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Table 1 Baseline Demographics and Disease Characteristics

From: Efficacy and safety of upadacitinib in patients with active psoriatic arthritis and axial involvement: results from two phase 3 studies

Parameter, mean (SD)c

SELECT-PsA 1 (non-bDMARD-IR)a

SELECT-PsA 2 (bDMARD-IR)b

Without Axial Involvement

(n = 885)

Axial Involvement by Investigator Alone

(n = 396)

Axial Involvement by Investigator + PRO-Based

(n = 290)

Without Axial Involvement

(n = 272)

Axial Involvement by Investigator Alone

(n = 151)

Axial Involvement by Investigator + PRO-Based

(n = 121)

Age, years

51.5 (11.7)

50.1 (13.0)

50.0 (12.7)

54.5 (11.6)

51.9 (12.0)

52.2 (11.9)

Sex, n (%)

 Female

472 (53.3)

199 (50.3)

153 (52.8)

153 (56.3)

80 (53.0)

67 (55.4)

 Male

413 (46.7)

197 (49.7)

137 (47.2)

119 (43.8)

71 (47.0)

54 (44.6)

Race, n (%)

 American Indian or Alaska Native

2 (0.2)

2 (0.5)

1 (0.3)

2 (0.7)

1 (0.7)

1 (0.8)

 Asian

71 (8.0)

44 (11.1)

27 (9.3)

19 (7.0)

17 (11.3)

10 (8.3)

 Black or African American

1 (0.1)

5 (1.3)

4 (1.4)

7 (2.6)

5 (3.3)

4 (3.3)

 Multiple

9 (1.0)

6 (1.5)

6 (2.1)

0

1 (0.7)

1 (0.8)

 Native Hawaiian or Other Pacific Islander

1 (0.1)

2 (0.5)

1 (0.3)

2 (0.7)

0

0

 White

801 (90.5)

337 (85.1)

251 (86.6)

242 (89.0)

127 (84.1)

105 (86.8)

Ethnicity, n (%)

 Hispanic or Latino/a

146 (16.5)

44 (11.1)

37 (12.8)

52 (19.1)

37 (24.5)

30 (24.8)

 Not Hispanic or Latino/a

739 (83.5)

352 (88.9)

253 (87.2)

220 (80.9)

114 (75.5)

91 (75.2)

BMI (kg/m2)

30.5 (7.0)

30.1 (6.5)

30.5 (6.4)

31.5 (7.1)

31.8 (8.1)

32.6 (8.4)

Duration of PsA diagnosis, years

6.0 (7.1)

6.3 (7.2)

6.9 (7.7)

10.5 (9.5)

9.9 (9.2)

10.4 (9.7)

Duration of PsA symptoms, years

8.9 (8.5)

9.9 (9.0)

10.0 (8.9)

13.8 (10.9)

12.7 (9.4)

13.0 (9.9)

Overall BASDAI

5.3 (2.2)

5.8 (2.0)

6.7 (1.5)

5.9 (2.2)

6.2 (2.0)

6.9 (1.4)

 BASDAI Q2 (neck, back, or hip pain)d

4.6 (3.2)

5.8 (2.8)

7.1 (1.6)

5.5 (3.2)

6.4 (2.7)

7.4 (1.7)

 BASDAI Q3 (pain in joints other than neck, back, or hip)d

5.9 (2.6)

6.1 (2.4)

6.9 (1.9)

6.2 (2.6)

6.3 (2.3)

6.9 (1.8)

ASDAS (CRP)

3.1 (1.0)

3.4 (1.0)

3.7 (0.8)

3.2 (1.1)

3.4 (1.0)

3.6 (0.8)

Patient’s assessment of paind

6.0 (2.1)

6.2 (2.0)

6.7 (1.7)

6.4 (2.2)

6.6 (2.0)

6.9 (1.8)

Patient’s global assessment of disease activityd

6.4 (2.0)

6.4 (2.1)

7.0 (1.8)

6.7 (2.0)

7.0 (1.9)

7.2 (1.8)

Physician’s global assessment of disease activityd

6.5 (1.6)

6.7 (1.7)

6.9 (1.6)

6.4 (1.8)

6.7 (1.8)

7.0 (1.6)

TJC68

19.3 (13.6)

22.0 (15.6)

23.5 (16.1)

23.3 (16.7)

28.2 (18.4)

30.0 (18.8)

SJC66

11.1 (8.1)

12.2 (10.1)

12.8 (10.7)

11.0 (8.0)

12.9 (9.3)

12.7 (9.7)

Presence of dactylitis,e n (%)

245 (27.7)

144 (36.4)

101 (34.8)

64 (23.5)

55 (36.4)

45 (37.2)

Presence of enthesitis,f n (%)

665 (75.1)

320 (80.8)

236 (81.4)

218 (80.1)

128 (84.8)

108 (89.3)

BSA with psoriasis, n (%)

  < 3%

460 (52.0)

185 (46.7)

128 (44.1)

103 (37.9)

59 (39.1)

51 (42.1)

  ≥ 3%

425 (48.0)

211 (53.3)

162 (55.9)

169 (62.1)

92 (60.9)

70 (57.9)

hsCRP (mg/L)

10.5 (14.2)

12.6 (17.6)

13.2 (19.0)

11.0 (18.9)

10.4 (17.8)

11.6 (19.5)

  1. ASDAS Ankylosing Spondylitis Disease Activity Score, BASDAI Bath Ankylosing Spondylitis Disease Activity Index, bDMARD Biologic disease-modifying antirheumatic drug, BSA Body surface area, hsCRP High-sensitivity CRP, IR Inadequate response, PRO Patient-reported outcome, PsA Psoriatic arthritis, SJC66 swollen joint count 66, TJC68 Tender joint count 68
  2. aSub-groups shown include the following treatments from SELECT-PsA 1: placebo, adalimumab, and upadacitinib 15 mg
  3. bSub-groups shown include the following treatments from SELECT-PsA 2: placebo and upadacitinib 15 mg
  4. cData presented as mean (SD) unless indicated
  5. dMeasured via numeric rating scale, 0 to 10
  6. eAs determined by Leeds Dactylitis Index > 0
  7. fAs determined by Total Enthesitis Count > 0