The goal of this observational study is to learn about how effective Zymfentra (IFX=dyyb) is when treating patients with Crohn's disease (CD) and ulcerative colitis (UC) Does Zymfentra lead to a reduction in symptoms at intervals throughout one year? Participants being prescribed Zymfentra (IFX-dyyb as part of their regular medical care for CD or UC will answer online survey questions about their bowel habits for 1 year.
Evidence of small intestinal inflammation with endoscopically, radiologically or histologically demonstrated ulcerations, fistulation, mucosal fissuring, nodularity or cobblestoning, stricture formation or histologically demonstrated transmural inflammation with or without granuloma formation.
Isolated esophageal, gastric or duodenal inflammation with the finding of noncaseating granuloma.
Colonic inflammation which is patchy (normal segments separating areas of inflammation, as described above) or associated with one or more of the following features: complete rectal sparing, multiple (>10) aphthoid ulcers, deep ulceration (into the muscularis propria), transmural inflammation, extensive fibrosis and wall thickening, fistulation, non-caseating granuloma. (N.B. See note below regarding patchiness of endoscopically observed inflammation in patients with partially treated ulcerative colitis.)
The presence of complex suppurative perianal disease (i.e. more than a superficial fistula or uncomplicated superficial abscess).
1.
Inability to provide informed consent.
Non-English speaking
Patients presenting for a one-time consultation.
Adult patients with UC, CD, or IBDU starting Zymfentra (Infliximab-dyyb) in the setting of standard-of-care
Cohort
Prospective
Not listed
Clinical remission as evaluated by the Simple Clinical Colitis Activity Index (SCCAI) for the patient-reported outcomes.
The SCCAI is a 6-item that describes the symptoms and disease activity of a patient with UC at the time of assessment. A score of 0-4 is considered a clinical range of remission (but with more refined definitions of clinical remission with SCCAI ≤2 and very mild symptoms with a score \>2 ≤4), 5-7 mild activity, 8-16 moderate activity and \> 16 severe activity. A response will be defined as a decrease of the SCCAI score \< 5 points in patients with a baseline SCCAI ≥5.
Clinical remission as evaluated by the Simple Crohn's Disease Activity Index (sCDAI for the patient-reported outcomes.
The Short Crohn's Disease Activity Index (sCDAI) is a simplified version of the Crohn's Disease Activity Index (CDAI), used to assess disease severity in Crohn's disease patients. It reduces the number of variables required, making it easier and quicker to use in clinical practice. Recent data demonstrated, that collections of the parameters on a single day equally reflects reliable disease activity compared to a collection of data over 7 consecutive days, which is often hampered by missing data. A score of \< 150, 150-219, 220-450 and \>450 reflects remission, mild, moderate and severe Crohn's disease activity.
Response as measured by the Simple Endoscopic Score for Crohn's disease (SES-CD)
The Simple Endoscopic Score for Crohn's Disease (SES-CD) is a tool used to objectively measure the severity of Crohn's disease based on the extent and severity of ulcers, affected surface area, and luminal narrowing during an endoscopy. The total score is the sum of scores for these four features, and it is categorized as follows: 0-2 for remission, 3-6 for mild activity, 7-15 for moderate activity, and greater than 15 for severe activity. Mucosal healing will be defined by an SES-CD \< 4
Response as measured by the endoscopic Mayo score for ulcerative colitis
The Mayo endoscopic score is a four-point scale (1 to 3) used to assess the severity of ulcerative colitis (UC) based on a colonoscopy. It evaluates the severity of inflammation through findings like erythema, vascular pattern, friability, erosions, and spontaneous bleeding, with higher scores indicating more severe disease. Mucosal healing will be defined by an endoscopic Mayo score \<1.
Mucosal healing will be assessed in the setting of standard-of-care calprotectin levels.
Calprotectin is a surrogate marker of intestinal inflammation, and levels ≥ 250 mcg/g stool are associated with active mucosal inflammation, whereas levels \<150 mcg are considered to represent mild or no mucosal inflammation
Response as measured by Patient-Reported Outcomes Measurement Information System (PROMIS)- Depression
PROMIS measure of depression measures well-being. This is calculated as T scores. A clinically meaningful difference is considered to be a change in T score of ≥ 2.5 (scores are normalized at 50 with a standard deviation of 10). Higher scores mean more severe depression. Differences in PROMIS scores compared to baseline will be assessed.
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University of North Carolina, Chapel Hill
Lead sponsor
Celltrion
Collaborator
