AbbVie oral JAK1 Inibite Rinvoq Soumet yon nouvo endikasyon aplikasyon nan Etazini ak Ewop pou trete Psoriatic Atrit (PsA)!

AbbVie denyeman te anonse ke li te soumet yon aplikasyon nouvo endikasyon pou oral la anti-maladies Dwog Rinvoq (upadacitinib, 15 mg yon fwa chak jou) nan manje a ak administrasyon Dwog (FDA) ak ajans la medsin Ewopeyen (EMA) medikaman sa a se yon Selektif ak revesib JAK pou tretman nan pasyan granmoun ak Atrit inibite aktif (Psoriatic).

Michael Severino, MD, vis prezidan ak Prezidan AbbVie, te di: "Psoriatic Atrit se yon maladi heterogeneous konpleks ki manifeste atrave plizye zon, ki gen ladan jwenti ak po, sa ki lakoz doule chak jou, fatig ak Red. Nou gade pou pi devan pou mwen travay avek otorite yo regilasyon ak espwa yo pote Rinvoq pasyan yo ak maladi febles sa a pi vit ke posib. "

Nouvo aplikasyon sa a endikasyon ki baze sou done ki soti nan de faz III syans klinik, CHWAZI-PsA-1 (NCT03104400) ak CHWAZI-PsA-2 etid (NCT03104374). De etid sa yo enskri plis pase 2000 pasyan ak aktif PsA. Rezilta yo te montre ke nan tou de syans, Rinvoq rive nan endpoint prensipal la nan repons ACR20 konpare ak plasebo. Anplis de sa, 15 doz la mg nan Rinvoq ak adalimumab te montre ki pa enferyorite an repons a ACR20 nan semen 12 nan tretman. Pasyan yo ap resevwa Rinvoq tou te gen pi gwo amelyorasyon nan fonksyon fizik (HAQ-DI) ak sentom po (PASI 75), ak yon pi gwo pousantaj nan pasyan reyalize aktivite a maladi ki pi ba. Pami pasyan PsA, sekirite a nan Rinvoq se ki konsistan avek rezilta yo nan faz la deja rapote III Atrit Atrit ese klinik, e pa gen okenn nouvo risk sekirite pi gwo yo te jwenn.

--CHWAZI-PsA-1: se yon sant multi, randomized, doub-aveg, gwoup paralel, Dwog pozitif ak plasebo-kontwole faz III etid nan 1705 pasyan modifye omwen yon maladi abiotic anti-afyev nan (DMARD) ki fet nan pasyan granmoun ak anba-reponn PsA, efikasite a ak sekirite nan de doz nan Rinvoq (15 mg ak 30 mg yon fwa chak jou) relatif nan plasebo ak adalimumab yo te evalye. Nan etid la, pasyan yo te owaza asiyen yo resevwa Rinvoq 15 mg, Rinvoq 30 mg, adalimumab (40 mg, chak lot semen [EOW]), ak plasebo. Endpoint prensipal la te pwoposyon nan pasyan ki reyalize yon repons ACR20 nan semen 12 nan de-doz la Rinvoq tretman gwoup konpare ak gwoup la plasebo. Endpoints segonde gen ladan: chanjman nan evalyasyon sante kesyone (HAQ-DI) not soti nan debaz nan semen 12, pwoposyon nan pasyan ki reyalize PASI75 (psoriasis zon nan yon 75 endeks ki nan semen 16, ak maladi ki pi ba nan semen 24 pwoposyon nan pasyan ak aktivite (MDA).

Done ki te montre ke etid la te rive nan endpoint prensipal la: nan semen 12, 71% ak 79% nan pasyan nan 15 mg ak 30 gwoup mg reyalize repons ACR20, respektivman, ak 36% nan gwoup la plasebo (p<0.0001). when="" compared="" with="" adalimumab,="" the="" two="" doses="" of="" rinvoq="" achieved="" non-inferiority="" in="" the="" acr20="" response="" rate="" at="" the="" 12th="" week="" of="" treatment,="" and="" only="" the="" 30="" mg="" dose="" showed="" superiority.="" regarding="" the="" acr50="" response="" rate="" at="" the="" 12th="" week="" of="" treatment,="" the="" 15="" mg="" group,="" 30="" mg="" group,="" and="" placebo="" group="" were="" 38%,="" 52%,="" and="" 13%,="" respectively="" (nominal=""><0.0001). in="" terms="" of="" acr75="" response="" rate="" at="" the="" 12th="" week="" of="" treatment,="" 16%,="" 25%,="" and="" 2%="" in="" the="" 15="" mg="" group,="" 30="" mg="" group,="" and="" placebo="" group="" (nominal=""><>

Dapre mezi a nan a HAQ-DI not, fonksyon an fizik nan pasyan ki resevwa Rinvoq tou amelyore anpil nan semen 12: sa yo ki DI ke not yo nan pasyan yo nan 15mg ak 30mg Rinvoq gwoup tretman chanje soti nan debaz pa-0,42 ak-0,47, respektivman. Chanjman gwoup la te-0,14 (p<0.0001). at="" week="" 16,="" rinvoq="" also="" showed="" improvement="" in="" skin="" symptoms.="" among="" patients="" receiving="" 15="" mg="" and="" 30="" mg="" doses="" of="" rinvoq,="" 63%="" and="" 62%="" of="" patients="" achieved="" pasi75,="" respectively,="" and="" 21%="" of="" placebo=""><0.0001). the="" proportion="" of="" patients="" who="" achieved="" mda="" at="" the="" 24th="" week="" of="" treatment="" was="" 37%="" and="" 45%="" in="" the="" 15="" mg="" and="" 30="" mg="" rinvoq="" treatment="" groups,="" respectively,="" and="" 12%="" in="" the="" placebo="" group=""><0.0001). after="" 24="" weeks="" of="" treatment,="" 15="" mg="" and="" 30="" mg="" of="" rinvoq="" significantly="" inhibited="" radiological="" progression="" compared="" to="" placebo=""><0.01, assessed="" by="" change="" from="" baseline="" with="" psa="" sharp/van="" der="" heijde="" score).="" the="" suppression="" of="" joint="" damage="" is="" important="" for="" patients="" with="" psoriatic="" arthritis="" because="" it="" affects="" physical="" function="" and="" disability.="" in="" the="" study,="" rinvoq's="" safety="" was="" consistent="" with="" previous="" reports,="" and="" no="" new="" safety="" risks="" were="">

--CHWAZI-PsA 2: yon milti-sant, randomized, doub-aveg, gwoup paralel, etid plasebo-kontwole fet nan pasyan aktif PsA ak repons ase nan omwen yon sel maladi Byolojik-modifye anti-afyev nan Dwog (bDMARD), objektif la se evalye efikasite a ak sekirite nan Rinvoq relatif nan plasebo. Nan etid la, pasyan yo te owaza asiyen yo resevwa Rinvoq 15 mg, Rinvoq 30 mg, ak plasebo. Nan semen 24, yo te resevwa oral Rinvoq 15 mg oswa Rinvoq 30 mg.

Endpoint prensipal la nan etid la te pousantaj nan pasyan ki reyalize ACR20 padon apre 12 semen nan tretman. Endpoints segonde ki gen ladan chanjman nan evalyasyon sante kesyone (HAQ-DI) soti nan debaz, pwoposyon nan pasyan ki reyalize ACR50 ak ACR70 nan semen 12, ak pwoposyon nan PASI 75 rive nan semen 16 ak pwoposyon nan pasyan ki te rive nan aktivite a maladi minimom (MDA) nan semen 24. Pwose a se kontinyel ak pwose a long tem ekspansyon toujou avegle yo evalye sekirite a long-tem, tolerability, ak efikasite nan 2 doz yon fwa-chak jou (15 mg ak 30 mg) nan Rinvoq nan pasyan ki te ranpli faz la plasebo-kontwole.

Rezilta yo te montre ke tou de doz de Rinvoq (15 mg ak 30 mg yon fwa chak jou) rive nan endpoint prensipal la nan ACR20 pou fe nan semen 12 konpare ak plasebo. Anplis de sa, de doz la nan Rinvoq te montre anpil soulajman pi gwo nan tout endpoints segonde konpare ak plasebo.

Done yo espesifik yo se: (1) nan 12th semen nan tretman, 57% ak 64% nan pasyan nan 15-mg ak 30-mg gwoup tretman Rinvoq reyalize ACR20 padon, respektivman, ak 24% nan gwoup la plasebo (p<0.0001). (2)="" at="" the="" 12th="" week="" of="" treatment,="" 32%="" and="" 28%="" of="" patients="" in="" the="" 15-mg="" and="" 30-mg="" rinvoq="" treatment="" groups="" achieved="" acr50="" remission,="" respectively,="" and="" 5%="" in="" the="" placebo="" group=""><0.0001). (3)="" at="" the="" 12th="" week="" of="" treatment,="" 9%="" and="" 17%="" of="" patients="" in="" the="" 15-mg="" and="" 30-mg="" rinvoq="" treatment="" groups="" achieved="" acr70="" remission,="" respectively,="" and="" 0.5%="" in="" the="" placebo="" group=""><0.0001). (4)="" at="" the="" 12th="" week="" of="" treatment,="" the="" physical="" function="" (haq-di="" evaluation)="" of="" the="" patients="" treated="" with="" rinvoq="" was="" further="" improved.="" (5)="" rinvoq-treated="" patients="" showed="" improvement="" in="" skin="" symptoms.="" in="" the="" 16th="" week="" of="" treatment,="" 52%="" and="" 57%="" of="" patients="" in="" the="" 15-="" and="" 30-mg="" rinvoq="" treatment="" groups="" achieved="" pasi75="" remission,="" respectively,="" and="" 16%="" in="" the="" placebo="" group=""><0.0001). (6)="" in="" the="" 24th="" week="" of="" treatment,="" 25%="" and="" 29%="" of="" patients="" in="" the="" 15-="" and="" 30-mg="" rinvoq="" treatment="" groups="" achieved="" mda,="" respectively,="" and="" 3%="" in="" the="" placebo="" group=""><0.0001). (7)="" in="" this="" study,="" rinvoq's="" safety="" is="" consistent="" with="" previous="" research="" results,="" and="" no="" new="" safety="" risks="" have="" been="">

Aktif engredyan pharmaceutique la nan Rinvoq se upadacitinib, ki se yon Selektif oral ak revesib JAK1 dekouvri ak devlope pa Inibite. Li te devlope yo trete plizye maladies iminite-medyate maladi. JAK1 se yon kinaz ki jwe yon wol kle nan fizyopatolojik de maladi maladies dives kalite.

Nan mwa Out 2019, Rinvoq te resevwa premye paket nan mond lan pou tretman an nan modera nan grav aktif Atrit Atrit (RA) granmoun ak repons ki pa sifi oswa entoleran nan methotrexate (MTX). Nan mwa desanm 2019, Rinvoq te apwouve pa Inyon Ewopeyen an pou tretman de granmoun ak modere nan grav RA ki se anba-reponn oswa entoleran nan yon sel oswa plis maladi-modifye anti-afyev nan Dwog (DMARD). An RA, doz la apwouve nan Rinvoq se 15 mg.

Kounye a, Rinvoq trete psoriatic Atrit (PsA), RA, aksyo spondyloarthritis (axSpA), maladi Crohn (CD), atopic maladi po anfle (AD), kolit anflamasyon nan kolon (UC), faz III syans klinik nan arteritis selile (GCA) yo kontinyel.

Endistri a se tre optimis sou Rinvoq nan kandida biznis yo. Medikaman rechech sou mache a EvaluatePharma deja lage yon rapo predi ke ke lavant mondyal Rinvoq a nan 2024 pral rive 2.570.000.000 US dola, fe li nan 5th mond lan pi byen-vann anti-afyev nan Dwog.