Uporaba mikofenolat mofe0la v zdravljenju SLE. Rok Ješe Klinični oddelek za revmatologijo UKC Ljubljana
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1 Uporaba mikofenolat mofe0la v zdravljenju SLE Rok Ješe Klinični oddelek za revmatologijo UKC Ljubljana
2 Mikofenolat mofe=l (MMF) 2- morfolinoe=lni ester mikofenolne kisline produkt plesni Penicillium brevicompactum Sinclair A et al. Mycophenolate mofe=l: an overview. Lupus, 2006
3 MMF mehanizem delovanja pretvorba v mikofenolno kislino (MPA) inhibicija inozin- 5- monofosfat dehidrogenaze (IMPDH) à zavora de novo sinteze gvanozinskih nukleo=dov à zavora proliferacije in ak0vacije limfocitov T in B druge celice lahko uporabijo t.i. rešilno pot (limfoci= izključno de novo) močnejša inhibicija IMPDH =p II (izražena v ak=viranih limfoci=h) ugoden vpliv na proces ateroskleroze? Sinclair A et al. Mycophenolate mofe=l: an overview. Lupus, 2006
4 MMF neželeni učinki slabost, bruhanje, diareja ( 1/10) levkopenija, anemija, trombocitopenija ( 1/10) hepa==s (1/100 1/10) okužbe teratogenost (kontraindiciran v nosečnos=) SmPC CellCept 500 mg filmsko obložene tablete
5 Natrijev mikofenolat (v gastrorezistentnih tabletah) mikofenolna kislina v obliki natrijeve soli 1000 mg MMF 720 mg Na- MPA manjša incidenca GI neželenih učinkov pantoprazol ne vpliva na farmakokine=ko Na- MPA SmPC Myfor=c 360 mg gastrorezistentne tablete Darji P et al. Conversion From Mycophenolate Mofe=l to Enteric- coated Mycophenolate Sodium in Renal Transplant Recipients With Gastrointes=nal Tract Disorders. Transplant Proc, 2008 Rupprecht K et al. Bioavailability of Mycophenolate Mofe=l and Enteric- Coated Mycophenolate Sodium Is Differen=ally Affected by Pantoprazole in Healthy Volunteers. J Clin Pharmacol, 2013
6 MMF in SLE zgodovina 1995: pričetek uporabe (preprečevanje zavrnitve po presaditvi ledvice) 1998: prva uporaba za SLE (refraktarni lupusni glomerulonefri=s) 1999: prva serija primerov SLE (rezistentni in relapsirajoči prolifera=vni LGN) 2000: prva randomizirana kontrolirana raziskava za SLE (difuzni prolifera=vni LGN) Sinclair A et al. Mycophenolate mofe=l: an overview. Lupus, 2006
7 MMF in lupusni glomerulonefri=s (indukcijsko zdravljenje) 2 ključni raziskavi: Ginzler et al., 2005 [N=140, 24 tednov] Appel et al. (ALMS Group), 2009 [N=370, 24 tednov] LGN razred III, IV ali V MMF [1 à 3 g/dan] vs. IV CYC 6x[0,5 à 1 g/m 2 /mesec]
8 Indukcijsko zdravljenje LGN Ginzler EM et al. Mycophenolate Mofe=l or Intavenous Cyclophosphamide for Lupus Nephri=s. N Engl J Med, 2005
9 Indukcijsko zdravljenje LGN Appel GB et al. Mycophenolate Mofe=l versus Cyclophosphamie for Induc=on Treatment of Lupus Nephri=s. J Am Soc Nephrol, 2009
10 Indukcijsko zdravljenje LGN prolifera0vni LGN (III, IV): MMF (3g/dan) pri večini primerov (1A) IV CYC po Euro- Lupus shemi pri belcih (1B) IV CYC po NIH shemi primerljivo učinkovit, bolj toksičen (vendar edini dokazano učinkovit pri neugodnih prognos=čnih znakih) učinkovitost MMF verjetno večja pri temnopol=h membranski LGN (V): MMF pri večini primerov (2B) IV CYC po NIH shemi primerljivo učinkovit, bolj toksičen Bertsias GK et al. Joint European League Against Rheuma=sm and European Renal Associa=on European Dialysis and Transplant Associa=on (EULAR/ERA- EDTA) recommenda=ons for the management of adult and paediatric lupus nephri=s. Ann Rheum Dis, 2012
11 MMF in lupusni glomerulonefri=s (vzdrževalno zdravljenje) 2 ključni raziskavi: Houssiau et al. (MAINTAIN Trial), 2010 [N=105, 48 mesecev] (po indukciji z MP 3x750 mg + IV CYC 6x[500 mg/2 tedna]) Dooley et al. (ALMS Group), 2011 [N=227, 36 mesecev] (po indukciji z MMF ali IV CYC 6x[0,5 à 1 g/m 2 /mesec]) MMF [2 g/dan] vs. AZA [2 mg/kg/dan]
12 Vzdrževalno zdravljenje LGN Houssiau FA et al. Azathioprine versus Mycophenolate Mofe=l for Long- term immunosuppression in Lupus Nephri=s: Resilts from the MAINTAIN Nephri=s Trial. Ann Rheum Dis, 2010
13 Vzdrževalno zdravljenje LGN Dooley MA et al. Mycophenolate versus Azathioprine as Maintenance Therapy for Lupus Nephri=s. N Engl J Med, 2011
14 Vzdrževalno zdravljenje LGN MMF ali AZA - primerljiva učinkovitost (1A) nadaljevanje z MMF ob uspešnem indukcijskem zdravljenju Aza=oprin (AZA) v primeru načrtovane nosečnos= Kalcinevrinski inhibitorji (CNI) v izbranih primerih Bertsias GK et al. Joint European League Against Rheuma=sm and European Renal Associa=on European Dialysis and Transplant Associa=on (EULAR/ERA- EDTA) recommenda=ons for the management of adult and paediatric lupus nephri=s. Ann Rheum Dis, 2012
15 MMF in lupusni glomerulonefri=s Priporočila EULAR/ERA- EDTA (2012): Bertsias GK et al. Joint European League Against Rheuma=sm and European Renal Associa=on European Dialysis and Transplant Associa=on (EULAR/ERA- EDTA) recommenda=ons for the management of adult and paediatric lupus nephri=s. Ann Rheum Dis, 2012
16 MMF in zunajledvične manifestacije SLE ni (ločenih) podatkov o učinkovitos= iz randomiziranih študij posamezni primeri uspešnega zdravljenja rezistentnih manifestacij SLE: huda trombocitopenija, hemoli=čna anemija difuzna alveolarna krvavitev, kronični inters=cijski pnevmoni=s nevropsihiatrični SLE artri=s, kožni LE (ne CCLE?) enteri=s MMF predstavlja alterna0vo (Aringer et al., 2013): če z uveljavljenimi imunosupresivi ni mogoče umiri= bolezni če ni mogoče znižanje odmerka glukokor=koidov do 7,5 mg prednizolona/dan Doria A et al. Mycophenolate Mofe=l and Systemic Lupus Erythematosus. Lupus, 2006 Aringer M et al. Stellungnahme zum Einsatz von Mycophenolat- Mofe=l beim systemischen Lupus erythematodes. Z Rheumatol, 2013
17 MMF in zunajledvične manifestacije SLE Ginzler et al. (ALMS Group), 2009 (ak=vnost bolezni po BILAG indeksu ob indukcijskem zdravljenju LGN) Ginzler EM et al. Nonrenal Disease Ac=vity Following Mycophenolate Mofe=l or Intravenous Cyclophosphamide as Induc=on Treatment for Lupus Nephri=s. ArthriBs Rheum, 2010
18 Uporaba MMF na KOR UKCLJ (hospitalizirani pacien= s SLE 1/ /2014) Vsi hospitalizirani pacien0, N=66 Zadnja vzdrževalna terapija Pacien0 s prvič ugotavljano ledvično prizadetostjo, N=20 Zadnja vzdrževalna terapija MMF AZA CNI MTX MP+CQ CQ MP MMF AZA CNI MP+CQ RTX RTX
19 Zaključek MMF pri zdravljenju lupusnega glomerulonefri0sa: indukcija: primerljiva učinkovitost s CYC, manjša toksičnost vzdrževanje: primerljiva (boljša?) učinkovitost kot AZA à Zdravilo prve izbire za večino pacientov s prolifera0vnim in/ ali membranskim LGN Alterna=vno zdravilo za rezistentne zunajledvične manifestacije SLE MMF s pridom uporabljamo tudi na KOR UKCLJ
20
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