Intra-articular hyaluronan is without clinical effect in knee osteoarthritis: a multicentre, randomised, placebo-controlled, double-blind study of 337 patients followed for 1 year

Anette Jørgensen; Kristian Stengaard-Pedersen; Lars Ole Simonsen; Mogens Pfeiffer Jensen; Christian Eriksen; Henning Bliddal; Niels Wisbech Pedersen; Søren Bødtker; Kim Hørslev-Petersen; Lennart Ørtoft Snerum; Niels Egund; Helle Frimer-Larsen

doi:10.1136/ard.2009.118042

Intra-articular hyaluronan is without clinical effect in knee osteoarthritis: a multicentre, randomised, placebo-controlled, double-blind study of 337 patients followed for 1 year

Anette Jørgensen, Kristian Stengaard-Pedersen, Lars Ole Simonsen, Mogens Pfeiffer Jensen, Christian Eriksen, Henning Bliddal, Niels Wisbech Pedersen, Søren Bødtker, Kim Hørslev-Petersen, Lennart Ørtoft Snerum, Niels Egund, Helle Frimer-Larsen

60 Citationer (Scopus)

Abstract

Objective To examine the long-term efficacy and safety of five intra-articular injections with hyaluronan in knee osteoarthritis. Methods A multicentre, randomised, placebo-controlled double-blind study of 337 patients fulfilling the American College of Rheumatology (ACR) criteria for knee osteoarthritis (clinical and laboratory) and with a Lequesne algofunctional index score (LFI) of 10 or greater. Patients received a hyaluronan product (sodium hyaluronate; Hyalgan) (n= 167) or saline (n= 170) intra-articularly weekly for 5 weeks and were followed up to 1 year. Time to recurrence was the primary efficacy parameter. LFI, pain on walking 50 m based on visual analogue scale (VAS pain 50 m), paracetamol consumption, patients' global assessment, Nottingham health profile, joint effusion and number of responders were secondary efficacy parameters. The efficacy parameters were analysed by intention to treat (ITT) and per protocol (PP). All adverse events (AE) were recorded as safety parameters. Results Time to recurrence showed no significant treatment effect (ITT analysis, p = 0.26). Change from baseline in LFI and VAS pain 50 m for the ITT population showed no treatment effect. Paracetamol consumption, patients' global assessment, responder rates and AE displayed no significant difference between treatment groups, analysed by both ITT and PP. Treatment compliance was 95% in the hyaluronan group and 99% in the placebo group. No safety problems were registered. Conclusion In patients fulfilling the ACR criteria for osteoarthritis of the knee with moderate to severe disease activity (LFI >= 10), five intra-articular injections of hyaluronan did not improve pain, function, paracetamol consumption or other efficacy parameters 3, 6, 9 and 12 months after the treatment

Originalsprog	Engelsk
Tidsskrift	Annals of the Rheumatic Diseases
Vol/bind	69
Udgave nummer	6
Sider (fra-til)	1097-1102
Antal sider	6
ISSN	0003-4967
DOI	https://doi.org/10.1136/ard.2009.118042
Status	Udgivet - jun. 2010

Adgang til dokumentet

10.1136/ard.2009.118042

Citationsformater

Jørgensen, A., Stengaard-Pedersen, K., Simonsen, L. O., Jensen, M. P., Eriksen, C., Bliddal, H., Pedersen, N. W., Bødtker, S., Hørslev-Petersen, K., Snerum, L. Ø., Egund, N., & Frimer-Larsen, H. (2010). Intra-articular hyaluronan is without clinical effect in knee osteoarthritis: a multicentre, randomised, placebo-controlled, double-blind study of 337 patients followed for 1 year. Annals of the Rheumatic Diseases, 69(6), 1097-1102. https://doi.org/10.1136/ard.2009.118042

Intra-articular hyaluronan is without clinical effect in knee osteoarthritis: a multicentre, randomised, placebo-controlled, double-blind study of 337 patients followed for 1 year. / Jørgensen, Anette; Stengaard-Pedersen, Kristian; Simonsen, Lars Ole et al.

I: Annals of the Rheumatic Diseases, Bind 69, Nr. 6, 06.2010, s. 1097-1102.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Jørgensen, A, Stengaard-Pedersen, K, Simonsen, LO, Jensen, MP, Eriksen, C, Bliddal, H, Pedersen, NW, Bødtker, S, Hørslev-Petersen, K, Snerum, LØ, Egund, N & Frimer-Larsen, H 2010, 'Intra-articular hyaluronan is without clinical effect in knee osteoarthritis: a multicentre, randomised, placebo-controlled, double-blind study of 337 patients followed for 1 year', Annals of the Rheumatic Diseases, bind 69, nr. 6, s. 1097-1102. https://doi.org/10.1136/ard.2009.118042

@article{d0ef892b450b4ae391a2f43c692d4447,

title = "Intra-articular hyaluronan is without clinical effect in knee osteoarthritis: a multicentre, randomised, placebo-controlled, double-blind study of 337 patients followed for 1 year",

abstract = "Objective To examine the long-term efficacy and safety of five intra-articular injections with hyaluronan in knee osteoarthritis. Methods A multicentre, randomised, placebo-controlled double-blind study of 337 patients fulfilling the American College of Rheumatology (ACR) criteria for knee osteoarthritis (clinical and laboratory) and with a Lequesne algofunctional index score (LFI) of 10 or greater. Patients received a hyaluronan product (sodium hyaluronate; Hyalgan) (n= 167) or saline (n= 170) intra-articularly weekly for 5 weeks and were followed up to 1 year. Time to recurrence was the primary efficacy parameter. LFI, pain on walking 50 m based on visual analogue scale (VAS pain 50 m), paracetamol consumption, patients' global assessment, Nottingham health profile, joint effusion and number of responders were secondary efficacy parameters. The efficacy parameters were analysed by intention to treat (ITT) and per protocol (PP). All adverse events (AE) were recorded as safety parameters. Results Time to recurrence showed no significant treatment effect (ITT analysis, p = 0.26). Change from baseline in LFI and VAS pain 50 m for the ITT population showed no treatment effect. Paracetamol consumption, patients' global assessment, responder rates and AE displayed no significant difference between treatment groups, analysed by both ITT and PP. Treatment compliance was 95% in the hyaluronan group and 99% in the placebo group. No safety problems were registered. Conclusion In patients fulfilling the ACR criteria for osteoarthritis of the knee with moderate to severe disease activity (LFI >= 10), five intra-articular injections of hyaluronan did not improve pain, function, paracetamol consumption or other efficacy parameters 3, 6, 9 and 12 months after the treatment",

author = "Anette J{\o}rgensen and Kristian Stengaard-Pedersen and Simonsen, {Lars Ole} and Jensen, {Mogens Pfeiffer} and Christian Eriksen and Henning Bliddal and Pedersen, {Niels Wisbech} and S{\o}ren B{\o}dtker and Kim H{\o}rslev-Petersen and Snerum, {Lennart {\O}rtoft} and Niels Egund and Helle Frimer-Larsen",

year = "2010",

month = jun,

doi = "10.1136/ard.2009.118042",

language = "English",

volume = "69",

pages = "1097--1102",

journal = "Annals of the Rheumatic Diseases",

issn = "0003-4967",

publisher = "B M J Group",

number = "6",

}

TY - JOUR

T1 - Intra-articular hyaluronan is without clinical effect in knee osteoarthritis: a multicentre, randomised, placebo-controlled, double-blind study of 337 patients followed for 1 year

AU - Jørgensen, Anette

AU - Stengaard-Pedersen, Kristian

AU - Simonsen, Lars Ole

AU - Jensen, Mogens Pfeiffer

AU - Eriksen, Christian

AU - Bliddal, Henning

AU - Pedersen, Niels Wisbech

AU - Bødtker, Søren

AU - Hørslev-Petersen, Kim

AU - Snerum, Lennart Ørtoft

AU - Egund, Niels

AU - Frimer-Larsen, Helle

PY - 2010/6

Y1 - 2010/6

N2 - Objective To examine the long-term efficacy and safety of five intra-articular injections with hyaluronan in knee osteoarthritis. Methods A multicentre, randomised, placebo-controlled double-blind study of 337 patients fulfilling the American College of Rheumatology (ACR) criteria for knee osteoarthritis (clinical and laboratory) and with a Lequesne algofunctional index score (LFI) of 10 or greater. Patients received a hyaluronan product (sodium hyaluronate; Hyalgan) (n= 167) or saline (n= 170) intra-articularly weekly for 5 weeks and were followed up to 1 year. Time to recurrence was the primary efficacy parameter. LFI, pain on walking 50 m based on visual analogue scale (VAS pain 50 m), paracetamol consumption, patients' global assessment, Nottingham health profile, joint effusion and number of responders were secondary efficacy parameters. The efficacy parameters were analysed by intention to treat (ITT) and per protocol (PP). All adverse events (AE) were recorded as safety parameters. Results Time to recurrence showed no significant treatment effect (ITT analysis, p = 0.26). Change from baseline in LFI and VAS pain 50 m for the ITT population showed no treatment effect. Paracetamol consumption, patients' global assessment, responder rates and AE displayed no significant difference between treatment groups, analysed by both ITT and PP. Treatment compliance was 95% in the hyaluronan group and 99% in the placebo group. No safety problems were registered. Conclusion In patients fulfilling the ACR criteria for osteoarthritis of the knee with moderate to severe disease activity (LFI >= 10), five intra-articular injections of hyaluronan did not improve pain, function, paracetamol consumption or other efficacy parameters 3, 6, 9 and 12 months after the treatment

AB - Objective To examine the long-term efficacy and safety of five intra-articular injections with hyaluronan in knee osteoarthritis. Methods A multicentre, randomised, placebo-controlled double-blind study of 337 patients fulfilling the American College of Rheumatology (ACR) criteria for knee osteoarthritis (clinical and laboratory) and with a Lequesne algofunctional index score (LFI) of 10 or greater. Patients received a hyaluronan product (sodium hyaluronate; Hyalgan) (n= 167) or saline (n= 170) intra-articularly weekly for 5 weeks and were followed up to 1 year. Time to recurrence was the primary efficacy parameter. LFI, pain on walking 50 m based on visual analogue scale (VAS pain 50 m), paracetamol consumption, patients' global assessment, Nottingham health profile, joint effusion and number of responders were secondary efficacy parameters. The efficacy parameters were analysed by intention to treat (ITT) and per protocol (PP). All adverse events (AE) were recorded as safety parameters. Results Time to recurrence showed no significant treatment effect (ITT analysis, p = 0.26). Change from baseline in LFI and VAS pain 50 m for the ITT population showed no treatment effect. Paracetamol consumption, patients' global assessment, responder rates and AE displayed no significant difference between treatment groups, analysed by both ITT and PP. Treatment compliance was 95% in the hyaluronan group and 99% in the placebo group. No safety problems were registered. Conclusion In patients fulfilling the ACR criteria for osteoarthritis of the knee with moderate to severe disease activity (LFI >= 10), five intra-articular injections of hyaluronan did not improve pain, function, paracetamol consumption or other efficacy parameters 3, 6, 9 and 12 months after the treatment

U2 - 10.1136/ard.2009.118042

DO - 10.1136/ard.2009.118042

M3 - Journal article

SN - 0003-4967

VL - 69

SP - 1097

EP - 1102

JO - Annals of the Rheumatic Diseases

JF - Annals of the Rheumatic Diseases

IS - 6

ER -