Janus kinase inhibitors | 22 (2) | 13 (3) | 2 (1) | 6 (5) | 1 (1) | ||
Abatacept | 6 (0.5) | 6 (1.5) | |||||
Vedolizumab | 32 (3) | 22 (18) | 10 (5) | ||||
Metabolite inhibitors | |||||||
- Methotrexate monotherapy | 218 (19.5) | 161 (40) | 53 (27) | 4 (2) | |||
- Other metabolite inhibitorsf | 17 (1.5) | 11 (3) | 4 (2) | 2 (2) | |||
Prednisolone monotherapy | 13 (1) | 7 (2) | 2 (3) | 1 (0.5) |
Persistence of serological response
Controls | Patients | |||
---|---|---|---|---|
First sera assessment | Second sera assessment | First sera assessment | Second sera assessment | |
Median anti-RBD level (IQR) | 6187 (4105–7496) | 1520 (979–3766) | 2806 (1018–6068) | 608 (58–1053) |
Median change in anti-RBD level (IQR)# | − 3332 (− 5096 to − 2206) | − 2039 (− 4304 to − 806) | ||
Median percent change in anti-RBD level (IQR)* | − 66 (− 79 to − 49) | − 83 (− 94 to − 66) | ||
Mean (SD) number of days between first and second assessment## | 75 (16) | 75 (17) | ||
Anti-RBD <5, n (%) | 0 | 0 | 17 (1.5) | 56 (5) |
Anti-RBD 5–19, n (%) | 0 | 0 | 13 (1) | 74 (6.5) |
Anti-RBD 20–199, n (%) | 0 | 6 (5) | 62 (6) | 319 (29) |
Anti-RBD 200–1999, n (%) | 10 (7.5) | 70 (52) | 366 (33) | 511 (46) |
Anti-RBD 2000–8999, n (%) | 107 (80) | 58 (43) | 599 (54) | 145 (13) |
Anti-RBD ≥ 9000, n (%) | 17 (12.5) | 0 | 51 (4.5) | 3 (0.5) |
Factors influencing percent reduction in anti-RBD levels
Model 1 β (95% CI) | Model 2 β (95% CI) | Model 3 β (95% CI) | Model 4 β (95% CI) | |
---|---|---|---|---|
Demographics | ||||
Age in years | 0.0 (-0.0–0.1) | 0.1 (-0.0–0.1) | -0.0 (-0.1–0.0) | -0.0 (-0.1–0.0) |
Female gender | 1.2 (-0.1–2.4) | 1.2 (-0.1–2.4) | 0.7 (-0.6–1.9) | 0.7 (-0.6–2.1) |
Patients vs controls | -6.4 (-8.4–-4.3) ** | -4.9 (-7.4–-2.4)* | - | |
Vaccine type | ||||
BNT162b2 x 2 | - | |||
COVID-19 infection and vaccine | 8.3 (-0.2–16.8) | |||
Mixeda | 2.8 (0.2–5.4)* | |||
mRNA-1273 x 2 | 4.4 (3.0–5.9) ** | |||
Medication | ||||
Methotrexate monotherapy | -1.9 (-4.3– 0.5) | - | ||
Interleukin inhibitors | -0.9 (-4.5–2.7) | 1.8 (-1.7–5.3) | ||
Vedolizumab | 0.7 (-3.3–4.7) | 5.1 (0.7–9.5)* | ||
TNF mono | -8.6 (-10.7–-6.5) ** | -6.2 (-8.4–-4.1)** | ||
TNF comb | -8.1 (-10.4–-5.9)** | -6.0 (-8.0–-4.0)** | ||
Rituximab | -0.3 (-4.8–4.2) | 1.0 (-3.3–5.3) | ||
Diagnosis | ||||
Rheumatoid arthritis | - | |||
Psoriatic arthritis | 0.5 (-1.4–2.5) | |||
Spondyloarthritis | 0.8 (-1.4–3.1) | |||
Ulcerative colitis | -2.9 (-5.7–-0.2)* | |||
Crohn’s disease | -2.3 (-4.7–0.1) | |||
R2adjusted | 0.21 | 0.23 | 0.26 | 0.26 |