RAPID, COMPLETE, AND MAINTAINED CLEARANCE1-5

A MAJORITY OF PATIENTS WERE COMPLETELY CLEAR AT WEEK 16

IGA 0/1 AT WEEK 16:

93% (BIMZELX Q4W) vs 1% (placebo) co-primary endpoint; P<0.00012

84% (BIMZELX Q4W) vs 5% (placebo) co-primary endpoint; P<0.00014

*Prespecified secondary endpoint adjusted for multiplicity.

Non-responder imputation.

IGA=Investigator’s Global Assessment; PASI=Psoriasis Area and Severity Index; Q4W=every 4 weeks.

*Prespecified secondary endpoint adjusted for multiplicity.

Non-responder imputation.

IGA=Investigator’s Global Assessment; PASI=Psoriasis Area and Severity Index; Q4W=every 4 weeks.

 

 

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.

Non-responder imputation.

PASI=Psoriasis Area and Severity Index.

*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.

Non-responder imputation.

PASI=Psoriasis Area and Severity Index.

 

 

DURABLE SKIN CLEARANCE THROUGH 3 YEARS6

In the BE BRIGHT open-label extension study of phase 3 studies, 96.4% of patients who achieved PASI 90 at Week 16 maintained that level of clearance at 3 years.

Open graph in full screen

Line graph illustrating PASI 90 durable skin clearance through 3 years

In the BE BRIGHT open-label extension study of phase 3 studies, 82% of patients who achieved PASI 100 at Week 16 maintained that level of clearance at 3 years.

Open graph in full screen

Line graph illustrating PASI 100 skin clearance through 3 years

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.
NRI=non-responder imputation; OLE=open-label extension; PASI=Psoriasis Area and Severity Index; Q4W=every 4 weeks;
Q8W=every 8 weeks.

 

 

SEE TRANSFORMATIVE SKIN CLEARANCE3,4,7

 

 

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 ≥120 kg, 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 ≥120 kg, 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 ≥120 kg, 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 ≥120 kg, 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.

BSA=body surface area; PASI=Psoriasis Area and Severity Index; Q4W=every 4 weeks; Q8W=every 8 weeks.

 

 

Hard-to-Treat Areas

BIMZELX PROVIDED CLEARANCE OF SCALP, PALMOPLANTAR, AND NAIL PSORIASIS7

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Image of a table with scalp, palmoplantar, and nails clearance statistics in the two placebo- controlled clinical studies.
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Efficacy-RCM-ClearanceTable-2x-Mobile

*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.

IGA=Investigator’s Global Assessment; mNAPSI=modified Nail Psoriasis Severity Index; Q4W=every 4 weeks.

Study Designs

BE READY: BIMZELX VS PLACEBO1,2


Trial Design: a pivotal, phase 3, multicenter, randomized, placebo-controlled, double-blind trial comparing BIMZELX vs placebo. Co-primary endpoints were the proportion of BIMZELX patients achieving PASI 90 and the proportion of patients achieving an IGA score of 0/1 at Week 16 vs placebo. Ranked secondary endpoints included the proportion of patients achieving PASI 100 and Week 16, PASI 75 and Week 4, and scalp IGA 0/1 at Week 16.

 IGA 0/1=Investigator’s Global Assessment of clear or almost clear; PASI=Psoriasis Area and Severity Index.

BE RADIANT: BIMZELX VS COSENTYX®3

Trial Design: a phase 3b, randomized, double-blind, active comparator–controlled study comparing BIMZELX vs COSENTYX (300 mg weekly to Week 4, followed by every 4 weeks to Week 48). The primary endpoint was the percentage of BIMZELX patients achieving PASI 100 at Week 16 vs COSENTYX. Ranked secondary endpoints included the proportion of patients achieving PASI 75 at Week 4.

 PASI 100=100% improvement from baseline in Psoriasis Area and Severity Index.

BE VIVID: BIMZELX VS STELARA® AND PLACEBO4


Trial Design: a pivotal, phase 3, multicenter, randomized, placebo-controlled, double-blind trial comparing BIMZELX vs placebo and STELARA (45 mg or 90 mg [baseline weight-dependent dosing] at Week 0 and 4, then every 12 weeks). Co-primary endpoints were the proportion of BIMZELX patients achieving PASI 90 and the proportion of patients with an IGA score of 0/1 at Week 16 vs placebo. Ranked secondary endpoints included the proportion of patients achieving PASI 90 and PASI 100 at Week 16 and PASI 75 at Week 4 vs STELARA. Efficacy computed using NRI.

IGA 0/1=Investigator’s Global Assessment of clear or almost clear skin; NRI=non-responder imputation; PASI 100=100% improvement from baseline in Psoriasis Area and Severity Index; PASI 90=≥90% improvement from baseline in Psoriasis Area and Severity Index; PASI 75=≥75% improvement from baseline in Psoriasis Area and Severity Index.
 

BE SURE: BIMZELX VS HUMIRA®5


Trial Design: a 56-week, phase 3, double-blind, randomized, active comparator–controlled trial comparing BIMZELX vs HUMIRA (40 mg every 2 weeks for 24 weeks). Co-primary endpoints were the proportion of BIMZELX patients achieving PASI 90 and the proportion of patients with an IGA score of 0/1 at Week 16 vs HUMIRA. The five ranked secondary efficacy endpoints were a PASI 100 response at Week 16, a PASI 75 response at Week 4, a PASI 100 response at Week 24, a PASI 90 response at Week 24, and an IGA score of 0/1 at Week 24.


IGA 0/1=Investigator’s Global Assessment of clear or almost clear skin; PASI 100=100% improvement from baseline in Psoriasis Area and Severity Index; PASI 90=≥90% improvement from baseline in Psoriasis Area and Severity Index; PASI 75=≥75% improvement from baseline in Psoriasis Area and Severity Index.

BE BRIGHT: OPEN-LABEL EXTENSION


Trial Design: Upon completion of BE READY, BE VIVID and BE SURE, patients could enroll in the BE BRIGHT OLE. Dose adjustments to BIMZELX Q4W or Q8W could occur at Week 56, and to BIMZELX Q8W at OLE Week 24 or OLE Week 48 and after based on PASI 90 response. The primary objective of the OLE was to assess the long-term safety and tolerability of BIMZELX in adult subjects with moderate to severe plaque psoriasis. Results shown include patients who received BIMZELX Q4W through Week 16 then Q8W thereafter (N=186).

OLE=open-label extension; PASI=Psoriasis Area and Severity Index; Q4W-every 4 weeks; Q8W=every 8 weeks.

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THE ONLY IL-17 INHIBITOR WITH 8-WEEK DOSING1,8-10

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IL=interleukin.

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IMPORTANT SAFETY INFORMATION

Suicidal Ideation and Behavior

BIMZELX® (bimekizumab-bkzx) may increase the risk of suicidal ideation and behavior (SI/B). A causal association between treatment with BIMZELX and increased risk of SI/B has not been established. Prescribers should weigh the potential risks and benefits before using BIMZELX in patients with a history of severe depression or SI/B. Advise monitoring for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, advise to promptly seek medical attention, refer to a mental health professional as appropriate, and re-evaluate the risks and benefits of continuing treatment.

Infections

BIMZELX may increase the risk of infections. Do not initiate treatment with BIMZELX in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing BIMZELX. Instruct patients to seek medical advice if signs or symptoms suggestive of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer BIMZELX until the infection resolves.

Tuberculosis

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infection. Initiate treatment of latent TB prior to administering BIMZELX. Consider anti-TB therapy prior to initiation of BIMZELX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients for signs and symptoms of active TB during and after treatment.

Liver Biochemical Abnormalities

Elevated serum transaminases were reported in clinical trials with BIMZELX. Test liver enzymes, alkaline phosphatase and bilirubin at baseline, periodically during treatment with BIMZELX and according to routine patient management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt BIMZELX until a diagnosis of liver injury is excluded. Permanently discontinue use of BIMZELX in patients with causally associated combined elevations of transaminases and bilirubin. Avoid use of BIMZELX in patients with acute liver disease or cirrhosis.

Inflammatory Bowel Disease

Cases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in patients with active IBD. During BIMZELX treatment, monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs.

Immunizations

Prior to initiating therapy with BIMZELX, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with BIMZELX.

MOST COMMON ADVERSE REACTIONS

Most common adverse reactions (≥ 1%) are upper respiratory infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes Simplex infections, acne, folliculitis, other Candida infections, and fatigue.


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. Strober B, et al. Br J Dermatol. 2023;188(6):749-759. 7. Data on file. UCB, Inc.; Smyrna, GA. 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.