title: Long-Term Maintenance of Certolizumab Pegol Safety and Efficacy, in Combination with Methotrexate and as Monotherapy, in Rheumatoid Arthritis Patients.
abstract: BACKGROUND
  The safety and efficacy of certolizumab pegol (CZP) 400 mg every 4 weeks (Q4W) monotherapy (FAST4WARD/NCT00548834) and in combination with methotrexate (MTX) (014/NCT00544154) in active rheumatoid arthritis (RA) has been published previously. This report outlines final long-term outcomes from the open-label extension (OLE) study (015/NCT00160693), which enrolled patients from these randomized controlled trials (RCTs).
  
  
  METHODS
  Patients who withdrew from or completed the 24-week 014/FAST4WARD RCTs were enrolled and received CZP 400 mg Q4W with/without MTX. Exposure-adjusted event rates (ER) per 100 patient-years (PYs) of adverse events (AEs) and serious AEs (SAEs) were reported for all patients receiving ≥1 dose of CZP in RCTs or OLE (N = 427) between first CZP dose and up to 24 weeks after last CZP dose or study withdrawal. Efficacy assessments included clinical (ACR20/50/70 response rates, TJC, SJC) and patient-reported outcomes (HAQ-DI, PtGADA, pain, fatigue) to week 304 (5.8 years) in the CZP intent-to-treat population. SDAI and CDAI outcomes were analyzed post hoc. Outcomes for CZP monotherapy and CZP+MTX combination-therapy were compared.
  
  
  RESULTS
  Globally, ERs of AEs and SAEs were 408.1 and 25.2 per 100 PY, respectively. Eleven patients had AEs leading to death (ER 0.6). Improvements in clinical and patient-reported outcomes during the 24-week RCTs were maintained to week 304, and were similar between all subpopulations.
  
  
  CONCLUSIONS
  The longest exposure duration to date with CZP 400 mg Q4W treatment confirmed the safety profile observed in previous studies. Initial improvements in signs and symptoms of RA, including PROs, were maintained in both CZP monotherapy and CZP + MTX combination-therapy patients.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier, NCT00160693.
  
  
  BACKGROUND
  UCB Pharma.
authors.affiliation: Metroplex Clinical Research Center, University of Texas SW Medical Center, Dallas, USA. rfleischmann@arthdocs.com.
authors.forename: Roy
authors.initials: R
authors.lastname: Fleischmann
authors.affiliation: Karolinska Institute, Stockholm, Sweden.
authors.forename: Ronald F
authors.initials: RF
authors.lastname: van Vollenhoven
authors.affiliation: Institute of Rheumatology, Charles University in Prague, Prague, Czech Republic.
authors.forename: Jiri
authors.initials: J
authors.lastname: Vencovský
authors.affiliation: Schlosspark-Klinik, Charité University Medicine Berlin, Berlin, Germany.
authors.forename: Rieke
authors.initials: R
authors.lastname: Alten
authors.affiliation: UCB Pharma, Slough, UK.
authors.forename: Owen
authors.initials: O
authors.lastname: Davies
authors.affiliation: UCB Pharma, Brussels, Belgium.
authors.forename: Irina
authors.initials: I
authors.lastname: Mountian
authors.affiliation: UCB Pharma, Brussels, Belgium.
authors.forename: Marc
authors.initials: M
authors.lastname: de Longueville
authors.affiliation: UCB Pharma, Brussels, Belgium.
authors.forename: David
authors.initials: D
authors.lastname: Carter
authors.affiliation: Institute of Infection and Immunity, Cardiff University, Cardiff, UK.
authors.forename: Ernest
authors.initials: E
authors.lastname: Choy
keywords: Certolizumab pegol; Monotherapy; Open-label extension; Rheumatoid arthritis