IGF-1R Lub Hom Phiaj Monoclonal Antibody Tepezza nkag mus rau Phase 4 Kev Kho Mob Kuaj: Kev Kho Mob Ntev (tsis ua haujlwm) TED Cov Neeg Mob!

Kev Kho Kab Mob Qab Zib tsis ntev los no tshaj tawm tias Phase 4 kev sim tshuaj (NCT04583735) tshuaj xyuas qhov ua tau zoo thiab kev nyab xeeb ntawm Tepezza (teprotumumab) hauv kev kho mob ntev (tsis muaj zog) cov thyroid kab mob (TED) tau cuv npe thawj tus neeg mob.

Tepezza yog thawj zaug thiab tsuas yog tshuaj pom zoo los ntawm Asmeskas FDA rau kev kho mob ntawm TED. Nws tau pom zoo rau kev ua lag luam thaum Lub Ib Hlis 2020. Cov tshuaj yog tib neeg tib neeg monoclonal antibody (mAb) thiab cov tshuaj insulin zoo li kev loj hlob-1 tus txais. (IGF-1R) Kev npaj phiaj xwm. TED yog mob hnyav, mob hnyav, thiab tsis tshua muaj kab mob autoimmune uas cuam tshuam rau kev pom kev. Nws cuam tshuam nrog exophthalmos (muag muag), ob lub zeem muag, pom qhov muag tsis pom, mob, mob, thiab lub ntsej muag tsis xws luag.

TED pib nyob rau theem mob (nquag), thaum lub sijhawm cov cim thiab tsos mob ntawm kev mob, xws li mob qhov muag, o, exophthalmos (qhov muag), thiab daim ntawv kawm tiav, nce mus raws sijhawm. Tom qab ntawd, tus kab mob nkag mus rau lub sijhawm ntev (tsis ua haujlwm), kev mob tsis tshwm sim ntxiv lossis raug txo qis, tab sis cov cim tseem ceeb thiab cov tsos mob tseem yuav tshwm sim.

Qhov kev xaiv no, ob-qhov muag tsis pom, tswj cov placebo, pab pawg sib koom, ntau qhov chaw theem 4 kev sim yuav ntsuas qhov ua tau zoo, kev nyab xeeb thiab kev tiv taus ntawm Tepezza thiab cov placebo hauv kev kho mob TED cov neeg mob ntev. Thaum lub sijhawm tshuaj xyuas thawj zaug, txhua tus neeg mob yuav tsum muaj hnub nyoog tsawg kawg yog 18 xyoo thiab tau kuaj pom thawj zaug nrog TED yam tsawg 3 xyoos thiab tsawg dua 8 xyoo. Tus neeg mob yav dhau los tsis tau txais kev kho hluav taws xob orbital, kho qhov muag decompression lossis phais strabismus. Kwv yees li 60 tus neeg mob laus uas ua tau raws li cov txheej txheem kev tsim nyog tau txais yuav tau txais Tepezza lossis cov placebo infusion ntawm 2: 1 piv. Thawj koob tshuaj txhaj tshuaj yog 10 mg/kg, thiab seem 7 qhov tshuaj txhaj yog 20 mg/kg. Ib zaug txhua 3 lub lis piam, tag nrho ntawm 8 infusions.

Thawj qhov ua tau zoo kawg yog qhov hloov pauv ntawm qhov pib hauv exophthalmos (qhov muag) hauv qhov kev tshawb pom qhov muag ntawm lub lim tiam 24. Qhov kev sim no tseem yuav ntsuas exophthalmos cov lus teb, cov lus teb rau kev kawm tiav, kev hloov pauv hauv qhov mob, hloov cov leeg nqaij, thiab hloov pauv qhov tsos. thiab pom kev ua haujlwm subscales ntawm Graves Quality of Life (GO QoL) cov lus nug. Cov uas tau ua tiav lub sijhawm kho tuaj yeem xaiv nkag mus rau lub sijhawm qhib daim ntawv lo, thaum lub sijhawm lawv yuav tau txais 8 Tepezza infusions.

Dr. Raymond Douglas, tus kws tshawb fawb ntawm Phase 4 kev sim tshuaj thiab tus thawj coj ntawm Orbital thiab Thyroid Eye Disease Program ntawm Sid Sinai Medical Center hauv Tebchaws Meskas, hais tias:" Cov neeg mob nyob rau theem mob hnyav txuas ntxiv mus ntsib cov tsos mob ntawm qaug zog, xws li mob qhov muag thiab o, uas tuaj yeem cuam tshuam nrog kev ua neej nyob niaj hnub. Thiab xav tau kev kho mob, uas yog ntau heev. Hauv ntau qhov xwm txheej tshaj tawm thiab tshuaj xyuas, Tepezza kev kho mob nyob rau theem mob ntev tuaj yeem txhim kho cov tsos mob ntawm cov thyroid ophthalmopathy, suav nrog qhov muag o. Qhov kev sim 4 theem no yuav pab peb nkag siab cov kev soj ntsuam no hauv kev tswj hwm chaw kho mob."

Thyroid ophthalmopathy (TED) yog kab mob autoimmune zuj zus thiab ua rau lub cev tsis muaj zog. Lub qhov rais kab mob nquag muaj tsawg thiab tuaj yeem kho tau yam tsis muaj kev phais thaum lub sijhawm no. Txawm hais tias TED feem ntau tshwm sim hauv cov neeg mob hyperthyroidism lossis Grave' tus kab mob (hyperthyroidism), nws yog kab mob tshwj xeeb tshwm sim los ntawm autoantigens uas ua rau IGF-1R-mediated signaling complexes ntawm cov cell hauv qhov chaw. . Qhov no tuaj yeem ua rau muaj kev cuam tshuam tsis zoo, ua rau lub sijhawm ntev, tsis tuaj yeem ua rau puas tsuaj.

TED nquag siv tau ntev txog 3 xyoos thiab yog tus yam ntxwv ntawm qhov mob thiab nthuav cov nqaij tom qab lub qhov muag. Raws li TED nce qib, nws tuaj yeem ua rau muaj kev puas tsuaj loj, suav nrog qhov muag tawm (qhov muag pom qhov muag), strabismus (qhov muag tsis pom qhov muag), kev kawm tiav qib siab (ob lub zeem muag), thiab qee qhov, dig muag.

Yav dhau los, cov neeg mob yuav tsum tau mus dhau TED kom txog thaum tus kab mob tsis ua haujlwm (uas feem ntau ua rau tsis pom kev thiab pom kev tsis zoo) ua ntej yuav ua phais nyuaj thiab kim, tab sis kev phais yuav tsis rov kho qhov muag lossis pom. TED cov neeg mob feem ntau ntsib kev ua haujlwm ntev, kev puas siab puas ntsws, thiab kev khwv nyiaj txiag, suav nrog kev tsis muaj peev xwm ua haujlwm thiab koom nrog cov haujlwm ntawm kev ua neej nyob niaj hnub.

Tepezza cov khoom siv tshuaj muaj yees, teprotumumab, yog tib neeg IgG1 monoclonal antibody uas tsom mus rau cov insulin zoo li kev loj hlob zoo-1 tus txais (IGF-1R). Nws tau tsim los rau kev kho mob ntawm qhov nruab nrab mus rau mob qog noj ntshav (TED), uas feem ntau cuam tshuam nrog Grave' tus kab mob (Grave' tus kab mob, hyperthyroidism) muaj feem cuam tshuam. Hauv OPTIC txoj kev tshawb fawb, cov neeg mob kho nrog teprotumumab tau ntsib qhov tsis tau pom dua los ntawm exophthalmos, thiab ua ntej ntawd, kev phais tsuas yog ua tau tom qab qhov kawg ntawm tus kab mob nquag.

Kev pom zoo ntawm Tepezza ntawm kev ua lag luam muab cov kws kho mob nrog thawj cov tshuaj txhawm rau txo exophthalmos ntxiv rau lwm cov tsos mob thaum lub sijhawm TED.