DK2946206T3 - Evaluering, analyser og behandling af pkal-medierede forstyrrelser - Google Patents

Evaluering, analyser og behandling af pkal-medierede forstyrrelser Download PDF

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DK2946206T3
DK2946206T3 DK14740167.3T DK14740167T DK2946206T3 DK 2946206 T3 DK2946206 T3 DK 2946206T3 DK 14740167 T DK14740167 T DK 14740167T DK 2946206 T3 DK2946206 T3 DK 2946206T3
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Kusumam Joseph
Allen P Kaplan
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Dyax Corp
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Claims (13)

1. Fremgangsmåde, der omfatter: etablering af kontakt mellem en prøve, der indeholder plasmaprotease-Cl-inhibitor (Cl-INH), og et indfangningsreagens, der er immobiliseret på et substrat, og måling i prøven af et niveau af funktionel Cl-INH, der binder til indfangningsreagenset; hvor indfangningsreagenset omfatter: i) en aktiv form af faktor XII eller et Cl-INH-bindende fragment deraf, ii) en aktiv form af plasmakallikrein eller et Cl-INH-bindende fragment deraf eller iii) en kombination af i) og ii).
2. Fremgangsmåde ifølge krav 1, hvor niveauet af funktionel Cl-INH, der binder til indfangningsmidlet, måles ved anvendelse af et detektionsmiddel, der binder Cl-INH, som eventuelt er et antistof, der binder Cl-INH.
3. Fremgangsmåde ifølge krav 1 eller krav 2, hvor niveauet af funktionel Cl-INH, der binder til indfangningsmidlet, måles ved hjælp af et ELISA (enzyme-linked immunosorbent assay).
4. Fremgangsmåde ifølge et hvilket som helst af kravene 1 til 3, hvor prøven, der indeholder funktionel Cl-INH, er opnået fra et individ, hvor eventuelt prøven er en blodprøve eller en plasmaprøve, og hvor eventuelt individet har et symptom på en pKal-medieret forstyrrelse, hvilket symptom fortrinsvis er valgt fra gruppen, der består af: ødem, tilbagevende tilfælde af hævelse; hævelse, hvor hævelsen er fuldstændig eller overvejende perifer; nældefeber; rødme, smerter og hævelse i fravær af tegn på infektion; og ikke-histaminmedieret ødem; eller eventuelt hvor individet ikke har noget symptom på en pKal-medieret forstyrrelse på tidspunktet, hvor prøven indsamles, ikke tidligere har haft et symptom på en pKal-medieret forstyrrelse eller ikke har en pKal-medieret forstyrrelse i anamnesen.
5. Fremgangsmåde ifølge krav 4, hvor fremgangsmåden yderligere omfatter: identificering af, at individet er i risiko for at få eller har en pKal-medieret forstyrrelse, hvis niveauet af funktionel Cl-INH, der binder indfangningsreagenset i prøven, er reduceret sammenlignet med en referenceværdi, hvor den pKal-medierede forstyrrelse fortrinsvis er valgt fra gruppen, der består af ikke-histaminafhængig idiopatisk angioødem, rheumatoid arthritis, Crohns sygdom, lupus, Alzheimers sygdom, septisk shock, forbrændingsskade, iskæmi/reperfusions-skade i hjernen, cerebralt ødem, diabetisk retinopati, diabetisk nefropati, maculaødem, vasculitis, arteriel eller venøs trombose, trombose forbundet med ventrikulært hjælpeudstyr eller stents, heparininduceret trombocytopeni med trombose, tromboembolisk sygdom, og koronar hjertesygdom med ustabil angina pectoris, ødem, øjensygdom, urinsyregigt, intestinal tarmsygdom, oral mucositis, neuropatiske smerter, inflammatoriske smerter, spinalstenose-degenerativ spinal sygdom, postoperativ ileus, aortaaneurisme, osteoarthritis, hereditært angioødem (HAE), lungeemboli, apopleksi, hovedtraume eller peritumorhjerneødem, sepsis, akut midter cerebral arterie (MCA)-iskæmisk hændelse (apoplesi), restenose, systemisk lupus erythematosis og lupus nephritis, en autoimmun sygdom, en inflammationssygdom, en kardiovaskulær sygdom, en neurologisk sygdom, en sygdom forbundet med proteinfejlfoldning, en sygdom forbundet med angiogenese, hypertensiv nefropati og diabetisk nefropati, allergiske og respiratoriske sygdomme, og vævsskader.
6. Fremgangsmåde ifølge krav 5, hvor individet er resistent over for antihistaminbehandling, kortikosteroidbehandling eller begge.
7. Kit til påvisning af funktionel plasmaprotease-Cl-inhibitor (Cl-INH), der er i stand til at binde til et indfangningsreagens, som omfatter: a) et indfangningsreagens, der er immobiliseret på et substrat, hvor indfangningsreagenset omfatter: i) en aktiv form af faktor XII eller et Cl-INH-bindende fragment deraf; ii) en aktiv form af kallikrein eller et Cl-INH-bindende fragment deraf; eller iii) en kombination af i) og ii); b) et detektionsreagens, der binder Cl-INH; og eventuelt c) Cl-INH.
8. Kit ifølge krav 7, hvor detektionsreagenset er et anti-Cl-INH-antistof.
9. Fremgangsmåde til evaluering af behandlingen af en pKal-medieret forstyrrelse hos et individ, som omfatter: måling af niveauet af funktionel plasmaprotease-Cl-inhibitor (Cl-INH), der er i stand til at inhibere plasmakallikrein, faktor XII eller begge, i prøver indsamlet fra individet før og efter behandlingen eller i løbet af behandlingen, hvor prøven fortrinsvis er en blodprøve eller en plasmaprøve; hvor niveauerne af funktionel Cl-INH måles ved hjælp af fremgangsmåden ifølge et hvilket som helst af kravene 1-3; og evaluering af virkningen af behandlingen baseret på niveauet af funktionel Cl-INH, hvor en stigning i niveauet af funktionel Cl-INH efter behandlingen eller i løbet af behandlingen indikerer, at behandlingen er effektiv hos individet; hvor fortrinsvis individet er en human HAE-patient.
10. Fremgangsmåde ifølge krav 9, hvor behandlingen inddrager et kallikreinbindende middel, en bradykinin-B2- receptorangatonist eller et Cl-INH-erstatningsmiddel, og behandlingen fortrinsvis inddrager DX-88, DX-2930 eller EPIKAL-2.
11. Fremgangsmåde ifølge et hvilket som helst af krav 9 eller krav 10, hvor niveauet af funktionel Cl-INH måles ved hjælp af en proces, der omfatter: etablering af kontakt mellem prøverne, der er indsamlet fra individet, og et indfangningsreagens, der er immobiliseret på et substrat; og måling af niveauet af funktionel Cl-INH i prøven, der binder til indfangningsreagenset; hvor indfangningsreagenset omfatter: i) en aktiv form af faktor XII eller et Cl-INH-bindende fragment deraf, ii) en aktiv form af plasmakallikrein eller et Cl-INH-bindende fragment deraf eller iii) en kombination af i) og ii).
12. Fremgangsmåde ifølge krav 11, hvor niveauerne af funktionel Cl-INH måles ved anvendelse af et detektionsmiddel, der binder Cl-INH, som eventuelt er et antistof, der binder Cl-INH.
13. Fremgangsmåde ifølge krav 11 eller krav 12, hvor niveauet af funktionel Cl-INH måles ved hjælp af et ELISA (enzyme-linked immunosorbent assay).
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