ISISHWANKATHELO

I-Tildrakizumab yoNyango lwe-Psoriasis ye-Plaque ePhakathi-ukuya-eMandundu: Ngaba i-Sun Pharma's 'Ilumya' inokuba luKhetho olungcono?

I-Tildrakizumab iyathengiswa yi Ilanga Pharma phantsi kwegama lokurhweba i-Ilumya, kwaye ivunyiwe yi-FDA ngo-Matshi 2018 emva kokuhlalutya kwedatha evela kwiSigaba sesi-III se-multi-centre, i-randomized, i-placebo-controlled controlled trial trials reSURFACE 1 kunye ne-RESURFACE 2. Zomibini izifundo zifezekise isiphelo sokuqala ubuncinane kwi-75% yokukhutshwa kwesikhumba njengoko kulinganiswe ngamanqaku e-PASI kunye ne-PGA. Imvume evela kwiKhomishini yaseYurophu kunye ne-TGA, e-Australia yafika ngoSeptemba 2018. Ngokusekelwe kwiklinikhi kunye neendleko ezifanelekileyo ze-Ilumya, i-NICE, i-UK ikhuthaze ukusetyenziswa kwe-tildrakizumab kwi-2019 yonyango lwe-psoriasis enzima.

I-Plaque psoriasis sisifo sokudumba kwe-autoimmune esichaphazela abantu abamalunga nezigidi ezili-125 kwihlabathi liphela. Uninzi lweempawu eziqhelekileyo ziquka amabala abomvu kwiindawo zolusu, kuquka amadolo, ingqiniba, isikhumba sentloko okanye umqolo ongezantsi, eziye zidumbe kwaye zirhawuzelelwe kwaye zibuhlungu. I-80% yabantu abosulelwa sesi sifo baneempawu ezincinci ukuya kweziphakathi ngelixa i-20% inesimo esibi kakhulu isifo apho amacwecwe aqhekeka akhokelela ekopheni kunye nokungonwabi ngakumbi. I-Psoriasis ineempembelelo ezibalulekileyo kwezentlalo kunye nezoqoqosho kwizigulana eziphethwe sesi sifo. Umgangatho wobomi uchaphazeleka kanobom njengoko isigulana sikhula ngokudakumba kunye notyekelo lokuzibulala ngenxa yabantu 'abaqhelekileyo' abagcina umgama phakathi kwabo bosulelekileyo kubabangela ukuba bazive beneentloni kwaye bebashiya benxunguphele ngakumbi.

Iintlobo ngeentlobo zonyango ziyafumaneka kwi-psoriasis ngokuxhomekeke kubunzima beempawu. Ibandakanya unyango olusentloko kusetyenziswa izithambiso zolusu, ifototherapy, apho ulusu luvezwa kukukhanya kwe-UV kunye namayeza enkqubo ebandakanya amaziko ekhemikhali kunye nezinto zebhayoloji ezifana nezilwa-buhlungu.

Unyango lwebhayoloji kwi-vogue ye-psoriasis lubandakanya amajoni omzimba anjenge-etanercept, adalimumab, infliximab, ustekinumab kunye tildakizumab ukubalula ezimbalwa. Ezi zithinteli zisebenza ngokunciphisa ukudumba ngokujolisa kwiiseli ezisebenza ngokugqithisileyo zomkhosi wokhuselo lomzimba. Unyango lwebhayoloji luhlala lusetyenziswa kwiimeko ezinzima ze-psoriasis xa izigulane zingaphenduli kolunye unyango olukhankanywe ngasentla.

Phakathi kwamaqumrhu ebhayoloji asetyenziselwa unyango lwe-psoriasis, i-tildrakizumab ibonakala iyeyona isebenzayo malunga nokunciphisa iimpawu kunye neendleko zayo. Iziphumo zolingo lwezonyango zibonise ukuba i-tildrakizumab iphucula i-plaque enzima Psoriasis xa kuthelekiswa ne-placebo okanye i-etanercept enophuculo oluphawulweyo olubonwa kwiiveki ezingama-28. Ngaphezu koko, i-tildrakizumab ibonakala isebenza njengeadalimumab kunye ne-ustekinumab. Ngokubhekiselele kwiindleko, i-tildrakizumand ine-18% yeendleko ezingaphezulu kune-adalimumab rhoqo ngenyanga ekhokelela ekunciphiseni okukhulu kweendleko kwixesha leminyaka emihlanu.

I-Tildrakizumab iyathengiswa yi ilanga Pharms phantsi kwegama lorhwebo Ilumya, kwaye ivunyiwe yi-FDA ngo-Matshi 2018 emva kokuhlalutya kwedatha kwiSigaba se-III se-multi-centre, i-randomized, i-placebo-controlled controlled trial trials RESURFACE 1 kunye ne-RESURFACE 2. Zomibini izifundo zifumene isiphelo sokuqala ubuncinane kwi-75% yokukhutshwa kwesikhumba njengoko kulinganisiwe. ngamanqaku ePASI kunye nePGA. Imvume evela kwiKhomishini yaseYurophu kunye ne-TGA, e-Australia yafika ngoSeptemba 2018. Ngokusekelwe kwiklinikhi kunye neendleko ezifanelekileyo ze-Ilumya, i-NICE, i-UK ikhuthaze ukusetyenziswa kwe-tildrakizumab kwi-2019 yonyango lwe-psoriasis enzima.

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