Contributions
Abstract: EP1632
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Objective: Compare two year discontinuation rates and efficacy of fingolimod (FTY) and dimethyl fumarate (DMF) to natalizumab (NTZ).
Background: FTY and DMF are the most common MS oral therapies becoming available in 2010 and 2013, respectively. Limited comparative effectiveness data exists.
Methods: Patients prescribed FTY, DMF or NTZ at the Rocky Mountain MS Center at University of Colorado between January, 2010 and October, 2013 were identified. Clinician-reported data including demographics, disease history, relapses, MRI outcomes, and adverse events(AEs), were retrospectively collected. Primary outcome was the probability of discontinuing drug within two years, which is presented here. Data was analyzed with logistic regression controlling for age, disease duration, type of MS, gender, and presence of enhancing lesions on baseline MRI to estimate differences in the primary outcome.
Results: 271, 342 and 451 patients were evaluated on FTY, DMF and NTZ over two years. Patients had a mean age of 42.5 (FTY), 45.8 (DMF) and 39.8 (NTZ) years; were predominantly female (72.0% FTY; 69.6% DMF; 76.7% NTZ); and had a mean MS disease duration of 11-12 years for all groups. At ≤24 months, 93 (34.3%), 161 (47.1%) and 147 (32.6%) discontinued FTY, DMF and NTZ, respectively. FTY versus NTZ had an adjusted OR of 1.18 (95%CI: 0.85 - 1.65,p= 0.315) for discontinuation at ≤24 months. DMF versus NTZ had adjusted OR of 2.06 (95%CI: 1.50 - 2.83, p < 0.001). Primary reason for discontinuation: NTZ - +JCV antibodies (12.6%), FTY and DMF - adverse events (17.0% and 24.0%). The most common adverse events leading to discontinuation were gastro-intestinal related issues for FTY and DMF, and a rash at time of infusion for NTZ. Respectively for FTY, DMF and NTZ - 24 (8.9%),
44 (12.9%) and 27 (6.0%) had a clinical relapse, 28 (13.1%), 26 (10.0%) and 17 (5.8%) had gadolinium-enhancing lesions and 75 (35.1%), 82 (31.5%) and 74 (25.3%) had new T2 lesions.
Conclusions: There were fewer discontinuations with DMF vs. NTZ. Discontinuation rates in the first two years were driven by AEs and being positive for JC virus antibodies. Further analyses will investigate NTZ superiority in efficacy outcomes using propensity matching and ATT doubly robust weighting methods.
Disclosure:
Brandi L Vollmer has nothing to disclose.
Kavita V Nair received grants from Novartis, Biogen, Gilead Sciences; consulting for Astellas and Genentech.
Stefan H Sillau has nothing to disclose.
John Corboy received research grants from National MS Society, Patient Centered Outcomes Research Instute, Novartis, Biogen, and MedDay, is editor for Neurology: Clinical Practice and a board member of the National Multiple Sclerosis Society, Colorado-Wyoming chapter
Timothy Vollmer received research grants/studies from Genzyme, Teva Neuroscience, NIH/NINDS, Rocky Mountain MS Center, EMD Serono, Biogen Idec, Ono Pharmaceuticals, Acorda Pharmaceuticals, MedImmune and conducts advisory boards, lectures and consultancy with Abbvie, Inc, Alcimed, American Academy of Neurology, CB Partners, Capmaels and Rasford, Celestial Intas Pharmaceuticals, LTD, Compass Learning, Genentech/Roche, Genzyme/Sanofi, Goodwin Procter, LLP, IMS Consulting Group, Medscape, Novartis Pharmaceuticals, Oxford Pharmagenesis, Patient Centered Outcomes Research Institute, Sommer Consulting, Teva Neuroscience, Xenoport, Inc.
Enrique Alvarez received research grants/studies from Genzyme, Biogen, Rocky Mountain MS Center, Novartis, Acorda and consulting for Genzyme, Genentech, Novartis, Acorda and Biogen.
Abstract: EP1632
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Objective: Compare two year discontinuation rates and efficacy of fingolimod (FTY) and dimethyl fumarate (DMF) to natalizumab (NTZ).
Background: FTY and DMF are the most common MS oral therapies becoming available in 2010 and 2013, respectively. Limited comparative effectiveness data exists.
Methods: Patients prescribed FTY, DMF or NTZ at the Rocky Mountain MS Center at University of Colorado between January, 2010 and October, 2013 were identified. Clinician-reported data including demographics, disease history, relapses, MRI outcomes, and adverse events(AEs), were retrospectively collected. Primary outcome was the probability of discontinuing drug within two years, which is presented here. Data was analyzed with logistic regression controlling for age, disease duration, type of MS, gender, and presence of enhancing lesions on baseline MRI to estimate differences in the primary outcome.
Results: 271, 342 and 451 patients were evaluated on FTY, DMF and NTZ over two years. Patients had a mean age of 42.5 (FTY), 45.8 (DMF) and 39.8 (NTZ) years; were predominantly female (72.0% FTY; 69.6% DMF; 76.7% NTZ); and had a mean MS disease duration of 11-12 years for all groups. At ≤24 months, 93 (34.3%), 161 (47.1%) and 147 (32.6%) discontinued FTY, DMF and NTZ, respectively. FTY versus NTZ had an adjusted OR of 1.18 (95%CI: 0.85 - 1.65,p= 0.315) for discontinuation at ≤24 months. DMF versus NTZ had adjusted OR of 2.06 (95%CI: 1.50 - 2.83, p < 0.001). Primary reason for discontinuation: NTZ - +JCV antibodies (12.6%), FTY and DMF - adverse events (17.0% and 24.0%). The most common adverse events leading to discontinuation were gastro-intestinal related issues for FTY and DMF, and a rash at time of infusion for NTZ. Respectively for FTY, DMF and NTZ - 24 (8.9%),
44 (12.9%) and 27 (6.0%) had a clinical relapse, 28 (13.1%), 26 (10.0%) and 17 (5.8%) had gadolinium-enhancing lesions and 75 (35.1%), 82 (31.5%) and 74 (25.3%) had new T2 lesions.
Conclusions: There were fewer discontinuations with DMF vs. NTZ. Discontinuation rates in the first two years were driven by AEs and being positive for JC virus antibodies. Further analyses will investigate NTZ superiority in efficacy outcomes using propensity matching and ATT doubly robust weighting methods.
Disclosure:
Brandi L Vollmer has nothing to disclose.
Kavita V Nair received grants from Novartis, Biogen, Gilead Sciences; consulting for Astellas and Genentech.
Stefan H Sillau has nothing to disclose.
John Corboy received research grants from National MS Society, Patient Centered Outcomes Research Instute, Novartis, Biogen, and MedDay, is editor for Neurology: Clinical Practice and a board member of the National Multiple Sclerosis Society, Colorado-Wyoming chapter
Timothy Vollmer received research grants/studies from Genzyme, Teva Neuroscience, NIH/NINDS, Rocky Mountain MS Center, EMD Serono, Biogen Idec, Ono Pharmaceuticals, Acorda Pharmaceuticals, MedImmune and conducts advisory boards, lectures and consultancy with Abbvie, Inc, Alcimed, American Academy of Neurology, CB Partners, Capmaels and Rasford, Celestial Intas Pharmaceuticals, LTD, Compass Learning, Genentech/Roche, Genzyme/Sanofi, Goodwin Procter, LLP, IMS Consulting Group, Medscape, Novartis Pharmaceuticals, Oxford Pharmagenesis, Patient Centered Outcomes Research Institute, Sommer Consulting, Teva Neuroscience, Xenoport, Inc.
Enrique Alvarez received research grants/studies from Genzyme, Biogen, Rocky Mountain MS Center, Novartis, Acorda and consulting for Genzyme, Genentech, Novartis, Acorda and Biogen.