Background Loss of health-related quality of life (HRQoL) is documented in Ankylosing Spondylitis (AS) patients and improvement has been observed upon therapy with anti-tumor necrosis factor (TNF) agents. Parameters such as higher ASDAS, elevated CRP and younger age have been described in literature to be associated with improved clinical outcomes.
Objectives The relationship between baseline (BL, pre-anti-TNF treatment) disease-specific parameters and HRQoL improvement during anti-TNF therapy with golimumab (GLM) or infliximab (IFX) was evaluated in the QUality of Life as Outcomes and its VAriation with DIsease States (QUO-VADIS) study.
Methods This prospective observational study included bio-naïve AS patients (modified New York criteria) newly treated with GLM or IFX (originator). Patients were followed-up for ∼6 months (data collected at BL, 3, and 6 months). Demographic and clinical characteristics, disease activity and HRQoL were summarized accordingly. The Classification and Regression Trees (CART) analysis evaluated the association of BL parameters (demographic, clinical, disease severity) with change in HRQoL at 6 months, measured by an improvement of ≥5 points of the Short-Form 36 (SF-36) Physical Component Summary (PCS) score. Clinical parameters included Bath AS Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI), and AS Disease Activity Scores (ASDAS).
Results 963 patients received ≥1 dose of medication; 78% received GLM and 22%received IFX. Mean age was 42.7 years, 61.4% were male, and 65.3% had ≥ one comorbidity. Mean symptom and diagnosis duration were 11.6 and 5.3 years, respectively, and 63.8%of patients were Human Leukocyte Antigen (HLA)-B27 positive. At BL, mean BASDAI, ASDAS-CRP and BASFI scores were 6.21, 3.59 and 5.34, respectively. High and very high ASDAS disease activity was observed in 41.4% and 49.3% of patients, respectively. Clinical and HRQoL improvements were shown in all collected measures following 6 months of treatment with GLM or IFX, as documented in the Table. PCS response at 6 months (improvement of ≥5 points from BL) was achieved in 52.3% (n=504) of patients. Using CART analysis, the baseline parameters, and their cutoff values, associated with HRQoL improvement as measured by SF-36 PCS response at 6 months were ASDAS (≥3.48), C-Reactive Protein (CRP) (≥8.55 mg/L), and age (≤35.5 years), and BASFI (≥1.15). This algorithm correctly identified 57.5% (sensitivity) of the patients who had improvement on PCS >5 points and 61.0% (specificity) of the patients who had improvement on PCS ≤5 points with ROC-AUC=0.61.
Conclusions This study demonstrated clinical and HRQoL improvements over 6 months in a large, real-world population of AS patients newly treated with GLM or IFX. The QUO-VADIS study also demonstrates, for the first time, the association of parameters such as higher ASDAS, elevated CRP and younger age with improvements in HRQoL and with a more robust response. The use of these predicting factors may aid clinicians in better evaluating which patients to start on antiTNF therapy with GLM or IFX.
Disclosure of Interest F. Van Den Bosch Consultant for: Abbvie, Bristol Myers Squibb, Celgene, Janssen, Merck & Co., Inc., Novartis, Pfizer and UCB, R.-M. Flipo Grant/research support from: Ipsen Pharma, Menarini France, and Savie, J. Braun Consultant for: Abbvie (Abbott), Amgen, Boehringer Ingelheim, Bristol-Myers-Squibb, Celgene, CELLTRION, Centocor, Chugai, EBEWE Pharma, Janssen, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis and UCB, S. Sajjan Employee of: Merck Sharp & Dohme, S. Kachroo Employee of: Merck Sharp & Dohme, N. Vastesaeger Employee of: Merck Sharp & Dohme, M. Govoni Employee of: Merck Sharp & Dohme