A majority of patients were completely clear at Week 16
IGA 0/1 at Week 16: 93% (BIMZELX Q4W), 1% (placebo)—(P<0.0001) co-primary endpoint vs placebo4
Prespecified secondary endpoint adjusted for multiplicity.
IGA 0/1 at Week 16: 84% (BIMZELX Q4W) vs 5% (placebo) co-primary endpoint; P<0.00014
Prespecified secondary endpoint adjusted for multiplicity.
Skin clearance you can see from the very first dose*
*From the very first dose as measured at Week 4; results were not immediate.
†Prespecified secondary endpoint adjusted for multiplicity.
‡Endpoints not adjusted for multiplicity. Nominal P value.
*From the very first dose as measured at Week 4; results were not immediate.
†Prespecified secondary endpoint adjusted for multiplicity.
‡Endpoints not adjusted for multiplicity. Nominal P value.
Durable skin clearance through 4 years
In BE BRIGHT: 88% of patients were PASI 90 at Year 46
OLE LIMITATIONS: The open-label extension has limitations with a lack of comparator and the potential enrichment of the patient population.
Efficacy computed using modified NRI.
In BE BRIGHT: ~73% of patients were PASI 100 at Year 46
OLE LIMITATIONS: The open-label extension has limitations with a lack of comparator and the potential enrichment of the patient population.
Efficacy computed using modified NRI.
See transformative skin clearance3,4,6
Week 0
PASI 31.6; BSA 61%
Week 0
PASI 31.6; BSA 61%
Actual patient from the BE VIVID clinical trial who received a dose of 320 mg Q4W to Week 52. The recommended dose for BIMZELX is 320 mg Q4W for 16 weeks, then Q8W thereafter. For patients weighing 120 kg (265 lb) or more, a dose of 320 mg Q4W after Week 16 may be considered. The patient achieved PASI 90 at Week 16 (co-primary endpoint). Results are reflective of the average response in the trial patient population.
Actual patient from the BE RADIANT clinical trial who received a dose of 320 mg Q4W to Week 48. The recommended dose for BIMZELX is 320 mg Q4W for 16 weeks, then Q8W thereafter. For patients weighing 120 kg (265 lb) or more, a dose of 320 mg Q4W after Week 16 may be considered. The patient achieved PASI 100 at Week 16 (co-primary endpoint). Results are reflective of the average response in the trial patient population.
Actual patient from the BE RADIANT clinical trial who received a dose of 320 mg Q4W to Week 48. The recommended dose for BIMZELX is 320 mg Q4W for 16 weeks, then Q8W thereafter. For patients weighing 120 kg (265 lb) or more, a dose of 320 mg Q4W after Week 16 may be considered. The patient achieved PASI 100 at Week 16 (co-primary endpoint). Results are reflective of the average response in the trial patient population.
Actual patient from the BE RADIANT clinical trial who received a dose of 320 mg Q4W to Week 48. The recommended dose for BIMZELX is 320 mg Q4W for 16 weeks, then Q8W thereafter. For patients weighing 120 kg (265 lb) or more, a dose of 320 mg Q4W after Week 16 may be considered. The patient achieved PASI 100 at Week 16 (co-primary endpoint). Results are reflective of the average response in the trial patient population.
Hard-to-treat areas
BIMZELX provided clearance of scalp,
palmoplantar, and nail psoriasis6
Secondary endpoint adjusted for multiplicity; P<0.001 for BIMZELX vs placebo in both studies.
Other efficacy endpoint not adjusted for multiplicity.
Q4W dosing.
In BE READY, 91%, 35%, and 60% of patients in the BIMZELX arm had scalp, palmoplantar, or nail involvement, respectively, at baseline. In the placebo arm, 91%, 45%, and 58% of patients had scalp, palmoplantar, or nail involvement, respectively, at baseline.
In BE VIVID, 94%, 40%, and 60% of patients in the BIMZELX arm had scalp, palmoplantar, or nail involvement, respectively, at baseline. In the placebo arm, 88%, 40%, and 61% of patients had scalp, palmoplantar, or nail involvement, respectively, at baseline.
Study designs
BIMZELX vs PLACEBO1,2
BIMZELX vs COSENTYX® (secukinumab)3
BIMZELX vs STELARA® (ustekinumab) AND PLACEBO4
BIMZELX vs HUMIRA® (adalimumab)5
OPEN-LABEL EXTENSION6,7
Want more information about BIMZELX?
BSA=body surface area; IGA=Investigator’s Global Assessment; mNAPSI=modified Nail Psoriasis Severity Index; NRI=nonresponder imputation; OLE=open-label extension; PASI=Psoriasis Area and Severity Index; Q4W=every 4 weeks; Q8W=every 8 weeks.
References: 1. BIMZELX® [prescribing information]. Smyrna, GA: UCB, Inc. 2. Gordon KB, et al. Lancet. 2021;397(10273):475-486. 3. Reich K, et al. N Engl J Med. 2021;385(2):142-152. 4. Reich K, et al. Lancet. 2021;397(10273):487-498. 5. Warren RB, et al. N Engl J Med. 2021;385(2):130-141. 6. Data on file. UCB, Inc.; Smyrna, GA. 7. Strober B, et al. Br J Dermatol. 2023;188(6):749-759. 8. COSENTYX® [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp. 9. TALTZ® [prescribing information]. Indianapolis, IN: Eli Lilly and Company. 10. SILIQ® [prescribing information]. Bridgewater, NJ: Bausch Health US, LLC.
