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Compilenewborn
Recently, UCB (UCB) announced the new interim data of Phase 3 BE BRIGHT study at the 2021 American Academy of Dermatology (AAD) Summer Meeting
.
This is an open-label extension (OLE) trial, conducted in adult patients with moderate to severe plaque psoriasis, and is evaluating the long-term safety, tolerability, and effectiveness of the IL-17A/IL-17F inhibitor bimekizumab Sex
The data published at the meeting showed that in patients who achieved complete or almost complete removal of skin lesions after 16 weeks of treatment with bimekizumab, the majority of them were treated with continuous maintenance administration every 4 weeks (Q4W) or every 8 weeks (Q8W).
The patient maintained the treatment response for up to 2 years
.
These data further supplement the clinical evidence obtained in the bimekizumab phase 3 clinical project, and further emphasize the potential of bimekizumab to provide complete skin lesion removal for up to 2 years in adult patients with moderate to severe plaque psoriasis
Bimekizumab is a humanized monoclonal IgG1 antibody that can selectively inhibit IL-17A and IL-17F, which are two key cytokines that drive the inflammatory process
.
IL-17F and IL-17A have overlapping biological properties and drive inflammation independently of IL-17A
Currently, the application of bimekizumab for the treatment of adult patients with moderate to severe plaque psoriasis is under review by the US and European regulatory agencies
.
On June 25 this year, bimekizumab received positive opinions on the approval of the EU CHMP proposal.
At this meeting, U.
S.
Bi shared that during the 2 years of bimekizumab treatment, the researchers assessed that the skin lesions were completely cleared or almost completely cleared (IGA 0/1), body surface area (BSA) ≤ 1%, psoriasis area and severity The degree index achieves 100% improvement (PASI 100) to maintain the situation
.
This analysis included patients who were treated with bimekizumab 320mg Q4W in 3 key phase 3 studies and showed treatment response at week 16, and received bimekizumab 320mg Q4W or Q8W maintenance dose treatment from week 16 (weeks 16-56) ), and continue to receive the same maintenance dose for 48 weeks in the open-label BE BRIGHT study, namely Q4W/Q4W/Q4W or Q4W/Q8W/Q8W
Initially, 989 patients were randomized to receive bimekizumab Q4W treatment
.
At week 16, 87.
Among patients who reached IGA 0/1 at week 16, more than 90% maintained IGA 0/1 at week 48 of the OLE trial (continuous Q4W and Q8W maintenance dosing: 94.
4% and 96.
2%, respectively)
.
Similarly, among patients who achieved BSA ≤ 1% at week 16, more than 90% of patients maintained BSA ≤ 1% at week 48 of the OLE trial (continuous Q4W and Q8W maintenance dosing: 90.
In the BE READY, BE VIVID, and BE SURE studies, the most frequently reported adverse events (TEAE) during treatment in patients treated with bimekizumab were nasopharyngitis, oral candidiasis, and upper respiratory tract infections
Reference source: Interim trial data for UCB's bimekizumab shows positive results
