“In response to an anonymous comment on the Natalizumab retinitis post yesterday. I think it is appropriate to warn all MSers on fingolimod to be vigilant as well about infections and opportunistic infections.”
“The two case studies below highlight that opportunistic infections and severe viral infections are an issue on fingolimod. The first case report below is of a near fatal case of herpes simplex virus encephalitis (HSVE). This is not surprising, in fact in the phase 3 TRANSFORMS trial there was a fatality due to HSVE in an MSer on fingolimod, albeit on the higher, 1.25mg, dose.”
“The second case is of a MSers on fingolimod developing Kaposi’s sarcoma, which is due to a specific herpesvirus. Kaposi’s sarcoma is classified as an opportunistic infection and is seen most commonly in people with AIDS and in people who have had a transplant and are on immunosuppression. Although this patient had a lymphopenia (<500 lymphocytes per mm3, WHO Grade 3) the counts were never below 200 (WHO Grade 4, a level in Europe at which the EMA guidelines recommend interrupting fingolimod dosing). In relation to lymphocyte counts on fingolimod; there is no correlation between the absolute levels and infectious complications. Therefore it is impossible to predict who will develop infections, including opportunistic infections, based on the lymphocyte count. Therefore the only strategy is clinical vigilance; this means reporting any new skin lesions, or new symptoms, to your neurology team or family doctor. Don’t take unnecessary risks; opportunistic infections in immunocompromised patients can be associated with relatively mild and indolent symptoms, at least initially. Based on these and other case reports, e.g. PML, I would predict the occurrence of other opportunistic infections in MSers on fingolimod.”
“One infection that can be screened for is HPV, the cause of cervical cancer. If you are a woman on fingolimod please make sure you don’t miss your regular cervical, or PAP, smears. If you live in a country in which this is not mandatory please ask your family doctor to arrange for this to happen. As always prevention is better than cure.”
|Kaposi’s sarcoma (source Wikipedia)|
Epub: Pfender et al. Reactivation of herpesvirus under fingolimod: A case of severe herpes simplex encephalitis. Neurology. 2015 May 8.