TY - JOUR
T1 - Efficacy and Safety of Intravenous Golimumab in Ankylosing Spondylitis Patients with Early and Late Disease Through One Year of the GO-ALIVE Study
AU - Deodhar, Atul A.
AU - Shiff, Natalie J.
AU - Gong, Cinty
AU - Hsia, Elizabeth C.
AU - Lo, Kim Hung
AU - Kim, Lilliane
AU - Xu, Stephen
AU - Reveille, John D.
N1 - Funding Information:
This work was supported by Janssen Research & Development, LLC, Spring House, PA, including funding and guidance for the conduct of the research and the preparation of the article, including the collection, analysis, and interpretation of data; writing of the report; and the decision to submit the article for publication.
Funding Information:
A.A.D. received consulting fees for participation in Advisory Boards from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, GlaxoSmithKline, Janssen, MoonLake, Novartis, Pfizer, and UCB; research grant funding from AbbVie, Eli Lilly, GlaxoSmithKline, Novartis, Pfizer, and UCB; and speaker's fees from AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, and UCB. J.D.R. received consulting fees for participation in Advisory Boards from Eli Lilly and UCB and research grant funding from Eli Lilly and Janssen Research & Development. N.J.S. is an employee of Janssen Scientific Affairs, LLC, a wholly owned subsidiary of Johnson & Johnson, and owns stock in Abbvie, Gilead, and Johnson & Johnson. C.G. is an employee of Janssen Scientific Affairs, LLC, a wholly owned subsidiary of Johnson & Johnson, and owns stock in Johnson & Johnson. E.C.H., K.H.L., L.K., and S.X. are employees of Janssen Research & Development, LLC, a wholly owned subsidiary of Johnson & Johnson, and own stock in Johnson & Johnson.
Publisher Copyright:
© Wolters Kluwer Health, Inc. All rights reserved.
PY - 2022/8/1
Y1 - 2022/8/1
N2 - 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.
AB - 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.
KW - ankylosing spondylitis
KW - efficacy
KW - inflammatory back pain
KW - intravenous golimumab
KW - safety
KW - tumor necrosis factor inhibitor
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UR - http://www.scopus.com/inward/citedby.url?scp=85135211907&partnerID=8YFLogxK
U2 - 10.1097/RHU.0000000000001853
DO - 10.1097/RHU.0000000000001853
M3 - Article
C2 - 35653615
AN - SCOPUS:85135211907
SN - 1076-1608
VL - 28
SP - 270
EP - 277
JO - Journal of Clinical Rheumatology
JF - Journal of Clinical Rheumatology
IS - 5
ER -