PMID- 30148434
OWN - NLM
STAT- MEDLINE
DCOM- 20190516
LR  - 20190516
IS  - 0392-856X (Print)
IS  - 0392-856X (Linking)
VI  - 37
IP  - 2
DP  - 2019 Mar-Apr
TI  - Clinical and quality of life improvements with golimumab or infliximab in a 
      real-life ankylosing spondylitis population: the QUO-VADIS study.
PG  - 199-207
AB  - OBJECTIVES: The QUO VADIS study evaluated disease activity and health-related 
      quality-of-life (HRQoL) in ankylosing spondylitis (AS) patients treated with 
      golimumab (GLM) or infliximab (IFX, originator) during routine clinical care. 
      METHODS: This prospective observational study followed biologics-naive AS 
      patients newly treated with GLM or IFX for 6 months. Disease activity (BASDAI, 
      BASFI, ASAS, and ASDAS) and HRQoL improvement (>/=5 points of SF-36 Physical 
      Component Summary [PCS] score; PCS response) were measured. A Classification and 
      Regression Trees (CART) analysis evaluated association of baseline parameters 
      with PCS response at 6 months. RESULTS: 963 patients (mean age 43 years, 61% 
      male, 64% HLA-B27 positive) received >/=1 dose of medication (78% GLM; 22% IFX). 
      Disease activity was reduced; mean (SD) changes from baseline at month 6 of -2.7 
      (BASDAI) and -2.1 (BASFI) and 40% and 35% achievement of BASDAI50 and ASAS40 
      response, respectively, were observed. PCS response was achieved at month 6 in 
      52% of patients. Using CART analysis, baseline parameters (cut-off values) 
      associated with HRQoL improvement were ASDAS (>/=3.48), C-reactive protein (>/=8.55 
      mg/L), age (</=35.5 years), and BASFI (>/=1.15). This algorithm correctly identified 
      57.5% (sensitivity) of PCS responders (>/=5 points) and 61.0% (specificity) of PCS 
      non-responders (<5points) with ROC-AUC=0.61. Serious adverse events (AEs) 
      occurred in 1.8% of patients; the most common AEs were infections (7.7%). 
      CONCLUSIONS: We demonstrated clinical and HRQoL improvements over 6 months in a 
      large, real-world population of AS patients newly treated with GLM or IFX; higher 
      ASDAS, elevated CRP, and younger age were associated with improvements in HRQoL 
      and an overall more robust response.
FAU - Van den Bosch, Filip
AU  - Van den Bosch F
AD  - Ghent University Hospital, Belgium and VIB Center for Inflammation Research, 
      Ghent, Belgium.
FAU - Flipo, Rene-Marc
AU  - Flipo RM
AD  - University Hospital of Lille, France.
FAU - Braun, Jurgen
AU  - Braun J
AD  - Rheumazentrum Ruhrgebiet, Herne; and Ruhr-Universitat Bochum, Germany.
FAU - Vastesaeger, Nathan
AU  - Vastesaeger N
AD  - MSD Belgium, Brussels, Belgium.
FAU - Kachroo, Sumesh
AU  - Kachroo S
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Govoni, Marinella
AU  - Govoni M
AD  - MSD Italy, Rome, Italy. marinella.govoni@merck.com.
LA  - eng
PT  - Journal Article
DEP - 20180719
PL  - Italy
TA  - Clin Exp Rheumatol
JT  - Clinical and experimental rheumatology
JID - 8308521
RN  - 0 (Antibodies, Monoclonal)
RN  - 91X1KLU43E (golimumab)
RN  - B72HH48FLU (Infliximab)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal/*therapeutic use
MH  - Female
MH  - Humans
MH  - Infliximab/*therapeutic use
MH  - Male
MH  - Prospective Studies
MH  - *Quality of Life
MH  - Severity of Illness Index
MH  - *Spondylitis, Ankylosing/drug therapy/psychology
EDAT- 2018/08/28 06:00
MHDA- 2019/05/17 06:00
CRDT- 2018/08/28 06:00
PHST- 2018/02/26 00:00 [received]
PHST- 2018/05/07 00:00 [accepted]
PHST- 2018/08/28 06:00 [pubmed]
PHST- 2019/05/17 06:00 [medline]
PHST- 2018/08/28 06:00 [entrez]
AID - 12741 [pii]
PST - ppublish
SO  - Clin Exp Rheumatol. 2019 Mar-Apr;37(2):199-207. Epub 2018 Jul 19.