APPENDIX 1.

Baseline demographics and clinical characteristics in PALACE 1: intent-to-treat population (n = 504*). Values are mean (SD) or n (%).

CharacteristicsPlacebo, n = 168Apremilast
20 mg BID, n = 16830 mg BID, n = 168
Age, yrs51.1 (12.1)48.7 (11.0)51.4 (11.7)
Age ≥ 65 yrs19 (11.3)11 (6.5)22 (13.1)
Female80 (47.6)83 (49.4)92 (54.8)
Race
  White153 (91.1)150 (89.3)152 (90.5)
  Asian8 (4.8)8 (4.8)8 (4.8)
  Black0 (0.0)2 (1.2)0 (0.0)
  Other7 (4.2)8 (4.8)8 (4.8)
Region
  North America81 (48.2)73 (43.5)69 (41.1)
  Europe39 (23.2)41 (24.4)42 (25.0)
  Rest of world48 (28.6)54 (32.1)57 (33.9)
Weight, kg89.8 (22.4)88.8 (21.1)87.1 (19.6)
Body mass index, kg/m231.1 (6.6)30.9 (7.3)30.6 (5.9)
Duration of PsA, yrs7.3 (7.1)7.2 (6.8)8.1 (8.1)
Swollen joint count, 0–7612.8 (8.8)12.5 (9.5)12.8 (7.8)
Tender joint count, 0–7823.3 (15.2)22.2 (15.9)23.1 (14.5)
HAQ-DI, 0–31.2 (0.6)1.2 (0.6)1.2 (0.6)
Patient’s global assessment, 0–100 mm VAS58.8 (22.3)55.3 (23.7)55.9 (21.5)
Physician’s global assessment, 0–100 mm VAS55.2 (20.3)54.1 (21.8)55.7 (19.2)
CRP, mg/dl, normal range < 0.51.1 (1.436)0.90 (1.409)0.84 (1.024)
Patient assessment of pain, 0–100 mm VAS61.2 (20.2)54.9 (22.9)57.9 (20.2)
SF-36v2 PF score33.8 (10.6)35.1 (10.7)33.0 (10.2)
DAS28, CRP4.9 (1.0)4.8 (1.1)4.9 (1.0)
CDAI, 0–7629.7 (12.0)28.4 (13.1)29.4 (11.5)
Duration of psoriasis, yrs15.7 (13.0)15.5 (11.9)16.5 (12.3)
PASI score, 0–729.1 (9.5)7.4 (8.7)9.2 (9.7)
Presence of enthesitis98 (58.3)103 (61.3)114 (67.9)
MASES, 0–135.4 (3.5)5.0 (3.3)4.4 (3.1)
Presence of dactylitis68 (40.5)59 (35.1)68 (40.5)
Dactylitis severity score, 0–20§3.3 (3.3)4.1 (4.2)2.9 (2.4)
Prior use of DMARD, biologic-naive120 (71.4)129 (76.8)124 (73.8)
Prior use of biologics41 (24.4)37 (22.0)41 (24.4)
Prior biologic failures19 (11.3)14 (8.3)14 (8.3)
Baseline DMARD use110 (65.5)111 (66.1)106 (63.1)
  Methotrexate, mean dose 16.6 mg/week90 (53.6)95 (56.5)88 (52.4)
  Leflunomide, mean dose, 17.2 mg/day11 (6.5)10 (6.0)9 (5.4)
  Sulfasalazine, mean dose, 2.3 g/day18 (10.7)16 (9.5)20 (11.9)
Baseline corticosteroids, mean dose, 6.1 mg/day12 (7.1)25 (14.9)16 (9.5)
Baseline use of NSAID118 (70.2)123 (73.2)120 (71.4)
  • From Kavanaugh A, et al. Ann Rheum Dis 2014;73:1020–6, with permission.

  • * The n reflects the no. randomized patients; actual no. patients available for each endpoint may vary.

  • Examined among patients who had body surface area ≥ 3% affected at baseline.

  • Examined among patients who had enthesitis at baseline.

  • § Examined among patients who had dactylitis at baseline.

  • Prednisone ≤ 10 mg/day (or equivalent). PsA: psoriatic arthritis; HAQ-DI: Health Assessment Questionnaire-Disability Index; VAS: visual analog scale; CRP: C-reactive protein; SF-36v2 PF: Medical Outcomes Study Short Form-36 health survey version 2 Physical Functioning domain; DAS28: 28-joint Disease Activity Score; CDAI: Clinical Disease Activity Index; PASI: Psoriasis Area and Severity Index; MASES: Maastricht Ankylosing Spondylitis Enthesitis Score; DMARD: disease-modifying antirheumatic drugs; NSAID: nonsteroidal anti-inflammatory drugs.