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Clinical and quality of life improvements with golimumab or infliximab in a real-life ankylosing spondylitis population: the QUO-VADIS study

1, 2, 3, 4, 5, 6

  1. Ghent University Hospital, Belgium and VIB Center for Inflammation Research, Ghent, Belgium.
  2. University Hospital of Lille, France.
  3. Rheumazentrum Ruhrgebiet, Herne; and Ruhr-Universität Bochum, Germany.
  4. MSD Belgium, Brussels, Belgium.
  5. Merck & Co., Inc., Kenilworth, NJ, USA.
  6. MSD Italy, Rome, Italy. marinella.govoni@merck.com

CER11207 Submission on line
2019 Vol.37, N°2 - PI 0199, PF 0207
Full Papers

Rheumatology Article

 

Abstract

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-naïve 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.

PMID: 30148434 [PubMed]

Received: 26/02/2018 - Accepted : 07/05/2018 - In Press: 19/07/2018 - Published: 19/03/2019