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Table 1 Baseline demographic and disease characteristics, comorbidities, and prior and concomitant medications for RA

From: Effectiveness and safety of intravenous golimumab with and without concomitant methotrexate in patients with rheumatoid arthritis in the prospective, noninterventional AWARE study

 

IV golimumab + methotrexate1

IV golimumab without methotrexate

Total

Patients, N

420

265

685

Age, years (range)

61.3 ± 12.8 (21, 88)

60.3 ± 14.4 (22, 89)

60.9 ± 13.4 (21, 89)

Female

367 (87.4)

215 (81.1)

582 (85.0)

Weight, kg, N

397

251

648

 

82.6 ± 23.5

83.7 ± 22.0

83.0 ± 22.9

BMI, kg/m2, N

392

249

641

 All patients

30.7 ± 8.1

30.5 ± 7.7

30.6 ± 8.0

 Underweight (< 18.5)

7 (1.8)

4 (1.6)

11 (1.7)

 Normal (18.5 to < 25)

96 (24.5)

57 (22.9)

153 (23.9)

 Overweight (25 to < 30)

106 (27.0)

72 (28.9)

178 (27.8)

 Obese (≥ 30)

183 (46.7)

116 (46.6)

299 (46.6)

Smoking status

 Current

42 (10.0)

25 (9.4)

67 (9.8)

 Former

84 (20.0)

71 (26.8)

155 (22.6)

 Never

133 (31.7)

77 (29.1)

210 (30.7)

 Unknown

161 (38.3)

92 (34.7)

253 (36.9)

Disease duration, years

8.7 ± 9.4

10.0 ± 10.8

9.2 ± 10.0

CDAI score (0–76)2

 All patients, N

419

263

682

30.8 ± 15.1

32.6 ± 15.4

31.5 ± 15.2

 Biologic-naïve patients, n

168

73

241

29.1 ± 14.1

31.3 ± 16.0

29.8 ± 14.7

 Biologic-experienced patients, n

251

190

441

32.0 ± 15.6

33.1 ± 15.2

32.4 ± 15.4

Comorbidities3

 Myocardial infarction

7 (1.7)

3 (1.1)

10 (1.5)

 Congestive heart failure

4 (1.0)

6 (2.3)

10 (1.5)

 Peripheral vascular disease

9 (2.1)

5 (1.9)

14 (2.0)

 Cerebrovascular disease

10 (2.4)

5 (1.9)

15 (2.2)

 Diabetes mellitus

62 (14.8)

38 (14.3)

100 (14.6)

 Malignancies

17 (4.0)

11 (4.2)

28 (4.1)

 Liver disease

4 (1.0)

2 (0.8)

6 (0.9)

 Hyperlipidemia

113 (26.9)

78 (29.4)

191 (27.9)

Prior biologic treatment

252 (60.0)

191 (72.1)

443 (64.7)

 1 biologic

125 (29.8)

73 (27.5)

198 (28.9)

 2 biologics

58 (13.8)

49 (18.5)

107 (15.6)

 3+ biologics

69 (16.4)

69 (26.0)

138 (20.1)

Prior and concomitant RA medications

 Any prior or concomitant csDMARDs

420 (100)

160 (60.4)

580 (84.7)

  csDMARDs other than MTX4

118 (28.1)

129 (48.7)

247 (36.1)

  1 csDMARDs

302 (71.9)

70 (26.4)

372 (54.3)

  ≥ 2 csDMARDs

118 (28.1)

90 (34.0)

208 (30.4)

 Any prior or concomitant tsDMARDS5

26 (6.2)

26 (9.8)

52 (7.6)

  1. Data presented as n (%) or mean ± standard deviation, unless otherwise specified
  2. BMI body mass index, CDAI Clinical Disease Activity Index, cs/tsDMARD conventional synthetic/targeted synthetic disease-modifying anti-rheumatic drug, IV intravenous, RA rheumatoid arthritis
  3. 1Includes patients who reported using concomitant methotrexate either at baseline or at any time during the study
  4. 2Higher scores indicate more severe disease
  5. 3History of prior or ongoing comorbidity at study entry
  6. 4Includes azathioprine, gold (sodium aurothiomalate or auranofin), hydroxychloroquine, leflunomide, mycophenolate, and sulfasalazine
  7. 5Includes baricitinib and tofacitinib
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BMC Rheumatology

ISSN: 2520-1026

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