Bimekizumab Reinitiation Following Treatment Interruption Between Two Open‐Label Extension Periods: A North American Study in Participants With Moderate to Severe Plaque Psoriasis

People with moderate to severe plaque psoriasis receiving long‐term biologic treatment may experience interruptions. It is important to assess response maintenance during interruptions and response recapture upon reinitiation. The BE RADIANT open‐label extension (OLE) and BE BRIGHT OLE studies investigated bimekizumab efficacy and safety up to 3 and 4 years, respectively (including feeder studies). Some US/Canadian participants completing the OLEs (with any feeder study treatment) experienced bimekizumab treatment interruption before entering a second OLE (OLE2; 48 weeks). We report efficacy and safety upon bimekizumab reinitiation following this real‐world interruption. Analyzed participants received bimekizumab every 8 weeks (Q8W) for at least the final 80 weeks of the first OLE. After interruption, those with Investigator’s Global Assessment (IGA) ≤ 2 at OLE2 baseline received bimekizumab Q8W; those with IGA ≥ 3 received bimekizumab Q4W to Week 16, and then Q8W. Psoriasis Area and Severity Index (PASI), IGA, and Dermatology Life Quality Index (DLQI) scores/categories were assessed at the last preinterruption timepoint and throughout OLE2 (observed cases). Treatment‐emergent adverse events (TEAEs) are reported using exposure‐adjusted incidence rates per 100 participant‐years (PY). In total, 217 participants entered OLE2 following bimekizumab treatment interruption (median duration [range]: 5 [1–12] months). PASI = 0 was achieved by 72.0% before interruption and maintained by 19.2% at OLE2 baseline; PASI = 0 was recaptured by OLE2 Week 12 (68.4%) and sustained to OLE2 Week 48 (68.2%). IGA and DLQI responses followed similar trends. The TEAE rate during OLE2 was 84.2/100 PY (serious TEAEs: 6.0/100 PY; discontinuations due to TEAEs: 2.1/100 PY). Overall, responses were well‐maintained during treatment interruption; clinical efficacy responses were largely recaptured after 3 months of bimekizumab retreatment and maintained through 1 year with no unexpected safety findings. These results suggest that bimekizumab is suitable for people with moderate to severe plaque psoriasis undergoing treatment interruptions, in addition to those being treated continuously.

Trial Registration: ClinicalTrials.gov identifier (NCT03598790) and (NCT03536884).