PSO Data

Not actual patient.

In BE READY and BE VIVID, one of the co-primary endpoints was PASI 90 at Week 161,2  * †
PASI 90: BIMZELX 320 mg Q4W 88% (n=670) vs placebo 3% (n=169), NRI, pooled results1,2
PASI 100 at Week 16: BIMZELX 320 mg Q4W 64% (n=670) vs 1% placebo (n=169), NRI, pooled results1,2†‡

IGA 0/1 at Week 16: BIMZELX 320 mg Q4W 89% (n=670) vs 3% placebo (n=169), NRI, pooled results1,2 * †

 

In patients with moderate-to-severe plaque psoriasis§

BIMZELX proved superiority vs Cosentyx® (secukinumab)3

PASI 100 through Week 48 (NRI)
BIMZELX (IL-17A + IL-17F) vs Cosentyx (IL-17A)

Rheuma-PSO-Data-Superiority-Graph-Desktop
Rheuma-PSO-Data-Superiority-Graph-Mobile

 

See study design

 

In pooled BE READY and BE VIVID trials, the co-primary endpoint of IGA 0/1 with at least a 2-category improvement from baseline was also met.1,2

The P value for BE READY was <0.0001, and the P value for BE VIVID was <0.0001.1,2

Prespecified secondary endpoint adjusted for multiplicity.

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, consider a dosage of 320 mg every 4 weeks after Week 16. On-label dosing was used for comparator drug.3,4

Patients randomly assigned to BIMZELX received a dose of 320 mg every 4 weeks to Week 16, after which they either continued to receive a dose of 320 mg every 4 weeks or switched to revised maintenance dosing of 320 mg every 8 weeks.3

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.

 

 

BIMZELX demonstrated superiority vs Humira® (adalimumab) and Stelara® (ustekinumab) in PASI 90 at Week 162,5 

 

Rheuma-PSO-Data-Superiority-vs-Humira-Graph-Desktop
Rheuma-PSO-Data-Superiority-vs-Humira-Graph-Mobile

 

Co-primary endpoints of PASI 90 and IGA 0/1 with at least a 2-category improvement from baseline were met in both BE SURE (BIMZELX vs Humira; P<0.001) and BE VIVID (BIMZELX vs placebo; P<0.0001).2,5

PASI 100: secondary endpoint and other efficacy endpoints vs placebo in BE SURE; unranked endpoint vs ustekinumab in BE VIVID.2,5

Prespecified secondary enpoint adjusted for multiplicity.2,5

Sourcing: In BE SURE, 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.

Sourcing: In BE VIVD, 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.

DATA FROM PSO TRIALS*:

The BE SURE trial showed that at Week 16, PASI 90 and PASI 100 were reached by 86% and 61% of BIMZELX patients vs 47% and 24% of patients receiving adalimumab, respectively.5

The BE VIVID trial showed that at Week 16, PASI 90 and PASI 100 were reached by 85% and 59% of BIMZELX patients vs 50% and 21% of patients receiving ustekinumab, respectively.2

Co-primary endpoints of PASI 90 and IGA 0/1 with at least a 2-category improvement from baseline were met in both BE SURE (BIMZELX vs Humira; P<0.001) and BE VIVID (BIMZELX vs placebo; P<0.0001). PASI 100: secondary endpoint in BE SURE and other efficacy endpoint in BE VIVID. BE SURE PASI 100 (NRI) and BE VIVID PASI 90 (NRI): prespecified secondary endpoint adjusted for multiplicity.2,5

 

Explore PSO safety

IGA=Investigator’s Global Assessment; NRI=nonresponder imputation; PASI=Psoriasis Area and Severity Index; Q4W=every 4 weeks; Q8W=every 8 weeks.
 

References: 1. Gordon KB, et al. Lancet. 2021;397(10273):475-486. 2. Reich K, et al. Lancet. 2021;387(10273):487-498. 3. Reich K, et al. N Engl J Med. 2021;385(2):142-152. 4. BIMZELX [prescribing information]. Smyrna, GA: UCB, Inc. 5. Warren RB, et al. N Engl J Med. 2021;385(2):130-141.

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).