KLASIFIKACIJA IMUNOSUPRESIVA
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1 Primena mikofenolične ne kiseline (MPA) i plazmafereze u lečenju enju nefrotskog sindroma Prof. dr. Zoran Kovačević
2 PREVALENCA
3 KLASIFIKACIJA IMUNOSUPRESIVA GLIKOKORTIKOIDI ANALOZI VITAMINA D HLORAMBUCIL REGULATORI GENSKE EKSPRESIJE CIKLOFOSFAMID CIKLOSPORIN ALKILIRAJUĆI AGENSI TAKROLIMUS INHIBITORI KALCINEURINA MIKOFENOLAT MOFETIL AZITIOPRIN INHIBITORI SINTEZE PURINA
4 KLASIFIKACIJA IMUNOSUPRESIVA SIROLIMUS S EVEROLIMUS ERTANECEPT INFLIKSIMAB mtor INHIBITORI SIROLIMUS ADALIMUMAB RITUKSIMAB EKULIZUMAB ANTI TNF-α AGENSI ALEMTUZUMAB IVIG MONOKLONALNA ANTITELA LEVAMISOL IMUNOMODULIRAJUĆI AGENSI
5 PRIMARNI GLOMERULONEFRITISI- STANDARDNA IMUNOSUPRESIVNA TERAPIJA kortikosteroidi ortikosteroidi TERAPIJSKI PROBLEM STANDARDNE IMUNOSUPRESIVNE TERAPIJE ciklofosfamid ciklosporin azatioprin nedovoljna efikasnost neželjeni efekti azatioprin
6 Mycophenolic icna kiselina (MPA PA) 1969 Immunosupresivni efekat MPA (Mitsui A, Suzuki S.: J. Antibiotics, 1969) 1995 Potvrda FDA u SAD za prevenciju odbacivanja u transplantiranom bubregu
7 MIKOFENOLIČNA KISELINA MPA - mehanizam dejstva Inhibitor de novo 1 biosinteze i purina - blokadom inozin monofosfat dehidrogenaze Eugui EM and Allison AC. Ann NY Acad Sci 1993;
8 UTICAJ MPA NA PATOGENETSKE MEHANIZME ZNAČAJNE ZA PROGRESIJU PRIMARNIH GLOMERULONEFRITISA Proliferacija TIB limfocita Antitela Glikozilacija il ij i ekspresija athezivnih molekula MPA Progresija primarnih glomerulonefritisa Proliferacija glatkih miš. ćelija krvnih sudova Proliferacija mezangijalnih ćelija
9 Myfortic MMF Myfortic Mikofenolat Natrijum - so Odloženo oslobadjanje gastrorezistentna formula Oslobadja se u tankom crevu 720 mg 2 x dnevno MMF Mikofenolat mofetil ester Aktivna supstanca -MPA Oslobadja Olbdj se odmah 1000 mg 2 x dnevno
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11 Bolest minimalnih promena Bolesnici 24 dece (relapsirajući MCD) I grupa MPA (2 g/dnevno) II grupa CSA (4 do 5 mg/(kg/dnevno, ciljana vrednost mg/l Vreme praćenja 12 meseci Rezultati: I grupa relapsi bolja renalna funkcija, manje neželjenih efekata ¹Dorresteijn EM et al. Mycophenolate mofetil versus cyclosporine for remission maintenance in nephrotic syndrome. Pediatr Nephrol 2008;23(11):
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13 Fokalno segmentna glomeruloskleroza MMA predstavlja alternativnu ti terapijsku opciju objavljeno je nekoliko nekontrolisanih i jedna randomizovana studija, uglavnom kod pacijenata sa NS rezistentnim na konvencionalnu terapiju većina ukazuje na komparabilnu stopu remisije u odnosu na standardne terapijske režime u jedinoj randomizovanoj prospektivnoj studiji /¹Senthil Nayagam L et al./, praćena su 33 odrasla pacijenta sa FSGS i rezistentnim NS tokom 6 meseci prva grupa je bila na monoterapijii steroidima (1 mg/kg/d -6 meseci ), dok je druga bila na kombinovanoj terapiji prednisolonom (0.5 mg/kg/d tokom 8-12 sedmica) sa MMF (2 g/d- tokom 6 meseci) u rezultatima publikovanim 2008.g nije dokazana superiornost MMFu postizanju i održavanje remisije NS, odnosno postignuti su slični rezultati.. ¹¹Senthil Nayagam L et al. Mycophenolate mofetil or standard therapy for membranous nephropathy and focal segmental glomeruloscler lerosis:a pilot study. Nephrol Dial Transplant 2008;23(6):
14 Idiopatska membranska nefropatija MPA je poslednjih godina uvedena kao "spasavajuća" terapijska opcija u lečenju IMN : iskustva sa MPA uključuju brojne nekontrolisane retrospektivne studije slučaja koje ukazuju na efikasnost MPA u postizanju i održavanju remisije IMN, ali se moraju prihvatiti sa rezervom zbog samog dizajna studija rezultati većine prospektivnih randomizovanih kontrolisanih studija koje su relativno limitirane brojem pacijenata, ukazuju na podjednaku efikasnost MPA sa ostalim terapijskim protokolima u lečenju MN
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17 Idiopatska membranska nefropatija u Francuskoj multicentričnoj randomizovanoj kontrolisanoj studiji (¹Dussol B i sar.) koja je obuhvatila 32 pacijenta u periodu praćenja tokom godinu dana MMF je korišćen kao inicijalni monoterapijski protokol komparativno sa renoprotektivnom terapijom rezultati su ukazali na podjednaku efikasnost oba terapijska režima slični rezultati su dobijeni u prospektivnoj studiji ²Brantena i sar. koji su komparirali MMF i ciklofosfamid f id tokom perioda praćenja ć od 2 g. ¹ Dussol B et al. Mycophenolate mofetil monotherapy in membranous nephropathy: a 1-year randomized controlled trial. Am J Kidney Dis 2008;52(4): ²Branten AJ et al. Mycophenolate mofetil in idiopathic membranous nephropathy: a clinical trial with comparison to a historic control group treated with yclophosphamide. Am J Kidney Dis 2007;50(2):248-56
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19 IgA nefropatija Različiti terapijski protokoli MMA primenjen u 4 randomizovane kontrolisane studije i 2 kohortne studije (kao "spasavajuća" terapija) ¹Chen i sar.u u studiji sa 62 odrasla pacijenta sa ph uznapredovalom IgA sa proteinurijom preko 2,0g/24h, primenili su MMF( g/d) u odnosu na kontrolnu grupu sa oralnim prednizonom (0.8 mg/kg/d) nakon jednogodišnjeg tretmana sa MMA ova grupa je pokazala značajnu redukciju proteinurije kao i ph regresiju intersticijskih promena u odnosu na kontrolnu grupu ¹Chen X et al.a randomized control trial of mycophenolate mofeil treatment in severe IgA nephropathy. Zhonghua Yi Xue Za Zhi 2002;82(12):
20 IgA nefropatija ¹Maes i sar.u u studiji sa 34 pacijenta, a tokom perioda praćenja od 36 meseci, nisu evidentirali superiornost MMF na stopu redukcije proteinurije i prezervacije renalne funkcije u odnosu na kontrolnu grupu sa placebom (obe grupe bile na renoprotektivnoj terapiji) Slične rezultate u izostanku benefita primenjenog MMF u odnosu na grupu sa placebom, publikovali su ²Frisch i sar. koji su u duplo slepoj kontrolisanoj studiji sa 32 visokorizična pacijenta sa IgA u periodu praćenja od 24 meseca (predhodno godinu dana primenjen MMF 2g/d) evidentirali pogorsanje bubrežne funkcije u grupi sa MMF u 30% pacijenata u odnosu na 13% iz kontrolne grupe ¹Maes BD et al. Mycophenolate mofetil in IgA nephropathy: results of a 3-year prospective placebo-controlled controlled randomized study. Kidney Int 2004;65(5): ²Frisch G al. Mycophenolate mofetil (MMF) vs placebo in patients with moderately advanced IgA nephropathy: a double-blind blind randomized controlled trial. Nephrol Dial Transplant 2005;20(10):
21 Mycophenolate Mofetil in High-Risk Patients with Primary Glomerulonephritis: Results of a 1-Year Prospective Study Nada Dimkovic a Dragan Jovanovic b Zoran Kovacevic b Violeta Rabrenovic b Vidosava Nesic c Marina Savin c Branka Mitic e Marina Ratkovic h Slobodan Curic f Igor Mitic f Steva Pljesa g Gordana Perunicic-Pekovic g Jelena Marinkovic d Jovan Popovic a Danica Vujic a a Center for Renal Diseases, Zvezdara University Medical Center, b Clinic for Nephrology, Military Academy, c Institute for Urology and Nephrology, Clinical Center Serbia, and d Institute of Medical Statistics and Informatics, School of Medicine, University of Belgrade, Belgrade, e Institute for Nephrology, Clinical Center Nis, Nis, f Clinic for Internal Medicine, Clinical Center Novi Sad, Novi Sad, and g Clinic for Internal Medicine, University Teaching Hospital Zemun, Zemun, Serbia; h Clinic for Internal Medicine, Clinical Center Montenegro, Podgorica, Montenegro Nephron Clin Pract 2009; 111:c189 c196
22 KRITERIJUMI : uključujući bolesnici stariji od 18 god. ph potvrđenim PGN /osim IgA GN/ steroidno zavisni steroidna rezistencija progresija bub. slabosti ispoljavanje než. efekata
23 KRITERIJUMI : isključujući ostala bubrežna oboljenja i sekundarni GN Cre /s > 350 mol/l ili GFR < 25 ml/min; ulkusna bolest, hepatitis B i C, HIV. bolesti zavisnosti Alergija na MMF
24 DIZAJN STUDIJE Kompletna remisija Proteinurija < 0.5 g/l/24 h i/ili odnos proteinurije i kreatinina (Up/c) < 0.3. Parcijalna remisija Smanjenje proteinurije za 50% ili više od početne vrednosti dok je GFR nepromenjena ili u poboljšanju
25 n = 51 bol / 47 bol Prosečne starosti 41,2 ± 13,6 god Cilj studije : ispitivanje efikasnosti i bezbednosti MMF u lečenju bolesnika sa prim.glomerulonefritisima koji su rezistentni na standardne IS protokole Ili steroid-zavisni ili steroid rezistentni. MPGN 15 / 13 FSGS 13 / 13 MGN 12 / 11 MzPGN 10 / 9 30, 21 MCD 1/1 1 Dimkovic N, Jovanovic D,Kovacevic Z, Rabrenovic V, Nesic V,Savin M et al. Mycophenolate Mofetil in High-Risk Patients with Primary Glomerulonephritis: Results of a 1-Year Prospective Study Nephron Clin Pract 2009; 111:c189 c196
26 Parametri praćenja : Dimkovic N, Jovanovic D,Kovacevic Z, Rabrenovic V, Nesic V,Savin M et al. Mycophenolate Mofetil in High-Risk Patients with Primary Glomerulonephritis: Results of a 1-Year Prospective Study Nephron Clin Pract 2009; 111:c189 c196
27 Mycophenolate Mofetil in High-Risk Patients with Primary Glomerulonephritis: Results of a 1-Year Prospective Study Nada Dimkovica Dragan Jovanovic b Zoran Kovacevic b Violeta Rabrenovicb Vidosava Nesic c Marina Savin c Branka Mitic e Marina Ratkovich Slobodan Curicf Igor Mitic f Steva Pljesa g Gordana Perunicic-Pekovic g Jelena Marinkovicd Jovan Popovic a Danica Vujic a acenter for Renal Diseases, Zvezdara University Medical Center, bclinic for Nephrology, Military Academy, cinstitute for Urology and Nephrology, Clinical Center Serbia, and dinstitute of Medical Statistics and Informatics, School of Medicine, University of Belgrade, Belgrade, einstitute for Nephrology, Clinical i l Center Nis, Nis, fclinic i for Internal Medicine, i Clinical i l Center Novi Sad, Novi Sad, and gclinic i for Internal Medicine, i University it Teaching Hospital Zemun, Zemun, Serbia; hclinic for Internal Medicine, Clinical Center Montenegro, Podgorica, Montenegro icture slide Nephron Clin Pract 2009;111:c189 c196 Fig. 1. Up/c in patients with different types of GN during treatment period p < Fig. 2. Mean AUC for proteinuria in patients with different types p < / 001 između 4 / 5 vizite
28 GFR (MDRD) kod bolesnika sa različitim tipovima GN u toku lečenja sa MMF Dimkovic N, Jovanovic D,Kovacevic Z, Rabrenovic V, Nesic V,Savin M et al. Mycophenolate Mofetil in High-Risk Patients with Primary Glomerulonephritis: Results of a 1-Year Prospective Study Nephron Clin Pract 2009; 111:c189 c196
29 Zaključak MMF je pokazao efikasnost u 70% bolesnika sa PGN, koji su postigli parcijalnu ili kompletnu remisiju u periodu praćenja. Kod 8 (17%) bolesnika smanjena je proteinurija i popravila se bubrežna funkcija Povoljan efekat MMF morao bi da se potvrdi u dužem vremenskom periodu praćenja posebno nakon prekida terapije Potrebne su prospektivne i dobro dizajnirane studije koje bi p p j j j potvrdile da je MMF alternativa lečenja kod bolesnika sa PGN koji nisu povoljno odreagovali na standardnu terapiju.
30 INDIKACIJE ZA MPA DOPUNSKA ili MONOTERAPIJA steroid rezistentnih NS steroid-zavisnih NS cikosporin-zavisni NS ciklosporin-rezistentnih rezistentnih NS kod ispoljenih neželjenih efekata Th pogoršenje renalne funkcije progresije bubrežne insuficijencije
31 KOMPLIKACIJE MPA Gastrointerstinalni Leukopenija Infekcije Malignitet?
32 Primena Pi plazmafereze u lečenju č primarnih glomerulonefritisa
33 PRIMENA PLAZMAFEREZE U LEČENJU PRIMARNIH GLOMERULONEFRITISA postupak odvajanja plazme pomoću selektivno propustljive membrane ili procesom centrifugiranja susbstitucioni rastvori- albumini, SSP, plazma ekspanderi eliminacija patogenih supstanci- cirkulišući imuni kompleksi, k autoantitela, tit imunoglobulini, li i toksini, i citokini, medijatori sepse, lipoproteini primena u brojnim oblastima medicine
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35 ANTI GBM GLOMERULONEFRITIS podaci preko 20 nekontrolisanih studija ukazuju da primena PF u kombinaciji sa imunosupresivnom terapijom obezbeđuje stopu preživljavanja preko 80% kao i očuvanje bubrežne funkcije preko 45% ¹ PF su bile manje efikasne kod oliguričnih pacijenata, sa s-kreatininom> 600 µmol/l, kod dijalizno zavisnih dve kontrolisane studije su evaluirale efikasnost PF u odnosu na konvencionalnu IS terapiju², ali su iste limitirane malim brojem pacijenata rana dijagnoza i pravovremeni terapijski pristup presudni su za ishod lečenja³ potrebne prospektivne randomizovane ovane kontrolisane studije ¹Vinen CS et all. Acute glomerulonephritis. Postgrad Med J Apr;79(930):206-13; ² Madore F et all.plasmapheresis. Technical aspects and indications. Crit Care Clin Apr;18(2): ³Hirayama K et all. Anti-glomerular basement membrane antibody disease in Japan: part of the nationwide rapidly progressive glomerulonephritis survey in Japan. Clin Exp Nephrol Oct;12(5):
36 PAUCI- IMUNI GLOMERULONEFRITIS prognoza je generalno loša¹ (80% razvija terminalnu bubreznu insuficijenciju) ij ij pet randomizovanih kontrolisanih studija su komparirale efikasnost PF u donosu na IS terapiju ² rezultati tri studije su ukazali ali na superiornost PF u subgrupi sa s-kreatininom > 800 µmol/l u odnosu na grupe sa umerenom kliničkom formom bolesti ostale dve studije su ukazale na podjednaku efikasnost grupe sa PF u odnosu na standardnu IS terapiju, sto se slaže sa rezultatima 12 nekontrolisanih studija slučaja nijedna od navedenih studija nije evidentirala benefit na preživljavanje pacijenata odsustvo prospektivnih randomizovanih kontrolisanih studija sa vecim brojem pacijenata ¹Chen M et all. ANCA-negative pauci-immune immune crescentic glomerulonephritis. Nat Rev Nephrol Jun;5(6): ²Hitoshi Yokoyama et all.advances ances in apheresis therapy for glomerular lar diseases. Clin Exp Nephrol (2007) 11:
37 IMUNOKOMPLEKSNI KREŠČEND GLOMERULONEFRITIS IgA nefropatija-iako iako su IgA At detektabilna u 33-55% pacijenata njihov titar ne korelira sa težinom bolesti ne postoje čvrsti dokazi o efikasnosti nekoliko nekontrolisanih studija sa malim brojem pacijenata¹² Nicholls i sar.³ su evidentirali benefit primene PF u progresivnim formama, ali bez znacajnijeg efekta na prolongiranu prezervaciju bubrežne funkcije neophodne prospektivne kontrolisane studije ¹ Fujinaga et all.plasma excange combined with immunosupresive treatment in child with rapidly progresive IgA nephropathy.pediatrtr Nephrology 2007 Jun;22(6): ²Chambers ME, et all. Plasmapheresis for crescentic IgA nephropathy: a report of two cases and review of the literature. J Clin Apher. 1999; 99;14(4): ³Nicholls K et al. Plasma exchange in progressive IgA nephropathy. J Clin Apheresis 1990;5:
38 Fokalnosegmentna glomeruloskleroza kod dece predstavlja uzrok 7-15% idiopatskog nefrotskog sindroma postransplantaciono rekurencija preko 30% i gubitak grafta preko 50% plazmafereza značajna za eliminaciju faktora permeabilnosti redukuje proteinuriju i stabilizuje renalnu funkciju¹ smanjuju stopu posttransplantacione rekurencije* ¹Skálová S, Plasmapheresis-induced induced clinical improvement in a patient with steroid-resistant resistant nephrotic syndrome due to podocin (NPHS2) gene mutationacta Medica (Hradec Kralove). 2010;53(3): ¹Passerini i P et all. Controversial issues in the Giornale Italiano di Nefrologia: how to treat t patients t with focal segmental glomerular l scle lerosis. G Ital Nefrol Sep-Oct;26(5): * Moroni G et all. Long-term outcome of renal transplantation in adults with focal segmental glomerulosclerosis. Transpl Int Feb;23(2): Gungor O et all. Plasmapheresis therapy in renal transplant patients: five-year experience. Transplant Proc Apr;43(3): Tsagalis G et all. Combination treatment with plasmapheresis and rituximab for recurrent focal segmental glomerulosclerosis after renal transplantation. Artif Organs Apr;35(4):
39 Primena mikofenolične kiseline (MPA) i plazmafereze u lečenju primarnih glomerulonefritisa iskustva u primeni MPA u lečenju primarnih glomerulopatija su ograničena rezultati dosadasnjih studija ukazuju na bezbednu i efikasnu primenu MPA u lečenju pre svega MCD, kao i FGS i MN. Kod IgA nefropatije rezultati su kontroverzni neophodna su dalja istraživanja radi implementacije MPA u terapijske protokole primarnih glomerulopatija plazmafereze imaju značajnu ulogu u lečenju rapidoprogresivnih formi GN kao i FGS neophodne su prospektivne, kontrolisane randomizovane studije sa većim brojem pacijenata
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