SAT0341 Strontium Ranelate Improves Osteoarthritis Symptoms Compared to Placebo in Patients with Knee OA - The Sekoia Study. (23rd January 2014)

• Record Type: Journal Article
• Authors: Bruyère, O.; Richette, P.; Bellamy, N.; Brown, J.; Chapurlat, R.; Chevalier, X.; Czerwinski E, E.; Devogelaer, J.; March, L.; Pavelka, K.; Punzi, L.; Cooper, C.; Reginster, J.
• Is Part Of: Annals of the rheumatic diseases. Volume 72:Supplement 3(2013)
• Page Start: A698
• Page End: A699
• Publication Date: 2014-01-23
• Subjects: Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2013-eular.2066
• Languages: English
• ISSNs: 0003-4967

Abstract

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 Patients prematurely withdrawn from the study were counted as non-responding patients.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/m 2, 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.