Clinical efficacy of bimekizumab on disease activity measures in joint and skin (PD-PPS)
| Category (N) | Week 8 | Week 20 | ||
| Placebo n=12 | Bimekizumab Top three doses n=30 | Placebo n=12 | Bimekizumab Top three doses n=30 | |
| n=12 | n=30 | n=11 | n=30 | |
| ACR20, n (%) (95% CI) | 2 (16.7) (4.7 to 44.8) | 24 (80.0) (62.7 to 90.5) | 6 (54.5) (28.0 to 78.7) | 23 (76.7) (59.1 to 88.2) |
| ACR50, n (%) (95% CI) | 1 (8.3) (1.5 to 35.4) | 12(40.0) (24.6 to 57.7) | 2 (18.2) (5.1 to 47.7) | 17 (56.7) (39.2 to 72.6) |
| ACR70, n (%) (95% CI) | 0 (0 to 24.2) | 7 (23.3) (11.8 to 40.9) | 0 (0 to 25.9) | 11 (36.7) (21.9 to 54.5) |
| n=5 | n=15 | n=5 | n=15 | |
| PASI75, n (%)* (95% CI) | 0 (0 to 43.4) | 15 (100) (79.6 to 100) | 0 (0 to 43.4) | 15 (100) (79.6 to 100) |
| PASI100, n (%)* (95% CI) | 0 (0 to 43.4) | 13 (86.7) (62.1 to 96.3) | 0 (0 to 43.4) | 11 (73.3) (48.0 to 89.1) |
| n=12 | n=30 | n=11 | n=30 | |
| SJC mean change from baseline (%) (SD) | −17 (54) | −73 (34) | −47 (50) | −71 (42) |
| TJC mean change from baseline (%) (SD) | −27 (32) | −56 (30) | −49 (34) | −59 (36) |
| n=9 | n=22 | n=8 | n=22 | |
| LEI mean change from baseline (95% CI) | −2.00 (−2.9 to –1.1) | −2.45 (−3.4 to –1.6) | −2.63 (−4.46 to –0.79) | −2.18 (−2.94 to –1.42) |
| n=12 | n=30 | n=11 | n=30 | |
| PtGA mean (SD) % change from baseline | −29 (25) | −64 (32) | −32 (32) | −63 (33) |
| PGA mean (SD) % change from baseline | −17 (47) | −59 (26) | −21 (39) | −57 (46) |
| n=11 | n=29 | n=10 | n=29 | |
| DAS28(CRP) mean (SD) % change from baseline | −1.2 (1.2) | −1.9 (0.8) | −1.4 (1.4) | −2.0 (1.1) |
Subject 003–00320 was excluded from the ACR20, ACR50, ACR70, SJC, TJC, LEI, PtGA, PGA and DAS28(CRP) analyses for all time points after week 8, due to receiving an increased dose of naproxen, adalimumab and leflunomide for control of worsening disease.
*PD-PPS lesion analysis set: patients with body surface area (BSA) ≥3% psoriasis involvement at baseline. Modifications to concomitant therapy were permitted post week 8.
ACR, American College of Rheumatology; DAS28(CRP), Disease Activity Score-28 joint count using C-reactive protein; LEI, Leeds Enthesitis Index; PASI, Psoriasis Area and Severity Index; PD-PPS, pharmacodynamics per-protocol set; PGA, Physician’s Global Assessment; PtGA, Patient’s Global Assessment; SJC, swollen joint count; TJC, tender joint count.