Background/Purpose : We assessed baseline parameters associated with health-related quality-of-life (HRQoL) improvement in AS patients with anti-TNF treatment (golimumab [GLM]; infliximab [IFX; originator]) 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 ≥ 1 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), 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.

Conclusion: The QUO-VADIS study demonstrated clinical and HRQoL improvements over 6 months in a large, real-world population of AS patients newly treated with GLM or IFX, with results similar to clinical studies ⁽¹⁾.   The 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. References: Inman et al. Arthritis Rheum. 2008 Nov; 58(11): 3402-12.

Table:  Improvement in Clinical and QoL Parameters Following 6 months of Treatment