Iziguli ezine-ulcerative colitis (UC) ezithatha i-mirikizumab zathola amazinga aphezulu ngokwezibalo okuxolelwa emtholampilo emasontweni ayi-12 uma kuqhathaniswa neziguli ezithatha i-placebo ocwaningweni olubalulekile lwe-LUCENT-1 lweSigaba sesi-3 se-Eli Lilly kanye neNkampani. Iziguli ezithathe i-mirikizumab ziphinde zazuza ukuthuthuka okuphawulekayo kwezibalo kuzo zonke iziphetho ezibalulekile ezihlanganisa umtholampilo, izimpawu, i-endoscopic kanye nezinyathelo ze-histologic (izinga leselula lethishu), uma kuqhathaniswa nalezo ezithatha i-placebo. Imiphumela evela ocwaningweni lokungeniswa kwekilasi lokuqala luka-Lilly yethulwa cishe ku-17th Congress ye-European Crohn's and Colitis Organization (ECCO), eyenzeka Feb. 16-19, 2022.

"Abantu abane-ulcerative colitis banokuvuvukala kwe-mucosal ku-colon, okubangela ukopha kwe-rectal, ukuhamba njalo endlini yokugezela kanye nesidingo esiphuthumayo sokuphuma kwamathumbu," kusho uGeert D'Haens, MD, Ph.D., umbhali oholayo kanye noProfessor. weGastroenterology e-Amsterdam University Medical Centers. "I-Mirikizumab inamandla okunciphisa kakhulu ukuvuvukala, isize abantu ukuthi bakhululeke futhi banciphise ukuphuthuma kwamathumbu, okuwumphumela omusha, ogxile esigulini ongakaze ufundwe ngaphambili ocwaningweni lweSigaba 3 se-ulcerative colitis."

Lolu cwaningo lwembulunga yonke lweziguli eziyi-1,162 lwaluhlanganisa iziguli ezingakaze zizame ukwelashwa kwe-biologic (i-biologic-naïve) kanye neziguli ezinzima ukwelapha ezazike zathatha i-biologic ehlulekile. Isiguli esisodwa kwezine eselashwe nge-mirikizumab (24.2%, n=210/868) safinyelela isiphetho esiyinhloko sokukhululeka emtholampilo emasontweni ayi-12, uma kuqhathaniswa nesisodwa kweziyisikhombisa ku-placebo (13.3%, n= 39/294, p=0.00006), okubonisa ukukhululeka kwezimpawu okuthuthukisiwe nokuxazululwa noma ukuxazulula okuseduze kokuvuvukala. Cishe izingxenye ezimbili kwezintathu zeziguli ezithatha i-mirikizumab (63.5%, n=551/868) zathola impendulo yomtholampilo, uma kuqhathaniswa nengxenye engaphansi kwengxenye yeziguli eziphathwe nge-placebo (42.2%, n=124/294, p<0.00001). Ukuze uthole indlela yokwenza, bheka isigaba esingezansi esithi “Mayelana ne-LUCENT-1 Study”.

Cishe uhhafu weziguli ezithatha i-mirikizumab (45.5%, n=395/868) zithole ukukhululwa okubonakalayo emasontweni ayi-12, uma kuqhathaniswa nengxenye engaphansi kwengxenye yesithathu yeziguli ezithatha i-placebo (27.9%, n=82/294, p<0.001). Ekuqaleni kwamasonto amane, ngaphezu kwesiguli esisodwa kweziyisihlanu esathatha i-mirikizumab (21.8%, n=189/868) saba nokuthuthuka okusheshayo kwezimpawu zabo, uma kuqhathaniswa nesiguli esisodwa kweziyisishiyagalombili ezithatha i-placebo (12.9%, n=38) /294, p<0.001).

Ngokushesha nje emavikini amabili futhi zaqhubeka emasontweni ayi-12, iziguli ezelashwa nge-mirikizumab zaba nokuncipha okukhulu ngokwezibalo esikalini sokuqina samathumbu samaphuzu ayi-11. Emasontweni angu-12, iziguli zinesilinganiso sokunciphisa amaphuzu we-2.59 (2.32 kuya ku-2.85), uma kuqhathaniswa nokunciphisa isilinganiso samaphuzu we-1.63 (1.18 kuya ku-2.09) ezigulini eziku-placebo (p<0.00001). Isiphetho sokuphuthuma kwamathumbu emavikini angu-2 sachazwa kusengaphambili kodwa asizange silawulwe ukuphindaphindeka.

Iphrofayili yokuphepha iyonke yayifana naleyo yocwaningo lwangaphambili lwe-mirikizumab ku-UC futhi ihambisana naleyo yamanye amasosha omzimba alwa ne-IL-23p19 kwezinye izindawo zokwelapha. Iziguli ezithatha i-mirikizumab, uma kuqhathaniswa nalezo eziku-placebo, zibike imvamisa ephansi yezehlakalo ezimbi kakhulu (i-mirikizumab: 2.8%, n=27; i-placebo: 5.3%, n=17) futhi mancane amathuba okuba ziluyeke ucwaningo ngenxa yezehlakalo ezimbi ( i-mirikizumab: 1.6%, n=15; i-placebo: 7.2%, n=23).

LOKHO ONGAKUTHATHE KULESI SIHLOKO:

In as early as two weeks and sustained through 12 weeks, patients treated with mirikizumab had a statistically significant reduction on an 11-point bowel urgency severity scale.
“Mirikizumab has the potential to significantly reduce inflammation, help people achieve remission and reduce bowel urgency, which is a novel, patient-centric outcome that hasn’t been studied before in a Phase 3 trial for ulcerative colitis.
Patients with moderately-to-severely active ulcerative colitis (UC) who took mirikizumab achieved statistically superior rates of clinical remission at 12 weeks compared to patients taking placebo in Eli Lilly and Company’s pivotal LUCENT-1 Phase 3 study.