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MORE PATIENTS STAND OUT WITH BIMZELX

In head-to-head studies, BIMZELX was superior to COSENTYX® (measured by PASI 100 at Week 16, and PASI 75 at Week 4), HUMIRA®, and STELARA® (measured by PASI 90 at Week 16 and PASI 75 at Week 4).

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vs COSENTYX (secukinumab)

vs HUMIRA (adalimumab)

vs STELARA (ustekinumab)

62% OF BIMZELX PATIENTS WERE COMPLETELY CLEAR AT WEEK 16 VS 49% OF COSENTYX PATIENTS (PRIMARY ENDPOINT)1    

BE RADIANT: BIMZELX (IL-17A + IL-17F) vs COSENTYX (IL-17A)(NRI)1

Week 4

Week 16

 

Week 4

Week 16

 


PASI 100 at Week 48: 74% (BIMZELX Q4W, n=147), 66% (BIMZELX Q4W/Q8W, n=215), and 48% (COSENTYX Q1W/Q4W, n=354) — (P<0.001)1*

•Sourcing: In this study, the secukinumab used as a biologic active control was sourced from 11 countries. Comparability between non-US-approved secukinumab and US-approved secukinumab has not been established.

*Prespecified secondary endpoint adjusted for multiplicity.

†Endpoints not adjusted for multiplicity. Nominal P value.

‡Prespecified secondary endpoint not adjusted for multiplicity. Nominal P value.

IL=interleukin; NRI-non-responder imputation; PASI=Psoriasis Area and Severity Index; Q1W=every 1 week; Q4W=every 4 weeks; Q8W=every 8 weeks.

 

 

48-Week Study Against COSENTYX

BE RADIANT: BIMZELX vs COSENTYX1

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.

 

 

1.8x MORE PATIENTS ACHIEVED COMPLETE PASI 90 AT WEEK 16 WITH BIMZELX VS HUMIRA2*

BE SURE: BIMZELX (IL-17A + IL-17F) vs HUMIRA (anti-TNF-α)(NRI)2

Week 4

Week 16

Week 4

Week 16

 


IGA 0/1 at Week 16: 85% (BIMZELX Q4W) vs 57% (HUMIRA) — (P<0.001) co-primary endpoint2

PATIENTS WHO SWITCHED FROM HUMIRA TO BIMZELX EXPERIENCED RAPID AND LASTING SKIN CLEARANCE

After switching to BIMZELX, 96.1% of patients achieved PASI 90 at Year 32,3‡

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PASI 90

After switching to BIMZELX, 69.2% of patients achieved PASI 100 at Year 32,3‡

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PASI 90

OLE LIMITATIONS: The open-label extension has limitations with a lack of comparator and the potential enrichment of the patient population.

•Sourcing: In this study, the adalimumab used as a biologic active control was sourced from countries across North America, Europe, Asia, and Australia. Comparability between non-US-approved adalimumab and US-approved adalimumab has not been established.3

*Prespecified secondary endpoint adjusted for multiplicity.

†Endpoints not adjusted for multiplicity. Nominal P value.

‡Upon completion of BE SURE, patients could enroll in the BE BRIGHT open-label extension (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. Efficacy computed using modified NRI.

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

 

 

24-Week Study Against HUMIRA

BE SURE: BIMZELX vs HUMIRA2

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.

 

 

MORE THAN 5 TIMES AS MANY PATIENTS ACHIEVED PASI 75 AT WEEK 4 WITH BIMZELX VS STELARA4*

BE VIVID: BIMZELX (IL-17A + IL-17F) vs STELARA (IL-12/23)(NRI)4

Week 4

Week 16

Week 4

Week 16

 

IGA 0/1 at Week 16: 84% (BIMZELX Q4W) vs 53% (ustekinumab) (secondary endpoint)4

•Sourcing: In this study, the ustekinumab used as a biologic active control was sourced from 11 countries. Comparability between non-US-approved ustekinumab and US-approved ustekinumab has not been established.3

*Prespecified secondary endpoint adjusted for multiplicity.

†Endpoints not adjusted for multiplicity. Nominal P value.

IGA=Investigator's Global Assessment; IL=interleukin; NRI=non-responder imputation; PASI=Psoriasis Area and Severity Index; Q4W=every 4 weeks.

 

 

52-Week Study Against STELARA

BE VIVID: BIMZELX vs STELARA AND PLACEBO3


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 Weeks 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.

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SWITCHING FROM ANOTHER BIOLOGIC?

See skin clearance when patients switched to BIMZELX

THE ONLY IL-17 INHIBITOR WITH 8-WEEK DOSING5-8

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IL=interleukin.

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INDICATIONS

BIMZELX is indicated for the treatment of adult patients with active psoriatic arthritis, active non-radiographic axial spondyloarthritis with objective signs of inflammation, active ankylosing spondylitis, and moderate-to-severe plaque psoriasis patients who are candidates for systemic therapy or phototherapy

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 (≥1%) adverse reactions in plaque psoriasis include upper respiratory tract infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes Simplex infections, acne, folliculitis, other candida infections, and fatigue.

Most common (≥2%) adverse reactions in psoriatic arthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infections.

Most common (≥2%) adverse reactions in non-radiographic axial spondyloarthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, cough, fatigue, musculoskeletal pain, myalgia, tonsillitis, transaminase increase, and urinary tract infections.

Most common (≥2%) adverse reactions in ankylosing spondylitis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, injection site pain, rash, and vulvovaginal mycotic infections.

Please see the full Prescribing Information.

Most common (≥2%) adverse reactions in PsA, nr-axSpA, and AS include upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infections. Other most common (≥2%) adverse reactions specific to each indication include: urinary tract infections (PsA); cough, fatigue, musculoskeletal pain, myalgia, tonsillitis, transaminase increase, and urinary tract infections (nr-axSpA); injection site pain, rash, and vulvovaginal mycotic infections (AS).

References:

1. Reich K, et al. N Engl J Med. 2021;385(2):142-152. 2. Warren RB, et al. N Engl J Med. 2021;385(2):130-141. 3. Data on file. UCB, Inc.; Smyrna, GA. 4. Reich K, et al. Lancet. 2021;397(10273):487-498. 5. BIMZELX® [prescribing information]. Smyrna, GA: UCB, Inc. 6. COSENTYX® [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp. 7. TALTZ® [prescribing information]. Indianapolis, IN: Eli Lilly and Company. 8. SILIQ® [prescribing information]. Bridgewater, NJ: Bausch Health US, LLC.