AuteurprincipalDevauchelle-Pensec(2005)Type d’étude Posologie Suivi Critères d’évaluation RésultatsSérie de casn=16Sjögren primaireAbstractRituximab:375 mg/m²/sem pdt 2semaines12 sem Examen cliniqueBiologieQualité de vieSécheresse oculaire etbuccaleEcho-doppler glandessalivaires- Amélioration subjectivedu syndrome sec et del’asthénie- Pas d’améliorationobjective du syndrome sec(test Schirmer, taux basaldu flux salivaire)- Rémission manifestationspulmonaires : n=1/1- Taux autoAc non modifiésGottenberg(2005)Série de casn=6Rituximab:375mg/m²/sem pdt 2 à4 semaines6 à 11mois- Symptômes extraglandulaires- EVA sécheresse etasthénie- AutoAc anti-SSA etanti-SSB- Amélioration symptômesextra-exocrines : n=5/6- ↓scores EVA sécheresseet asthénie- ↓ corticothérapie n= 5/6- Persistance des auto-AcVoulgarelis(2004)Série de casn=4Sjögren associé àun LNH agressif àcellulesB(+cryoglobulinémiemixte type II n=3)Rituximab:375mg/m² à chaquepremier jour de cycleCHOP ;8 cycles CHOP autotal.10 à 23mois- RC lymphome- Manifestationssystémiques(neuropathie,lymphadénopathies,purpura, anémie,arthralgies)- Titres ANA, autoAcanti-SSA et anti-SSB- RC lymphome : n=4/4- Disparitioncryoglobulinémie (n=3/3) etpurpura (n=3/3) ;améliorationneuropathie (n=2/2).- Titres ANA et autoAc nonmodifiésEVA: échelle visuelle analogique mesurant la sécheresse buccale et oculaire ;MFI: Multidimensional Fatigue Inventory : échelle comprenant 20 items évaluant l’asthénie et validée pour le syndrome deSjögren (plus le score est élevé, plus l’asthénie est importante) ;SF-36 : questionnaire mesurant la qualité de vie (un score élevé reflète un bon niveau de qualité de vie) ;titre ANA : anticorps antinucléaire ;RC : rémission complète.Bibliographie1. Seror R, Sorde C, Guillevin L, Hachulla E, Masson C, Ittah M, Candon S, Le Guern V, Aouba A, Sibilia J,Gottenberg JE, Mariette X. Tolerance and efficacy of <strong>rituximab</strong> and changes in serum B cell biomarkers inpatients with systemic complications of primary Sjögren’s syndrome. Ann Rheum Dis, Mar 2007; 66: 351 – 3572. Devauchelle-Pensec V., Morvan J., Pennec Y., Pers J.O., Jamin C, Jousse-Joulin S., Roudaut A., Cochener B.,Quintin-Roué I., Renaudineau Y., Youinou P., Saraux A. Rituximab (anti-CD20) in the treatment of primary Sjögren’ssyndrome (PSS): Results of an open label study (PHRC Brest 2003).3. Gottenberg JE, Guillevin L, Lambotte O, Combe B, Allanore Y, Cantagrel A, Larroche C, Soubrier M, Bouillet L,Dougados M, Fain O, Farge D, Kyndt X, Lortholary O, Masson C, Moura B, Remy P, Thomas T, Wendling D, Anaya JM,Sibilia J, Mariette X; Club Rheumatismes et Inflammation (CRI). Tolerance and short term efficacy of <strong>rituximab</strong> in 43patients with systemic autoimmune diseases. Ann Rheum Dis. 2005 Jun; 64(6):913-20.4. Harner KC, Jackson LW, Drabick JJ. Normalization of anticardiolipin antibodies following <strong>rituximab</strong> therapy formarginal zone lymphoma in a patient with Sjogren's syndrome. Rheumatology (Oxford). 2004 Oct; 43(10):1309-10.5. Pijpe J, van Imhoff GW, Spijkervet FK, Roodenburg JL, Wolbink GJ, Mansour K, Vissink A, Kallenberg CG, BootsmaH. Rituximab treatment in patients with primary Sjogren's syndrome: an open-label phase II study. Arthritis Rheum. 2005Sep; 52(9):2740-50.6. Ring T, Kallenbach M, Praetorius J, Nielsen S, Melgaard B. Successful treatment of a patient with primary Sjogren'ssyndrome with Rituximab. Clin Rheumatol. 2005 Nov 8; 1.7. Voulgarelis M, Giannouli S, Anagnostou D, Tzioufas AG. Combined therapy with <strong>rituximab</strong> pluscyclophosphamide/doxorubicin/vincristine/prednisone (CHOP) for Sjogren's syndrome-associated B-cell aggressive non-Hodgkin's lymphomas. Rheumatology (Oxford). 2004 Aug; 43(8):1050-3.- 66 -
Résumé-abstractSeror R, Sorde C, Guillevin L, Hachulla E, Masson C, Ittah M, Candon S, Le Guern V, Aouba A, Sibilia J,Gottenberg JE, Mariette X. Tolerance and efficacy of <strong>rituximab</strong> and changes in serum B cell biomarkers inpatients with systemic complications of primary Sjögren’s syndrome. Ann Rheum Dis, Mar 2007; 66: 351 – 357Objective: To investigate the safety and efficacy of <strong>rituximab</strong> (RTX) for systemic symptoms in patients withprimary Sjögren’s syndrome (pSS), and changes in B cell biomarkers. Patients and methods: The records of 16patients with pSS according to the American European consensus group criteria were reviewed retrospectively.Results: Patients, all women, had a median age of 58.5 (range 41–71) years and a disease duration of 9.5 (range0–25) years. RTX was prescribed for lymphoma (n = 5), refractory pulmonary disease with polysynovitis (n = 2),severe polysynovitis (n = 2), mixed cryoglobulinaemia (n = 5), thrombocytopenia (n = 1) and mononeuritismultiplex (n = 1). The median follow-up duration was 14.5 (range 2–48) months. Three patients experiencedadverse events, including one mild serum sickness-like reaction with the presence of human antichimericantibodies. Efficacy of treatment was observed in 4 of 5 patients with lymphomas and in 9 of 11 patients withsystemic involvement. Dryness was improved in only a minority of patients. Corticosteroid dose was reduced in11 patients. RTX induced decreased rheumatoid factor, -globulin and ß2-microglobulin levels, and the level of Bcell activating factor of the tumour necrosis factor family (BAFF) increased concomitantly with B cell depletion.Five patients were re-treated, with good efficacy and tolerance, except for one with probable serum sickness-likereaction. Conclusion: This study shows good efficacy and fair tolerance of RTX for systemic features. In addition,RTX allows for a marked reduction in corticosteroid use. Except for BAFF, the level of which increases, serum Bcell biomarker levels decrease after taking RTX. Controlled trials should be performed to confirm the efficacy ofRTX in pSS.Pijpe J, van Imhoff GW, Spijkervet FK, Roodenburg JL, Wolbink GJ, Mansour K, Vissink A, Kallenberg CG,Bootsma H. Rituximab treatment in patients with primary Sjogren's syndrome: an open-label phase II study.Arthritis Rheum. 2005 Sep;52(9):2740-50.OBJECTIVE: To investigate the safety and efficacy of B cell depletion treatment of patients with active primarySjogren's syndrome of short duration (early primary SS) and patients with primary SS and mucosa-associatedlymphoid tissue (MALT)-type lymphoma (MALT/primary SS). METHODS: Fifteen patients with primary SS wereincluded in this phase II trial. Inclusion criteria for the early primary SS group were B cell hyperactivity (IgG >15gm/liter), presence of autoantibodies (IgM rheumatoid factor, anti-SSA/SSB), and short disease duration (
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