Bimekizumab treatment in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors: 52-week safety and efficacy from the phase III BE COMPLETE study and its open-label extension BE VITAL

Abstract

Objectives: To assess 52-week safety and efficacy of bimekizumab in patients with active psoriatic arthritis (PsA) and prior inadequate response/intolerance to tumour necrosis factor inhibitors.

Methods: Patients completing the 16-week phase III double-blind, placebo-controlled BE COMPLETE (NCT03896581) study entered the open-label extension, BE VITAL (NCT04009499). All patients in BE VITAL received 160 mg bimekizumab every 4 weeks. Safety and efficacy are reported to week 52.

Results: A total of 347/400 (86.8%) patients completed week 52. To week 52, the exposure-adjusted incidence rate/100 patient-years for ≥1 treatment-emergent adverse event (TEAE) was 126.0, and was 7.0 for serious TEAEs. The most frequent TEAEs were SARS-CoV-2 (COVID-19), oral candidiasis, nasopharyngitis and urinary tract infection. All fungal infections were mild or moderate in severity and localised; two patients discontinued the study due to oral candidiasis. No cases of active tuberculosis, uveitis or inflammatory bowel disease were reported. One sudden death occurred. Sustained efficacy was observed with bimekizumab from week 16 to ‍52 across clinical and patient-reported outcomes. At week 52, 51.7% bimekizumab-randomised and 40.6% placebo/bimekizumab patients (receiving bimekizumab from week 16 to 52) had ≥50% improvement in the American College of Rheumatology criteria. Complete skin clearance (Psoriasis Area and Severity Index 100) was achieved by 65.9% bimekizumab and 60.2% placebo/bimekizumab patients at week 52. Minimal disease activity was achieved by 47.2% bimekizumab and 33.1% placebo/bimekizumab patients at week 52.

Conclusions: Bimekizumab demonstrated a safety profile consistent with previous reports; no new safety signals were identified. Sustained efficacy was observed from week 16 to 52.

Keywords: arthritis, psoriatic; biological therapy; tumor necrosis factor inhibitors.

Figure 1

Patient disposition. *Patients who withdrew from the study treatment or deviated from assigned randomised treatment but returned for all scheduled visits up to and including week 52. †Two patients classified as ongoing as they did not have a visit for week 52 but no formal discontinuation reason was reported. BKZ, bimekizumab; OLE, open-label extension; Q4W, every 4 weeks.

Figure 2

ACR Responders to Week 52. Randomised set. For binary variables, p values were calculated using a logistic regression model with treatment, prior TNFi exposure, and region as stratification factors. ACR: American College of Rheumatology; BKZ: bimekizumab; NRI: non-responder imputation; OC: observed case; Q4W: every 4 weeks; TNFi: tumour necrosis factor inhibitor.

Figure 3

PASI responders to week 52. Randomised set, in patients with psoriasis affecting ≥3% BSA at baseline. For binary variables, p values were calculated using a logistic regression model with treatment, prior TNFi exposure and region as stratification factors. BKZ, bimekizumab; BSA, body surface area; NRI, non-responder imputation; OC, observed case; PASI, Psoriasis Area and Severity Index; Q4W, every 4 weeks; TNFi, tumour necrosis factor inhibitor.

Figure 4

Additional efficacy outcomes to week 52. Randomised set.*In patients with psoriasis affecting ≥3% BSA at baseline, PBO n=88; BKZ n=176. For binary variables, p values were calculated using a logistic regression model with treatment, prior TNFi exposure and region as stratification factors. ACR, American College of Rheumatology; BKZ, bimekizumab; BSA, body surface area; MDA, minimal disease activity; NRI, non-responder imputation; OC, observed case; PASI, Psoriasis Area and Severity Index; PBO, Placebo; Q4W, every 4 weeks; TNFi, tumour necrosis factor inhibitor; VLDA, very low disease activity.