A phase III study to evaluate the long-term safety and efficacy of fasinumab in patients with pain due to osteoarthritis of the knee or hip

A phase III study to evaluate the long-term safety and efficacy of fasinumab in patients with pain due to osteoarthritis of the knee or hip

Background: Pain associated with osteoarthritis (OA) is frequently disabling; treatments are often ineffective or intolerable. Fasinumab selectively inhibits nerve-growth factor and has shown efficacy for the management of OA pain. Methods: In this randomized, double-blind, phase III safety study, p...

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Main Authors: Stephen J. DiMartino, Jingning Mei, Thomas J. Schnitzer, Haitao Gao, Simon Eng, Christine Winslow, Tina Ho, Kenneth C. Turner, Hazem E. Hassan, Yamini Patel, John D. Davis, Ngan Trinh, Angela Manley, Garen Manvelian, Michael Fetell, Ned Braunstein, Gregory P. Geba, Paula Dakin
Format: Article
Language:English
Published: Elsevier 2024-12-01
Series:Osteoarthritis and Cartilage Open
Subjects:
Fasinumab
Osteoarthritis
Pain
Safety
Online Access:http://www.sciencedirect.com/science/article/pii/S2665913124001006
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Summary:Background: Pain associated with osteoarthritis (OA) is frequently disabling; treatments are often ineffective or intolerable. Fasinumab selectively inhibits nerve-growth factor and has shown efficacy for the management of OA pain. Methods: In this randomized, double-blind, phase III safety study, patients with moderate-to-severe OA pain and history of inadequate pain relief received placebo or fasinumab (at 1, 3, 6, and 9 ​mg every 4 weeks [Q4W] and 1 and 6 ​mg every 8 weeks [Q8W] for 52 weeks). Primary safety endpoints included adverse events, adjudicated arthropathies (AAs), and joint replacements (JRs). Co-primary endpoints of an efficacy sub-study were change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and physical function scores. During the study, higher fasinumab doses were discontinued for safety; 1 ​mg doses continued. Results: Of 13,945 patients screened, 5331 were randomized; 1074 were included in the efficacy sub-study. AAs and JRs occurred in all groups. Increased severity of disease at baseline was associated with higher rates of AAs and JRs. A dose-dependent risk of AA or JR was observed for fasinumab; in the 1 ​mg groups, only a small percentage of patients with JR had prior AA. Fasinumab significantly improved WOMAC pain and physical function scores compared with placebo; least squares mean differences versus placebo were −1.22 and ​−1.20 for 1 ​mg Q4W and −0.73 and ​−0.74 for 1 ​mg Q8W, respectively (P<0.001). Conclusion: AAs and JRs showed a dose relationship to fasinumab and were associated with baseline OA status. Fasinumab achieved statistically significant improvements in WOMAC pain and physical function scores compared with placebo.
ISSN:2665-9131

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