biostudies-literatureUnknown332(11)Louis E<h4>Importance</h4>The clinical effects of risankizumab (a monoclonal antibody that selectively targets the p19 subunit of IL-23) for the treatment of ulcerative colitis are unknown.<h4>Objective</h4>To evaluate the efficacy and safety of risankizumab when administered as an induction and a maintenance therapy for patients with ulcerative colitis.<h4>Design, setting, and participants</h4>Two phase 3 randomized clinical trials were conducted. The induction trial was conducted at 261 clinical centers (in 41 countries) and enrolled 977 patients from November 5, 2020, to August 4, 2022 (final follow-up on May 16, 2023). The maintenance trial was conducted at 238 clinical centers (in 37 countries) and enrolled 754 patients from August 28, 2018, to March 30, 2022 (final follow-up on April 11, 20JAMA881-897https://www.ebi.ac.uk/biostudies/studies/S-EPMC11264075biostudies-literatureRisankizumab for Ulcerative Colitis: Two Randomized Clinical Trials.PMC11264075Portela FMantzaris GCastro Laria LSamson JMPatel Bvan Zyl JEsaki MChang CHRajabally MVera Mendoza MShu LLuzza FOhmiya NGoldis APivorunas VAsonuma KLodhia NSchreiber SLopes SAguilar HZhan QIguchi MMunck LWright JFriedenberg KPatel KKatz LSiffledeen JLutgens MGiannini EGToyokawa TAltwegg RSaito DEdin AHu NHasselblatt PVarela Trastoy PCummings FGarcia Lopez SOzeki KReinisch WPenchev PSasaki MSchock JSeicean ADurina JPoulsen ABoland BOka SPrivitera ASujino TPetryka RSaruta MHong JBaert FMinistro PLing KLParkes GChou JWPanaccione RKjeldsen JGasbarrini AMatsushima KMatsushima MChiplunker AKim TOMertens JUenoyama YFlamant MCao QRomanczyk TCheon JHGinsburg PStanchev DSaibeni SMisselwitz BAlfaro IMushahwar ABiedermann LKierkus JMartin Arranz MDZisman TMcNeil DKuge HSturm AYasuda HJovanovic IBalaz JTu CHVerma DDeppe HKopon AChen YChen SWaked ITalarek MRicaurte JGearry RNakamura MTanaka HTakeuchi KGreenbloom SBarnes MDuVall GAMotoya SLahat-Zok ATsarynna NIshiguro YAtkinson KLi YBoland BSArmuzzi AZhong JDerovs ASiddiqui JAbe YRafalskiy VHisamatsu TWallace KSuzuki TLiu MSoykan IColombel JFNishida ATakedatsu HGoncalves TRan ZIshigami KLordal MVangeli MBessissow THou XMross MAgafina ASharapova KAtreya RD'Haens GZou XPeyrin-Biroulet LColecchia AGoncalves SRuffinengo OKuo CJTakatsu NHeeren SMaemoto ARydzewska-Wyszkowska GD'Cunha RPinzon Te LLWeber JSassaki LPhillips RRosa JMayoral JAlvarez ETokito STzouvala MLim AGriffiths BHou JNakai KZhang XINSPIRE and COMMAND Study GroupJonaitis LKashnikov VTreton XLiu FKalabic JZhang GHoriki NGettueva MShah NKlaus JZhang JZhang HVanasek TBrooker JSwaminath AValenzuela CAvni-Biron ILaharie DDeetlefs ENeimark EOjeas HCicala MKapur SSu LCEszyk JSanchez Gonzalez YLungen LNaumann AKapur KAlkim HKravchenko TGeccherle ASugimoto KDelgado BTarabar DLoftus EAn POchiai TLoftus EVHassanein TReindl WNishimata NKrause TBeck KDiGiovanna MHebuterne XLevine HEcharri Piudo AMelmed GYLasa JTavares HLevine PYounes ZAl Bawardy BStokesberry DRegula JFrancesconi CSawah HGerasimova EManolakopoulos SAnanthakrishnan ADalal SKim DDalal RKerman DSmolyarchuk EJang BISikorski PLee JRahier JFYokoyama KVarganova DMasuda TGrgov SParra RBorzan VRoblin XKang SBTakatori HCheng LSteel ATang TUlbrych JHirai FKucharzik TKent ABalderramo DFranchimont DLouis ESiegmund BAberra FFumery MBullock JHuilgol VDiculescu MMSpeight RKrznaric ZLee KMGionchetti PFreedland CWu KFukuda KFerrante MVyshyvanyuk VLachance JRKobayashi TAhmad THiggins PBossuyt PSchubert SSchiefke IFujii TGregus MKamikozuru KArdizzone SNovillo AKazenaite EWalsen GNishikawa TErzin YSegal AIto HSarles HWang XPukitis AAoyama NShulman SNakajima KPouzar JKleczkowski DYamamoto TBamias GPark DIInns SDewit OKandulski AKakuta YMelmed GEndo YKaser AGao XBerkelhammer CYang SSedghi SOhnishi YShimizu MInamdar NDrobne DDuan WRLaclav MPeter JKoutroubakis IColard ABortlik MGoldin ESvoboda PCosintino RKato JKim YHHernandez Ramirez VLin CPKawanishi TSalem OSchultz MCerqueira RBeaton MMatsuoka KAli EPuljiz ZSong GAHisanaga YSvorcan PKaiser Junior RMonteleone GfalseRisankizumab for Ulcerative Colitis: Two Randomized Clinical Trials.<h4>Importance</h4>The clinical effects of risankizumab (a monoclonal antibody that selectively targets the p19 subunit of IL-23) for the treatment of ulcerative colitis are unknown.<h4>Objective</h4>To evaluate the efficacy and safety of risankizumab when administered as an induction and a maintenance therapy for patients with ulcerative colitis.<h4>Design, setting, and participants</h4>Two phase 3 randomized clinical trials were conducted. The induction trial was conducted at 261 clinical centers (in 41 countries) and enrolled 977 patients from November 5, 2020, to August 4, 2022 (final follow-up on May 16, 2023). The maintenance trial was conducted at 238 clinical centers (in 37 countries) and enrolled 754 patients from August 28, 2018, to March 30, 2022 (final follow-up on April 11, 202024-01-01T00:00:00Z2024 Sep2026-06-03T04:47:48.154Z2026-04-24T03:13:53.498ZS-EPMC112640753903780010.1001/jama.2024.12414