Efficacy and Safety of Intravenous Golimumab in Ankylosing Spondylitis Patients With Early and Late Disease Through One Year of the GO-ALIVE Study

Atul A Deodhar, Natalie J Shiff, Cinty Gong, Elizabeth C Hsia, Kim Hung Lo, Lilliane Kim, Stephen Xu, John D Reveille, Atul A Deodhar, Natalie J Shiff, Cinty Gong, Elizabeth C Hsia, Kim Hung Lo, Lilliane Kim, Stephen Xu, John D Reveille

Abstract

Background/objective: This post hoc analysis assessed efficacy and safety of intravenous (IV) golimumab in ankylosing spondylitis (AS) patients with early disease (ED) versus late disease (LD).

Methods: The phase 3, double-blind, GO-ALIVE study randomized patients to IV golimumab 2 mg/kg at weeks 0 and 4 and then every 8 weeks through week 52, or placebo at weeks 0, 4, and 12 with crossover to IV golimumab at week 16. Clinical efficacy was assessed by ≥20% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS20), ≥50% improvement in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI 50), and Ankylosing Spondylitis Disease Activity Score (ASDAS) <1.3 (inactive disease). Using self-reported duration of inflammatory back pain (IBP), patients were grouped into quartiles: first = ED and fourth = LD. Descriptive statistics summarized efficacy and safety findings through 1 year.

Results: Early disease patients (n = 60) were ~10 years younger and had shorter median AS (IBP) symptom duration (2-3 years) versus LD patients (n = 52; 21-24 years). At week 16, numerically higher proportions of golimumab- than placebo-treated patients achieved ASAS20 (ED: 71% vs. 32%; LD: 67% vs. 21%), BASDAI 50 (ED: 40% vs. 12%; LD: 33% vs. 7%), and ASDAS <1.3 (ED: 17% vs. 4%; LD 8% vs. 0%) regardless of IBP duration. Efficacy was durable through 1 year of treatment; however, response rates were numerically higher in patients with ED versus LD. Through week 60, adverse events and serious adverse events, respectively, were reported by 46% and 3% of ED patients and 61% and 2% of LD patients.

Conclusion: Prompt diagnosis of AS and early treatment with IV golimumab may yield more robust improvements in disease activity.

Trial registration: ClinicalTrials.gov NCT02186873.

Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.

Figures

FIGURE 1
FIGURE 1
The proportions of patients achieving (A) ASAS20 at week 16, (B) ASAS20 at week 52, (C) ASAS40 at week 16, and (D) ASAS40 at week 52 among patients with early and late disease. ASAS20/40 response = improvement of at least 20%/40% from baseline in the ASAS criteria.
FIGURE 2
FIGURE 2
The proportions of patients achieving (A) BASDAI 50 at week 16 and (B) BASDAI 50 at week 52 among patients with early and late disease. BASDAI50 response = at least 50% improvement in Bath Ankylosing Spondylitis Disease.
FIGURE 3
FIGURE 3
The proportions of patients achieving (A) ASDAS clinically important improvement at week 16, (B) ASDAS clinically important improvement at week 52, (C) ASDAS major improvement at week 16, (D) ASDAS major improvement at week 52, (E) ASDAS inactive disease at week 16, and (F) ASDAS inactive disease at week 52 among patients with early and late disease.
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/9336574/bin/jcr-28-270-g004.jpg

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Source: PubMed

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