rituximab

Comité de qualificationPr CAULIN Charles, Président, thérapeutique, ParisPr AULAGNER Gilles, pharmacien, représentant desHCL, LyonMme BONGRAND Marie-Claude, pharmacien,représentante des Pharmaciens de CHU, MarseilleDr DUMARCET Nathalie, AfssapsDr CHASSANY Olivier, méthodologiste, ParisMme FAUCHER-GRASSIN Joëlle, pharmacien,représentante des Pharmaciens de CHU PoitiersPr LAVILLE Maurice, praticien hospitalier,représentant des HCL, LyonMme MONTAGNIER-PETRISSANS Catherine,pharmacien, représentante de la Juste prescription del’AP-HP, ParisM. LIEVRE Michel, pharmacologue, LyonMme PIVOT, pharmacien, représentante des HCLLyonPr RICHÉ Christian, pharmacologue, BrestM. ROPERS Jacques, AfssapsDr ROSENHEIM Michel, médecin de santé publique,ParisPr VICAUT Eric, médecin de santé publique, ParisLa Commission d’AMM du 8 Novembre 2007 présidée par le Pr Daniel VITTECOQ n’a pas émisd’objection à ce référentiel, qui a également été visé par la Commission de la transparence de laHAS, présidée par le Pr Gilles BOUVENOT.Résumés-abstractsZaja F, Bacigalupo A, Patriarca F, Stanzani M, Van Lint MT, Filì C, Scimè R, Milone G, Falda M, Vener C, LaszloD, Alessandrino PE, Narni F, Sica S, Olivieri A, Sperotto A, Bosi A, Bonifazi F, Fanin R; GITMO (Gruppo ItalianoTrapianto Midollo Osseo). Treatment of refractory chronic GVHD with rituximab: a GITMO study. Bone MarrowTransplant. 2007 Aug;40(3):273-7.The anti-CD20 chimaeric monoclonal antibody Rituximab has recently been shown to induce significant clinicalresponse in a proportion of patients with refractory chronic graft-versus-host disease (cGVHD). We now report 38patients, median age 48 years (22-61), receiving Rituximab for refractory cGVHD, assessed for clinical responseand survival. Median duration of cGVHD before Rituximab was 23 months (range 2-116), the median number offailed treatment lines was 3 (range 1 to > or =6) and the median follow-up after Rituximab was 11 months (1-88).Overall response rate was 65%: skin 17/20 (63%), mouth 10/21 (48%), eyes 6/14 (43%), liver 3/12 (25%), lung3/8 (37.5%), joints 4/5, gut 3/4, thrombocytopaenia 2/3, vagina 0/2, pure red cell aplasia 0/1 and, myastheniagravis 1/1. During the study period 8/38 died: causes of death were cGVHD progression (n=3), disease relapse(n=1), infection (n=3), sudden death (n=1). The actuarial 2 year survival is currently 76%. We confirm thatRituximab is effective in over 50% of patients with refractory cGVHD and may have a beneficial impact onsurvival.Cutler C, Miklos D, Kim HT, Treister N, Woo SB, Bienfang D, Klickstein LB, Levin J, Miller K, Reynolds C,Macdonell R, Pasek M, Lee SJ, Ho V, Soiffer R, Antin J, Ritz J, Alyea E. Rituximab for steroid-refractory chronicgraft-vs.-host disease. Blood. 2006 March 21.B cells may be implicated in the pathophysiology of chronic GVHD, as evidenced by antibody production againstsex-mismatched, Y chromosome-encoded minor HLA antigens in association with chronic GVHD. We thereforedesigned a phase I-II study of anti-B cell therapy with rituximab in steroid-refractory chronic GVHD. Twenty-onepatients were treated with thirty-eight cycles of rituximab. Rituximab was tolerated well, and toxicity was limited toinfectious events. The clinical response rate was 70%, including two patients with complete responses.Responses were limited to patients with cutaneous and musculoskeletal manifestations of chronic GVHD andwere durable through one year after therapy. The median dose of prednisone among treated subjects fell from 40mg/day to 10 mg/day, one year after rituximab therapy (p=0.0001). A chronic GVHD symptom score improved inthe majority of treated patients. Antibody titers against Y chromosome-encoded minor HLA antigens fell andremained low while titers against infectious antigens (EBV, tetanus) remained stable or rose during the treatmentperiod. We conclude that specific anti-B cell therapy with rituximab may be beneficial for patients with steroidrefractorychronic GVHD.Ratanatharathorn V, Ayash L, Reynolds C, Silver S, Reddy P, Becker M, Ferrara JL, Uberti JP. Treatment ofchronic graft-versus-host disease with anti-CD20 chimeric monoclonal antibody. Biol Blood Marrow Transplant.2003 Aug; 8:505-11.We reviewed the clinical outcome of 8 patients with steroid-refractory chronic graft-versus-host disease (GVHD)who received an anti-CD20 chimeric monoclonal antibody (rituximab). Rituximab was given by intravenous- 40 -