In PsA patients, 

Sustained
Improvements in Pain,
Fatigue, and Function

Not actual patient.

Clinically significant and sustained pain relief1

PtAAP VAS change from baseline over time to 2 years (OC)1 

Line graphs showing sustained PtAAP VAS pain relief through 2 years in bio-naïve patients with PsA.
Rheuma-PsA-PROS-Pain-Relief-1-Mobile

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 16 (n=417); Week 104 (n=350).1
Placebo to BIMZELX 160 mg Q4W (OC): Week 16 (n=266); Week 104 (n=232).1
Baseline PtAAP score, mean (SD): 53.6 (24.3) in BIMZELX 160 mg Q4W patients vs 56.8 (23.2) in placebo patients.2
Randomized set; other efficacy endpoint not adjusted for multiplicity; nominal P value.
The PtAAP VAS or “Pain VAS” is part of the ACR core set of measures in arthritis. Subjects assessed their arthritis pain
using a VAS where 0 is “no pain” and 100 is “most severe pain.”1,3 

 

PtAAP VAS change from baseline over time to 2 years (OC)1

Line graphs showing sustained PtAAP VAS pain relief through 2 years in bio-experienced patients with PsA.
Rheuma-PsA-PROS-Pain-Relief-2-Mobile

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 16 (n=260); Week 100 (n=212).1
Placebo to BIMZELX 160 mg Q4W (OC): Week 16 (n=125); Week 100 (n=104).1
Baseline PtAAP score, mean (SD): 58.3 (24.2) in BIMZELX 160 mg Q4W patients vs 61.7 (24.6) in placebo patients.4
Randomized set; other efficacy endpoint not adjusted for multiplicity; nominal P value.
The PtAAP VAS or “Pain VAS” is part of the ACR core set of measures in arthritis. Subjects assessed their arthritis pain using a VAS where 0 is “no pain” and 100 is “most severe pain.”1,3 

 

Sustained relief from fatigue1

 

FACIT-F change from baseline over time to 2 years (OC)1

Line graphs showing sustained FACIT-F fatigue relief through 2 years in bio-naïve patients with PsA.
Rheuma-PsA-PROS-Fatigue-Relief-1-Mobile

 

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 16 (n=416); Week 104 (n=349).1
Placebo to BIMZELX 160 mg Q4W (OC): Week 16 (n=265); Week 104 (n=232).1
Baseline FACIT-F score, mean (SD): 37.8 (9.6) in BIMZELX 160 mg Q4W patients vs 36.0 (10.2) in placebo patients.5
Randomized set; other efficacy endpoint not adjusted for multiplicity; nominal P value.
Functional Assessment of Chronic Illness: Therapy-Fatigue. Score range of 0 to 52.1  

 

FACIT-F change from baseline over time to 2 years (OC)1 

Line graphs showing sustained FACIT-F fatigue improvements through 2 years in bio-experienced patients with PsA.
Rheuma-PsA-PROS-Fatigue-Relief-2-Mobile

 

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 16 (n=260); Week 88 (n=217).1
Placebo to BIMZELX 160 mg Q4W (OC): Week 16 (n=125); Week 88 (n=106).1
Baseline FACIT-F score, mean (SD): 35.3 (10.5) in 16 BIMZELX 160 mg Q4W patients vs 36.3 (9.9) in placebo patients.6
Randomized set; other efficacy endpoint not adjusted for multiplicity; nominal P value. 
Functional Assessment of Chronic Illness Therapy-Fatigue. Score range of 0 to 52.1 

 

Sustained improvement in daily physical function1

HAQ-DI score change from baseline over time to 2 years (OC)1

Rheuma-PsA-PROS-Daily-Physical-Function-1-Desktop
Rheuma-PsA-PROS-Daily-Physical-Function-1-Mobile

 

HAQ-DI criteria

HAQ-DI criteria

 

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 16 (n=417); Week 104 (n=350).1
Placebo to BIMZELX 160 mg Q4W (OC): Week 16 (n=266); Week 104 (n=232).1
Baseline HAQ-DI score, mean (SD): 0.82 (0.59) in BIMZELX 160 mg Q4W patients vs 0.89 (0.61) in placebo patients.2
Randomized set; other efficacy endpoint not adjusted for multiplicity; nominal P value. The HAQ-DI score ranges from 0 to 3.
A lower HAQ-DI score indicates an improvement in function.1 

 

HAQ-DI score change from baseline over time to 2 years (OC)1

Line graphs showing improved HAQ-DI daily physical function through 2 years in bio-experienced patients with PsA.
Rheuma-PsA-PROS-Daily-Physical-Function-2-Mobile

 

HAQ-DI criteria

HAQ-DI criteria

 

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 16 (n=260); Week 100 (n=212).1
Placebo to BIMZELX 160 mg Q4W (OC): Week 16 (n=125); Week 100 (n=104).1
Baseline HAQ-DI score, mean (SD): 0.97 (0.59) in 16 BIMZELX 160 mg Q4W patients vs 1.04 (0.69) in placebo patients.4
Randomized set; other efficacy endpoint not adjusted for multiplicity; nominal P value. The HAQ-DI score ranges from 0 to 3.
A lower HAQ-DI score indicates an improvement in function.1 

 

Demonstrated efficacy over time in bio-naïve and bio-experienced patients1

ACR=American College of Rheumatology; FACIT-F=Functional Assessment of Chronic Illness Therapy-Fatigue; HAQ-DI=Health Assessment Questionnaire Disability Index; PtAAP=Patient Assessment of Arthritis Pain; Q4W=every 4 week; SD=standard deviation; VAS=visual analog score.

 

References: 1. Data on file. UCB, Inc., Smyrna, GA. 2. McInnes IB, et al. Lancet. 2023;401(10370):25-37. 3. Nikiphorou E, et al. Arthritis Res Ther. 2016;18(1):251. 4. Merola JF, et al. Lancet. 2023;401(10370):38-48. 5. Ritchlin CT, et al. Ann Rheum Dis. 2023;82(11):1404-1414. 6. Coates LC, et al. RMD Open. 2024;10(1)(suppl):e003855.

 

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).