John D Reveille1,2, Atul Deodhar1,2, Paul H Caldron1,2, Anna Dudek1,2, Diane D Harrison1,2, Lilianne Kim1,2, Kim Hung Lo1,2, Jocelyn H Leu1,2, Elizabeth C Hsia3,4. 1. From the University of Texas McGovern Medical School, Houston, Texas; Oregon Health & Science University, Portland, Oregon; Arizona Arthritis and Rheumatology Associates, Phoenix, Arizona; Janssen Research & Development LLC, Spring House, Pennsylvania; University of Pennsylvania, Philadelphia, Pennsylvania, USA; AMED Medical Center, Warsaw, Poland. 2. J.D. Reveille, MD, University of Texas McGovern Medical School; A. Deodhar, MD, Oregon Health & Science University; P.H. Caldron, DO, Arizona Arthritis and Rheumatology Associates; A. Dudek, MD, PhD, AMED Medical Center; D.D. Harrison, MD, MPH, Janssen Research & Development LLC; L. Kim, PhD, Janssen Research & Development LLC; K.H. Lo, PhD, Janssen Research & Development LLC; J.H. Leu, PharmD, PhD, Janssen Research & Development LLC; E.C. Hsia, MD, MSCE, Janssen Research & Development LLC, and University of Pennsylvania. 3. From the University of Texas McGovern Medical School, Houston, Texas; Oregon Health & Science University, Portland, Oregon; Arizona Arthritis and Rheumatology Associates, Phoenix, Arizona; Janssen Research & Development LLC, Spring House, Pennsylvania; University of Pennsylvania, Philadelphia, Pennsylvania, USA; AMED Medical Center, Warsaw, Poland. ehsia@its.jnj.com. 4. J.D. Reveille, MD, University of Texas McGovern Medical School; A. Deodhar, MD, Oregon Health & Science University; P.H. Caldron, DO, Arizona Arthritis and Rheumatology Associates; A. Dudek, MD, PhD, AMED Medical Center; D.D. Harrison, MD, MPH, Janssen Research & Development LLC; L. Kim, PhD, Janssen Research & Development LLC; K.H. Lo, PhD, Janssen Research & Development LLC; J.H. Leu, PharmD, PhD, Janssen Research & Development LLC; E.C. Hsia, MD, MSCE, Janssen Research & Development LLC, and University of Pennsylvania. ehsia@its.jnj.com.
Abstract
OBJECTIVE: Evaluate safety and efficacy of intravenous (IV) golimumab (GOL) in patients with active ankylosing spondylitis (AS) through 1 year. METHODS: A total of 208 patients were randomized to IV infusions of GOL 2 mg/kg (n = 105) at weeks 0, 4, and every 8 weeks thereafter or placebo (n = 103) at weeks 0, 4, and 12, then crossover to GOL at weeks 16, 20, and every 8 weeks thereafter through Week 52. Efficacy was assessed using the Assessment of Spondyloarthritis international Society (ASAS) criteria, the Ankylosing Spondylitis Disease Activity Score (ASDAS), the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and the Bath Ankylosing Spondylitis Functional Index (BASFI). Health-related quality of life was assessed using the AS Quality of Life (ASQoL) index. Efficacy and safety were monitored through Week 52 and Week 60, respectively. RESULTS: The primary endpoint (ASAS20) and all controlled endpoints at Week 16 were achieved. At Week 52, 69.5% and 65.0% of patients in the GOL group and placebo crossover group, respectively, achieved an ASAS20; 56.2% and 51.5% achieved an ASAS40; 56.2% and 55.3% achieved a BASDAI50; 24.8% and 24.3% achieved ASAS partial remission; and 25.7% and 26.2% met ASDAS inactive disease criteria (all last observation carried forward). Mean changes from baseline to Week 52 in BASFI and ASQoL scores were similar between the GOL group and the placebo crossover group (BASFI: -2.7 and -2.6; ASQoL: -5.5 and -5.4). Through Week 60, 55.4% of all GOL-treated patients had ≥ 1 adverse events (AE); 3.4% had ≥ 1 serious AE. CONCLUSION:Efficacy was maintained through 1 year with IV GOL 2 mg/kg among patients with active AS. AE were consistent with the known safety profile of GOL.
RCT Entities:
OBJECTIVE: Evaluate safety and efficacy of intravenous (IV) golimumab (GOL) in patients with active ankylosing spondylitis (AS) through 1 year. METHODS: A total of 208 patients were randomized to IV infusions of GOL 2 mg/kg (n = 105) at weeks 0, 4, and every 8 weeks thereafter or placebo (n = 103) at weeks 0, 4, and 12, then crossover to GOL at weeks 16, 20, and every 8 weeks thereafter through Week 52. Efficacy was assessed using the Assessment of Spondyloarthritis international Society (ASAS) criteria, the Ankylosing Spondylitis Disease Activity Score (ASDAS), the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and the Bath Ankylosing Spondylitis Functional Index (BASFI). Health-related quality of life was assessed using the AS Quality of Life (ASQoL) index. Efficacy and safety were monitored through Week 52 and Week 60, respectively. RESULTS: The primary endpoint (ASAS20) and all controlled endpoints at Week 16 were achieved. At Week 52, 69.5% and 65.0% of patients in the GOL group and placebo crossover group, respectively, achieved an ASAS20; 56.2% and 51.5% achieved an ASAS40; 56.2% and 55.3% achieved a BASDAI50; 24.8% and 24.3% achieved ASAS partial remission; and 25.7% and 26.2% met ASDAS inactive disease criteria (all last observation carried forward). Mean changes from baseline to Week 52 in BASFI and ASQoL scores were similar between the GOL group and the placebo crossover group (BASFI: -2.7 and -2.6; ASQoL: -5.5 and -5.4). Through Week 60, 55.4% of all GOL-treated patients had ≥ 1 adverse events (AE); 3.4% had ≥ 1 serious AE. CONCLUSION: Efficacy was maintained through 1 year with IV GOL 2 mg/kg among patients with active AS. AE were consistent with the known safety profile of GOL.
Authors: Panagiotis Athanassiou; Anastasios Kotrotsios; Ioannis Kallitsakis; Andreas Bounas; Theodoros Dimitroulas; Alexandros Garyfallos; Maria G Tektonidou; Giorgos Vosvotekas; Achilleas Livieratos; Evangelia Petrikkou; Gkikas Katsifis Journal: Qual Life Res Date: 2021-11-28 Impact factor: 4.147
Authors: M Elaine Husni; Atul Deodhar; Sergio Schwartzman; Soumya D Chakravarty; Elizabeth C Hsia; Jocelyn H Leu; Yiying Zhou; Kim H Lo; Arthur Kavanaugh Journal: Arthritis Res Ther Date: 2022-03-21 Impact factor: 5.156
Authors: Atul A Deodhar; Natalie J Shiff; Cinty Gong; Elizabeth C Hsia; Kim Hung Lo; Lilliane Kim; Stephen Xu; John D Reveille Journal: J Clin Rheumatol Date: 2022-06-01 Impact factor: 3.902