Diagnostika in zdravljenje SLE. Matija Tomšič KO za revmatologijo UKC Ljubljana
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1 Diagnostika in zdravljenje SLE Matija Tomšič KO za revmatologijo UKC Ljubljana
2 M.H., rojena zbolela v starosti 16 let: metuljast eritem obraza, levkopenija, proteinurija, patološki sediment seča (DPLGN), visok titer protitelesa proti DNK, znižan komplement Zdravljenje: metilprednizolon+ciklofosfamid (NHI) neuspešno metilprednizolon+ciklosporin remisija bolezni 1997 zagon bolezni metuljast eritem, levkopenija Zdravljenje: antimalarik
3 Prikaz primera M.H., rojena 1977 Posneto leta 2001
4 M.H., rojena zagon bolezni: eritem obraza, povišana TT, patološki sediment seča (DPLGN), perikarditis, plevritis, peritonitis, vaskulitis črevesja Zdravljenje: metilprenizolon + ciklofosfamid (NHI) + hidroksiklorokin učinkovito 2002 remisija bolezni metilprednizolon+mikofenolat mofetil + hidroksiklorokin (3leta) 2005 remisija bolezni hidroksiklorokin okvara sluha 2009
5 M.H., rojena remisija bolezni rodila zdravega fantka 2011 remisija bolezni rodila zdravo punčko remisija bolezni - zdravil ne prejema Definicija Kronična, sistemska vnetna bolezen, ki pogosto poteka v zagonih, s povišano telesno temperaturo in prizadetostjo kože, sklepov, ledvic, seroznih mren..
6 Umrljivost bolnikov s SLE Celotna umrljivost bolnikov s SLE je v multinacionalni raziskavi (N-9547) je 2,4 x višja kot v populaciji 3 Standardizirani indeks smrtnosti Celotna populacija Bolniki s SLE Bernatsky S et al. Arthritis Rheum. 2006; 54:
7 Boljše preživetje zaradi boljših diagnostičnih možnosti in zdravljenja Preživetje bolnikov s SLE (%) FDA odobrila animalarike in glukokorikoide Boljša diagnosika Imunosupresivna zdravila uvedena v Klasifikacijska merila Klasifikacijska merila Priporočila za zdravljenje year preživetje survival 10- year preživetje survival Priporočila za zdravljenje Borchers AT, et al. Autoimmun Rev 2004; 3: ; 2. ACR Ad Hoc Committee on SLE Guidelines. Arthritis Rheum 1999; 42: ; 3. Bertsias G, et al. Ann Rheum Dis 2008; 67:
8 Diagnoza
9 4/11
10
11 senzitivnost/specifičnost
12 P.T., rojen : povišana telesna temperatura : eritem lic : bolečine in otekline sklepov, občutek otekanja pridobil 8 kg TT : tiščoča bolečina v p.k., ki se poslabša ob globokem vdihu : IPP plevritis obojestransko
13 P.T., rojen : Infekcijska klinika Dg.: SLE? : URA KO za revmatologijo
14 P.T., rojen 1976 SR 40, CRP 16 Prehodna levkopenija (3,8) normocitna anemija Hb. 110 Kreatinin 104 Urin bp Hep-2 in ENA neg. acl IgG 20, IgM 9, + LA UZ srca - manjši perikardialni izliv
15 5/11
16 P.T., rojen1976 Diagnoza: okužba s Parvo B19 Zdravljenje: NSAR
17 Zdravljenje
18 Hochberg MC, Silman AJ, Smolen JS, Weinblatt ME, Weisman M, eds. Rheumatology, 4 th ed. Mosby Elsevier Sistemski lupus eritematozus etiopatogeneza
19 Nefarmakološki ukrepi Splošna priporočila za vse bolnike: Seznanjanje bolnika z boleznijo Varovanje pred soncem Načrtovanje nosečnosti Sprememba življenjskega sloga (kajenje, primerna telesna teža, redna telesna vadba) Reden nadzor krvnega tlaka, lipidov in krvnega sladkorja
20 Srčnožilna bolezen pri bolnikih s SLE Prevalenca klinično izražene ISB med 8-16% Z različnimi neinvazivnimi preiskavami so aterosklerozo dokazali pri 28 40% bolnikov s SLE pomembno več kot pri kontrolni skupini Borchers AT et al. Autoimmunity Reviews (2004)
21 Nefarmakološki ukrepi Splošna priporočila za vse bolnike: Seznanjanje bolnika z boleznijo Varovanje pred soncem Načrtovanje nosečnosti Sprememba življenjskega sloga (kajenje, primerna telesna teža, redna telesna vadba) Reden nadzor krvnega tlaka, lipidov in krvnega sladkorja
22 T2T priporočila za SLE Dopolnilno zdravljenje: Antihipertenzivi Hipolipemiki Zdravila za zniževanje krvnega sladkorja Antiagregacijska in antikoagulantna zdravila Zdravila za zaščito kosti van Vollenhoven RF et al Ann Rheum Dis 2014;73:
23 Zdravljenje je odvisno od prizadetih organov Antimalariki NSAR Glukokortikoidi Ciklofosfamid Azatioprin Metotreksat Mikofenolat mofetil Leflunomid Metotreksat Mikofenolat Leflunomid mofetil Rituxima Ciklosporin A Tacrolimus IVIG Rituksimab Abatacept Belimumab
24 Zdravila in SLE Večina zdravil, ki jih uporabljamo pri zdravljenju bolnikov s SLE se uporablja off-label. V 50 letih prejšnjega stoletja je FDA odobrila Aspirin Hidroksiklorokin Kortizol Prednisolon Kvinakrin
25 Zdravljenje je odvisno od prizadetih organov Antimalariki NSAR Glukokortikoidi Ciklofosfamid Azatioprin Metotreksat Mikofenolat mofetil Leflunomid Metotreksat Mikofenolat Leflunomid mofetil Rituxima Ciklosporin A Tacrolimus IVIG Rituximab Abatacept Belimumab
26 T2T priporočila za SLE Pri bolniku s SLE bi morali ob spremljanju bolezni redno uporabljati vsaj eno validirano merilo za določanje aktivnosti bolezni. van Vollenhoven RF et al Ann Rheum Dis 2014;73:
27 Validirana merila za določanje aktivnosti bolezni SELENA (Safety of Estrogen in Lupus National Assessment) -SLEDAI SLEDAI-2K BILAG SLAM-R ECLAM
28 Antimalariki (HCQ ) Quinine uporaba prvič opisana leta 1894* Vrsto let smo ga predpisovali pri Kožnih in sluzničnih spremembah Skeletno mišičnih težavah Splošnih simptomih *Payne JF. A post-graduate lecture on lupus erythematosus. Clin J 1894;4:223
29 Antimalariki (HCQ ) Raziskave v zadnjih letih kažejo na širšo terapevtsko učinkovitost: Zmanjša število zagonov bolezni 1 Zmanjša verjetnost venskih in arterijskih tromboz 2 Zmanjša verjetnost srčnega zapleta neonatalnega lupusa 3 Zmanjša umrljivost 4 1. Tsakonas E et al. Lupus 1998;7: Jung H et al. Arthritis Rheum 2010;62: Izmirly PM et al. Ann Rheum Dis 2010;69: Alarcon GS et al. Ann Rheum Dis 2007;66:
30 T2T priporočila za SLE Neodvisno od drugega zdravljenja je pri vseh bolnikih s SLE treba resno razmisliti tudi o sočasnem zdravljenju z antimalariki. van Vollenhoven RF et al Ann Rheum Dis 2014;73:
31 Glukokortikoidi 1. Hench PS. Ann Intern Med 1952;36:1-38
32 Glukokortikoidi (GK) GK so še vedno osnovno zdravilo za zdravljenje bolnikov s SLE Z dokazi podprti podatki o odmerjanju in trajanju zdravljenja z GK pri različnih manifestacijah SLE so pičli. Klinična odločitev pogosto temelji na klinični izkušnji in ne na dokazih. Luijten R K.M.A.C. et al. Autoimmunity Reviews 2013; 12:
33 T2T priporočila za SLE Neželeni učinki glukokortikoidi (GK) so odvisni od odmerka Za SLE ni jasnih podatkov ali obstaja varen nizek odmerek GK Vzdrževalno zdravljenje z GK: Čim nižji vzdrževalni odmerki, če je le mogoče naj se ukinejo. van Vollenhoven RF et al Ann Rheum Dis 2014;73:
34 Ciklofosfamid (CYC) Zdravilo se uporablja v zdravljenju lupusnega nefritisa že skoraj 40 let 1 Vrsto let smo ga uporabljali po shemi NHI 6 mesecev 1g/mesec nato 2-6 krat 1 g/3 mesece V zadnjem desetletju ELN skupina 6 krat 500 mg/2 tedna nato azatioprin 2 1. Austin HA 3rd et al. N Engl J Med 1986;314: Houssiau FA et al. Arthritis Rheum 2002;46:
35 Mikofenolat mofetil (MMF) Zgodnje raziskave so nakazale možnost, da je MMF bolj učinkovit od CYC pri lupusnem nefritisu 1 Kasnejše večje raziskave tega niso potrdile, sta pa zdravili primerljivi glede učinkovitosti 2 1. Contreras G et al. N Engl J Med 2004;350: Appel GB et al. J Am Soc Nephrol 2009;20:
36 Grootscholten C et al: Arthritis Rheum 2007; 56: Azatioprin (AZA) Zdravilo se uporablja v zdravljenju sistemskega lupusa že skoraj 50 let. Dokazano manj uspešen v primerjavi s CYC ali MMF pri indukciji remisije pri lupusnem GN 1 Uspešno ga uporabljamo pri bolnikih brez ledvične prizadetosti kot zdravilo, ki omogoči zdravljenje z nižjimi odmerki GK
37 Rituksimab (RTX) Številne nekontrolirane raziskave in prikazi primerov nekaterim bolnikom RTX pomaga Dve večji randomizirani raziskavi nista potrdili primarnega cilja raziskave LUNAR (lupus nefritis) 1 EXPLORER (z drugimi manifestacijami lupusa) 2 Rovin B, et al. Arthritis Rheum 2012;64: Merrill JT, et al. Arthritis Rheum 2010;62:
38 Zdravljenje je odvisno od prizadetih organov Antimalariki NSAR Glukokortikoidi Ciklofosfamid Azatioprin Metotreksat Mikofenolat mofetil Leflunomid Metotreksat Mikofenolat Leflunomid mofetil Rituxima Ciklosporin A Tacrolimus IVIG Rituximab Abatacept Belimumab
39 Belimumab Je prvo zdravilo v več kot 50 letih, ki je bilo posebej razvito in odobreno za zdravljenje bolnikov SLE (kot dodatno zdravilo ob standardnem zdravljenju)
40 SLE etiopatogeneza Luijten R.K.M.A.C. et al. Autoimmunity Reviews 2013; 12:
41 *B-lymphocyte stimulator BR3
42 Temelj uporabe anti-blys terapije pri avtoimunskih boleznih BLyS transgenske živali razvijejo autoimunske bolezni 5-7 Živali z avtoimunskimi boleznimi imajo zvišan nivo BLyS 3 Bolniki z avtoimunskimi boleznimi imajo zvišan BLyS in nivo korelira z aktivnostjo bolezni 9,10 BLyS BLyS antagonisti so učinkoviti pri živalskih modelih 3,8 BLyS je esencialni faktor za razvoj B-celic 1-4 B celice so glavni krivci za razvoj avtoimunskih boleznih 3 1. Moore PA et al. Science. 1999;285:260-3; 2. Schneider P et al. J Exp Med. 1999;189: ; 3. Gross JA et al. Nature. 2000;404:995-9; 4. Batten M et al. J Exp Med. 2000;192: ; 5. Groom J et al. J Clin Invest. 2002;109:59-68; 6. Mackay F et al. J Exp Med. 1999;190: ; 7. Khare SJ et al. Proc Natl Acad Sci U S A. 2000; 97: Ramanujam M et al. J Clin Invest. 2006;116: Cheema G et al. Arthritis Rheum. 2001;44: ; 10. Petri M et al. Arthritis Rheum. 2008;58:
43 BLyS Receptorji na različnih razvojnih fazah B celic BLyS se veže na vse 3 receptorje, predvsem pa na BR3, ki je izražen v zgodnjih obdobjih B-celičnega razvoja BR3 TACI BCMA Odvisnost od BLyS Plazmatka, ki izdeluje PT Matična celica Pro- B celica Pre- B celica Immature B cell Transitional B cell Mature B cell Spominske B celice Kostni mozeg Cirkulacija, Vranica Periferija Cancro MP et al. J Clin Invest. 2009;119:
44 BLISS study design: treatment and efficacy assessment Treatment arms BLISS BLISS Belimumab infusions and efficacy assessments (weeks) Placebo + SoC BLISS-52 n=287 BLISS-76 n=275 BLISS Primary endpoint: SRI at Week Belimumab 1 mg/kg + SoC [Off-label dose] BLISS-52 n=288 BLISS-76 n=271 Belimumab 10 mg/kg + SoC BLISS-52 n=290 BLISS-76 n= * BLISS * Progressive restrictions on concurrent medications * No assessments performed at Week 2. SRI = Systemic Lupus Erythematosus Responder Index. 1. Navarra SV, et al. Lancet 2011; 377: ; 2. Furie RA, et al. Arthritis Rheum 2011; 63: ; 3. Benlysta (belimumab) SmPC 2014.
45 SRI* končni cilj Klinično pomembno izboljšanje SRI je sestavljen iz 3 najbolj pogosto uporabljenih indeksov SRI potrdi izboljšanje aktivnosti le če ne pride istočasno do poslabšanja v drugih organskih sistemih *SLE respond indeks 1. Navarra S et al. ACR Abstr LB1. 2. Furie RA et al. Arthritis Rheum. 2009;61:
46 Primary efficacy endpoint summary SRI response rate at Week 52 Placebo + SoC Belimumab 10mg/kg + SoC BLISS 43.6% (n=287) vs 57.6% (n=290) P= ,2 BLISS 33.8% (n=275) vs 43.2% (n=273) P= ,3 Pooled & 38.8% (n=562) vs 50.6% (n=563) Odds ratio (95% CI) = 1.7 (1.3, 2.2) P< ,5 SRI = Systemic Lupus Erythematosus Responder Index. 1. Benlysta (belimumab) SmPC; 2. Navarra SV, et al. Lancet 2011; 377: ; 3. Furie RA, et al. Arthritis Rheum 2011; 63: ; 4. van Vollenhoven RF, et al. Ann Rheum Dis 2012; 71: ; 5. Manzi S, et al. Ann Rheum Dis 2012; 71:
47 Probability of a severe SLE flare over weeks Placebo + SoC HDA & Belimumab 10 mg/kg + SoC Probability of severe SLE flare Study week 29.6 (n=287) 19.0 (n=305) HR (95% CI) vs. placebo: 0.61 ( ) P=0.004 A significant (39%) reduction in risk of first severe flare was observed in patients treated with belimumab 10 mg/kg + SoC compared with placebo + SoC (P=0.004) HDA = patients with high disease activity at baseline, low complement factor 3 (<90 mg/ dl) and/or complement factor 4 (<16 mg/dl) and anti-dsdna 30 IU/mL at baseline. van Vollenhoven RF, et al. Ann Rheum Dis 2012; 71:
48 Placebo + SoC Changes in corticosteroid use during Belimumab 10 mg/kg + SoC Pooled trial populations No. of paients Percentage of paients reducing steroid doses from baseline dose >7.5 mg/d by 25% to 7.5 mg/d Weeks P=0.045 Patients with HDA (NS) * * The number of pavents receiving corvcosteroids >7.5 mg/d at baseline = 63.5% of the total HDA populavon 2 A greater percentage of patients with HDA who received belimumab 10 mg/kg + SoC reduced their corticosteroid dose by 25% to 7.5 mg/d compared with placebo + SoC; however, this difference was not statistically significant 1,2 HDA & HDA = patients with high disease activity at baseline, low complement factor 3 (<90 mg/dl) and/or complement factor 4 (<16 mg/dl) and anti-dsdna 30 IU/mL at baseline. 1. Benlysta (belimumab) SmPC 2014; 2. van Vollenhoven RF, et al. Ann Rheum Dis 2012; 71:
49 Change in FACIT-fatigue over 52 weeks HDA & Placebo + SoC Belimumab 10 mg/kg + SoC Mean change in FACIT- FaIgue score from baseline # P<0.001; + P<0.01 # # Study Week P = (n=305) 1.99 (n=287) A significant improvement in FACIT-Fatigue score was reported in patients treated with belimumab 10 mg/kg + SoC compared with placebo + SoC at Week 52 (P<0.01) 1,2 HDA = patients with high disease activity at baseline, low complement factor 3 (<90 mg/dl) and/or complement factor 4 (<16 mg/dl) and anti-dsdna 30 IU/mL at baseline. 1. Benlysta (belimumab) SmPC 2014; 2. van Vollenhoven RF, et al. Ann Rheum Dis 2012; 71:
50 Neželeni učinki Kumulativno &
51 Adverse event profiles in the pooled population* Placebo + SoC, % (n=675) 1,2 Belimumab 10 mg/kg + SoC, % (n=674) 1,2 At least one: Adverse event Serious adverse event Severe adverse event Serious and/or severe, Common adverse events (occurring in >10%) Headache Upper respiratory tract infection Arthralgia Nausea Urinary tract infection Diarrhoea Fatigue Serious adverse events (occurring in >1%) Pneumonia Urinary tract infection Lupus nephritis Pyrexia Cellulitis * One placebo-controlled Phase II trial and two placebo-controlled Phase III trials. Serious refers to an adverse event that results in death, an immediate threat to life, inpatient hospitalisation, prolongation of an existing hospitalisation, persistent or significant disability/incapacity, or a congenital/birth defect that is medically important. Severe refers to a grade 3/4 adverse event. Pooled & 1. Benlysta (belimumab) SmPC 2014; 2. Wallace DJ, et al. Lupus 2013; 22:
52 Rates of infection Pooled & Placebo + SoC, % (n=675) 1,2 Belimumab 10 mg/kg + SoC, % (n=674) 1,2 Patients with 1: Infection Serious infection* Severe infection Infection resulting in discontinuation Infection resulting in death Infections of special interest Cellulitis Sepsis Fungal Herpes virus All respiratory Upper respiratory Lower respiratory Pneumonia Opportunistic * Serious refers to an adverse event that results in death, an immediate threat to life, inpatient hospitalisation, prolongation of an existing hospitalisation, persistent or significant disability/incapacity, or a congenital/birth defect that is medically important. Severe refers to a grade 3/4 adverse event. One report of Acinetobacter bacterium and one of disseminated cytomegalovirus. 1. Benlysta (belimumab) SmPC 2014; 2. Wallace DJ, et al. Lupus 2013; 22:
53 Rates of mortality observed in all treatment arms* Pooled & Placebo + SoC (n=675) Belimumab 1, 4 & 10 mg/kg + SoC (n=1347) Death, n 3 11 Infection-related 1 4 Cardiovascular 1 1 SLE-related - 1 Suicide - 2 Cerebrovascular - 1 Malignancy - 1 Unknown 1 1 * One placebo-controlled Phase II trial and two placebo-controlled Phase III trials. 1 and 4 mg/kg dose belimumab are not registered for use. 1. Benlysta (belimumab) SmPC 2014; 2. Wallace DJ, et al. Lupus 2013; 22:
54 Odobritev belimumab in Belimumab je odobren za zdravljenje v EU od leta 2011 Belimumab je zdravilo: ki ga dodamo standardnemu zdravljenju, da bi znižali aktivnost bolezni za zdravljenje odraslih bolnikov s SLE, ki imajo dokazana avtoprotitelesa največ pridobijo bolniki, ki imajo kljub standardnem zdravljenju, visoko aktivno bolezen Odmerjanje: 10 mg/kg na dan 0, 14, 28 in nato na 4 tedne
55 Belimumab utrinki iz ACR 2014 Maria Dall'era, MD University of California nima ustreznih bolnikov za zdravljenje z belimumabom Odmev od poslušalcev: nekateri imajo izkušnje so zadovoljni.
56 Belimumab utrinki iz ACR 2014 Prof. Bevra Hahn, MD, UCLA Zdravilo za bolnike z blagim SLE, nizek komplemet, + adnk večina bolniko potrebuje dodatno zdravljenje varnost je sprejemljiva, podobna kot standardna terapija, do 7 let 1/3 bolnikov odgovori na zdravljenje in želi z njim nadaljevati je drago zdravilo ni podatkov kdaj lahko prekinemo zdravljenje
57 Belimumab utrinki iz ACR 2014 Prof. David Isenberg - University College Hospital London Kaj bi morda NICE prepričalo, da bi sprejelo belimumab: Uporaba omejena na BILAG centre Samo za bolnike s SLEDAI >6 ali vsaj en BILAG A Neodzivnost na GK in na vsaj dve immumodulirajoči zdravili, Obvezna presoja po 6 mesecih zdravljenja - uspeh SLEDAI Vse podatke bi morali poslati na centralni register (UK BSR- BR BILAG register)
58 Zahvaljujem se vam za pozornost!
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