Efficacy and safety of a single intra-articular injection of non-animal stabilized hyaluronic acid (NASHA) in patients with osteoarthritis of the knee

Roy D Altman, Christian Åkermark, André D. Beaulieu, Thomas Schnitzer, Stephen Hugenberg, Michele Hooper, Thomas Schnitzer, William Garrett, Michael Schiff, Joseph Markenson, Mary Bell, William Bensen, Simon Carette, Peter Fowler, Alfred Cividino, Anders Björkman, Christian Åkermark, Torsten Adalberth, Jan Ericsäter, Gunnar Bergentz & 1 others Tönu Saartok

Research output: Contribution to journalArticle

89 Citations (Scopus)

Abstract

Objective. Non-animal stabilized hyaluronic acid (NASHA) is a novel hyaluronan (HA) preparation with a 4-week intra-articular half-life. This study compared the efficacy of a single injection of NASHA with placebo in patients with osteoarthritis (OA) of the knee. Design. This was a 26-week randomized, double-blind, multicenter study of a single intra-articular knee injection with either NASHA or placebo (saline). Assessments included the Western Ontario McMasters Universities osteoarthritis index (WOMAC, Likert Scale) and patients' overall global disease status. A positive response was defined as a reduction in WOMAC pain score for the study knee of 40% from baseline with a minimum improvement of ≥5 points. Results. A total of 346 (NASHA 172; placebo 174) patients were treated. WOMAC scores and quality of life were improved in both the NASHA and placebo groups. For the overall population, there were no statistically significant between-group differences in response rates for any efficacy parameters. In patients with OA confined to the knee (N=216), a greater response to NASHA than placebo was observed at week 6 (P=0.025). There were few treatment-related events. Conclusions. NASHA was not superior to placebo for the primary efficacy analysis. However, these data may be confounded by the inclusion of patients with OA at other sites, as significant benefits over placebo were found among patients with OA confined to the knee. Future trials of OA that examine a local therapy might need to consider restricting the study population to those patients having OA of only the signal joint.

Original languageEnglish (US)
Pages (from-to)642-649
Number of pages8
JournalOsteoarthritis and Cartilage
Volume12
Issue number8
DOIs
StatePublished - Aug 2004

Fingerprint

Hyaluronic acid
Intra-Articular Injections
Knee Osteoarthritis
Hyaluronic Acid
Osteoarthritis
Safety
Placebos
Knee
Joints
Ontario
Double-Blind Method
Population
Multicenter Studies
Half-Life
Quality of Life
Pain
Injections
Therapeutics

Keywords

  • Hyaluronic acid
  • Intra-articular
  • Knee
  • Osteoarthritis
  • Randomized controlled trial

ASJC Scopus subject areas

  • Orthopedics and Sports Medicine

Cite this

Efficacy and safety of a single intra-articular injection of non-animal stabilized hyaluronic acid (NASHA) in patients with osteoarthritis of the knee. / Altman, Roy D; Åkermark, Christian; Beaulieu, André D.; Schnitzer, Thomas; Hugenberg, Stephen; Hooper, Michele; Schnitzer, Thomas; Garrett, William; Schiff, Michael; Markenson, Joseph; Bell, Mary; Bensen, William; Carette, Simon; Fowler, Peter; Cividino, Alfred; Björkman, Anders; Åkermark, Christian; Adalberth, Torsten; Ericsäter, Jan; Bergentz, Gunnar; Saartok, Tönu.

In: Osteoarthritis and Cartilage, Vol. 12, No. 8, 08.2004, p. 642-649.

Research output: Contribution to journalArticle

Altman, RD, Åkermark, C, Beaulieu, AD, Schnitzer, T, Hugenberg, S, Hooper, M, Schnitzer, T, Garrett, W, Schiff, M, Markenson, J, Bell, M, Bensen, W, Carette, S, Fowler, P, Cividino, A, Björkman, A, Åkermark, C, Adalberth, T, Ericsäter, J, Bergentz, G & Saartok, T 2004, 'Efficacy and safety of a single intra-articular injection of non-animal stabilized hyaluronic acid (NASHA) in patients with osteoarthritis of the knee', Osteoarthritis and Cartilage, vol. 12, no. 8, pp. 642-649. https://doi.org/10.1016/j.joca.2004.04.010
Altman, Roy D ; Åkermark, Christian ; Beaulieu, André D. ; Schnitzer, Thomas ; Hugenberg, Stephen ; Hooper, Michele ; Schnitzer, Thomas ; Garrett, William ; Schiff, Michael ; Markenson, Joseph ; Bell, Mary ; Bensen, William ; Carette, Simon ; Fowler, Peter ; Cividino, Alfred ; Björkman, Anders ; Åkermark, Christian ; Adalberth, Torsten ; Ericsäter, Jan ; Bergentz, Gunnar ; Saartok, Tönu. / Efficacy and safety of a single intra-articular injection of non-animal stabilized hyaluronic acid (NASHA) in patients with osteoarthritis of the knee. In: Osteoarthritis and Cartilage. 2004 ; Vol. 12, No. 8. pp. 642-649.
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abstract = "Objective. Non-animal stabilized hyaluronic acid (NASHA) is a novel hyaluronan (HA) preparation with a 4-week intra-articular half-life. This study compared the efficacy of a single injection of NASHA with placebo in patients with osteoarthritis (OA) of the knee. Design. This was a 26-week randomized, double-blind, multicenter study of a single intra-articular knee injection with either NASHA or placebo (saline). Assessments included the Western Ontario McMasters Universities osteoarthritis index (WOMAC, Likert Scale) and patients' overall global disease status. A positive response was defined as a reduction in WOMAC pain score for the study knee of 40{\%} from baseline with a minimum improvement of ≥5 points. Results. A total of 346 (NASHA 172; placebo 174) patients were treated. WOMAC scores and quality of life were improved in both the NASHA and placebo groups. For the overall population, there were no statistically significant between-group differences in response rates for any efficacy parameters. In patients with OA confined to the knee (N=216), a greater response to NASHA than placebo was observed at week 6 (P=0.025). There were few treatment-related events. Conclusions. NASHA was not superior to placebo for the primary efficacy analysis. However, these data may be confounded by the inclusion of patients with OA at other sites, as significant benefits over placebo were found among patients with OA confined to the knee. Future trials of OA that examine a local therapy might need to consider restricting the study population to those patients having OA of only the signal joint.",
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T1 - Efficacy and safety of a single intra-articular injection of non-animal stabilized hyaluronic acid (NASHA) in patients with osteoarthritis of the knee

AU - Altman, Roy D

AU - Åkermark, Christian

AU - Beaulieu, André D.

AU - Schnitzer, Thomas

AU - Hugenberg, Stephen

AU - Hooper, Michele

AU - Schnitzer, Thomas

AU - Garrett, William

AU - Schiff, Michael

AU - Markenson, Joseph

AU - Bell, Mary

AU - Bensen, William

AU - Carette, Simon

AU - Fowler, Peter

AU - Cividino, Alfred

AU - Björkman, Anders

AU - Åkermark, Christian

AU - Adalberth, Torsten

AU - Ericsäter, Jan

AU - Bergentz, Gunnar

AU - Saartok, Tönu

PY - 2004/8

Y1 - 2004/8

N2 - Objective. Non-animal stabilized hyaluronic acid (NASHA) is a novel hyaluronan (HA) preparation with a 4-week intra-articular half-life. This study compared the efficacy of a single injection of NASHA with placebo in patients with osteoarthritis (OA) of the knee. Design. This was a 26-week randomized, double-blind, multicenter study of a single intra-articular knee injection with either NASHA or placebo (saline). Assessments included the Western Ontario McMasters Universities osteoarthritis index (WOMAC, Likert Scale) and patients' overall global disease status. A positive response was defined as a reduction in WOMAC pain score for the study knee of 40% from baseline with a minimum improvement of ≥5 points. Results. A total of 346 (NASHA 172; placebo 174) patients were treated. WOMAC scores and quality of life were improved in both the NASHA and placebo groups. For the overall population, there were no statistically significant between-group differences in response rates for any efficacy parameters. In patients with OA confined to the knee (N=216), a greater response to NASHA than placebo was observed at week 6 (P=0.025). There were few treatment-related events. Conclusions. NASHA was not superior to placebo for the primary efficacy analysis. However, these data may be confounded by the inclusion of patients with OA at other sites, as significant benefits over placebo were found among patients with OA confined to the knee. Future trials of OA that examine a local therapy might need to consider restricting the study population to those patients having OA of only the signal joint.

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KW - Randomized controlled trial

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