DE22199371T1 - Verfahren zur beurteilung des risikos der entwicklung einer viruserkrankung unter verwendung eines genetischen tests - Google Patents
Verfahren zur beurteilung des risikos der entwicklung einer viruserkrankung unter verwendung eines genetischen tests Download PDFInfo
- Publication number
- DE22199371T1 DE22199371T1 DE22199371.0T DE22199371T DE22199371T1 DE 22199371 T1 DE22199371 T1 DE 22199371T1 DE 22199371 T DE22199371 T DE 22199371T DE 22199371 T1 DE22199371 T1 DE 22199371T1
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- immunosuppressive drug
- sequencing
- jcv
- natalizumab
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- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
- C12Q1/6876—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
- C12Q1/6883—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q2600/00—Oligonucleotides characterized by their use
- C12Q2600/106—Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
Abstract
Immunsuppressives Medikament zur Verwendung bei der Behandlung eines Leidens bei einem Subjekt, das einer Therapie mit einem immunsuppressiven Medikament bedarf,wobei ein verringerte Risiko einer progressiven multifokalen Leukoenzephalopathie (PML) bei dem Subjekt auf eine Infektion des Gehirns durch das John-Cunningham-Virus (JCV) zurückzuführen ist,wobei das verringerte Risiko des Subjekts auf das Fehlen einer genomischen Variation ausgewählt aus der Gruppe bestehend aus Folgendem zurückzuführen ist: chr9:137779251, G>A und chr1:160769595, AG>A,wobei die Chromosomenposition der genomischen Variation in Bezug auf UCSC hg19 definiert ist.
Claims (11)
- Immunsuppressives Medikament zur Verwendung bei der Behandlung eines Leidens bei einem Subjekt, das einer Therapie mit einem immunsuppressiven Medikament bedarf, wobei ein verringerte Risiko einer progressiven multifokalen Leukoenzephalopathie (PML) bei dem Subjekt auf eine Infektion des Gehirns durch das John-Cunningham-Virus (JCV) zurückzuführen ist, wobei das verringerte Risiko des Subjekts auf das Fehlen einer genomischen Variation ausgewählt aus der Gruppe bestehend aus Folgendem zurückzuführen ist: chr9:137779251, G>A und chr1:160769595, AG>A, wobei die Chromosomenposition der genomischen Variation in Bezug auf UCSC hg19 definiert ist.
- Immunsuppressives Medikament zur Verwendung nach
Anspruch 1 , wobei es sich bei dem Leiden um Krebs, eine Organtransplantation oder eine Autoimmunerkrankung handelt, wobei optional: (i) die Autoimmunerkrankung aus der Gruppe bestehend aus Addison-Krankheit, Anti-NMDA-Rezeptor-Enzephalitis, Antisynthetase-Syndrom, aplastischer Anämie, Autoimmunanämien, autoimmunhämolytischer Anämie, Autoimmunpankreatitis, Behcet-Krankheit, bullösen Hautstörungen, Zöliakie - Sprue (glutensensitive Enteropathie), chronischem Müdigkeitssyndrom, chronisch entzündlicher demyelinisierender Polyneuropathie, chronischer lymphatischer Leukämie, Morbus Crohn, Dermatomyositis, Devic-Krankheit, Erythroblastopenie, Evans-Syndrom, fokaler segmentaler Glomerulosklerose, Granulomatose mit Polyangiitis, Morbus Basedow, Basedow-Ophthalmopathie, Guillain-Barre-Syndrom, Hashimoto-Thyreoiditis, idiopathischer thrombozytopenischer Purpura (ITP), IgA-Nephropathie, IgA-vermittelten Autoimmunerkrankungen, 1gG4-bedingter Erkrankung, entzündlicher Darmerkrankung, juveniler idiopathischer Arthritis, multipler Sklerose, Myasthenia gravis, Myelom, Non-Hodgkin-Lymphom, Opsoclonus-Myoklonus-Syndrom (OMS), Pemphigoid, Pemphigus, Pemphigus vulgaris, perniziöser Anämie, Polymyositis, Psoriasis, reiner Erythroblastopenie, reaktiver Arthritis, rheumatoider Arthritis, Sarkoidose, Sklerodermie, Sjögren-Syndrom, systemischem Lupus erythematodes, thrombozytopenischer Purpura, thrombotischer thrombozytopenische Purpura, Typ-I-Diabetes, Colitis ulcerosa, Vaskulitis, Vitiligo und Kombinationen davon ausgewählt ist; (ii) die Autoimmunerkrankung multiple Sklerose oder Morbus Crohn ist; oder (iii) die Autoimmunerkrankung eine schubförmige Form der multiplen Sklerose ist. - Immunsuppressives Medikament zur Verwendung nach einem der vorhergehenden Ansprüche, wobei (i) das immunsuppressive Medikament Abatacept, Abrilumab, Acalabrutinib, Adalimumab, adrenocorticotropes Hormon, Agatolimod-Natrium, Aldesleukin, Alefacept, Alemtuzumab, Alisertib, Alvespimycinhydrochlorid, Alvocidib, Ambrisentan, Aminocamptothecin, Amiselimod, Anakinra, Andecaliximab, Andrographolide, Anifrolumab, Antithymozyten-Ig, Apatinib, Apelisib, Asparaginase, Atacicept, Atezolizumab, Avelumab, Azacitidin, Azathioprin, Bafetinib, Baminercept, Baricitinib, Basiliximab, Becatecarin, Begelomab, Belatacept, Belimumab, Bemcentinib, Bendamustin, Betalutin mit Lilotomab, Bevacizumab, Bimekizumab, Binimetinib, Bleomycin, Blinatumomab, BNZ-1, Bortezomib, Brentuximab Vedotin, Bryostatin 1, Bucillamin, Buparlisib, Busulfan, Canakinumab, Capecitabin, Carboplatin, Carfilzomib, Carmustin, Cediranibmaleat, Cemiplimab, Ceralifimod, Cerdulatinib, Certolizumab, Cetuximab, Chidamid, Chlorambucil, Cilengitid, Cirmtuzumab, Cisplatin, Cladribin, Clazakizumab, Clemastin, Clioquinol, Kortikosteroide, Cyclophosphamid, Cyclosporin, Cytarabin, zytotoxische Chemotherapie, Daclizumab, Dalfampridin, Daprolizumab Pegol, Daratumumab, Dasatinib, Defactinib, Defibrotid, Denosumab, Dexamethason, Diacerein, Dimethylfumarat, Dinaciclib, Diroximelfumarat, Doxorubicin, Doxorubicin, Durvalumab, Duvelisib, Duvortuxizumab, Eculizumab, Efalizumab, Eftilagimod alpha, eine Neuropeptidkombination aus Metenkefalin und Tridecactid, Elezanumab, Elotuzumab, Encorafenib, Entinostat, Entospletinib, Enzastaurin, Epacadostat, Epirubicin, Epratuzumab, Eritoran-Tetranatrium, Etanercept, Etoposid, Etrolizumab, Everolimus, Evobrutinib, Filgotinib, Fingolimod, Firategrast, Fludarabin, Fluorouracil, Fontolizumab, Forodesinhydrochlorid, Fostamatinib, Galunisertib, Ganetespib, Ganitumab, Gemcitabin, Gemtuzumab Ozogamicin, Gerilimzumab, Glasdegib, Glassia, Glatirameracetat, Glembatumumab Vedotin, Glesatinib, Golimumab, Guadecitabin, Hydrocortison, Hydroxychloroquinsulfat, Hydroxyharnstoff, Ibritumomab Tiuxetan, Ibrutinib, Ibudilast, Idarubicin, Idebenon, Idelalisib, Ifosfamid, Iguratimod, Imatinib, Imexon, Infliximab, Inotuzumab Ozogamicin, Interferon alfa-2, Interferon beta-1a, Interferon beta-1b, Interferon gamma-1, Ipilimumab, Irofulven, Isatuximab, Ispinesib, Itacitinib, Ixazomib, Lapatinib, Laquinimod, Laromustin, LD-Aminopterin, Leflunomid, Lenalidomid, Lenvatinib, Letrozol, Levamisol, Levocabastin, Liponsäure, Lirilumab, Lonafarnib, Lumiliximab, Masitinib, Mavrilimumab, Melphalan, Mercaptopurin, Methotrexat, Methoxsalen, Methylprednison, Milatuzumab, Mitoxantron, Mizoribin, Mocetinostat, Monalizumab, Mosunetuzumab, Motesanibdiphosphat, Moxetumomab Pasudotox, Muromonab-CD3, Mycophenolatmofetil, Mycophenolsäure, Namilumab, Natalizumab, Navitoclax, Neihulizumab, Nerispirdin, Neurovax, Niraparib, Nivolumab, Obatoclaxmesylat, Obinutuzumab, Oblimersen-Natrium, Ocrelizumab, Ofatumumab, Olokizumab, Opicinumab, Oprelvekin, Osimertinib, Otelixizumab, Oxaliplatin, Oxcarbazepin, Ozanimod, Paclitaxel, Pacritinib, Palifermin, Panobinostat, Pazopanib, Peficitinib, Pegfilgrastim, Peginterferon beta-1a, Pegsunercept (peg stnf-ri), Pembrolizumab, Pemetrexed, Penclomedin, Pentostatin, Perifosin, Pevonedistat, Pexidartinib, Picoplatin, Pidilizumab, Pivanex, Pixantron, Pleneva, Plovameracetat, Polatuzumab Vedotin, Pomalidomid, Ponatinib, Ponesimod, Prednison/Prednisolon, Pyroxamid, Ravulizimab-cwvz, rekombinantes IL-12, Relatlimab, Rhigf-1, Rhigm22, Rigosertib, Rilonacept, Rituximab, Ruxolitinib, Sarilumab, Secukinumab, Selumetinib, Simvastatin, Sintilimab, Siplizumab, Siponimod, Sirolimus, Sirukumab, Sitravatinib, Sonidegib, Sorafenib, Sotrastaurinacetat, Sunitinib, Sunphenon Epigallocatechingallat, Tabalumab, Tacrolimus, Talabostatmesylat, Talacotuzumab, Tanespimycin, Tegafur/Gimeracil/Oteracil, Temozolomid, Temsirolimus, Tenalisib, Terameprocol, Teriflunomid, Thalidomid, Thiarabin, Thiotepa, Tipifarnib, Tirabrutinib, Tislelizumab, Tivozanib, Tocilizumab, Tofacitinib, Tregalizumab, Tremelimumab, Treosulfan, Ublituximab, Umbralisib, Upadacitinib, Urelumab, Ustekinumab, Varlilumab, Vatelizumab, Vedolizumab, Veliparib, Veltuzumab, Venetoclax, Vinblastin, Vincristin, Vinorelbinditartrat, Visilizumab, Vismodegib, Vistusertib, Voriconazol, Vorinostat, Vosaroxin, Ziv-Aflibercept, 6,8-Bis(benzylthio)octansäure oder eine beliebige Kombination davon umfasst; (ii) das immunsuppressive Medikament Natalizumab, Interferon beta-1a, Interferon beta-1b, Glatirameracetat, Peginterferon beta-1a, Teriflunomid, Fingolimod, Dimethylfumarat, Alemtuzumab, Mitoxantron, Rituximab, Daclizumab, Ocrelizumab, Diroximelfumarat oder Siponimod oder eine beliebige Kombination davon umfasst; oder (iii) das immunsuppressive Medikament Adalimumab, Alemtuzumab, Alemtuzumab, Azathioprin, Belimumab, Bevacizumab, Bortezomib, Eculizumab, Leflunomid, Brentuximab Vedotin, Cetuximab, Cyclophosphamid, Dimethylfumarat, Efalizumab, Fingolimod, Fludarabin, Fumarsäure, Imatinib, Infliximab, Methotrexat, Mycophenolatmofetil, Natalizumab, Daclizumab, Rituximab, Vedolizumab, Ruxolitinib oder Ocrelizumab umfasst.
- Immunsuppressives Medikament zur Verwendung nach einem der vorhergehenden Ansprüche, wobei das immunsuppressive Medikament Natalizumab umfasst, wobei optional: (i) Natalizumab über eine intravenöse Infusion verabreicht wird; (ii) etwa 100 mg bis etwa 500 mg Natalizumab verabreicht werden; (iii) etwa 100 mg bis etwa 500 mg Natalizumab in vier Wochen verabreicht werden; (iv) etwa 100 mg bis etwa 500 mg Natalizumab über eine intravenöse Infusion in vier Wochen verabreicht werden; (v) etwa 100 mg bis etwa 500 mgNatalizumab über eine intravenöse Infusion in sechs Wochen verabreicht werden; (vi) etwa 100 mg bis etwa 500 mg Natalizumab über eine intravenöse Infusion in acht Wochen verabreicht werden; oder (vii) das Natalizumab subkutan verabreicht wird.
- Immunsuppressives Medikament zur Verwendung nach einem der vorhergehenden Ansprüche, wobei die Genomsequenzen des Subjekts durch einen Gentest bestimmt werden, der den Nachweis der genomischen Variation in einer von dem Subjekt erhaltenen Polynukleinsäureprobe umfasst, wobei optional: (i) der Gentest Analysieren eines gesamten Genoms oder des gesamten Exoms des Subjekts umfasst; (ii) der Gentest Analysieren von Nukleinsäureinformationen umfasst, die bereits für ein gesamtes Genom oder ein gesamtes Exom des Subjekts erhalten wurden; (iii) der Gentest Analysieren von Nukleinsäureinformationen umfasst, die bereits für ein gesamtes Genom oder ein gesamtes Exom des Subjekts erhalten wurden, wobei die Nukleinsäureinformationen aus einer In-silico-Analyse erhalten werden; (iv) das Subjekt ist ein menschliches Subjekt ist; oder (v) die Polynukleinsäureprobe eine Polynukleinsäure aus Blut, Speichel, Urin, Serum, Tränen, Haut, Gewebe oder Haar des Subjekts umfasst.
- Immunsuppressives Medikament zur Verwendung nach
Anspruch 5 , wobei der Gentest Microarray-Analyse, PCR, Sequenzierung, Nukleinsäurehybridisierung oder eine beliebige Kombination davon umfasst, wobei optional: (i) die Microarray-Analyse aus der Gruppe bestehend aus einer Comparative Genomic Hybridization (CGH)-Array-Analyse und einer SNP-Array-Analyse ausgewählt ist, oder (ii) die Sequenzierung aus der Gruppe bestehend aus Massively Parallel Signature Sequencing (MPSS), Polony-Sequenzierung, 454-Pyrosequenzierung, Illumina-Sequenzierung, Illumina (Solexa)-Sequenzierung unter Verwendung der 10X Genomics-Bibliotheksvorbereitung, SOLiD-Sequenzierung, lonenhalbleitersequenzierung, DNA-Nanoball-Sequenzierung, Heliscope-Einzelmolekülsequenzierung, Einzelmolekül-Echtzeitsequenzierung (SMRT), RNAP-Sequenzierung, Nanopore-DNA-Sequenzierung, Sequenzierung durch Hybridisierung und mikrofluidische Sanger-Sequenzierung ausgewählt ist. - Immunsuppressives Medikament zur Verwendung nach einem der vorhergehenden Ansprüche, wobei die genomische Variation eine heterozygote SNV oder eine homozygote SNV ist.
- Immunsuppressives Medikament zur Verwendung nach einem der vorhergehenden Ansprüche, wobei: (a) das immunsuppressive Medikament zur Verwendung ferner einen Wirkstoff umfasst, der eine JCV-Viruslast im Subjekt verringert; oder (b) das immunsuppressive Medikament zur Verabreichung vor oder in Verbindung mit einem Mittel bestimmt ist, das die Viruslast bei dem Subjekt verringert, wobei optional: (i) das immunsuppressive Medikament verabreicht wird, nachdem die Viruslast verringert worden ist; oder (ii) der Wirkstoff, der die Viruslast verringert, ein Wirkstoff ist, der auf JCV abzielt.
- Verfahren zur Verringerung des Risikos, dass ein Subjekt an einer progressiven multifokalen Leukoenzephalopathie (PML) erkrankt, umfassend (a) Testen eines Subjekts auf das Vorhandensein einer genomischen Variation, ausgewählt aus der Gruppe bestehend aus: chr9:137779251, G>A und chr1:160769595, AG>A, wobei die Chromosomenposition der genomischen Variation in Bezug auf UCSC hg19 definiert ist; (b) Bestimmen, dass das Subjekt die genomische Variation aufweist, und (c) von der Verabreichung eines immunsuppressiven Medikaments an das Subjekt Abraten, bei dem festgestellt wurde, dass es die genomische Variation aufweist, wobei das immunsuppressive Medikament Natalizumab, Interferon beta-1a, Interferon beta-1b, Glatirameracetat, Peginterferon beta-1a, Teriflunomid, Fingolimod, Dimethylfumarat, Alemtuzumab, Mitoxantron, Rituximab, Daclizumab, Ocrelizumab, Diroximelfumarat oder Siponimod umfasst, wobei optional: (i) das Beraten den Hinweis umfasst, dass Verabreichen eines immunsuppressiven Medikaments kontraindiziert ist; (ii) das Beraten den Hinweis umfasst, dass Verabreichen eines immunsuppressiven Medikaments das Risiko erhöht, dass das Subjekt an einer progressiven multifokalen Leukoenzephalopathie (PML) erkrankt; (iii) das Beraten den Hinweis umfasst, dass Verabreichen eines immunsuppressiven Medikaments ein Faktor ist, der das Risiko erhöht, dass das Subjekt an einer progressiven multifokalen Leukoenzephalopathie (PML) erkrankt; oder (iv) wobei das immunsuppressive Medikament Natalizumab umfasst.
- Verfahren zum Erkennen, dass bei einem Subjekt ein Risiko besteht, an einer progressiven multifokalen Leukoenzephalopathie (PML) zu erkranken, umfassend: (a) Analysieren einer Polynukleinsäureprobe von dem Subjekt auf eine genomische Variation ausgewählt aus einer Gruppe bestehend aus: chr9:137779251, G>A und chr1:160769595, AG>A, wobei die Chromosomenposition der genomischen Variation in Bezug auf UCSC hg19 definiert ist; (b) Feststellen des Vorhandenseins der genetischen Variation in der Polynukleinsäureprobe; und (c) Erkennen, dass bei dem Subjekt ein hohes Risiko besteht, an PML zu erkranken; wobei das Subjekt immunsupprimiert ist, wobei optional das Subjekt HIV hat, eine Organtransplantation erhalten hat oder an einem Leiden laboriert, das aus Krebs, einer hämatologischen Malignität, einer Autoimmunerkrankung oder idiopathischer CD4+-Lymphozytopenie (ICL) ausgewählt ist.
- Immunsuppressives Medikament zur Verwendung nach einem der
Ansprüche 1 bis8 oder Verfahren nachAnspruch 9 oder10 , ferner umfassend Analysieren auf das Vorhandensein von JCV in einer biologischen Probe von dem Subjekt, wobei das Analysieren auf das Vorhandensein von JCV einen JCV-Antikörpertest oder einen oligoklonalen IgM-Bandentest in CSF umfasst wobei optional: das Analysieren auf das Vorhandensein von JCV Testen des Subjekts mit dem JCV-Antikörpertest umfasst, wobei der JCV-Antikörpertest das Vorhandensein von JCV nachweist oder nicht, oder der JCV-Antikörpertest Inkontaktbringen eines JCV-Nachweisreagenzes mit einer biologischen Probe von dem Subjekt umfasst, wobei optional das JCV-Nachweisreagenz aus der Gruppe bestehend aus einem Anti-JCV-Antikörper, einem JCV-spezifischen Primer und Kombinationen davon ausgewählt ist.
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