Article Figures & Data
Figures
- Figure 1.
Baseline disease activity assessments in patients with PsA included in phase III RCTs of bDMARDs, published between 2015 and 2020, including the pooled means/proportions (95% CI) of (A) SJCs, (B) TJCs, (C) presence of enthesitis, and (D) active skin psoriasis (BSA ≥ 3%). ASTRAEA: Active Psoriatic Arthritis Randomized Trial; bDMARD: biologic disease-modifying antirheumatic drug; BSA: body surface area; PsA: psoriatic arthritis; RCT: randomized controlled trial; RE: random effects; SEAM-PSA: Study of Etanercept and Methotrexate in Subjects With Psoriatic Arthritis; SJC: swollen joint count; TJC: tender joint count.
Tables
- Table 1.
Baseline characteristics of participants in the 10 selected phase III RCTs of bDMARDs.
FUTURE 1
(SEC)10FUTURE 2
(SEC)11GO-VIBRANT
(GOL)12ASTRAEA
(ABA)13SPIRIT-P1
(IXE)14SPIRIT-P2
(IXE)15FUTURE 5
(SEC)16SEAM-PsA
(ETN)17DISCOVER
1 (GUS)18DISCOVER
2 (GUS)19Pooled Mean/% (95% CI) Total no. of enrolled
patients606 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, yrsNR 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
paind55.8 (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.
- Table 2.
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.
