PMID- 28353191
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220331
IS  - 2198-6576 (Print)
IS  - 2198-6584 (Electronic)
IS  - 2198-6576 (Linking)
VI  - 4
IP  - 1
DP  - 2017 Jun
TI  - Long-Term Maintenance of Certolizumab Pegol Safety and Efficacy, in Combination 
      with Methotrexate and as Monotherapy, in Rheumatoid Arthritis Patients.
PG  - 57-69
LID - 10.1007/s40744-017-0060-8 [doi]
AB  - INTRODUCTION: 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. TRIAL REGISTRATION: ClinicalTrials.gov identifier, 
      NCT00160693. FUNDING: UCB Pharma.
FAU - Fleischmann, Roy
AU  - Fleischmann R
AD  - Metroplex Clinical Research Center, University of Texas SW Medical Center, 
      Dallas, USA. rfleischmann@arthdocs.com.
FAU - van Vollenhoven, Ronald F
AU  - van Vollenhoven RF
AD  - Karolinska Institute, Stockholm, Sweden.
FAU - Vencovsky, Jiri
AU  - Vencovsky J
AD  - Institute of Rheumatology, Charles University in Prague, Prague, Czech Republic.
FAU - Alten, Rieke
AU  - Alten R
AD  - Schlosspark-Klinik, Charite University Medicine Berlin, Berlin, Germany.
FAU - Davies, Owen
AU  - Davies O
AD  - UCB Pharma, Slough, UK.
FAU - Mountian, Irina
AU  - Mountian I
AD  - UCB Pharma, Brussels, Belgium.
FAU - de Longueville, Marc
AU  - de Longueville M
AD  - UCB Pharma, Brussels, Belgium.
FAU - Carter, David
AU  - Carter D
AD  - UCB Pharma, Brussels, Belgium.
FAU - Choy, Ernest
AU  - Choy E
AD  - Institute of Infection and Immunity, Cardiff University, Cardiff, UK.
LA  - eng
SI  - ClinicalTrials.gov/NCT00160693
PT  - Journal Article
DEP - 20170328
PL  - England
TA  - Rheumatol Ther
JT  - Rheumatology and therapy
JID - 101674543
PMC - PMC5443729
OTO - NOTNLM
OT  - Certolizumab pegol
OT  - Monotherapy
OT  - Open-label extension
OT  - Rheumatoid arthritis
EDAT- 2017/03/30 06:00
MHDA- 2017/03/30 06:01
PMCR- 2017/03/28
CRDT- 2017/03/30 06:00
PHST- 2017/01/23 00:00 [received]
PHST- 2017/03/30 06:00 [pubmed]
PHST- 2017/03/30 06:01 [medline]
PHST- 2017/03/30 06:00 [entrez]
PHST- 2017/03/28 00:00 [pmc-release]
AID - 10.1007/s40744-017-0060-8 [pii]
AID - 60 [pii]
AID - 10.1007/s40744-017-0060-8 [doi]
PST - ppublish
SO  - Rheumatol Ther. 2017 Jun;4(1):57-69. doi: 10.1007/s40744-017-0060-8. Epub 2017 
      Mar 28.