Effects of hydroxychloroquine on symptomatic improvement in primary Sjögren syndrome: the JOQUER randomized clinical trial.
Identifieur interne : 000128 ( PubMed/Corpus ); précédent : 000127; suivant : 000129Effects of hydroxychloroquine on symptomatic improvement in primary Sjögren syndrome: the JOQUER randomized clinical trial.
Auteurs : Jacques-Eric Gottenberg ; Philippe Ravaud ; Xavier Puéchal ; Véronique Le Guern ; Jean Sibilia ; Vincent Goeb ; Claire Larroche ; Jean-Jacques Dubost ; Stéphanie Rist ; Alain Saraux ; Valérie Devauchelle-Pensec ; Jacques Morel ; Gilles Hayem ; Pierre Hatron ; Aleth Perdriger ; Damien Sene ; Charles Zarnitsky ; Djilali Batouche ; Valérie Furlan ; Joelle Benessiano ; Elodie Perrodeau ; Raphaele Seror ; Xavier MarietteSource :
- JAMA [ 1538-3598 ] ; 2014.
English descriptors
- KwdEn :
- Adult, Aged, Double-Blind Method, Enzyme Inhibitors (therapeutic use), Fatigue (drug therapy), Fatigue (etiology), Female, Humans, Hydroxychloroquine (therapeutic use), Male, Middle Aged, Pain (drug therapy), Pain (etiology), Sjogren's Syndrome (complications), Sjogren's Syndrome (drug therapy), Treatment Outcome.
- MESH :
- chemical , therapeutic use : Enzyme Inhibitors, Hydroxychloroquine.
- complications : Sjogren's Syndrome.
- drug therapy : Fatigue, Pain, Sjogren's Syndrome.
- etiology : Fatigue, Pain.
- Adult, Aged, Double-Blind Method, Female, Humans, Male, Middle Aged, Treatment Outcome.
Abstract
Primary Sjögren syndrome is a systemic autoimmune disease characterized by mouth and eye dryness, pain, and fatigue. Hydroxychloroquine is the most frequently prescribed immunosuppressant for the syndrome. However, evidence regarding its efficacy is limited.
DOI: 10.1001/jama.2014.7682
PubMed: 25027140
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Effects of hydroxychloroquine on symptomatic improvement in primary Sjögren syndrome: the JOQUER randomized clinical trial.</title><author><name sortKey="Gottenberg, Jacques Eric" sort="Gottenberg, Jacques Eric" uniqKey="Gottenberg J" first="Jacques-Eric" last="Gottenberg">Jacques-Eric Gottenberg</name><affiliation><nlm:affiliation>Department of Rheumatology, Service de Rhumatologie, Hôpitaux Universitaires de Strasbourg, Centre de Référence National Pour les Maladies Auto-Immunes Systémiques Rares, Université de Strasbourg, Strasbourg, France.</nlm:affiliation></affiliation></author><author><name sortKey="Ravaud, Philippe" sort="Ravaud, Philippe" uniqKey="Ravaud P" first="Philippe" last="Ravaud">Philippe Ravaud</name><affiliation><nlm:affiliation>Department of Epidemiology and Public Health, Hotel Dieu, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Puechal, Xavier" sort="Puechal, Xavier" uniqKey="Puechal X" first="Xavier" last="Puéchal">Xavier Puéchal</name><affiliation><nlm:affiliation>Department of Internal Medicine, Cochin Hospital, AP-HP, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Le Guern, Veronique" sort="Le Guern, Veronique" uniqKey="Le Guern V" first="Véronique" last="Le Guern">Véronique Le Guern</name><affiliation><nlm:affiliation>Department of Internal Medicine, Cochin Hospital, AP-HP, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Sibilia, Jean" sort="Sibilia, Jean" uniqKey="Sibilia J" first="Jean" last="Sibilia">Jean Sibilia</name><affiliation><nlm:affiliation>Department of Rheumatology, Service de Rhumatologie, Hôpitaux Universitaires de Strasbourg, Centre de Référence National Pour les Maladies Auto-Immunes Systémiques Rares, Université de Strasbourg, Strasbourg, France.</nlm:affiliation></affiliation></author><author><name sortKey="Goeb, Vincent" sort="Goeb, Vincent" uniqKey="Goeb V" first="Vincent" last="Goeb">Vincent Goeb</name><affiliation><nlm:affiliation>Department of Rheumatology, Amiens University Hospital, Amiens, France.</nlm:affiliation></affiliation></author><author><name sortKey="Larroche, Claire" sort="Larroche, Claire" uniqKey="Larroche C" first="Claire" last="Larroche">Claire Larroche</name><affiliation><nlm:affiliation>Department of Internal Medicine, Avicenne Hospital, AP-HP, Bobigny, France.</nlm:affiliation></affiliation></author><author><name sortKey="Dubost, Jean Jacques" sort="Dubost, Jean Jacques" uniqKey="Dubost J" first="Jean-Jacques" last="Dubost">Jean-Jacques Dubost</name><affiliation><nlm:affiliation>Department of Rheumatology, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.</nlm:affiliation></affiliation></author><author><name sortKey="Rist, Stephanie" sort="Rist, Stephanie" uniqKey="Rist S" first="Stéphanie" last="Rist">Stéphanie Rist</name><affiliation><nlm:affiliation>Department of Rheumatology, Orléans Hospital, Orléans, France.</nlm:affiliation></affiliation></author><author><name sortKey="Saraux, Alain" sort="Saraux, Alain" uniqKey="Saraux A" first="Alain" last="Saraux">Alain Saraux</name><affiliation><nlm:affiliation>Department of Rheumatology, Brest University Hospital, Brest, France.</nlm:affiliation></affiliation></author><author><name sortKey="Devauchelle Pensec, Valerie" sort="Devauchelle Pensec, Valerie" uniqKey="Devauchelle Pensec V" first="Valérie" last="Devauchelle-Pensec">Valérie Devauchelle-Pensec</name><affiliation><nlm:affiliation>Department of Rheumatology, Brest University Hospital, Brest, France.</nlm:affiliation></affiliation></author><author><name sortKey="Morel, Jacques" sort="Morel, Jacques" uniqKey="Morel J" first="Jacques" last="Morel">Jacques Morel</name><affiliation><nlm:affiliation>Department of Rheumatology, Montpellier University Hospital, Montpellier, France.</nlm:affiliation></affiliation></author><author><name sortKey="Hayem, Gilles" sort="Hayem, Gilles" uniqKey="Hayem G" first="Gilles" last="Hayem">Gilles Hayem</name><affiliation><nlm:affiliation>Department of Rheumatology, Hôpital Bichat, AP-HP, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Hatron, Pierre" sort="Hatron, Pierre" uniqKey="Hatron P" first="Pierre" last="Hatron">Pierre Hatron</name><affiliation><nlm:affiliation>Department of Internal Medicine, Lille University Hospital, Lille, France.</nlm:affiliation></affiliation></author><author><name sortKey="Perdriger, Aleth" sort="Perdriger, Aleth" uniqKey="Perdriger A" first="Aleth" last="Perdriger">Aleth Perdriger</name><affiliation><nlm:affiliation>Department of Rheumatology, Rennes University Hospital, Rennes, France.</nlm:affiliation></affiliation></author><author><name sortKey="Sene, Damien" sort="Sene, Damien" uniqKey="Sene D" first="Damien" last="Sene">Damien Sene</name><affiliation><nlm:affiliation>Department of Internal Medicine, Lariboisère Hospital, AP-HP, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Zarnitsky, Charles" sort="Zarnitsky, Charles" uniqKey="Zarnitsky C" first="Charles" last="Zarnitsky">Charles Zarnitsky</name><affiliation><nlm:affiliation>Department of Rheumatology, Le Havre Hospital, Le Havre, France.</nlm:affiliation></affiliation></author><author><name sortKey="Batouche, Djilali" sort="Batouche, Djilali" uniqKey="Batouche D" first="Djilali" last="Batouche">Djilali Batouche</name><affiliation><nlm:affiliation>Department of Rheumatology, Hôpitaux Universitaires Paris-Sud, AP-HP, INSERM U 1012, Université Paris Sud, Le Kremlin Bicêtre, France.</nlm:affiliation></affiliation></author><author><name sortKey="Furlan, Valerie" sort="Furlan, Valerie" uniqKey="Furlan V" first="Valérie" last="Furlan">Valérie Furlan</name><affiliation><nlm:affiliation>Department of Pharmacy, Hôpitaux Universitaires Paris-Sud, AP-HP, Le Kremlin Bicêtre, France.</nlm:affiliation></affiliation></author><author><name sortKey="Benessiano, Joelle" sort="Benessiano, Joelle" uniqKey="Benessiano J" first="Joelle" last="Benessiano">Joelle Benessiano</name><affiliation><nlm:affiliation>Department of Centre de Ressources Biologiques, Bichat Hospital, AP-HP, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Perrodeau, Elodie" sort="Perrodeau, Elodie" uniqKey="Perrodeau E" first="Elodie" last="Perrodeau">Elodie Perrodeau</name><affiliation><nlm:affiliation>Department of Epidemiology and Public Health, Hotel Dieu, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Seror, Raphaele" sort="Seror, Raphaele" uniqKey="Seror R" first="Raphaele" last="Seror">Raphaele Seror</name><affiliation><nlm:affiliation>Department of Rheumatology, Hôpitaux Universitaires Paris-Sud, AP-HP, INSERM U 1012, Université Paris Sud, Le Kremlin Bicêtre, France.</nlm:affiliation></affiliation></author><author><name sortKey="Mariette, Xavier" sort="Mariette, Xavier" uniqKey="Mariette X" first="Xavier" last="Mariette">Xavier Mariette</name><affiliation><nlm:affiliation>Department of Rheumatology, Hôpitaux Universitaires Paris-Sud, AP-HP, INSERM U 1012, Université Paris Sud, Le Kremlin Bicêtre, France.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2014">2014</date><idno type="RBID">pubmed:25027140</idno><idno type="pmid">25027140</idno><idno type="doi">10.1001/jama.2014.7682</idno><idno type="wicri:Area/PubMed/Corpus">000128</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Effects of hydroxychloroquine on symptomatic improvement in primary Sjögren syndrome: the JOQUER randomized clinical trial.</title><author><name sortKey="Gottenberg, Jacques Eric" sort="Gottenberg, Jacques Eric" uniqKey="Gottenberg J" first="Jacques-Eric" last="Gottenberg">Jacques-Eric Gottenberg</name><affiliation><nlm:affiliation>Department of Rheumatology, Service de Rhumatologie, Hôpitaux Universitaires de Strasbourg, Centre de Référence National Pour les Maladies Auto-Immunes Systémiques Rares, Université de Strasbourg, Strasbourg, France.</nlm:affiliation></affiliation></author><author><name sortKey="Ravaud, Philippe" sort="Ravaud, Philippe" uniqKey="Ravaud P" first="Philippe" last="Ravaud">Philippe Ravaud</name><affiliation><nlm:affiliation>Department of Epidemiology and Public Health, Hotel Dieu, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Puechal, Xavier" sort="Puechal, Xavier" uniqKey="Puechal X" first="Xavier" last="Puéchal">Xavier Puéchal</name><affiliation><nlm:affiliation>Department of Internal Medicine, Cochin Hospital, AP-HP, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Le Guern, Veronique" sort="Le Guern, Veronique" uniqKey="Le Guern V" first="Véronique" last="Le Guern">Véronique Le Guern</name><affiliation><nlm:affiliation>Department of Internal Medicine, Cochin Hospital, AP-HP, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Sibilia, Jean" sort="Sibilia, Jean" uniqKey="Sibilia J" first="Jean" last="Sibilia">Jean Sibilia</name><affiliation><nlm:affiliation>Department of Rheumatology, Service de Rhumatologie, Hôpitaux Universitaires de Strasbourg, Centre de Référence National Pour les Maladies Auto-Immunes Systémiques Rares, Université de Strasbourg, Strasbourg, France.</nlm:affiliation></affiliation></author><author><name sortKey="Goeb, Vincent" sort="Goeb, Vincent" uniqKey="Goeb V" first="Vincent" last="Goeb">Vincent Goeb</name><affiliation><nlm:affiliation>Department of Rheumatology, Amiens University Hospital, Amiens, France.</nlm:affiliation></affiliation></author><author><name sortKey="Larroche, Claire" sort="Larroche, Claire" uniqKey="Larroche C" first="Claire" last="Larroche">Claire Larroche</name><affiliation><nlm:affiliation>Department of Internal Medicine, Avicenne Hospital, AP-HP, Bobigny, France.</nlm:affiliation></affiliation></author><author><name sortKey="Dubost, Jean Jacques" sort="Dubost, Jean Jacques" uniqKey="Dubost J" first="Jean-Jacques" last="Dubost">Jean-Jacques Dubost</name><affiliation><nlm:affiliation>Department of Rheumatology, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.</nlm:affiliation></affiliation></author><author><name sortKey="Rist, Stephanie" sort="Rist, Stephanie" uniqKey="Rist S" first="Stéphanie" last="Rist">Stéphanie Rist</name><affiliation><nlm:affiliation>Department of Rheumatology, Orléans Hospital, Orléans, France.</nlm:affiliation></affiliation></author><author><name sortKey="Saraux, Alain" sort="Saraux, Alain" uniqKey="Saraux A" first="Alain" last="Saraux">Alain Saraux</name><affiliation><nlm:affiliation>Department of Rheumatology, Brest University Hospital, Brest, France.</nlm:affiliation></affiliation></author><author><name sortKey="Devauchelle Pensec, Valerie" sort="Devauchelle Pensec, Valerie" uniqKey="Devauchelle Pensec V" first="Valérie" last="Devauchelle-Pensec">Valérie Devauchelle-Pensec</name><affiliation><nlm:affiliation>Department of Rheumatology, Brest University Hospital, Brest, France.</nlm:affiliation></affiliation></author><author><name sortKey="Morel, Jacques" sort="Morel, Jacques" uniqKey="Morel J" first="Jacques" last="Morel">Jacques Morel</name><affiliation><nlm:affiliation>Department of Rheumatology, Montpellier University Hospital, Montpellier, France.</nlm:affiliation></affiliation></author><author><name sortKey="Hayem, Gilles" sort="Hayem, Gilles" uniqKey="Hayem G" first="Gilles" last="Hayem">Gilles Hayem</name><affiliation><nlm:affiliation>Department of Rheumatology, Hôpital Bichat, AP-HP, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Hatron, Pierre" sort="Hatron, Pierre" uniqKey="Hatron P" first="Pierre" last="Hatron">Pierre Hatron</name><affiliation><nlm:affiliation>Department of Internal Medicine, Lille University Hospital, Lille, France.</nlm:affiliation></affiliation></author><author><name sortKey="Perdriger, Aleth" sort="Perdriger, Aleth" uniqKey="Perdriger A" first="Aleth" last="Perdriger">Aleth Perdriger</name><affiliation><nlm:affiliation>Department of Rheumatology, Rennes University Hospital, Rennes, France.</nlm:affiliation></affiliation></author><author><name sortKey="Sene, Damien" sort="Sene, Damien" uniqKey="Sene D" first="Damien" last="Sene">Damien Sene</name><affiliation><nlm:affiliation>Department of Internal Medicine, Lariboisère Hospital, AP-HP, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Zarnitsky, Charles" sort="Zarnitsky, Charles" uniqKey="Zarnitsky C" first="Charles" last="Zarnitsky">Charles Zarnitsky</name><affiliation><nlm:affiliation>Department of Rheumatology, Le Havre Hospital, Le Havre, France.</nlm:affiliation></affiliation></author><author><name sortKey="Batouche, Djilali" sort="Batouche, Djilali" uniqKey="Batouche D" first="Djilali" last="Batouche">Djilali Batouche</name><affiliation><nlm:affiliation>Department of Rheumatology, Hôpitaux Universitaires Paris-Sud, AP-HP, INSERM U 1012, Université Paris Sud, Le Kremlin Bicêtre, France.</nlm:affiliation></affiliation></author><author><name sortKey="Furlan, Valerie" sort="Furlan, Valerie" uniqKey="Furlan V" first="Valérie" last="Furlan">Valérie Furlan</name><affiliation><nlm:affiliation>Department of Pharmacy, Hôpitaux Universitaires Paris-Sud, AP-HP, Le Kremlin Bicêtre, France.</nlm:affiliation></affiliation></author><author><name sortKey="Benessiano, Joelle" sort="Benessiano, Joelle" uniqKey="Benessiano J" first="Joelle" last="Benessiano">Joelle Benessiano</name><affiliation><nlm:affiliation>Department of Centre de Ressources Biologiques, Bichat Hospital, AP-HP, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Perrodeau, Elodie" sort="Perrodeau, Elodie" uniqKey="Perrodeau E" first="Elodie" last="Perrodeau">Elodie Perrodeau</name><affiliation><nlm:affiliation>Department of Epidemiology and Public Health, Hotel Dieu, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Seror, Raphaele" sort="Seror, Raphaele" uniqKey="Seror R" first="Raphaele" last="Seror">Raphaele Seror</name><affiliation><nlm:affiliation>Department of Rheumatology, Hôpitaux Universitaires Paris-Sud, AP-HP, INSERM U 1012, Université Paris Sud, Le Kremlin Bicêtre, France.</nlm:affiliation></affiliation></author><author><name sortKey="Mariette, Xavier" sort="Mariette, Xavier" uniqKey="Mariette X" first="Xavier" last="Mariette">Xavier Mariette</name><affiliation><nlm:affiliation>Department of Rheumatology, Hôpitaux Universitaires Paris-Sud, AP-HP, INSERM U 1012, Université Paris Sud, Le Kremlin Bicêtre, France.</nlm:affiliation></affiliation></author></analytic><series><title level="j">JAMA</title><idno type="eISSN">1538-3598</idno><imprint><date when="2014" type="published">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Double-Blind Method</term><term>Enzyme Inhibitors (therapeutic use)</term><term>Fatigue (drug therapy)</term><term>Fatigue (etiology)</term><term>Female</term><term>Humans</term><term>Hydroxychloroquine (therapeutic use)</term><term>Male</term><term>Middle Aged</term><term>Pain (drug therapy)</term><term>Pain (etiology)</term><term>Sjogren's Syndrome (complications)</term><term>Sjogren's Syndrome (drug therapy)</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Enzyme Inhibitors</term><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Sjogren's Syndrome</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Fatigue</term><term>Pain</term><term>Sjogren's Syndrome</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Fatigue</term><term>Pain</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Primary Sjögren syndrome is a systemic autoimmune disease characterized by mouth and eye dryness, pain, and fatigue. Hydroxychloroquine is the most frequently prescribed immunosuppressant for the syndrome. However, evidence regarding its efficacy is limited.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">25027140</PMID><DateCreated><Year>2014</Year><Month>7</Month><Day>16</Day></DateCreated><DateCompleted><Year>2014</Year><Month>07</Month><Day>28</Day></DateCompleted><DateRevised><Year>2016</Year><Month>10</Month><Day>17</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1538-3598</ISSN><JournalIssue CitedMedium="Internet"><Volume>312</Volume><Issue>3</Issue><PubDate><Year>2014</Year><Month>Jul</Month><Day>16</Day></PubDate></JournalIssue><Title>JAMA</Title><ISOAbbreviation>JAMA</ISOAbbreviation></Journal><ArticleTitle>Effects of hydroxychloroquine on symptomatic improvement in primary Sjögren syndrome: the JOQUER randomized clinical trial.</ArticleTitle><Pagination><MedlinePgn>249-58</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1001/jama.2014.7682</ELocationID><Abstract><AbstractText Label="IMPORTANCE" NlmCategory="OBJECTIVE">Primary Sjögren syndrome is a systemic autoimmune disease characterized by mouth and eye dryness, pain, and fatigue. Hydroxychloroquine is the most frequently prescribed immunosuppressant for the syndrome. However, evidence regarding its efficacy is limited.</AbstractText><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">To evaluate the efficacy of hydroxychloroquine for the main symptoms of primary Sjögren syndrome: dryness, pain, and fatigue.</AbstractText><AbstractText Label="DESIGN, SETTING, AND PARTICIPANTS" NlmCategory="METHODS">From April 2008 to May 2011, 120 patients with primary Sjögren syndrome according to American-European Consensus Group Criteria from 15 university hospitals in France were randomized in a double-blind, parallel-group, placebo-controlled trial. Participants were assessed at baseline, week 12, week 24 (primary outcome), and week 48. The last follow-up date for the last patient was May 15, 2012.</AbstractText><AbstractText Label="INTERVENTIONS" NlmCategory="METHODS">Patients were randomized (1:1) to receive hydroxychloroquine (400 mg/d) or placebo until week 24. All patients were prescribed hydroxychloroquine between weeks 24 and 48.</AbstractText><AbstractText Label="MAIN OUTCOMES AND MEASURES" NlmCategory="METHODS">The primary end point was the proportion of patients with a 30% or greater reduction between weeks 0 and 24 in scores on 2 of 3 numeric analog scales (from 0 [best] to 10 [worst]) evaluating dryness, pain, and fatigue.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">At 24 weeks, the proportion of patients meeting the primary end point was 17.9% (10/56) in the hydroxychloroquine group and 17.2% (11/64) in the placebo group (odds ratio, 1.01; 95% CI, 0.37-2.78; P = .98). Between weeks 0 and 24, the mean (SD) numeric analog scale score for dryness changed from 6.38 (2.14) to 5.85 (2.57) in the placebo group and 6.53 (1.97) to 6.22 (1.87) in the hydroxychloroquine group. The mean (SD) numeric analog scale score for pain changed from 4.92 (2.94) to 5.08 (2.48) in the placebo group and 5.09 (3.06) to 4.59 (2.90) in the hydroxychloroquine group. The mean (SD) numeric analog scale for fatigue changed from 6.26 (2.27) to 5.72 (2.38) in the placebo group and 6.00 (2.52) to 5.94 (2.40) in the hydroxychloroquine group. All but 1 patient in the hydroxychloroquine group had detectable blood levels of the drug. Hydroxychloroquine had no efficacy in patients with anti-SSA autoantibodies, high IgG levels, or systemic involvement. During the first 24 weeks, there were 2 serious adverse events in the hydroxychloroquine group and 3 in the placebo group; in the last 24 weeks, there were 3 serious adverse events in the hydroxychloroquine group and 4 in the placebo group.</AbstractText><AbstractText Label="CONCLUSIONS AND RELEVANCE" NlmCategory="CONCLUSIONS">Among patients with primary Sjögren syndrome, the use of hydroxychloroquine compared with placebo did not improve symptoms during 24 weeks of treatment. Further studies are needed to evaluate longer-term outcomes.</AbstractText><AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">clinicaltrials.gov Identifier: NCT00632866.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Gottenberg</LastName><ForeName>Jacques-Eric</ForeName><Initials>JE</Initials><AffiliationInfo><Affiliation>Department of Rheumatology, Service de Rhumatologie, Hôpitaux Universitaires de Strasbourg, Centre de Référence National Pour les Maladies Auto-Immunes Systémiques Rares, Université de Strasbourg, Strasbourg, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ravaud</LastName><ForeName>Philippe</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Department of Epidemiology and Public Health, Hotel Dieu, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Puéchal</LastName><ForeName>Xavier</ForeName><Initials>X</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, Cochin Hospital, AP-HP, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Le Guern</LastName><ForeName>Véronique</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, Cochin Hospital, AP-HP, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sibilia</LastName><ForeName>Jean</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Rheumatology, Service de Rhumatologie, Hôpitaux Universitaires de Strasbourg, Centre de Référence National Pour les Maladies Auto-Immunes Systémiques Rares, Université de Strasbourg, Strasbourg, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Goeb</LastName><ForeName>Vincent</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Department of Rheumatology, Amiens University Hospital, Amiens, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Larroche</LastName><ForeName>Claire</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, Avicenne Hospital, AP-HP, Bobigny, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dubost</LastName><ForeName>Jean-Jacques</ForeName><Initials>JJ</Initials><AffiliationInfo><Affiliation>Department of Rheumatology, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rist</LastName><ForeName>Stéphanie</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Department of Rheumatology, Orléans Hospital, Orléans, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Saraux</LastName><ForeName>Alain</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Rheumatology, Brest University Hospital, Brest, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Devauchelle-Pensec</LastName><ForeName>Valérie</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Department of Rheumatology, Brest University Hospital, Brest, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Morel</LastName><ForeName>Jacques</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Rheumatology, Montpellier University Hospital, Montpellier, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hayem</LastName><ForeName>Gilles</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Department of Rheumatology, Hôpital Bichat, AP-HP, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hatron</LastName><ForeName>Pierre</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, Lille University Hospital, Lille, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Perdriger</LastName><ForeName>Aleth</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Rheumatology, Rennes University Hospital, Rennes, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sene</LastName><ForeName>Damien</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, Lariboisère Hospital, AP-HP, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zarnitsky</LastName><ForeName>Charles</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Department of Rheumatology, Le Havre Hospital, Le Havre, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Batouche</LastName><ForeName>Djilali</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Department of Rheumatology, Hôpitaux Universitaires Paris-Sud, AP-HP, INSERM U 1012, Université Paris Sud, Le Kremlin Bicêtre, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Furlan</LastName><ForeName>Valérie</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Department of Pharmacy, Hôpitaux Universitaires Paris-Sud, AP-HP, Le Kremlin Bicêtre, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Benessiano</LastName><ForeName>Joelle</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Centre de Ressources Biologiques, Bichat Hospital, AP-HP, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Perrodeau</LastName><ForeName>Elodie</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Department of Epidemiology and Public Health, Hotel Dieu, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Seror</LastName><ForeName>Raphaele</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Department of Rheumatology, Hôpitaux Universitaires Paris-Sud, AP-HP, INSERM U 1012, Université Paris Sud, Le Kremlin Bicêtre, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mariette</LastName><ForeName>Xavier</ForeName><Initials>X</Initials><AffiliationInfo><Affiliation>Department of Rheumatology, Hôpitaux Universitaires Paris-Sud, AP-HP, INSERM U 1012, Université Paris Sud, Le Kremlin Bicêtre, France.</Affiliation></AffiliationInfo></Author></AuthorList><Language>ENG</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT00632866</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType 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Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D010146" MajorTopicYN="N">Pain</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="N">drug therapy</QualifierName><QualifierName UI="Q000209" MajorTopicYN="N">etiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012859" MajorTopicYN="N">Sjogren's Syndrome</DescriptorName><QualifierName UI="Q000150" MajorTopicYN="N">complications</QualifierName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2014</Year><Month>7</Month><Day>17</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2014</Year><Month>7</Month><Day>17</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2014</Year><Month>7</Month><Day>30</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">25027140</ArticleId><ArticleId IdType="pii">1887760</ArticleId><ArticleId IdType="doi">10.1001/jama.2014.7682</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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