Table 1

Demographics and baseline characteristics

CharacteristicsRZB 150 mg
N=224
PBO
N=219
Female, n (%)124 (55.4)120 (54.8)
Age (years), median (range)53 (23–84)52 (24 to 83)
Race, n (%)
 White218 (97.3)210 (95.9)
 Black or African–American2 (0.9)3 (1.4)
 Asian2 (0.9)3 (1.4)
 Other2 (0.9)3 (1.4)
Not Hispanic/Latino, n (%)182 (81.3)176 (80.4)
BMI (kg/m2), mean (SD)31.5 (8.0)31.2 (6.8)
PsA duration (years), mean (SD)8.2 (8.2)8.2 (8.3)
Swollen joint count,* mean (SD)13.0 (8.7)13.6 (9.0)
Tender joint count,† mean (SD)22.8 (14.9)22.3 (13.8)
Patient’s assessment of pain,‡ mean (SD)55.0 (23.5)57.0 (23.1)
PtGA of disease activity,‡ mean (SD)56.2 (21.8)56.2 (23.0)
PGA of disease activity,‡ mean (SD)63.0 (17.0)60.7 (16.4)
HAQ-DI, mean (SD)1.10 (0.62)1.13 (0.63)
hsCRP (mg/L),§ mean (SD)7.5 (10.9)8.2 (17.1)
Presence of psoriasis affecting ≥3% BSA, n (%)123 (54.9)119 (54.3)
 BSA (%),¶ mean (SD)12.5 (15.4)11.7 (14.9)
 PASI,¶ mean (SD)7.7 (6.7)8.4 (9.9)
MDA, n (%)5 (2.2)5 (2.3)
Presence of enthesitis,** n (%)147 (65.6)158 (72.1)
 LEI,†† mean (SD)3.0 (1.5)3.0 (1.6)
Presence of dactylitis,‡‡ n (%)40 (17.9)57 (26.3)
 LDI,§§ mean (SD)78.9 (98.4)109.8 (155.3)
SF-36 PCS score, mean (SD)35.6 (8.8)35.2 (9.1)
FACIT-Fatigue score, mean (SD)28.2 (11.5)27.7 (12.7)
Prior csDMARDs, n (%)
 012 (5.4)11 (5.0)
 188 (39.3)81 (37.0)
 260 (26.8)60 (27.4)
 ≥364 (28.6)67 (30.6)
Any prior biologic, n (%)105 (46.9)101 (46.1)
Prior failed biologics, n (%)
 0137 (61.2)132 (60.3)
 172 (32.1)64 (29.2)
 ≥215 (6.7)23 (10.5)
Prior TNF antagonist, n (%)103 (46.0)100 (45.7)
Concomitant medication at baseline, n (%)
 MTX¶¶110 (49.1)99 (45.2)
 csDMARD other than MTX***31 (13.8)30 (13.7)
 MTX and another csDMARD8 (3.6)10 (4.6)
 Oral corticosteroids28 (12.5)22 (10.0)
 NSAIDs141 (62.9)145 (66.2)
  • *Based on 66 joints.

  • †Based on 68 joints.

  • ‡Scored as millimetres on a 100 mm horizontal visual analogue scale.

  • §Reference range: 0–10 mg/dL.

  • ¶Among patients with ≥3% BSA affected by psoriasis (RZB, n=23; PBO, n=119).

  • **LEI >0.

  • ††Among patients with LEI >0 (RZB, n=147; PBO, n=158).

  • ‡‡LDI >0.

  • §§Among patients with LDI>0 (RZB, n=40; PBO, n=57).

  • ¶¶As monotherapy or in combination with another csDMARD.

  • ***Sulfasalazine, leflunomide or apremilast, without MTX.

  • BMI, body mass index; BSA, body surface area; csDMARD, conventional synthetic disease-modifying antirheumatic drug; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy–Fatigue; HAQ-DI, Health Assessment Questionnaire–Disability Index; hsCRP, high-sensitivity C reactive protein; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; MDA, minimal disease activity; MTX, methotrexate; NSAID, non-steroidal anti-inflammatory drug; PASI, Psoriasis Area and Severity Index; PBO, placebo; SF-36 PCS, 36-Item Short Form Health Survey Physical Component Summary; PGA, physician’s global assessment; PsA, psoriatic arthritis; PtGA, patient’s global assessment; RZB, risankizumab; TNF, tumour necrosis factor.