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SAT0341 Strontium Ranelate Improves Osteoarthritis Symptoms Compared to Placebo in Patients with Knee OA - The Sekoia Study

Identifieur interne : 001A64 ( Istex/Corpus ); précédent : 001A63; suivant : 001A65

SAT0341 Strontium Ranelate Improves Osteoarthritis Symptoms Compared to Placebo in Patients with Knee OA - The Sekoia Study

Auteurs : O. Bruyère ; P. Richette ; N. Bellamy ; J. Brown ; R. Chapurlat ; X. Chevalier ; E. Czerwinski E ; J. Devogelaer ; L. March ; K. Pavelka ; L. Punzi ; C. Cooper ; J. Reginster

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RBID : ISTEX:8D0E840F653A776E14FB2D1805104116F2673E6C

English descriptors

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 Patients prematurely withdrawn from the study were counted as non-responding patients.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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DOI: 10.1136/annrheumdis-2013-eular.2066

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ISTEX:8D0E840F653A776E14FB2D1805104116F2673E6C

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<div type="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.</div>
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<affiliation>Rhumatologie, Hôpital Henri-Mondor, University Paris XII, UPEC, 94010 Créteil, France</affiliation>
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<affiliation>Krakowskie Centrum Medyczne, ul. Kopernika 32, 31-501 Kraków, Poland</affiliation>
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<affiliation>Université catholique de Louvain, Saint-Luc university hospital, B-1200 Brussels, Belgium</affiliation>
<affiliation>Université catholique de Louvain, Saint-Luc university hospital, B-1200 Brussels, Belgium</affiliation>
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<affiliation>University of Sydney. Institute of Bone and Joint Research, Royal North Shore Hospital, St Leonards- Sydney, Australia</affiliation>
<affiliation>University of Sydney. Institute of Bone and Joint Research, Royal North Shore Hospital, St Leonards- Sydney, Australia</affiliation>
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<forename type="first">K.</forename>
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<affiliation>Revmatologický ustav, Institute of Rheumatology, Na Slupi 4, 128 50 Prague 2, Czech Republic</affiliation>
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<forename type="first">L.</forename>
<surname>Punzi</surname>
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<affiliation>Department of Medicine DIMED, Medical School, University of Padova, Via Giustiniani 2, 35128 Padova, Italy</affiliation>
<affiliation>Department of Medicine DIMED, Medical School, University of Padova, Via Giustiniani 2, 35128 Padova, Italy</affiliation>
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<affiliation>MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton SO16 6YD, United Kingdom</affiliation>
<affiliation>MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton SO16 6YD, United Kingdom</affiliation>
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<p>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.</p>
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<article-categories>
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<subject>Scientific Abstracts</subject>
<subj-group>
<subject>Osteoarthritis</subject>
</subj-group>
</subj-group>
</article-categories>
<title-group>
<article-title>SAT0341 Strontium Ranelate Improves Osteoarthritis Symptoms Compared to Placebo in Patients with Knee OA - The Sekoia Study</article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author" xlink:type="simple">
<name name-style="western">
<surname>Bruyère</surname>
<given-names>O.</given-names>
</name>
<xref ref-type="aff" rid="af03411">
<sup>1</sup>
</xref>
<xref ref-type="aff" rid="af03412">
<sup>2</sup>
</xref>
</contrib>
<contrib contrib-type="author" xlink:type="simple">
<name name-style="western">
<surname>Richette</surname>
<given-names>P.</given-names>
</name>
<xref ref-type="aff" rid="af03413">
<sup>3</sup>
</xref>
</contrib>
<contrib contrib-type="author" xlink:type="simple">
<name name-style="western">
<surname>Bellamy</surname>
<given-names>N.</given-names>
</name>
<xref ref-type="aff" rid="af03414">
<sup>4</sup>
</xref>
</contrib>
<contrib contrib-type="author" xlink:type="simple">
<name name-style="western">
<surname>Brown</surname>
<given-names>J.</given-names>
</name>
<xref ref-type="aff" rid="af03415">
<sup>5</sup>
</xref>
</contrib>
<contrib contrib-type="author" xlink:type="simple">
<name name-style="western">
<surname>Chapurlat</surname>
<given-names>R.</given-names>
</name>
<xref ref-type="aff" rid="af03416">
<sup>6</sup>
</xref>
</contrib>
<contrib contrib-type="author" xlink:type="simple">
<name name-style="western">
<surname>Chevalier</surname>
<given-names>X.</given-names>
</name>
<xref ref-type="aff" rid="af03417">
<sup>7</sup>
</xref>
</contrib>
<contrib contrib-type="author" xlink:type="simple">
<name name-style="western">
<surname>Czerwinski E</surname>
<given-names>E.</given-names>
</name>
<xref ref-type="aff" rid="af03418">
<sup>8</sup>
</xref>
</contrib>
<contrib contrib-type="author" xlink:type="simple">
<name name-style="western">
<surname>Devogelaer</surname>
<given-names>J.</given-names>
</name>
<xref ref-type="aff" rid="af03419">
<sup>9</sup>
</xref>
</contrib>
<contrib contrib-type="author" xlink:type="simple">
<name name-style="western">
<surname>March</surname>
<given-names>L.</given-names>
</name>
<xref ref-type="aff" rid="af034110">
<sup>10</sup>
</xref>
</contrib>
<contrib contrib-type="author" xlink:type="simple">
<name name-style="western">
<surname>Pavelka</surname>
<given-names>K.</given-names>
</name>
<xref ref-type="aff" rid="af034111">
<sup>11</sup>
</xref>
</contrib>
<contrib contrib-type="author" xlink:type="simple">
<name name-style="western">
<surname>Punzi</surname>
<given-names>L.</given-names>
</name>
<xref ref-type="aff" rid="af034112">
<sup>12</sup>
</xref>
</contrib>
<contrib contrib-type="author" xlink:type="simple">
<name name-style="western">
<surname>Cooper</surname>
<given-names>C.</given-names>
</name>
<xref ref-type="aff" rid="af03411">
<sup>1</sup>
</xref>
</contrib>
<contrib contrib-type="author" xlink:type="simple">
<name name-style="western">
<surname>Reginster</surname>
<given-names>J.</given-names>
</name>
<xref ref-type="aff" rid="af034113">
<sup>13</sup>
</xref>
</contrib>
</contrib-group>
<aff id="af03411">
<sup>1</sup>
MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton SO16 6YD, United Kingdom</aff>
<aff id="af03412">
<sup>2</sup>
Public Health, Epidemiology and Health Economics and Department of Motricity Sciences, University of Liège, CHU Sart Tilman, Bat B23, Liège, Belgium</aff>
<aff id="af03413">
<sup>3</sup>
Université Paris 7, UFR médicale, Assistance Publique-Hôpitaux de Paris, Hôpital Lariboisière, Fédération de Rhumatologie, Paris, France</aff>
<aff id="af03414">
<sup>4</sup>
CONROD, The University of Queensland, Royal Brisbane and Women’s Hospital, Herston, Queensland, Australia</aff>
<aff id="af03415">
<sup>5</sup>
Centre de recherche du CHU de Québec, Department of Medicine, Faculty of Medicine, Laval University and Rheumatology Division, CHU de Québec, Quebec City, Canada</aff>
<aff id="af03416">
<sup>6</sup>
INSERM UMR 1033, Service de Rhumatologie et Pathologie Osseuse, Université de Lyon, Hôpital Edouard Herriot, Lyon</aff>
<aff id="af03417">
<sup>7</sup>
Rhumatologie, Hôpital Henri-Mondor, University Paris XII, UPEC, 94010 Créteil, France</aff>
<aff id="af03418">
<sup>8</sup>
Krakowskie Centrum Medyczne, ul. Kopernika 32, 31-501 Kraków, Poland</aff>
<aff id="af03419">
<sup>9</sup>
Université catholique de Louvain, Saint-Luc university hospital, B-1200 Brussels, Belgium</aff>
<aff id="af034110">
<sup>10</sup>
University of Sydney. Institute of Bone and Joint Research, Royal North Shore Hospital, St Leonards- Sydney, Australia</aff>
<aff id="af034111">
<sup>11</sup>
Revmatologický ustav, Institute of Rheumatology, Na Slupi 4, 128 50 Prague 2, Czech Republic</aff>
<aff id="af034112">
<sup>12</sup>
Department of Medicine DIMED, Medical School, University of Padova, Via Giustiniani 2, 35128 Padova, Italy</aff>
<aff id="af034113">
<sup>13</sup>
Public Health Epidemiology and Health Economics, University of Liège, Liège, Belgium</aff>
<pub-date pub-type="ppub">
<month>06</month>
<year>2013</year>
</pub-date>
<volume>72</volume>
<volume-id pub-id-type="other">72</volume-id>
<volume-id pub-id-type="other">72</volume-id>
<issue>Suppl 3</issue>
<issue-id pub-id-type="other">annrheumdis;72/Suppl_3</issue-id>
<issue-id pub-id-type="other" content-type="supplement">Suppl_3</issue-id>
<issue-id pub-id-type="other">72/Suppl_3</issue-id>
<issue-title>Annual European Congress of Rheumatology EULAR abstracts 2013, 12–15 June 2013, Spain</issue-title>
<fpage seq="2">A698</fpage>
<permissions>
<copyright-statement>© 2013, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</copyright-statement>
<copyright-year>2013</copyright-year>
</permissions>
<self-uri content-type="pdf" xlink:role="full-text" xlink:href="annrheumdis-72-A698-2.pdf"></self-uri>
<abstract>
<sec>
<title>Objectives</title>
<p>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).</p>
</sec>
<sec>
<title>Methods</title>
<p>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.</p>
</sec>
<sec>
<title>Results</title>
<p>ITT population included 1371(82%) patients. Mean±SD age was 63±7years, BMI 30±5 kg/m
<sup>2</sup>
, 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:</p>
<fig id="UT1" position="float">
<graphic xlink:href="annrheumdis-72-A698-2-F1.jpg" alt-version="no" position="float" xlink:type="simple"></graphic>
</fig>
<p>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).</p>
</sec>
<sec>
<title>Conclusions</title>
<p>SrRan treatment is associated with greater number of patients with relevant improvement in symptoms. This can be evidenced from M6 considering MPCI pain responders.</p>
</sec>
<sec>
<title>Disclosure of Interest</title>
<p>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.</p>
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<affiliation>MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton SO16 6YD, United Kingdom</affiliation>
<affiliation>Public Health, Epidemiology and Health Economics and Department of Motricity Sciences, University of Liège, CHU Sart Tilman, Bat B23, Liège, Belgium</affiliation>
<affiliation>MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton SO16 6YD, United Kingdom</affiliation>
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<namePart type="family">Richette</namePart>
<affiliation>Université Paris 7, UFR médicale, Assistance Publique-Hôpitaux de Paris, Hôpital Lariboisière, Fédération de Rhumatologie, Paris, France</affiliation>
<affiliation>Université Paris 7, UFR médicale, Assistance Publique-Hôpitaux de Paris, Hôpital Lariboisière, Fédération de Rhumatologie, Paris, France</affiliation>
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</role>
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<name type="personal">
<namePart type="given">N.</namePart>
<namePart type="family">Bellamy</namePart>
<affiliation>CONROD, The University of Queensland, Royal Brisbane and Women’s Hospital, Herston, Queensland, Australia</affiliation>
<affiliation>CONROD, The University of Queensland, Royal Brisbane and Women’s Hospital, Herston, Queensland, Australia</affiliation>
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<namePart type="given">J.</namePart>
<namePart type="family">Brown</namePart>
<affiliation>Centre de recherche du CHU de Québec, Department of Medicine, Faculty of Medicine, Laval University and Rheumatology Division, CHU de Québec, Quebec City, Canada</affiliation>
<affiliation>Centre de recherche du CHU de Québec, Department of Medicine, Faculty of Medicine, Laval University and Rheumatology Division, CHU de Québec, Quebec City, Canada</affiliation>
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<namePart type="given">R.</namePart>
<namePart type="family">Chapurlat</namePart>
<affiliation>INSERM UMR 1033, Service de Rhumatologie et Pathologie Osseuse, Université de Lyon, Hôpital Edouard Herriot, Lyon</affiliation>
<affiliation>INSERM UMR 1033, Service de Rhumatologie et Pathologie Osseuse, Université de Lyon, Hôpital Edouard Herriot, Lyon</affiliation>
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<roleTerm type="text">author</roleTerm>
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<namePart type="given">X.</namePart>
<namePart type="family">Chevalier</namePart>
<affiliation>Rhumatologie, Hôpital Henri-Mondor, University Paris XII, UPEC, 94010 Créteil, France</affiliation>
<affiliation>Rhumatologie, Hôpital Henri-Mondor, University Paris XII, UPEC, 94010 Créteil, France</affiliation>
<role>
<roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal">
<namePart type="given">E.</namePart>
<namePart type="family">Czerwinski E</namePart>
<affiliation>Krakowskie Centrum Medyczne, ul. Kopernika 32, 31-501 Kraków, Poland</affiliation>
<affiliation>Krakowskie Centrum Medyczne, ul. Kopernika 32, 31-501 Kraków, Poland</affiliation>
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<namePart type="given">J.</namePart>
<namePart type="family">Devogelaer</namePart>
<affiliation>Université catholique de Louvain, Saint-Luc university hospital, B-1200 Brussels, Belgium</affiliation>
<affiliation>Université catholique de Louvain, Saint-Luc university hospital, B-1200 Brussels, Belgium</affiliation>
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<roleTerm type="text">author</roleTerm>
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<namePart type="given">L.</namePart>
<namePart type="family">March</namePart>
<affiliation>University of Sydney. Institute of Bone and Joint Research, Royal North Shore Hospital, St Leonards- Sydney, Australia</affiliation>
<affiliation>University of Sydney. Institute of Bone and Joint Research, Royal North Shore Hospital, St Leonards- Sydney, Australia</affiliation>
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<namePart type="family">Pavelka</namePart>
<affiliation>Revmatologický ustav, Institute of Rheumatology, Na Slupi 4, 128 50 Prague 2, Czech Republic</affiliation>
<affiliation>Revmatologický ustav, Institute of Rheumatology, Na Slupi 4, 128 50 Prague 2, Czech Republic</affiliation>
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<namePart type="given">L.</namePart>
<namePart type="family">Punzi</namePart>
<affiliation>Department of Medicine DIMED, Medical School, University of Padova, Via Giustiniani 2, 35128 Padova, Italy</affiliation>
<affiliation>Department of Medicine DIMED, Medical School, University of Padova, Via Giustiniani 2, 35128 Padova, Italy</affiliation>
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<affiliation>MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton SO16 6YD, United Kingdom</affiliation>
<affiliation>MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton SO16 6YD, United Kingdom</affiliation>
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<namePart type="given">J.</namePart>
<namePart type="family">Reginster</namePart>
<affiliation>Public Health Epidemiology and Health Economics, University of Liège, Liège, Belgium</affiliation>
<affiliation>Public Health Epidemiology and Health Economics, University of Liège, Liège, Belgium</affiliation>
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<dateIssued encoding="w3cdtf">2013-06</dateIssued>
<copyrightDate encoding="w3cdtf">2013</copyrightDate>
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<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.</abstract>
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<topic>Osteoarthritis</topic>
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<identifier type="ISSN">0003-4967</identifier>
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