The purpose of this study is to estimate and compare the incidence of overall malignancy, serious infection, and opportunistic infections between new users of ustekinumab and new users of other biologic therapies among adult participants with Crohn's disease (CD) or ulcerative colitis (UC).
Study Type
OBSERVATIONAL
Enrollment
1,056
Participants who are new users of ustekunumab will be included in the cohort. No study treatment will be administered as a part of this study.
Participants who are new users of other biologic therapies (for examples for example, infliximab, adalimumab, or vedolizumab administered as per the prescription record) will be included in this cohort. No study treatment will be administered as a part of this study.
NMCP
Portsmouth, Virginia, United States
RECRUITINGIncidence Rate for Malignancy
The incidence rates for malignancy (including Non-melanoma skin cancer \[NMSC\]) will be estimated as the number of incident cases (that is, counts of unique participants) divided by the total at-risk time.
Time frame: Up to 10 years and 3 months
Opportunistic Infection (OI)
The OI will be estimated as the number of incident cases (that is counts of unique participants) divided by the total at-risk time.
Time frame: Up to 10 years and 3 months
Serious Infection
The serious infections will be estimated as the number of incident cases (that is counts of unique participants) divided by the total at-risk time.
Time frame: Up to 10 years and 3 months
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