NEJM: Phase III clinical results of new psoriasis drug Bimukizumab received positive evaluation

Psoriasis, commonly known as "psoriasis", is a chronic, recurrent, and inflammatory autoimmune disease
.
Plaque psoriasis is a type of psoriasis.

01 Summary

Up to now, the star products that have been clinically approved for the treatment of moderate to severe plaque psoriasis mainly include Usnumab (Ustekinumab, IL23 and IL12 inhibitor) and Adalimumab (Adalimumab, TNF inhibitor) And secukinumab (Secukinumab, IL17A inhibitor)
.

Recently, the efficacy of UCB's new specific dual antibody Bimekizumab (selectively inhibit IL17A and IL17F) has attracted much attention
.
IL17A has been proven to play a key role in the pathogenesis of plaque psoriasis, psoriatic arthritis and ankylosing spondylitis.

The two phase three BE VIVID and BE READY in the first phase of UCB have demonstrated the non-inferiority of bimekizumab compared to usnumab
.
Recently, UCB announced the positive results (BE SURE and BE RADIANT) comparing the efficacy and safety of Bimekizumab, adalimumab and secukinumab in patients with moderate to severe plaque psoriasis

02 Clinical results of BE READY and BE VIVID

The BE READY and BE VIVID studies were designed to evaluate the efficacy and safety of bimekizumab in adult patients with moderate to severe chronic plaque psoriasis compared to placebo and uznumab, respectively
.

The primary endpoints of the two studies were the psoriasis area and severity index (PASI index, the higher the score, the more serious the disease) improved by at least 90%, and the researcher’s overall assessment scale score dropped to 0 or 1 (IGA, 0 or 1 means that the skin lesion is completely cleared or almost cleared)
.

In early February of this year, UCB has published two three-phase positive data in "Lancet" at the same time
.
The data showed that patients who received Bimekizumab had better PASI 90 response and skin lesion clearance levels compared to patients who received placebo or Johnson & Johnson's usnumab

From these two key phase three experiments, it can be seen that the efficacy of Bimekizumab is beyond doubt.
What is more prominent is that the treatment group achieved a rapid response, and significant effects can be seen in the 4th week
.

03 Clinical results of BE SURE and BE RADIANT

On April 23, 2021, UCB announced in the New England Journal the latest results of its Phase III BE SURE and BE RADIANT clinical trials, which were compared with adalimumab and secukinumab for moderate to severe psoriasis
.

BE SURE randomly assigned patients with moderate to severe plaque psoriasis at a ratio of 1:1:1:

(1) Receive subcutaneous injection of Bimekizumab at a dose of 320 mg every 4 weeks for 56 weeks;

(2) Receive subcutaneous injection of Bimekizumab at a dose of 320 mg every 4 weeks for 16 weeks, and then once every 8 weeks for 16 to 56 weeks;

(3) Adalimumab was injected subcutaneously at a dose of 40 mg every 2 weeks for 24 weeks, followed by Bimekizumab at a dose of 320 mg every 4 weeks until the 56th week
.

The primary efficacy endpoint is consistent with BE VIVID and BE READY, measured by PASI 90 remission and IGA reduction to 0 or 1
.

       The study enrolled 478 patients with an average age of 44.
9 years and an average PASI score of 19.
8 at baseline
.
At week 16, 275 (86.

       In this 56-week trial, Bimekizumab showed superiority to adalimumab in reducing symptoms of plaque psoriasis through week 16, but it was associated with a higher frequency of oral candidiasis and diarrhea.

.
In order to compare with other therapeutic drugs, the efficacy and safety of Bimekizumab in plaque psoriasis need to be verified by longer-term and large-scale trials

       BE RADIENT is a head-to-head comparison, and randomly assigns patients with moderate to severe plaque psoriasis at a ratio of 1:1:

       (1) Receive 320 mg of bimekizumab every 4 weeks for 16 weeks;

       (2) Receive 320 mg of secukinumab every week for 4 weeks, and then once every 4 weeks until 48 weeks;

       By the 16th week, patients receiving bimekizumab were divided into 1:2 maintenance treatment every 4 weeks or every 8 weeks
.

       Similarly, Bimekizumab showed superiority in efficacy evaluation, but the incidence of oral Candida was significantly higher than that of secukinumab (19.
3% vs 3.
0%)
.

       04 Bimekizumab expected progress

       Based on the four Phase 3 results, Bimekizumab has been proven to be superior to Uselumumab, Adalimumab, and Sekkizumab
.

       On April 23, 2021, UCB’s official website announced that it will publish 11 electronic abstracts at the American Academy of Dermatology Virtual Conference Experience 2021 (AAD VMX) from April 23 to 25, including three phase 3 (BE VIVID, BE The summary results of READY and BE SURE), as well as the evaluation of the efficacy of patients undergoing adalimia conversion therapy in BE SURE, and the evaluation of the quality of life of each group
.
In addition, the Phase 3b BE RADIANT trial will be reported orally to evaluate the efficacy and safety of bimekizumab in the treatment of moderate to severe plaque psoriasis compared with secukinumab

       At the end of 2020, the FDA and EMA also announced that they have accepted the application for the approval of the biological agent and the application for marketing authorization of Bimekizumab for the treatment of moderate to severe plaque psoriasis.

       With its excellent three-phase performance, Bimekizumab will surely divide the psoriasis market share, but its time to enter the market is lagging behind other drugs.

       Reference materials:

       https://       https://       https://       https://       https://       https:// Moderate-to-Severe-Plaque-Psoriasis

       https:// Psoriasis