OP0114 Inefficacy of Hydroxychoroquine in Primary Sjögren’s Syndrome: Results at 12 Months of the Randomized Placebo-Controlled Trial of Plaquenil in Primary Sjögren’s Syndrome
Identifieur interne : 000734 ( Istex/Corpus ); précédent : 000733; suivant : 000735OP0114 Inefficacy of Hydroxychoroquine in Primary Sjögren’s Syndrome: Results at 12 Months of the Randomized Placebo-Controlled Trial of Plaquenil in Primary Sjögren’s Syndrome
Auteurs : J. E. Gottenberg ; P. Ravaud ; X. Puechal ; V. Le Guern ; J. Sibilia ; V. Goeb ; C. Larroche ; J. J. Dubost ; S. Rist ; A. Saraux ; V. Devauchelle ; J. Morel ; G. Hayem ; E. Hachulla ; A. Perdriger ; D. Sene ; C. Zarnitsky ; E. Perrodeau ; D. Batouche ; V. Furlan ; J. Benessiano ; R. Seror ; X. MarietteSource :
- Annals of the Rheumatic Diseases [ 0003-4967 ] ; 2013-06.
Abstract
Background Hydroxychloroquine (HQ, Plaquenil) is often prescribed in patients with primary Sjögren’s syndrome (pSS). However, except a crossover trial, no controlled trial has ever evaluated HQ versus placebo. ObjectivesMethods 120 patients with pSS were randomly assigned to receive HQ (400 mg/j) or placebo for 24 weeks (controlled phase) and were all prescribed HQ between week 24 and week 48 (open extension). All patients fulfilled the AECG criteria. A favorable overall response (primary outcome criteria) was defined as the patient having >or= 30% improvement between weeks 0 and 24 in the values on 2 of the 3 patient’s VAS evaluating dryness, pain and fatigue. Secondary end points were the evolution of the ESSDAI, the ESSPRI, Schirmer’s test and unstimulated salivary flow, serum gammaglobulin levels, and of SF-36, HAD, PROFAD, and SSI. Serum interferon-regulated chemokines (CXCL10, CCL2 and CCL19) were assessed at baseline and W24 in the 45 patients with available serum. Results Baseline characteristics of the 120 patients were as following: mean age 55.9 years, 91.7% of women, median disease duration: 5 years, anti-SSA positivity : 55.1%, patients with systemic involvement at enrollment: 30%. At 6 months, 19.2% of patients receiving placebo and 19.6% of patients treated with HQ had a favorable overall response (p = 0.9). At 12 months, 18.8% of patients treated for 6 months with placebo, then 6 months with HQ and 32.1% patients treated with 12 months with HQ were responders (p= 0.1). No significant difference was observed in any of the secondary outcome criteria. No significant difference was observed in patients with anti-SSA autoantibodies, high IgG levels, or systemic involvement. In patients treated with HQ, a trend towards a decrease of serum IgG was observed, as well as a significant decrease of IgM. In patients with HQ, a decrease in serum CXCL10 (from 50.5 to 35.8 pg/ml vs from 27.7 to 38.7 pg/ml under placebo, p=0.001) and CCL19 (from 241.6 to 160.9 pg/ml vs from 142.3 to 131.1 pg/ml, p=0.3), but not CCL2, was observed. In the HQ arm, all except 1 had detectable blood levels of HQ at 6 months. Baseline levels of HQ or of IFN-regulated chemokines were not associated with a favorable overall response. Tolerance of HQ was comparable to placebo. Conclusions The results of this controlled trial did not show any evidence of short term efficacy of HQ in pSS. HQ induced a decrease in serum level of CXCL10 and CCL19, 2 IFN-induced chemokines but no association with response to HQ could be identified in any subgroup of patients. Disclosure of Interest None Declared
Url:
DOI: 10.1136/annrheumdis-2013-eular.319
Links to Exploration step
ISTEX:6957B01E0820E02B882EF2308BD862DF4E2A7629Le document en format XML
<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">OP0114 Inefficacy of Hydroxychoroquine in Primary Sjögren’s Syndrome: Results at 12 Months of the Randomized Placebo-Controlled Trial of Plaquenil in Primary Sjögren’s Syndrome</title><author><name sortKey="Gottenberg, J E" sort="Gottenberg, J E" uniqKey="Gottenberg J" first="J. E." last="Gottenberg">J. E. Gottenberg</name><affiliation><mods:affiliation>Rhumatology, Chu, Strasbourg</mods:affiliation></affiliation></author><author><name sortKey="Ravaud, P" sort="Ravaud, P" uniqKey="Ravaud P" first="P." last="Ravaud">P. Ravaud</name><affiliation><mods:affiliation>Epidemiology, INSERM U738</mods:affiliation></affiliation></author><author><name sortKey="Puechal, X" sort="Puechal, X" uniqKey="Puechal X" first="X." last="Puechal">X. Puechal</name><affiliation><mods:affiliation>Internal Medicine, Chu, Paris</mods:affiliation></affiliation></author><author><name sortKey="Le Guern, V" sort="Le Guern, V" uniqKey="Le Guern V" first="V." last="Le Guern">V. Le Guern</name><affiliation><mods:affiliation>Internal Medicine, Chu, Paris</mods:affiliation></affiliation></author><author><name sortKey="Sibilia, J" sort="Sibilia, J" uniqKey="Sibilia J" first="J." last="Sibilia">J. Sibilia</name><affiliation><mods:affiliation>Rhumatology, Chu, Strasbourg</mods:affiliation></affiliation></author><author><name sortKey="Goeb, V" sort="Goeb, V" uniqKey="Goeb V" first="V." last="Goeb">V. Goeb</name><affiliation><mods:affiliation>Rhumatology, Chu, Rouen</mods:affiliation></affiliation></author><author><name sortKey="Larroche, C" sort="Larroche, C" uniqKey="Larroche C" first="C." last="Larroche">C. Larroche</name><affiliation><mods:affiliation>Rhumatology, Chu, Bobigny</mods:affiliation></affiliation></author><author><name sortKey="Dubost, J J" sort="Dubost, J J" uniqKey="Dubost J" first="J. J." last="Dubost">J. J. Dubost</name><affiliation><mods:affiliation>Rhumatology, Chu, Clermont Ferrand</mods:affiliation></affiliation></author><author><name sortKey="Rist, S" sort="Rist, S" uniqKey="Rist S" first="S." last="Rist">S. Rist</name><affiliation><mods:affiliation>Rhumatology, Chu, Orleans</mods:affiliation></affiliation></author><author><name sortKey="Saraux, A" sort="Saraux, A" uniqKey="Saraux A" first="A." last="Saraux">A. Saraux</name><affiliation><mods:affiliation>Rhumatology, Chu, Brest</mods:affiliation></affiliation></author><author><name sortKey="Devauchelle, V" sort="Devauchelle, V" uniqKey="Devauchelle V" first="V." last="Devauchelle">V. Devauchelle</name><affiliation><mods:affiliation>Rhumatology, Chu, Brest</mods:affiliation></affiliation></author><author><name sortKey="Morel, J" sort="Morel, J" uniqKey="Morel J" first="J." last="Morel">J. Morel</name><affiliation><mods:affiliation>Rhumatology, Chu, Montpellier</mods:affiliation></affiliation></author><author><name sortKey="Hayem, G" sort="Hayem, G" uniqKey="Hayem G" first="G." last="Hayem">G. Hayem</name><affiliation><mods:affiliation>Rhumatology, Chu, Paris</mods:affiliation></affiliation></author><author><name sortKey="Hachulla, E" sort="Hachulla, E" uniqKey="Hachulla E" first="E." last="Hachulla">E. Hachulla</name><affiliation><mods:affiliation>Internal Medicine, Chu, Lille</mods:affiliation></affiliation></author><author><name sortKey="Perdriger, A" sort="Perdriger, A" uniqKey="Perdriger A" first="A." last="Perdriger">A. Perdriger</name><affiliation><mods:affiliation>Rhumatology, Chu, Rennes</mods:affiliation></affiliation></author><author><name sortKey="Sene, D" sort="Sene, D" uniqKey="Sene D" first="D." last="Sene">D. Sene</name><affiliation><mods:affiliation>Internal Medicine, Chu, Paris</mods:affiliation></affiliation></author><author><name sortKey="Zarnitsky, C" sort="Zarnitsky, C" uniqKey="Zarnitsky C" first="C." last="Zarnitsky">C. Zarnitsky</name><affiliation><mods:affiliation>Rhumatology, Chu, Le Havre</mods:affiliation></affiliation></author><author><name sortKey="Perrodeau, E" sort="Perrodeau, E" uniqKey="Perrodeau E" first="E." last="Perrodeau">E. Perrodeau</name><affiliation><mods:affiliation>Epidemiology</mods:affiliation></affiliation></author><author><name sortKey="Batouche, D" sort="Batouche, D" uniqKey="Batouche D" first="D." last="Batouche">D. Batouche</name><affiliation><mods:affiliation>Rhumatology, Chu, Paris</mods:affiliation></affiliation></author><author><name sortKey="Furlan, V" sort="Furlan, V" uniqKey="Furlan V" first="V." last="Furlan">V. Furlan</name><affiliation><mods:affiliation>Pharmacology</mods:affiliation></affiliation></author><author><name sortKey="Benessiano, J" sort="Benessiano, J" uniqKey="Benessiano J" first="J." last="Benessiano">J. Benessiano</name><affiliation><mods:affiliation>Biology, Chu, Paris, France</mods:affiliation></affiliation></author><author><name sortKey="Seror, R" sort="Seror, R" uniqKey="Seror R" first="R." last="Seror">R. Seror</name><affiliation><mods:affiliation>Rhumatology, Chu, Paris</mods:affiliation></affiliation></author><author><name sortKey="Mariette, X" sort="Mariette, X" uniqKey="Mariette X" first="X." last="Mariette">X. Mariette</name><affiliation><mods:affiliation>Rhumatology, Chu, Paris</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:6957B01E0820E02B882EF2308BD862DF4E2A7629</idno><date when="2013" year="2013">2013</date><idno type="doi">10.1136/annrheumdis-2013-eular.319</idno><idno type="url">https://api.istex.fr/document/6957B01E0820E02B882EF2308BD862DF4E2A7629/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">000734</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">OP0114 Inefficacy of Hydroxychoroquine in Primary Sjögren’s Syndrome: Results at 12 Months of the Randomized Placebo-Controlled Trial of Plaquenil in Primary Sjögren’s Syndrome</title><author><name sortKey="Gottenberg, J E" sort="Gottenberg, J E" uniqKey="Gottenberg J" first="J. E." last="Gottenberg">J. E. Gottenberg</name><affiliation><mods:affiliation>Rhumatology, Chu, Strasbourg</mods:affiliation></affiliation></author><author><name sortKey="Ravaud, P" sort="Ravaud, P" uniqKey="Ravaud P" first="P." last="Ravaud">P. Ravaud</name><affiliation><mods:affiliation>Epidemiology, INSERM U738</mods:affiliation></affiliation></author><author><name sortKey="Puechal, X" sort="Puechal, X" uniqKey="Puechal X" first="X." last="Puechal">X. Puechal</name><affiliation><mods:affiliation>Internal Medicine, Chu, Paris</mods:affiliation></affiliation></author><author><name sortKey="Le Guern, V" sort="Le Guern, V" uniqKey="Le Guern V" first="V." last="Le Guern">V. Le Guern</name><affiliation><mods:affiliation>Internal Medicine, Chu, Paris</mods:affiliation></affiliation></author><author><name sortKey="Sibilia, J" sort="Sibilia, J" uniqKey="Sibilia J" first="J." last="Sibilia">J. Sibilia</name><affiliation><mods:affiliation>Rhumatology, Chu, Strasbourg</mods:affiliation></affiliation></author><author><name sortKey="Goeb, V" sort="Goeb, V" uniqKey="Goeb V" first="V." last="Goeb">V. Goeb</name><affiliation><mods:affiliation>Rhumatology, Chu, Rouen</mods:affiliation></affiliation></author><author><name sortKey="Larroche, C" sort="Larroche, C" uniqKey="Larroche C" first="C." last="Larroche">C. Larroche</name><affiliation><mods:affiliation>Rhumatology, Chu, Bobigny</mods:affiliation></affiliation></author><author><name sortKey="Dubost, J J" sort="Dubost, J J" uniqKey="Dubost J" first="J. J." last="Dubost">J. J. Dubost</name><affiliation><mods:affiliation>Rhumatology, Chu, Clermont Ferrand</mods:affiliation></affiliation></author><author><name sortKey="Rist, S" sort="Rist, S" uniqKey="Rist S" first="S." last="Rist">S. Rist</name><affiliation><mods:affiliation>Rhumatology, Chu, Orleans</mods:affiliation></affiliation></author><author><name sortKey="Saraux, A" sort="Saraux, A" uniqKey="Saraux A" first="A." last="Saraux">A. Saraux</name><affiliation><mods:affiliation>Rhumatology, Chu, Brest</mods:affiliation></affiliation></author><author><name sortKey="Devauchelle, V" sort="Devauchelle, V" uniqKey="Devauchelle V" first="V." last="Devauchelle">V. Devauchelle</name><affiliation><mods:affiliation>Rhumatology, Chu, Brest</mods:affiliation></affiliation></author><author><name sortKey="Morel, J" sort="Morel, J" uniqKey="Morel J" first="J." last="Morel">J. Morel</name><affiliation><mods:affiliation>Rhumatology, Chu, Montpellier</mods:affiliation></affiliation></author><author><name sortKey="Hayem, G" sort="Hayem, G" uniqKey="Hayem G" first="G." last="Hayem">G. Hayem</name><affiliation><mods:affiliation>Rhumatology, Chu, Paris</mods:affiliation></affiliation></author><author><name sortKey="Hachulla, E" sort="Hachulla, E" uniqKey="Hachulla E" first="E." last="Hachulla">E. Hachulla</name><affiliation><mods:affiliation>Internal Medicine, Chu, Lille</mods:affiliation></affiliation></author><author><name sortKey="Perdriger, A" sort="Perdriger, A" uniqKey="Perdriger A" first="A." last="Perdriger">A. Perdriger</name><affiliation><mods:affiliation>Rhumatology, Chu, Rennes</mods:affiliation></affiliation></author><author><name sortKey="Sene, D" sort="Sene, D" uniqKey="Sene D" first="D." last="Sene">D. Sene</name><affiliation><mods:affiliation>Internal Medicine, Chu, Paris</mods:affiliation></affiliation></author><author><name sortKey="Zarnitsky, C" sort="Zarnitsky, C" uniqKey="Zarnitsky C" first="C." last="Zarnitsky">C. Zarnitsky</name><affiliation><mods:affiliation>Rhumatology, Chu, Le Havre</mods:affiliation></affiliation></author><author><name sortKey="Perrodeau, E" sort="Perrodeau, E" uniqKey="Perrodeau E" first="E." last="Perrodeau">E. Perrodeau</name><affiliation><mods:affiliation>Epidemiology</mods:affiliation></affiliation></author><author><name sortKey="Batouche, D" sort="Batouche, D" uniqKey="Batouche D" first="D." last="Batouche">D. Batouche</name><affiliation><mods:affiliation>Rhumatology, Chu, Paris</mods:affiliation></affiliation></author><author><name sortKey="Furlan, V" sort="Furlan, V" uniqKey="Furlan V" first="V." last="Furlan">V. Furlan</name><affiliation><mods:affiliation>Pharmacology</mods:affiliation></affiliation></author><author><name sortKey="Benessiano, J" sort="Benessiano, J" uniqKey="Benessiano J" first="J." last="Benessiano">J. Benessiano</name><affiliation><mods:affiliation>Biology, Chu, Paris, France</mods:affiliation></affiliation></author><author><name sortKey="Seror, R" sort="Seror, R" uniqKey="Seror R" first="R." last="Seror">R. Seror</name><affiliation><mods:affiliation>Rhumatology, Chu, Paris</mods:affiliation></affiliation></author><author><name sortKey="Mariette, X" sort="Mariette, X" uniqKey="Mariette X" first="X." last="Mariette">X. Mariette</name><affiliation><mods:affiliation>Rhumatology, Chu, Paris</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Annals of the Rheumatic Diseases</title><title level="j" type="abbrev">Ann Rheum Dis</title><idno type="ISSN">0003-4967</idno><idno type="eISSN">1468-2060</idno><imprint><publisher>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher><date type="published" when="2013-06">2013-06</date><biblScope unit="volume">72</biblScope><biblScope unit="issue">Suppl 3</biblScope><biblScope unit="page" from="A90">A90</biblScope></imprint><idno type="ISSN">0003-4967</idno></series><idno type="istex">6957B01E0820E02B882EF2308BD862DF4E2A7629</idno><idno type="DOI">10.1136/annrheumdis-2013-eular.319</idno><idno type="href">annrheumdis-72-A90-1.pdf</idno><idno type="ArticleID">annrheumdis-2013-eular.319</idno><idno type="local">annrheumdis;72/Suppl_3/A90-a</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0003-4967</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">Background Hydroxychloroquine (HQ, Plaquenil) is often prescribed in patients with primary Sjögren’s syndrome (pSS). However, except a crossover trial, no controlled trial has ever evaluated HQ versus placebo. ObjectivesMethods 120 patients with pSS were randomly assigned to receive HQ (400 mg/j) or placebo for 24 weeks (controlled phase) and were all prescribed HQ between week 24 and week 48 (open extension). All patients fulfilled the AECG criteria. A favorable overall response (primary outcome criteria) was defined as the patient having >or= 30% improvement between weeks 0 and 24 in the values on 2 of the 3 patient’s VAS evaluating dryness, pain and fatigue. Secondary end points were the evolution of the ESSDAI, the ESSPRI, Schirmer’s test and unstimulated salivary flow, serum gammaglobulin levels, and of SF-36, HAD, PROFAD, and SSI. Serum interferon-regulated chemokines (CXCL10, CCL2 and CCL19) were assessed at baseline and W24 in the 45 patients with available serum. Results Baseline characteristics of the 120 patients were as following: mean age 55.9 years, 91.7% of women, median disease duration: 5 years, anti-SSA positivity : 55.1%, patients with systemic involvement at enrollment: 30%. At 6 months, 19.2% of patients receiving placebo and 19.6% of patients treated with HQ had a favorable overall response (p = 0.9). At 12 months, 18.8% of patients treated for 6 months with placebo, then 6 months with HQ and 32.1% patients treated with 12 months with HQ were responders (p= 0.1). No significant difference was observed in any of the secondary outcome criteria. No significant difference was observed in patients with anti-SSA autoantibodies, high IgG levels, or systemic involvement. In patients treated with HQ, a trend towards a decrease of serum IgG was observed, as well as a significant decrease of IgM. In patients with HQ, a decrease in serum CXCL10 (from 50.5 to 35.8 pg/ml vs from 27.7 to 38.7 pg/ml under placebo, p=0.001) and CCL19 (from 241.6 to 160.9 pg/ml vs from 142.3 to 131.1 pg/ml, p=0.3), but not CCL2, was observed. In the HQ arm, all except 1 had detectable blood levels of HQ at 6 months. Baseline levels of HQ or of IFN-regulated chemokines were not associated with a favorable overall response. Tolerance of HQ was comparable to placebo. Conclusions The results of this controlled trial did not show any evidence of short term efficacy of HQ in pSS. HQ induced a decrease in serum level of CXCL10 and CCL19, 2 IFN-induced chemokines but no association with response to HQ could be identified in any subgroup of patients. Disclosure of Interest None Declared</div></front></TEI><istex><corpusName>bmj</corpusName><author><json:item><name>J. E. Gottenberg</name><affiliations><json:string>Rhumatology, Chu, Strasbourg</json:string></affiliations></json:item><json:item><name>P. Ravaud</name><affiliations><json:string>Epidemiology, INSERM U738</json:string></affiliations></json:item><json:item><name>X. Puechal</name><affiliations><json:string>Internal Medicine, Chu, Paris</json:string></affiliations></json:item><json:item><name>V. Le Guern</name><affiliations><json:string>Internal Medicine, Chu, Paris</json:string></affiliations></json:item><json:item><name>J. Sibilia</name><affiliations><json:string>Rhumatology, Chu, Strasbourg</json:string></affiliations></json:item><json:item><name>V. Goeb</name><affiliations><json:string>Rhumatology, Chu, Rouen</json:string></affiliations></json:item><json:item><name>C. Larroche</name><affiliations><json:string>Rhumatology, Chu, Bobigny</json:string></affiliations></json:item><json:item><name>J. J. Dubost</name><affiliations><json:string>Rhumatology, Chu, Clermont Ferrand</json:string></affiliations></json:item><json:item><name>S. Rist</name><affiliations><json:string>Rhumatology, Chu, Orleans</json:string></affiliations></json:item><json:item><name>A. Saraux</name><affiliations><json:string>Rhumatology, Chu, Brest</json:string></affiliations></json:item><json:item><name>V. Devauchelle</name><affiliations><json:string>Rhumatology, Chu, Brest</json:string></affiliations></json:item><json:item><name>J. Morel</name><affiliations><json:string>Rhumatology, Chu, Montpellier</json:string></affiliations></json:item><json:item><name>G. Hayem</name><affiliations><json:string>Rhumatology, Chu, Paris</json:string></affiliations></json:item><json:item><name>E. Hachulla</name><affiliations><json:string>Internal Medicine, Chu, Lille</json:string></affiliations></json:item><json:item><name>A. Perdriger</name><affiliations><json:string>Rhumatology, Chu, Rennes</json:string></affiliations></json:item><json:item><name>D. Sene</name><affiliations><json:string>Internal Medicine, Chu, Paris</json:string></affiliations></json:item><json:item><name>C. Zarnitsky</name><affiliations><json:string>Rhumatology, Chu, Le Havre</json:string></affiliations></json:item><json:item><name>E. Perrodeau</name><affiliations><json:string>Epidemiology</json:string></affiliations></json:item><json:item><name>D. Batouche</name><affiliations><json:string>Rhumatology, Chu, Paris</json:string></affiliations></json:item><json:item><name>V. Furlan</name><affiliations><json:string>Pharmacology</json:string></affiliations></json:item><json:item><name>J. Benessiano</name><affiliations><json:string>Biology, Chu, Paris, France</json:string></affiliations></json:item><json:item><name>R. Seror</name><affiliations><json:string>Rhumatology, Chu, Paris</json:string></affiliations></json:item><json:item><name>X. Mariette</name><affiliations><json:string>Rhumatology, Chu, Paris</json:string></affiliations></json:item></author><articleId><json:string>annrheumdis-2013-eular.319</json:string></articleId><language><json:string>eng</json:string></language><originalGenre><json:string>abstract</json:string></originalGenre><abstract>Background Hydroxychloroquine (HQ, Plaquenil) is often prescribed in patients with primary Sjögren’s syndrome (pSS). However, except a crossover trial, no controlled trial has ever evaluated HQ versus placebo. ObjectivesMethods 120 patients with pSS were randomly assigned to receive HQ (400 mg/j) or placebo for 24 weeks (controlled phase) and were all prescribed HQ between week 24 and week 48 (open extension). All patients fulfilled the AECG criteria. A favorable overall response (primary outcome criteria) was defined as the patient having >or= 30% improvement between weeks 0 and 24 in the values on 2 of the 3 patient’s VAS evaluating dryness, pain and fatigue. Secondary end points were the evolution of the ESSDAI, the ESSPRI, Schirmer’s test and unstimulated salivary flow, serum gammaglobulin levels, and of SF-36, HAD, PROFAD, and SSI. Serum interferon-regulated chemokines (CXCL10, CCL2 and CCL19) were assessed at baseline and W24 in the 45 patients with available serum. Results Baseline characteristics of the 120 patients were as following: mean age 55.9 years, 91.7% of women, median disease duration: 5 years, anti-SSA positivity : 55.1%, patients with systemic involvement at enrollment: 30%. At 6 months, 19.2% of patients receiving placebo and 19.6% of patients treated with HQ had a favorable overall response (p = 0.9). At 12 months, 18.8% of patients treated for 6 months with placebo, then 6 months with HQ and 32.1% patients treated with 12 months with HQ were responders (p= 0.1). No significant difference was observed in any of the secondary outcome criteria. No significant difference was observed in patients with anti-SSA autoantibodies, high IgG levels, or systemic involvement. In patients treated with HQ, a trend towards a decrease of serum IgG was observed, as well as a significant decrease of IgM. In patients with HQ, a decrease in serum CXCL10 (from 50.5 to 35.8 pg/ml vs from 27.7 to 38.7 pg/ml under placebo, p=0.001) and CCL19 (from 241.6 to 160.9 pg/ml vs from 142.3 to 131.1 pg/ml, p=0.3), but not CCL2, was observed. In the HQ arm, all except 1 had detectable blood levels of HQ at 6 months. Baseline levels of HQ or of IFN-regulated chemokines were not associated with a favorable overall response. Tolerance of HQ was comparable to placebo. Conclusions The results of this controlled trial did not show any evidence of short term efficacy of HQ in pSS. HQ induced a decrease in serum level of CXCL10 and CCL19, 2 IFN-induced chemokines but no association with response to HQ could be identified in any subgroup of patients. Disclosure of Interest None Declared</abstract><qualityIndicators><score>5.043</score><pdfVersion>1.4</pdfVersion><pdfPageSize>594.72 x 841.68 pts</pdfPageSize><refBibsNative>false</refBibsNative><keywordCount>0</keywordCount><abstractCharCount>2611</abstractCharCount><pdfWordCount>1543</pdfWordCount><pdfCharCount>9446</pdfCharCount><pdfPageCount>1</pdfPageCount><abstractWordCount>422</abstractWordCount></qualityIndicators><title>OP0114 Inefficacy of Hydroxychoroquine in Primary Sjögren’s Syndrome: Results at 12 Months of the Randomized Placebo-Controlled Trial of Plaquenil in Primary Sjögren’s Syndrome</title><genre><json:string>abstract</json:string></genre><host><volume>72</volume><publisherId><json:string>ard</json:string></publisherId><pages><first>A90</first></pages><issn><json:string>0003-4967</json:string></issn><issue>Suppl 3</issue><genre><json:string>journal</json:string></genre><language><json:string>unknown</json:string></language><eissn><json:string>1468-2060</json:string></eissn><title>Annals of the Rheumatic Diseases</title></host><publicationDate>2013</publicationDate><copyrightDate>2013</copyrightDate><doi><json:string>10.1136/annrheumdis-2013-eular.319</json:string></doi><id>6957B01E0820E02B882EF2308BD862DF4E2A7629</id><score>0.3019413</score><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/6957B01E0820E02B882EF2308BD862DF4E2A7629/fulltext/pdf</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/6957B01E0820E02B882EF2308BD862DF4E2A7629/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/6957B01E0820E02B882EF2308BD862DF4E2A7629/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">OP0114 Inefficacy of Hydroxychoroquine in Primary Sjögren’s Syndrome: Results at 12 Months of the Randomized Placebo-Controlled Trial of Plaquenil in Primary Sjögren’s Syndrome</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher><availability><p>© 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</p></availability><date>2013</date></publicationStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">OP0114 Inefficacy of Hydroxychoroquine in Primary Sjögren’s Syndrome: Results at 12 Months of the Randomized Placebo-Controlled Trial of Plaquenil in Primary Sjögren’s Syndrome</title><author xml:id="author-1"><persName><forename type="first">J. E.</forename><surname>Gottenberg</surname></persName><affiliation>Rhumatology, Chu, Strasbourg</affiliation></author><author xml:id="author-2"><persName><forename type="first">P.</forename><surname>Ravaud</surname></persName><affiliation>Epidemiology, INSERM U738</affiliation></author><author xml:id="author-3"><persName><forename type="first">X.</forename><surname>Puechal</surname></persName><affiliation>Internal Medicine, Chu, Paris</affiliation></author><author xml:id="author-4"><persName><forename type="first">V.</forename><surname>Le Guern</surname></persName><affiliation>Internal Medicine, Chu, Paris</affiliation></author><author xml:id="author-5"><persName><forename type="first">J.</forename><surname>Sibilia</surname></persName><affiliation>Rhumatology, Chu, Strasbourg</affiliation></author><author xml:id="author-6"><persName><forename type="first">V.</forename><surname>Goeb</surname></persName><affiliation>Rhumatology, Chu, Rouen</affiliation></author><author xml:id="author-7"><persName><forename type="first">C.</forename><surname>Larroche</surname></persName><affiliation>Rhumatology, Chu, Bobigny</affiliation></author><author xml:id="author-8"><persName><forename type="first">J. J.</forename><surname>Dubost</surname></persName><affiliation>Rhumatology, Chu, Clermont Ferrand</affiliation></author><author xml:id="author-9"><persName><forename type="first">S.</forename><surname>Rist</surname></persName><affiliation>Rhumatology, Chu, Orleans</affiliation></author><author xml:id="author-10"><persName><forename type="first">A.</forename><surname>Saraux</surname></persName><affiliation>Rhumatology, Chu, Brest</affiliation></author><author xml:id="author-11"><persName><forename type="first">V.</forename><surname>Devauchelle</surname></persName><affiliation>Rhumatology, Chu, Brest</affiliation></author><author xml:id="author-12"><persName><forename type="first">J.</forename><surname>Morel</surname></persName><affiliation>Rhumatology, Chu, Montpellier</affiliation></author><author xml:id="author-13"><persName><forename type="first">G.</forename><surname>Hayem</surname></persName><affiliation>Rhumatology, Chu, Paris</affiliation></author><author xml:id="author-14"><persName><forename type="first">E.</forename><surname>Hachulla</surname></persName><affiliation>Internal Medicine, Chu, Lille</affiliation></author><author xml:id="author-15"><persName><forename type="first">A.</forename><surname>Perdriger</surname></persName><affiliation>Rhumatology, Chu, Rennes</affiliation></author><author xml:id="author-16"><persName><forename type="first">D.</forename><surname>Sene</surname></persName><affiliation>Internal Medicine, Chu, Paris</affiliation></author><author xml:id="author-17"><persName><forename type="first">C.</forename><surname>Zarnitsky</surname></persName><affiliation>Rhumatology, Chu, Le Havre</affiliation></author><author xml:id="author-18"><persName><forename type="first">E.</forename><surname>Perrodeau</surname></persName><affiliation>Epidemiology</affiliation></author><author xml:id="author-19"><persName><forename type="first">D.</forename><surname>Batouche</surname></persName><affiliation>Rhumatology, Chu, Paris</affiliation></author><author xml:id="author-20"><persName><forename type="first">V.</forename><surname>Furlan</surname></persName><affiliation>Pharmacology</affiliation></author><author xml:id="author-21"><persName><forename type="first">J.</forename><surname>Benessiano</surname></persName><affiliation>Biology, Chu, Paris, France</affiliation></author><author xml:id="author-22"><persName><forename type="first">R.</forename><surname>Seror</surname></persName><affiliation>Rhumatology, Chu, Paris</affiliation></author><author xml:id="author-23"><persName><forename type="first">X.</forename><surname>Mariette</surname></persName><affiliation>Rhumatology, Chu, Paris</affiliation></author></analytic><monogr><title level="j">Annals of the Rheumatic Diseases</title><title level="j" type="abbrev">Ann Rheum Dis</title><idno type="pISSN">0003-4967</idno><idno type="eISSN">1468-2060</idno><imprint><publisher>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher><date type="published" when="2013-06"></date><biblScope unit="volume">72</biblScope><biblScope unit="issue">Suppl 3</biblScope><biblScope unit="page" from="A90">A90</biblScope></imprint></monogr><idno type="istex">6957B01E0820E02B882EF2308BD862DF4E2A7629</idno><idno type="DOI">10.1136/annrheumdis-2013-eular.319</idno><idno type="href">annrheumdis-72-A90-1.pdf</idno><idno type="ArticleID">annrheumdis-2013-eular.319</idno><idno type="local">annrheumdis;72/Suppl_3/A90-a</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2013</date></creation><langUsage><language ident="en">en</language></langUsage><abstract><p>Background Hydroxychloroquine (HQ, Plaquenil) is often prescribed in patients with primary Sjögren’s syndrome (pSS). However, except a crossover trial, no controlled trial has ever evaluated HQ versus placebo. ObjectivesMethods 120 patients with pSS were randomly assigned to receive HQ (400 mg/j) or placebo for 24 weeks (controlled phase) and were all prescribed HQ between week 24 and week 48 (open extension). All patients fulfilled the AECG criteria. A favorable overall response (primary outcome criteria) was defined as the patient having >or= 30% improvement between weeks 0 and 24 in the values on 2 of the 3 patient’s VAS evaluating dryness, pain and fatigue. Secondary end points were the evolution of the ESSDAI, the ESSPRI, Schirmer’s test and unstimulated salivary flow, serum gammaglobulin levels, and of SF-36, HAD, PROFAD, and SSI. Serum interferon-regulated chemokines (CXCL10, CCL2 and CCL19) were assessed at baseline and W24 in the 45 patients with available serum. Results Baseline characteristics of the 120 patients were as following: mean age 55.9 years, 91.7% of women, median disease duration: 5 years, anti-SSA positivity : 55.1%, patients with systemic involvement at enrollment: 30%. At 6 months, 19.2% of patients receiving placebo and 19.6% of patients treated with HQ had a favorable overall response (p = 0.9). At 12 months, 18.8% of patients treated for 6 months with placebo, then 6 months with HQ and 32.1% patients treated with 12 months with HQ were responders (p= 0.1). No significant difference was observed in any of the secondary outcome criteria. No significant difference was observed in patients with anti-SSA autoantibodies, high IgG levels, or systemic involvement. In patients treated with HQ, a trend towards a decrease of serum IgG was observed, as well as a significant decrease of IgM. In patients with HQ, a decrease in serum CXCL10 (from 50.5 to 35.8 pg/ml vs from 27.7 to 38.7 pg/ml under placebo, p=0.001) and CCL19 (from 241.6 to 160.9 pg/ml vs from 142.3 to 131.1 pg/ml, p=0.3), but not CCL2, was observed. In the HQ arm, all except 1 had detectable blood levels of HQ at 6 months. Baseline levels of HQ or of IFN-regulated chemokines were not associated with a favorable overall response. Tolerance of HQ was comparable to placebo. Conclusions The results of this controlled trial did not show any evidence of short term efficacy of HQ in pSS. HQ induced a decrease in serum level of CXCL10 and CCL19, 2 IFN-induced chemokines but no association with response to HQ could be identified in any subgroup of patients. Disclosure of Interest None Declared</p></abstract></profileDesc><revisionDesc><change when="2013-06">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/6957B01E0820E02B882EF2308BD862DF4E2A7629/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="corpus bmj" wicri:toSee="no header"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="no"</istex:xmlDeclaration><istex:docType PUBLIC="-//NLM//DTD Journal Archiving and Interchange DTD v2.3 20070202//EN" URI="archivearticle.dtd" name="istex:docType"></istex:docType><istex:document><article article-type="abstract" xml:lang="EN"><front><journal-meta><journal-id journal-id-type="hwp">annrheumdis</journal-id><journal-id journal-id-type="nlm-ta">Ann Rheum Dis</journal-id><journal-id journal-id-type="publisher-id">ard</journal-id><journal-title>Annals of the Rheumatic Diseases</journal-title><abbrev-journal-title abbrev-type="publisher">Ann Rheum Dis</abbrev-journal-title><abbrev-journal-title>Ann Rheum Dis</abbrev-journal-title><issn pub-type="ppub">0003-4967</issn><issn pub-type="epub">1468-2060</issn><publisher><publisher-name>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">annrheumdis-2013-eular.319</article-id><article-id pub-id-type="doi">10.1136/annrheumdis-2013-eular.319</article-id><article-id pub-id-type="other">annrheumdis;72/Suppl_3/A90-a</article-id><article-id pub-id-type="other">annrheumdis;annrheumdis-2013-eular.319</article-id><article-id pub-id-type="other">A90.1</article-id><article-id pub-id-type="other">annrheumdis-2013-eular.319</article-id><article-categories><subj-group subj-group-type="heading"><subject>Oral Presentations</subject><subj-group subj-group-type="heading"><subject>Abstract session: Novel treatment in SLE and Sjögren’s syndrome</subject></subj-group></subj-group></article-categories><title-group><article-title>OP0114 Inefficacy of Hydroxychoroquine in Primary Sjögren’s Syndrome: Results at 12 Months of the Randomized Placebo-Controlled Trial of Plaquenil in Primary Sjögren’s Syndrome</article-title></title-group><contrib-group><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Gottenberg</surname><given-names>J. E.</given-names></name><xref ref-type="aff" rid="AF01141"><sup>1</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Ravaud</surname><given-names>P.</given-names></name><xref ref-type="aff" rid="AF01142"><sup>2</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Puechal</surname><given-names>X.</given-names></name><xref ref-type="aff" rid="AF01143"><sup>3</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Le Guern</surname><given-names>V.</given-names></name><xref ref-type="aff" rid="AF01143"><sup>3</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Sibilia</surname><given-names>J.</given-names></name><xref ref-type="aff" rid="AF01141"><sup>1</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Goeb</surname><given-names>V.</given-names></name><xref ref-type="aff" rid="AF01144"><sup>4</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Larroche</surname><given-names>C.</given-names></name><xref ref-type="aff" rid="AF01145"><sup>5</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Dubost</surname><given-names>J. J.</given-names></name><xref ref-type="aff" rid="AF01146"><sup>6</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Rist</surname><given-names>S.</given-names></name><xref ref-type="aff" rid="AF01147"><sup>7</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Saraux</surname><given-names>A.</given-names></name><xref ref-type="aff" rid="AF01148"><sup>8</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Devauchelle</surname><given-names>V.</given-names></name><xref ref-type="aff" rid="AF01148"><sup>8</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Morel</surname><given-names>J.</given-names></name><xref ref-type="aff" rid="AF01149"><sup>9</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Hayem</surname><given-names>G.</given-names></name><xref ref-type="aff" rid="AF011410"><sup>10</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Hachulla</surname><given-names>E.</given-names></name><xref ref-type="aff" rid="AF011411"><sup>11</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Perdriger</surname><given-names>A.</given-names></name><xref ref-type="aff" rid="AF011412"><sup>12</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Sene</surname><given-names>D.</given-names></name><xref ref-type="aff" rid="AF01143"><sup>3</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Zarnitsky</surname><given-names>C.</given-names></name><xref ref-type="aff" rid="AF011413"><sup>13</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Perrodeau</surname><given-names>E.</given-names></name><xref ref-type="aff" rid="AF011414"><sup>14</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Batouche</surname><given-names>D.</given-names></name><xref ref-type="aff" rid="AF011410"><sup>10</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Furlan</surname><given-names>V.</given-names></name><xref ref-type="aff" rid="AF011415"><sup>15</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Benessiano</surname><given-names>J.</given-names></name><xref ref-type="aff" rid="AF011416"><sup>16</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Seror</surname><given-names>R.</given-names></name><xref ref-type="aff" rid="AF011410"><sup>10</sup></xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Mariette</surname><given-names>X.</given-names></name><xref ref-type="aff" rid="AF011410"><sup>10</sup></xref></contrib></contrib-group><aff id="AF01141"><sup>1</sup>Rhumatology, Chu, Strasbourg</aff><aff id="AF01142"><sup>2</sup>Epidemiology, INSERM U738</aff><aff id="AF01143"><sup>3</sup>Internal Medicine, Chu, Paris</aff><aff id="AF01144"><sup>4</sup>Rhumatology, Chu, Rouen</aff><aff id="AF01145"><sup>5</sup>Rhumatology, Chu, Bobigny</aff><aff id="AF01146"><sup>6</sup>Rhumatology, Chu, Clermont Ferrand</aff><aff id="AF01147"><sup>7</sup>Rhumatology, Chu, Orleans</aff><aff id="AF01148"><sup>8</sup>Rhumatology, Chu, Brest</aff><aff id="AF01149"><sup>9</sup>Rhumatology, Chu, Montpellier</aff><aff id="AF011410"><sup>10</sup>Rhumatology, Chu, Paris</aff><aff id="AF011411"><sup>11</sup>Internal Medicine, Chu, Lille</aff><aff id="AF011412"><sup>12</sup>Rhumatology, Chu, Rennes</aff><aff id="AF011413"><sup>13</sup>Rhumatology, Chu, Le Havre</aff><aff id="AF011414"><sup>14</sup>Epidemiology</aff><aff id="AF011415"><sup>15</sup>Pharmacology</aff><aff id="AF011416"><sup>16</sup>Biology, Chu, Paris, France</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="1">A90</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-A90-1.pdf"></self-uri><abstract><sec><title>Background</title><p>Hydroxychloroquine (HQ, Plaquenil) is often prescribed in patients with primary Sjögren’s syndrome (pSS). However, except a crossover trial, no controlled trial has ever evaluated HQ versus placebo.</p></sec><sec><title>Objectives</title></sec><sec><title>Methods</title><p>120 patients with pSS were randomly assigned to receive HQ (400 mg/j) or placebo for 24 weeks (controlled phase) and were all prescribed HQ between week 24 and week 48 (open extension). All patients fulfilled the AECG criteria. A favorable overall response (primary outcome criteria) was defined as the patient having >or= 30% improvement between weeks 0 and 24 in the values on 2 of the 3 patient’s VAS evaluating dryness, pain and fatigue. Secondary end points were the evolution of the ESSDAI, the ESSPRI, Schirmer’s test and unstimulated salivary flow, serum gammaglobulin levels, and of SF-36, HAD, PROFAD, and SSI. Serum interferon-regulated chemokines (CXCL10, CCL2 and CCL19) were assessed at baseline and W24 in the 45 patients with available serum.</p></sec><sec><title>Results</title><p>Baseline characteristics of the 120 patients were as following: mean age 55.9 years, 91.7% of women, median disease duration: 5 years, anti-SSA positivity : 55.1%, patients with systemic involvement at enrollment: 30%. At 6 months, 19.2% of patients receiving placebo and 19.6% of patients treated with HQ had a favorable overall response (p = 0.9). At 12 months, 18.8% of patients treated for 6 months with placebo, then 6 months with HQ and 32.1% patients treated with 12 months with HQ were responders (p= 0.1). No significant difference was observed in any of the secondary outcome criteria. No significant difference was observed in patients with anti-SSA autoantibodies, high IgG levels, or systemic involvement. In patients treated with HQ, a trend towards a decrease of serum IgG was observed, as well as a significant decrease of IgM. In patients with HQ, a decrease in serum CXCL10 (from 50.5 to 35.8 pg/ml vs from 27.7 to 38.7 pg/ml under placebo, p=0.001) and CCL19 (from 241.6 to 160.9 pg/ml vs from 142.3 to 131.1 pg/ml, p=0.3), but not CCL2, was observed. In the HQ arm, all except 1 had detectable blood levels of HQ at 6 months. Baseline levels of HQ or of IFN-regulated chemokines were not associated with a favorable overall response. Tolerance of HQ was comparable to placebo.</p></sec><sec><title>Conclusions</title><p>The results of this controlled trial did not show any evidence of short term efficacy of HQ in pSS. HQ induced a decrease in serum level of CXCL10 and CCL19, 2 IFN-induced chemokines but no association with response to HQ could be identified in any subgroup of patients.</p></sec><sec><title>Disclosure of Interest</title><p>None Declared</p></sec></abstract></article-meta></front></article></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>OP0114 Inefficacy of Hydroxychoroquine in Primary Sjögren’s Syndrome: Results at 12 Months of the Randomized Placebo-Controlled Trial of Plaquenil in Primary Sjögren’s Syndrome</title></titleInfo><titleInfo type="alternative" lang="en" contentType="CDATA"><title>OP0114 Inefficacy of Hydroxychoroquine in Primary Sjögren’s Syndrome: Results at 12 Months of the Randomized Placebo-Controlled Trial of Plaquenil in Primary Sjögren’s Syndrome</title></titleInfo><name type="personal"><namePart type="given">J. E.</namePart><namePart type="family">Gottenberg</namePart><affiliation>Rhumatology, Chu, Strasbourg</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">P.</namePart><namePart type="family">Ravaud</namePart><affiliation>Epidemiology, INSERM U738</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">X.</namePart><namePart type="family">Puechal</namePart><affiliation>Internal Medicine, Chu, Paris</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">V.</namePart><namePart type="family">Le Guern</namePart><affiliation>Internal Medicine, Chu, Paris</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J.</namePart><namePart type="family">Sibilia</namePart><affiliation>Rhumatology, Chu, Strasbourg</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">V.</namePart><namePart type="family">Goeb</namePart><affiliation>Rhumatology, Chu, Rouen</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">C.</namePart><namePart type="family">Larroche</namePart><affiliation>Rhumatology, Chu, Bobigny</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J. J.</namePart><namePart type="family">Dubost</namePart><affiliation>Rhumatology, Chu, Clermont Ferrand</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">S.</namePart><namePart type="family">Rist</namePart><affiliation>Rhumatology, Chu, Orleans</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">A.</namePart><namePart type="family">Saraux</namePart><affiliation>Rhumatology, Chu, Brest</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">V.</namePart><namePart type="family">Devauchelle</namePart><affiliation>Rhumatology, Chu, Brest</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J.</namePart><namePart type="family">Morel</namePart><affiliation>Rhumatology, Chu, Montpellier</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">G.</namePart><namePart type="family">Hayem</namePart><affiliation>Rhumatology, Chu, Paris</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">E.</namePart><namePart type="family">Hachulla</namePart><affiliation>Internal Medicine, Chu, Lille</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">A.</namePart><namePart type="family">Perdriger</namePart><affiliation>Rhumatology, Chu, Rennes</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">D.</namePart><namePart type="family">Sene</namePart><affiliation>Internal Medicine, Chu, Paris</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">C.</namePart><namePart type="family">Zarnitsky</namePart><affiliation>Rhumatology, Chu, Le Havre</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">E.</namePart><namePart type="family">Perrodeau</namePart><affiliation>Epidemiology</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">D.</namePart><namePart type="family">Batouche</namePart><affiliation>Rhumatology, Chu, Paris</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">V.</namePart><namePart type="family">Furlan</namePart><affiliation>Pharmacology</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J.</namePart><namePart type="family">Benessiano</namePart><affiliation>Biology, Chu, Paris, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">R.</namePart><namePart type="family">Seror</namePart><affiliation>Rhumatology, Chu, Paris</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">X.</namePart><namePart type="family">Mariette</namePart><affiliation>Rhumatology, Chu, Paris</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="abstract" displayLabel="abstract"></genre><originInfo><publisher>BMJ Publishing Group Ltd and European League Against Rheumatism</publisher><dateIssued encoding="w3cdtf">2013-06</dateIssued><copyrightDate encoding="w3cdtf">2013</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType></physicalDescription><abstract>Background Hydroxychloroquine (HQ, Plaquenil) is often prescribed in patients with primary Sjögren’s syndrome (pSS). However, except a crossover trial, no controlled trial has ever evaluated HQ versus placebo. ObjectivesMethods 120 patients with pSS were randomly assigned to receive HQ (400 mg/j) or placebo for 24 weeks (controlled phase) and were all prescribed HQ between week 24 and week 48 (open extension). All patients fulfilled the AECG criteria. A favorable overall response (primary outcome criteria) was defined as the patient having >or= 30% improvement between weeks 0 and 24 in the values on 2 of the 3 patient’s VAS evaluating dryness, pain and fatigue. Secondary end points were the evolution of the ESSDAI, the ESSPRI, Schirmer’s test and unstimulated salivary flow, serum gammaglobulin levels, and of SF-36, HAD, PROFAD, and SSI. Serum interferon-regulated chemokines (CXCL10, CCL2 and CCL19) were assessed at baseline and W24 in the 45 patients with available serum. Results Baseline characteristics of the 120 patients were as following: mean age 55.9 years, 91.7% of women, median disease duration: 5 years, anti-SSA positivity : 55.1%, patients with systemic involvement at enrollment: 30%. At 6 months, 19.2% of patients receiving placebo and 19.6% of patients treated with HQ had a favorable overall response (p = 0.9). At 12 months, 18.8% of patients treated for 6 months with placebo, then 6 months with HQ and 32.1% patients treated with 12 months with HQ were responders (p= 0.1). No significant difference was observed in any of the secondary outcome criteria. No significant difference was observed in patients with anti-SSA autoantibodies, high IgG levels, or systemic involvement. In patients treated with HQ, a trend towards a decrease of serum IgG was observed, as well as a significant decrease of IgM. In patients with HQ, a decrease in serum CXCL10 (from 50.5 to 35.8 pg/ml vs from 27.7 to 38.7 pg/ml under placebo, p=0.001) and CCL19 (from 241.6 to 160.9 pg/ml vs from 142.3 to 131.1 pg/ml, p=0.3), but not CCL2, was observed. In the HQ arm, all except 1 had detectable blood levels of HQ at 6 months. Baseline levels of HQ or of IFN-regulated chemokines were not associated with a favorable overall response. Tolerance of HQ was comparable to placebo. Conclusions The results of this controlled trial did not show any evidence of short term efficacy of HQ in pSS. HQ induced a decrease in serum level of CXCL10 and CCL19, 2 IFN-induced chemokines but no association with response to HQ could be identified in any subgroup of patients. Disclosure of Interest None Declared</abstract><relatedItem type="host"><titleInfo><title>Annals of the Rheumatic Diseases</title></titleInfo><titleInfo type="abbreviated"><title>Ann Rheum Dis</title></titleInfo><genre type="journal">journal</genre><identifier type="ISSN">0003-4967</identifier><identifier type="eISSN">1468-2060</identifier><identifier type="PublisherID">ard</identifier><identifier type="PublisherID-hwp">annrheumdis</identifier><identifier type="PublisherID-nlm-ta">Ann Rheum Dis</identifier><part><date>2013</date><detail type="title"><title>Annual European Congress of Rheumatology EULAR abstracts 2013, 12–15 June 2013, Spain</title></detail><detail type="volume"><caption>vol.</caption><number>72</number></detail><detail type="issue"><caption>no.</caption><number>Suppl 3</number></detail><extent unit="pages"><start>A90</start></extent></part></relatedItem><identifier type="istex">6957B01E0820E02B882EF2308BD862DF4E2A7629</identifier><identifier type="DOI">10.1136/annrheumdis-2013-eular.319</identifier><identifier type="href">annrheumdis-72-A90-1.pdf</identifier><identifier type="ArticleID">annrheumdis-2013-eular.319</identifier><identifier type="local">annrheumdis;72/Suppl_3/A90-a</identifier><accessCondition type="use and reproduction" contentType="copyright">© 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</accessCondition><recordInfo><recordContentSource>BMJ</recordContentSource></recordInfo></mods></metadata><enrichments><json:item><type>multicat</type><uri>https://api.istex.fr/document/6957B01E0820E02B882EF2308BD862DF4E2A7629/enrichments/multicat</uri></json:item><json:item><type>refBibs</type><uri>https://api.istex.fr/document/6957B01E0820E02B882EF2308BD862DF4E2A7629/enrichments/refBibs</uri></json:item></enrichments><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/France/explor/LeHavreV1/Data/Istex/Corpus
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000734 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Istex/Corpus/biblio.hfd -nk 000734 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/France
|area= LeHavreV1
|flux= Istex
|étape= Corpus
|type= RBID
|clé= ISTEX:6957B01E0820E02B882EF2308BD862DF4E2A7629
|texte= OP0114 Inefficacy of Hydroxychoroquine in Primary Sjögren’s Syndrome: Results at 12 Months of the Randomized Placebo-Controlled Trial of Plaquenil in Primary Sjögren’s Syndrome
}}
| This area was generated with Dilib version V0.6.25. |  |