Table 1 General patient characteristics and occurrence of side-effects

Female sex

70 (60%)

72 (61%)

65 (61%)

69 (64%)

RF positive

64 (55%)

73 (61%)

75 (71%)

86 (80%)

Mean age in years (SD)

54 (14)

53 (13)

53 (12)

53 (13)

Mean DAS28^a during follow-up (SD)

2.4 (1.3)

3.0 (1.5)

2.0 (1.2)

3.7 (1.4)

Mean MTX^b dose in mg during follow-up (SD)

16.0 (8.2)

20.5 (8.0)

11.8 (8.0)

19.9 (7.9)

Adalimumab added

16 (14%)

42 (35%)

–

–

HCQ^c added

–

–

23 (21%)

45 (42%)

Discontinued study due to adverse events

16 (14%)

20 (17%)

3 (3%)

1 (1%)

Medical history at baseline

Cardiovascular disease

6 (5%)

6 (5%)

10 (9%)

11 (10%)

Diabetes

2 (2%)

5 (4%)

6 (6%)

3 (3%)

Chronic pulmonary disease

6 (5%)

5 (4%)

8 (8%)

2 (2%)

Malignancy^d

1 (1%

1 (1%)

4 (4%)

0 (0%)

Chronic gastro-intestinal disease

1 (1%)

1 (1%)

0 (0%)

1 (1%)

Side-effects: Number of visits (%) (number of patients)

Nausea

50 (2.3%) (22)

152 (6.3%) (43)

16 (2.6%) (15)

26 (4.2%) (25)

Vomiting

7 (0.3%) (2)

8 (0.3%) (6)

3 (0.5%) (3)

6 (1.0%) (6)

Abdominal Pain

13 (0.6%) (12)

17 (0.7%) (12)

3 (0.5%) (3)

11 (1.8%) (11)

GI Ulcer^e

15 (0.7%) (9)

35 (1.4%) (18)

9 (1.4%) (9)

3 (0.5%) (3)

Loss of appetite

1 (0.0%) (1)

4 (0.2%) (3)

0 (0.0%) (0)

3 (0.5%) (3)

Elevated ALT/AST^f

48 (2.2%) (20)

84 (3.5%) (34)

16 (2.6%) (16)

15 (2.4%) (14)

Any MTX^b side-effect

128 (5.9%) (51)

272 (11.2%) (73)

42 (6.8%) (37)

54 (8.7%) (44)

Any adverse event

483 (21.1%) (96)

647 (26.7%) (104)

241 (38.7%) (97)

219 (35.2%) (93)