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  5. Drug Trials Snapshots: BIMZELX
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Drug Trials Snapshots: BIMZELX

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.

Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the BIMZELX Prescribing Information for all of the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).

Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).

BIMZELX (bimekizumab-bkzx)
bim zel’ex
UCB, Inc.
Original Approval date
: October 17, 2023


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

BIMZELX is an anti-interleukin (IL)-17A and IL-17F monoclonal antibody that is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

How is this drug used?

BIMZELX is a solution for subcutaneous injection that is taken as 320 mg (given as two subcutaneous injections of 160 mg each) at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing ≥120 kg, a dosage of 320 mg every 4 weeks after Week 16 may be considered.

Who participated in the clinical trials?

The FDA approved BIMZELX based on evidence of safety and efficacy from two placebo-controlled clinical trials which included a total of 839 patients with moderate to severe plaque psoriasis. The trials were conducted at 182 sites in 13 countries including Australia, Belgium, Canada, Germany, Hungary, Italy, Japan, Poland, Republic of Korea, Russian Federation, Taiwan, the United Kingdom, and the United States.

In addition, safety analyses were performed on the combined results of these two placebo-controlled clinical trials. Supportive safety analyses were performed using data from two additional active-controlled clinical trials in a total of 1,169 patients.

How were the trials designed?

The benefit and side effects of BIMZELX were evaluated in two clinical trials of 839 patients ages 18 years and older with moderate to severe plaque psoriasis.

Both trials evaluated a dose of 320 mg of BIMZELX. Trial Ps-1 was a 52-week, multicenter, randomized, double-blind, placebo- and active comparator-controlled, parallel-group, phase 3 trial with ustekinumab as a comparator. In this trial, at Week 16 both subjects previously receiving BIMZELX 320 mg every four weeks and subjects previously receiving placebo were treated with BIMZELX 320 mg every four weeks. Subjects who were treated with ustekinumab continued to receive ustekinumab after Week 16.

Trial Ps-2 was a 56-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 trial. At Week 16, subjects previously receiving BIMZELX 320 mg every four weeks who had achieved a 90% improvement on their Psoriasis Area and Severity Index (PASI) score were rerandomized to treatment with BIMZELX 320 mg every four weeks, BIMZELX 320 mg every eight weeks, or placebo (i.e., treatment with BIMZELX was withdrawn). Subjects previously treated with placebo continued placebo at Week 16. Subjects in the placebo group who fell below 75% improvement in their PASI response after Week 16 were retreated with BIMZELX 320 mg every four weeks.

The benefit of BIMZELX compared to placebo was assessed after 16 weeks of treatment using the Investigator’s Global Assessment (IGA) scale that measures the severity of disease on a scale of 0 to 4 and the PASI for both trials.

DEMOGRAPHICS SNAPSHOT

Figure 1 summarizes how many males and females were enrolled in the combined clinical trials (Pool S1) used to evaluate the safety and efficacy of BIMZELX.

Figure 1. Baseline Demographics by Sex

Pie chart summarizing how many male and female patients were in the clinical trial. In total, 602 (72%) male patients and 237 (28%) female patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 2 summarizes the percentage of patients by race enrolled in the combined clinical trials used to evaluate the safety and efficacy of BIMZELX.

Figure 2. Baseline Demographics by Race

Pie chart summarizing how many White, Black or African American, Asian, Native Hawaiian or Pacific Islander, and missing race patients were in the clinical trial. In total, 703 (83.8%) White patients, 15 (1.8%) Black or African American patients, 109 (13.0%) Asian patients, 3 (0.4%) Native Hawaiian or Pacific Islander patients, and 9 (1.1%) patients with missing race data participated in the clinical trial.

Source: Adapted from FDA Review

Figure 3 summarizes the percentage of patients by age group were in the combined trials used to evaluate the safety and efficacy of BIMZELX.

Figure 3. Baseline Demographics by Age

Pie chart summarizing how many patients by age were in the clinical trial. In total, 770 (92%) patients between 18 and 64 years of age and 69 (8%) patients 65 years of age and older participated in the clinical trial.

Source: Adapted from FDA Review

Figure 4 summarizes the percentage of patients by ethnicity in the clinical trial used to evaluate the side effects of BIMZELX.

Figure 4. Baseline Demographics for Ethnicity

Figure 4 summarizes the percentage of patients by ethnicity in the clinical trial used to evaluate the side effects of BIMZELX.

Source: Adapted from FDA Review

What are the benefits of this drug?

More patients achieved clear or almost clear skin after treatment with BIMZELX in comparison to those who were treated with placebo.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: BIMZELX worked similarly in males or females.
  • Race: BIMZELX worked similarly in White and patients of other races. However, the sample size for races other than White was relatively small.
  • Age: The number of patients older than 65 years of age was limited. Therefore, differences in response between patients older and younger than 65 years of age could not be determined.

What are the possible side effects?

  • upper respiratory tract infections
  • headache
  • herpes simplex infections (cold sores in or around the mouth)
  • small red bumps on your skin
  • feeling tired
  • fungal infections (oral thrush or infections in the mouth, throat, skin, nails, feet, or genitals)
  • pain, redness, or swelling at injection site
  • stomach flu (gastroenteritis)
  • acne

Treatment with BIMZELX has been associated with suicidal thoughts and behavior, infections, liver laboratory abnormalities, and inflammatory bowel disease.

Patients should not receive live vaccines while being treated with BIMZELX.

Were there any differences in side effects of the clinical trials among sex, race, and age?

Although certain adverse reactions were more frequent in some subgroups, because of the small subgroup sample sizes, it cannot be concluded that these differences are clinically meaningful.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

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