Comparison of baseline characteristics from a real-world study (PsABio) and pooled data from 10 bDMARD phase III RCTs.
| RCTsa | PsABiob | P | |
|---|---|---|---|
| Total no. of patients starting treatment | 5654 | 930 | – |
| Age, yrs | 48.6 (41.3 to 56.0) | 49.7 (12.5) | < 0.001 |
| Female sex | 50.7 (48.1 to 53.2) | 55.2 (51.3) | 0.01 |
| Weight, kg | 85.4 (70.6 to 100.1) | 80.9 (17.0) | < 0.001 |
| BMI, kg/m2 | 30.6 (23.6 to 37.6) | 28.1 (5.8) | < 0.001 |
| Time since PsA diagnosis, yrs | 6.3 (1.6 to 10.9) | 6.8 (7.4) | 0.03 |
| MTX ongoing at baseline | 49.6 (37.1 to 62.1) | 35.7 (332) | < 0.001 |
| Previous bDMARDs | |||
| None | 72 (51.3 to 91.8) | 50.4 (469) | < 0.001 |
| 1 | 19.4 (5.6 to 31.7) | 33 (307) | < 0.001 |
| ≥ 2 | 8.6 (2.3 to 14.3) | 16.6 (154) | < 0.001 |
| SJC | 11.8 (6.5 to 17.1) | 5.7 (7.6) | < 0.001 |
| TJC | 21.5 (12.5 to 30.6) | 11.9 (11.6) | < 0.001 |
| Enthesitis | 64.7 (61.1 to 68.5) | 48.2 (448) | < 0.001 |
| Leeds Enthesitis Index | 2.9 (1.6 to 4.2) | 1.2 (1.6) | < 0.001 |
| Dactylitis | 37.7 (30.6 to 44.7) | 19.8 (184) | < 0.001 |
| Dactylitis count | 5.0 (−0.9 to 10.9) | 3.1 (3.1) | < 0.001 |
| BSA ≥ 3% | 62.2 (54 to 70.3) | 54 (442/819)c | < 0.001 |
| PASI score (0-72) | 8.0 (1.5 to 14.4) | NR | – |
| Psoriatic nail disease | 67.6 (59.8 to 75.3) | 40.1 (373) | < 0.001 |
| PGAd | 59.7 (48.1 to 71.2) | 54.1 (20.1) | < 0.001 |
| PtGAd | 61.4 (47.8 to 74.9) | 60.7 (23.7) | 0.45 |
| Patient-reported paind | 60.1 (46.3 to74.0) | 60.7 (23.9) | 0.71 |
| HAQ-DI score | 1.2 (1.1 to 1.3) | 1.1 (0.7) | < 0.001 |
| CRP, mg/dLe | 1.1 (−0.1 to 2.3) | 1.4 (2.8) | 0.002 |
↵a For RCTs, continuous data are indicated as pooled mean (95% CI) and discrete data are indicated as pooled percentage (95% CI).
↵b For PsABio, continuous data are indicated as mean (SD) and discrete data are indicated as % (n).
↵c Total patients: N = 819; data indicated as (%) n/N.
↵d Assessed on a 0-100 mm VAS.
↵e Normal range: 0-0.5 mg/dL. bDMARD: biologic disease-modifying antirheumatic drug; BSA: body surface area; CRP: C-reactive protein; HAQ-DI: Health Assessment Questionnaire–Disability Index; MTX: methotrexate; NR: not reported; PASI: Psoriasis Area and Severity Index; PGA: physician global assessment; PsA: psoriatic arthritis; PtGA: patient global assessment; RCTs: randomized controlled trials; SJC: swollen joint count; TJC: tender joint count; VAS: visual analog scale.