Pooled study outcomes at week 16
| Placebo (n=414) | Bimekizumab 160 mg Q4W (n=698) | P value* | |
| Pain VAS | |||
| CfB at week 16 (MI), mean (95% CI) | −5.7 (–8.2, –3.3) | −25.2 (–27.2, –23.1) | *** |
| ≥30% responders (NRI), n (%) | 105 (25.4) | 421 (60.3) | *** |
| ≥50% responders (NRI), n (%) | 72 (17.4) | 346 (49.6) | *** |
| ≥70% responders (NRI), n (%) | 38 (9.2) | 246 (35.2) | *** |
| Median time to 30% improvement, weeks | NE† | 7.9 | – |
| Median time to 50% improvement, weeks | NE† | 9.1 | – |
| Median time to 70% improvement, weeks | NE† | NE† | – |
| FACIT-Fatigue | |||
| CfB at week 16 (MI), mean (95% CI) | 1.1 (0.3, 2.0) | 4.5 (3.9, 5.1) | *** |
| MCID (NRI), n (%)‡ | 138 (36.3) | 336 (53.1) | *** |
| HAQ-DI | |||
| CfB at week 16 (MI), mean (95% CI) | −0.08 (–0.12, –0.04) | −0.30 (–0.34, –0.27) | *** |
| MCID (NRI), n (%)§ | 95 (28.7) | 291 (53.0) | *** |
| Normative value responders (NRI), n (%)¶ | 153 (37.0) | 398 (57.0) | *** |
| PsAID-12 | |||
| CfB at week 16 (MI), mean (95% CI) | −0.5 (–0.7, –0.3) | −2.0 (–2.1, –1.8) | *** |
| Patients with reduction ≥3 from baseline (NRI), n (%)** | 25 (8.4) | 206 (41.7) | *** |
| PASS, n (%)†† | 219 (52.9) | 567 (81.2) | *** |
| PsAQoL | |||
| CfB at week 16 (MI), mean (95% CI) | −0.2 (–0.6, 0.2) | −2.1 (–2.5, –1.8) | *** |
| EQ-5D-3L VAS | |||
| CfB at week 16 (MI), mean (95% CI) | 1.7 (–0.7, 4.1) | 11.5 (9.7, 13.3) | *** |
| EQ-5D-3L Utility (UK tariff) | |||
| CfB at week 16 (MI), mean (95% CI) | 0.03 (0.01, 0.06) | 0.16 (0.14, 0.17) | *** |
| SF-36 PCS | |||
| CfB at week 16 (MI), mean (95% CI) | 2.1 (1.3, 2.8) | 6.7 (6.1, 7.3) | *** |
| MCID (NRI), n (%)‡‡ | 129 (31.2) | 368 (52.7) | *** |
| SF-36 MCS | |||
| CfB at week 16 (MI), mean (95% CI) | −0.8 (–1.6, –0.1) | 0.7 (0.1, 1.3) | **** |
Randomised set.
*Nominal p values reported; analyses were not adjusted for multiplicity. ***denotes nominal p<0.001, ****denotes nominal p<0.01.
†Not evaluable as the number of patients achieving this threshold to week 16 was too few for analysis.
‡FACIT-Fatigue MCID defined as CfB ≥4 in patients with FACIT-Fatigue ≤48 at baseline; n values placebo/bimekizumab: 380/633.
§HAQ-DI MCID defined as decrease from baseline ≥0.35 in patients with HAQ-DI ≥0.35 at baseline; n values placebo/bimekizumab: 331/549.
¶Defined as HAQ-DI ≤0.5.
**In patients with PsAID-12 total score ≥3 at baseline; n values placebo/bimekizumab: 299/494.
††Patients achieving a PsAID-12 score of ≤4.
‡‡SF-36 PCS MCID defined as increase from baseline ≥5.
CfB, change from baseline; FACIT, Functional Assessment of Chronic Illness Therapy; HAQ-DI, Health Assessment Questionnaire-Disability Index; MCID, minimal clinically important difference; MCS, Mental Component Summary; MI, multiple imputation; NE, not evaluable; NRI, non-responder imputation; PASS, Patient Acceptable Symptom State; PCS, Physical Component Summary; PsAID-12, Psoriatic Arthritis Impact of Disease-12; PsAQoL, Psoriatic Arthritis Quality of Life; Q4W, every 4 weeks; SF-36, Short-Form 36-item Health Survey; VAS, Visual Analogue Scale.