Is there a link between amyotrophic lateral sclerosis and treatment with TNF-alpha inhibitors?

Abstract

The pan-European database EudraVigilance database (EVD) contains all serious adverse drug reaction (ADR) reports for all drugs approved within the European Union. In our routine signal detection in EVD, we have observed a cluster of reports of amyotrophic lateral sclerosis (ALS) in relation to treatment with TNF-alpha inhibitors, mainly used in rheumatoid arthritis (RA). The number of reported cases on 15 December 2012 was established to be between 58 and 73 (Table I). The uncertainty in exact numbers is due to possible duplicate reporting. In five of the reports more than one TNF-alpha blocker were reported as suspected drug. The cases originated from 14 different countries. In comparison, the highest number of reported ALS cases in EVD, in relation to any other drug indicated for the use in RA, was found for methotrexate with three cases. In literature three cases of ALS during TNF-alpha blockade treatment have been described (1-3).