1'041.1711
`...... lzuIIwb T .... tment for Multiple Sclerosis In
`Clinic •• Practice Dinah Thy#!rltd, Lynda Hillman. Volute
`Woolllttt. Dora Kro.tuclti, Anndt~ Wundu, &attll!, WA
`OBJECnVE: To dMc:ribe clinical and MRl outC'ome .her lreatml!:nt with
`nauil:llunab (or up to 3..6 yeti"', BACKGR OUND: Nalalllumab, an alpha.
`int.epin antqOni.ft. ia iPdieated (or 11M! In reclap.in, multiple ,dl!:ro.ia
`(MS) but can callM rve .evere l ide effecu (PML. olber infec:\ioM). With
`the ~l i.nI;:ruM 01 PML eueI reported in late 1M009, poMlble UIIOcia·
`tiorI with pre'ri0UI immune IUppreuioa and duration of natalitumab UUt·
`rnent ia diKuPed. DESIGNIMETHODS: RelrOllpect.ive ~ rullon.l
`• tUlly of 169 COM«Utive MS patienu uuted with natalilumab a t the
`Univeraity 01 WashingtOn. Clinic p~ion. MRland laboratory momtor·
`in, including antibodY'politivity, lide etrecte and COu.eIJ for diKontinuft·
`tion wen evahuted. RESULTS: To date. 169 patienu l'eai!ived 1-4 1
`moothly infuaiOOl (mean 18.7): an ovuall total of 3 126 infulione. 69 pa.
`tieDUi tuove been ltUted f'or >2 ,.,... Patientil had (ailed multiple {1-41
`d ..... modil'yina tMn,ae. before: a aingle ~tienl wu ueatment·naiva.
`Clinical diteue ~on ... ..een in 11 plltienla. 8 of them continued
`natalltumab. Annual rollow·up MRl in almo.t all patienu wu und1ani(C!d.
`Eiaht ptotienu with .,o.ilive atltl·nat.alitumab antibodiea demOMU'ated ei(cid:173)
`ther hypenen.itivlty reaction ( n - 6 )ord~ progreuion ( n ~2). Two(ll,l,1
`palieota developed lhingle. while on natalitumab. 'Murty pa.lIenta (17.7""
`diKoolinued n.atalitumab due to patient'a deci. ion (no bene6tJtoo hi,h
`ri.k), hyperRnaitivity reactinn, dia.eue Pf'OKTt'lIion •• ide erreetl nr intended
`p~. CONCLUSIONSIRELEVANCE: In our cohort IUltalh:umab
`w .. f'ouod to be very dfecllva in .tabilir.ing the coune of d i_ In the
`~ty of patienta. So w, we have DOt ot.uved any _ere eide errectl.
`UpdaWd information, In partkular in licht of recent new PML ca.. and
`pouibly UlCreued PML rilk with previOUI immuoe 'Uppreulon and treat(cid:173)
`ment duratinn, will be presented.
`DI.:loMINi Dr. Thyvlel baa GOlhlnll 10 diKlOlie. Dr. Hillman baa Mlh11ll1O dilclOlie
`Dr. WOCII-<ett 11M ~ to dikIOIIe. Dr Kruutkl hal rw;rthillllO dlet:_ Dr. Wund~
`...... tlon ror Kti ... iti.. ..;tIt s.yer ~tkalt, DID
`hM ~ pe.-al _
`s.-. .....:I """'"'-- n..r.pevtia.
`1'041.177
`
`U .. 0' GI.tlr.mer Acet.te during Pregnllncy:
`
`Off .... "" Women. Choice Aaron E. Miller. Jennifer L.
`RfUJrtion, New Yor., NY
`OBJECTIVE: Tn determine the willingn ... of women to UN glatiramer
`aoet.Ite (GA) during .ltempted conceptinn and throughnut pregnancy and
`outco~ of ~ncy in womeo remAilWl( 00 GA. BACK(cid:173)
`to _
`GROUND: MS hquenuy ~ women who deaife p~. Tboee
`t.akinc d ..... 1DCIdityulc qenta r- e dikmma. 1f they chIcootinue medi(cid:173)
`caboQ pnor to attemptifl( to eonc:eive. they will 1c.e dnIr protection. How(cid:173)
`ever'. continuing mediation may have riIIb to the fetul. Beeauee GA haa II
`c.tecorY B ratinl. we havil proIpeclively ' UggNted t~t wnmen conlider
`remaining lion GA while attemptln, COIIception and during pregnane:)'. DE(cid:173)
`S IONIMETBODS: Women QOfItemplating pregnane)' were eouueled about
`the proI and COllI of l'tOl.Iinifl( on GA while attemptina to conceive end
`duri", prep1IIIIq. The)' wera told Clkhey would have no proteCtion frvm
`MS while nff medication. (2)Prepanc:y ill auocIatecl WIth lower relapM nile
`compereci to non-prqnaru:y periodJ. (3ln!lapte rete ill hi,ber du.ri.na the
`poK-panum period. end (.lrMumption or mediCiltion immedietely after
`delivery might DOt be adeqUitely protective dunn( that n:l0I'e TUloen.ble
`penod_ The term -c.tepry B pregnancy ratina" w .. explAIned and the
`difficulty nf 1mowina: whether GA WBI truly .. fe w .. emphalill!d. p.tienw
`then decided whether to continu. GA. RESULTS: 85 women ... ere eoun(cid:173)
`IIIled about the potential UN of GA durin, pregnancy. Only 8 patientl
`initially dilCOrltinued Ok • remained on GA, but diKootinued when PrIII-
`1W11. Amoni the 23 _
`who mnained on GA, 27 ~ have
`~ 18 retlulWd in normJl children and S are ongoiaa. One minor
`COIlI"n1u.1 anomaly reqwred no InterventIOn. Two pnocnanciM ... ere termi-
`nated betau.ee nfTrilorny 21 fetUl8ll, thought unrelated to GA. One ectopie
`prqnaney and 3 other miKeniape oecurred (2 In one pataent after lYF).
`CONCLUSIONSIRELEVANCE: MOlt WQaien orrered the option of re(cid:173)
`mainlna on GA for pregnancy choc»e to continue the medication. TheIe
`rMulti in a limited number or pallenbl .uggMl that GA may be ..rely
`COIltinued dunn( prepancy.
`DilctoN,.. Dr. Miller bu ~iftd prrwanal _
`...... lIoOo for ...-unt;" '"'" B.....,
`Idee, Pft..- IDC, EMD s.-. T ... N~. OluoSmithKlinoo. '-.. o-.a~.
`loe., s..&-A_tiI ~ lM.. MMd s.-. Noorarw, Ofto.. &roIOId. "'ri(cid:173)
`.... DalldU~ &ad Aeordoo ~ _. _Ill'-"I....-br . ......,. boud
`........ .-uu ~_t~ -w. Dr Mill«_ ~ved~_
`J*Io"lbl 11:1 ... ediwrial capaa\,. Ibr Continuum. Dr MIller b.u ~ - .d I
`.... ppon l'rom "-'d. Thenlpeu\ks, ImauUle ToIaranoI Networit. T .... N~.
`Nov..,.u.. Oenentech. Inc., Oenzymol Corporltion., and Immune ToI • ...,.... Net .. orlr.. Dr
`Reardon 11M " ' .. eeI pI,.w _penutioD ror artl_ with Bayer H .. lth ear.. Bio-
`pAId., Dlos.r-. ,...... N~ Dr. Reudon 11M I1ICIeIvecI -..:II .upport
`~ No.-.rtk. ,....,. N~. atid AtJorde.
`
`1'041.178
`Immunologic •• Re.pon.e to GI.tlr.m.r Acet.t.
`In MS P.tlent •• ft.r DIHe,.nt Pret,..tments -
`The CoplmmunoNet Study Nino KieitU!r, TjaJf Z~muen.
`Drew,.. (Armony
`OBJECTIVE: Tn inv$lpte the Immunological n!!fIpQnM! to the MS immu(cid:173)
`nomodulator glatiraaaer acetate (GA) in MS patientl Jtan.inl de novo on
`GA in compar;..on to patienu .witicbiag rrom interfel"Oll.l (lYN). OlllOJl·
`an~ CMXl and natalitum.b (NA),. BACKG ROUND: It it nol dNr
`
`whether the Immunolo,aca.l and 10 probably the cllDlcal respoPR to GA I.
`altered by different pretreatmentlllFN. MX. NAI As antigen-based ther .
`apy. GA i. believed to de .... elop IU treatm.nt effkU by the Induction Of
`lpecafic ImmunolOfical chanll"'l ranR'lng from altered mOflocyte functiOll
`over modified T cell funclion up to GA-lpecific anubOOi ... As lOme MS
`treatmentA are limited regardlOJr their duration CMX. probably NA). it i. Of
`high clinical lOU-relt what .re the ImmunnlQlrical efTcct.a or dlffe~n t MS
`pretrealmentl on the follow1I\1 GA treatmenL DESIGNIMETHODS: At.
`protpecll .... e multicenter tnal !CoplmmunoN'et Triall. 32 paliCnUl .~
`de novo lion GA. 19 patienbl,wltchmg from IFN to GA. I) pauentl deeteal.t.
`Inl from MX to GA .nd 4 patlf'nl.lllwitcliing from NA to GA "'ere D.IHNtd
`over 1 yean by an extensive Immunological protocol In comblOallnn WiLb
`detailed chnica1 .nalfI'll. Prollferabon and cyt.olune prodUCliOO (3H thynd •
`dine and CFSEI or PBL to GA and tetanUi toxoid u w.1I u GA-.pecirte(cid:173)
`antibodle. were analyazed at varioU3 timepointl. RESULTS: There Wert
`no ,igJllficant dirrerentelJ regl\rding the dcerealle of proliferiltion to GA OVer
`time In all patienta .tarting on GA whi~h eould be firat.een 3 month. IlIter
`.tartlnt GA. THI-nI2 .hin '1''' present in all patientl at month 6 i,.....
`'pecliVfl the different preln'atmentl. Analya" of M'rum antibodietlto GA did
`not demonltrate IIgnificant dllTel't'lla!S bet"'ec>D the dIfferent grou~. All
`patienta did ~linically well. CONCLUSJONSiRELEVANCE: From the iaa,
`munnlogical point, GA aeem. to be userul platfonn dru, which can be WIld
`Independent of different prE:trealmenla (LFN. NA, MX) al no immuooloekal
`diff'erencee ... ere _n betwet'n palientl atarted de novo on GA and patientJ
`IWitched on GA. Supported by: TEVA PhannalSenofi Aventi. German,.
`DI.tebu .... Dr KIwwt- hu nothlnjllO cbJIcbe. Dr Z_ * received ~
`campll!OIIIlion for enftolti .. WIth Be)'., HMlthe ..... O,.n hl~. :.t.rd.&RIOO, N~
`Slin.on·Aventill PN~tlmla. l ~ •• nd Teo-. Nwl"IKIerInI ..... peaUr_ Dr ~
`... bill! re(~heel _fd1 .uppart from e.,.., lleelmc.re. 8iopn Id«. N".,.,.,
`s...af!·A_WI ~waII,I"" .• alld T .... Nf'\I~
`POII.179
`Development and First Evaluation of the New
`Patient Management and Documentation System
`MSDS 3D for Patients with Multiple Sclerosis Tial'
`Z,emSten, Fabian Kralz«h . Marro Eulltz. Raimar Kempde, NimJ
`Kleiner. DrelKien, Germany
`OBJECTIVE: To de\lelop and evalulte a new Multiple Sderoeia patient
`management JOftware and hardware M50S 3D fnr guidehne-bued IMII'
`..,ment and dueumentatlnn nr loiS patienU. BACKGROUND: Multipll.
`.tandan!
`Sdel'Oll. DocumentatIon Syltem fMSOS) hal been cW,'elnped u
`1015 documentation .)'Stem in Gennany linoe 2001 to generate data fnr tht
`Gennan MS I't'glt try. Up to nnw, there hal becon lin interface to pallent.nd
`nul'll dota for multidlmen.ional evaluation (fatigue. depree.inn, Qat.,
`loiS treatment proLOCOli get mort! and IlIOn
`trfat.ment ~mentJ. M
`complacated with amplen:lentahon orne..- drop. MSDS 3D wu del-·e1oped ..
`chenp the .alely donamentahon to a pallent mlnqoement lyatem aooord·
`il\l current l'udeliQel. DESIGNIMETHODS: In additIOn to the local bani·
`ware runnill&' MSOS. II touch-llaftn and mternet·baaed module (interr.ot
`to patient'. mobde phone) wu developed for thi. project. Uling ABS-VO
`If)(:hnology to add patient' •• nd nurae', daUl u.ina thi. interface. Special
`treatment and .tudy modul .. _'ere del--eloped "'Ith a def1n~ mit achedlilt
`and ma.ndatory f!lUmlnationl ... hlCh are doc:umented and VlIuaJized b}'
`MSDS. Other reportJ ego rrum neuroradiolOf\'u. ophthalmnlogilta .... i ...
`plemented Illloa the MSDS Internet. aerver. A touch ICreen tennlnal Wit
`develnped fnr collecting pallent·. dllta. RESULTS: In a pilot ve~kiL
`MSDS 30 wu teJ;ted in 100 repre:eentaU\'e patienu by ph)'SlCian. IJ\Id
`nunN. MSOS 30 touch ICn!l'n and Internet baIf!d patient module wel ... 1111
`acc:epted by the patienLl and the phylicaOi. A6, not nnly documentation. but
`patient m.nagement W8iI provided by thi. IOft ... art'. quality or patient mati·
`agement '1''' .ignificanlly improved and IItandardized. CONCLUSIONI'
`RELEVANCE: A fi ... t .tep of multiditnenlional doc:wnentatio.o and patieat
`rnanlpttleOt of MS pallenn w .. taken by the develnpmenl and rtnt ... aI·
`Ultion of MS patientL 1'hl're it the need aot only by a IOfteware-cuw.l
`doaameDtabOn, but wmdardized pati.nl management accordina the MS
`guidelinee. Further .ludies IRe-pallo. X-Scalel are on the way to Implemeat
`the MS management IOftware in ChOlCalltudl('l and daily dinicaJ prac:tita
`DiRto-.... Or_ z;e-.. liN reoeived pe~ _penIIItlon lOr .ruvitom .. ith s.;,w
`HMltlD,.. 8iopn l&tc. Me~ Novana, SannII·Aven~ Phannaceutkall. 1-..
`alld ,...... N~ ... ..-.ur Or Zoec:nuen 11M 1'IICIt1'n!d ..-n::b .uppon ~
`~ HNhlxaN, ~ IdK. Nova"'" SannII·A~tiI Pbenaantvt-.k. .......
`TII'f'. N~ Dr_ KnltudI bu n(II.hlD( 10 d,... Or E",IILa lIN ~ ..
`~ Dr ~mpc ....... received pe.-I DOlnlpIGoAt;on lOr ectm~ With 8 ......
`LIMe, T .... Bayer Haltbrare. Nooo.ru.,1f'III Nud! &rwno ... _hanl end.pMDf
`Or KleI_ hM ~ to ~
`POII.lao
`Intellectual Enrichment Less.ns the Negative
`Imp.ct of Brain Atrophy on Cognition In Multiple
`Sclerosl. Jame8 F. Sumowdi. Glrn,. R. Wyitr, Nancy ChiD,..'
`valloll. John DeLuca, Wrsl Orangr. NJ
`OBJECTIVE: Tn detennine ... hether lifetime antellec:tUlI ennchment ....
`el1l the neptivelmpaet. ofbraln dilell.!lll lion cognitive ltatw in penone.,.\11
`MUltiple Sdero.iII IMS). That i •. whether COffOitivc ruerve protectl M!I
`patlentl rrom cognitive decline. BACKGROUND: About 50'1 of loiS pt
`lIenl.l develop ooenltive impairment. 8llpecially Iinwed inronnation prDOIIIP
`in. and le.miD( I memory dYlrunction. MRI marken of MS diM_
`progreulon (i.e .• brain atrophy I ere relati~'t'ly weak pred.ictnn or OOI"ita"
`.tatUi. Thi. indirf>ct relatiolUhlp between MS dill'''lIe lind cornition may.
`explained by the protective errl!C1. or Metime inlCIJectual enrichment, ... fUdI
`hal been .hown to I_n the effect of brain dileue lion t'IOf(nition in ~
`neurolop: populabONl Ce.I" •• A1Wimer'a dlMAll). DESIGNlMETIiO __
`
`.uk NEUROLOOY 1-4 MarckS, 10 10 (Suppll)
`
`MYLAN PHARMS. INC. EXHIBIT 1082 PAGE 1
`...... lzuIIwb T .... tment for Multiple Sclerosis In
`Clinic •• Practice Dinah Thy#!rltd, Lynda Hillman. Volute
`Woolllttt. Dora Kro.tuclti, Anndt~ Wundu, &attll!, WA
`OBJECnVE: To dMc:ribe clinical and MRl outC'ome .her lreatml!:nt with
`nauil:llunab (or up to 3..6 yeti"', BACKGR OUND: Nalalllumab, an alpha.
`int.epin antqOni.ft. ia iPdieated (or 11M! In reclap.in, multiple ,dl!:ro.ia
`(MS) but can callM rve .evere l ide effecu (PML. olber infec:\ioM). With
`the ~l i.nI;:ruM 01 PML eueI reported in late 1M009, poMlble UIIOcia·
`tiorI with pre'ri0UI immune IUppreuioa and duration of natalitumab UUt·
`rnent ia diKuPed. DESIGNIMETHODS: RelrOllpect.ive ~ rullon.l
`• tUlly of 169 COM«Utive MS patienu uuted with natalilumab a t the
`Univeraity 01 WashingtOn. Clinic p~ion. MRland laboratory momtor·
`in, including antibodY'politivity, lide etrecte and COu.eIJ for diKontinuft·
`tion wen evahuted. RESULTS: To date. 169 patienu l'eai!ived 1-4 1
`moothly infuaiOOl (mean 18.7): an ovuall total of 3 126 infulione. 69 pa.
`tieDUi tuove been ltUted f'or >2 ,.,... Patientil had (ailed multiple {1-41
`d ..... modil'yina tMn,ae. before: a aingle ~tienl wu ueatment·naiva.
`Clinical diteue ~on ... ..een in 11 plltienla. 8 of them continued
`natalltumab. Annual rollow·up MRl in almo.t all patienu wu und1ani(C!d.
`Eiaht ptotienu with .,o.ilive atltl·nat.alitumab antibodiea demOMU'ated ei(cid:173)
`ther hypenen.itivlty reaction ( n - 6 )ord~ progreuion ( n ~2). Two(ll,l,1
`palieota developed lhingle. while on natalitumab. 'Murty pa.lIenta (17.7""
`diKoolinued n.atalitumab due to patient'a deci. ion (no bene6tJtoo hi,h
`ri.k), hyperRnaitivity reactinn, dia.eue Pf'OKTt'lIion •• ide erreetl nr intended
`p~. CONCLUSIONSIRELEVANCE: In our cohort IUltalh:umab
`w .. f'ouod to be very dfecllva in .tabilir.ing the coune of d i_ In the
`~ty of patienta. So w, we have DOt ot.uved any _ere eide errectl.
`UpdaWd information, In partkular in licht of recent new PML ca.. and
`pouibly UlCreued PML rilk with previOUI immuoe 'Uppreulon and treat(cid:173)
`ment duratinn, will be presented.
`DI.:loMINi Dr. Thyvlel baa GOlhlnll 10 diKlOlie. Dr. Hillman baa Mlh11ll1O dilclOlie
`Dr. WOCII-<ett 11M ~ to dikIOIIe. Dr Kruutkl hal rw;rthillllO dlet:_ Dr. Wund~
`...... tlon ror Kti ... iti.. ..;tIt s.yer ~tkalt, DID
`hM ~ pe.-al _
`s.-. .....:I """'"'-- n..r.pevtia.
`1'041.177
`
`U .. 0' GI.tlr.mer Acet.te during Pregnllncy:
`
`Off .... "" Women. Choice Aaron E. Miller. Jennifer L.
`RfUJrtion, New Yor., NY
`OBJECTIVE: Tn determine the willingn ... of women to UN glatiramer
`aoet.Ite (GA) during .ltempted conceptinn and throughnut pregnancy and
`outco~ of ~ncy in womeo remAilWl( 00 GA. BACK(cid:173)
`to _
`GROUND: MS hquenuy ~ women who deaife p~. Tboee
`t.akinc d ..... 1DCIdityulc qenta r- e dikmma. 1f they chIcootinue medi(cid:173)
`caboQ pnor to attemptifl( to eonc:eive. they will 1c.e dnIr protection. How(cid:173)
`ever'. continuing mediation may have riIIb to the fetul. Beeauee GA haa II
`c.tecorY B ratinl. we havil proIpeclively ' UggNted t~t wnmen conlider
`remaining lion GA while attemptln, COIIception and during pregnane:)'. DE(cid:173)
`S IONIMETBODS: Women QOfItemplating pregnane)' were eouueled about
`the proI and COllI of l'tOl.Iinifl( on GA while attemptina to conceive end
`duri", prep1IIIIq. The)' wera told Clkhey would have no proteCtion frvm
`MS while nff medication. (2)Prepanc:y ill auocIatecl WIth lower relapM nile
`compereci to non-prqnaru:y periodJ. (3ln!lapte rete ill hi,ber du.ri.na the
`poK-panum period. end (.lrMumption or mediCiltion immedietely after
`delivery might DOt be adeqUitely protective dunn( that n:l0I'e TUloen.ble
`penod_ The term -c.tepry B pregnancy ratina" w .. explAIned and the
`difficulty nf 1mowina: whether GA WBI truly .. fe w .. emphalill!d. p.tienw
`then decided whether to continu. GA. RESULTS: 85 women ... ere eoun(cid:173)
`IIIled about the potential UN of GA durin, pregnancy. Only 8 patientl
`initially dilCOrltinued Ok • remained on GA, but diKootinued when PrIII-
`1W11. Amoni the 23 _
`who mnained on GA, 27 ~ have
`~ 18 retlulWd in normJl children and S are ongoiaa. One minor
`COIlI"n1u.1 anomaly reqwred no InterventIOn. Two pnocnanciM ... ere termi-
`nated betau.ee nfTrilorny 21 fetUl8ll, thought unrelated to GA. One ectopie
`prqnaney and 3 other miKeniape oecurred (2 In one pataent after lYF).
`CONCLUSIONSIRELEVANCE: MOlt WQaien orrered the option of re(cid:173)
`mainlna on GA for pregnancy choc»e to continue the medication. TheIe
`rMulti in a limited number or pallenbl .uggMl that GA may be ..rely
`COIltinued dunn( prepancy.
`DilctoN,.. Dr. Miller bu ~iftd prrwanal _
`...... lIoOo for ...-unt;" '"'" B.....,
`Idee, Pft..- IDC, EMD s.-. T ... N~. OluoSmithKlinoo. '-.. o-.a~.
`loe., s..&-A_tiI ~ lM.. MMd s.-. Noorarw, Ofto.. &roIOId. "'ri(cid:173)
`.... DalldU~ &ad Aeordoo ~ _. _Ill'-"I....-br . ......,. boud
`........ .-uu ~_t~ -w. Dr Mill«_ ~ved~_
`J*Io"lbl 11:1 ... ediwrial capaa\,. Ibr Continuum. Dr MIller b.u ~ - .d I
`.... ppon l'rom "-'d. Thenlpeu\ks, ImauUle ToIaranoI Networit. T .... N~.
`Nov..,.u.. Oenentech. Inc., Oenzymol Corporltion., and Immune ToI • ...,.... Net .. orlr.. Dr
`Reardon 11M " ' .. eeI pI,.w _penutioD ror artl_ with Bayer H .. lth ear.. Bio-
`pAId., Dlos.r-. ,...... N~ Dr. Reudon 11M I1ICIeIvecI -..:II .upport
`~ No.-.rtk. ,....,. N~. atid AtJorde.
`
`1'041.178
`Immunologic •• Re.pon.e to GI.tlr.m.r Acet.t.
`In MS P.tlent •• ft.r DIHe,.nt Pret,..tments -
`The CoplmmunoNet Study Nino KieitU!r, TjaJf Z~muen.
`Drew,.. (Armony
`OBJECTIVE: Tn inv$lpte the Immunological n!!fIpQnM! to the MS immu(cid:173)
`nomodulator glatiraaaer acetate (GA) in MS patientl Jtan.inl de novo on
`GA in compar;..on to patienu .witicbiag rrom interfel"Oll.l (lYN). OlllOJl·
`an~ CMXl and natalitum.b (NA),. BACKG ROUND: It it nol dNr
`
`whether the Immunolo,aca.l and 10 probably the cllDlcal respoPR to GA I.
`altered by different pretreatmentlllFN. MX. NAI As antigen-based ther .
`apy. GA i. believed to de .... elop IU treatm.nt effkU by the Induction Of
`lpecafic ImmunolOfical chanll"'l ranR'lng from altered mOflocyte functiOll
`over modified T cell funclion up to GA-lpecific anubOOi ... As lOme MS
`treatmentA are limited regardlOJr their duration CMX. probably NA). it i. Of
`high clinical lOU-relt what .re the ImmunnlQlrical efTcct.a or dlffe~n t MS
`pretrealmentl on the follow1I\1 GA treatmenL DESIGNIMETHODS: At.
`protpecll .... e multicenter tnal !CoplmmunoN'et Triall. 32 paliCnUl .~
`de novo lion GA. 19 patienbl,wltchmg from IFN to GA. I) pauentl deeteal.t.
`Inl from MX to GA .nd 4 patlf'nl.lllwitcliing from NA to GA "'ere D.IHNtd
`over 1 yean by an extensive Immunological protocol In comblOallnn WiLb
`detailed chnica1 .nalfI'll. Prollferabon and cyt.olune prodUCliOO (3H thynd •
`dine and CFSEI or PBL to GA and tetanUi toxoid u w.1I u GA-.pecirte(cid:173)
`antibodle. were analyazed at varioU3 timepointl. RESULTS: There Wert
`no ,igJllficant dirrerentelJ regl\rding the dcerealle of proliferiltion to GA OVer
`time In all patienta .tarting on GA whi~h eould be firat.een 3 month. IlIter
`.tartlnt GA. THI-nI2 .hin '1''' present in all patientl at month 6 i,.....
`'pecliVfl the different preln'atmentl. Analya" of M'rum antibodietlto GA did
`not demonltrate IIgnificant dllTel't'lla!S bet"'ec>D the dIfferent grou~. All
`patienta did ~linically well. CONCLUSJONSiRELEVANCE: From the iaa,
`munnlogical point, GA aeem. to be userul platfonn dru, which can be WIld
`Independent of different prE:trealmenla (LFN. NA, MX) al no immuooloekal
`diff'erencee ... ere _n betwet'n palientl atarted de novo on GA and patientJ
`IWitched on GA. Supported by: TEVA PhannalSenofi Aventi. German,.
`DI.tebu .... Dr KIwwt- hu nothlnjllO cbJIcbe. Dr Z_ * received ~
`campll!OIIIlion for enftolti .. WIth Be)'., HMlthe ..... O,.n hl~. :.t.rd.&RIOO, N~
`Slin.on·Aventill PN~tlmla. l ~ •• nd Teo-. Nwl"IKIerInI ..... peaUr_ Dr ~
`... bill! re(~heel _fd1 .uppart from e.,.., lleelmc.re. 8iopn Id«. N".,.,.,
`s...af!·A_WI ~waII,I"" .• alld T .... Nf'\I~
`POII.179
`Development and First Evaluation of the New
`Patient Management and Documentation System
`MSDS 3D for Patients with Multiple Sclerosis Tial'
`Z,emSten, Fabian Kralz«h . Marro Eulltz. Raimar Kempde, NimJ
`Kleiner. DrelKien, Germany
`OBJECTIVE: To de\lelop and evalulte a new Multiple Sderoeia patient
`management JOftware and hardware M50S 3D fnr guidehne-bued IMII'
`..,ment and dueumentatlnn nr loiS patienU. BACKGROUND: Multipll.
`.tandan!
`Sdel'Oll. DocumentatIon Syltem fMSOS) hal been cW,'elnped u
`1015 documentation .)'Stem in Gennany linoe 2001 to generate data fnr tht
`Gennan MS I't'glt try. Up to nnw, there hal becon lin interface to pallent.nd
`nul'll dota for multidlmen.ional evaluation (fatigue. depree.inn, Qat.,
`loiS treatment proLOCOli get mort! and IlIOn
`trfat.ment ~mentJ. M
`complacated with amplen:lentahon orne..- drop. MSDS 3D wu del-·e1oped ..
`chenp the .alely donamentahon to a pallent mlnqoement lyatem aooord·
`il\l current l'udeliQel. DESIGNIMETHODS: In additIOn to the local bani·
`ware runnill&' MSOS. II touch-llaftn and mternet·baaed module (interr.ot
`to patient'. mobde phone) wu developed for thi. project. Uling ABS-VO
`If)(:hnology to add patient' •• nd nurae', daUl u.ina thi. interface. Special
`treatment and .tudy modul .. _'ere del--eloped "'Ith a def1n~ mit achedlilt
`and ma.ndatory f!lUmlnationl ... hlCh are doc:umented and VlIuaJized b}'
`MSDS. Other reportJ ego rrum neuroradiolOf\'u. ophthalmnlogilta .... i ...
`plemented Illloa the MSDS Internet. aerver. A touch ICreen tennlnal Wit
`develnped fnr collecting pallent·. dllta. RESULTS: In a pilot ve~kiL
`MSDS 30 wu teJ;ted in 100 repre:eentaU\'e patienu by ph)'SlCian. IJ\Id
`nunN. MSOS 30 touch ICn!l'n and Internet baIf!d patient module wel ... 1111
`acc:epted by the patienLl and the phylicaOi. A6, not nnly documentation. but
`patient m.nagement W8iI provided by thi. IOft ... art'. quality or patient mati·
`agement '1''' .ignificanlly improved and IItandardized. CONCLUSIONI'
`RELEVANCE: A fi ... t .tep of multiditnenlional doc:wnentatio.o and patieat
`rnanlpttleOt of MS pallenn w .. taken by the develnpmenl and rtnt ... aI·
`Ultion of MS patientL 1'hl're it the need aot only by a IOfteware-cuw.l
`doaameDtabOn, but wmdardized pati.nl management accordina the MS
`guidelinee. Further .ludies IRe-pallo. X-Scalel are on the way to Implemeat
`the MS management IOftware in ChOlCalltudl('l and daily dinicaJ prac:tita
`DiRto-.... Or_ z;e-.. liN reoeived pe~ _penIIItlon lOr .ruvitom .. ith s.;,w
`HMltlD,.. 8iopn l&tc. Me~ Novana, SannII·Aven~ Phannaceutkall. 1-..
`alld ,...... N~ ... ..-.ur Or Zoec:nuen 11M 1'IICIt1'n!d ..-n::b .uppon ~
`~ HNhlxaN, ~ IdK. Nova"'" SannII·A~tiI Pbenaantvt-.k. .......
`TII'f'. N~ Dr_ KnltudI bu n(II.hlD( 10 d,... Or E",IILa lIN ~ ..
`~ Dr ~mpc ....... received pe.-I DOlnlpIGoAt;on lOr ectm~ With 8 ......
`LIMe, T .... Bayer Haltbrare. Nooo.ru.,1f'III Nud! &rwno ... _hanl end.pMDf
`Or KleI_ hM ~ to ~
`POII.lao
`Intellectual Enrichment Less.ns the Negative
`Imp.ct of Brain Atrophy on Cognition In Multiple
`Sclerosl. Jame8 F. Sumowdi. Glrn,. R. Wyitr, Nancy ChiD,..'
`valloll. John DeLuca, Wrsl Orangr. NJ
`OBJECTIVE: Tn detennine ... hether lifetime antellec:tUlI ennchment ....
`el1l the neptivelmpaet. ofbraln dilell.!lll lion cognitive ltatw in penone.,.\11
`MUltiple Sdero.iII IMS). That i •. whether COffOitivc ruerve protectl M!I
`patlentl rrom cognitive decline. BACKGROUND: About 50'1 of loiS pt
`lIenl.l develop ooenltive impairment. 8llpecially Iinwed inronnation prDOIIIP
`in. and le.miD( I memory dYlrunction. MRI marken of MS diM_
`progreulon (i.e .• brain atrophy I ere relati~'t'ly weak pred.ictnn or OOI"ita"
`.tatUi. Thi. indirf>ct relatiolUhlp between MS dill'''lIe lind cornition may.
`explained by the protective errl!C1. or Metime inlCIJectual enrichment, ... fUdI
`hal been .hown to I_n the effect of brain dileue lion t'IOf(nition in ~
`neurolop: populabONl Ce.I" •• A1Wimer'a dlMAll). DESIGNlMETIiO __
`
`.uk NEUROLOOY 1-4 MarckS, 10 10 (Suppll)
`
`MYLAN PHARMS. INC. EXHIBIT 1082 PAGE 1
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