In nr-axSpA patients, 

ASAS40: Proven
Efficacy in a Bold
Endpoint

Not actual patient.

Rapid and sustained ASAS40 responses in nr-axSpA patients

Primary endpoint: ASAS40 at Week 16 (NRI)1,2* 

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See study design

See study design

 

Randomized set.

Nominal P value at Week 4.

ASAS40 (OC)1*

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See study design

See study design

 

OC: Observed case analysis of patients with missing data at a specific time not included. Open-label extension limitations: lack of a comparator past Week 16 and use of select study populations that were more likely to show drug effect.
 

BIMZELX 160 mg Q4W (OC): Week 4 (n=128); Week 104 (n=96).1
Placebo to BIMZELX 160 mg Q4W (OC): Week 4 (n=125); Week 104 (n=93).1

 

Randomized set; other efficacy endpoint not adjusted for multiplicity; nominal P value; likely to show drug effect.

 

ASAS domains

ASAS40 is defined as at least 40% improvement and an absolute improvement of ≥2 units on an NRS (0 to 10) from baseline in at least three of the following four domains, with no worsening in the fourth domain3 :

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Most patients achieved disease control as measured by ASDAS-LDA

BE MOBILE 1: ASDAS-CRP states over time (MI)1 *

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The open-label extension had limitations due to a lack of comparator past Week 16 and the use of select study populations that were more likely to show a drug effect.
 

Includes patients originally randomized to placebo.

Missing data imputed using multiple imputation (MI); pooled randomized set; other efficacy endpoint not adjusted for multiplicity.
Baseline score, mean (SD): 3.7 (0.8) in BIMZELX 160 mg Q4W patients vs 3.7 (0.7) in placebo patients.2

ASDAS: a composite index used to assess disease activity

 

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ASAS40=≥40% response in the Assessment in SpondyloArthritis international Society criteria; ASDAS-LDA=Ankylosing Spondylitis Disease Activity Score-Low Disease Activity; BASDAI=Bath Ankylosing Spondylitis Disease Activity Index; BASFI=Bath Ankylosing Spondylitis Functional Index; CRP=C-reactive protein; MI=multiple imputation; NRI=nonresponder imputation; NRS=numeric rating scale; Q4W=every 4 weeks; SD=standard deviation.

References: 1. Data on file. UCB, Inc., Smyrna, GA. 2. van der Heijde D, et al. Ann Rheum Dis. 2023;82(4):515-526. 3. van der Heijde D, et al. Ann Rheum Dis. 2023;82(4)(suppl):S1-S27.
4. Aranda-Valera IC, et al. Rheumatology (Oxford). 2020;59(7):1545-1549. 5. Nikiphorou E, et al. Arthritis Res Ther. 2016;18(1):251. 6. Zochling J. Arthritis Care Res (Hoboken). 2011;63(Suppl 11):S47-S58.

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).