A watan Nuwamban 2017, FDA ta amince da Fasenra na nazari don magance fuka-fizin eosinophilic
A watan Nuwambar 2017, FDA ta amince da sabon tsarin nazarin maganin babban sakari na asibiti zuwa flamme eosinophilic (watau eosinophilic fuka) da ake kira benralizumab (Fasenra).
Bisa ga NIH, wakili na halitta "abu ne da aka yi daga kwayoyin halitta ko kayansa kuma ana amfani dasu a cikin rigakafi, ganewa, ko maganin ciwon daji da sauran cututtuka.
Ma'aikata na kwayoyin halitta sun hada da kwayoyin cuta, interleukins, da maganin alurar rigakafi. "Ana iya kiran mai daukar nauyin kwayar halitta ko dai wani wakili ne, kwayoyin halitta, ko kwayoyin halitta.
A dukan duniya, kimanin mutane miliyan 315 suna da asma. Daga cikin wadannan mutane, tsakanin kashi biyar da 10 bisa dari na da ciwon sukari mai tsanani kuma, idan ya cancanta, zai iya amfana daga yin amfani da kwayar halitta.
Ta yaya Fasenra Zai Yi aiki?
Don fahimtar yadda Fasenra ke aiki, yana da muhimmanci a bincika dangantakar dake tsakanin eosinophils, wani nau'in jini na jini, da kuma asma. Yawancin lokaci, eosinophils kare mu daga tsutsotsi na parasitic. Lokacin da aka ba da izini ba, duk da haka, eosinophils zai iya lalata kyallen takarda kuma haifar da asma. Ayyukan eosinophil da aikin suna amfani da cytokine da ake kira interleukin-5 (IL-5).
Fasenra ne mai rikici guda daya wanda ke aiki a kan masu karɓar IL-5 a kan eosinphils. A cikin wani labarin 2015 da aka wallafa a cikin Labaran Harkokin Kula da Lafiya na Yanzu , Goldman da mawallafa sunyi bayanin haka: "Benralizumab [Fasenra] ya jawo hanzari, da sauri, da kusan cikakkiyar ƙarancin eosinophils ta hanyar cytotoxicity mai sassaucin kwayar halitta, wanda ke da alaka da kwayoyin halitta, wani tsari na apoptotic na eosinophil kawarwa shafe kwayoyin kisa Kwayoyin. "Bisa ga mahimmanci, Fasenra ya kaddamar da kawar da eosinophils.
Sauran cututtukan guda guda guda biyu da suka hada da IL-5-mepolizumab (Nucala) da reslizumab (Cinqair) -bind IL-5 kuma ta haka ne ke haifar da ragowar eosinophil ta hanyoyi masu ma'ana da kuma kai tsaye. Abin mahimmanci, kamar Fasenra, duka biyu da Nucala da Cinqair sune ƙwayar cutar.
ZONDA Clinical Trial
A lokacin gwaje-gwaje na III na gwajin, masu bincike na AstraZeneca sun yi la'akari da cewa Fasenra na iya rage yawan bukatar guracocorticoid maganin kulawa da kula da ciwon fuka a cikin marasa lafiya da ciwon eosinophilia, ko karuwa a yawan adadin eosinophils a cikin jini.
Abu mai mahimmanci, maganin lokaci mai tsawo tare da tsarin jiki, ko na baki, glucocorticoids yana da mummunan sakamako masu illa wanda ya shafi musculoskeletal, endocrin, na zuciya da jijiyoyin zuciya, da kuma na tsakiya masu juyayi. Mutanen da suke daukar glucocorticoids na maganganu na dogon lokaci suna samun ragowar rayuwa. Abin takaici, tsakanin 32 da 45 bisa dari na mutanen da ke fama da ciwon sukari mai tsanani da suka riga sun dauki kwayoyin glucocorticoids da kuma bronchodilators sun dogara ne akan saurin (gwargwado) maganin glucocorticoid magance fuka.
A cikin gwajin ta ZONDA, an shigar da mutane 369, kuma 220 daga cikin wadannan marasa lafiya sun shiga cikin kungiyoyi uku. A lokacin gwajin makonni 28, ƙungiyar gwaji na farko sun sami asibiti na Fasenra a cikin kowane mako hudu, ƙungiyar gwaji na biyu sun sami asibiti na Fasenra a kowane mako takwas, kuma rukunin kulawa sun sami asibiti. Bugu da ƙari, masu bincike sun rage yawan glucocorticoid maganin da dukkanin kungiyoyi uku suka dauka zuwa matakin da ake bukata don sarrafa fuka. Masu bincike kuma sun tantance lokuttan da suka dace da ƙwaƙwalwar fuka-fuka na yau da kullum, aiki mai kwakwalwa, bayyanar cututtuka, da aminci.
A nan ne sakamakon gwaji na asibiti:
- A cikin ƙungiyoyi masu gwaji sunyi Fasenra, magungunan karshe na tsakiya na glucocorticoid sun kasance kashi 75 cikin dari na ƙasa fiye da wadanda ke da tushe.
- A cikin rukuni na wuribo, kashi na karshe na tsakiya na glucocorticoid ya kasance kashi 25 cikin dari na ƙasa fiye da wadanda ke da tushe.
- Masu shiga Fasenra sun fi sau sau hudu suna iya samun raguwa na glucocorticoid na gwargwadon wadanda suke karbar wuribo.
- A tsarin gwaji na shan Fasenra kowane mako hudu, haɗarin tarin fuka a kowace shekara ya ragu kashi 55 cikin dari idan aka kwatanta da na ƙungiyar kulawa.
- A cikin tsarin gwajin shan fasenra kowane mako takwas, yawan abin da ya faru na shekara-shekara na ƙwaƙwalwa a fuka ya ragu kashi 70 cikin dari idan aka kwatanta da na ƙungiyar kulawa.
- Ayyuka na huhu kamar yadda aka yi amfani da ƙararrawar ƙirar tilasta a cikin 1 na biyu (FEV1) ba ya bambanta da wadanda ke shan Fasenra ba idan aka kwatanta da wadanda suke shan wuri.
- Kashi hamsin bisa dari na marasa lafiya da ke karbar asali na asali (watau glucocorticoids), wanda basu da ko kuma daidai da 12.5 MG kowace rana, sun iya dakatar da yin amfani da glucocorticoids baki daya yayin shan Fasenra.
- Hanyoyi na kimanta yanayin halayen rayuwa na wadanda suke shan Fasenra idan aka kwatanta da wadanda suka shafe su. Wasu matakan sun nuna kyautatawa a cikin bayyanar cututtukan fuka, wasu kuma ba su nuna canji ba idan aka kwatanta da marasa lafiya.
- Hanyoyin da ke faruwa a cikin al'amuran da suka faru sun kasance kamar wadanda suke shan Fasenra da wadanda suke zaune, wanda ya nuna cewa Fasenra mai yiwuwa ne mai lafiya.
Don haka, mene ne fassarar tarin fuka take nufi? A cewar Nair da abokan aiki:
An nuna mummunan ƙwayar fuka da ciwo da ƙwayar fuka wanda ya haifar da ƙarar lokaci na tsawon glucocorticoid don akalla kwanaki 3 don magance alamar cutar, wani rahoto ta hanyar gaggawa wanda ya haifar da ciwon sukari wanda ya haifar da magani tare da glucocorticoid a madadin majinyar magunguna masu kulawa na yau da kullum, ko kuma asibiti na asibiti saboda fuka.
A lokacin gwajin ZONDA, mutane 166, ko kashi 75 cikin dari, na marasa lafiya da suka yi Fasenra sun sha kashi akalla sakamako guda ɗaya. A nan ne cutarwa na mummunar tasiri da aka gani a lokacin gwaji na asibiti:
- Nasopharyngitis (kashi 17)
- Kwanƙasar fuka (kashi 13)
- Bronchitis (kashi 10)
Na bayanin kula, nasopharyngitis yana nufin ƙonawa da hanci da kuma babbar hanyar jirgin sama. Kalmar sanyi ta yau da kullum tana nufin nasopharyngitis. Bronchitis yana nufin ƙonawa daga cikin ƙananan hanyoyi, ko kuma ƙuƙwarar daji a cikin huhu.
A cikakke, marasa lafiya 28 (kashi 13) sun san abin da masu bincike suka dauka cewa "mummunan cututtuka" -a mafi yawan yawan ciwon fuka. Sai kawai marasa lafiya guda biyu da suke shan Fasenra yana buƙatar dakatar da miyagun ƙwayoyi. Wadannan marasa lafiya guda biyu sun mutu a lokacin fitina amma sun haifar da rashin alaka da Fasenra-wanda ya yi rashin lafiya ya mutu saboda ciwon zuciya kuma ɗayan ya mutu da ciwon huhu. (Duk wadannan marasa lafiya suna da wasu cututtuka daban-daban.
Masu bincike sun tabbatar da cewa a cikin mutanen da ke fama da ciwon sukari mai tsanani, za a iya rage yawan aikin glucocorticoid a cikin wadanda suka karbi Fasenra a kowane mako takwas. Mafi mahimmanci, a cikin gwajin ZONDA, masu bincike sun gano cewa yawancin halayen ƙwayar fuka da aka yi a kowace shekara ya kasance a cikin mutanen da ke shan Fasenra a kowane mako takwas idan aka kwatanta da wadanda ke shan magani a kowane mako hudu.
Ƙarin Ƙaramar Gwaji
A cikin wasu gwaje-gwajen gwaji guda biyu da aka kira SIROCCO da CALIMA, masu bincike sun bincika fasinra Fasenra. A cikin wadannan gwaje-gwajen, waɗanda aka buga wasu watanni kafin sakamakon gwajin ZONDA, masu binciken sun gano cewa injections na Fasenra a kowane mako hudu ko takwas sun rage yawan tarin fuka, inganta aikin sutura (watau ƙãra ƙa'idar FEV1), inganta tsarin kula da alamun, kuma zubar da jinin jini a cikin marasa lafiya da ƙididdigar fiye da 300 kwayoyin / microliter. Bugu da ƙari, masu bincike sun gano cewa - duk da cewa ba a gwada gwaje-gwaje na lissafi ba - bazawar Fasenra a kowane mako takwas ya kasance ya fi tasiri fiye da ba da magani a kowane mako hudu. Abu mahimmanci, yin amfani da miyagun ƙwayoyi a kowane mako takwas ya rage nauyin shan magani a kan mai haƙuri.
Abin banmamaki, yayin gwajin ZONDA, kashi 20 cikin 100 na marasa lafiya da ke shan Fasenra ba su sami wani raguwa a cikin kwayoyin glucocorticoid na kwayoyin ba ko da yake jini eosinophil ya ƙidaya wadannan marasa lafiya sun kasance kamar wadanda suka fi raguwa a ginsinsu na glucocorticoid na karshe. Nair da abokan aiki sunyi zaton "watakila kasancewar zubar da jinin jini bazai iya gano eosinophil a matsayin kwayar maɓallin kullun a wasu marasa lafiya ba."
Yayin da aka gudanar da gwaje-gwajen SIROCCO da CALIMA, Goldman da masu bincike sun yi nazarin ko Fasenra zai iya rage yawan yawan tarin fuka a cikin marasa lafiya ba tare da la'akari da lissafin eosinophil ba. Masu binciken sun gano cewa a cikin mutanen da ke da ƙananan eosinophil fiye da ko daidai da 150 kwayoyin halitta / microliter-Fasenra "rage nauyin cututtuka da kula da lafiyar lafiyar mutanen da ke fama da wuya-da-bi da bi da iyakacin iyakar maganin."
Hakazalika, gwaje-gwaje na asibitoci da suka gabata sun nuna cewa wasu kwayoyin anti-IL-5 a halin yanzu a kasuwa, Nucala da Cinqair, suna da tasiri a cikin marasa lafiya da ƙananan eosinophil a cikin jini (watau mafi girma ko kuma daidai da 150 kwayoyin / microliter) .
Yawanci, daidaitattun zinariya don ganewar asali na fuka-fizin eosinophilic ya haɗa da nunawa da kumburi a cikin hanyoyi na lantarki wanda ya dogara ne akan nazarin kwayar halitta ko kuma sputum induced. Wadannan hanyoyin, duk da haka, suna da wuya a yi kuma suna buƙatar horo na musamman; Saboda haka, ba a yin amfani da su ba. Maimakon haka, likitoci na dogara ne akan ƙididdigar eosinophil, wanda ko da yake yana da faɗi game da ƙwayar ƙwayar ƙwayar fuka, ba cikakke ba ne. Bugu da ƙari kuma, ƙididdigar eosinophil ya bambanta sosai dangane da lokaci kuma suna kula da maganin corticosteroid.
A cewar Goldman da co-marubuta:
Sakamakon binciken yanzu yana tabbatar da yiwuwar yiwuwar gano maƙaryata mai yiwuwa ga masu amsawa zuwa farfadowa na eosinophil, dangane da ƙimar jini eosinophil na [kwayoyin kwayoyin halitta / microliter] kadai. Ƙarin cikakkun bayanai game da siffar eosinophilic wanda ya fi ƙarfin jini eosinophil yana buƙata wanda yana amfani da hade da halaye na asibiti (misali, polyposis na hanci), tare da lissafin eosinophil jini. Dole ne a auna ƙididdigar eosinophil na jini a lokuta da yawa don magance matsaloli masu canji wanda zai iya haifar da cututtukan da aka rasa don marasa lafiya tare da kumburi eosinophilic.
Fasenra vs. gasar
A halin yanzu, bashi ne yadda Fasenra ya kwarewa akan sauran ilimin halittu da ke da manufa IL-5: Nucala da Cinqair. A cikin wata kasida mai suna "Benralizumab don maganin fuka," Saco da marubuta sun rubuta cewa Fasenra yana buƙatar naƙasa fiye da Nucala da Cinqair. Duk da haka, masu bincike sun rubuta wadannan abubuwa game da kwatanta kwayoyi uku:
Wasu cigaba a cikin bayyanar cututtukan fuka-fuka da kuma rayuwa na rayuwa ta kasance tare da dukkanin kwayoyin halittu guda uku, amma mahimmancin asibiti na waɗannan haɓaka ba su da cikakkiyar bayani ... Har sai ingancin gwajin gwajin gwagwarmaya ya kwatanta sau uku, zabar daga cikinsu don maganin fushinophilic fuka ya kasance da wuya.
AstraZeneca, wanda shine makerin Fasenra, yayi niyya don farashin ƙwayar miyagun ƙwayoyi fiye da Nucala da Cinqair, da sauran ƙwayoyin ilimin IL-5 a halin yanzu a kasuwa. Ko da yake farashin kwayoyi sun bambanta bisa dalilai da dama, bisa ga wasu ƙididdigar, farashin Nucala kimanin $ 32,500 a kowace shekara, kuma Cinqair tana da farashin irin wannan. A ƙarshe, saboda Fasenra za a iya sarrafawa da yawa fiye da waɗannan nau'o'in halittu, farashin zai zama ƙasa.
> Sources:
> Goldman M et al. Ƙungiyar dake tsakanin sanadin eosinophil da jini da kuma benralizumab gameda tasiri ga marasa lafiya da tsananin ciwon sukari: subanalyses na Sashen na III na SIROCCO da na CALIMA. Binciken Lafiya na Yanzu da Rahoto . 2017; 33: 1605-1613. https://doi.org/10.1080/03007995.2017.1347091.
> Nair P et al. Cigaban Glucocorticoid-Sparing Effect of Benralizumab a cikin Tashin Asthma. Jaridar New England Journal of Medicine . 2017; 376: 2448-58. https://doi.org/10.1056/NEJMoa1703501.
> Saco TV et al. Benralizumab don maganin fuka. Binciken Masana na Clinical Pharmacology. Binciken Masana na Ciwon Imani . 2017; 13 (5): 405-413. http://www.tandfonline.com/doi/full/10.1080/1744666X.2017.1316194.
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