Table 1.
Baseline demographics of per protocol population
|
MIVAC I |
MIVAC II |
||||
|---|---|---|---|---|---|
| Hold methotrexate (n=80) | Continue methotrexate (n=78) | Hold methotrexate (n=76) | Continue methotrexate (n=81) | ||
| Age, years | 48 (38–53) | 49 (39–59) | 53 (42–59) | 53 (50–62) | |
| Sex | |||||
| Female | 73 (91%) | 75 (96%) | 65 (86%) | 70 (86%) | |
| Male | 7 (9%) | 3 (4%) | 11 (14%) | 11 (14%) | |
| Diagnosis | |||||
| Rheumatoid arthritis | 69 (86%) | 72 (92%) | 70 (92%) | 80 (99%) | |
| Psoriatic arthritis | 11 (14%) | 6 (8%) | 6 (8%) | 1 (1%) | |
| Comorbidities | 27 (34%) | 25 (32%) | 28 (37%) | 33 (41%) | |
| Interval between first and second vaccine doses, days | 90 (85–88) | 93 (87–104) | 91 (88–95) | 92 (86–103) | |
| DAS28-erythrocyte sedimentation rate | 2·7 (2·4–3·2) | 2·6 (2·0–3·3) | 2·7 (2·3–3·4) | 2·8 (2·1–3·5) | |
| cDAPSA | 2·0 (3·0–4·5) | 2·5 (1·3–3·8) | 3·0 (2·8–3·0) | 3·0* | |
| MI (kg/m2) | 23·2 (20·9–25·7) | 22·6 (19·7–26·1) | 24·1 (21·8–26·7) | 24·2 (21·5–27·4) | |
| Drug treatment | |||||
| Hydroxychloroquine | 64 (80%) | 65 (83%) | 62 (82%) | 66 (81%) | |
| Sulfasalazine | 10 (13%) | 15 (19%) | 10 (13%) | 14 (17%) | |
| Leflunomide | 8 (10%) | 4 (5%) | 10 (13%) | 8 (10%) | |
| Tofacitinib | 1 (1%) | 5 (6%) | 2 (3%) | 3 (4%) | |
| Anti-tumor necrosis factor | 1 (1%) | 1 (1%) | 0 | 1 (1%) | |
| Methotrexate, mg/week | 17·5 (10·0–25·0) | 15·0 (10·0–20·0) | 15 (9·4–25·0) | 17·5 (7·5–25·0) | |
| Prednisolone† | 29 (36%) | 23 (29%) | 24 (32%) | 26 (32%) | |
| Prednisolone, mg/day | 2·1 (1·2–2·5) | 1·8 (1·1–2·5) | 2·1 (0·8–2·4) | 2·1 (1·4–2·5) | |
Data are median (IQR) or n (%). DAS28=disease activity score in 28 joints· cDAPSA=Clinical Disease Activity Index for Psoriatic Arthritis·
*
Only one patient with psoriatic arthritis was included in this group·
†
Prednisolone dose ≤5 mg or equivalent dose of another corticosteroid.