ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 255

Clinically Meaningful Effect of Strontium Ranelate On Knee Osteoarthritis Symptoms

O. Bruyere1, N. Bellamy2, J. Brown3, P. Richette4, L. Punzi5, X. Chevalier6, Cyrus Cooper7 and Jean-Yves Reginster1, 1Department of Public Health, Epidemiology and Health Economics, University of Liège, Liège, Belgium, 2CONROD. The University of Queensland, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia, 3Rheumatology Centre,, Quebec City, QC, Canada, 4Centre Viggo Petersen / Service de Rhumatologie, Hôpital Lariboisière, Paris, France, 5Cattedra e Divisione di Reumatologia, Azienda Ospedaliera di Padova, Padova, Italy, 6Service de Rhumatologie, Hôpital Henri-Mondor, Creteil, France, 7NDORMS; MRC Lifecourse Epidemiology Unit, University of Oxford; Southampton General Hospital, Southampton, United Kingdom

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords:

Session Information

Title: Osteoarthritis - Clinical Aspects

Session Type: Abstract Submissions (ACR)

Background/Purpose: In the SEKOIA study, strontium ranelate 2g/day has been demonstrated to reduce total WOMAC score, pain subscore and global knee pain assessed using a visual analog scale (VAS) in comparison to placebo in patients with symptomatic primary knee osteoarthritis. The aim of these complementary analyses was to determine the number of patients considered as responders in terms of MPCI (Minimal Perceptible Clinical Improvement) and MCII (Minimal Clinical Important Improvement).

Methods:

SEKOIA is a double-blind, placebo-controlled, randomized, international 3-year study aiming to demonstrate the effects of strontium ranelate on the radiographic progression of knee osteoarthritis. Clinical symptoms were assessed every 6 months over 3 years by the WOMAC questionnaire and a VAS. Percentages of patients reaching MPCI or MCII published values (1,2) were compared using a chi² test.

Results:

ITT set included 1371 (82%) patients. In mean, age was 63±7 years, BMI was 30±5 kg/m2, VAS was 54±22 mm, and WOMAC was 132±62 mm.  61% were KL II and 69% were female. Over 3 years, SrRan was associated with a greater number of MPCI and MCII responders as described in the table hereafter. This suggests that a greater number of patients reaches a threshold of improvement of their knee OA symptoms considered as clinically relevant with strontium ranelate treatment over 3 years compared to placebo.

 

Placebo

(N = 472)

n (%)

Strontium ranelate 2 g

(N = 454)

n (%)

Difference relative

to placebo

[95% CI]

p-value

WOMAC Pain subscore

 

 

 

 

Patients above MPCI threshold (9.7mm)    

255 (55)

289 (65.5)

10.6 [4.2 ; 16.9]

0.001

WOMAC Stifness subscore

 

 

 

 

Patients above MPCI threshold (10mm)  

247 (52.8)

270 (60.1)

7.4 [0.9 ; 13.8]

0.025

WOMAC Physical function subscore

 

 

 

 

Patients above MPCI threshold (9.3mm)

229 (49.1)

257 (57.9)

8.7 [2.3 ; 15.2]

0.008

Patients above MCII threshold (-9.1mm)

231 (49.6)

257 (57.9)

8.3 [1.9 ; 14.8]

0.012

Knee pain by VAS

 

 

 

 

Patients above MCII threshold (-19.9mm)                

277 (59.4)                

302 (67.7)                 

8.27 [2.05; 14.49]

0.010

MPCI responders were statistically significantly greater from M18 (pain and function WOMAC subscores, p = 0.003 and p = 0.013, respectively) compared to the placebo group. Interestingly, after 2 years of treatment a significantly greater number of MPCI responders were observed for the WOMAC stiffness subscore (p = 0.008) in the strontium ranelate group. An earlier effect, close to statistical significance (p = 0.051) was also detectable for physical function MPCI responders.

Conclusion:

This study demonstrates that positive effects of Strontium Ranelate on pain and physical function in patients with knee OA are clinically meaningful. Effect is early with a greater number of MPCI responders observed as soon as 18 months of treatment.

References

1 Ehrich et al. J Rheumatol. 2000; 27:2635-41.

2 Tubach et al. Ann Rheu Dis 2005; 64. 29-33.

Disclosure:

O. Bruyere,

IBSA, Merck Sharp & Dohme, Nutraveris, Novartis, Pfizer, Rottapharm, Servier, Theramex,

2,

IBSA, Rottapharm, Servier, SMB, Merck Sharp & Dohme, Novartis, Pfizer,Theramex ,

5;

N. Bellamy,

Servier,

5;

J. Brown,

Abbott, Amgen, Arthrolab, Bristol Myers Squibb, Eli Lilly, Merck, Novartis, Pfizer, Roche, sanofi-aventis, Servier, Takeda and Warner-Chilcott,

5;

P. Richette,

Servier, Novartis, Negma, Expanscience. Wyeth Roche, Merck Sharp and Dohme, Genevrier, Ménarini. Ipsen. Pfizer. Sobi. Bioibérica. Fidia. BMS ,

5;

L. Punzi,
None;

X. Chevalier,

Expanscience, Negma, Genevriers, Merck Sharp and Dohme, Rottapharm, Fidia, Servier, Pierre Fabre, Smith Nephews,Ibsa, Genzyme,

5,

Roche for the department association,

2;

C. Cooper,

Amgen, ABBH, Novartis, Pfizer, Merck Sharp and Dohme, Eli Lilly, Servier,

5;

J. Y. Reginster,

Servier, Novartis, Negma, Lilly, Wyeth, Amgen, GlaxoSmithKline, Roche, Merckle, Nycomed, NPS, Theramex, UCB, Merck Sharp and Dohme, Lilly, Rottapharm, IBSA, Genevrier, Novartis, Servier, Roche, GlaxoSmithKline, Teijin, Teva, Ebewee Pharma, Zodiac, Analis,,

5,

Bristol Myers Squibb, Merck Sharp and Dohme, Rottapharm, Teva, Lilly, Novartis, Roche, GlaxoSmithKline, Amgen, Servier,

2.

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