Contributions
Abstract: P704
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Introduction: MSFIRST, a sub-study of the MSBase registry, is an Australian multi-centre study to implement a user-friendly safety module to track incidence and characteristics of safety outcomes in MS patients. The comparative long term safety profile of disease-modifying drugs (DMD) in MS treatment is unknown and incidence and trends over time in serious adverse events (SAEs) are less well reported in real world practice.
Objective: MSFIRST is a prospective, longitudinal study, enrolling since 1 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 no treatment.
Methods: Rates of SAE"s by treatment group including fingolimod (FTY), natalizumab (NAT) and combined group of interferon and glatiramer acetate (IFN/GA) were calculated as no. of events per 100 person-years of follow-up. The relative risk of SAE by treatment group was estimated using a longitudinal Poisson regression model offset by DMD exposure time and adjusted for age, sex and disease duration.
Results: At 6 April 2016 there were 3115 patients enrolled contributing 4590.8 person-years of follow-up at a mean (SD) of 17.4 months (14.2) per patient. 1303 adverse events have been observed. A total of 79 immunosuppression related or severe infection events, 75 herpes zoster, 56 non-melanoma skin cancer (NMSC) and 53 malignancy events observed at an incidence rate of 0.27, 0.33, 0.31 and 0.44 events per 100 person-years respectively.
Natalizumab (NAT) was associated with 3.14 times the risk of infections (aRR 3.14; 95% CI 1.04, 9.46) relative to IFN/GA, whilst there was no difference between FTY and IFN/GA (aRR 2.06; 95% CI 0.72, 5.88). There was no difference in the risk of herpes zoster between FTY (aRR 1.00; 95% CI 0.44, 2.29) or NAT (aRR 1.37; 95% CI 0.54, 3.49) relative to IFN/GA group. Similarly, there was no difference in the risk of NMSC between IFN/GA and either FTY (aRR 0.79; 95% CI 0.28, 2.24) or NAT (aRR 0.79; 95% CI 0.21, 2.93). No difference in the risk of malignancy was observed between FTY (aRR 1.47; 95% CI 0.50, 4.30) or NAT (aRR 2.57; 95% CI 0.76, 8.70) compared with IFN/GA.
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 both the incidence and timing of treatment-associated SAE"s.
Disclosure:
Jodi Haartsen - JH has received honoraria for talks and advisory boards, and support for scientific meetings, from Novartis, Biogen Idec, Merck-Serono and Genzyme.
Tim Spelman - TS received compensation for serving on scientific advisory boards, honoraria for consultancy and funding for travel from Biogen Inc; speaker honoraria from Novartis.
Josephine Baker - JB has received travel assistance from Novartis/Bayer/Merck and advisory committees Novartis/Biogen/Genzyme
Susan Agland - SA has received honoraria for talks and advisory boards, and support for scientific meetings, from Bayer, Biogen Idec, Genzyme Merck, and Novartis.
Jeannette Lechner-Scott - J L-S has accepted travel compensation from Novartis, Biogen and Merck Serono. Her institution receives the honoraria for talks and advisory board commitment as well as research grants from Bayer Health Care, Biogen Idec, CSL, Genzyme Sanofi, Merck, Novartis and TEVA.
Therese Burke - Nothing to disclose
Steve Vucic - Nothing to disclose
Louise Rath - LR - travel grants from Biogen & Novatis and Speakers Honorarium from Biogen, Novartis & Genzyme
Olga Skibina - OS - research grant from Biogen, Travel grants from Biogen, Novartis & Bayer and Speakers Honorarium from Bayer, Biogen, Genzyme & Novartis
Marie Toubia - Nothing to disclose
Mark Slee - Nothing to disclose
Sue McGregor - Nothing to disclose
Bruce Taylor - BVT has served on advisory boards for Novartis, Biogen, Genzyme and Bayer Schering. He has received travel assistance from Novartis and Teva. He is currently receiving research funding from the NHMRC Australia and MS research Australia.
Annmaree O"Connell - Nothing to disclose
Michael Barnett - Nothing to disclose
Susanne Baker - SB has received honorarium educational, conference and travel support from Biogen Idec, Sanofi, Genzyme, Bayer, Novartis and Merck Serono.
Meena Sharma - MS has received honorarium, professional development education and conference attendance support from Biogen Idec, Sanofi Aventis, Genzyme, Bayer Schering, Novartis and Merck Serono.
Suzanne Hodgkinson - SH has received honorarium, travel, educational, and research grants from Genzyme, Biogen Idec, Bayer, Merck Serono, Novartis, Sanofi Aventis
Susan Walters - Nothing to disclose
Allan Kermode - Nothing to disclose
Wendy Hayes - Nothing to disclose
Ernest Butler - Nothing to disclose
Neil Shuey - Nothing to disclose
Cameron Shaw - CS received travel assistance from Biogen Idec and Novartis.
Rosemarie Portley - Nothing to disclose
Todd Hardy - TH has received honoraria for talks and advisory boards, and support for scientific meetings, from Novartis, Biogen Idec, Merck-Serono, Alexion and Genzyme.
Ik Lin Tan - Nothing to disclose
Helmut Butzkueven - HB has received consulting fees from Genzyme, Biogen, Novartis, Merck and Oxford PharmaGenesis; and grant/research support from Biogen, Novartis, Merck and Genzyme
Abstract: P704
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Introduction: MSFIRST, a sub-study of the MSBase registry, is an Australian multi-centre study to implement a user-friendly safety module to track incidence and characteristics of safety outcomes in MS patients. The comparative long term safety profile of disease-modifying drugs (DMD) in MS treatment is unknown and incidence and trends over time in serious adverse events (SAEs) are less well reported in real world practice.
Objective: MSFIRST is a prospective, longitudinal study, enrolling since 1 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 no treatment.
Methods: Rates of SAE"s by treatment group including fingolimod (FTY), natalizumab (NAT) and combined group of interferon and glatiramer acetate (IFN/GA) were calculated as no. of events per 100 person-years of follow-up. The relative risk of SAE by treatment group was estimated using a longitudinal Poisson regression model offset by DMD exposure time and adjusted for age, sex and disease duration.
Results: At 6 April 2016 there were 3115 patients enrolled contributing 4590.8 person-years of follow-up at a mean (SD) of 17.4 months (14.2) per patient. 1303 adverse events have been observed. A total of 79 immunosuppression related or severe infection events, 75 herpes zoster, 56 non-melanoma skin cancer (NMSC) and 53 malignancy events observed at an incidence rate of 0.27, 0.33, 0.31 and 0.44 events per 100 person-years respectively.
Natalizumab (NAT) was associated with 3.14 times the risk of infections (aRR 3.14; 95% CI 1.04, 9.46) relative to IFN/GA, whilst there was no difference between FTY and IFN/GA (aRR 2.06; 95% CI 0.72, 5.88). There was no difference in the risk of herpes zoster between FTY (aRR 1.00; 95% CI 0.44, 2.29) or NAT (aRR 1.37; 95% CI 0.54, 3.49) relative to IFN/GA group. Similarly, there was no difference in the risk of NMSC between IFN/GA and either FTY (aRR 0.79; 95% CI 0.28, 2.24) or NAT (aRR 0.79; 95% CI 0.21, 2.93). No difference in the risk of malignancy was observed between FTY (aRR 1.47; 95% CI 0.50, 4.30) or NAT (aRR 2.57; 95% CI 0.76, 8.70) compared with IFN/GA.
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 both the incidence and timing of treatment-associated SAE"s.
Disclosure:
Jodi Haartsen - JH has received honoraria for talks and advisory boards, and support for scientific meetings, from Novartis, Biogen Idec, Merck-Serono and Genzyme.
Tim Spelman - TS received compensation for serving on scientific advisory boards, honoraria for consultancy and funding for travel from Biogen Inc; speaker honoraria from Novartis.
Josephine Baker - JB has received travel assistance from Novartis/Bayer/Merck and advisory committees Novartis/Biogen/Genzyme
Susan Agland - SA has received honoraria for talks and advisory boards, and support for scientific meetings, from Bayer, Biogen Idec, Genzyme Merck, and Novartis.
Jeannette Lechner-Scott - J L-S has accepted travel compensation from Novartis, Biogen and Merck Serono. Her institution receives the honoraria for talks and advisory board commitment as well as research grants from Bayer Health Care, Biogen Idec, CSL, Genzyme Sanofi, Merck, Novartis and TEVA.
Therese Burke - Nothing to disclose
Steve Vucic - Nothing to disclose
Louise Rath - LR - travel grants from Biogen & Novatis and Speakers Honorarium from Biogen, Novartis & Genzyme
Olga Skibina - OS - research grant from Biogen, Travel grants from Biogen, Novartis & Bayer and Speakers Honorarium from Bayer, Biogen, Genzyme & Novartis
Marie Toubia - Nothing to disclose
Mark Slee - Nothing to disclose
Sue McGregor - Nothing to disclose
Bruce Taylor - BVT has served on advisory boards for Novartis, Biogen, Genzyme and Bayer Schering. He has received travel assistance from Novartis and Teva. He is currently receiving research funding from the NHMRC Australia and MS research Australia.
Annmaree O"Connell - Nothing to disclose
Michael Barnett - Nothing to disclose
Susanne Baker - SB has received honorarium educational, conference and travel support from Biogen Idec, Sanofi, Genzyme, Bayer, Novartis and Merck Serono.
Meena Sharma - MS has received honorarium, professional development education and conference attendance support from Biogen Idec, Sanofi Aventis, Genzyme, Bayer Schering, Novartis and Merck Serono.
Suzanne Hodgkinson - SH has received honorarium, travel, educational, and research grants from Genzyme, Biogen Idec, Bayer, Merck Serono, Novartis, Sanofi Aventis
Susan Walters - Nothing to disclose
Allan Kermode - Nothing to disclose
Wendy Hayes - Nothing to disclose
Ernest Butler - Nothing to disclose
Neil Shuey - Nothing to disclose
Cameron Shaw - CS received travel assistance from Biogen Idec and Novartis.
Rosemarie Portley - Nothing to disclose
Todd Hardy - TH has received honoraria for talks and advisory boards, and support for scientific meetings, from Novartis, Biogen Idec, Merck-Serono, Alexion and Genzyme.
Ik Lin Tan - Nothing to disclose
Helmut Butzkueven - HB has received consulting fees from Genzyme, Biogen, Novartis, Merck and Oxford PharmaGenesis; and grant/research support from Biogen, Novartis, Merck and Genzyme