Flares and adverse events in patients with inflammatory RMDs, stratified by medication
| MTX mono/combi (no biologicals or tsDMARDs) (n=895) | Other csDMARD mono/combi (no biologicals or tsDMARDs) (n=657) | TNF mono/combi (n=1173) | RTX mono/combi (n=260) | Other biologics mono/combi (n=511) | tsDMARD mono/combi (n=175) | Immunosuppressants mono/combi (no biologics or tsDMARDs) (n=995) | ||
| Flare following vaccination | Yes | 32 (4) | 31 (5) | 65 (6) | 7 (3) | 27 (5) | 8 (5) | 27 (3) |
| No | 765 (85) | 520 (79) | 799 (68) | 204 (78) | 415 (81) | 150 (86) | 870 (87) | |
| Unknown/missing | 98 (11) | 106 (16) | 309 (26) | 49 (19) | 69 (14) | 17 (10) | 98 (10) | |
| Severity of flare | Mild/minor | 13 (1) | 14 (2) | 19 (2) | 3 (1) | 6 (1) | 4 (2) | 11 (1) |
| Moderate | 14 (2) | 11 (2) | 39 (3) | 1 (<1) | 17 (3) | 3 (2) | 8 (1) | |
| Severe/major without hospitalisation | 1 (<1) | 3 (<1) | 4 (<1) | 1 (<1) | 1 (<1) | 2 (<1) | ||
| Severe/major with hospitalisation | 2 (<1) | 2 (<1) | 1 (<1) | 6 (<1) | ||||
| Unknown/missing | 2 (<1) | 1 (<1) | 3 (<1) | 1 (<1) | 3 (1) | 1 (1) | ||
| New medication or dosage increase due to flare | 12 (1) | 11 (2) | 16 (1) | 1 (<1) | 8 (2) | 15 (2) | ||
| Vaccine-related AEs | Yes | 314 (35) | 276 (42) | 412 (35) | 87 (33) | 172 (34) | 61 (35) | 352 (35) |
| No | 581 (65) | 381 (58) | 761 (65) | 173 (67) | 339 (66) | 114 (65) | 643 (65) | |
| AE severity (only collected for AEs of special interest) | Non-serious | 12 (1) | 16 (2) | 13 (1) | 2 (1) | 17 (3) | 3 (2) | 19 (2) |
| Severe – Important medical event | 1 (<1) | 3 (<1) | 1 (<1) | 1 (<1) | 3 (2) | 4 (<1) | ||
| Severe - Hospitalisation (or prolongation of existing hospitalisation) | 1 (<1) | 1 (<1) | 1 (<1) | 1 (1) | 2 (<1) | |||
| Severe - Life-threatening | 1 (<1) | 1 (<1) | 1 (<1) | 1 (<1) | ||||
| Missing | 1 (<1) | 2 (<1) | ||||||
All values are N (%) unless stated otherwise.
AEs, adverse events; combi, combination therapy; csDMARDs, conventional synthetic disease-modifying antirheumatic drugs; mono, monotherapy; MTX, methotrexate; RMD, rheumatic and musculoskeletal disease; RTX, rituximab; TNF, tumour necrosis factor; tsDMARD, targeted synthetic disease-modifying antirheumatic drug.