Bimekizumab shows rapid, effective treatment of plaque psoriasis
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A phase 3 study found bimekizumab to be more efficacious in the treatment of plaque psoriasis than both ustekinumab and placebo.
“Bimekizumab differs from other [interleukin] drugs currently available in that it blocks two molecules, IL-17A and IL-17F,” Mark Lebwohl, MD, one of the study’s authors and Waldman Chair of Dermatology at the Icahn School of Medicine at Mount Sinai, told Healio. “There’s a big overlap between those molecules in the body. ... One of the things they do is they cause psoriasis.”
The multicenter, randomized, double-blind, active-comparator, placebo-controlled BE VIVID trial included 567 patients and took place at 105 locations across 11 countries.
Subjects were randomly assigned 4:2:1 to receive bimekizumab 320 mg every 4 weeks, ustekinumab 45 mg or 90 mg (weight-dependent dosing) at weeks 0 and 4 and then every 12 weeks, or placebo every 4 weeks. Evaluations were conducted at weeks 1, 2 and 4 and then every 4 weeks through week 52.
At week 16, 85% of those in the bimekizumab group had a 90% improvement in Psoriasis Area Severity Index score compared with 50% in the ustekinumab group and 5% in the placebo group (both P < .0001).
PASI 100 was observed in 59% of subjects in the bimekizumab group at week 16 compared with 21% in the ustekinumab group and 0% in the placebo group (both P < .0001).
“To this day, we have never before had a drug that at the end of the placebo-control period of a study has a majority of patients achieving PASI 100, meaning not a dot of psoriasis left,” Lebwohl said.
At week 52, 82% of bimekizumab subjects still had a score of PASI 90 compared with 56% of ustekinumab subjects and 0% of placebo subjects.
Investigator’s Global Assessment response was also greater at all time points for bimekizumab than either ustekinumab or placebo.
In addition, the speed of bimekizumab’s effectiveness was noted.
“This drug was incredibly fast. At week 4, 76.9% of patients achieved PASI 75,” Lebwohl said. “The magnitude of the response and the speed of the response beat everything else we have. This gives us a drug that is safe, effective and works to a degree we haven’t seen before. It gives us yet another option to improve the effectiveness of the current armamentarium of psoriasis that we have.”
Perspective
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Jerry Bagel, MD, MS
Ustekinumab became FDA approved for the treatment of psoriasis in September 2009, dosed at 45 mg for patients less than 100 kg and 90 mg for patients more than 100 kg, with dosing at 0 and 4 weeks and then every 12 weeks. It has a 12-week PASI 75 response rate of 70% and PASI 90 response rate of 41%, with a relatively good safety profile compared with TNF inhibitor. This resulted in Stelara (ustekinumab, Janssen Biotech) becoming a favorite biologic agent for the treatment of psoriasis.
From a practical perspective, the question is, what do patients want? They want to be clear, and they do not want to do anything about it. Well, here is Stelara. Four shots a year, and 40% of patients with very little residual psoriasis. They do not have to think about their skin except for 4 days a year. And even more so, no black box warnings. It does not seem to have increased risk for opportunistic infections, demyelinating diseases, inflammatory bowel disease or congestive heart failure.
Although Stelara’s risk-benefit ratio has remained favorable over the past decade, a new cadre of biologic agents has entered the psoriatic therapeutic armamentarium. The IL-17 and IL-23 monoclonal antibodies have exhibited a higher efficacy. The PASI 90 has in some cases approached 85%, not only at 12 weeks or 16 weeks, but maintained through week 52 and in some studies through 5 years. PASI 100 has been exhibited in more than 50% at week 16 through 5 years.
The BE VIVID study compares the efficacy and safety of bimekizumab vs. ustekinumab from a 52-week, multicenter, double-blind, active-comparator, placebo-controlled phase 3 trial.
Bimekizumab is mechanistically unique in that it binds both IL-17A and IL-17F as opposed to just IL-17A, such as in Taltz (ixekizumab, Eli Lilly and Company), Cosentyx (secukinumab, Novartis) and Siliq (brodalumab, Bausch Health).
The baseline demographics of the ustekinumab and bimekizumab groups were similar, equally regionally distributed through Asia, Australia, Europe and North America. Disease duration was 18 years, baseline PASI was 22, body surface area was 28%, and 39% were on previous biologic therapy.
The data clearly reveal that bimekizumab at week 16 showed PASI 90, PASI 100 and DLQI 0/1 at 85%, 59% and 67%, respectively. Ustekinumab’s 16-week data showed PASI90 in 50%, PASI 100 in 21% and DLQI 0.1 in 42%.
At week 52, PASI 90 for bimekizumab was 82%, while ustekinumab was 56%.
Remarkably week 4 PASI 75 for bimekizumab was 77%, while ustekinumab was 15%. In practical terms, to start with PASI 22 and after only one dose of bimekizumab and 4 weeks, three-quarters of all patients PASI dropped to 5 or less is fast. This is compared with less than 20% of those on ustekinumab. Patients want fast. Patients want high efficacy. I see patients choosing rapid onset and higher long-term efficacy over fewer shots.
The safety profile between the two medications is similar except for an increased frequency of mild Candida infections on bimekizumab.
Bimekizumab appears to be a very effective, relatively safe biologic therapy that shows better efficacy than ustekinumab. I am sure it will be utilized often in the treatment of psoriasis. I would like to see a head-to-head study between bimekizumab and either guselkumab or risankizumab.
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