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Now Approved!

For adults with MODERATE-TO-SEVERE plaque psoriasis
WHO ARE CANDIDATES FOR SYSTEMIC THERAPY OR PHOTOTHERAPY

For adults with moderate-to-severe plaque psoriasis WHO ARE CANDIDATES FOR SYSTEMIC THERAPY OR PHOTOTHERAPY

BIMZELX® has
arrived

Introducing the first and only approved biologic to
selectively inhibit IL-17A + IL-17F.1,2

SKIN CLEARANCE
RESULTS CONSISTENTLY
DEMONSTRATED
ACROSS 4 STUDIES1-5

Skin Clearance
at Week 16

 

 

Bar graph illustrating skin clearance at Week 16 for 4 clinical studies

  • IGA=Investigator’s Global Assessment; PASI=Psoriasis Area and Severity Index.
  • PASI 90 results in the placebo arms of BE READY and BE VIVID were 1% and 5%, respectively.
  • IGA 0/1 results in the placebo arms of BE READY and BE VIVID were 1% and 5%, respectively.
  • PASI 90 and IGA 0/1 data combined from 2 BIMZELX arms: BIMZELX every 4 weeks (PASI 90, 87%; IGA 0/1, 87%) and BIMZELX
  • every 4 weeks to every 8 weeks (PASI 90, 85%; IGA 0/1, 83%). Both groups received BIMZELX every 4 weeks through Week 16. 

BE READY:a pivotal, 56-week, phase 3, multicenter, randomized, placebo-controlled, double-blind trial comparing BIMZELX vs placebo. Co-primary endpoints were the proportion of patients achieving PASI 90 and the proportion of patients achieving an IGA score of 0/1 at Week 16.

BE RADIANT:a 48-week, phase 3b, multicenter, randomized, double-blind, active-comparator-controlled study comparing BIMZELX vs secukinumab. The primary endpoint was the percentage of patients achieving PASI 100 at Week 16. PASI 100 was achieved in 62% of patients receiving BIMZELX at Week 16. 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.3

BE VIVID:a pivotal, 52-week, phase 3, multicenter, randomized, placebo-controlled, double-blind trial comparing BIMZELX vs ustekinumab. Co-primary endpoints were the proportion of patients achieving PASI 90 and the proportion of patients with an IGA score of 0/1 at Week 16 vs placebo. 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.4

BE SURE:a 56-week, phase 3, multicenter, randomized, double-blind, active-comparator-controlled trial comparing BIMZELX vs adalimumab. Co-primary endpoints were the proportion of patients achieving PASI 90 and the proportion of patients with an IGA score of 0/1 at Week 16. 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.5

STARTING FROM
THE VERY FIRST DOSE*

Grey and green circular graph with the words, 'up to 45%' in the middle

OF CLINICAL TRIAL
PATIENTS ACHIEVED

PASI 90

AT WEEK 42-6

  • From the very first dose as measured at Week 4; results were not immediate.
  • PASI 90 at Week 4 was an other efficacy variable across 4 clinical trials. Week 4 PASI 90 results ranged from 36% to 45% (nominal P values). PASI 75 at Week 4 was a ranked secondary endpoint, adjusted for multiplicity, across 4 clinical trials. Week 4 PASI 75 ranged from 71% to 77% (P<0.001 against all comparators).2-6

 

 

RAPID RESULTS
THAT LAST

Grey and green circular graph with the number, '87%' in the middle

OF CLINICAL TRIAL
PATIENTS ACHIEVED

PASI 90

AT YEAR 37*

  • 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 non-responder imputation (NRI).
 

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

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BIMZELX® 101 product overview to share with patients living with moderate-to-severe plaque psoriasis

BIMZELX 101

Download this helpful resource for you and your patients to learn more about BIMZELX.

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EXPERIENCE
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Let's Get Started

For information about starting patients on BIMZELX, explore the BIMZELX NavigateTM portal or request a representative to get the materials you need.

START HERE
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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. Reich K, et al. N Engl J Med. 2021;385(2):142-152. 3. Gordon KB, et al. Lancet. 2021;397(10273):475-486. 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. Thaçi D, et al. J Cutan Med. 2022;6(6):s68.