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SAT0341 Strontium Ranelate Improves Osteoarthritis Symptoms Compared to Placebo in Patients with Knee OA - The Sekoia Study
  1. O. Bruyère1,2,
  2. P. Richette3,
  3. N. Bellamy4,
  4. J. Brown5,
  5. R. Chapurlat6,
  6. X. Chevalier7,
  7. E. Czerwinski E8,
  8. J. Devogelaer9,
  9. L. March10,
  10. K. Pavelka11,
  11. L. Punzi12,
  12. C. Cooper1,
  13. J. Reginster13
  1. 1MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton SO16 6YD, United Kingdom
  2. 2Public Health, Epidemiology and Health Economics and Department of Motricity Sciences, University of Liège, CHU Sart Tilman, Bat B23, Liège, Belgium
  3. 3Université Paris 7, UFR médicale, Assistance Publique-Hôpitaux de Paris, Hôpital Lariboisière, Fédération de Rhumatologie, Paris, France
  4. 4CONROD, The University of Queensland, Royal Brisbane and Women’s Hospital, Herston, Queensland, Australia
  5. 5Centre de recherche du CHU de Québec, Department of Medicine, Faculty of Medicine, Laval University and Rheumatology Division, CHU de Québec, Quebec City, Canada
  6. 6INSERM UMR 1033, Service de Rhumatologie et Pathologie Osseuse, Université de Lyon, Hôpital Edouard Herriot, Lyon
  7. 7Rhumatologie, Hôpital Henri-Mondor, University Paris XII, UPEC, 94010 Créteil, France
  8. 8Krakowskie Centrum Medyczne, ul. Kopernika 32, 31-501 Kraków, Poland
  9. 9Université catholique de Louvain, Saint-Luc university hospital, B-1200 Brussels, Belgium
  10. 10University of Sydney. Institute of Bone and Joint Research, Royal North Shore Hospital, St Leonards- Sydney, Australia
  11. 11Revmatologický ustav, Institute of Rheumatology, Na Slupi 4, 128 50 Prague 2, Czech Republic
  12. 12Department of Medicine DIMED, Medical School, University of Padova, Via Giustiniani 2, 35128 Padova, Italy
  13. 13Public Health Epidemiology and Health Economics, University of Liège, Liège, Belgium

Abstract

Objectives In SEKOIA, strontium ranelate 2g/day (SrRan) has shown a structure-modifying activity with significant symptomatic improvement compared to placebo in patients with knee OA. This analysis aimed to determine proportion of patients considered as symptomatic responders as per WOMAC pain sub-score and OMERACT-OARSI-like responders, as well as the number of patients reaching MPCI (Minimal Perceptible Clinical Improvement) and MCII (Minimal Clinical Important Improvement).

Methods SEKOIA was a double-blind, placebo-controlled, randomized, 3-year study aiming to demonstrate effects of strontium ranelate on radiographic progression of knee OA. It included men and women over 50 years old, with symptomatic primary knee OA (at least 40 on 100 mm VAS on most days of previous month, Kellgren and Lawrence [KL] grade 2 or 3, and JSW 2.5–5mm). Symptoms were assessed every 6 months using the WOMAC questionnaire. Proportions of patients with at least 20% or 50% improvement from baseline of WOMAC pain sub-score, proportion of OMERACT-OARSI-like responders (calculated without patient’s global assessment as it was not assessed in SEKOIA) and percentages of patients reaching MPCI or MCII values, were compared between groups using a chi² test. Patients prematurely withdrawn from the study were counted as non-responding patients.

Results ITT population included 1371(82%) patients. Mean±SD age was 63±7years, BMI 30±5 kg/m2, and WOMAC 132±62 mm. 66 % were KL grade II and 69% were female. Over 3 years, a greater percentage of patients treated with SrRan 2g were considered as symptomatic responders compared to placebo:

For physical function, MCII and MPCI responders were statistically significantly greater in the SrRan 2g group compared to the placebo group from M12 (p=0.019 and p=0.027, respectively). For pain, the rate of responders was greater in the SrRan 2g group from M6 (p=0.024).

Conclusions SrRan treatment is associated with greater number of patients with relevant improvement in symptoms. This can be evidenced from M6 considering MPCI pain responders.

Disclosure of Interest O. Bruyère Grant/research support from: IBSA, Merck Sharp & Dohme, Nutraveris, Novartis, Pfizer, Rottapharm, Servier, Theramex, P. Richette Consultant for: Servier, Novartis, Negma, Expanscience. Wyeth Roche, Merck Sharp and Dohme, Genevrier, Ménarini. Ipsen. Pfizer. Sobi. Bioibérica. Fidia. BMS, Paid instructor for: Servier, Novartis, Negma, Expanscience. Wyeth Roche, Merck Sharp and Dohme, Genevrier, Ménarini. Ipsen. Pfizer. Sobi. Bioibérica. Fidia. BMS, N. Bellamy Shareholder of: Registered copyright and trademark holder of the WOMAC® Index, Consultant for: Servier, J. Brown Grant/research support from: Abbott, Amgen, Arthrolab, Bristol Myers Squibb, Eli Lilly, Merck, Novartis, Pfizer, Roche, sanofi-aventis, Servier, Takeda and Warner-Chilcott, Consultant for: Abbott, Amgen, Arthrolab, Bristol Myers Squibb, Eli Lilly, Merck, Novartis, Pfizer, Roche, sanofi-aventis, Servier, Takeda and Warner-Chilcott, Speakers bureau: Abbott, Amgen, Arthrolab, Bristol Myers Squibb, Eli Lilly, Merck, Novartis, Pfizer, Roche, sanofi-aventis, Servier, Takeda and Warner-Chilcott, R. Chapurlat Grant/research support from: Merck, Amgen, Servier, Lilly, Roche, Novartis, X. Chevalier Grant/research support from: Roche for the department association, Consultant for: Expanscience, Negma, Genevriers, Merck Sharp and Dohme, Rottapharm, Fidia, Servier, Pierre Fabre, Smith Nephews, Paid instructor for: Merck Sharp and Dohme, Servier, Expanscience, Ibsa, Genzyme, E. Czerwinski E Grant/research support from: Amgen, Andromeda Biotech Ltd., AstraZeneca, Biotest AG, Eli Lilly, INC Research, Johnson&Johnson, Merck Serono, Novartis, Pfizer, Roche, Servier, Shire Movetis, J. Devogelaer Consultant for: Novartis, Paid instructor for: Merck, Sharpe & Dohme, Servier, Procter & Gamble, Roche, and Amgen, L. March Grant/research support from: Servier, MSD, Pfizer, Abbott, UCB, Paid instructor for: Servier, MSD, Pfizer, Abbott, UCB, K. Pavelka Paid instructor for: BMS, Abbott, Pfizer, MSD, Amgen, L. Punzi Grant/research support from: Abbott SpA, Menarini Spa, Fidia SpA, Sobi SpA, UCB SpA, Consultant for: Abbott SpA, Menarini Spa, Fidia SpA, Sobi SpA, UCB SpA, C. Cooper Consultant for: Amgen, ABBH, Novartis, Pfizer, Merck Sharp and Dohme, Eli Lilly, Servier, J. Reginster Grant/research support from: Bristol Myers Squibb, Merck Sharp and Dohme, Rottapharm, Teva, Lilly, Novartis, Roche, GlaxoSmithKline, Amgen, Servier, Consultant for: Servier, Novartis, Negma, Lilly, Wyeth, Amgen, GlaxoSmithKline, Roche, Merckle, Nycomed, NPS, Theramex, UCB, Paid instructor for: Merck Sharp and Dohme, Lilly, Rottapharm, IBSA, Genevrier, Novartis, Servier, Roche, GlaxoSmithKline, Teijin, Teva, Ebewee Pharma, Zodiac, Analis, Theramex, Nycomed, Novo-Nordisk.

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