Table 1.
Patient demographics and baseline disease characteristics
| PBO n=281 |
BKZ 160 mg every 4 weeks n=431 |
Reference arm (ADA 40 mg every 2 weeks) n=140 |
|
| Age, years, mean (SD) | 48.7 (11.7) | 48.5 (12.6) | 49.0 (12.8) |
| Male, n (%) | 127 (45.2) | 201 (46.6) | 71 (50.7) |
| BMI, kg/m2, mean (SD) | 29.6 (6.1) | 29.2 (6.8) | 28.4 (5.9) |
| Race, white,* n (%) | 270 (96.1) | 410 (95.1) | 133 (95.0) |
| Time since PsA diagnosis,† years, mean (SD) | 5.6 (6.5) | 6.0 (7.3) | 6.1 (6.8) |
| cDMARDs at baseline, n (%) | 194 (69.0) | 301 (69.8) | 99 (70.7) |
| Use of MTX at baseline, n (%) | 163 (58.0) | 252 (58.5) | 82 (58.6) |
| BSA affected by PSO ≥3%, n (%) | 140 (49.8) | 217 (50.3) | 68 (48.6) |
| PASI,‡ mean (SD) | 7.9 (5.6) | 8.2 (6.8) | 8.6 (7.6) |
| TJC (of 68 joints), mean (SD) | 17.1 (12.5) | 16.8 (11.8) | 17.5 (13.1) |
| SJC (of 66 joints), mean (SD) | 9.5 (7.3) | 9.0 (6.2) | 9.7 (7.1) |
| Presence of enthesitis (LEI),§¶ n (%) | 70 (24.9) | 143 (33.2) | 36 (25.7) |
| Score,¶** mean (SD) | 2.9 (1.5) | 2.5 (1.5) | 2.3 (1.6) |
| Presence of enthesitis (SPARCC),¶†† n (%) | 90 (32.0) | 166 (38.5) | 44 (31.4) |
| Score,¶** mean (SD) | 4.7 (3.8) | 4.6 (3.8) | 4.4 (3.9) |
| Presence of dactylitis,‡‡§§ n (%) | 33 (11.7) | 56 (13.0) | 11 (7.9) |
| Score,§§¶¶ mean (SD) | 47.3 (41.1) | 46.7 (54.3) | 49.7 (31.9) |
| Nail psoriasis,***††† n (%) | 156 (55.5) | 244 (56.6) | 75 (53.6) |
| Score,†††‡‡‡ mean (SD) | 4.0 (2.1) | 4.1 (2.5) | 3.7 (2.3) |
| HAQ-DI score,§§§ mean (SD) | 0.89 (0.61) | 0.82 (0.59) | 0.86 (0.54) |
| hs-CRP ≥6 mg/L, n (%) | 121 (43.1) | 158 (36.7) | 44 (31.4) |
| BASDAI score ≥4,¶¶¶ n (%) | 213 (75.8) | 311 (72.2) | 107 (76.4) |
| PtAAP,§§§ mean (SD) | 56.8 (23.2) | 53.6 (24.3) | 56.7 (23.9) |
| Patient’s global assessment score,§§§ mean (SD) | 58.6 (23.5) | 54.4 (23.4) | 57.1 (21.8) |
| Physician’s global assessment score,¶¶¶ mean (SD) | 57.2 (15.1) | 57.2 (16.3) | 57.3 (17.5) |
| SF-36 PCS score,‡‡‡‡ mean (SD) | 36.9 (9.7) | 38.1 (9.4) | 37.6 (8.8) |
| PsAID-12 score,§§§ mean (SD) | 4.1 (1.9) | 3.9 (1.9) | 4.3 (1.8) |
| FACIT-Fatigue score,§§§ mean (SD) | 36.0 (10.2) | 37.8 (9.6) | 36.4 (8.8) |
| Bone erosion ≥1 and/or hs-CRP ≥6 mg/L, n (%) | 236 (84.0) | 365 (84.7) | 116 (82.9) |
| vdHmTSS score,**** mean (SD) | 12.3 (22.5) | 12.5 (30.0) | 13.8 (26.5) |
| vdHmTSS score in at-risk set,†††† mean (SD) | 14.5 (23.9) | 14.4 (32.0) | 16.5 (28.4) |
The ADA 40 mg every 2 weeks treatment arm served as an active reference. The study was not powered for statistical comparisons of ADA with BKZ or PBO.
*Race was reported by the patient. Missing for patients enrolled in France (data missing for one patient receiving BKZ and two patients receiving ADA). PBO: 270; BKZ: 410; ADA: 133.
†Data missing for two patients receiving PBO, eight patients receiving BKZ and one patient receiving ADA.
‡In patients with psoriasis affecting ≥3% BSA at baseline; PBO/BKZ: n=140; BKZ: n=217; ADA: n=68.
§LEI >0.
¶Data missing for six patients receiving BKZ and one patient receiving ADA.
**In patients with enthesitis at baseline.
††SPARCC >0.
‡‡LDI >0.
§§Data missing for one patient receiving PBO, seven patients receiving BKZ and one patient receiving ADA.
¶¶In patients with dactylitis at baseline.
***mNAPSI >0.
†††Data missing for seven patients receiving BKZ.
‡‡‡In patients with nail psoriasis at baseline.
§§§Data missing for one patient receiving BKZ.
¶¶¶Data missing for one patient receiving PBO, five patients receiving BKZ and one patient receiving ADA.
****Radiographic set (patients with valid radiographs of hands and feet at baseline, as assessed by ≥2 reviewers); PBO: n=269; BKZ: n=420; ADA: n=135.
††††At‑risk subgroup defined as patients with elevated hs‑CRP and/or with at least one bone erosion at baseline; PBO: n=227; BKZ: n=361; ADA: n=112.
‡‡‡‡Data missing for one patient receiving BKZ and one patient receiving ADA.
ADA, adalimumab; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BKZ, bimekizumab; BMI, body mass index; BSA, body surface area; cDMARD, conventional disease‑modifying antirheumatic drug; FACIT‑Fatigue, Functional Assessment of Chronic Illness Therapy‑Fatigue; HAQ‑DI, Health Assessment Questionnaire‑Disability Index; hs-CRP, high-sensitivity C-reactive protein; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; mNAPSI, modified Nail Psoriasis Severity Index; MTX, methotrexate; PASI, Psoriasis Area and Severity Index; PBO, placebo; PCS, Physical Component Summary; PsAID‑12, Psoriatic Arthritic Impact of Disease‑12 questionnaire; PSO, psoriasis; PtAAP, Patient’s Assessment of Arthritis Pain; SF‑36, Short‑Form 36‑item Health Survey; SJC, swollen joint count; SPARCC, Spondyloarthritis Research Consortium of Canada; TJC, tender joint count; vdHmTSS, van der Heijde modified Total Sharp Score.