Bimekizumab Is a Safe and Effective Treatment for Active Psoriatic Arthritis

The randomized, double-blind BE ACTIVE trial compared bimekizumab versus placebo in patients with active psoriatic arthritis. According to the findings, bimekizumab was associated with significantly improved outcomes and an acceptable safety profile.

“Dual neutralisation of interleukin 17A (IL17A) and interleukin 17F (IL17F) is a potential novel therapeutic approach in psoriatic arthritis. We assessed bimekizumab, a monoclonal antibody that selectively neutralises IL17A and IL17F, in patients with active psoriatic arthritis,” the study authors wrote.

The phase 2B study spanned 41 sites across six countries (Czech Republic, Germany, Hungary, Poland, Russia, and the U.S.). Patients aged 18 years or older with active adult-onset psoriatic arthritis with at least six months of symptoms were randomized to placebo, 16 mg bimekizumab, 160 mg bimekizumab, 160 mg bimekizumab with a one-off 320 mg loading dose, or 320 mg bimekizumab. Interventions were performed every four weeks for 12 weeks, at which time placebo and low-dose bimekizumab patients were randomized again to either 160 mg or 320 mg bimekizumab (the rest of the cohort continued its original course of treatment) for up to 48 weeks. Eligibility screening took place between Oct. 27, 2016, and July 16, 2018. Patients and researchers were both blinded to the intervention and dose during the initial 12 weeks as well as the subsequent period after re-randomization. The main outcome measure was the proportion of patients with at least 50% improvement in the American College of Rheumatology response criteria (ACR50) at week 12.

Bimekizumab Outperforms Placebo at all Doses

Final analysis included 206 randomized patients; 42 patients were assigned to placebo, and each active treatment group had 41 patients. Compared to the placebo group, the intervention groups had significantly better ACR50 response outcomes at week 12: 16 mg (odds ratio [OR]=4.2; 95% confidence interval [CI], 1.1–15.2; P=0.032), 160 mg (OR=8.1; 95% CI, 2.3–28.7; P=0.0012), and 160 mg (loading dose) (OR=9.7; 95% CI, 2.7–34.4; P=0.0004). Treatment-emergent adverse events (AEs) at the 12-week mark presented in 57% of placebo patients (n= 24) and 41% of patients in all of the bimekizumab groups (n = 68); most of the AEs were mild or moderate. Eight of the nine patients who sustained serious treatment-emergent AEs were in one of the bimekizumab groups. There were no recorded cases of death or inflammatory bowel disease.

The study was published in The Lancet.

“Bimekizumab doses of 16 mg and 160 mg (with or without a 320 mg loading dose) were associated with significant improvements in ACR50 compared with placebo, with an acceptable safety profile. Our results support phase 3 investigation of bimekizumab as a treatment for psoriatic arthritis,” concluded the researchers.