Demonstrated safety profile at Week 16 across indications3

BKZ_PsA_SafetyProfile_Week16_Table_v05 1
In BIMZELX PSO clinical studies, the vast majority of oral candidiasis cases:
  • Were mild to moderate4
  • Resolved with standard therapy4

 

Common adverse events occurring in ≥1% of subjects receiving BIMZELX and more frequently than in the placebo group in BE VIVID and BE READY.

Common adverse events occurring in ≥2% of subjects receiving BIMZELX and more frequently in the placebo group in BE COMPLETE 
and BE OPTIMAL.

Upper respiratory infections (URI) in PSO studies 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. URI include nasopharyngitis, upper respiratory tract infection, pharyngitis, sinusitis, and rhinitis in PsA studies.

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

Injection-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.

Long-term safety

 

teaes

 

Data were pooled from the BE SURE, BE VIVID, and BE READY phase 3 trials, their open-label extension (OLE) BE BRIGHT, and the BE RADIANT phase 3b trial.

BE OPTIMAL Week 52 and BE COMPLETE Week 16 completers were eligible for the BE VITAL open-label extension. Patients randomized to the reference (adalimumab) arm in BE OPTIMAL were switched to receive BIMZELX 160 mg Q4W at Week 52 regardless of treatment response. All events included in the table were reported after patients switched to BIMZELX. Data are shown by individual feeder study.

For PsA studies only, data shown as % (n/N) experiencing event.

In PsA studies, excluding non-melanoma skin cancer.

Additional safety data

 

15.4% of patients receiving BIMZELX experienced oral candidiasis in Year 1: recurrence rate was low1

add safety 1
Safety Additional
  • Most patients with recurrent candidiasis had 2 events total2
  • Led to a low rate of discontinuation (0.2% of BIMZELX patients)4

 

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 exposure in PSO studies4 

incidence candidiasis
oral candidis mobile

 

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.1

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.

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CI=confidence interval; EAIR=exposure-adjusted incidence rate; IBD=inflammatory bowel disease; MACE=major adverse cardiac event; OLE=open-label extension; P-Y=patient-years; TEAE=treatment emergent adverse event; Q4W=every 4 weeks; Q8W=every 8 weeks; URI=upper respiratory infection.

References: 1. Data on file. UCB, Inc.; Smyrna, GA. 2. Mease PJ, et al. Rheumatol Ther. 2024;11(5):1363-1382. 3. BIMZELX® [prescribing information]. Smyrna, GA: UCB, Inc. 4. Gordon KB, et al. JAMA Dermatol. 2022;158(7):735-744. 

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).