Results from two phase 3 clinical trials demonstrate bimekizumab as a safe, effective therapy with long-term durability for the treatment of moderate to severe plaque psoriasis. The results were selected as two separate late-breaking research abstracts at the American Academy of Dermatology Virtual Meeting Experience (AAD VMX) 2020. Biopharmaceutical company UCB shared the trial results in a Saturday morning webinar before day two of AAD VMX 2020.1
The first trial, BE VIVID (NCT03370132), was a 52-week phase 3, randomized, double-blinded, controlled superiority study comparing bimekizumab to ustekinumab (Stelara) and placebo.2 In the study, 567 patients with moderate to severe psoriasis were randomized 4:2:1 to receive either bimekizumab 320 mg once every four weeks (Q4W), ustekinumab 45 mg or 90 mg weight-based dose at baseline and week 4 then subsequently once every 12 weeks, or placebo Q4W followed by bimekizumab 320 mg Q4W. Co-primary endpoints included Psoriasis Area and Severity Index (PASI) 90 and Investigator's Global Assessment (IGA) 0/1 vs placebo at week 16. Other outcomes measured were PASI 100 at week 16; PASI 90, PASI 100, and IGA 0/1 at week 52; and safety data.
After 16 weeks of treatment, 85.0% and 84.1% of the bimekizumab group achieved PASI 90 and IGA 0/1, respectively, compared with 49.7% and 53.4% of patients receiving ustekinumab and 4.8% and 4.8% of patients receiving placebo. Of the patients, 58.6% who received bimekizumab achieved PASI 100 at week 16 vs only 20.9% with ustekinumab. Further, at week 52, the bimekizumab-treated patients achieved PASI 90, PASI 100, and IGA 0/1 rates of 81.6%, 64.2%, and 77.9%, respectively. By comparison, the ustekinumab group achieved the same scale rates of 55.8%, 38.0%, and 60.7%, respectively. BE VIVID demonstrated a similar bimekizumab safety profile as ustekinumab; over 52 weeks, incidence of serious treatment-emergent adverse events (TEAE) was 6.1% for bimekizumab vs 7.4% for ustekinumab.
In addition, bimekizumab showed great long-term durability in BE READY (NCT03410992), a 56-week phase 3, randomized, double-blinded, placebo-controlled study with randomized withdrawal.3 The trial randomized 435 patients with moderate to severe psoriasis 4:1 to receive either bimekizumab 320 mg Q4W or placebo. At week 16, patients who achieved PASI 90 were re-randomized 1:1:1 to bimekizumab 320 mg Q8W (n=100) or Q4W (n=106) or placebo (n=105) through week 56. Relapse was defined as less than PASI 75 from week 20. The study primary endpoints were PASI 90 and IGA 0/1 at week 16, and secondary endpoints were PASI 100 at week 16; PASI 90, PASI 100, and IGA 0/1 at week 56; and safety data.
The results of BE READY showed more patients achieved PASI 90 (90.8%), PASI 100 (68.2%), and IGA 0/1 (92.6%) with bimekizumab at week 16 vs placebo (1.2%, 1.2%, and 1.2%, respectively). Additionally, at week 56, PASI 90 and IGA 0/1 was maintained in both bimekizumab arms, including 91.0% and 90.0% for Q8W and 86.8% and 86.8% for Q4W, respectively.
At week 56, PASI 100 was 83.0% for the Q8W arm and 70.8% for the Q4W arm. Notably, at week 56, PASI 90 was reduced in 16.2% of patients who were re-randomized to placebo. Median time to relapse for this group was approximately 28 weeks.
“We are very excited to share the results of BE VIVID and BE READY today,” said Dr Iris Loew-Friedrich, chief medical officer of UCB, at the June 13 virtual presentation. “We are confident that a therapy that achieves rapid and complete resolution of psoriatic inflammation, along with a durable response and delivered through a more convenient dosing schedule, could transform the experience of patients living with psoriasis.”
1. Loew-Friedrich I, Reich K, Gordon K. UCB virtual press briefing. June 13, 2020. [No URL available]
2. Reich K, Papp KA, Blauvelt A, et al. Efficacy and safety of bimekizumab in patients with moderate-to-severe plaque psoriasis: results from BE VIVID, a 52-week phase 3, randomized, doubleb-linded, ustekinumab- and placebo-controlled study. Presented at: American Academy of Dermatology Virtual Meeting Experience 2020; June 12-14, 2020.
3. Gordon K, Foley P, Krueger J, et al. Efficacy and safety of bimekizumab in patients with moderate-to-severe plaque psoriasis: results from BE READY, a 56-week Phase 3, randomized, double-blinded, placebo-controlled study with randomized withdrawal. Presented at: American Academy of Dermatology Virtual Meeting Experience 2020; June 12-14, 2020.