Substantial pain
reduction at Week 48
for a majority of
patients1

Skin pain severity by HSSQ assessment1,2

OC, Pooled

BKZ HS PainSeverity HSSQ

Based on pooled data from pivotal trials as observed prespecified exploratory endpoints where patients with missing data at a specific time were not included. No clinical or statistical conclusions can be drawn.1

The HSSQ assesses four items (skin pain, itch, smell or odor, drainage or oozing) over the past seven days using a numerical scale ranging from 0 (no symptom) to 10 (symptom as bad as you can imagine).2

You can help your appropriate patients find relief from HS symptoms1

Treatment with BIMZELX resulted in a reduction of AN
count and draining tunnels1

REDUCTION OF
ABSCESSES & NODULES1

HS Vector

 

mean reduction from baseline in inflammatory lesion count at Week 48

N=211

NO NEW DRAINING
TUNNELS1

HS Vector_90

 

of patients had
NO NEW draining tunnels at Week 48

n/N=189/211

Based on the results from the pivotal trials, the approved dosing for BIMZELX in HS is 320 mg Q2W to Week 16, followed by Q4W thereafter.1

Based on pooled data from pivotal trials as observed prespecified exploratory endpoints where patients with missing data at a specific time were not included. No clinical or statistical conclusions can be drawn.1

BIMZELX Is the FIRST AND ONLY Approved Therapy That Measures QOL Through HiSQOL, an HS-specific Tool3

HiSQOL is more specific to HS than other measures.4

It assesses three areas:

HS SPECIFIC SYMPTOMS4

HS_symptoms_icon
  • Itch
  • Pain
  • Drainage
  • Odor 

PSYCHOSOCIAL IMPACT4

HS_psychosocial_icon
  • Depression
  • Embarrassment
  • Anxiety
  • Concentration
  • Sexual desire

DAILY LIVING ACTIVITIES4

HS_activities_icon
  • Walking
  • Exercising
  • Sleeping
  • Sexual activity
  • Bathing
  • Putting on clothing
  • Working/studying
  • Choosing clothing

The 17-items, assessed under the 3 areas, are added to create a total ranging from 0 to 68, with higher scores indicating more severe impact on HRQOL.4

Improved Scores as Early as Week 16 and Sustained Through Week 481

CHANGE IN MEAN HiSQOL TOTAL SCORE OVER TIME

MI,* Pooled

BKZ HS MeanHiSQOL
 

The mean HiSQOL Total Score fell from “VERY SEVERE” at baseline to “MILD” by Week 16. This response was sustained out to Week 48.

Based on pooled data from pivotal trials as prespecified exploratory endpoints. No clinical or statistical conclusions can be drawn.1

In the MI analysis, patients who discontinued study treatment due to lack of efficacy or adverse events, or who received systemic antibiotics identified as rescue medication for HS by the principal investigator, were set to missing and subsequently imputed using MI. All other missing data were also imputed using MI.

AN=abscesses and nodules; HiSQOL=Hidradenitis Suppurativa Quality of Life; HRQOL=health-related quality of life; HS=hidradenitis suppurativa; HSSQ=Hidradenitis Suppurativa Symptom Questionnaire; MI=multiple imputation; OC=observed case; QOL=Quality of Life; Q2W=every 2 weeks; Q4W=every 4 weeks.

References: 1. Data on file. UCB, Inc.; Smyrna, GA. 2. Ingram JR, Ciarvino V, Rolleri R, et al. Electronic patient-reported outcomes in hidradenitis suppurativa: content validity and usability of the electronic Hidradenitis Suppurativa Symptom Daily Diary, Hidradenitis Suppurativa Symptom Questionnaire, and Hidradenitis Suppurativa Quality of Life Questionnaire. Dermatology. 2024;240(1):65-76. 3. Kimball AB, Jemec GBE, Sayed CJ, et al. Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48-week, randomised, double-blind, placebo-controlled, multicentre phase 3 trials. Lancet. 2024;403(10443):2504-2519. 4. Kirby JS, Thorlacius L, Villumsen B, et al. The Hidradenitis Suppurativa Quality of Life (HiSQOL) score: development and validation of a measure for clinical trials. Br J Dermatol. 2020;183(2):340-348.

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).