Atul Deodhar1,2, John D Reveille1,2, Diane D Harrison1,2, Lilianne Kim1,2, Kim Hung Lo1,2, Jocelyn H Leu1,2, Elizabeth C Hsia3,4. 1. From the Oregon Health & Science University, Portland, Oregon; University of Texas McGovern Medical School, Houston, Texas; Janssen Research & Development LLC, Spring House, Pennsylvania; University of Pennsylvania, Philadelphia, Pennsylvania, USA. 2. A. Deodhar, MD, Oregon Health & Science University; J.D. Reveille, MD, University of Texas McGovern Medical School; 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, University of Pennsylvania. 3. From the Oregon Health & Science University, Portland, Oregon; University of Texas McGovern Medical School, Houston, Texas; Janssen Research & Development LLC, Spring House, Pennsylvania; University of Pennsylvania, Philadelphia, Pennsylvania, USA. ehsia@its.jnj.com. 4. A. Deodhar, MD, Oregon Health & Science University; J.D. Reveille, MD, University of Texas McGovern Medical School; 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, University of Pennsylvania. ehsia@its.jnj.com.
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 BathAnkylosing Spondylitis Disease Activity Index (BASDAI50), and change in the BathAnkylosing 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).
RCT Entities:
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: U Kiltz; J Braun; A Becker; J-F Chenot; M Dreimann; L Hammel; A Heiligenhaus; K-G Hermann; R Klett; D Krause; K-F Kreitner; U Lange; A Lauterbach; W Mau; R Mössner; U Oberschelp; S Philipp; U Pleyer; M Rudwaleit; E Schneider; T L Schulte; J Sieper; A Stallmach; B Swoboda; M Winking Journal: Z Rheumatol Date: 2019-12 Impact factor: 1.372
Authors: A Deodhar; S D Chakravarty; C Cameron; S Peterson; R Hensman; S Fogarty; P Spin; S Kafka; S Nair; L S Gensler Journal: Clin Rheumatol Date: 2020-02-27 Impact factor: 2.980
Authors: John Tesser; Shelly Kafka; Raphael J DeHoratius; Stephen Xu; Elizabeth C Hsia; Anthony Turkiewicz Journal: Arthritis Res Ther Date: 2019-08-20 Impact factor: 5.156
Authors: L S Gensler; S D Chakravarty; Chris Cameron; S Peterson; P Spin; S Kafka; S Nair; A Deodhar Journal: Clin Rheumatol Date: 2020-05-04 Impact factor: 2.980