Table 5

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 vaccinationYes32 (4)31 (5)65 (6)7 (3)27 (5)8 (5)27 (3)
No765 (85)520 (79)799 (68)204 (78)415 (81)150 (86)870 (87)
Unknown/missing98 (11)106 (16)309 (26)49 (19)69 (14)17 (10)98 (10)
Severity of flareMild/minor13 (1)14 (2)19 (2)3 (1)6 (1)4 (2)11 (1)
Moderate14 (2)11 (2)39 (3)1 (<1)17 (3)3 (2)8 (1)
Severe/major without hospitalisation1 (<1)3 (<1)4 (<1)1 (<1)1 (<1)2 (<1)
Severe/major with hospitalisation2 (<1)2 (<1)1 (<1)6 (<1)
Unknown/missing2 (<1)1 (<1)3 (<1)1 (<1)3 (1)1 (1)
New medication or dosage increase due to flare12 (1)11 (2)16 (1)1 (<1)8 (2)15 (2)
Vaccine-related AEsYes314 (35)276 (42)412 (35)87 (33)172 (34)61 (35)352 (35)
No581 (65)381 (58)761 (65)173 (67)339 (66)114 (65)643 (65)
AE severity (only collected for AEs of special interest)Non-serious12 (1)16 (2)13 (1)2 (1)17 (3)3 (2)19 (2)
Severe – Important medical event1 (<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-threatening1 (<1)1 (<1)1 (<1)1 (<1)
Missing1 (<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.