October 18, 2023
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Main attractions:
- Bimzelx (bimekizumab-bkzx) is the first and only interleukin 17A and 17F inhibitor approved in this indication.
- The approval is indicated for systemic therapy candidates with moderate to severe plaque psoriasis.
UCB announced in a press release that the FDA has approved Bimzelx for the treatment of moderate to severe plaque psoriasis in adults eligible for systemic therapy or phototherapy.
“While achieving completely clear skin has been shown to significantly reduce the negative impact of psoriasis on quality of life, many people with the condition do not achieve completely clear skin or almost completely with their current therapy,” Emmanuel Caeymaex, executive vice president of immunology solutions and head of US solutions at UCB, told Healio. “We believe Bimzelx will make a real and meaningful difference in the lives of people with psoriasis in the United States.”
According to the press release, the approval of Bimzelx (bimekizumab-bkzx) makes it the first and only psoriasis treatment that selectively inhibits interleukin (IL) 17A and 17F.
Emmanuel Caeymaex
The recommended dosage for Bimzelx is 320 mg, divided into two 160 mg subcutaneous injections, at weeks 0, 4, 8, 12 and 16, then every 8 weeks going forward. If the patient weighs 120 kg or more, dosing may be continued every 4 weeks after week 16.
The drug’s approval is supported by data from three phase 3 trials: READY, ALIVE, and BE SURE. These studies evaluated the effectiveness and safety of Bimzelx in more than 1,400 patients with moderate to severe plaque psoriasis.
Results from these studies showed that Bimzelx resulted in higher skin clearance at week 16 than placebo, ustekinumab and adalimumab. According to the press release, more than 8 out of 10 Bimzelx recipients achieved PASI 90 and IGA 0/1 by week 16, and about 6 out of 10 achieved PASI 100.
Bimzelx boasts rapid responses with more than seven out of 10 patients achieving PASI 75 as early as week 4. Furthermore, positive responses achieved at week 16 have been shown to be maintained for up to 1 year. .
The most common adverse reactions, occurring in 1% or more of patients, include upper respiratory tract infections, oral candidiasis, headache, injection site reactions, fungal skin infections, gastroenteritis , herpes simplex infection, acne, folliculitis, other diseases. Candida infection and fatigue.
“We are proud that Bimzelx is now approved in the US,” said Caeymaex.
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Joel M. Gelfand, MD, MSCE
The approval of Bimzelx represents a new frontier in what dermatologists can offer patients with moderate to severe psoriasis. It appears to be the fastest-acting and most effective treatment option for moderate to severe psoriasis to date.
That said, this is a new biologic that targets IL-17A and IL-17F. The FDA has issued warnings about suicidal ideation and behavior (1.8% of patients taking Bimzelx vs. 0.6% of patients taking placebo), infections (36% of patients taking Bimzelx vs. 23% of patients taking placebo users). The FDA also recommends liver enzyme testing at baseline and as routine management, and warns against the use of Bimzelx in patients with active tuberculosis or active inflammatory bowel disease.
However, serious side effects are quite rare with Bimzelx and the drug is very well tolerated; although compared to other probiotics, the skin mucosa Candida Infection is quite common and clinicians will need to be prepared to identify and treat this infection.
I look forward to treating my psoriasis patients who do not want to use other biologic medications with Bimzelx.
Joel M. Gelfand, MD, MSCE
James J. Leyden Professor of Dermatology and Epidemiology Director of the Center for Clinical Sciences in Dermatology Director of the Center for Psoriasis and Phototherapy Perelman School of Medicine at the University of Pennsylvania
Disclosure: Gelfand reports no related financial disclosures.
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