| アブストラクト | CONTEXT: Bispecific antibodies (bsAbs) recently reshaped the treatment landscape of multiple myeloma (MM). Rare cases of progressive multifocal leukoencephalopathy (PML) have been reported in MM patients, and more recently in bsAbs-treated patients. OBJECTIVES: We aimed to investigate a potential safety signal for PML in patients with MM treated with bsAbs. METHODS: We included all patients with MM treated with bsAbs identified in the French prospective registry of JC polyomavirus infections of the central nervous system and/or from the French pharmacovigilance database (FPVD). We also performed a systematic review. We then assessed whether a disproportionality signal for PML reporting exists, comparing bsAbs and other MM therapies in VigiBase(R), the world pharmacovigilance database. RESULTS: In the registry-FPVD cohort, 14 patients were included; all had at least triple-refractory MM, with a median disease duration of 13 years (IQR, 10-14) and were exposed to BCMA-targeting bsAbs (median time to PML diagnosis: 22 months, IQR, 12-24); 10 (71%) were in complete response. Main clinical manifestations included motor deficit, cognitive impairment and visual symptoms (8/14 patients each, 57%). Twelve (86%) had died from PML by month 12. Similar features and outcomes were observed in the systematic review (n=14 cases). PML reporting was significantly higher with bsAbs than with other MM therapies (Reporting Odds Ratio 17.7; 95% CI, 12.1-26.1). INTERPRETATION: PML may represent an emerging complication in patients with MM receiving bsAbs. Vigilant monitoring and rapid assessment of new neurological deficits are critical in this population. |
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| 投稿者 | Le Henaff, Jean-Roch; Le Guennec, Loic; Schiro, Pauline; Bihan, Kevin; Gasnault, Jacques; Stankoff, Bruno; Taoufik, Yassine; Treiner, Emmanuel; Bensoussan, Daniele; Lhomme, Sebastien; L'Honneur, Anne-Sophie; Bonneville, Fabrice; Shor, Natalia; Pourcher, Valerie; Pignolet, Beatrice; Lievin, Baptiste; Javaux, Clement; Le Guen, Julien; Brissot, Eolia; Limouzin, Pierre-Antoine; Richaud, Clemence; Lioure, Bruno; Wirth, Thomas; Petitgas, Paul; Herbel, Simon; Coustilleres, Francois; Rusu, Elena-Camelia; Maerten, Laura; Perrot, Aurore; Sommet, Agnes; Roos-Weil, Damien; Lafaurie, Margaux; Weiss, Nicolas; Martin-Blondel, Guillaume |
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| 組織名 | Toulouse University Hospital, Toulouse, France.;Pitie-Salpetriere University Hospital, Paris, France.;CHU de Bicetre, Kremlin-Bicetre, Le Kremlin Bicetre, France.;Sorbonne University, Pitie-Salpetriere Hospital, APHP, Paris, France.;Department of Immunology, APHP, Hopital Bicetre, Kremlin Bicetre, France.;Chu Toulouse, Toulouse, France.;Unite de Therapie cellulaire et Tissus and MTInov, Vantoeuvre les Nancy, France.;APHP, Paris, France.;Toulouse University Hospital, University Toulouse 3-Paul Sabatier, Toulouse,;France.;APHP, Groupe Hospitalier Pitie-Salpetriere, Paris, France.;AP-HP Hopital Pitie-Salpetriere, Universite Pierre et Marie Curie-Paris 6, Paris,;Croix Rousse University Hospital, Lyon, France.;Hopital Europeen Georges Pompidou, Paris, France.;Sorbonne Universite, INSERM UMR-S 938, CRSA, service d'hematologie et therapie;cellulaire, AP-HP, Hopital Saint-Antoine, Paris, France.;Pellegrin University Hospital, Bordeaux, France.;Gabriel Montpied University Hospital, Clermont-Ferrand, France.;Hopitaux Universitaires de Strasbourg, Strasbourg, France.;University Hospital of Strasbourg, Strasbourg, France.;Quimper Hospital, Quimper, France.;Necker University Hospital, Paris, France.;CHRU Tours, Tours, France.;Toulon Hospital, Toulon, France.;Avicenne University Hospital, Bobigny, France.;Universite de Toulouse, CHU Toulouse, Toulouse, France.;Pitie-Salpetriere, paris, France.;Toulouse University Hospital Center, Toulouse, France.;Sorbonne Universite, AP-HP.Sorbonne Universite, Hopital Pitie-Salpetriere, Paris,;CHU Toulouse, Toulouse, France. |
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