From the very first dose,* more than half of COSENTYX® (secukinumab) PASI 90 nonresponders achieved PASI 90 after switching to BIMZELX1

BE RADIANT OPEN-LABEL EXTENSION (OLE): Patients who failed to achieve PASI 90 at the end of the randomized period with COSENTYX were switched to BIMZELX.

 

After switching to BIMZELX 

PASI90
bkz week 4
 

In the BE RADIANT trial, 53 trial patients randomized to receive CONSENTYX failed to achieve PASI 90 at Week 48. After switching, 53% and 21% achieved PASI 90 and PASI 100, respectively, after a single dose of BIMZELX (measured at 4 weeks).

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

METHODS: On BE RADIANT, patients who completed the 48-week double-blinded treatment period entered the OLE and received BIMZELX Q4W or Q8W, depending on PASI response at Week 48 (PASI <90 or PASI ≥90, respectively). All patients were transitioned to BIMZELX Q8W at Week 64. 

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

 

From the very first dose,* two-thirds of HUMIRA® (adalimumab)
PASI 90 nonresponders achieved PASI 90 after switching to BIMZELX1 

 

BE SURE OLE: Patients who failed to achieve PASI 90 at the end of the randomized period with  HUMIRA were switched to BIMZELX. 

 

After switching to BIMZELX

pasi90
bkz week4
 

In the BE SURE trial, 54 trial patients randomized to receive HUMIRA failed to achieve PASI 90 at Week 24. After switching, 67% and 33% achieved PASI 90 and PASI 100, respectively, after a single dose of BIMZELX (measured at 4 weeks). 

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

METHODS: On completion of BE SURE, patients were able to enroll in the BE BRIGHT OLE and received BIMZELX Q4W or Q8W, depending on PASI response on completion of BE SURE (PASI <90 or ≥90, respectively). At Week 24 of BE BRIGHT, patients receiving BIMZELX 320 mg Q4W who achieved ≥90% improvement from baseline in PASI (PASI 90) were eligible to switch to BIMZELX 320 mg Q8W, at the discretion of the investigator. All patients were transitioned to BIMZELX Q8W at Week 64. 

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

 

42% of STELARA® (ustekinumab) PASI 90 nonresponders
achieved PASI 100 after a single dose of BIMZELX1

 

BE VIVID OLE: patients who failed to achieve PASI 90 at the end of the randomized
period with STELARA were switched to BIMZELX. 

 

After switching to BIMZELX

pasi91
bkz 79
 

In the BE VIVID trial, 44 trial patients randomized to receive STELARA failed to achieve PASI 90 at Week 52. After switching, 79% and 42% achieved PASI 90 and PASI 100, respectively, after a single dose of BIMZELX (measured at 4 weeks). 

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

METHODS: On completion of BE VIVID, patients were able to enroll in the BE BRIGHT OLE and received BIMZELX Q4W or Q8W, depending on PASI response on completion of BE VIVID (PASI <90 or ≥90, respectively). At Week 24 of BE BRIGHT, patients receiving BIMZELX 320 mg Q4W who achieved ≥90% improvement from baseline in PASI (PASI 90) were eligible to switch to BIMZELX 320 mg Q8W, at the discretion of the investigator. All patients were transitioned to BIMZELX Q8W at Week 64.  

 

The only IL-17 inhibitor with
8-week dosing for PSO2-5

section-il-17-inhibitor

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OLE=open-label extension; PASI=Psoriasis Area and Severity Index; Q4W=every 4 weeks; Q8W=every 8 weeks.

References: 1. Kokolakis G, et al. Br J Dermatol. 2023;188:330-340. 2. BIMZELX® [prescribing information]. Smyrna, GA: UCB, Inc. 3. COSENTYX® [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp. 4. TALTZ® [prescribing information]. Indianapolis, IN: Eli Lilly and Company.  5. 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).