Table 2.
Efficacy outcomes at week 16 and week 52
| Endpoint | Placebo (weeks 0–16) n=133 |
BKZ 160 mg Q4W (weeks 16–52)¶¶ n=133 |
BKZ 160 mg Q4W n=267 |
|||||
| Week 16 | Week 52 | Week 16 | Week 52 | |||||
| NRI %* |
OC % (n/N) |
NRI %* |
OC % (n/N) |
NRI %* |
OC % (n/N) |
NRI %* |
OC % (n/N) |
|
| ACR20 response | 15.8 | 16.8 (21/125) | 60.2 | 71.4 (80/112) | 67.0 | 68.1 (179/263) | 68.2 | 78.4 (182/232) |
| ACR50 response† | 6.8 | 7.2 (9/125) | 40.6 | 48.6 (54/111) | 43.4 | 44.1 (116/263) | 51.7 | 59.7 (138/231) |
| ACR70 response | 0.8 | 0.8 (1/125) | 25.6 | 30.6 (34/111) | 26.6 | 27.0 (71/263) | 35.6 | 40.8 (95/233) |
| PASI75 response‡ | 10.2 (9/88) | 11.4 (9/79) | 80.7 (71/88) | 97.3 (71/73) | 82.4 (145/176) | 83.3 (145/174) | 84.1 (148/176) | 94.9 (148/156) |
| PASI90 response‡ | 6.8 (6/88) | 7.6 (6/79) | 73.9 (65/88) | 89.0 (65/73) | 68.8 (121/176) | 69.5 (121/174) | 74.4 (131/176) | 84.0 (131/156) |
| PASI100 response‡ | 4.5 (4/88) | 5.1 (4/79) | 60.2 (53/88) | 72.6 (53/73) | 58.5 (103/176) | 59.2 (103/174) | 65.9 (116/176) | 74.4 (116/156) |
| MDA response | 6.0 | 6.4 (8/125) | 33.1 | 39.3 (44/112) | 44.2 | 44.9 (118/263) | 47.2 | 54.3 (126/232) |
| VLDA response | 2.3 | 2.4 (3/125) | 15.0 | 17.9 (20/112) | 13.5 | 13.7 (36/263) | 23.6 | 27.0 (63/233) |
| ACR50+PASI100 response‡ | 1.1 (1/88) | 1.3 (1/79) | 34.1 (30/88) | 41.7 (30/72) | 33.5 (59/176) | 33.9 (59/174) | 46.6 (82/176) | 52.9 (82/155) |
| Complete resolution of enthesitis (LEI)§ | 22.2 (8/36) | 23.5 (8/34) | 58.3 (21/36) | 72.4 (21/29) | 49.1 (52/106) | 50.0 (52/104) | 56.6 (60/106) | 68.2 (60/88) |
| Complete resolution of enthesitis (SPARCC)¶ | 23.5 (12/51) | 25.0 (12/48) | 52.9 (27/51) | 65.9 (27/41) | 45.9 (56/122) | 47.1 (56/119) | 52.5 (64/122) | 62.7 (64/102) |
| Complete resolution of dactylitis** | 42.9 (6/14) | 42.9 (6/14) | 85.7 (12/14) | 92.3 (12/13) | 70.6 (24/34) | 72.7 (24/33) | 85.3 (29/34) | 93.5 (29/31) |
| Complete resolution of nail psoriasis†† | 14.5 (12/83) | 15.4 (12/78) | 61.4 (51/83) | 68.0 (51/75) | 45.9 (73/159) | 46.5 (73/157) | 67.3 (107/159) | 74.3 (107/144) |
| HAQ-DI MCID response‡‡ | 21.8 (24/110) | 23.1 (24/104) | 50.0 (55/110) | 59.8 (55/92) | 56.3 (130/231) | 57.3 (130/227) | 55.0 (127/231) | 62.9 (127/202) |
| MI, mean (SE) | MI, mean (SE) | |||||||
| HAQ-DI change from baseline | −0.07 (0.04) | −0.35 (0.06) | −0.38 (0.03) | −0.39 (0.03) | ||||
| PtAAP score change from baseline | −4.5 (2.1) | −29.5 (2.7) | −27.7 (1.7) | −32.2 (1.8) | ||||
| Week 16 | Week 40§§ | Week 16 | Week 40§§ | |||||
| SF-36 PCS score change from baseline | 1.4 (0.7) | 7.3 (0.9) | 7.3 (0.5) | 8.4 (0.6) | ||||
| PsAID-12 total score change from baseline | −0.3 (0.2) | −2.2 (0.2) | −2.2 (0.1) | −2.5 (0.1) | ||||
| FACIT-Fatigue score change from baseline | 0.0 (0.7) | 4.4 (0.8) | 5.4 (0.6) | 6.0 (0.6) | ||||
Randomised set. Previously reported data through week 16 included for reference.14
*n/N reported for subgroups.
†ACR50 at week 16 was the primary end point of BE COMPLETE.
‡In patients with psoriasis affecting ≥3% BSA at baseline.
§Patients with enthesitis at baseline defined by LEI >0.
¶Patients with enthesitis at baseline defined by SPARCC >0.
**Patients with dactylitis at baseline defined by LDI >0.
††Patients with nail psoriasis at baseline (mNAPSI score >0).
‡‡Patients who had a HAQ-DI decrease from baseline of ≥0.35 in patients with HAQ-DI ≥0.35 at baseline.
§§Data not collected at week 52.
¶¶Patients randomised to PBO at baseline who switched to bimekizumab at week 16.
ACR, American College of Rheumatology; BKZ, bimekizumab; BSA, body surface area; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue; HAQ-DI, Health Assessment Questionnaire-Disability Index; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; MCID, minimum clinically important difference; MDA, minimal disease activity; MI, multiple imputation; mNAPSI, modified Nail Psoriasis Severity Index; NRI, non-responder imputation; OC, observed case; PASI, Psoriasis Area and Severity Index; PsAID-12, Psoriatic Arthritis Impact of Disease-12; PtAAP, Patient’s Assessment of Arthritis Pain; Q4W, every 4 weeks; SE, standard error; SF-36 PCS, Short-Form 36-item Health Survey Physical Component Summary; SPARCC, Spondyloarthritis Research Consortium of Canada; VLDA, very low disease activity.