Baseline characteristics of participants in the 10 selected phase III RCTs of bDMARDs.
| FUTURE 1 (SEC)10 | FUTURE 2 (SEC)11 | GO-VIBRANT (GOL)12 | ASTRAEA (ABA)13 | SPIRIT-P1 (IXE)14 | SPIRIT-P2 (IXE)15 | FUTURE 5 (SEC)16 | SEAM-PsA (ETN)17 | DISCOVER 1 (GUS)18 | DISCOVER 2 (GUS)19 | Pooled Mean/% (95% CI) | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Total no. of enrolled patients | 606 | 397 | 480 | 424 | 417 | 363 | 996 | 851 | 381 | 739 | 5654 |
| Age, yrs | 49.0 (11.7) | 48.0 (12.0) | 46.2 (11.9) | 50.4 (11.0) | 49.5 (11.9) | 51.9 (12.0) | 48.8 (12.4) | 48.4 (13.1) | 48.4 (11.4) | 45.7 (11.7) | 48.6 (41.3 to 56.0) |
| Female sex, n (%) | 330 (54.5) | 205 (51.6) | 231 (48.1) | 233 (55) | 225 (54) | 194 (53.4) | 496 (49.8) | 432 (50.8) | 186 (48.8) | 351 (47.5) | 50.7 (48.1 to 53.2) |
| Weight, kg | 82.9 (20.4) | 87.1 (19.6) | NR | NR | 85.6 (20.9) | 88.7 (21.6) | 83.4 (19.2) | NR | 86.1 (18.8) | 84.3 (19.5) | 85.4 (70.6 to 100.1) |
| BMI, kg/m2 | NR | NR | NR | 31.0 (6.5) | 30.0 (8.5) | 30.9 (7.2) | NR | 30.3 (6.8) | NR | NR | 30.6 (23.6 to 37.6) |
| Time since PsA diagnosis, yrs | NR | NR | 5.8 (6.0) | 8.5 (8.2) | 6.7 (7.2) | 10.0 (8.1) | 6.6 (7.3) | 3.2 (6.3) | 6.7 (6.6) | 5.5 (5.7) | 6.3 (1.6 to 10.9) |
| MTX ongoing at baseline, n (%) | 368 (60.7) | 185 (46.6) | 336 (70) | 256 (60.4) | 226 (54.2) | 149 (41) | 499 (50.1) | 0 (0) | 211 (55.4) | 443 (59.9) | 49.6 (37.1 to 62.1) |
| Previous bDMARDs, n (%) | |||||||||||
| None | 428 (70.6) | 258 (65) | 480 (100) | 165 (38.9) | 417 (100) | 0 (0) | 701 (70.4) | 851 (100) | 263 (69) | 739 (100) | 72 (51.3 to 91.8) |
| 1 | 109 (18) | 79 (19.9) | 0 (0) | 186 (43.9) | 0 (0) | 235 (64.7) | 197 (19.8) | 0 (0) | 102 (26.8) | 0 (0) | 19.4 (5.6 to 31.7) |
| ≥ 2 | 69 (11.4) | 60 (15.1) | 0 (0) | 73 (17.2) | 0 (0) | 128 (35.3) | 98 (9.8) | 0 (0) | 16 (4.2) | 0 (0) | 8.6 (2.3 to 14.3) |
| GCs at baseline, n (%) | 95 (15.7) | 81 (20.4) | 133 (27.7) | 107 (25.2) | NR | NR | 168 (16.9) | NR | 54 (14.2) | 145 (19.6) | 18.8 (15.9 to 21.7) |
| SJC, 0-66 | 13.4 (11.2)a | 11.5 (9.4)a | 14.0 (8.3) | 11.6 (7.5) | 11.0 (7.4) | 12.3 (10.1) | 11.5 (10.1)a | 11.9 (9.5) | 9.9 (7.4) | 12.3 (7.2) | 11.8 (6.5 to 17.1) |
| TJC, 0-68 | 24.1 (17.3)b | 22.5 (17.0)b | 25.6 (14.1) | 20.2 (13.3) | 20.1 (13.4) | 23.3 (15.9) | 21.0 (15.8)b | 19.9 (14.9) | 19.2 (14.0) | 21.3 (12.8) | 21.5 (12.5 to 30.6) |
| Enthesitis, n (%) | 372 (61.4) | 253 (63.7) | 366 (76.3) | 272 (64.2) | 242 (58) | 221 (60.9) | 602 (60.4) | 57 (67.7) | 222 (58.3) | 506 (68.5) | 64.7 (61.1 to 68.5) |
| LEI | NR | 3.1 (1.7) | 3.1 (1.6) | NR | 2.9 (1.7) | 2.9 (1.6) | NR | NR | 2.8 (1.6) | 2.8 (1.6) | 2.9 (1.6 to 4.2) |
| Dactylitis, n (%) | 324 (53.5) | 137 (34.5) | 258 (53.8) | 111 (26.2) | 157 (37.6) | 62 (17.1) | 389 (39.1) | 284 (33.4) | 142 (37.3) | 331 (44.8) | 37.7 (30.6 to 44.7) |
| Dactylitis count | NR | 3.5 (3.6) | 9.6 (9.7) | NR | NR | NR | NR | NR | 8.1 (10.0) | 8.3 (9.5) | 5.0 (−0.9 to 10.9) |
| BSA, % | NR | NR | NR | NR | NR | 11.1 (16.4) | NR | 11.4 (16.4) | 13.3 (17.3) | 17.4 (20.3) | 12.9 (−4.16 to 29.9) |
| BSA ≥ 3%, n (%) | 325 (53.6) | 192 (48.4) | 394 (82.1) | 294 (69.3) | 267 (69.5) | 203 (55.9) | 514 (51.6) | 548 (64.4) | NR | NR | 62.2 (54 to 70.3) |
| PASI score (0-72) | 13.8 (11.4)c | NR | 9.9 (9.4)c | 7.3 (7.9)c | 6.1 (6.9) | 5.9 (7.6) | NR | NR | 8.5 (9.6) | 9.9 (11.1) | 8.0 (1.5 to 14.4) |
| Psoriatic nail disease, n (%) | NR | NR | NR | NR | 289 (69.3) | 236 (65) | NR | NR | NR | NR | 67.6 (59.8 to 75.3) |
| PGAd | 56.4 (18.6) | 56.5 (16.5) | 63.0 (16.5) | 54.4 (19.2) | 56.9 (18.9) | 61.3 (19.4) | 55.9 (19.3) | NR | 62.3 (16.7) | 66.0 (15.3) | 59.7 (48.1 to 71.2) |
| PtGAd | 55.6 (22.8) | 60.0 (19.2) | 64.0 (20.0) | 61.8 (23.1) | 61.4 (20.2) | 65.5 (20.8) | 53.9 (22.7) | NR | 62.3 (20.7) | 64.7 (18.7) | 61.4 (47.8 to 74.9) |
| Patient-reported paind | 55.8 (22.5) | 57.3 (20.5) | 63.5 (20.5) | 64.3 (22.7) | 58.9 (20.9) | 63.5 (20.8) | 54.3 (23.9) | NR | 59.0 (21.0) | 62.7 (19.3) | 60.1 (46.3 to 74.0) |
| HAQ-DI score | 1.2 (0.7) | 1.2 (0.6) | 1.3 (0.6) | 1.3 (0.7) | 1.2 (0.6) | 1.2 (0.6) | 1.3 (0.6) | 1.2 (0.0) | 1.1 (0.6) | 1.3 (0.6) | 1.2 (1.1 to 1.3) |
| CRP, mg/dLe | NR | NR | 1.9 (1.7) | 1.4 (2.6)f | 1.4 (2.2)f | 1.4 (2.4)f | NR | NR | 0.7 (0.9) | 1.2 (1.4) | 1.1 (−0.1 to 2.3) |
Values are mean (SD) unless otherwise specified. Studies are presented by date of publication. All patients included in each RCT were analyzed together, regardless of the treatment arm. When the data were presented only by treatment arm, weighted means and SD were calculated for the continuous data, and percentages were recalculated for the discrete data. Heterogeneity ranged from 0 to 100% across the binary outcomes, whereas all the continuous outcomes showed an I2 value of 0% (data not shown).
↵a SJC of 76 joints.
↵b TJC of 78 joints.
↵c PASI was assessed only in patients in whom psoriasis affected ≥ 3% of BSA.
↵d Assessed on a 0-100 mm VAS.
↵e Normal range: 0-0.5 mg/dL.
↵f CRP originally indicated as mg/L and converted into mg/dL. ABA: abatacept; ASTRAEA: Active Psoriatic Arthritis Randomized Trial; bDMARD: biologic disease-modifying antirheumatic drug; BSA: body surface area; CRP: C-reactive protein; ETN: etanercept; GC: glucocorticoid; GOL: golimumab; GUS: guselkumab; HAQ-DI: Health Assessment Questionnaire–Disability Index; IXE: ixekizumab; LEI: Leeds Enthesitis Index; MTX: methotrexate; NR: not reported; PASI: Psoriasis Area and Severity Index; PGA: physician global assessment; PsA: psoriatic arthritis; PtGA: patient global assessment; RCT: randomized controlled trial; SEAM-PsA: Study of Etanercept and Methotrexate in Subjects With Psoriatic Arthritis; SEC: secukinumab; SJC: swollen joint count; TJC: tender joint count; VAS: visual analog scale.