Table 1.
Summary of the most relevant currently available efficacy and safety data on bimekizumab and sonelokimab.
| Drug | Disease | Trial | Active comparator | Objective | Dose regimen | Efficacy | Most common AEs | |
|---|---|---|---|---|---|---|---|---|
| BIMEKIZUMAB | Psoriasis | BE ABLE 1 (NCT02905006) (n = 250) | Efficacy and safety | PASI90 at 12 weeks (%) | Nasopharyngitis, respiratory tract infection and oral candidiasis | |||
| Placebo | 0% | |||||||
| 64 mg Q4W | 46 | |||||||
| 160 mg Q4W | 67 | |||||||
| 160 mg Q4W (320 mg LD at baseline) | 75 | |||||||
| 320 mg Q4W | 79 | |||||||
| 480 mg Q4W | 72 | |||||||
| BE ABLE 2 (NCT03010527) (n = 217) | Long-term efficacy and safety (extension study from BE ABLE 1) | (*) | PASI90 at 60 weeks (%) | Nasopharyngitis, respiratory tract infection and oral candidiasis | ||||
| Placebo → 160 Q4W | 90 | |||||||
| 64 mg Q4W | 100 | |||||||
| 160 mg Q4W | 80 | |||||||
| 320 mg Q4W | 85 | |||||||
| 480 mg → 320 Q4W | 85 | |||||||
| BE READY (NCT03410992) (n = 435) | Efficacy and safety | PASI90 at 16 weeks (%) | IGA0/1 at 16 weeks (%) | Nasopharyngitis, oral candidiasis, respiratory tract infection | ||||
| Placebo | 1 | 1 | ||||||
| 320 mg Q4W | 91 | 93 | ||||||
| Be VIVID (NCT03370133) (n = 567) | Ustekinumab | Efficacy and safety | Placebo | 5 | 5 | Nasopharyngitis, oral candidiasis, respiratory tract infection | ||
| BKZ 320 mg Q4W | 85 | 84 | ||||||
| UST 45/90 mg Q12W | 50 | 53 | ||||||
| BE SURE (NCT03412747) (n = 478) | Adalimumab | Efficacy and safety | BKZ 320 mg Q4W until week 16 Q8W | 86 | 85 | Upper respiratory tract infections, oral candidiasis, hypertension and diarrhea | ||
| ADA 40 mg Q2W until week 24 BKZ | 47 | 57 | ||||||
| BE RADIANT (NCT03536884) (n = 743) | Secukinumab | Efficacy and safety | PASI100 at 16 weeks (%) | PASI100 at 48 weeks (%) | Upper respiratory tract infections, oral candidiasis, urinary tract infection | |||
| BKZ 320 mg Q4W | 62 | 67 | ||||||
| SEC 300 mg weekly until week 8 Q4W | 49 | 46 | ||||||
| PsA | BE ACTIVE (NCT02969525) (n = 206) | Efficacy and safety | ACR50 at 12 weeks (%) | ACR20 at 12 weeks (%) | Nasopharyngitis and oral candidiasis | |||
| Placebo | 7 | 19 | ||||||
| 16 mg Q4W | 27 | 54 | ||||||
| 160 mg Q4W | 41 | 73 | ||||||
| 160 mg Q4W 320 mg LD at baseline) | 46 | 61 | ||||||
| 320 mg Q4W | 24 | 51 | ||||||
| BE COMPLETE (NCT03896581) (n = 390) | Efficacy and safety in anti-TNF inadequate-responders | Ongoing | ||||||
| BE OPTIMAL (NCT03895203) (n = 840) | Adalimumab | Efficacy and safety | Ongoing | |||||
| BE VITAL (NCT04009499) (n = 1045) | Safety (incident AE) | Ongoing | ||||||
| SONELOKIMAB | Psoriasis | NCT02156466 (n = 44) | Safety/tolerability, immunogenicity, pharmacokinetics/pharmacodynamic and efficacy | Days 1, 15, 29 | PASI90 at 85 days (%) | Pruritus, headache, hypertension, nasopharyngitis, somnolence and bronchitis | ||
| Placebo | 0 | |||||||
| 30 mg | 50 | |||||||
| 60 mg | 88 | |||||||
| 120 mg | 88 | |||||||
| 250 mg | 100 | |||||||
| NCT03384745 (n = 313) | Secukinumab | Efficacy, safety and tolerability | (**) | IGA 0/1 at 12 weeks (%) | Nasopharyngitis, pruritus, upper respiratory tract infections | |||
| Placebo | 0 | |||||||
| 30 mg 0, 2, 4, 8 w | 48 | |||||||
| 60 mg 0, 2, 4, 8 w | 85 | |||||||
| 120 mg 0, 2, 4, 8 w | 77 | |||||||
| 120 mg+ 0, 2, 4, 6, 8, 10 w | 88 | |||||||
| SEC 300 mg 0, 1, 2, 3, 4, 8 w | 77 | |||||||
Patients who achieved PASI90 at week 12 received bimekizumab 64, 160, or 320 mg for an additional 48 weeks (60 weeks in total). Patients receiving placebo in BE ABLE 1 were switched to bimekizumab 160 mg and patients receiving bimekizumab 480 mg were switched to 320 mg. The other dose regimes were maintained.
This clinical trial consisted of a 12-week induction period, a 12-week dose escalation period and a 12-week evaluation of response period. Detailed explanation of administration regimes is included in the main text.
ADA, adalimumab; AE, adverse effects; BKZ, bimekizumab; LD, loading dose; PsA, psoriatic arthritis; Q4W, every 4 weeks; SEC, secukinumab; UST, ustekinumab.