Colitis, Ulcerative, Crohn Disease
Conditions
Brief summary
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).
Interventions
DRUGUstekinumab
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.
DRUGOther Biologic Therapies
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.
Sponsors
Janssen Scientific Affairs, LLC
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult men and women with CD or UC who are new users of ustekinumab or the comparator drugs during the study period * Participants must have at least 1 year of enrollment history with the DoD EHR database immediately prior to new use (that is, exposure index date) of ustekinumab or the comparator drugs
Exclusion criteria
* Participants below 18 years of age on the exposure index date * Participants who do not meet the definition for CD or UC prior to or on the exposure index date * Participants with any records of human immunodeficiency virus (HIV) diagnosis, organ or tissue transplant, or malignancy (excluding non-melanoma skin cancer \[NMSC\]) at any time prior to or on the exposure index date * Participants with a physician diagnosis of rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis within 12 months prior to or on the exposure index date * In the analysis of infection outcomes, participants diagnosed with the same infection of interest both within 60 days prior to or on the exposure index date and within 60 days after the exposure index date will be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate for Malignancy | Up to 10 years and 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opportunistic Infection (OI) | Up to 10 years and 3 months | The OI will be estimated as the number of incident cases (that is counts of unique participants) divided by the total at-risk time. |
| Serious Infection | Up to 10 years and 3 months | 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. |
Countries
United States
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJanssen Scientific Affairs, LLC Clinical Trial
Janssen Scientific Affairs, LLC
Outcome results
None listed