Contributions
Abstract: P789
Type: Poster
Abstract Category: Therapy - disease modifying - 32 Others
Introduction: The comparative long term safety profile of disease-modifying drugs (DMD) in Multiple Sclerosis treatment is unknown. MS FIRST, a sub-study of the MSBase registry, is an Australian multi-centre study to implement a user-friendly safety module to track safety outcomes in MS therapy over the long term.
Objective: MSFIRST is a prospective, longitudinal study, enrolling since 1st January 2012. The primary objective of this study is to track and compare the incidence of safety outcomes in MS patients who either receive DMD or who are on no treatment.
Methods: Rates of adverse events by treatment group including fingolimod (FINGO), natalizumab (NAT), interferon (IFN), glatiramer acetate (GA) or no treatment group were calculated as the number of events per 100 person-years of follow-up. The relative risk of SAE´s by treatment was estimated using a longitudinal Poisson regression model offset by DMD exposure time and clustered at the level of the individual patient, adjusting for age, sex and disease duration.
Results: As per 1st December 2016 there were 3360 patients enrolled contributing to a total of 6033.59 person-years of follow-up at a mean (SD) of 520.17 days per patient. A total of 1632 adverse events have been observed. A total of 87 immunosuppression related or severe infection events were observed with an incidence rate of 1.44 infections per 100 person-years of follow-up: 89 herpes zoster, 72 non-melanoma skin cancer (NMSC) and 66 malignancy events observed at an incidence rate of 1.48, 1.19 and 1.09 events per 100 person-years respectively. Compared to a No DMT MS control group, there was a increase in observed infection for NAT (RR 1.52) 0.0011 and FINGO (RR 1.87), p< 0.001. There was an increased risk of NMSC in FINGO (RR 1.75, p< 0.001). All other cancer rates were lower in NAT treated patients (RR 0.42, p< 0.001) and trended lower in FINGO (RR 0.79, p=0.06). Herpes Zoster events were increased only in FINGO treated patients (RR 1.47, p< 0.009) and reported significant medical conditions had a slightly lower rate of reports in NAT (0.47, p< 0.001) and FINGO
(RR 0.70, P< 0.001) than untreated group.
Conclusions: The establishment of a large, prospective multi-drug safety module for use in routine practice has been successful to date in Australia. Long term monitoring in clinical practice could provide important insights into incidence and timing of treatment-associated SAE´s. This data will be updated for the ECTRIMS meeting.
Disclosure:
Jodi Haartsen recieved travel and conference support and speaker fees from Merck, Novartis, Genzyme, and Biogen.
Tim Spelman received honoraria for consultancy, funding for travel and compensation for serving on scientific advisory boards from Biogen Idec Inc; speaker honoraria from Novartis.
Jo Baker has support for education and travel from Biogen, Sanofi/Genzyme and Teva. Advisory fees - Biogen. Jeannette Lechner-Scott accepted travel compensation from Novartis, Biogen and Merck Serono. Her institution receives the honoraria for talks and advisory board commitment and also clinic support from Bayer Health Care, Biogen, CSL, Genzyme Sanofi, Merck Serono and Novartis.
Louise Rath recieved travel and conference support and speaker fees from Merck, Novartis, Genzyme, and Biogen.
Olga Skibina has accepted travel and conference support and speaker fees from Merck, Novartis, Genzyme, Bayer and Biogen.
Bruce Taylor has been paid honoraria for scientific advisory boards for Merck, Sanofi Genzyme, Biogen and Novartis and has received speakers fees for Teva, Novartis and Genzyme and received travel assistance from Novartis, Teva and Biogen and receive research funding from the National health & Medical research Council Australia and MS research Australia.
Annemaree OConnell received sponsorship from all the Pharmas in the past except Genzyme. ie Merck, Teva, Novartis, Biogen and Bayer
Sue Baker Educational support and honorarium has been given by Biogen Idec, Senofi Aventis, Genzyme, Bayer Schering, Novartis and Merck Serono. Suzanne Hodgkinson received travel grants and some clinic support from all of the major MS drugs pharmaceuticals.
Michael Barnett has received institutional support for research, speaking and/or participation in advisory boards (Biogen, Novartis, and Sanofi Genzyme); research consultant (Medical Safety Systems).
Sue Walters has nothing to disclose.
Allan Kermode has nothing to disclose.
Meena Sharma has nothing to disclose.
Therese Burke has nothing to disclose.
Mark Slee has nothing to disclose.
Marie Toubia has no disclosures .
Neil Sheuy has received travel grants from Biogen, Novartis, and Bayer and has
participated in clinical trials for Genzyme, Roche, Alexion, Medimmune, Biogen, and
Novartis.
Cameron Shaw received travel assistance from Biogen Idec and Novartis.
Rosemary Portley has no disclosures.
Todd Hardy has received honoraria for talks and advisory boards, and support for scientific meetings from Novartis, Biogen Idec, Merck-Serono, and Genzyme.
Helmut Butzkueven on scientific advisory boards for Biogen, Novartis and Sanofi-Aventis and has received conference travel support from Novartis, Biogen and Sanofi Aventis. He serves on steering committes for trials conducted by Biogen and Novartis, and has received research support from Merck Serono, Novartis and Biogen.
Abstract: P789
Type: Poster
Abstract Category: Therapy - disease modifying - 32 Others
Introduction: The comparative long term safety profile of disease-modifying drugs (DMD) in Multiple Sclerosis treatment is unknown. MS FIRST, a sub-study of the MSBase registry, is an Australian multi-centre study to implement a user-friendly safety module to track safety outcomes in MS therapy over the long term.
Objective: MSFIRST is a prospective, longitudinal study, enrolling since 1st January 2012. The primary objective of this study is to track and compare the incidence of safety outcomes in MS patients who either receive DMD or who are on no treatment.
Methods: Rates of adverse events by treatment group including fingolimod (FINGO), natalizumab (NAT), interferon (IFN), glatiramer acetate (GA) or no treatment group were calculated as the number of events per 100 person-years of follow-up. The relative risk of SAE´s by treatment was estimated using a longitudinal Poisson regression model offset by DMD exposure time and clustered at the level of the individual patient, adjusting for age, sex and disease duration.
Results: As per 1st December 2016 there were 3360 patients enrolled contributing to a total of 6033.59 person-years of follow-up at a mean (SD) of 520.17 days per patient. A total of 1632 adverse events have been observed. A total of 87 immunosuppression related or severe infection events were observed with an incidence rate of 1.44 infections per 100 person-years of follow-up: 89 herpes zoster, 72 non-melanoma skin cancer (NMSC) and 66 malignancy events observed at an incidence rate of 1.48, 1.19 and 1.09 events per 100 person-years respectively. Compared to a No DMT MS control group, there was a increase in observed infection for NAT (RR 1.52) 0.0011 and FINGO (RR 1.87), p< 0.001. There was an increased risk of NMSC in FINGO (RR 1.75, p< 0.001). All other cancer rates were lower in NAT treated patients (RR 0.42, p< 0.001) and trended lower in FINGO (RR 0.79, p=0.06). Herpes Zoster events were increased only in FINGO treated patients (RR 1.47, p< 0.009) and reported significant medical conditions had a slightly lower rate of reports in NAT (0.47, p< 0.001) and FINGO
(RR 0.70, P< 0.001) than untreated group.
Conclusions: The establishment of a large, prospective multi-drug safety module for use in routine practice has been successful to date in Australia. Long term monitoring in clinical practice could provide important insights into incidence and timing of treatment-associated SAE´s. This data will be updated for the ECTRIMS meeting.
Disclosure:
Jodi Haartsen recieved travel and conference support and speaker fees from Merck, Novartis, Genzyme, and Biogen.
Tim Spelman received honoraria for consultancy, funding for travel and compensation for serving on scientific advisory boards from Biogen Idec Inc; speaker honoraria from Novartis.
Jo Baker has support for education and travel from Biogen, Sanofi/Genzyme and Teva. Advisory fees - Biogen. Jeannette Lechner-Scott accepted travel compensation from Novartis, Biogen and Merck Serono. Her institution receives the honoraria for talks and advisory board commitment and also clinic support from Bayer Health Care, Biogen, CSL, Genzyme Sanofi, Merck Serono and Novartis.
Louise Rath recieved travel and conference support and speaker fees from Merck, Novartis, Genzyme, and Biogen.
Olga Skibina has accepted travel and conference support and speaker fees from Merck, Novartis, Genzyme, Bayer and Biogen.
Bruce Taylor has been paid honoraria for scientific advisory boards for Merck, Sanofi Genzyme, Biogen and Novartis and has received speakers fees for Teva, Novartis and Genzyme and received travel assistance from Novartis, Teva and Biogen and receive research funding from the National health & Medical research Council Australia and MS research Australia.
Annemaree OConnell received sponsorship from all the Pharmas in the past except Genzyme. ie Merck, Teva, Novartis, Biogen and Bayer
Sue Baker Educational support and honorarium has been given by Biogen Idec, Senofi Aventis, Genzyme, Bayer Schering, Novartis and Merck Serono. Suzanne Hodgkinson received travel grants and some clinic support from all of the major MS drugs pharmaceuticals.
Michael Barnett has received institutional support for research, speaking and/or participation in advisory boards (Biogen, Novartis, and Sanofi Genzyme); research consultant (Medical Safety Systems).
Sue Walters has nothing to disclose.
Allan Kermode has nothing to disclose.
Meena Sharma has nothing to disclose.
Therese Burke has nothing to disclose.
Mark Slee has nothing to disclose.
Marie Toubia has no disclosures .
Neil Sheuy has received travel grants from Biogen, Novartis, and Bayer and has
participated in clinical trials for Genzyme, Roche, Alexion, Medimmune, Biogen, and
Novartis.
Cameron Shaw received travel assistance from Biogen Idec and Novartis.
Rosemary Portley has no disclosures.
Todd Hardy has received honoraria for talks and advisory boards, and support for scientific meetings from Novartis, Biogen Idec, Merck-Serono, and Genzyme.
Helmut Butzkueven on scientific advisory boards for Biogen, Novartis and Sanofi-Aventis and has received conference travel support from Novartis, Biogen and Sanofi Aventis. He serves on steering committes for trials conducted by Biogen and Novartis, and has received research support from Merck Serono, Novartis and Biogen.