Bimekizumab in patients with psoriatic arthritis with prior inadequate response to tnf inhibitors: improvements of psarc over 16 weeks in the phase 3 be complete trial

Abstract Background/Aims Bimekizumab (BKZ) is a humanised monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A and has demonstrated clinical effectiveness in both joint and skin outcomes in patients with active psoriatic arthritis (PsA). Psoriatic Arthritis Response Criteria (PsARC) is used routinely for drug reimbursement in clinical practice in the UK. We report PsARC response rates along with HRQoL estimates at week (wk) 16 in TNF inadequate responder (TNFi-IR) patients with active PsA from the phase 3, 16-wk BE COMPLETE trial (NCT03896581). Methods BE COMPLETE is a randomised, multicentre, double-blind, placebo (PBO)-controlled, parallel group study. Patients who had an inadequate response or intolerance to treatment with 1 or 2 TNFis were randomised (2:1) to BKZ 160 mg every 4 wks (Q4W) or PBO for 16 wk. We report response rates for PsARC at wk 16, and the association of PsARC responders with HRQoL-related outcomes for the randomised set. Data are reported as non-responder imputation (NRI) and observed cases. Results 400 patients were randomised at baseline (BKZ: 267; PBO: 133). Baseline characteristics were comparable between groups (mean age: 50.5 yrs; BMI: 29.8 kg/m2; disease duration: 9.5 yrs and 47.5% were male). At wk 16, PsARC response (NRI) was achieved by 85.4% with BKZ and 30.8% with PBO (Table). Numerically greater improvements in physical functioning and fatigue measure were achieved from baseline among PsARC responders compared to non-responders (Table). Over 16 wks, safety was in line with previous BKZ studies and no new safety signals were observed. Conclusion In patients with prior TNFi-IR with active PsA, BKZ treatment demonstrated a greater improvement in musculoskeletal symptoms at wk 16 compared to PBO. Patients with PsARC response had numerically greater improvements in HRQoL and improvements in fatigue measures. No new safety signals were observed. Disclosure P. Sharma: Other; PS has received conference sponsorship Amgen 2015 for National Osteoporosis Conference; Janssen Advisory Board board Nov 22. D.R. Jadon: Other; DRJ received research/education grants/honoraria: AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Fresenius Kabi, Gilead, GSK, Healthcare Celltrion, Janssen, Merck, Novartis, Pfizer, Roche, Sandoz and UCB. D. McGonagle: Grants/research support; DM has received research grants/research support from AbbVie, Celgene, Janssen, Merck, and Pfizer. Other; DM has recevied honoraria or consultation fees and has been paid as a speaker for AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer, and UCB Pharma. B. Ink: Shareholder/stock ownership; BI is a shareholder of AbbVie, GlaxoSmithKline and UCB Pharma. D. Assudani: Shareholder/stock ownership; Employee and shareholder of UCB Pharma. V. Taieb: Other; VT is employee of UCB Pharma. L.C. Coates: Consultancies; LCC has worked as a paid consultant for AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Gilead, Galapagos, Janssen, Moonlake, Novartis, Pfizer and UCB Pharma. Member of speakers’ bureau; LCC has been paid as a speaker for AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Medac, Novartis, Pfizer and UCB Pharma. Grants/research support; LCC has received grants/research support from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma.