Adverse effect of Pneumocystis Jirovecii infection associated with rituximab therapy for autoimmune disease are more frequently reported in older vs. younger patient - 18/11/22

Doi : 10.1016/j.therap.2022.10.065

Léa Lemoine ^a,^b,⁎ , Marie Sara Agier ^c,^d, Alexandra Audemard-Verger ^a,^b, Laurent Chouchana ^e, Joëlle Michot ^f, Annie Pierre Jonville-Béra ^c,^d, Francois Maillot ^a,^b,^g
^a Department of Internal Medicine and Clinical Immunology, CHRU Tours, 37044 Tours, France
^b University of Tours, 37000 Tours, France
^c Regional Pharmacovigilance Center of Tours, Service de Pharmacosurveillance, CHRU, 37000 Tours, France
^d Université de Tours, Université de Nantes, INSERM, methodS in Patients-centered outcomes and HEalth ResEarch (SPHERE) - UMR 1246, Tours 37044, France
^e Regional Center of Pharmacovigilance, Department of Pharmacology, Cochin Hospital, AP-HP Centre - Université Paris Cité, 75000 Paris, France
^f Regional Center of Pharmacovigilance, Saint Antoine Hospital (AP-HP), 75000 Paris, France
^g LabEx MabImprove, 37000 Tours, France

^⁎Corresponding. CHRU Tours–Service de Médecine Interne, Hôpital Bretonneau, 2, boulevard Tonnellé, 37044 Tours cedex 9, France.CHRU Tours–Service de Médecine Interne, Hôpital Bretonneau2, boulevard TonnelléTours cedex 937044France

Sous presse. Épreuves corrigées par l'auteur. Disponible en ligne depuis le Friday 18 November 2022
Cet article a été publié dans un numéro de la revue, cliquez ici pour y accéder

Summary

Introduction

Rituximab is a chimeric anti-CD20 antibody commonly used to treat patients with autoimmune diseases. Such diseases mainly affect young people, but older patients may also be concerned. So far, very little data exist concerning the safety of rituximab in older patients with autoimmune diseases.

Methods

This study was intended to describe the adverse reaction profile of rituximab in patients over 75 years of age treated for autoimmune diseases and to compare such profile to those observed in patients below 75 years of age. Adverse reactions related to rituximab were reported to the French Pharmacovigilance Network. From such reports, a descriptive analysis as well as a disproportionality analysis were performed to identify safety signals.

Results

1096 reports of rituximab-related adverse reactions reported in France between 2006 and 2019, were included in the study, such as 127 in the older group (>75 years) and 969 in the younger group (<75 years). Infusion reactions were less frequently reported than other adverse drug reaction in older patients (11 vs. 27%, P<0.001). By contrast, a higher rate of opportunistic infection due to Pneumocystis jirovecii was reported in the older subject group (3.9 vs. 0.6%, P<0.001), along with neutropenia (22.8 vs. 9.3%, P<0.0001). These results were confirmed by the disproportionality analysis.

Conclusion

Pneumocystis jirovecii infection was significatively more reported in older patients treated by Rituximab which probably reflects a higher incidence in this population. The use of anti-pneumocystis prophylaxis should be considered in this population.

Le texte complet de cet article est disponible en PDF.

Keywords : Rituximab, Age, Autoimmune diseases, Opportunistic infection, Adverse drug reaction