Adverse events (AEs)
AEs | Tapering csDMARD first (n=94) | Tapering TNF-inhibitor first (n=95) |
MTX | ||
Patients reporting AE due to MTX | 32 (34) | 35 (37) |
Off day | 7 (7) | 8 (8) |
Nausea | 22 (23) | 18 (19) |
Fatigue | 7 (7) | 8 (8) |
Acne | 0 (0) | 3 (3) |
Hair loss | 5 (5) | 5 (5) |
Abnormalities of oral mucosa | 1 (1) | 3 (3) |
Headache | 1 (1) | 0 (0) |
Burden of AE due to MTX, VAS (0–100), mean (SD) | 20 (27) | 20 (27) |
TNF-inhibitor | ||
Patients reporting AE due to TNF-inhibitor | 23 (24) | 21 (22) |
Pain of injection | 13 (14) | 7 (7) |
Fear of injection | 3 (3) | 4 (4) |
Irritation at place of injection | 8 (9) | 10 (11) |
General skin changes | 5 (5) | 3 (3) |
Itch | 1 (1) | 1 (1) |
Gastrointestinal complaints | 2 (2) | 2 (2) |
Fatigue | 2 (2) | 1 (1) |
Burden of AE due to TNF-inhibitor, VAS (0–100), mean (SD) | 7.6 (12) | 10 (19) |
Serious AE* | 10 (12) | 5 (6) |
*Serious AEs per tapering arm were, respectively: tapering conventional synthetic disease-modifying antirheumatic drug (csDMARDs) first 7 × hospitalisation (3 × total hip replacement surgery, 1 × pneumonia, 1 × decompression shoulder, 1 × pancreatitis, 1 × angina pectoris), 1 × herpes zoster, 1 × basal cell carcinoma, 1 × large-cell lung carcinoma; tapering tumour necrosis factor inhibitor (TNF-inhibitor) first 4 × hospitalisation (2 × peripheral vascular disease, 1 × total knee replacement, 1 × myocardial infarction), 1 × bruised rib.
MTX, methotrexate; VAS, Visual Analogue Scale.