U-Amgen namhlanje ubhengeze iziphumo kuhlalutyo oludityanisiweyo lwe-post-hoc olubalulekileyo lweSigaba sesi-3 se-NAVIGATOR kunye ne-PATHWAY iSigaba se-2b solingo lubonise i-TEZSPIRE™ (tezepelumab-ekko) ibonise ukuncitshiswa kweqondo lokunyuka kwesifuba sonyaka (AAER) kuwo onke amacandelwana e-biomarker ezigulane ezine-asthma enzima. I-1 Ezi ziphumo zixhasa indima ye-TEZSPIRE njengonyango lokuqala lweklasi kubantu abaninzi abaphila ne-asthma enzima, kungakhathaliseki ukuba kumanqanaba e-biomarker.1
Kuhlalutyo oluhlanganisiweyo, i-TEZSPIRE, xa yongezwa kumgangatho wokunyamekela (i-SoC), ukunciphisa ukunyuka kwe-asthma kwizigulane, kungakhathaliseki ukubala kwe-eosinophil yesiseko segazi, kubonisa ukusebenza okuhambelanayo kunye ne-71% (≥300 iiseli nge-microliter nganye), i-48% (<300 iiseli nge-microliter nganye) kunye ne-48% (<150 iiseli nge-microliter nganye) ukunciphisa i-AAER kwiiveki ze-52, xa kuthelekiswa ne-placebo eyongezwe kwi-SoC.1 Kuhlalutyo olufanayo, i-TEZSPIRE ibonise ukuphuculwa kwe-AAER kwizigulane kungakhathaliseki ukuba i-nitric oxide i-fractional exhaled nitric oxide. I-FeNO) inqanaba kunye nesimo sokungabikho komzimba kwiiveki ze-52, xa kuthelekiswa ne-placebo.1
Ukongezelela, kuhlalutyo lokuhlola oluchazwe kwangaphambili oluvela kwi-NAVIGATOR, i-TEZSPIRE ibonise ukusebenza okuhambelanayo unyaka wonke kungakhathaliseki ixesha lonyaka. I-2% (ekwindla) xa kuthelekiswa ne-placebo.63 Umlinganiselo wezigulane ezinokwenyuka wawuphantsi kwiqela le-TEZSPIRE kuneqela le-placebo kuwo onke amaxesha onyaka.46
"Uninzi lwezigulana ezibukhali ze-asthma zinabaqhubi abaninzi bokudumba, okubangelwa zizifo, usulelo lwentsholongwane kunye nebhaktiriya, kunye nongcoliseko lomoya, zonke ezinokuthi zibe negalelo ekwandeni okuqhubekayo. Ezi ziphumo zitsha zibonisa amandla e-TEZSPIRE okunciphisa ukunyanzeliswa kwe-asthma enzima kwizigulane kungakhathaliseki amanqanaba e-biomarker kunye nezinto ezibangela ixesha lonyaka, "watsho uGqr Jonathan Corren, ilungu le-clinical faculty kwi-David Geffen School of Medicine, UCLA, kunye nomphandi oyintloko wolingo lwe-PATHWAY.
"Siyavuya ukuqhubeka sibona izigulane zifumana ukuhlaselwa kwe-asthma embalwa emva kokunyangwa kunye ne-TEZSPIRE ngokusekelwe kwiziphumo ezivela kuhlalutyo lwamva nje kwi-NAVIGATOR kunye ne-PATHWAY izilingo," kusho uDavid M. Reese, MD, umongameli oyintloko woPhando kunye noPhuhliso e-Amgen. "Ezi ziphumo zomeleza ngakumbi inkolelo yethu yokuba i-TEZSPIRE inamandla okuba liyeza lokuguqula abantu abaphila ne-asthma enzima kungakhathaliseki ixesha lonyaka okanye uhlobo oluthile lwe-asthma enzima."
Ezi ziphumo zinikezelwa kwi-2022 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.
I-TEZSPIRE ivunyiwe e-United States kunyango lwe-asthma enzima kwaye iphantsi kohlaziyo lolawulo kwi-EU, eJapan kunye namanye amazwe amaninzi emhlabeni jikelele.
INTO ONOKUYITHATHA KWELI NQAKU:
- Kuhlalutyo oluhlanganisiweyo, i-TEZSPIRE, xa yongezwa kumgangatho wokunyamekela (i-SoC), ukunciphisa ukunyuka kwe-asthma kwizigulane, kungakhathaliseki ukubala kwe-eosinophil yegazi esisiseko, kubonisa ukusebenza okuhambelanayo kunye ne-71% (≥300 iiseli nge-microliter nganye), i-48% (<300 iiseli nge-microliter nganye) kunye ne-48% (<150 iiseli nge-microliter) ukunciphisa kwi-AAER kwiiveki ze-52, xa kuthelekiswa ne-placebo eyongezwe kwi-SoC.
- “Ezi ziphumo zomeleza ngakumbi inkolelo yethu yokuba i-TEZSPIRE inamandla okuba liyeza lokuguqula abantu abanesifo sombefu esiqatha kungakhathaliseki ixesha lonyaka okanye uhlobo oluthile lwesifuba esinzima.
- I-TEZSPIRE ivunyiwe e-United States kunyango lwe-asthma enzima kwaye iphantsi kohlaziyo lolawulo kwi-EU, eJapan kunye namanye amazwe amaninzi emhlabeni jikelele.
