Contributions
Abstract: P1206
Type: Poster
Abstract Category: Therapy - disease modifying - 29 Risk management for disease modifying treatments
Background: Progressive Multifocal Leukoencephalopathy (PML) is an uncommon side effect emerging in natalizumab (NTZ) treated patient. Despite previous studies suggest that an early PML detection leads to a better prognosis, PML is frequently diagnosed in its advanced stages.
Goals: To investigate if the PML early diagnosis is feasible, its impact on clinical outcome and to determine whether the frequency of magnetic resonance images (MRI) impact on the early PML identification.
Methods: Clinical and MRI data at PML diagnosis of 49 PML patients were retrospectively collected from 32 Italian sites. The MRI prior to the diagnostic one (i.e. pre-diagnostic) was also collected. MRIs were analyzed for PML lesions by two experts, the PML lesions at diagnosis and pre-diagnosis were manually delineated and their volume was automatically calculated. An index was created to estimate the monthly increment of lesions during the diagnostic delay. Finally, lesions volume at their first appearance was compared between patients who performed MRI infrequently (every 12 or 6 months) vs frequently
(every 3 or 4 months).
Results: The pre-diagnostic MRI was available for 28 patients (57.14%); these MRIs were performed 5 months (median) prior to the diagnostic ones. In 20 patients out of 28 (71.42%) the PML lesion was already noticeable at the pre-diagnostic MRI, but it was not detected. The lesions volume was 1.94 cm3 (mean) at pre-diagnosis and 17.6 cm3 (mean) at diagnosis. The lesion volume change (diagnosis/pre-diagnosis, mean 13.91) correlates with the diagnostic delay (in months) (r=0.44, p=0.04). Each month of diagnostic delay, the lesion triplicate its volume (lesion change months of diagnostic delay: 13.91/5=2.75).
Prior to PML onset, 26% of patients underwent routinely MRI every 12 months; 36% every 6 months; 22% every 4 months and 16% every 3 months. 7 patients (14.2%) were asymptomatic at PML onset: they performed a MRI scan every 3 (n=3) or 4 months (n=4). The frequency of MRI significantly affected the lesion volume at their first appearance (t=4.55, p=0.033), being the lesions smaller in patients who underwent MRI scan more frequently.
Conclusions: Early diagnosis of PML is feasible since in the 71.4% of patients PML lesion was detectable 5 months prior to PML diagnosis. Frequent monitoring using MRI is helpful for the early detection of PML lesions. Thus, early diagnosis is feasible through frequent MRI monitoring and a correct interpretation of images.
Disclosure:
Dr. Scarpazza has nothing to disclose.
Dr. De Rossi received speaker honoraria from Biogen and Teva and travel grants from Biogen, Teva and Merk Serono.
Dr. Prosperini received consulting fees from Biogen and Novartis; speaker honoraria from Biogen, Genzyme, Novartis and Teva; travel grants from Biogen, Genzyme, Novartis and Teva; research grants from the Italian MS Society (Associazione Italiana Sclerosi Multipla) and Genzyme.
Dr. Cosottini received speaker honoraria from Biogen.
Dr. Capra received consulting fees from Novartis, Biogen-Idec and lecture fees and/or travel grants from Novartis, Biogen-Idec, Genzyme and Sanofi-Aventis.
Dr. Gerevini received speaker honoraria from Biogen-Idec.
Abstract: P1206
Type: Poster
Abstract Category: Therapy - disease modifying - 29 Risk management for disease modifying treatments
Background: Progressive Multifocal Leukoencephalopathy (PML) is an uncommon side effect emerging in natalizumab (NTZ) treated patient. Despite previous studies suggest that an early PML detection leads to a better prognosis, PML is frequently diagnosed in its advanced stages.
Goals: To investigate if the PML early diagnosis is feasible, its impact on clinical outcome and to determine whether the frequency of magnetic resonance images (MRI) impact on the early PML identification.
Methods: Clinical and MRI data at PML diagnosis of 49 PML patients were retrospectively collected from 32 Italian sites. The MRI prior to the diagnostic one (i.e. pre-diagnostic) was also collected. MRIs were analyzed for PML lesions by two experts, the PML lesions at diagnosis and pre-diagnosis were manually delineated and their volume was automatically calculated. An index was created to estimate the monthly increment of lesions during the diagnostic delay. Finally, lesions volume at their first appearance was compared between patients who performed MRI infrequently (every 12 or 6 months) vs frequently
(every 3 or 4 months).
Results: The pre-diagnostic MRI was available for 28 patients (57.14%); these MRIs were performed 5 months (median) prior to the diagnostic ones. In 20 patients out of 28 (71.42%) the PML lesion was already noticeable at the pre-diagnostic MRI, but it was not detected. The lesions volume was 1.94 cm3 (mean) at pre-diagnosis and 17.6 cm3 (mean) at diagnosis. The lesion volume change (diagnosis/pre-diagnosis, mean 13.91) correlates with the diagnostic delay (in months) (r=0.44, p=0.04). Each month of diagnostic delay, the lesion triplicate its volume (lesion change months of diagnostic delay: 13.91/5=2.75).
Prior to PML onset, 26% of patients underwent routinely MRI every 12 months; 36% every 6 months; 22% every 4 months and 16% every 3 months. 7 patients (14.2%) were asymptomatic at PML onset: they performed a MRI scan every 3 (n=3) or 4 months (n=4). The frequency of MRI significantly affected the lesion volume at their first appearance (t=4.55, p=0.033), being the lesions smaller in patients who underwent MRI scan more frequently.
Conclusions: Early diagnosis of PML is feasible since in the 71.4% of patients PML lesion was detectable 5 months prior to PML diagnosis. Frequent monitoring using MRI is helpful for the early detection of PML lesions. Thus, early diagnosis is feasible through frequent MRI monitoring and a correct interpretation of images.
Disclosure:
Dr. Scarpazza has nothing to disclose.
Dr. De Rossi received speaker honoraria from Biogen and Teva and travel grants from Biogen, Teva and Merk Serono.
Dr. Prosperini received consulting fees from Biogen and Novartis; speaker honoraria from Biogen, Genzyme, Novartis and Teva; travel grants from Biogen, Genzyme, Novartis and Teva; research grants from the Italian MS Society (Associazione Italiana Sclerosi Multipla) and Genzyme.
Dr. Cosottini received speaker honoraria from Biogen.
Dr. Capra received consulting fees from Novartis, Biogen-Idec and lecture fees and/or travel grants from Novartis, Biogen-Idec, Genzyme and Sanofi-Aventis.
Dr. Gerevini received speaker honoraria from Biogen-Idec.