111372016
`The ACROSS study: long—term efficacy offingolimod in patients with... ECTRIMS Online Library. Derfuss T. Sep 16 2016; 145898
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`The ACROSS study: long-term efficacy of fingolimod in patients with
`RRMS (Follow-up at 10 years)
`Author(s): T Derfuss. J Sastre-Garriga,X Montalban, M Rodegher, G Gannon, M Bezuidenhoudt. M Van Hoef. D Silva.
`L Kappos
`ECTRIMS Onlihe Library Dertuss T Sep15.2015.145898
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`
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`k. ;
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`I.
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`Prof. Tobias Derfuss
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`Abstract
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`Discussion Forum (0)
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`IContn'bution
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`Abstract: P1215
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`Wpe: Poster
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`Dist-Patents- Randino
`
`o VIEWEPOSTER
`19 slides
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`0009
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`Abstract Category: Therapy- disease modifying - Long-term treatment monitoring
`
`Background: Long-term assessment of disability outcomes
`etfectiveness ofmultiple sclerosis (MS) treatments.
`
`is
`
`important
`
`in the evaluation of the
`
`Objective: In relapsing-remitting MS patients initially enrolled in the phase II proof of concept study we
`evaluated the effect of fingolimod on disability at 10 years. We also determined time to first use of an
`ambulatory device orwheelchair, change in MS functional composite (MSFC) score and MRI outcomes.
`
`Methods: ACROSS was a multicentre, single visit, follow-up study at 10 years, of patients originally
`enrolled in the phase II fingolimod trial. Disability progression is defined as an increase in EDSS score of
`1.5 (ti'om baseline score 0). or 1 (from baseline score 1-5), or 0.5 (from baseline score >5). Patients in the
`continuous fingolim od treatment group (contin-fingo: patients with 26 years of exposure to fingolimod) and
`non-continuous treatment group (non-contin-fingo; patients with < 8 years of exposure to fingolimod) were
`compared using ANCOVA (EDSS) and Cox proportional hazards model (use ofwheel chair) analysis. MRI
`outcomes will be presented separately.
`
`Results: ACROSS enrolled 62.3% (175/281) patients of the original phase II study: mean age was 37.4
`years and 66.9% were women. A total of 59.4% (104/175) were in contin-fingo. 37% of the full phase II
`cohort(104l281).
`
`Disability progression at 10 years was reported in 72 (41.1%) patients. Significantly less patients
`progressed in contin-fingo vs non-contin-fingo groups (33.7% vs 52.7%, p=0.0268). Change from baseline
`EDSS was significantly lower in the contin-fingo vs non-contin-fingo groups (0.58 vs 1.17; p=0.0155). A
`four-fold difference in the time to use of wheelchair was found in favour of contin—fingo vs non-contin-fingo
`groups (HR: 0.24 [95%CI: 0.07 to 0.851).
`
`Twenty- six (14.9%) patients developed secondary progressive MS. significantly less in the contin-fingo vs
`non-contin-fingo groups (10 [9.6%]vs14[25.5%];p=0.0107).
`
`Conclusions: Ten year single visit follow up ofpatients enrolled in the fingolimod phase II study shows high
`treatment persistence. Disability progression was lower in patients on continuous fingolimod compared to
`those who interrupted treatment. Although the study was of observational nature, a causal link between
`reduced disability progression and fingolimod treatment is plausible.
`
`httpzllmlineli braryectrim s—congresseulectrim 5/2016732ndf145898/tobiasderfusstheacross.studylong-term.efiicacy.of.lingolimod.in.patients.htm|?f=m2
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`Apotex v. Novartis
`lPR2017-00854
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`NOVARTIS 2056
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`Apotex v. Novartis
`IPR2017-00854
`NOVARTIS 2056
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`11:3!2016
`
`The ACROSS study: long—term efficacy offingolimod in patients with... ECTRIMS Online Library. Derfuss T. Sep 16 2016; 145898
`
`Disclosure: Funding source: This study is supported by Novartis Pharma AG, Basel, Switzerland.
`
`Tobias DertiJss serves on scientific advisory boards for Novartis Pharmaceuticals. Merck Serono, Biogen
`Idec, Genzyme, GeNeuro. Mitsubishi Pharma. Teva Pharmaceuticals and Bayer Schering Pharma; has
`received tiJnding for travel andfor speaker honoraria fi'om Biogen Idec, Genzyme, Novartis, Merck Serono
`and Bayer Schering Pharma; and receives research support from Biogen Iclec, Novartis Pharma, the
`European Union.the Swiss National Foundation and the Swiss MS Society.
`
`Jaume Sastre-Garriga received personal fees from Merck-Serena. Biogen ldec, Teva, Roche, and Novartis.
`outside the submitted work.
`
`Xavier Montalban has been a steering committee member of clinical trials or participated in advisory boards
`of clinical
`trials in the past years with Bayer, Schering Pharma. Biogen Idec, EMD Merck Serono,
`Genentech. Genzyme. Novartis, Sanofi-Aventis, and Teva Pharmaceuticals.
`
`Ludwig Kappos’ institution (University Hospital Basel) has received in the last 3 years and used exclusively
`for research support: steering committee, advisory board, and consultancy fees (Actelion. Addex. Bayer
`HealthCare, Biogen ldec, Biotica, Genzyme, Lilly, Merck, Mitsubishi, Novartis, Ono Pharma, Pfizer,
`Receptos, Sanofi, Santhera, Siemens, Teva, UCEl, Xenoport); speaker fees (Bayer HealthCare, Biogen
`Idec, Merck, Novartis, Sanofi. Teva); support of educational activities (Bayer HealthCare, Biogen, CSL
`Behring, Genzyme, Merck, Novartis, Sanofi, Teva); royalties (Neurostatus Systems GmbH); grants (Bayer
`HealthCare, Biogen Idec, European Union, Merck. Novartis, Roche Research Foundation, Swiss MS
`Society. Swiss National Research Foundation).
`
`Grainne Gannon, Mauritz Elezuidenhouclt, Marlies Van Hoefand Diego Silva are employees ofNovartis.
`
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`httpzllmlineli braryectrim s—congresseulectrim s/2016l32ndf145898/tobias.derfuss.the.across.study.|ong—term.efiicacy.of.tingolimod.in.patients.htm|?f=m2
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