Drug Update · Dermatology

Bimekizumab (Bimzelx) FDA Approves for Moderate to Severe Plaque Psoriasis; BE VIVID: PASI90 85% vs 50% Ustekinumab

July 09, 2026

FDA approval date

2023-10-17

Primary trial

BE VIVID (phase 3)

PASI90 at week 16

85% with bimekizumab vs 50% with ustekinumab; 5% with placebo [1]

IGA 0/1 at week 16

84% with bimekizumab vs 53% with ustekinumab; 5% with placebo [1]

BE VIVID enrollment

567 randomized (bimekizumab n=321; ustekinumab n=163; placebo n=83) [1]

Clinical Perspective

This update affects dermatologists, dermatology nurse practitioners, physician assistants, and other clinicians who treat adults with moderate to severe plaque psoriasis. The BE VIVID data support that bimekizumab produces higher skin clearance at week 16 than ustekinumab by PASI90 and IGA 0/1 metrics, which may inform treatment selection where rapid and high rates of complete or near-complete clearance are priorities ^[1]^[3]. How durable are these higher clearance rates beyond the trial periods and how to optimize long-term safety monitoring (liver enzymes, infection screening, and bowel symptoms) in routine practice remain open questions?

Dr. Divya Agarwal, MBBS, MD (Dermatology, Venereology & Leprosy) · Dermatology

The FDA approved bimekizumab (BIMZELX) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy on 2023-10-17, based on phase 3 data from the BE VIVID trial showing a week-16 PASI90 rate of 85% with bimekizumab versus 50% with ustekinumab and 5% with placebo ^[1]^[3]. The BE VIVID trial also reported an IGA 0/1 rate of 84% with bimekizumab versus 53% with ustekinumab at week 16 ^[1].

Clinical Context

Bimekizumab is a humanized IgG1 monoclonal antibody that selectively binds and inhibits interleukin (IL)-17A and IL-17F (and IL-17A/F), blocking their interaction with the IL-17 receptor complex, as described in the trial publication and the prescribing information ^[1]^[3]. The drug is manufactured and marketed by UCB; the BE VIVID phase 3 program and the product label identify UCB as the sponsor and manufacturer ^[1]^[2]. The FDA-approved indication is moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy; the original U.S. approval date was 2023-10-17 and subsequent labeling updates are reflected in the prescribing information ^[3]^[2].

Key Findings

BE VIVID showed that bimekizumab achieved a PASI90 of 85% at week 16 versus 50% with ustekinumab (risk difference 35 [95% CI 27-43]; p<0·0001) and 5% with placebo (risk difference 80 [74-86]; p<0·0001) in the intention-to-treat population (bimekizumab n=321; ustekinumab n=163; placebo n=83) ^[1].
The BE VIVID coprimary IGA endpoint was also met: bimekizumab achieved an IGA response (clear or almost clear, score 0 or 1) of 84% at week 16 versus 53% with ustekinumab (risk difference 30 [95% CI 22-39]; p<0·0001) and 5% with placebo (risk difference 79 [73-85]; p<0·0001) ^[1].
Secondary and other efficacy outcomes presented in the trial publication included higher rates of PASI100 and IGA 0 with bimekizumab versus ustekinumab and placebo at week 16; for example, PASI100 was 59% with bimekizumab versus 0% with placebo in Trial Ps-1, and comparable results were reported in Trial Ps-2 and Trial Ps-3 detailed in the label and publication ^[1]^[3].

Safety & Tolerability

In BE VIVID, serious treatment-emergent adverse events were reported in 24 (6%) of 395 patients in the bimekizumab group (including those who switched from placebo at week 16) and 13 (8%) of 163 in the ustekinumab group ^[1].
The US prescribing information lists adverse reactions observed in clinical trials, including upper respiratory tract infections, oral candidiasis (oral thrush and other candida infections), headache, injection site reactions, tinea infections, gastroenteritis, Herpes simplex infections, acne, folliculitis, and fatigue; for psoriatic arthritis, urinary tract infection and diarrhea were among listed events; for non-radiographic axial spondyloarthritis, musculoskeletal pain, myalgia, cough, tonsillitis, and transaminase increase were listed; for ankylosing spondylitis, injection site pain, rash, and vulvovaginal mycotic infection were listed ^[2].
Warnings in the label include monitoring for infections (including tuberculosis), liver biochemical abnormalities, inflammatory bowel disease, and recommendations regarding immunizations; suicidal ideation and behavior were prospectively monitored and reported in trials with higher rates in some trial populations receiving bimekizumab versus placebo ^[2]^[3].

Study Design

BE VIVID was a multicentre, randomized, double-blind, active-comparator and placebo-controlled phase 3 trial conducted across 105 sites in 11 countries; adults ≥18 years with moderate to severe plaque psoriasis (PASI ≥12, ≥10% BSA, IGA ≥3) were randomized 4:2:1 to bimekizumab 320 mg every 4 weeks, ustekinumab (weight-based dosing) every 12 weeks, or placebo every 4 weeks; placebo patients switched to bimekizumab at week 16. Clinicians should consult current prescribing information for full dosing guidance. A total of 567 patients were enrolled and randomized in BE VIVID (bimekizumab n=321; ustekinumab n=163; placebo n=83) ^[1]. The FDA approved bimekizumab for plaque psoriasis on 2023-10-17 based on these and other trial data summarized in the prescribing information ^[1]^[3].

FAQ

Q1 What is bimekizumab (BIMZELX) approved for?

Bimekizumab (BIMZELX) is approved by the US Food and Drug Administration for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. The FDA original approval date for BIMZELX is 2023-10-17, and the approval and prescribing information summarize multiple phase 3 trials including BE VIVID that supported the indication. Clinicians should consult current prescribing information for complete dosing guidance.

Q2 How does bimekizumab work?

Bimekizumab is a humanized IgG1 monoclonal antibody that selectively binds interleukin 17A and interleukin 17F (and IL-17A/F), inhibiting their interaction with the IL-17 receptor complex, thereby reducing downstream proinflammatory cytokine and chemokine release implicated in psoriasis pathophysiology. This mechanism is described in the trial publication and prescribing information.

Q3 What is the recommended dose of bimekizumab for plaque psoriasis?

For plaque psoriasis the US label gives a recommended dose of 320 mg administered by subcutaneous injection at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter; for patients weighing ≥120 kg the label notes considering 320 mg every 4 weeks after Week 16. Dosing intervals and administration details, including preparation and injection instructions, are provided in the full prescribing information. Clinicians should consult current prescribing information for complete dosing guidance.

Q4 What are the most common side effects and safety considerations?

Across clinical trials and the US label, commonly reported adverse reactions include upper respiratory tract infections, oral candidiasis (thrush) and other candida infections, headache, injection site reactions, tinea infections, gastroenteritis, Herpes simplex infections, acne, folliculitis, and fatigue; psoriatic arthritis and other indications showed overlapping event lists such as urinary tract infection and diarrhea in some populations. The prescribing information also includes warnings to evaluate and monitor for infections including tuberculosis, check liver enzymes and bilirubin, avoid live vaccines during treatment, and monitor for signs or new onset of inflammatory bowel disease; suicidal ideation and behavior were prospectively monitored and reported in trials. Clinicians should consult current prescribing information for complete dosing guidance.

Bimekizumab (Bimzelx) FDA Approves for Moderate to Severe Plaque Psoriasis; BE VIVID: PASI90 85% vs 50% Ustekinumab

Bimekizumab (Bimzelx) FDA Approves for Moderate to Severe Plaque Psoriasis; BE VIVID: PASI90 85% vs 50% Ustekinumab

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

Study Design

FAQ

References

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