Efficacy of rituximab in systemic manifestations of primary Sjögren's syndrome: results in 78 patients of the AutoImmune and Rituximab registry
Identifieur interne : 000195 ( France/Analysis ); précédent : 000194; suivant : 000196Efficacy of rituximab in systemic manifestations of primary Sjögren's syndrome: results in 78 patients of the AutoImmune and Rituximab registry
Auteurs : Jacques-Eric Gottenberg [France] ; Gael Cinquetti [France] ; Claire Larroche [France] ; Bernard Combe [France] ; Eric Hachulla [France] ; Olivier Meyer [France] ; Edouard Pertuiset [France] ; Guy Kaplanski [France] ; Laurent Chiche [France] ; Jean-Marie Berthelot [France] ; Bruno Gombert [France] ; Philippe Goupille [France] ; Christian Marcelli [France] ; Séverine Feuillet [France] ; Jean Leone [France] ; Jean Sibilia [France] ; Charles Zarnitsky [France] ; Philippe Carli [France] ; Stephanie Rist [France] ; Philippe Gaudin [France] ; Carine Salliot [France] ; Muriel Piperno ; Adeline Deplas [France] ; Maxime Breban [France] ; Thierry Lequerre [France] ; Pascal Richette [France] ; Charles Ghiringhelli [France] ; Mohamed Hamidou [France] ; Philippe Ravaud [France] ; Xavier Mariette [France]Source :
- Annals of the Rheumatic Diseases [ 0003-4967 ] ; 2013-06.
English descriptors
- Teeft :
- Autoimmune, Autoimmune diseases, Autoimmune pancreatitis, Club rhumatismes, Common practice, Corticosteroid, Data collection, Essdai, French society, Immunosuppressant, Infusion, Lymphoma, Median, Present study, Primary syndrome, Registry, Renal involvement, Rheum, Rheumatoid arthritis, Rheumatology, Rhumatologie, Rituximab, Rituximab regimen, Rituximab registry, Second cycle, Second infusion, Serious infections, Serum disease, Syndrome, Systemic, Systemic complications, Systemic involvement, Systemic lupus erythematosus, Vasculitis.
Abstract
Objectives To evaluate the efficacy and safety of rituximab in patients with primary Sjögren's syndrome (pSS). Methods The AutoImmune and Rituximab registry has included 86 patients with pSS treated with rituximab, prospectivey followed up every 6 months for 5 years. Results Seventy-eight patients with pSS (11 men, 67 women), who already had at least one follow-up visit, were analysed. Median age was 59.8 years (29–83), median duration of disease was 11.9 years (3–32). Indications for treatment were systemic involvement for 74 patients and only severe glandular involvement in four patients. The median European Sjögren's Syndrome disease activity index (ESSDAI) was 11 (2–31). 17 patients were concomitantly treated with another immunosuppressant agent. Median follow-up was 34.9 months (6–81.4) (226 patient-years). Overall efficacy according to the treating physician was observed in 47 patients (60%) after the first cycle of rituximab. Median ESSDAI decreased from 11 (2–31) to 7.5 (0–26) (p<0.0001). Median dosage of corticosteroid decreased from 17.6 mg/day (3–60) to 10.8 mg/day (p=0.1). Forty-one patients were retreated with rituximab. Four infusion reactions and one delayed serum sickness-like disease resulted in rituximab discontinuation. Three serious infections (1.3/100 patient-years) and two cancer-related deaths occurred. Conclusions In common practice, the use of rituximab in pSS is mostly restricted to patients with systemic involvement. This prospective study shows good efficacy and tolerance of rituximab in patients with pSS and systemic involvement.
Url:
DOI: 10.1136/annrheumdis-2012-202293
Affiliations:
- France
- Alsace (région administrative), Aquitaine, Basse-Normandie, Centre-Val de Loire, Champagne-Ardenne, Grand Est, Haute-Normandie, Hauts-de-France, Languedoc-Roussillon, Lorraine (région), Nord-Pas-de-Calais, Nouvelle-Aquitaine, Occitanie (région administrative), Pays de la Loire, Poitou-Charentes, Provence-Alpes-Côte d'Azur, Région Centre, Région Normandie, Île-de-France
- Bobigny, Bordeaux, Boulogne-Billancourt, Caen, La Rochelle, Le Havre, Lille, Marseille, Metz, Montpellier, Nantes, Orléans, Paris, Pontoise, Reims, Rouen, Strasbourg, Toulon, Tours
- Université Paris-Sud
Links toward previous steps (curation, corpus...)
- to stream Istex, to step Corpus: 002324
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- to stream Istex, to step Checkpoint: 000191
- to stream Main, to step Merge: 001140
- to stream Main, to step Curation: 001139
- to stream Main, to step Exploration: 001139
- to stream France, to step Extraction: 000195
Links to Exploration step
ISTEX:52A3B80A2058E94C2AC1BECDAEDC9D33451FAAA8Le document en format XML
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Loire</region><region type="old region">Pays de la Loire</region><settlement type="city">Nantes</settlement></placeName></affiliation></author><author><name sortKey="Gombert, Bruno" sort="Gombert, Bruno" uniqKey="Gombert B" first="Bruno" last="Gombert">Bruno Gombert</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Service de Médecine Polyvalente - Rhumatologie, CH de La Rochelle, La Rochelle</wicri:regionArea><placeName><region type="region">Nouvelle-Aquitaine</region><region type="old region">Poitou-Charentes</region><settlement type="city">La Rochelle</settlement></placeName></affiliation></author><author><name sortKey="Goupille, Philippe" sort="Goupille, Philippe" uniqKey="Goupille P" first="Philippe" last="Goupille">Philippe Goupille</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Service de Rhumatologie, CHU Tours, Tours</wicri:regionArea><placeName><region type="region">Centre-Val de Loire</region><region type="old region">Région Centre</region><settlement type="city">Tours</settlement></placeName></affiliation></author><author><name sortKey="Marcelli, Christian" sort="Marcelli, Christian" uniqKey="Marcelli C" first="Christian" last="Marcelli">Christian Marcelli</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Service de Rhumatologie, CHU de Caen, Caen</wicri:regionArea><placeName><region type="region">Région Normandie</region><region type="old region">Basse-Normandie</region><settlement type="city">Caen</settlement></placeName></affiliation></author><author><name sortKey="Feuillet, Severine" sort="Feuillet, Severine" uniqKey="Feuillet S" first="Séverine" last="Feuillet">Séverine Feuillet</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Service de Pneumologie, Hôpital Saint Louis, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Leone, Jean" sort="Leone, Jean" uniqKey="Leone J" first="Jean" last="Leone">Jean Leone</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Service de Médecine Interne, Hôpital Debré, Reims</wicri:regionArea><placeName><region type="region">Grand Est</region><region type="old region">Champagne-Ardenne</region><settlement type="city">Reims</settlement></placeName></affiliation></author><author><name sortKey="Sibilia, Jean" sort="Sibilia, Jean" uniqKey="Sibilia J" first="Jean" last="Sibilia">Jean Sibilia</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Service de Rhumatologie, Centre National de Références des Maladies Auto-Immunes Systémiques Rares, Hôpitaux Universitaires de Strasbourg, Immunorhumathologie Moléculaire, INSERM UMR S 1109, Université de Strasbourg, Strasbourg</wicri:regionArea><placeName><region type="region">Grand Est</region><region type="old region">Alsace (région administrative)</region><settlement type="city">Strasbourg</settlement></placeName></affiliation></author><author><name sortKey="Zarnitsky, Charles" sort="Zarnitsky, Charles" uniqKey="Zarnitsky C" first="Charles" last="Zarnitsky">Charles Zarnitsky</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Service de Rhumatologie, Groupe Hospitalier du Havre, Le Havre</wicri:regionArea><placeName><region type="region">Région Normandie</region><region type="old region">Haute-Normandie</region><settlement type="city">Le Havre</settlement></placeName></affiliation></author><author><name sortKey="Carli, Philippe" sort="Carli, Philippe" uniqKey="Carli P" first="Philippe" last="Carli">Philippe Carli</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Service de Médecine Interne, HIA Sainte-Anne, Toulon</wicri:regionArea><placeName><region type="region">Provence-Alpes-Côte d'Azur</region><region type="old region">Provence-Alpes-Côte d'Azur</region><settlement type="city">Toulon</settlement></placeName></affiliation></author><author><name sortKey="Rist, Stephanie" sort="Rist, Stephanie" uniqKey="Rist S" first="Stephanie" last="Rist">Stephanie Rist</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Service de Rhumatologie, CHR Orléans, Orléans</wicri:regionArea><placeName><region type="region">Centre-Val de Loire</region><region type="old region">Région Centre</region><settlement type="city">Orléans</settlement></placeName></affiliation></author><author><name sortKey="Gaudin, Philippe" sort="Gaudin, Philippe" uniqKey="Gaudin P" first="Philippe" last="Gaudin">Philippe Gaudin</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Service de Rhumatologie, CHU Hôpital Sud, Grenoble, Echirolles</wicri:regionArea><wicri:noRegion>Echirolles</wicri:noRegion><wicri:noRegion>Echirolles</wicri:noRegion></affiliation></author><author><name sortKey="Salliot, Carine" sort="Salliot, Carine" uniqKey="Salliot C" first="Carine" last="Salliot">Carine Salliot</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Service de Rhumatologie, CHR Orléans, Orléans</wicri:regionArea><placeName><region type="region">Centre-Val de Loire</region><region type="old region">Région Centre</region><settlement type="city">Orléans</settlement></placeName></affiliation></author><author><name sortKey="Piperno, Muriel" sort="Piperno, Muriel" uniqKey="Piperno M" first="Muriel" last="Piperno">Muriel Piperno</name><affiliation><wicri:noCountry code="subField"></wicri:noCountry></affiliation></author><author><name sortKey="Deplas, Adeline" sort="Deplas, Adeline" uniqKey="Deplas A" first="Adeline" last="Deplas">Adeline Deplas</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Service de Rhumatologie, CH Niort</wicri:regionArea><wicri:noRegion>CH Niort</wicri:noRegion><wicri:noRegion>CH Niort</wicri:noRegion></affiliation></author><author><name sortKey="Breban, Maxime" sort="Breban, Maxime" uniqKey="Breban M" first="Maxime" last="Breban">Maxime Breban</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Service de Rhumatologie, CHU Ambroise Paré, Boulogne Billancourt</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Boulogne-Billancourt</settlement></placeName></affiliation></author><author><name sortKey="Lequerre, Thierry" sort="Lequerre, Thierry" uniqKey="Lequerre T" first="Thierry" last="Lequerre">Thierry Lequerre</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Service de Rhumatologie, CHU Rouen, Rouen</wicri:regionArea><placeName><region type="region">Région Normandie</region><region type="old region">Haute-Normandie</region><settlement type="city">Rouen</settlement></placeName></affiliation></author><author><name sortKey="Richette, Pascal" sort="Richette, Pascal" uniqKey="Richette P" first="Pascal" last="Richette">Pascal Richette</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Service de Rhumatologie, Hôpital Lariboisière, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Ghiringhelli, Charles" sort="Ghiringhelli, Charles" uniqKey="Ghiringhelli C" first="Charles" last="Ghiringhelli">Charles Ghiringhelli</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Service de Médecine Interne, Hôpital Saint André, Bordeaux</wicri:regionArea><placeName><region type="region">Nouvelle-Aquitaine</region><region type="old region">Aquitaine</region><settlement type="city">Bordeaux</settlement></placeName></affiliation></author><author><name sortKey="Hamidou, Mohamed" sort="Hamidou, Mohamed" uniqKey="Hamidou M" first="Mohamed" last="Hamidou">Mohamed Hamidou</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Service de Médecine Interne, CHU de Nantes, Nantes</wicri:regionArea><placeName><region type="region">Pays de la Loire</region><region type="old region">Pays de la Loire</region><settlement type="city">Nantes</settlement></placeName></affiliation></author><author><name sortKey="Ravaud, Philippe" sort="Ravaud, Philippe" uniqKey="Ravaud P" first="Philippe" last="Ravaud">Philippe Ravaud</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>INSERM U738, Département d'Epidémiologie, Biostatistiques et Recherche Clinique, Hôtel Dieu, Centre d'épidémiologie clinique, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Mariette, Xavier" sort="Mariette, Xavier" uniqKey="Mariette X" first="Xavier" last="Mariette">Xavier Mariette</name><affiliation wicri:level="4"><country xml:lang="fr">France</country><wicri:regionArea>Service de Rhumatologie, Université Paris Sud, AP-HP, Hôpitaux Universitaires Paris Sud, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Paris-Sud</orgName></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">6</biblScope><biblScope unit="page" from="1026">1026</biblScope></imprint><idno type="ISSN">0003-4967</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0003-4967</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="Teeft" xml:lang="en"><term>Autoimmune</term><term>Autoimmune diseases</term><term>Autoimmune pancreatitis</term><term>Club rhumatismes</term><term>Common practice</term><term>Corticosteroid</term><term>Data collection</term><term>Essdai</term><term>French society</term><term>Immunosuppressant</term><term>Infusion</term><term>Lymphoma</term><term>Median</term><term>Present study</term><term>Primary syndrome</term><term>Registry</term><term>Renal involvement</term><term>Rheum</term><term>Rheumatoid arthritis</term><term>Rheumatology</term><term>Rhumatologie</term><term>Rituximab</term><term>Rituximab regimen</term><term>Rituximab registry</term><term>Second cycle</term><term>Second infusion</term><term>Serious infections</term><term>Serum disease</term><term>Syndrome</term><term>Systemic</term><term>Systemic complications</term><term>Systemic involvement</term><term>Systemic lupus erythematosus</term><term>Vasculitis</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">Objectives To evaluate the efficacy and safety of rituximab in patients with primary Sjögren's syndrome (pSS). Methods The AutoImmune and Rituximab registry has included 86 patients with pSS treated with rituximab, prospectivey followed up every 6 months for 5 years. Results Seventy-eight patients with pSS (11 men, 67 women), who already had at least one follow-up visit, were analysed. Median age was 59.8 years (29–83), median duration of disease was 11.9 years (3–32). Indications for treatment were systemic involvement for 74 patients and only severe glandular involvement in four patients. The median European Sjögren's Syndrome disease activity index (ESSDAI) was 11 (2–31). 17 patients were concomitantly treated with another immunosuppressant agent. Median follow-up was 34.9 months (6–81.4) (226 patient-years). Overall efficacy according to the treating physician was observed in 47 patients (60%) after the first cycle of rituximab. Median ESSDAI decreased from 11 (2–31) to 7.5 (0–26) (p<0.0001). Median dosage of corticosteroid decreased from 17.6 mg/day (3–60) to 10.8 mg/day (p=0.1). Forty-one patients were retreated with rituximab. Four infusion reactions and one delayed serum sickness-like disease resulted in rituximab discontinuation. Three serious infections (1.3/100 patient-years) and two cancer-related deaths occurred. Conclusions In common practice, the use of rituximab in pSS is mostly restricted to patients with systemic involvement. This prospective study shows good efficacy and tolerance of rituximab in patients with pSS and systemic involvement.</div></front></TEI><affiliations><list><country><li>France</li></country><region><li>Alsace (région administrative)</li><li>Aquitaine</li><li>Basse-Normandie</li><li>Centre-Val de Loire</li><li>Champagne-Ardenne</li><li>Grand Est</li><li>Haute-Normandie</li><li>Hauts-de-France</li><li>Languedoc-Roussillon</li><li>Lorraine (région)</li><li>Nord-Pas-de-Calais</li><li>Nouvelle-Aquitaine</li><li>Occitanie (région administrative)</li><li>Pays de la Loire</li><li>Poitou-Charentes</li><li>Provence-Alpes-Côte d'Azur</li><li>Région Centre</li><li>Région Normandie</li><li>Île-de-France</li></region><settlement><li>Bobigny</li><li>Bordeaux</li><li>Boulogne-Billancourt</li><li>Caen</li><li>La Rochelle</li><li>Le Havre</li><li>Lille</li><li>Marseille</li><li>Metz</li><li>Montpellier</li><li>Nantes</li><li>Orléans</li><li>Paris</li><li>Pontoise</li><li>Reims</li><li>Rouen</li><li>Strasbourg</li><li>Toulon</li><li>Tours</li></settlement><orgName><li>Université Paris-Sud</li></orgName></list><tree><noCountry><name sortKey="Piperno, Muriel" sort="Piperno, Muriel" uniqKey="Piperno M" first="Muriel" last="Piperno">Muriel Piperno</name></noCountry><country name="France"><region name="Grand Est"><name sortKey="Gottenberg, Jacques Eric" sort="Gottenberg, Jacques Eric" uniqKey="Gottenberg J" first="Jacques-Eric" last="Gottenberg">Jacques-Eric Gottenberg</name></region><name sortKey="Berthelot, Jean Marie" sort="Berthelot, Jean Marie" uniqKey="Berthelot J" first="Jean-Marie" last="Berthelot">Jean-Marie Berthelot</name><name sortKey="Breban, Maxime" sort="Breban, Maxime" uniqKey="Breban M" first="Maxime" last="Breban">Maxime Breban</name><name sortKey="Carli, Philippe" sort="Carli, Philippe" uniqKey="Carli P" first="Philippe" last="Carli">Philippe Carli</name><name sortKey="Chiche, Laurent" sort="Chiche, Laurent" uniqKey="Chiche L" first="Laurent" last="Chiche">Laurent Chiche</name><name sortKey="Cinquetti, Gael" sort="Cinquetti, Gael" uniqKey="Cinquetti G" first="Gael" last="Cinquetti">Gael Cinquetti</name><name sortKey="Combe, Bernard" sort="Combe, Bernard" uniqKey="Combe B" first="Bernard" last="Combe">Bernard Combe</name><name sortKey="Deplas, Adeline" sort="Deplas, Adeline" uniqKey="Deplas A" first="Adeline" last="Deplas">Adeline Deplas</name><name sortKey="Feuillet, Severine" sort="Feuillet, Severine" uniqKey="Feuillet S" first="Séverine" last="Feuillet">Séverine Feuillet</name><name sortKey="Gaudin, Philippe" sort="Gaudin, Philippe" uniqKey="Gaudin P" first="Philippe" last="Gaudin">Philippe Gaudin</name><name sortKey="Ghiringhelli, Charles" sort="Ghiringhelli, Charles" uniqKey="Ghiringhelli C" first="Charles" last="Ghiringhelli">Charles Ghiringhelli</name><name sortKey="Gombert, Bruno" sort="Gombert, Bruno" uniqKey="Gombert B" first="Bruno" last="Gombert">Bruno Gombert</name><name sortKey="Goupille, Philippe" sort="Goupille, Philippe" uniqKey="Goupille P" first="Philippe" last="Goupille">Philippe Goupille</name><name sortKey="Hachulla, Eric" sort="Hachulla, Eric" uniqKey="Hachulla E" first="Eric" last="Hachulla">Eric Hachulla</name><name sortKey="Hamidou, Mohamed" sort="Hamidou, Mohamed" uniqKey="Hamidou M" first="Mohamed" last="Hamidou">Mohamed Hamidou</name><name sortKey="Kaplanski, Guy" sort="Kaplanski, Guy" uniqKey="Kaplanski G" first="Guy" last="Kaplanski">Guy Kaplanski</name><name sortKey="Larroche, Claire" sort="Larroche, Claire" uniqKey="Larroche C" first="Claire" last="Larroche">Claire Larroche</name><name sortKey="Leone, Jean" sort="Leone, Jean" uniqKey="Leone J" first="Jean" last="Leone">Jean Leone</name><name sortKey="Lequerre, Thierry" sort="Lequerre, Thierry" uniqKey="Lequerre T" first="Thierry" last="Lequerre">Thierry Lequerre</name><name sortKey="Marcelli, Christian" sort="Marcelli, Christian" uniqKey="Marcelli C" first="Christian" last="Marcelli">Christian Marcelli</name><name sortKey="Mariette, Xavier" sort="Mariette, Xavier" uniqKey="Mariette X" first="Xavier" last="Mariette">Xavier Mariette</name><name sortKey="Meyer, Olivier" sort="Meyer, Olivier" uniqKey="Meyer O" first="Olivier" last="Meyer">Olivier Meyer</name><name sortKey="Pertuiset, Edouard" sort="Pertuiset, Edouard" uniqKey="Pertuiset E" first="Edouard" last="Pertuiset">Edouard Pertuiset</name><name sortKey="Ravaud, Philippe" sort="Ravaud, Philippe" uniqKey="Ravaud P" first="Philippe" last="Ravaud">Philippe Ravaud</name><name sortKey="Richette, Pascal" sort="Richette, Pascal" uniqKey="Richette P" first="Pascal" last="Richette">Pascal Richette</name><name sortKey="Rist, Stephanie" sort="Rist, Stephanie" uniqKey="Rist S" first="Stephanie" last="Rist">Stephanie Rist</name><name sortKey="Salliot, Carine" sort="Salliot, Carine" uniqKey="Salliot C" first="Carine" last="Salliot">Carine Salliot</name><name sortKey="Sibilia, Jean" sort="Sibilia, Jean" uniqKey="Sibilia J" first="Jean" last="Sibilia">Jean Sibilia</name><name sortKey="Zarnitsky, Charles" sort="Zarnitsky, Charles" uniqKey="Zarnitsky C" first="Charles" last="Zarnitsky">Charles Zarnitsky</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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