Bimekizumab treatment in patients with plaque psoriasis: effectiveness and safety compared to placebo.
Näytönastekatsaukset
10.11.2021
Level of evidence: A
Subcutaneous bimekizumab treatment at the dose of 320 mg monthly increases the proportion of patients with plaque psoriasis achieving the PASI90 and IGA 0/1 responses at week 16 when compared to placebo (PASI90 approximately 85–91 % vs. 1–5 % and IGA 0/1 84–93 % vs. 1–5 % respectively), and adverse events seem to be mild.
Approximately 60 % of patients with bimekizumab had an adverse event compared to 35–47 % of those treated with placebo. The adverse events were mild, and severe adverse events seemed not to be treatment related. The evidence is based on three RCT with low risk of bias and therefore the quality and the applicability of the evidence is good.
| Reference | Study type | Population | Intervention and comparison | Outcomes | Risk of bias |
|---|---|---|---|---|---|
| RCT=randomized controlled trial, PBO= placebo, PASI=Psoriasis Area Severity Index, PP=plaque psoriasis, IGA=Investigator's Global Assessment (on a 5-point scale), BKZ=Bimekizumab, sc=subcutaneous, PASI75= ≥75% reduction in baseline Psoriasis Area and Severity Index, PASI90= ≥90% reduction in baseline Psoriasis Area and Severity Index, PASI100= 100% reduction in baseline Psoriasis Area and Severity Index, P-SIM=Psoriasis Symptoms and Impacts Measure. | |||||
| «Papp KA, Merola JF, Gottlieb AB ym. Dual neutralization of both interleukin 17A and interleukin 17F with bimekizumab in patients with psoriasis: Results from BE ABLE 1, a 12-week randomized, double-bl»1 | RCT, double-blind PBO-controlled phase IIb multicenter study. (BE ABLE 1) | 250 patients ≥ 18 years, with confirmed moderate-to-severe PP ≥ 6 months (PASI ≥ 12, affected body surface area ≥ 10 %, IGA score ≥ 3), candidates for systemic psoriasis therapy or phototherapy. | BKZ 64mg, BKZ 160mg, BKZ 160mg + loading dose 320mg, BKZ 320mg, BKZ 480mg or PBO sc. every 4 weeks. A total of 3 injections. | Primary: PASI90 at week 12 Secondary: PASI90 at week 8; PASI75 and PASI100 at week 12; and IGA response at weeks 8 and 12. | Low |
| «Reich K, Papp KA, Blauvelt A ym. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, acti»2 | RCT, multicenter double-blind PBO-controlled phase 3 withdrawal study. (BE READY) | 435 patients ≥ 18 years with moderate-to-severe PP ≥ 6months. (PASI ≥ 12, affected body surface area ≥ 10 %, IGA score ≥ 3 ) | BKZ 320mg (n=349) or PBO (n=86) sc. every 4 weeks. | Primary: PASI90 and IGA 0/1 at week 16. Secondary: PASI100 or IGA 0 at week 16, PASI75 at week 4; P-SIM at week 16; scalp IGA of 0/1 at week 16; and PASI90 at week 56. | Low |
| «Reich K, Papp KA, Blauvelt A ym. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, acti»3 | RCT, multicenter double-blind, active comparator and PBO-controlled phase 3 study. (BE VIVID) | 567 patients ≥ 18 years with moderate-to-severe PP ≥ 6 months. (PASI ≥ 12, affected body surface area ≥ 10 %, IGA score ≥ 3) | BKZ 320 mg (n=321) Ustekinumab (n=163) PBO (n=83) | Primary: PASI90 and IGA 0/1 at week 16. Secondary: PASI100 at week 16, IGA 0 at week 16, PASI 75 at week 4, scalp IGA at week 16, PASI90 and IGA at weeks 12 and 52, P-SIM at week 16. | Low |
Results
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Absolute difference (95% CI) |
|---|---|---|---|---|---|
| I=intervention; C=comparison; CI=confidence interval, BKZ=Bimekizumab, PBO= placebo, NA=not applicable. *results not shown | |||||
| «Papp KA, Merola JF, Gottlieb AB ym. Dual neutralization of both interleukin 17A and interleukin 17F with bimekizumab in patients with psoriasis: Results from BE ABLE 1, a 12-week randomized, double-bl»1 | N=250 n=39 BKZ 64 mg, n=43 BKZ 160 mg, n=40 BKZ 160 mg + loading dose 320 mg, n=43 BKZ 320 mg, n=43 BKZ 480 mg, n=42 PBO | 12 weeks | BKZ 64 mg: 69.2 % BKZ 160 mg: 55.8 % BKZ 160 mg + loading dose 320 mg: 60.0 % BKZ 320 mg: 60.5 % BKZ 480 mg: 58.1 % | 35.7 % | 33.5 % 20.1 % 24.3 % 24.8 % 22.4 % |
| «Reich K, Papp KA, Blauvelt A ym. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, acti»2 | N=435 n=349 BKZ 320 mg, n=86 PBO | 16 weeks | BKZ 320mg: 61 % | 41 % | 20 % |
| «Reich K, Papp KA, Blauvelt A ym. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, acti»3 | N=567 n=321 BKZ 320 mg n=163 Ustekinumab* n=83 PBO | 16 weeks | BKZ 320mg: 56 % | 47 % | 9 % |
| Level of evidence: high | |||||
References
- Papp KA, Merola JF, Gottlieb AB ym. Dual neutralization of both interleukin 17A and interleukin 17F with bimekizumab in patients with psoriasis: Results from BE ABLE 1, a 12-week randomized, double-blinded, placebo-controlled phase 2b trial. J Am Acad Dermatol 2018;79:277-286.e10 «PMID: 29609013»PubMed
- Reich K, Papp KA, Blauvelt A ym. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial. Lancet 2021;397:487-498 «PMID: 33549193»PubMed
- Reich K, Papp KA, Blauvelt A ym. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial. Lancet 2021;397:487-498 «PMID: 33549193»PubMed