Tus Inhibitor Xeljanz (tofacitinib) tau pom zoo los ntawm US FDA rau nws cov lus qhia thib tsib!

Pfizer tsis ntev los no tshaj tawm tias US Food and Drug Administration (FDA) tau pom zoo ib qho kev qhia tshiab rau cov tshuaj tiv thaiv kab mob Xeljanz (): rau kev kho mob cov lus teb rau ib los yog ntau tshaj qog necrosis factor (TNF) blockers Cov neeg laus uas tsis txaus los yog intolerant active ankylosing spondylitis (AS). Hauv European Union, Xeljanz tau pom zoo thaum lub Kaum Ib Hlis 2021 rau kev kho mob ntawm cov neeg laus cov neeg mob uas nquag nquag AS uas tsis teb rau cov kev kho mob ib txwm muaj.

Ankylosing spondylitis (AS) is a type of arthritis that can cause inflammation in certain parts of the spine, affecting more than 350,000 people in the United States. This disease usually occurs in early adulthood and can cause pain, swelling, and may restrict movement. This approval gives clinicians and patients an additional oral treatment option.

This regulatory approval also confirms the clinical value and versatility of Xeljanz. Xeljanz is the first and only oral JAK inhibitor approved for 5 indications in the United States and the European Union. It is the largest of all JAK inhibitors. The 4 indications previously approved include: (1) Moderate to severe Adult patients with active rheumatoid arthritis (RA); (2) adults with active psoriatic arthritis (PsA); (3) adults with moderate to severe active ulcerative colitis (UC); (4) ) Patients with active polyarticular juvenile idiopathic arthritis (pcJIA) and juvenile PsA aged 2 years and older.

Tofacitinib Mechanism of Action: Inhibition of JAK

Qhov kev pom zoo AS yog ua raws li cov txiaj ntsig zoo ntawm theem 3 kev tshawb fawb soj ntsuam (A3921120). Cov ntaub ntawv qhia tau hais tias raws li International Spondyl Arthritis Association Assessment Standards (ASAS), ntawm 16th lub lim tiam ntawm kev kho mob, Xeljanz tau ua tiav thawj qhov kawg (ASAS20 teb) thiab qhov tseem ceeb thib ob qhov kawg (ASAS40 teb) piv nrog cov placebo.

A3921120 yog ntau lub chaw, ob qhov muag tsis pom kev, cov placebo-tswj theem 3 txoj kev tshawb fawb ua nyob rau hauv 270 cov neeg laus uas muaj AS. Cov neeg mob no ua tau raws li kev hloov kho AS New York cov qauv (MNY) thiab raug kuaj rau 2 lossis ntau dua cov tshuaj uas tsis yog steroids Cov lus teb tsis txaus lossis tsis kam rau cov tshuaj tiv thaiv kab mob (NSAID) kho. Hauv txoj kev tshawb no, cov neeg mob tau muab tso rau 5mg koob tshuaj Xeljanz lossis placebo ob zaug ib hnub rau 16 lub lis piam, thiab tag nrho ntawm 269 tus neeg mob tau txais kev kho mob. Cov neeg mob tsim nyog uas tau ua tiav 16 lub lis piam kho ob qhov muag tsis pom kev tau raug xaiv kom tau txais kev kho mob qhib Xeljanz ntawm koob tshuaj 5 mg ob zaug ib hnub rau 32 lub lis piam ntxiv, thiab tom qab ntawd nkag mus rau 4 lub lis piam tom qab.

Cov txiaj ntsig tau pom tias txoj kev tshawb fawb tau mus txog qhov kawg ntawm qhov kawg: ntawm 16 lub lis piam ntawm kev kho mob, piv nrog cov pab pawg placebo, qhov feem pua ​​​​ntawm cov neeg mob hauv pawg kho mob Xeljanz uas ua tiav ASAS20 cov lus teb tau nce ntxiv (56.4% vs 29.4%; p [GG. lt; 0.0001). Tsis tas li ntawd, piv nrog cov placebo pab pawg, qhov feem pua ​​​​ntawm cov neeg mob hauv Xeljanz pab pawg kho mob uas ua tiav ASAS40 cov lus teb tau nce ntxiv (40.6% vs 12.5%; p< 0.0001),="" uas="" yog="" qhov="" tseem="" ceeb="" thib="" ob="" qhov="" kawg="" ntawm="" txoj="" kev="" tshawb="" no.="" .="" asas20/40="" yog="" siv="" los="" txiav="" txim="" txog="" kev="" txhim="" kho="" lossis="" kev="" kho="" mob.="" hauv="" txoj="" kev="" tshawb="" no,="" cov="" ntaub="" ntawv="" kev="" nyab="" xeeb="" tau="" pom="" hauv="" as="" cov="" neeg="" mob="" kho="" nrog="" xeljanz="" tau="" ua="" raws="" li="" kev="" nyab="" xeeb="" profile="" pom="" hauv="" cov="" neeg="" mob="" rheumatoid="" mob="" caj="" dab="" (ra)="" thiab="" psoriatic="" mob="" caj="" dab="" (psa),="" tshwm="" sim="" hauv="" txhua="" pab="" pawg="" kho="" mob="" feem="" ntau="" tshwm="" sim="" hauv=""> 5% ntawm cov neeg mob muaj xws li: kab mob ua pa sab sauv, nasopharyngitis, raws plab, nce alanine aminotransferase (ALT), arthralgia, thiab mob taub hau.

Ankylosing spondylitis (AS) yog ib hom kab mob inflammatory uas cuam tshuam rau txiv neej thiab poj niam thaum ntxov laus. Thawj cov tsos mob feem ntau tshwm sim ua ntej hnub nyoog 30 xyoo thiab tsis tshua tshwm sim tom qab hnub nyoog 45. Cov tsos mob ntawm AS muaj xws li mob nraub qaum thiab pob tw thiab txhav. Nyob rau tib lub sijhawm, qee cov neeg mob tuaj yeem muaj kev sib txuas ntawm tus txha caj qaum. AS tuaj yeem ua rau mob hnyav rau cov neeg mob thiab cuam tshuam rau kev noj qab haus huv ntawm lub neej zoo.

Cov tshuaj nquag muaj nyob ntawm Xeljanz yogtofacitinib

Nyob rau hauv Suav lag luam, Xeljanz tau pom zoo rau kev lag luam hauv lub Peb Hlis 2017 rau kev kho mob ntawm cov neeg mob nruab nrab mus rau hnyav RA cov neeg laus uas tsis txaus lossis tsis tuaj yeem kho MTX. Xeljanz tuaj yeem siv ua ke nrog MTX lossis lwm yam tsis yog tshuaj lom neeg DMARDs. Qhov pom zoo pom zoo koob tshuaj ntawm cov tshuaj no yog 5 mg, noj ob zaug hauv ib hnub, nrog lossis tsis muaj zaub mov. Qhov kev pom zoo no ua rau Xeljanz thawj JAK inhibitor los kho mob rheumatoid mob caj dab (RA) hauv Suav lag luam.