Effect of Intravenous Golimumab on Fatigue and the Relationship with Clinical Response in Adults with Active Ankylosing Spondylitis in the Phase 3 GO-ALIVE Study

• DOI: 10.1007/s40744-023-00556-y
• Publication Date: 2023-06-15T16:02:17Z
• Authors: Atul Deodhar; Natalie J. Shiff; Cinty Gong; Eric K. H. Chan; Elizabeth C. Hsia; Kim Hung Lo; Alianu Akawung; Lilianne Kim; Stephen Xu; John D. Reveille
• Keywords: Golimumab; Spondylitis

We studied the effect of intravenous (IV)-golimumab on fatigue and association improvement with clinical response post hoc in adults active ankylosing spondylitis (AS) GO-ALIVE trial. Patients were randomized to IV-golimumab 2 mg/kg (N = 105) at week (W) 0, W4, then every 8 W (Q8W) or placebo 103) W0, W12, crossover W16, W20, Q8W through W52. Fatigue measures included Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question #1 (fatigue; 0 [none], 10 [worst]; decrease indicates improvement) 36-Item Short Form Health Survey (SF-36) vitality subscale (0 [worst], 100 [best]; increase improvement). Minimum clinically important difference is ≥ 1 for BASDAI-fatigue 5 SF-36 vitality. primary endpoint was Assessment SpondyloArthritis international Society 20% criteria (ASAS20). Other outcomes assessed other ASAS responses, Score, Functional score. The distribution-based minimally differences (MIDs) determined relationship between via multivariable logistic regression. Mean changes BASDAI-fatigue/SF-36 scores greater versus W16 (- 2.74/8.46 - 0.73/2.08, both nominal p ≤ 0.003); by W52 (after crossover), groups narrowed 3.18/9.39 3.07/9.17). MIDs achieved proportions IV-golimumab-treated placebo-treated patients (75.2%/71.4% 42.7%/35.0%). A one-point/five-point increased likelihood achieving ASAS20 (odds ratios [95% confidence intervals]: 3.15 [2.21, 4.50] 2.10 [1.62, 2.71], respectively) ASAS40 (3.04 [2.15, 4.28] 2.24 [1.68, 3.00], responses W16; concurrent improvements consistent. predicted (1.62 [1.35, 1.95] 1.52 [1.25, 1.86], [1.37, 1.92] 1.44 [1.20, 1.73], provided sustained AS that positively associated response. ClinicalTrials.gov identifier, NCT02186873.