Primary Endpoints:
BE OPTIMAL primary endpoint: ACR50 at Week 16: 44% (BIMZELX), 10% (placebo) – (P<0.0001)
BE COMPLETE primary endpoint: ACR50 at Week 16: 43% (BIMZELX), 7% (placebo) – (P<0.0001)

Rapid joint improvement from the very first dose*

ACR20 and ACR50 response rates at Week 4 (NRI)1,2† 

BE OPTIMAL ACR20 ACR50 Week 4 Desktop
BE OPTIMAL ACR20 ACR50 Week 4 Mobile

 

ACR20 and ACR50 response rates at Week 4 (NRI)1,2† 

BE COMPLETE ACR20 ACR50 Week 4 Desktop
BE COMPLETE ACR20 ACR50 Week 4 Mobile

 

Joint results that are fast

 

In BE OPTIMAL, a difference in responder rates for BIMZELX vs placebo were observed as early as Week 2 for ACR20, after a single dose1‡ 

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

Endpoints not adjusted for multiplicity. Nominal P values.

ACR20: 117 (27%) of 431 with BIMZELX vs 22 (8%) of 281 with placebo.

Significant joint improvement achieved at Week 16

ACR50 and ACR70 response (NRI)1,2 

BE OPTIMAL ACR50 ACR70 Week16 Desktop
BE OPTIMAL ACR50 ACR70 Week16 Mobile

ACR50 and ACR70 response (NRI)1,2  

BE COMPLETE ACR50 ACR70 Week16 Desktop
BE COMPLETE ACR50 ACR70 Week16 Mobile

Consistent responses in bio-naïve patients (BE OPTIMAL) and patients with inadequate response or intolerance to TNF-α inhibitors (BE COMPLETE) 

Complete resolution*
Pooled data from the BE OPTIMAL and BE COMPLETE studies showed that a greater proportion of patients with enthesitis and patients with dactylitis at baseline reached complete resolution at Week 16 when taking BIMZELX compared to placebo.

  • Enthesitis: 50% vs 35% (P=0.0083)*  
  • Dactylitis: 76% vs 51% (P=0.0022)* 

 

Per protocol, data were pooled from patients in BE OPTIMAL and BE COMPLETE with dactylitis (n=90) and enthesitis (n=249) at baseline. Ranked secondary endpoint adjusted for multiplicity.

Maintained joint improvement achieved over 2 years 

BE COMPLETE: 2-year open-label extension ACR50 (NRI)3

BE COMPLETE 2 year ACR 50 Desktop
BE COMPLETE 2 year ACR 50 Mobile

Consistent results were demonstrated over 2 years in the open-label extension for BE OPTIMAL.3

Improved symptoms plus inhibition of structural damage

  • 89% of patients experienced no radiographic progression through 1 year4 *†

 

Structural damage progression in the hands, wrists, and feet was assessed on plain radiographs using the van der Heijde modified Total Sharp Score (vdHmTSS). No progression was defined as a change from baseline in vdHmTSS of ≤0.5. 

Observed cases from the overall study population. No progression was observed in 326/365 patients.

Study designs

BIMZELX vs PLACEBO 

(bio-naïve)1

BE OPTIMAL

BIMZELX vs PLACEBO
(inadequate response or intolerance to TNF-α inhibitors)2

BE COMPLETE

The only IL-17 inhibitor with
8-week dosing for PSO5-8

section-il-17-inhibitor

View dosing & administration

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ACR=American College of Rheumatology criteria; IGA=Investigator’s Global Assessment; NRI=nonresponder imputation; PASI=Psoriasis Area and Severity Index; TNFα-IR=TNFα intolerance
or inadequate response; Q4W=every 4 weeks; Q8W=every 8 weeks. 

References: 1. McInnes IB, et al. Lancet. 2023;401(10370):25-37. 2. Merola JF, et al. Lancet. 2023;401(10370):38-48. 3. Mease PJ, et al. Rheumatol Ther. 2024;11(5):1363-1382. 4. Ritchlin CT, et al. Ann Rheum Dis. 2023;82(11):1404-1414. 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).