References
- AbrahamCChoJHInflammatory bowel diseaseN Engl J Med2009361212066207819923578
- XavierRJPodolskyDKUnravelling the pathogenesis of inflammatory bowel diseaseNature2007448715242743417653185
- FeaganBGRochonJFedorakRNMethotrexate for the treatment of Crohn’s disease. The North American Crohn’s Study Group InvestigatorsN Engl J Med199533252922977816064
- PresentDHKorelitzBIWischNGlassJLSacharDBPasternackBSTreatment of Crohn’s disease with 6-mercaptopurine. A long-term, randomized, double-blind studyN Engl J Med1980302189819876102739
- PelusoIPalloneFMonteleoneGInterleukin-12 and Th1 immune response in Crohn’s disease: pathogenetic relevance and therapeutic implicationWorld J Gastroenterol200612355606561017007011
- RyanCThrashBWarrenRBMenterAThe use of ustekinumab in autoimmune diseaseExpert Opin Biol Ther201010458760420218921
- LeonardiCLKimballABPappKAEfficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1)Lancet200837196251665167418486739
- PappKALangleyRGLebwohlMEfficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2)Lancet200837196251675168418486740
- McInnesIBKavanaughAGottliebABEfficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT 1 trialLancet2013382989478078923769296
- RitchlinCRahmanPKavanaughAEfficacy and safety of the anti-IL-12/23 p40 monoclonal antibody, ustekinumab, in patients with active psoriatic arthritis despite conventional non-biological and biological anti-tumour necrosis factor therapy: 6-month and 1-year results of the phase 3, multicentre, double-blind, placebo-controlled, randomised PSUMMIT 2 trialAnn Rheum Dis201473699099924482301
- Stelara® [package insert]Horsham, PAJanssen Biotech, Inc.32014 Available from: https://www.stelarainfo.com/pdf/prescribingin-formation.pdfAccessed August 9, 2016
- MannonPJFussIJMayerLAnti-interleukin-12 antibody for active Crohn’s diseaseN Engl J Med2004351202069207915537905
- SandbornWJGasinkCGaoLLUstekinumab induction and maintenance therapy in refractory Crohn’s diseaseN Engl J Med2012367161519152823075178
- SandbornWJFeaganBGFedorakRNA randomized trial of Ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with moderate-to-severe Crohn’s diseaseGastroenterology200813541130114118706417
- FDA Approves STELARA® (ustekinumab) for Treatment of Adults with Moderately to Severely Active Crohn’s Disease. Janssen Biotech, Inc. [press release]PR Newswire2016926 Available from: http://www.prnewswire.com/news-releases/fda-approves-stelara-ustekinumab-for-treatment-of-adults-with-moderately-to-severely-active-crohns-disease-300333868.htmlAccessed October 7, 2016
- TrinchieriGInterleukin-12 and the regulation of innate resistance and adaptive immunityNat Rev Immunol20033213314612563297
- KobayashiMFitzLRyanMIdentification and purification of natural killer cell stimulatory factor (NKSF), a cytokine with multiple biologic effects on human lymphocytesJ Exp Med198917038278452504877
- PreskyDHYangHMinettiLJA functional interleukin 12 receptor complex is composed of two beta-type cytokine receptor subunitsProc Natl Acad Sci U S A1996932414002140078943050
- ParhamCChiricaMTimansJA receptor for the heterodimeric cytokine IL-23 is composed of IL-12 Rbeta1 and a novel cytokine receptor subunit, IL-23RJ Immunol2002168115699570812023369
- AggarwalSGhilardiNXieMHde SauvageFJGurneyALInterleukin-23 promotes a distinct CD4 T cell activation state characterized by the production of interleukin-17J Biol Chem200327831910191412417590
- WilsonNJBonifaceKChanJRDevelopment, cytokine profile and function of human interleukin 17-producing helper T cellsNat Immunol20078995095717676044
- DuvalletESemeranoLAssierEFalgaroneGBoissierMCInterleukin-23: a key cytokine in inflammatory diseasesAnn Med201143750351121585245
- GeremiaAArancibia-CarcamoCVFlemingMPIL-23-responsive innate lymphoid cells are increased in inflammatory bowel diseaseJ Exp Med201120861127113321576383
- BensonJMSachsCWTreacyGTherapeutic targeting of the IL-12/23 pathways: generation and characterization of ustekinumabNat Biotechnol201129761562421747388
- NeurathMFFussIKelsallBLStuberEStroberWAntibodies to interleukin 12 abrogate established experimental colitis in miceJ Exp Med19951825128112907595199
- UhligHHMcKenzieBSHueSDifferential activity of IL-12 and IL-23 in mucosal and systemic innate immune pathologyImmunity200625230931816919486
- BeckerCDornhoffHNeufertCCutting edge: IL-23 cross-regulates IL-12 production in T cell-dependent experimental colitisJ Immunol200617752760276416920909
- StroberWFussIJProinflammatory cytokines in the pathogenesis of inflammatory bowel diseasesGastroenterology201114061756176721530742
- NiederreiterLAdolphTEKaserAAnti-IL-12/23 in Crohn’s disease: bench and bedsideCurr Drug Targets201314121379138424138637
- WangWWangEQBalthasarJPMonoclonal antibody pharmacokinetics and pharmacodynamicsClin Pharmacol Ther200884554855818784655
- US FDA Center for Drug Evaluation and ResearchUstekinumab2013 Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125261s086lbl.pdfAccessed July 18, 2016
- GottliebABCooperKDMcCormickTSA phase 1, double-blind, placebo-controlled study evaluating single subcutaneous administrations of a human interleukin-12/23 monoclonal antibody in subjects with plaque psoriasisCurr Med Res Opin20072351081109217519075
- OrdasIMouldDRFeaganBGSandbornWJAnti-TNF monoclonal antibodies in inflammatory bowel disease: pharmacokinetics-based dosing paradigmsClin Pharmacol Ther201291463564622357456
- ZhuYHuCLuMPopulation pharmacokinetic modeling of ustekinumab, a human monoclonal antibody targeting IL-12/23p40, in patients with moderate to severe plaque psoriasisJ Clin Pharmacol200949216217519179295
- ZhouHDavisHMRisk-based strategy for the assessment of pharmacokinetic drug-drug interactions for therapeutic monoclonal antibodiesDrug Discov Today20091417–1889189819520183
- GriffithsCEStroberBEvan de KerkhofPComparison of ustekinumab and etanercept for moderate-to-severe psoriasisN Engl J Med2010362211812820071701
- ToedterGPBlankMLangYChenDSandbornWJde VilliersWJRelationship of C-reactive protein with clinical response after therapy with ustekinumab in Crohn’s diseaseAm J Gastroenterol2009104112768277319672253
- FeaganBGSandbornWJGasinkCUstekinumab as Induction and Maintenance Therapy for Crohn’s diseaseN Engl J Med2016 In Press
- SandbornWGasinkCBlankMO-001 A multicenter, double-blind, placebo-controlled phase 3 study of ustekinumab, a human IL-12/23P40 mAB, in moderate-service Crohn’s disease refractory to anti-TFNalpha: UNITI-1 (abstract)Inflamm Bowel Dis201622Suppl 1S1
- FeaganBGasinkCLangYOP054-LB4 A multicenter, double-blind, placebo-controlled Ph3 study of ustekinumab, a human monoclonal antibody to IL-12/23p40, in patients with moderately-severely active Crohn’s disease who are naïve or not refractory to anti-TNFa: UNITI-2 (abstract)United European Gastroenterol J2015362
- SandbornWFeaganBGGasinkC768 A phase 3 randomized, multicenter, double-blind, placebo-controlled study of ustekinumab maintenance therapy in moderate-severe Crohn’s disease patients: results from IM-UNITI (abstract)Gastroenterology20161504S157S158
- BatistaDDYadavSHarmsenWSSu1420 Ustekinumab treatment for Crohn’s disease in clinical practice: experience at a tertiary medical center (abstract)Gastroenterology20141465S-464S-465
- KopylovUAfifWCohenASubcutaneous ustekinumab for the treatment of anti-TNF resistant Crohn’s disease – the McGill experienceJ Crohns Colitis20148111516152224996483
- WilsPBouhnikYMichettiPSubcutaneous ustekinumab provides clinical benefit for two-thirds of patients with Crohn’s disease refractory to anti-tumor necrosis factor agentsClin Gastroenterol Hepatol2016142242250e241e24226432476
- KhorramiSGinardDMarin-JimenezIUstekinumab for the treatment of refractory Crohn’s disease: the Spanish experience in a large multicentre open-label cohortInflamm Bowel Dis20162271662166927306072
- AdedokunOXuZGasinkCPharmacokinetics and exposure-response relationships of intravenously administered ustekinumab during induction treatment in patients with Crohn’s disease: results from the UNITI-1 and UNITI-2 studies (abstract)J Crohns Colitis201610S23S24
- AdedokunOJXuZGasinkCSa1934 Pharmacokinetics and exposure-response relationships of ustekinumab during IV induction and SC maintenance treatment of patients with Crohn’s disease with ustekinumab: results from the UNITI-1, UNITI-2, and IM-UNITI studies (abstract)Gastroenterology20161504S408
- BattatRKopylovUBessissowTAssociation of ustekinumab trough concentrations with clinical, biochemical, and endoscopic outcomes (abstract)J Crohns Colitis201610S74
- LangowskiJLZhangXWuLIL-23 promotes tumour incidence and growthNature2006442710146146516688182
- BrundaMJLuistroLWarrierRRAntitumor and antimetastatic activity of interleukin 12 against murine tumorsJ Exp Med19931784122312308104230
- KhannaRFeaganBGUstekinumab for the treatment of Crohn’s diseaseImmunotherapy20135880381523902548
- PappKAGriffithsCEGordonKLong-term safety of ustekinumab in patients with moderate-to-severe psoriasis: final results from 5 years of follow-upBr J Dermatol2013168484485423301632
- PappKGottliebABNaldiLSafety surveillance for ustekinumab and other psoriasis treatments from the Psoriasis Longitudinal Assessment and Registry (PSOLAR)J Drugs Dermatol201514770671426151787
- HincheyJChavesCAppignaniBA reversible posterior leukoencephalopathy syndromeN Engl J Med199633484945008559202
- GrattonDSzaparyPGoyalKFakharzadehSGermainVSaltielPReversible posterior leukoencephalopathy syndrome in a patient treated with ustekinumab: case report and review of the literatureArch Dermatol2011147101197120221680761
- LoftusEVAugustinMBissonnetteRMo1884 prevalence of inflammatory bowel disease among patients with psoriasis and incidence of serious infections in this subset: results from the PSOLAR registry (abstract)Gastroenterology20161504S805
- RyanCLeonardiCLKruegerJGAssociation between biologic therapies for chronic plaque psoriasis and cardiovascular events: a meta-analysis of randomized controlled trialsJAMA2011306886487121862748
- BadatYMeissnerWGLaharieDDemyelination in a patient receiving ustekinumab for refractory Crohn’s diseaseJ Crohns Colitis2014891138113924572561
- McConnellRAMahadevanUUse of immunomodulators and biologics before, during, and after pregnancyInflamm Bowel Dis201622121322326444103
- MartinPLSachsCImaiNDevelopment in the cynomolgus macaque following administration of ustekinumab, a human anti-IL-12/23p40 monoclonal antibody, during pregnancy and lactationBirth Defects Res B Dev Reprod Toxicol201089535136320540088
- SchaufelbergBWHornECatherJRahawiKPregnancy outcomes in women exposed to ustekinumab in the psoriasis clinical development program (abstract)J Am Acad Dermatol2014705AB178
- MahadevanUMartinCKaneSVDubinskyMSandsBESandbornW437 Do infant serum levels of biologic agents at birth correlate with risk of adverse outcomes? Results from the PIANO registry (abstract)Gastroenterology20161504S91S92
- NguyenGCSeowCHMaxwellCThe Toronto consensus statements for the management of inflammatory bowel disease in pregnancyGastroenterology20161503734757.e73126688268
- DeepakPBruiningDHUpdate on the medical management of Crohn’s diseaseCurr Gastroenterol Rep201517114126363802
- TerdimanJPGrussCBHeidelbaughJJSultanSFalck-YtterYTAmerican gastroenterological association institute guideline on the use of thiopurines, methotrexate, and anti-TNF-alpha biologic drugs for the induction and maintenance of remission in inflammatory Crohn’s diseaseGastroenterology201314561459146324267474
- DingNSHartADe CruzPSystematic review: predicting and optimising response to anti-TNF therapy in Crohn’s disease – algorithm for practical managementAliment Pharmacol Ther2016431305126515897
- Ben-HorinSChowersYReview article: loss of response to anti-TNF treatments in Crohn’s diseaseAliment Pharmacol Ther201133998799521366636
- BillioudVSandbornWJPeyrin-BirouletLLoss of response and need for adalimumab dose intensification in Crohn’s disease: a systematic reviewAm J Gastroenterol2011106467468421407178
- SandsBEFeaganBGRutgeertsPEffects of vedolizumab induction therapy for patients with Crohn’s disease in whom tumor necrosis factor antagonist treatment failedGastroenterology20141473618627.e61324859203
- SandbornWJFeaganBGRutgeertsPVedolizumab as induction and maintenance therapy for Crohn’s diseaseN Engl J Med2013369871172123964933
- Ben-HorinSCasteeleNVSchreiberSLakatosPBiosimilars in inflammatory bowel disease: facts and fears of extrapolationClin Gastroenterol Hepatol2016 Epub521
- PapamichaelKVan StappenTJairathVReview article: pharmacological aspects of anti-TNF biosimilars in inflammatory bowel diseasesAliment Pharmacol Ther201542101158116926365281
- TillackCEhmannLMFriedrichMAnti-TNF antibody-induced psoriasiform skin lesions in patients with inflammatory bowel disease are characterised by interferon-gamma-expressing Th1 cells and IL-17A/IL-22-expressing Th17 cells and respond to anti-IL-12/IL-23 antibody treatmentGut201463456757723468464
- FrelingEBaumannCCunyJFCumulative incidence of, risk factors for, and outcome of dermatological complications of anti-TNF therapy in inflammatory bowel disease: a 14-year experienceAm J Gastroenterol201511081186119626195181
- GuerraIPerez-JeldresTIborraMIncidence, clinical characteristics, and management of psoriasis induced by anti-TNF therapy in patients with inflammatory bowel disease: a nationwide cohort studyInflamm Bowel Dis201622489490126933750
- FahmyMRamamoorthySHataTSandbornWJUstekinumab for peristomal pyoderma gangrenosumAm J Gastroenterol2012107579479522552250
- GoldminzAMBottoNCGottliebABSeverely recalcitrant pyoderma gangrenosum successfully treated with ustekinumabJ Am Acad Dermatol2012675e237e23823062936
- GuenovaETeskeAFehrenbacherBInterleukin 23 expression in pyoderma gangrenosum and targeted therapy with ustekinumabArch Dermatol2011147101203120521680759
- GheitaTAElGIIEl-FishawyHSAboul-EzzMAKenawySAInvolvement of IL-23 in enteropathic arthritis patients with inflammatory bowel disease: preliminary resultsClin Rheumatol201433571371724384828
- LevinAAGottliebABSpecific targeting of interleukin-23p19 as effective treatment for psoriasisJ Am Acad Dermatol201470355556124373779
- CampaMMansouriBWarrenRMenterAA review of biologic therapies targeting IL-23 and IL-17 for use in moderate-to-severe plaque psoriasisDermatol Ther201661112
- Boehringer Ingelheim’s investigational biologic cleared skin better, faster and for longer than ustekinumab in phase II psoriasis study. Boehringer Ingelheim, Inc. [press release]Boehringer Ingelheim, Inc.2015108 Available from: https://www.boehringer-ingelheim.com/press-release/boehringer-ingelheim-s-investigational-biologic-cleared-skin-better-faster-and-longerAccessed October 7, 2016
- PappKMenterASofenHEfficacy and safety of different dose regimens of a selective IL-23p19 inhibitor (BI 655066) compared with ustekinumab in patients with moderate-to-severe plaque psoriasis with and without psoriatic arthritis (abstract)Arthritis Rheumatol201567Suppl 10 Available from: http://acrabstracts.org/abstract/efficacy-and-safety-of-different-dose-regimens-of-a-selective-il-23p19-inhibitor-bi-655066-compared-with-ustekinumab-in-patients-with-moderate-to-severe-plaque-psoriasis-with-and-without-psoriatic-a/Accessed October 9, 2016
- Janssen Research & Development LLCA study of guselkumab in participants with moderate to severe plaque-type psoriasis and an inadequate response to ustekinumab (NAVIGATE)Bethesda (MD)National Library of Medicine (US)2000 [cited 2016 Oct 7]. NLM Identifier: NCT02203032 Available from: https://www.clinicaltrials.gov/ct2/show/NCT02203032Accessed October 7, 2016
- SandsBEChenJPenneyM830 Initial evaluation of MEDI2070 (specific anti-IL-23 antibody) in patients with active Crohn’s disease who have failed anti-TNF antibody therapy: a randomized, double-blind placebo-controlled phase 2A induction study (abstract)Gastroenterology20151484S-163S-164
- FeaganBGSandbornWPanésJ812a Efficacy and safety of induction therapy with the selective IL-23 inhibitor BI 655066, in patients with moderate-to-severe Crohn’s disease: results of a randomized, double-blind, placebo-controlled phase II study (abstract)Gastroenterology20161504S1266
- Sun Pharma and Merck & Co IncEnter into Licensing Agreement for Tildrakizumab, Merck & Co., Inc. [press release]Merck Sharp & Dohme Corp website2014917 Available from: http://www.merck.com/licensing/our-partnership/sunpharma_partnership.htmlAccessed October 7, 2016
- SandbornWJThe present and future of inflammatory bowel disease treatmentGastroenterol Hepatol2016127438441
- KuehbacherTNikolausSSchreiberSSerum soluble IL2-receptor is increased in a subpopulation of Crohns disease patients, who respond to open label use of ustekinumab, a human monoclonal antibody to IL-12/23p40 (abstract)Gastroenterology20111405S-589