In 2010, our analysis of spontaneous and published reports of Progressive Multifocal Leukoencephalopathy (PML) coming from different sources (FDA Adverse Event Reporting System–AERS, WHO VigiBase and MEDLINE) suggested a possible strong relationship between PML and Monoclonal Antibodies (MAbs), especially when used in autoimmune diseases. Recently, Schmedt and colleagues, by using the public version of FDA AERS, have performed the first disproportionality analysis for the possible association between PML and immunosuppressive drugs, and found disproportionality signals for several immunosuppressants, especially MAbs (e.g. natalizumab, efalizumab and rituximab). This study prompted us to refine our analysis by applying a similar disproportionality method, in order to confirm or reject our previous speculation. Therefore, we performed a step-by-step disproportionality analysis for PML in the FDA AERS database by checking disproportionality for: (i) immunosuppressants vs. other drugs; (ii) among immunosuppressants, MAbs vs. Non-MAbs and (iii) each MAb, separately.

Carlo Piccinni, Chiara Sacripanti, Elisabetta Poluzzi, Fabrizio De Ponti (2013). Disproportionality signal of progressive multifocal leukoencephalopathy: monoclonal antibodies versus other immunosuppressants. PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 22(4), 443-445 [10.1002/pds.3414].

Disproportionality signal of progressive multifocal leukoencephalopathy: monoclonal antibodies versus other immunosuppressants

PICCINNI, CARLO;SACRIPANTI, CHIARA;POLUZZI, ELISABETTA;DE PONTI, FABRIZIO
2013

Abstract

In 2010, our analysis of spontaneous and published reports of Progressive Multifocal Leukoencephalopathy (PML) coming from different sources (FDA Adverse Event Reporting System–AERS, WHO VigiBase and MEDLINE) suggested a possible strong relationship between PML and Monoclonal Antibodies (MAbs), especially when used in autoimmune diseases. Recently, Schmedt and colleagues, by using the public version of FDA AERS, have performed the first disproportionality analysis for the possible association between PML and immunosuppressive drugs, and found disproportionality signals for several immunosuppressants, especially MAbs (e.g. natalizumab, efalizumab and rituximab). This study prompted us to refine our analysis by applying a similar disproportionality method, in order to confirm or reject our previous speculation. Therefore, we performed a step-by-step disproportionality analysis for PML in the FDA AERS database by checking disproportionality for: (i) immunosuppressants vs. other drugs; (ii) among immunosuppressants, MAbs vs. Non-MAbs and (iii) each MAb, separately.
2013
Carlo Piccinni, Chiara Sacripanti, Elisabetta Poluzzi, Fabrizio De Ponti (2013). Disproportionality signal of progressive multifocal leukoencephalopathy: monoclonal antibodies versus other immunosuppressants. PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 22(4), 443-445 [10.1002/pds.3414].
Carlo Piccinni;Chiara Sacripanti;Elisabetta Poluzzi;Fabrizio De Ponti
File in questo prodotto:
Eventuali allegati, non sono esposti

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11585/152377
 Attenzione

Attenzione! I dati visualizzati non sono stati sottoposti a validazione da parte dell'ateneo

Citazioni
  • ???jsp.display-item.citation.pmc??? 1
  • Scopus 5
  • ???jsp.display-item.citation.isi??? 5
social impact