Contributions
Abstract: 156
Type: Oral
PML associated with natalizumab treatment continues to be a significant problem of a clinically successful therapy. This is an overview of risk stratification developments and discusses the current approach to depict and calculate PML incidence and PML risk.
A) PML incidence and resulting -risk used in today"s clinical practice are potentially outdated and the risk for patients with prior immunosuppression might have been underestimated. B) Risk stratification according to treatment duration epochs likely suggests lower risk due to patients stopping treatment within a given epoch. PML incidence within the complete treatment epoch is statistically lowered due to the fact that patients at the beginning of an epoch presumably have a lower PML risk than the patients at the end. Periodical risk is not accurate in assessing risk for long treatment durations. C) Risk factor “JCV serostatus” has low specificity concerning PML prediction and anti-JCV seroconversion during treatment with natalizumab further lowers its specificity over time. D) Risk factor “treatment duration”: specificity varies depending on the average treatment duration and the number of short-term patients. These reduce overall average treatment duration and thus overall PML incidence, suggesting that short-term natalizumab patients are almost exclusively “non-PML”, even though they might still develop PML and it is cumulative incidence that the clinician must consider.
The talk will include blood, imaging and CSF biomarkers that have been investigated and/or validated for the use to predict or calculate individual or group risk figures for PML in association to natalizumab. From the academic developments, CD62L comprises most data from different cohorts for consideration as an additional marker to assess PML risk, ideally in combination to other established markers.
Disclosure: H. Wiendl receives honorarium for acting as a member of Scientific Advisory Boards and as consultant for Bayer Healthcare, Biogen Idec, CSL Behring, EMD Serono, Fresenius Medical Care, Merck Serono, Novartis, Sanofi- Genzyme, Roche and Teva, and receives research support from the German Ministry for Education and Research (BMBF), Deutsche Forschungsgesellschaft (DFG), Else Kröner Fresenius Foundation, Fresenius Foundation, Hertie Foundation, NRW Ministry of Education and Research, Interdisciplinary Center for Clinical Studies (IZKF) Muenster and RE Children"s Foundation.
Abstract: 156
Type: Oral
PML associated with natalizumab treatment continues to be a significant problem of a clinically successful therapy. This is an overview of risk stratification developments and discusses the current approach to depict and calculate PML incidence and PML risk.
A) PML incidence and resulting -risk used in today"s clinical practice are potentially outdated and the risk for patients with prior immunosuppression might have been underestimated. B) Risk stratification according to treatment duration epochs likely suggests lower risk due to patients stopping treatment within a given epoch. PML incidence within the complete treatment epoch is statistically lowered due to the fact that patients at the beginning of an epoch presumably have a lower PML risk than the patients at the end. Periodical risk is not accurate in assessing risk for long treatment durations. C) Risk factor “JCV serostatus” has low specificity concerning PML prediction and anti-JCV seroconversion during treatment with natalizumab further lowers its specificity over time. D) Risk factor “treatment duration”: specificity varies depending on the average treatment duration and the number of short-term patients. These reduce overall average treatment duration and thus overall PML incidence, suggesting that short-term natalizumab patients are almost exclusively “non-PML”, even though they might still develop PML and it is cumulative incidence that the clinician must consider.
The talk will include blood, imaging and CSF biomarkers that have been investigated and/or validated for the use to predict or calculate individual or group risk figures for PML in association to natalizumab. From the academic developments, CD62L comprises most data from different cohorts for consideration as an additional marker to assess PML risk, ideally in combination to other established markers.
Disclosure: H. Wiendl receives honorarium for acting as a member of Scientific Advisory Boards and as consultant for Bayer Healthcare, Biogen Idec, CSL Behring, EMD Serono, Fresenius Medical Care, Merck Serono, Novartis, Sanofi- Genzyme, Roche and Teva, and receives research support from the German Ministry for Education and Research (BMBF), Deutsche Forschungsgesellschaft (DFG), Else Kröner Fresenius Foundation, Fresenius Foundation, Hertie Foundation, NRW Ministry of Education and Research, Interdisciplinary Center for Clinical Studies (IZKF) Muenster and RE Children"s Foundation.