Number(%) of patients reporting adverse events per treatment arm
| A. MTX+SASP+HCQ+IM GCs (n=84) | B. MTX+SASP+HCQ+oral GCs (n=89) | C. MTX+oral GCs (n=90) | |
|---|---|---|---|
| Mawlaise | 11 (13) | 8 (10) | 9 (11) |
| Fatigue | 18 (21) | 20 (24) | 18 (21) |
| Gastrointestinal complaints | 43 (51) | 46 (55) | 25 (30) |
| Hypertension | 1 (1) | 2 (2) | 0 (0) |
| Oedema | 2 (2) | 1 (1) | 4 (5) |
| Infection | 3 (4) | 4 (5) | 9 (11) |
| Skin rashes | 8 (10) | 8 (10) | 7 (8) |
| Hair loss | 3 (4) | 2 (2) | 6 (7) |
| Muscle weakness | 0 (0) | 1 (1) | 3 (4) |
| Headache | 8 (10) | 10 (12) | 8 (10) |
| Visual impairment | 1 (1) | 9 (11) | 2 (2) |
| Feeling ‘sad’ | 2 (2) | 9 (11) | 8 (10) |
| Sleep disorder | 2 (2) | 6 (7) | 2 (2) |
| Dizziness | 1 (1) | 7 (8) | 1 (1) |
| Palpitations | 2 (2) | 2 (2) | 1 (1) |
| Bone marrow depression | 13 (15) | 4 (5) | 4 (5) |
| High creatinine | 0 (0) | 6 (7) | 3 (4) |
| Raised liver enzymes | 4 (5) | 7 (7) | 9 (11) |
| Hyperglycaemia | 0 (0) | 1 (1) | 0 (0) |
Results are shown as number (%).
GCs, glucocorticosteroids; HCQ, hydroxychloroquine; IM, intramuscular; MTX, methotrexate; SASP, sulfasalazine.
Bone marrow depression is defined as an anaemia, thrombocytopenia or leucopenia with respectively a haemoglobin level, platelet count and white blood cells count below the lower limit of the normal range. High creatinine, raised liver enzymes and hyperglycaemia are defined as having respectively a creatinine, liver transaminases and glucose level above the upper limit of the normal range.