Raws li tsab ntawv tshaj tawm tshaj tawm los ntawm Cloud-Native Healthcare's official WeChat account, nws tus khub Calliditas Therapeutics AB tau tshaj tawm cov txiaj ntsig zoo los ntawm kev qhib thoob ntiaj teb-Label Extension (OLE) txoj kev tshawb fawb ntawm NefIgArd Phase III sim rau Tarpeyo® (budesonide ncua - tso tawm cov tshuaj ntsiav, Nefecon).
The OLE study was designed to provide an additional 9 months of Tarpeyo® treatment to all patients who completed the NefIgArd Phase III trial with 24‑hour urinary protein >1 g/g and eGFR >30 ml / min thaum lub sijhawm ntawd.
Tag nrho ntawm 119 tus neeg mob tau tso npe rau hauv txoj kev tshawb no, suav nrog 45 tus neeg mob uas tau txais Tarpeyo® hauv NefIgArd Phase III sim. Cov ntaub ntawv qhia tau hais tias nyob rau hauv txhua tus neeg mob uas muaj IgA nephropathy (IgAN), suav nrog cov yav tas los kho nrog Tarpeyo® hauv NefIgArd Phase III sim, kev kho mob ntawm cov ntsiab lus tseem ceeb suav nrog cov zis protein- rau - creatinine ratio (UPCR) thiab kwv yees glomerular filtration rate (eGFR) nrog rau 9 lub hlis kev tshawb fawb. Hais txog kev nyab xeeb, cov ntaub ntawv kev nyab xeeb tom qab 9 lub hlis ntawm Tarpeyo® kev kho mob lossis rov tshwm sim tom qab ua tiav ntawm NefIgArd Phase III txoj kev tshawb fawb tau ua raws li cov ntaub ntawv tau tshaj tawm yav dhau los.
Lub ntiaj teb no NefIgArd Phase III kev soj ntsuam kev sim yog ib qho kev tshawb fawb randomized, ob-dig muag, multicenter txoj kev tshawb fawb uas ntsuas qhov ua tau zoo thiab kev nyab xeeb ntawm Tarpeyo® (16 mg ib hnub ib zaug) piv rau cov placebo hauv cov neeg laus nrog thawj IgA nephropathy tau txais kev kho RAS inhibitor zoo. Cov neeg mob tau randomized 1: 1 kom tau txais Tarpeyo® lossis sib piv cov placebo rau 9 lub hlis, ua raws li 15-hli kev kho mob-dawb rov qab lub sijhawm. Txoj kev tshawb fawb NefIgArd Phase III tau ntsib nws cov ntsiab lus tseem ceeb thiab cov ntsiab lus tseem ceeb thib ob, nrog cov ntaub ntawv tag nrho luam tawm hauvLub Lancet. Raws li cov txiaj ntsig no, US Food and Drug Administration (FDA) tau tso cai tag nrho ntawm Tarpeyo® nyob rau lub Kaum Ob Hlis 2023 rau kev kho mob ntawm cov neeg laus nrog IgA nephropathy uas muaj kev pheej hmoo ntawm kev kis kab mob, tsis hais txog cov proteinuria hauv paus.
The OLE study aimed to provide 9 months of Tarpeyo® treatment to patients who completed the NefIgArd Phase III trial with 24‑hour urinary protein >1 g/g and eGFR >30 ml / min Tag nrho ntawm 119 tus neeg mob tau cuv npe, suav nrog 45 tus uas tau txais kev kho mob nquag. Txhua tus neeg mob OLE tau kawm txuas ntxiv txhim kho RAS inhibitor therapy (ACEis thiab / lossis ARBs) thiab tau txais Tarpeyo® 16 mg ib hnub ib zaug rau 9 lub hlis, ua raws li 3 lub hlis tom qab. Thawj qhov kev tshuaj xyuas yog raws li UPCR thiab eGFR ntawm 9 lub hlis. Cov ntaub ntawv ntxaws ntxaws yuav raug nthuav tawm ntawm lub rooj sib tham txhua xyoo tom ntej ntawm European Renal Association-European Dialysis thiab Transplant Association (ERA-EDTA).
Tarpeyo® (Nefecon®) yog budesonide ncua-tso tshuaj ntsiav. Raws li covTsuas yog cov kab mob hloov kho rau IgA nephropathy thoob ntiaj teb, nws yog ib qho tshuaj tiv thaiv kab mob tiv thaiv kab mob hauv plab hnyuv mucosal B-cells. Nws tuaj yeem txo lub raum ua haujlwm poob qis los ntawm 50%, ncua lub raum kev ua haujlwm tsis zoo los ntawm 66% hauv cov neeg Suav, thiab kwv yees kom ncua sij hawm mus rau kev lim ntshav lossis hloov lub raum los ntawm 12.8 xyoo.
Lub caij no, budesonide nthuav tawm a90% first-pass metabolism tus nqi, pab txhawb kom muaj kev ruaj ntseg profile. Tarpeyo® yog tsim tshwj xeeb rau cov neeg mob IgA nephropathy. Txhua capsule muaj 4 mg ntawm budesonide, formulated rauLub hom phiaj tso tawm ntawm mucosal B-cells nyob rau hauv lub davhlau ya nyob twg ileum(xws li Peyer's thaj ua rau thaj). Thaum lub capsule dissolution, triple-coated microspheres muab kev tso tawm ruaj khov thiab ruaj khov ntawm budesonide, ua tiav cov kev pabcuam siab ntawm tag nrho cov hom phiaj. Qhov no txo qis kev tsim cov galactose-deficient IgA1 cov tshuaj tiv thaiv kab mob (Gd-IgA1), uas tsav IgA nephropathy, yog li cuam tshuam rau theem siab ntawm cov txheej txheem pathogenic kom ua tiav cov txiaj ntsig kho mob hauv IgA nephropathy.
