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CONSISTENT SAFETY PROFILE ACROSS KEY CLINICAL TRIALS THROUGH 3 YEARS1,2*

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Adverse Events

See 3-Year Safety Data

SAFETY PROFILE3

Lime green and light blue chart covering the most common adverse drug reactions occurring in greater than 1% of subjects on BIMZELX through Week 16 in placebo- controlled studies (BE VIVID and BE READY)
Lime green and light blue chart covering the most common adverse drug reactions occurring in greater than 1% of subjects on BIMZELX through Week 16 in placebo- controlled studies (BE VIVID and BE READY)

In BIMZELX clinical studies, the vast majority of oral candidiasis cases:

•Were mild to moderate1

•Resolved with standard therapy1

*Based on phase 2 and phase 3 studies. BE RADIANT was not included in this analysis, and adverse events in BE RADIANT were similar to those of the other clinical trials.

†Upper respiratory infections include nasopharyngitis, upper respiratory tract infection, pharyngitis, rhinitis, viral upper respiratory tract infection, tonsillitis, sinusitis, pharyngitis streptococcal, pharyngitis bacterial, peritonsillar abscess, viral rhinitis, and influenza.

‡Oral candidiasis includes oral candidiasis, oropharyngeal candidiasis, oral fungal infection, fungal pharyngitis, and oropharyngitis fungal.

§Infection site reactions include injection site reaction, injection site erythema, injection site pain, injection site edema, injection site bruising, and injection site swelling.

||Tinea infections include tinea pedis, fungal skin infection, tinea versicolor, tinea cruris, tinea infection, body tinea, and onychomycosis.

Gastroenteritis includes Enterovirus infection, gastroenteritis, gastroenteritis bacterial, and gastroenteritis viral.

#Herpes simplex infections include herpes simplex and oral herpes.

**Other candida infections include vulvovaginal candidiasis, vulvovaginal mycotic infection, skin candida, and genital candidiasis.

Q4W=every 4 weeks; URI=upper respiratory infection.

 

 

LONG-TERM SAFETY

Cumulative TEAE rates over 3 years in phase 2 and 3 trials1,2*

Lime green and blue bar chart covering cumulative TEAEs rates (all TEAEs and serious TEAEs) over 3 years in phase 2 and 3 trials
Lime green and blue bar chart covering cumulative TEAEs rates (all TEAEs and serious TEAEs) over 3 years in phase 2 and 3 trials

 

Dark teal bar chart covering TEAEs over 3 years
Dark teal bar chart covering TEAEs over 3 years

 

*Data are shown as of the data cutoff (one year: 1 Nov 2019; two years: 9 Nov 2020; three years: 23 Oct 2021). Data are pooled from four phase 2 and four phase 3 trials. Phase 2 data were not collected beyond 2 years. BE RADIANT was not included in the analysis.

†Evaluated at 13 months.

EAIR=exposure-adjusted incidence rate; IBD=inflammatory bowel disease; MACE=major adverse cardiac event; PY=patient-years; TEAE=treatment emergent adverse event.

 

 

Additional Safety Data

15.4% of patients receiving BIMZELX experienced oral candidiasis in Year 1:
6% had a recurrent event2 

 

Purple and dark teal bar chart showing 1 year and then year 1+ 2, illustrating that 15.4% of patients receiving BIMZELX experienced oral candidiasis in Year 1; 6% of patients experienced 2 or more events.
Purple and dark teal bar chart showing 1 year and then year 1+ 2, illustrating that 15.4% of patients receiving BIMZELX experienced oral candidiasis in Year 1; 6% of patients experienced 2 or more events.

• Most patients with recurrent candidiasis had 2 events total2

• Led to a low rate of discontinuation (0.2% of BIMZELX patients)1

 

*Includes patients who received BIMZELX in phase 2 and 3 studies. Excludes BE RADIANT. Patients who initiated BIMZELX at feeder study Week 0, entered BE BRIGHT, and remained on treatment had 2 years of exposure. Other patients may have had a shorter exposure time.

 

The incidence of oral candidiasis decreased with prolonged BIMZELX exposure1 
 

Blue, lime green, purple, and dark teal chart showing the oral candidiasis rate over 2 years for the phase 3 feeder studies (BE VIVID, BE READY, and BE SURE) or the OLE (BE BRIGHT)
Blue, lime green, purple, and dark teal chart showing the oral candidiasis rate over 2 years for the phase 3 feeder studies (BE VIVID, BE READY, and BE SURE) or the OLE (BE BRIGHT)

The incidence rate of oral candidiasis tended to be lower on BIMZELX Q4W/Q8W than BIMZELX Q4W/Q4W.

 

†BE RADIANT data not included. Similar results for candidiasis seen in BE RADIANT vs the pooled analysis.5

‡Includes all patients who received BIMZELX during any of the phase 3 feeder studies (BE VIVID, BE READY, BE SURE) or the OLE (BE BRIGHT); the data cutoff for the ongoing BE BRIGHT trial was November 2020. TEAEs were assigned to the dose most recently received prior to the date of onset of the TEAE. Patients who received both BIMZELX 320 mg Q4W and Q8W at different times in the trials are included in the population count of both treatment groups but only once in each BIMZELX total group.


CI=confidence interval; EAIR=exposure-adjusted incidence rate; OLE=open-label extension; PY=patient-years; TEAE=treatment emergent adverse event; Q4W=every 4 weeks; Q8W=every 8 weeks.

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IMPORTANT SAFETY INFORMATION

Suicidal Ideation and Behavior

BIMZELX® (bimekizumab-bkzx) 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 adverse reactions (≥ 1%) are upper respiratory infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes Simplex infections, acne, folliculitis, other Candida infections, and fatigue.

References:

1. Gordon KB, et al. JAMA Dermatol. 2022;158(7):735-744. 2. Data on file. UCB, Inc.; Smyrna, GA. 3. BIMZELX® [prescribing information]]. Smyrna, GA: UCB, Inc.