Safety and Efficacy of Golimumab Administered Intravenously in Adults with Ankylosing Spondylitis: Results through Week 28 of the GO-ALIVE Study.

Abstract

OBJECTIVE:

To evaluate the safety and efficacy of intravenous golimumab (GOL) in patients with active ankylosing spondylitis (AS).

METHODS:

In a phase III, randomized, double-blind, placebo (PBO)-controlled trial, 208 patients were randomized (1:1) to intravenous (IV) infusions of GOL 2 mg/kg (n = 105) at weeks 0, 4, 12, and every 8 weeks, or PBO (n = 103) at weeks 0, 4, and 12, with crossover to GOL at Week 16. The primary endpoint was ≥ 20% improvement from baseline in the Assessment of Spondyloarthritis International Society Criteria (ASAS20) at Week 16. Secondary endpoints included ASAS40, ≥ 50% improvement in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI50), and change in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16. Safety was monitored through Week 28.

RESULTS:

Significantly greater proportions of GOL-treated patients had ASAS20 response at Week 2 (37.1% vs 19.4%; p = 0.005) and at Week 16 (73.3% vs 26.2%; p < 0.001). At Week 16, 41.0% of those receiving GOL achieved BASDAI50 compared with 14.6% of those taking PBO (p < 0.001), and the GOL group had greater mean improvement in BASFI (-2.4 vs -0.5; p < 0.001). Through Week 16, 23.3% of patients in the PBO group and 32.4% of patients in the GOL group had ≥ 1 adverse event (AE); infections being the commonest type of AE. Through Week 28, two GOL-treated patients had a serious AE.

CONCLUSION:

GOL 2 mg/kg administered IV at weeks 0, 4, and every 8 weeks significantly reduced the signs and symptoms of AS in adults. AE were consistent with other antitumor necrosis factor therapies, with no new safety signals (Clinicaltrials.gov: NCT02186873).

• Authors: Atul Deodhar, John D Reveille, Diane D Harrison, Lilianne Kim, Kim Hung Lo, Jocelyn H Leu, Elizabeth C Hsia
• Journal: The Journal of rheumatology (J Rheumatol) Vol. 45 Issue 3 Pg. 341-348 (03 2018) ISSN: 0315-162X [Print] Canada
• PMID: 29247154 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal
• Antirheumatic Agents
• golimumab

Topics

• Administration, Intravenous
• Adult
• Antibodies, Monoclonal (administration & dosage, adverse effects, therapeutic use)
• Antirheumatic Agents (administration & dosage, adverse effects, therapeutic use)
• Double-Blind Method
• Female
• Follow-Up Studies
• Humans
• Infections (chemically induced)
• Male
• Middle Aged
• Pancreatitis (chemically induced)
• Pneumonia (chemically induced)
• Severity of Illness Index
• Spondylitis, Ankylosing (drug therapy)
• Treatment Outcome