Unique aspects of pain reduction in osteoarthritis of the knee with LMWF-5A

Brian McGrath University Orthopaedic Center, Amherst, NY, USA Abstract: Osteoarthritis of the knee (OAK) is a common form of arthritis that can lead to substantial pain and disability. This commentary highlights key aspects of the recently published phase 3 A Efficacy and Safety Study of Two Doses...

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Autor principal:	McGrath B
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2015
Materias:	Diseases of the musculoskeletal system RC925-935
Acceso en línea:	https://doaj.org/article/ef0b13ceae3b4316a21c3670474b41c2
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spelling	oai:doaj.org-article:ef0b13ceae3b4316a21c3670474b41c22021-12-02T06:09:40ZUnique aspects of pain reduction in osteoarthritis of the knee with LMWF-5A1179-156Xhttps://doaj.org/article/ef0b13ceae3b4316a21c3670474b41c22015-02-01T00:00:00Zhttp://www.dovepress.com/unique-aspects-of-pain-reduction-in-osteoarthritis-of-the-knee-with-lm-peer-reviewed-article-OARRRhttps://doaj.org/toc/1179-156X Brian McGrath University Orthopaedic Center, Amherst, NY, USA Abstract: Osteoarthritis of the knee (OAK) is a common form of arthritis that can lead to substantial pain and disability. This commentary highlights key aspects of the recently published phase 3 A Efficacy and Safety Study of Two Doses of Intra-Articular Injection of Ampion™ in Adults With Pain Due to Osteoarthritis of the Knee (SPRING) study. SPRING (NCT01839331) was a multicenter, randomized, vehicle-controlled, double-blind trial that evaluated the safety and efficacy of the low-molecular-weight fraction of 5% human serum albumin (LMWF-5A) for treatment of pain, measured by the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain scale, in patients with symptomatic OAK (N=329). Patients in this study reflected many characteristics of "real-world" individuals with OAK, with a broad range of disease severity and disability. The most important finding from this study was that treatment with a single intra-articular injection of LMWF-5A led to significant pain reduction in the patients with objective radiographic evidence of severe disease and joint deterioration (Kellgren-Lawrence grade 3; P=0.04 and Kellgren-Lawrence grade 4; P=0.02). The magnitude of pain reduction in the entire cohort treated with LMWF-5A was 42% from baseline and the treatment effect compared with vehicle control (estimated difference in WOMAC pain, -0.25; P=0.004) was also notable, especially relative to a previously reported study of hyaluronic acid, in which only a marginally significant treatment effect was observed (mean difference in WOMAC pain compared with control, -0.15; P=0.047). Significant improvement in physical function observed with LMWF-5A (P=0.04) was also noted and suggests that LMWF-5A may provide therapeutic benefit for those who are limited in the activities of daily living. Intra-articular injection of LMWF-5A was well tolerated, and the adverse event profile was similar to that of control. These results demonstrate significant benefit of LMWF-5A for patients with greatest disability (Kellgren-Lawrence grades 3 and 4) and highest therapeutic need who have limited pharmacologic options for relief of pain associated with OAK. Keywords: human serum albumin, knee, osteoarthritis, pain, Kellgren-LawrenceMcGrath BDove Medical PressarticleDiseases of the musculoskeletal systemRC925-935ENOpen Access Rheumatology: Research and Reviews, Vol 2015, Iss default, Pp 19-22 (2015)
institution	DOAJ
collection	DOAJ
language	EN
topic	Diseases of the musculoskeletal system RC925-935
spellingShingle	Diseases of the musculoskeletal system RC925-935 McGrath B Unique aspects of pain reduction in osteoarthritis of the knee with LMWF-5A
description	Brian McGrath University Orthopaedic Center, Amherst, NY, USA Abstract: Osteoarthritis of the knee (OAK) is a common form of arthritis that can lead to substantial pain and disability. This commentary highlights key aspects of the recently published phase 3 A Efficacy and Safety Study of Two Doses of Intra-Articular Injection of Ampion™ in Adults With Pain Due to Osteoarthritis of the Knee (SPRING) study. SPRING (NCT01839331) was a multicenter, randomized, vehicle-controlled, double-blind trial that evaluated the safety and efficacy of the low-molecular-weight fraction of 5% human serum albumin (LMWF-5A) for treatment of pain, measured by the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain scale, in patients with symptomatic OAK (N=329). Patients in this study reflected many characteristics of "real-world" individuals with OAK, with a broad range of disease severity and disability. The most important finding from this study was that treatment with a single intra-articular injection of LMWF-5A led to significant pain reduction in the patients with objective radiographic evidence of severe disease and joint deterioration (Kellgren-Lawrence grade 3; P=0.04 and Kellgren-Lawrence grade 4; P=0.02). The magnitude of pain reduction in the entire cohort treated with LMWF-5A was 42% from baseline and the treatment effect compared with vehicle control (estimated difference in WOMAC pain, -0.25; P=0.004) was also notable, especially relative to a previously reported study of hyaluronic acid, in which only a marginally significant treatment effect was observed (mean difference in WOMAC pain compared with control, -0.15; P=0.047). Significant improvement in physical function observed with LMWF-5A (P=0.04) was also noted and suggests that LMWF-5A may provide therapeutic benefit for those who are limited in the activities of daily living. Intra-articular injection of LMWF-5A was well tolerated, and the adverse event profile was similar to that of control. These results demonstrate significant benefit of LMWF-5A for patients with greatest disability (Kellgren-Lawrence grades 3 and 4) and highest therapeutic need who have limited pharmacologic options for relief of pain associated with OAK. Keywords: human serum albumin, knee, osteoarthritis, pain, Kellgren-Lawrence
format	article
author	McGrath B
author_facet	McGrath B
author_sort	McGrath B
title	Unique aspects of pain reduction in osteoarthritis of the knee with LMWF-5A
title_short	Unique aspects of pain reduction in osteoarthritis of the knee with LMWF-5A
title_full	Unique aspects of pain reduction in osteoarthritis of the knee with LMWF-5A
title_fullStr	Unique aspects of pain reduction in osteoarthritis of the knee with LMWF-5A
title_full_unstemmed	Unique aspects of pain reduction in osteoarthritis of the knee with LMWF-5A
title_sort	unique aspects of pain reduction in osteoarthritis of the knee with lmwf-5a
publisher	Dove Medical Press
publishDate	2015
url	https://doaj.org/article/ef0b13ceae3b4316a21c3670474b41c2
work_keys_str_mv	AT mcgrathb uniqueaspectsofpainreductioninosteoarthritisofthekneewithlmwf5a
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Unique aspects of pain reduction in osteoarthritis of the knee with LMWF-5A

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