Background/Purpose: To evaluate patient-reported outcomes (PRO) of physical functioning, mental health functioning, health state, and health-related quality of life (HRQoL) in patients (pts) with active AS treated with intravenous (IV) golimumab (GLM), an anti-TNFα monoclonal antibody.

Methods: GO-ALIVE is a Phase 3, multicenter, randomized, double-blind, placebo(PBO)-controlled trial. Pts (≥18 years) had a diagnosis of definite AS (modified New York criteria) and BASDAI ≥4, total back pain visual analog scale (VAS) ≥4, and CRP ≥0.3mg/dL.  At baseline, 208 pts were randomized to IV GLM 2mg/kg (N=105) at Wks0, 4, and every 8 wks or PBO (N=103) at Wks0, 4, and 12, with crossover to IV GLM at Wk16. PRO instruments included: SF-36, a generic instrument designed to measure physical & mental health functioning; EQ-5D VAS, a generic measure of current health state; and AS Quality of Life (ASQoL), a disease-specific instrument designed to measure impact of AS on HRQoL.  SF-36 scores range from 0-100; higher scores indicate better functioning.  It has Physical (PCS) and Mental Component Summary (MCS) and 8 subscales (physical functioning, role-physical, body pain, general health, vitality, social functioning, role-emotional, & mental health).  EQ-5D has a scale of 0-100 (0=worst health you can imagine; 100=best health you can imagine).  ASQoL assesses sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, & social life in pts with AS; range: 0-18, higher scores indicating worse HRQoL.  Unadjusted p-values of least square mean differences between treatment groups were based on analysis of covariance controlling for prior anti-TNF therapy.

Results: Table summarizes mean changes from baseline at Wks8, 16, and 28. Mean improvements in SF-36 PCS/MCS were greater in the IV GLM group than PBO at Wk8 (6.83 vs 2.07, p<0.001; 5.56 vs 1.67, p=0.006, respectively) and maintained through Wk16 (8.52 vs 2.87, p<0.001; 6.47 vs 0.84, p<0.001, respectively). Greater mean improvements in all SF-36 subscales were observed in the IV GLM group at Wks8 & 16 compared to PBO (p<0.01, with the exception of the role-emotional subscale [p=0.058]). Proportion of pts achieving clinically meaningful change (≥5) in SF-36 PCS/MCS was higher in IV GLM than PBO at Wks8 & 16 (PCS: 58.1 vs 27.2, 67.6 vs 35.9, respectively; MCS: 48.6 vs 34.0, 54.3 vs 29.1, respectively; p<0.05 for all). Mean EQ-5D VAS improvements were greater (p<0.001) in IV GLM than PBO at Wks8 & 16 (17.61 vs 6.63, 20.32 vs 4.79, respectively). Greater mean improvements in ASQoL observed in IV GLM compared to PBO at Wks8 & 16 (-4.5 vs -1.5, p<0.001, -5.4 vs -1.8, p<0.001, respectively). By Wk28, after PBO crossover to IV GLM, mean improvement in PCS, MCS, EQ-5D VAS, and ASQoL was similar between the two treatment arms.

Conclusion: Adult pts with active AS treated with IV GLM showed marked improvements in physical functioning, mental health functioning, health state, and HRQoL.