I-Janssen Pharmaceutical Companies of Johnson & Johnson namuhla imemezele imiphumela emisha evela ocwaningweni lomtholampilo lweSigaba 2 GALAXI 1 olubonisa iningi (amaphesenti angama-57.4-73) labantu abadala abanesifo sika-Crohn's (CD) esisebenza ngokusesilinganisweni ukuya esibi kakhulu abalashwe nge-TREMFYA® (guselkumab) ifinyelelwe ekukhululweni komtholampilo (I-Crohn's Disease Activity Index [CDAI]<150)a ngeviki 48.1 Imiphumela yesonto lama-48 iphinde ibonise iningi (amaphesenti angu-57.4-73) eziguli ezithole ukukhululwa emtholampilo nge-TREMFYA zazingenalo ukwelashwa kwe-corticosteroid.1,b TREMFYA okwamanje akugunyaziwe ukwelashwa kwe-CD e-US2 Le datha yethulwa namuhla njengesethulo somlomo (OP24) eNgqungqutheleni ye-17 ye-European Crohn's and Colitis Organisation (ECCO), eyenzeka cishe kusukela ngoFebhuwari 16-19.1

"Le datha ye-GALAXI 48 yamasonto angu-1 imele isinyathelo esikhulu ekuthuthukisweni kwe-TREMFYA," kusho umbhali wocwaningo owethulayo uSolwazi Silvio Danese, uMqondisi, i-Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele kanye ne-University Vita-Salute San Raffaele, eMilan, e-Italy.c "Ngaphezu kwalokho, ukuxolelwa kwakufinyeleleka ezigulini kulolu cwaningo ngaphandle kwe-corticosteroids, okubalulekile ukuqaphela njengoba ukugwema ukusetshenziswa kwe-steroid isikhathi eside kuwukucatshangelwa okubalulekile lapho ukwelapha lezi ziguli."

Imiphumela yeviki lama-48 ikhonjisiwe

• Ukukhululwa komtholampilo: amaphesenti angu-63.9 eziguli ezelashwa nge-TREMFYA 200 mg intravenous (IV)/100 mg subcutaneous (SC), amaphesenti angu-73 elashwa nge-TREMFYA 600 mg IV/200 mg SC kanye namaphesenti angu-57.4 alashwe nge-TREMFYA 1200 mg IV/200 mg I-SC yazuza ukukhululwa komtholampilo.1, a Nge-STELARA® (ustekinumab), eyayisetshenziswa njengengalo yokubhekisela, amaphesenti angu-58.7 eziguli athola ukukhululwa komtholampilo.1 Ucwaningo aluzange lunikezwe amandla okuhlola umehluko phakathi kwamaqembu okwelapha.1

• I-Corticosteroid-free Clinical Remission: b Amaphesenti angu-59 eziguli elashwe nge-TREMFYA 200 mg IV/100 mg SC, amaphesenti angu-71.4 alashwa nge-TREMFYA 600 mg IV/200 mg SC, kanye namaphesenti angu-55.7 alashwe nge-TREMFYA 1200 mg IV/200 mg SC, kuzuzwe ukukhululwa komtholampilo kwamahhala kwe-corticosteroid (i-CDAI <150 futhi akukho ukwelashwa kwe-corticosteroid ngeviki lama-48). Ingxenye yeziguli eqenjini le-STELARA yayingamaphesenti angama-58.7

• Umphumela Obikiwe Ngesiguli (PRO)-2 remission: e Amaphesenti angu-57.4 eziguli ezelashwe nge-TREMFYA 200 mg IV/100 mg SC, amaphesenti angu-69.8 elashwe nge-TREMFYA 600 mg IV/200 mg SC, kanye nama-50.8 aphathwa nge-TREMFYA 1200 mg IV/ 200 mg SC ithole ukuxolelwa kwe-PRO-2,e Ingxenye yeziguli eqenjini le-STELARA yayingamaphesenti angama-1

Wonke amaqembu omthamo we-TREMFYA ngesikhathi sokwelashwa kwamasonto angu-48 ku-GALAXI 1 ayenedatha yokuphepha efanayo, ehambisana nephrofayili eyaziwayo yokuphepha ye-TREMFYA ezinkomba ezivunyelwe.1,2 Amazinga omcimbi obalulekile wokuphepha ayefana phakathi kwamaqembu amathathu e-dosing.1 Ku-TREMFYA 200 mg IV/100 mg SC, 600 mg IV/200 mg SC, 1200 mg IV/200 mg SC kanye namaqembu e-STELARA, izehlakalo ezingezinhle (AEs) zenzeke ngamaphesenti angu-71.2, amaphesenti angu-80.8, amaphesenti angu-69.9, namaphesenti angu-84.5, ngokulandelana.1 Izehlakalo ezimbi kakhulu (ama-SAE) zenzeke kumaphesenti angu-8.2, amaphesenti angu-6.8, amaphesenti angu-6.8, namaphesenti angu-12.7 ngokulandelana.1 Azikho izifo ezingosomathuba, izigameko zesifo sofuba, noma ukufa kwabikwa kunoma yiliphi iqembu.1 Ukutheleleka kwenzeka ngamaphesenti angu-34.2, amaphesenti angu-41.1, Amaphesenti angu-34.2, namaphesenti angu-36.6, ngokulandelana.1 Izifo ezinzima zenzeke ngamaphesenti angu-2.7, angu-2.7, amaphesenti angu-1.4, nangu-1.4, ngokulandelana.1

"Ngesimo esiqhubekayo sempilo yonke njengesifo sika-Crohn, kubalulekile ukuphenya izindlela ezintsha zokwelapha ezingase zibe khona ngokuqonda ukuthi ukuxolelwa kuwumgomo omkhulu," kusho u-Jan Wehkamp, MD, Ph.D., Vice President, Gastroenterology Disease Area Leader, Janssen Research & Development, LLC. "Le datha emisha igcizelela ukuzibophezela okuqhubekayo kukaJanssen ekuphenyeni isayensi yezindlela ne-TREMFYA ekuthuthukisweni kwezindlela zokwelapha ezengeziwe ezingase zibhekane nezinhlobo eziningi zezifo ezithathelwana ngomzimba njengesifo sikaCrohn."

U-Janssen umemezele ngaphambilini imiphumela yohlaziyo lwesikhashana lwamasonto ayi-12 kanye nedatha ephezulu yamaviki angama-48 evela ocwaningweni lweSigaba sesi-2 se-GALAXI.3,4 Izivivinyo zemitholampilo zeSigaba se-3 ezihlola i-TREMFYA yokwelashwa kwe-CD emaphakathi ukuya konamandla kakhulu ziyaqhubeka futhi zibhalisa ababambiqhaza ngenkuthalo. . Funda kabanzi nge-Janssen Global Trial Finder.

LOKHO ONGAKUTHATHE KULESI SIHLOKO:

All TREMFYA dose groups during the 48-week treatment period in GALAXI 1 had comparable safety data, consistent with the known safety profile for TREMFYA in approved indications.
1 In the TREMFYA 200 mg IV/100 mg SC, 600 mg IV/200 mg SC, 1200 mg IV/200 mg SC and STELARA groups, adverse events (AEs) occurred in 71.
9 percent of patients treated with TREMFYA 200 mg intravenous (IV)/100 mg subcutaneous (SC), 73 percent treated with TREMFYA 600 mg IV/200 mg SC and 57.