New three-year BIMZELX®▼ (bimekizumab) data reinforce long-term maintenance of complete skin clearance in moderate to severe plaque psoriasis

Bimekizumab is the first selective IL-17A and IL-17F inhibitor to be approved in the European Union for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. (3)

Data presented from the BE BRIGHT OLE study showed that over eight out of 10 patients who achieved complete skin clearance (PASI 100) following 16 weeks of bimekizumab treatment maintained PASI 100 response and health-related quality of life outcomes through to three years with continuous maintenance dosing.* In addition, approximately nine out of 10 patients who achieved absolute PASI (PASI ≤2) at week 16 maintained this response through to three years. (1) Pooled data from up to three years of treatment in Phase 2 and 3 clinical trials showed that bimekizumab was generally well-tolerated over this period with no safety signals identified. (2)

“These positive results highlight the deep and long-lasting skin clearance achieved with bimekizumab, along with a consistent safety and tolerability profile, and reinforce the positive relationship clearing skin has on patients’ quality of life. These new data add to the growing body of evidence supporting longer-term use of bimekizumab in moderate to severe plaque psoriasis,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB. 

“The findings presented today show that bimekizumab provided maintenance of completely clear skin and health-related quality of life outcomes in the majority of patients with moderate to severe plaque psoriasis over a three-year period,” said Dr Bruce Strober, Clinical Professor of Dermatology at Yale University, Connecticut, U.S. “The goal of psoriasis treatment often is complete clearance of skin symptoms and the availability of long-term data across treatment options is important since it supports healthcare providers and patients to be more informed when making treatment decisions.”

Three-year data from the BE BRIGHT OLE study

All patients who had completed one of the pivotal Phase 3 studies (BE SURE, BE VIVID and BE READY) were eligible to enter the BE BRIGHT OLE study. (1) On OLE entry, patients were assigned to bimekizumab 320 mg every four weeks (Q4W) or every eight weeks (Q8W) based on PASI 90 response at the end of the respective Phase 3 study.

In all bimekizumab-randomized patients:1¥

• Among week 16 PASI 100 responders (N=503), 89.3 percent achieved PASI 100 at year one (week 52) and 82.0 percent at year three (OLE week 96)

• Among week 16 PASI ≤2 responders (N=694), 96.5 percent achieved PASI ≤2 at year one (week 52) and 94.2 percent at year three (OLE week 96)

• Among week 16 PASI 100 responders in BE SURE and BE READY only (N=330), 92.0 percent achieved the Dermatology Life Quality Index (DLQI) 0/1 at year one (week 56), and 88.0 percent at year three (OLE week 96)

In bimekizumab-randomized patients (320 mg Q4W for 16 weeks, and then every eight weeks [Q8W] through three years, BE SURE and BE READY only):1¥

• Among week 16 PASI 100 responders (N=147), 93.6 percent achieved PASI 100 at year one (week 52) and 84.4 percent at year three (OLE week 96)

• Among week 16 PASI ≤2 responders (N=189), 98.9 percent achieved PASI ≤2 at year one (week 52) and 96.8 percent at year three (OLE week 96)

• Among week 16 PASI 100 responders (N=147), 95.8 percent achieved DLQI 0/1 at year one (week 56) and 92.5 percent at year three (OLE week 96)

Pooled safety data from up to three years of treatment in Phase 2 and 3 clinical trials

Total bimekizumab exposure was 4245.3 patient-years (PY; N=1789) across the Phase 2 and 3 trials, and 3876.4 PY (N=1495; Q4W: 1965.6 PY; Q8W: 1914.5 PY) in the Phase 3 trials. (2) Treatment emergent adverse events (TEAEs) occurred at an exposure-adjusted incidence rate (EAIR) of 186.1 per 100 PY, serious TEAEs were seen at an EAIR of 5.6 new cases per 100 PY and TEAEs leading to discontinuation at 3.5 new cases per 100 PY. (2) 

The most common TEAEs in the Phase 2 and 3 trials with bimekizumab were nasopharyngitis, oral candidiasis and upper respiratory tract infection at EAIRs of 15.3, 10.2 and 7.1 new cases per 100 PY, respectively. (2) The EAIR for oral candidiasis showed a decrease compared with two years of bimekizumab treatment (10.2 versus 12.6 new cases per 100 PY) and was lower with bimekizumab dosed Q8W compared with Q4W (7.1 and 15.9 per 100 PY, respectively). (2)  The vast majority of oral candidiasis events were mild to moderate (99.4 percent) and none were serious. (2) Serious infections occurred at a rate of 1.2/100 PY. The most frequently reported were serious coronavirus infections (0.2 per 100 PY). (2) 

*The recommended bimekizumab dose for adult patients with plaque psoriasis is 320 mg (given as two subcutaneous injections of 160 mg) at week 0, 4, 8, 12, 16 and every eight weeks thereafter.3 For some patients with a body weight≥120 kg who did not achieve complete skin clearance at week 16, 320 mg every 4 weeks after week 16 may further improve treatment response.3 In the studies reported at EADV 2022, patients received maintenance dosing of bimekizumab 320 mg Q4W or Q8W.

¥ Modified non-responder imputation analyses

References

(1) Strober B, Tada Y, Mrowietz U et al. Bimekizumab maintenance of response through three years in patients with moderate to severe plaque psoriasis who responded at Week 16: Results from the BE BRIGHT open-label extension trial. Abstract presented at the 31st EADV Congress.

(2) Gordon KB, Langley RG, Warren RB et al. Bimekizumab safety in patients with moderate to severe plaque psoriasis: Analysis of pooled data from up to three years of treatment in phase 2 and 3 clinical trials. Abstract presented at the 31st EADV Congress.

(3) BIMZELX (bimekizumab) EU Summary of Product Characteristics, March 2022. Available at: https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf Last accessed: August 2022.