PMID- 23918037
OWN - NLM
STAT- MEDLINE
DCOM- 20141230
LR  - 20220408
IS  - 1468-2060 (Electronic)
IS  - 0003-4967 (Print)
IS  - 0003-4967 (Linking)
VI  - 73
IP  - 12
DP  - 2014 Dec
TI  - Long-term safety and efficacy of certolizumab pegol in combination with 
      methotrexate in the treatment of rheumatoid arthritis: 5-year results from the 
      RAPID 1 trial and open-label extension.
PG  - 2094-100
LID - 10.1136/annrheumdis-2013-203695 [doi]
AB  - OBJECTIVES: To examine the safety and efficacy of 5-year administration of 
      certolizumab pegol (CZP)+methotrexate (MTX) in patients with active rheumatoid 
      arthritis (RA). METHODS: Eligible patients from the Rheumatoid Arthritis 
      Prevention of Structural Damage (RAPID)1 randomised controlled trial (RCT) were 
      treated in open-label extension (OLE) with CZP 400 mg every other week (Q2W), 
      reduced to 200 mg Q2W after >/=6 months, +MTX. Combined safety data from RCT and 
      OLE are presented from initiation of CZP treatment to 12 wks post last visit in 
      patients receiving >/=1 dose of CZP (Safety population, N=958). Efficacy data are 
      presented to start of first site closure (wk 256 of CZP treatment: 52 wks in 
      RCT+204 wks in OLE) for all patients randomised to receive CZP (intent-to-treat 
      (ITT) population, N=783) and CZP patients who completed the 52 wk RCT and 
      enrolled into OLE (wk 52 CZP completers, N=508). Disease Activity Score (DAS)28 
      (Erythrocyte Sedimentation Rate (ESR)), American College of Rheumatology Criteria 
      (ACR) 20/50/70, Health Assessment Questionnaire - Disability Index (HAQ-DI), and 
      patient retention (Kaplan-Meier analysis) were assessed. RESULTS: Overall event 
      rate per 100 patient-years (ER) of adverse events (AEs) was 290.4, most 
      frequently: urinary tract infections (ER=7.9), nasopharyngitis (ER=7.3) and upper 
      respiratory tract infections (ER=7.3). ER of serious AEs was 20.3 
      (infections=5.9, malignancies=1.2). 21 patients (2.2%) experienced an AE 
      resulting in death (incidence rate=0.6). At wk 256 of treatment, 55.3% of the CZP 
      ITT population were estimated to remain on treatment (68.7% if solely withdrawals 
      due to AE or lack of efficacy were considered). In wk 52 CZP completers and CZP 
      ITT population, DAS28 (ESR) remission rates and improvements from baseline were 
      sustained to wk 256. CONCLUSIONS: CZP+MTX treatment provided a favourable 
      risk-benefit profile over 5 years in patients with active RA. No new safety 
      signals were identified.
CI  - Published by the BMJ Publishing Group Limited. For permission to use (where not 
      already granted under a licence) please go to 
      http://group.bmj.com/group/rights-licensing/permissions.
FAU - Keystone, Edward
AU  - Keystone E
AD  - University of Toronto, Toronto, Canada.
FAU - Landewe, Robert
AU  - Landewe R
AD  - Academic Medical Center Amsterdam & Atrium Medical Center, Heerlen, The 
      Netherlands.
FAU - van Vollenhoven, Ronald
AU  - van Vollenhoven R
AD  - Karolinska Institute, Stockholm, Sweden.
FAU - Combe, Bernard
AU  - Combe B
AD  - Montpellier University Hospital, Montpellier, France.
FAU - Strand, Vibeke
AU  - Strand V
AD  - Stanford University, Palo Alto, California, USA.
FAU - Mease, Philip
AU  - Mease P
AD  - Swedish Medical Center and University of Washington, Seattle, Washington, USA.
FAU - Shaughnessy, Laura
AU  - Shaughnessy L
AD  - UCB Pharma, Raleigh, North Carolina, USA.
FAU - VanLunen, Brenda
AU  - VanLunen B
AD  - UCB Pharma, Raleigh, North Carolina, USA.
FAU - van der Heijde, Desiree
AU  - van der Heijde D
AD  - Leiden University Medical Center, Leiden, The Netherlands.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130805
PL  - England
TA  - Ann Rheum Dis
JT  - Annals of the rheumatic diseases
JID - 0372355
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Immunoglobulin Fab Fragments)
RN  - 0 (Immunosuppressive Agents)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
RN  - UMD07X179E (Certolizumab Pegol)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal, Humanized/*therapeutic use
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Certolizumab Pegol
MH  - Cohort Studies
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Immunocompromised Host/immunology
MH  - Immunoglobulin Fab Fragments/*therapeutic use
MH  - Immunosuppressive Agents/*therapeutic use
MH  - Longitudinal Studies
MH  - Male
MH  - Methotrexate/*therapeutic use
MH  - Middle Aged
MH  - Pharyngitis/immunology
MH  - Polyethylene Glycols/*therapeutic use
MH  - Respiratory Tract Infections/immunology
MH  - Treatment Outcome
MH  - Urinary Tract Infections/immunology
PMC - PMC4251202
OTO - NOTNLM
OT  - Anti-TNF
OT  - DMARDs (biologic)
OT  - Rheumatoid Arthritis
EDAT- 2013/08/07 06:00
MHDA- 2014/12/31 06:00
CRDT- 2013/08/07 06:00
PHST- 2013/08/07 06:00 [entrez]
PHST- 2013/08/07 06:00 [pubmed]
PHST- 2014/12/31 06:00 [medline]
AID - annrheumdis-2013-203695 [pii]
AID - 10.1136/annrheumdis-2013-203695 [doi]
PST - ppublish
SO  - Ann Rheum Dis. 2014 Dec;73(12):2094-100. doi: 10.1136/annrheumdis-2013-203695. 
      Epub 2013 Aug 5.