Bimekizumab efficacy and safety in Chinese patients with psoriasis in the BE SHINING Phase 3 study.

BACKGROUND

Bimekizumab was well tolerated and demonstrated superior efficacy in global psoriasis studies; however, these included few Chinese patients.

OBJECTIVES

To evaluate the efficacy and safety of bimekizumab in Chinese patients with moderate to severe plaque psoriasis.

METHODS

In BE SHINING, patients were randomized 3:1 to bimekizumab 320 mg every 4 weeks (Q4W) to Week 16 then every 8 weeks (Q8W) to Week 32, or to placebo Q4W to Week 16 then bimekizumab Q4W to Week 32. Primary endpoints included achievement of ≥90% improvement from baseline in the Psoriasis Area and Severity Index (PASI 90) and Investigator's Global Assessment (IGA) of 0/1 at Week 16. Secondary endpoints included PASI 75/PASI 100 response rates at Week 4/16, respectively. Missing data were imputed as non-response; p values were based on the Cochran-Mantel-Haenszel test. Safety outcomes were assessed in patients who received ≥1 treatment dose (Weeks 0-32).

RESULTS

Overall, 133 patients were randomized (bimekizumab Q4W/Q8W: N = 100; placebo/bimekizumab Q4W: N = 33). Bimekizumab-treated patients had significantly higher primary endpoint response rates versus placebo (Week 16; PASI 90: 94.0% vs. 3.0%; IGA 0/1: 92.0% vs. 3.0%; p < 0.001 for both), and significantly higher rates of PASI 75 (Week 4; 74.0% vs. 3.0%; p < 0.001) and PASI 100 (Week 16; 65.0% vs. 0.0%; p < 0.001). Response rates were similar in bimekizumab Q4W/Q8W and placebo/bimekizumab Q4W patients at Week 32. Through Week 32, in patients who received ≥1 bimekizumab dose, rates of treatment-emergent adverse events (TEAEs), serious TEAEs and TEAEs leading to discontinuation were 73.8%, 6.2% and 5.4%. The most common TEAEs were upper respiratory tract infection, hepatic function abnormal and injection site pain; no new safety signals were identified.

CONCLUSIONS

Bimekizumab treatment was well tolerated and led to significantly higher clinical response rates versus placebo, including complete skin clearance, in Chinese patients with moderate to severe psoriasis. Findings were consistent with global studies.