Number (%) of patients with (serious) adverse events and treatment alterations due to side effects for each induction therapy group
| A. MTX+SASP+HCQ+IM GCs (n=85) | B. MTX+SASP+HCQ+oral GCs (n=89) | C. MTX+oral GCs (n=90) | |
|---|---|---|---|
| Serious AE(s) | 1 (1) | 4 (4) | 6 (7) |
| Patients with ≥1 AE(s) | 61 (72) | 67 (75) | 50 (56)* |
| Number of AEs per patient, median (IQR) | 1 (0–2) | 2 (1–2) | 1 (0–2) |
| Medication changes due to AE(s) | |||
| Patients with medication changes* | 19 (22) | 18 (20) | 14 (16) |
| Lowering MTX dosage <20 mg/week | 8 (9) | 6 (7) | 9 (10) |
| Stop MTX | 5 (6) | 6 (7) | 5 (6) |
| Stop SASP | 9 (11) | 7 (8) | NA |
| Stop HCQ | 2 (2) | 2 (2) | NA |
Results are shown a number (%) unless stated otherwise.
↵* p=0.026 and p=0.006 for respectively A vs C and B vs C.
Serious AEs per treatment arm are respectively: [A] 1× hospitalisation (pneumonia); [B] 4× hospitalisation (for respectively severe obstipation, transient ischaemic attack, gastroenteritis and unexplained chest pain); [C] 1× myocardial infarction, 1× colon carcinoma, 4× hospitalisation for respectively pneumonia, blood transfusion, syncope and exacerbation of rheumatoid arthritis.
AE, adverse events; GCs, glucocorticosteroids; HCQ, hydroxychloroquine; IM, intramuscular; MTX, methotrexate; SASP, sulfasalazine.