炎症性肠病治疗呈上升趋势

Inflammatory Bowel DiseaseTherapeutics on the Rise IQVIA Pipeline Link/Trial Link — September 2025. SWATI S KUMAR,Senior Insights Analyst, Pipeline Link/Trial Link, IQVIAVARUN BAJAJ,Insights Associate, Pipeline Link/Trial Link, IQVIA Table of contents Introduction1Current treatment options2Ulcerative colitis & Crohn’s disease clinical trial landscape2Pipeline landscape for ulcerative colitis and Crohn’s disease4Novel therapies in early development6Summary6About the authors6References7 Introduction CD most commonly affects the small intestineand proximal colon but can affect any part of thegastrointestinal tract from the mouth to the anus.The primary symptoms include persistent diarrhea,rectal bleeding and abdominal cramps.3CD has aprevalence of 100 to 300 per 100,000 population.4Compared to CD, UC has a higher prevalence inadults. In the pediatric population; however, UC isless prevalent than CD. The evolving pipeline and clinical triallandscape in ulcerative colitis andCrohn’s disease Inflammatory bowel disease (IBD) refers to agroup of conditions characterized by swelling andinflammation of the tissues in the digestive tract. Itis an autoimmune disorder that typically appearsas a sudden flare-up of symptoms. Most cases arediagnosed in individuals aged 35 years or younger,with a second peak of diagnosis occurring inindividuals in their 60s.1Globally, the highest ratesof IBD prevalence and incidence are observed inNorthern Europe and North America. Current research highlights the following key areasin IBD pathogenesis: immune dysregulation; geneticalterations; microbiota imbalances; microbialinfections; and links between IBD and otherinflammatory conditions. These collectively lead tointestinal damage and chronic inflammation.5 The 2 main types include ulcerative colitis (UC) andCrohn’s disease (CD). UC is an idiopathic inflammatorycondition which is characterized by chronicinflammation of the colon, leading to diffuse friability,superficial erosions, and associated rectal bleeding.It is the most common form of IBD with a prevalence of156 to 291 cases per 100,000 population and can affectany part of the large intestine. The primary symptomis bloody diarrhea, with or without mucus. Associatedsymptoms also include urgency or tenesmus,abdominal pain, malaise, weight loss, and fever.2 This article provides an update on current treatmentoptions for UC and CD, outlining the latestdevelopments including ongoing clinical trials ofkey experimental drugs with data sourced fromIQVIA Pipeline Link and IQVIA Trial Link. Globally, the highest rates of IBDprevalence and incidence are observedin Northern Europe and North America. of ozanimod treated patients achieved statisticallysignificant clinical remission at week 10 in the inductionphase compared to 6% of patients receiving placebo.9,10 Current treatment options Treatment for UC and CD involves a comprehensiveapproach which includes the use of medication,alterations in diet and nutrition, and sometimessurgical procedures to repair or remove affectedportions of the GI tract. While there is no known curefor both conditions, they can be successfully managedthrough treatments that reduce inflammation, alleviatesymptoms, and support long-term remission. Building on this success, Pfizer’s etrasimod (VELSIPITY)received approval in the USA in October 2023 foradults with moderately-to-severely active UC.11In February 2024, it gained EU approval, making it thefirst and only oral advanced UC therapy approved forpatients aged 16 years and older in the EU.12 The use of interleukin-23 (IL-23) inhibitors has alsoemerged as a treatment approach for IBD. IL-23 isa cytokine produced by activated monocytes anddendritic cells and its overexpression in inflamed guttissue drives immune dysregulation via downstreameffector cells.13In June 2024, AbbVie’s risankizumab(SKYRIZI) became the first IL-23 specific inhibitorapproved by the US FDA for both moderate-to-severeUC and CD, expanding upon its initial 2022 approvalfor CD.14 Anti-inflammatory medications are commonly thefirst step in the treatment of IBD. They includecorticosteroids such as prednisone and budesonidewhich help reduce inflammation in the body.Corticosteroids may be used in combination with animmune system suppressor to enhance the benefitfrom other medicines.6Over the last several years,biologics have been approved for the treatment of IBDand other inflammatory diseases. A group of biologicsknown as anti-tumor necrosis factor (TNF) agents workby binding to and blocking TNF-alpha (TNFA)— a protein that promotes inflammation in theintestine as well as other organs and tissues.7 Other IL-23 inhibitors that have been approved inthe USA and the EU for both UC and CD include Lilly’smirikizumab (OMVOH), a humanized IgG4 anti-humanIL-23p19 monoclonal antibody, and Johnson & Johnson’sguselkumab (TREMFYA), a dual-acting monoclonalantibody that blocks IL-23 while also binding to CD64, areceptor found on myeloid cells t