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BIMZELX is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

PUT PSORIASIS ON NOTICE WITH

TRANSFORMATIVE
RESULTS

The statement above is based on the results of the BE RADIANT (vs secukinumab), BE VIVID (vs ustekinumab), BE SURE (vs adalimumab), and BE READY (vs placebo) clinical trials; please go to the "Efficacy" page for clinical trial results and before-and-after images at Weeks 0, 4, 16, and 52.

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THE ONLY IL-17 INHIBITOR WITH DOSING EVERY 8 WEEKS1,7-9†

VIEW DOSING & ADMINISTRATION


The recommended dose of BIMZELX for adult patients with moderate-to-severe plaque psoriasis is 320 mg (given as 2 subcutaneous injections of 160 mg each) at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing >120 kg (264.5 lbs), consider a dosage of 320 mg every 4 weeks after Week 16.

IL=interleukin.

           
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CONSISTENT SAFETY PROFILE 
THROUGH 3 YEARS6‡

VIEW SAFETY PROFILE

Based on phase 2 and phase 3 studies. BE RADIANT was not included in this analysis, and adverse events in BE RADIANT were similar to those of the other clinical trials.

1ST & ONLY APPROVED
IL-17A + IL-17F INHIBITOR1-3

SEE HOW BIMZELX Targets Inflammation

The clinical relevance of the mechanism of action is unknown.

IL=interleukin.

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RAPID, COMPLETE, AND MAINTAINED CLEARANCE FROM THE VERY FIRST DOSE1-5*

Take a closer look at the efficacy of BIMZELX, including head-to-head results against COSENTYX®, HUMIRA®, and STELARA®, as well as skin clearance data for bio-experienced patients.

Explore Efficacy

*From the very first dose as measured at Week 4; results were not immediate.

TRANSFORMATIVE SKIN CLEARANCE6

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EXPLORE PATIENT BEFORE & AFTER

Actual patient from the BE VIVID clinical trial. Please see the "Before & After" page for detailed dosing and results information.

BSA=body surface area; PASI=Psoriasis Area and Severity Index.

HELP CLEAR THE WAY WITH

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Group 5285

Help make the treatment journey smooth from the start for your patients.

EXPLORE SUPPORT PROGRAM

MORE EXPERTS. MORE INSIGHTS.

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expert

HEAR FROM YOUR PEERS
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RAPID, COMPLETE, AND MAINTAINED CLEARANCE FROM THE VERY FIRST DOSE 1-5*

Take a closer look at the efficacy of BIMZELX, including head-to-head results against COSENTYX®, HUMIRA®, and STELARA®, as well as skin clearance data for bio-experienced patients.

Explore Efficacy

*From the very first dose as measured at Week 4; results were not immediate.

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US_PenOnlyVertica

THE ONLY IL-17 INHIBITOR WITH DOSING EVERY 8 WEEKS1,7-9‡

VIEW DOSING &
ADMINISTRATION

The recommended dose of BIMZELX for adult patients with moderate-to-severe plaque psoriasis is 320 mg (given as 2 subcutaneous injections of 160 mg each) at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing >120 kg (264.5 lbs), a dose of 320 mg every 4 weeks after Week 16 may be considered.1
IL=interleukin.

           
Image
YR3-Icon

CONSISTENT SAFETY PROFILE 
THROUGH 3 YEARS6‡

VIEW SAFETY PROFILE

Based on phase 2 and phase 3 studies. BE RADIANT was not included in this analysis, and adverse events in BE RADIANT were similar to those of the other clinical trials.

TRANSFORMATIVE SKIN CLEARANCE6

Image
Desktop


EXPLORE PATIENT
BEFORE & AFTER

Actual patient from the BE VIVID clinical trial. Please see the "Before & After" page for detailed dosing and results information.

BSA=body surface area; PASI=Psoriasis Area and Severity Index.

1ST & ONLY APPROVED
IL-17A + IL-17F INHIBITOR1-3

SEE HOW BIMZELX
TARGETS INFLAMMATION

 

The clinical relevance of the mechanism of action is unknown.

IL=interleukin.

HELP CLEAR THE WAY WITH

Image
Group 5285

Help make the treatment journey smooth from the start for your patients.

EXPLORE SUPPORT
PROGRAM

MORE EXPERTS. MORE INSIGHTS.

Image
expert
HEAR FROM YOUR PEERS

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. 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. COSENTYX® [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp. 8. TALTZ® [prescribing information]. Indianapolis, IN: Eli Lilly and Company. 9. SILIQ® [prescribing information]. Bridgewater, NJ: Bausch Health US, LLC.