Role of biologics and biosimilars in inflammatory bowel disease: current trends and future perspectives

References

• MachadoMAMacielAAde LemosLLAdalimumab in rheumatoid arthritis treatment: a systematic review and meta-analysis of randomized clinical trialsRev Bras Reum2013535419430
   PubMedGoogle Scholar
• HUMIRA^®(adalimumab)Injection [package insert]North Chicago, ILAbbVie Inc2017
   Google Scholar
• NgSCShiHYHamidiNWorldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studiesLancet2017390101142769277829050646
   PubMed Web of Science ®Google Scholar
• OrdásIEckmannLTalaminiMBaumgartDCSandbornWJUlcerative colitisLancet201238098531606161922914296
   PubMed Web of Science ®Google Scholar
• OttCSchölmerichJExtraintestinal manifestations and complications in IBDNat Rev Gastroenterol Hepatol2013101058559523835489
   PubMed Web of Science ®Google Scholar
• KornbluthASacharDBPractice Parameters Committee of the American College of GastroenterologyUlcerative colitis practice guidelines in adults: American College of Gastroenterology, Practice Parameters CommitteeAm J Gastroenterol2010105350152320068560
   PubMed Web of Science ®Google Scholar
• National Institute for Health and Clinical Excellence [webpage on the Internet]Crohn’s Disease: Management in Adults, Children and Young PeopleLondonRoyal College of Physicians (UK), National Clinical Guideline Centre2012 [updated May 2016]. Available at: https://www.nice.org.uk/guidance/cg152Accessed January 27, 2018
   Google Scholar
• ZhangY-ZLiY-YInflammatory bowel disease: pathogenesisWorld J Gastroenterol20142010919924415861
   PubMed Web of Science ®Google Scholar
• WallaceJLSharkeyKAPharmacotherapy of Inflammatory Bowel DiseaseBruntonLLChabnerBKnollmannBCGoodman and Gilman’s the Pharmacologic Basis of Therapeutics12 edNew York, NYMcGraw-Hill2011135154
   Google Scholar
• BruntonLLHilal-DandanRKnollmanBCGoodman & Gilman’s The Pharmacological basis of Therapeutics13th edNew York, NYMcGraw-Hill2018945954
   Google Scholar
• D’HaensGRSartorRBSilverbergMSPeterssonJRutgeertsPFuture directions in inflammatory bowel disease managementJ Crohns Colitis20148872673424742736
   PubMed Web of Science ®Google Scholar
• MorrowTFelconeLHDefining the difference: what makes biologics uniqueBiotechnol Healthc20041424262829
   PubMedGoogle Scholar
• ChanHCNgSCEmerging biologics in inflammatory bowel diseaseJ Gastroenterol201752214115027832357
   PubMed Web of Science ®Google Scholar
• FDAHumira (adalimumab): Prescribing information2012173 Available from: http://www.rxabbvie.com/pdf/humira.pdfAccessed March 13, 2018
   Google Scholar
• AbbVie – Pharmaceutical Products Available from: https://www.abbvie.com/our-science.htmlAccessed February 4, 2018
   Google Scholar
• KempeniJPreliminary results of early clinical trials with the fully human anti-TNFα monoclonal antibody D2E7Ann Rheum Dis199958I70I7210577977
   PubMed Web of Science ®Google Scholar
• LapadulaGMarchesoniAArmuzziAAdalimumab in the treatment of immune-mediated diseasesInt J Immunopathol Pharmacol2014271 suppl334824774505
   PubMed Web of Science ®Google Scholar
• LichtensteinGRPanaccioneRMallarkeyGEfficacy and safety of Adalimumab in Crohn’s diseaseTherap Adv Gastroenterol2008114350
   PubMedGoogle Scholar
• HanauerSBSandbornWJRutgeertsPHuman anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn’s disease: the CLASSIC-I trialGastroenterology2006130232333316472588
   PubMed Web of Science ®Google Scholar
• SandbornWJHanauerSBRutgeertsPAdalimumab for maintenance treatment of Crohn’s disease: results of the CLASSIC II trialGut20075691232123917299059
   PubMed Web of Science ®Google Scholar
• ColombelJFSandbornWJRutgeertsPAdalimumab for maintenance of clinical response and remission in patients with Crohn’s disease: the CHARM trialGastroenterology20071321526517241859
   PubMed Web of Science ®Google Scholar
• RutgeertsPSandbornWJEnnsRAdalimumab rapidly induces clinical response and remission in patients with moderate to severe Crohn’s disease who had secondary failure to infliximab therapy: results of the GAIN studyGut200655supplA20
   Google Scholar
• Côté-DaigneaultJBouinMLahaieRColombelJFPoitrasPBiologics in inflammatory bowel disease: what are the data?United European Gastroenterol J201535419428
   PubMed Web of Science ®Google Scholar
• HyamsJSGriffithsAMarkowitzJSafety and efficacy of adalimumab for moderate to severe Crohn’s disease in childrenGastroenterology2012143236537422562021
   PubMed Web of Science ®Google Scholar
• FaubionWADubinskyMRuemmeleFMLong-term efficacy and safety of Adalimumab in pediatric patients with Crohn’s diseaseInflamm Bowel Dis201723345346028129288
   PubMed Web of Science ®Google Scholar
• ChenXHouJYuanYAdalimumab for moderately to severely active ulcerative colitis: a systematic review and meta-analysisBio-Drugs2016303207217
   Google Scholar
• BurmesterGRPanaccioneRGordonKBMcIlraithMJLacerdaAPAdalimumab: long-term safety in 23 458 patients from global clinical trials in rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis and Crohn’s diseaseAnn Rheum Dis201372451752422562972
   PubMed Web of Science ®Google Scholar
• SchiffMHBurmesterGRKentJDSafety analyses of adalimumab (HUMIRA) in global clinical trials and US post marketing surveillance of patients with rheumatoid arthritisAnn Rheum Dis200665788989416439435
   PubMed Web of Science ®Google Scholar
• FDA2017140Cimzia (certolizumab pegol) – Prescribing information Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125160s270lbl.pdfAccessed February 5, 2018
   Google Scholar
• FDA. Center for Drug Evaluation and ResearchApplication number: BLA 125160/0. Pharmacology review(s)2008 Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125160s000_PharmR_P1.pdfAccessed February 5, 2018
   Google Scholar
• SandbornWJFeaganBGSloinovSCertolizumab pegol for the treatment of Crohn’s diseaseN Engl J Med2007357322823817634458
   PubMed Web of Science ®Google Scholar
• SchreiberSKhaliq-KareemiMLawranceICMaintenance therapy with certolizumab pegol for Crohn’s diseaseN Engl J Med2007357323925017634459
   PubMed Web of Science ®Google Scholar
• SandbornWJLeeSDRandallCLong-term safety and efficacy of certolizumab pegol in the treatment of Crohn’s disease: 7-year results from the PRECiSE 3 studyAliment Pharmacol Ther201440890391625146586
   PubMed Web of Science ®Google Scholar
• LeeSDRubinDTSandbornWJReinduction with certolizumab pegol in patients with Crohn’s disease experiencing disease exacerbation: 7-year data from the PRECiSE 4 studyInflamm Bowel Dis20162281870188027400222
   PubMed Web of Science ®Google Scholar
• SandbornWJAbreuMTD’HaensGCertolizumab pegol in patients with moderate to severe Crohn’s disease and secondary failure to infliximabClin Gastroenterol Hepatol20108868869520451663
   PubMed Web of Science ®Google Scholar
• DeeksEDCertolizumab pegol: a review in inflammatory autoimmune diseasesBioDrugs201630660761727704400
   PubMed Web of Science ®Google Scholar
• MazumdarSGreenwaldDGolimumabMAbs20091542243120065639
   PubMed Web of Science ®Google Scholar
• StrikASBerendsSEMathôtRAD’HaensGRLöwenbergMGolimumab for moderate to severe ulcerative colitisExpert Rev Gastroenterol Hepatol201711540140628276288
   PubMed Web of Science ®Google Scholar
• FDASimponi (Golimumab) – Prescribing information2017151 Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125289s024lbl.pdfAccessed February 5, 2018
   Google Scholar
• European Medicines AgencySummary of Product characteristics Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000992/WC500052368.pdfAccessed February 13, 2018
   Google Scholar
• SandbornWFeaganBMaranoCSubcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitisGastroenterology20141461859523735746
   PubMed Web of Science ®Google Scholar
• SandbornWFeaganBMaranoCSubcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitisGastroenterology201414619610923770005
   PubMed Web of Science ®Google Scholar
• FlamantMPaulSRoblinXGolimumab for the treatment of ulcerative colitisExpert Opin Biol Ther201717787988628472597
   PubMed Web of Science ®Google Scholar
• BrunnerHIRupertoNTzaribachevNfor the Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG)Subcutaneous golimumab for children with active polyarticular-course juvenile idiopathic arthritis: results of a multicentre, double-blind, randomised-withdrawal trialAnn Rheum Dis201877212928507219
   PubMed Web of Science ®Google Scholar
• LiangSDaiJHouSStructural basis for treating tumor necrosis factor alpha (TNFalpha)-associated diseases with the therapeutic antibody infliximabJ Biol Chem201328819137991380723504311
   PubMed Web of Science ®Google Scholar
• de RidderLBenningaMATaminiauJAHommesDWvan DeventerSJInfliximab use in children and adolescents with inflammatory bowel diseaseJ Pediatr Gastroenterol Nutr200745131417592358
   PubMed Web of Science ®Google Scholar
• FDARemicade (Infliximab) – Prescribing information2017151 Available from: http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/REMICADE-pi.pdf
   Google Scholar
• TarganSRHanauerSBvan DeventerSJA short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn’s disease. Crohn’s Disease cA2 Study GroupN Engl J Med199733715102910359321530
   PubMed Web of Science ®Google Scholar
• HanauerSBFeaganBGLichtensteinGRMaintenance infliximab for Crohn’s disease: the ACCENT I randomised trialLancet200235993171541154912047962
   PubMed Web of Science ®Google Scholar
• RutgeertsPVan AsscheGVermeireSReview article: infliximab therapy for inflammatory bowel disease – seven years onAliment Pharmacol Ther200623445146316441465
   PubMed Web of Science ®Google Scholar
• RutgeertsPFeaganBGOlsonAReinischWOlsonAJohannsetJA randomized placebo-controlled trial of infliximab therapy for active ulcerative colitis: act I trialGastroenterology2005128A105
   Google Scholar
• SandbornWJRachmilewitzDHanauerSBInfliximab induction and maintenance therapy for ulcerative colitis: the Act 2 trialGastroenterology2005128A104
   Google Scholar
• HesterbergPEWinsor-HinesDBriskinMJRapid resolution of chronic colitis in the cotton-top tamarin with an antibody to a gut-homing integrin alpha 4 beta 7Gastroenterology19961115137313808898653
   PubMed Web of Science ®Google Scholar
• LauMSTsaiHHReview of vedolizumab for the treatment of ulcerative colitisWorld J Gastrointest Pharmacol Ther20167110711126855816
   PubMedGoogle Scholar
• clinicaltrials.govVedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn’s Disease (CD) Available from: https://clinicaltrials.gov/ct2/show/NCT03138655. NLM identifier: NCT03138655Accessed April 7, 2018
   Google Scholar
• Long-term Safety IWith Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease Available from: https://clinicaltrials.gov/ct2/show/NCT03196427Accessed February 13, 2018
   Google Scholar
• FDAEntyvio (Vedolizumab) – Prescribing information2017121 Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125476s000lbl.pdfAccessed February 5, 2018
   Google Scholar
• FeaganBGRutgeertsPJSandsBE943b Induction therapy for ulcerative colitis: results of GEMINI I, a randomised placebo-controlled, double-blind, multicentre phase 3 trialGastroenterology2012142S160S161
   Web of Science ®Google Scholar
• Garnock-JonesKPVedolizumab: a review of its use in adult patients with moderately to severely active ulcerative colitis or Crohn’s diseaseBioDrugs2015291576725502899
   PubMed Web of Science ®Google Scholar
• SandbornWJFeaganBGRutgeertsPVedolizumab as induction and maintenance therapy for Crohn’s diseaseN Engl J Med2013369871172123964933
   PubMed Web of Science ®Google Scholar
• SandsBEFeaganBGRutgeertsPEffects of vedolizumab induction therapy for patients with Crohn’s disease in whom tumor necrosis factor antagonist treatment failedGastroenterology20141473618.e627.e24859203
   PubMed Web of Science ®Google Scholar
• GensickeHLeppertDYaldizliOMonoclonal antibodies and recombinant immunoglobulins for the treatment of multiple sclerosisCNS Drugs2012261113722171583
   PubMed Web of Science ®Google Scholar
• ZhangYWangHIntegrin signalling and function in immune cellsImmunology2012135426827522211918
   PubMed Web of Science ®Google Scholar
• FDATysabri (Natalizumab) – Prescribing information2017129 Available from: https://www.tysabri.com/content/dam/commercial/multiple-sclerosis/tysabri/pat/en_us/pdfs/tysabri_prescribing_information.pdfAccessed February 5, 2018
   Google Scholar
• SandbornWJColombelJFEnnsRNatalizumab induction and maintenance therapy for Crohn’s diseaseN Engl J Med2005353181912192516267322
   PubMed Web of Science ®Google Scholar
• TarganSRFeaganBGFedorakRNNatalizumab for the treatment of active Crohn’s disease: results of the ENCORE trialGastroenterology200713251672168317484865
   PubMed Web of Science ®Google Scholar
• GuagnozziDCaprilliRNatalizumab in the treatment of Crohn’s diseaseBiologics20082227528419707360
   PubMedGoogle Scholar
• LambYNDugganSTUstekinumab: a review in moderate to severe Crohn’s diseaseDrugs201777101105111428528528
   PubMed Web of Science ®Google Scholar
• European Medicines Agency [homepage on the Internet]Stelara 130 mg for solution for infusion: EU summary of product characteristics2017 Available from: http://www.ema.europa.eu/Accessed February 5, 2018
   Google Scholar
• FDAStelara (Ustekinumab) – Prescribing information2016137 Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761044lbl.pdfAccessed February 5, 2018
   Google Scholar
• FeaganBGSandbornWJGasinkCUstekinumab as induction and maintenance therapy for Crohn’s diseaseN Engl J Med2016375201946196027959607
   PubMed Web of Science ®Google Scholar
• SandbornWJGasinkCGaoLLUstekinumab induction and maintenance therapy in refractory Crohn’s diseaseN Engl J Med2012367161519152823075178
   PubMed Web of Science ®Google Scholar
• van der ValkMEMangenMJLeendersMHealthcare costs of inflammatory bowel disease have shifted from hospitalisation and surgery towards anti-TNFa therapy: results from the COIN studyGut2014631727923135759
   PubMed Web of Science ®Google Scholar
• WangJChowSCOn the regulatory approval pathway of biosimilar productsPharmaceuticals20125435336824281406
   PubMedGoogle Scholar
• FDA [webpage on the Internet]Biosimilars Available from: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/BiosimilarsAccessed January 30, 2018
   Google Scholar
• European Medicines Agency [webpage on the Internet]Biosimilar medicines (similar biological medicinal products) Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/general/general_content_001832.jsp&mid=WC0b01ac0580bb8fdaAccessed January 30, 2018
   Google Scholar
• ParamsothySClevelandNKZmeterNRubinDTThe role of biosimilars in inflammatory bowel diseaseGastroenterol Hepatol20161212741751
   Google Scholar
• FDAAmjevita (Adalimumab – atto) – Prescribing information2016161 Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761024lbl.pdfAccessed February 5, 2018
   Google Scholar
• FDACyltezo (Adalimumab – abdm) – Prescribing information2017138 Available from: https://www.accessdata.fda.gov/drug-satfda_docs/label/2017/761058lbl.pdfAccessed February 5, 2018
   Google Scholar
• FDAInflectra (Infliximab – dyyb) – Prescribing information2016156 Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125544s000lbl.pdfAccessed February 9, 2018
   Google Scholar
• FDARenflexis (Infliximab – abda) – Prescribing information2017154 Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761054Orig1s000lbl.pdfAccessed February 9, 2018
   Google Scholar
• FDAIxifi (Infliximab-qbtx) – Prescribing information2017137 Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761072s000lbl.pdfAccessed February 9, 2018
   Google Scholar
• FordACSandbornWJKhanKJHanauerSBTalleyNJMoayyediPEfficacy of biological therapies in inflammatory bowel disease: systematic review and meta-analysisAm J Gastroenterol2011106464465921407183
   PubMed Web of Science ®Google Scholar
• YanaiHHanauerSBAssessing response and loss of response to biological therapies in IBDAm J Gastroenterol2011106468569821427713
   PubMed Web of Science ®Google Scholar
• DaneseSVuittonLPeyrin-BirouletLBiologic agents for IBD: practical insightsNat Rev Gastroenterol Hepatol201512953754526284562
   PubMed Web of Science ®Google Scholar
• SandbornWJThe present and future of inflammatory bowel disease treatmentGastroenterol Hepatol2016127438441
   PubMedGoogle Scholar
• Adis EditorialTofacitinibDrugs R&D2010104271284
   PubMedGoogle Scholar
• CheryJRNA therapeutics: RNAi and antisense mechanisms and clinical applicationsPostdoc J201647355027570789
   PubMedGoogle Scholar
• JuifPEKraehenbuehlSDingemanseJClinical pharmacology, efficacy, and safety aspects of sphingosine-1-phosphate receptor modulatorsExpert Opin Drug Metab Toxicol201612887989527249325
   PubMed Web of Science ®Google Scholar