| アブストラクト | INTRODUCTION: Rituximab induced serum sickness (RISS) is a rare delayed hypersensitivity reaction. The aim of this study was to describe the epidemiological and clinical characteristics of the RISS cases reported in France. METHOD: Serum sickness cases involving rituximab were identified from the French PharmacoVigilance Database from 1998 to 2016. RESULTS: We analyzed 37 cases of RISS. Rituximab was prescribed for an autoimmune disease in 78% of cases. Serum sickness occurred mainly after the first injection (54%) with a median time to onset of 12days. The most frequent manifestations were rheumatologic symptoms (92%), fever (87%), and skin lesions (78%). The incidence was significantly higher when rituximab was used for autoimmune diseases than for a hematological malignancies. Taking into account the existence of a Systemic Lupus Erythematosus (SLE) as the indication of rituximab or as a comorbidity, the incidence of RISS in patients with SLE was even higher. DISCUSSION: We report on the largest series of RISS studied to date and confirm that this reaction preferentially occurs in patients with autoimmune disease, especially SLE. This may be due to B-cell lysis, leading to the release of intracellular antigens into the serum and subsequent antigen-antibody complex formation, especially in patients with elevated autoantibody production. This could also explain why RISS often occurred after a single injection. CONCLUSION: Patients generally recovered from RISS rapidly without obvious benefit from corticosteroid therapy. The risk of recurrence should prompt clinicians to question the use of rituximab after an episode of RISS. |
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| 投稿者 | Bayer, Guillaume; Agier, Marie-Sara; Lioger, Bertrand; Lepelley, Marion; Zenut, Marie; Lanoue, Mary-Christine; Maillot, Francois; Jonville-Bera, Annie-Pierre |
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| 組織名 | CHRU de Tours, Service de medecine interne, Tours, France; Universite Francois;Rabelais, Tours, France. Electronic address: guillaume.bayer@hotmail.fr.;CHRU de Tours, Centre Regional de pharmacovigilance Centre Val de Loire, Tours,;France.;CHRU de Tours, Service de medecine interne, Tours, France.;CHRU de Grenoble, Centre Regional de pharmacovigilance, Grenoble, France.;CHRU de Clermont-Ferrand, Centre Regional de pharmacovigilance, Clermont-Ferrand,;CHRU de Tours, OMEDIT Centre Val de Loire, Tours, France.;Rabelais, Tours, France.;France; Universite de Tours, Universite de Nantes, INSERM, SPHERE U1246, Tours, |
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