Superior results with BIMZELX

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

62% of BIMZELX patients were completely clear at Week 16 vs 49% of COSENTYX® (secukinumab) patients (primary endpoint)1

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

Week 4

BKZ_PsA_Efficacy_HeadtoHeadStudies_COSENTYX_Week4_v02 1
BKZ_PsA_Efficacy_HeadtoHeadStudies_COSENTYX_Week4_v02 2

 

Week 16

BKZ_PsA_Efficacy_HeadtoHeadStudies_COSENTYX_Week16_v02 1
BKZ_PsA_Efficacy_HeadtoHeadStudies_COSENTYX_Week16_Mobile

 

Study Designs

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.

1.8x more patients achieved complete PASI 90 at Week 16 with BIMZELX vs HUMIRA® (adalimumab)2

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

Week 4

Bimzelx vs Humira Week4

Week 16

Bimzelx vs Humira Week16 Desktop
Bimzelx vs Humira Week16 Mobile

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

Patients who switched from HUMIRA® (adalimumab) to BIMZELX experienced rapid and lasting skin clearance

After switching to BIMZELX, ~88% of patients achieved PASI 90 at Year 4 (mNRI)2,3‡ 

From Humira to Bimzelx Desktop
From Humira to Bimzelx Mobile

Study Designs

After switching to BIMZELX, 59%-70% of patients achieved PASI 100 at Year 42,3‡

From Humira to Bimzelx 100 Desktop
From Humira to Bimzelx 100 Mobile

Study Designs

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.

More than 5 times as many patients achieved PASI 75 at Week 4 with BIMZELX vs STELARA® (ustekinumab)4*

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

Week 4

week 4 ustekinumab
week 4 ustekinumab

 

Week 16

week 16 ustekinumab
week 16 ustekinumab

 

Study Designs

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.

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IGA=Investigator's Global Assessment; mNRI=modified nonresponder imputation; NRI=nonresponder imputation; PASI=Psoriasis Area and Severity Index; Q1W=every 1 week; Q4W=every 4 weeks; Q8W=every 8 weeks.

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.

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 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).