In AS patients, 

Sustained
Improvements in Pain,
Fatigue, and Function

Not actual patient.

Clinically significant and sustained improvement in BASDAI

BASDAI absolute value over time to Week 104 (MI)1* 

Rheuma-AS-PROS-BASDAI0-Graph
Rheuma-AS-PROS-BASDAI-Graph-Mobile


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.

 

Baseline BASDAI, mean (SD): 6.5 (1.3) in BIMZELX 160 mg Q4W patients vs 6.5 (1.3) in placebo patients.2

Missing data imputed using multiple imputation (MI); randomized set not adjusted for multiplicity; other efficacy endpoint; nominal P value.

BASDAI measures disease activity based on 5 key patient-reported outcomes3,4: 

Rheuma-AS-PROS-BASDAI-Disease-Activity
Rheuma-AS-PROS-BASDAI-Disease-Activity-Mobile

 

BASDAI ≥4=active disease.

Clinically significant and sustained nocturnal spinal pain relief 

Nocturnal spinal pain absolute value over time to Week 104 (MI)1*

Rheuma-AS-PROS-Nocturnal spinal pain
Rheuma-AS-PROS-Nocturnal spinal pain-Mobile


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.


Baseline nocturnal spinal pain, mean (SD): 6.6 (1.9) in BIMZELX 160 mg Q4W patients vs 6.8 (1.8) in placebo patients.2

Missing data imputed using multiple imputation (MI); randomized set not adjusted for multiplicity; other efficacy endpoint; nominal P value.

Significant and sustained total spinal pain relief

Total spinal pain absolute value over time to Week 104 (MI)1*

Rheuma-AS-PROS-Total spinal pain
Rheuma-AS-PROS-Total spinal pain-Mobile

 

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.

 

Baseline total spinal pain, mean (SD): 7.1 (1.6) in BIMZELX 160 mg Q4W patients vs 7.2 (1.2) in placebo patients.2

Missing data imputed using multiple imputation (MI); randomized set not adjusted for multiplicity; other efficacy endpoint; nominal P value.

Clinically significant and sustained morning stiffness relief

Morning stiffness (BASDAI Q5 & Q6) absolute value over time 
to Week 104 (MI)1*†

Rheuma-AS-PROS-Morning stiffness
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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.

 

Baseline morning stiffness, mean (SD): 6.7 (1.9) in BIMZELX 160 mg Q4W patients vs 6.8 (1.6) in placebo patients.2

Morning stiffness assessed as mean of BASDAI questions 5 and 6.5

Missing data imputed using multiple imputation (MI); randomized set not adjusted for multiplicity; other efficacy endpoint; nominal P value.

Sustained improvement in fatigue

FACIT-F absolute value over time to Week 104 (MI)1* 

Rheuma-AS-PROS-Fatigue
Rheuma-AS-PROS-Fatigue-Mobile

 

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.
 

Missing data imputed using multiple imputation (MI); randomized set not adjusted for multiplicity; other efficacy endpoint; nominal P value.

Baseline FACIT-F score, mean (SE): 30.7 (0.7) in BIMZELX 160 mg Q4W patients vs 33.1 (1.0) in placebo patients.1

BASDAI=Bath Ankylosing Spondylitis Disease Activity Index; CfB=change from baseline; FACIT-F=Functional Assessment of Chronic Illness Therapy-Fatigue; MI=multiple imputation; Q4W=every 4 weeks; SD=standard deviation; SE=standard error.

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. Zochling J. Arthritis Care Res (Hoboken). 2011;63(Suppl 11):S47-S58. 4. Garrett S, et al. J Rheumatol. 1994;21(12):2286-2291. 5. van der Heijde D, et al. Ann Rheum Dis. 2023;82(4)(suppl):S1-S27.

INDICATIONS

BIMZELX is indicated for the treatment of adults with active psoriatic arthritis, active non-radiographic axial spondyloarthritis with objective signs of inflammation, active ankylosing spondylitis, moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and moderate-to-severe hidradenitis suppurativa.

 

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 definitively 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, instruct 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, including serious 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 and hidradenitis suppurativa 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 infection.

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).