The necessity of validity diagnostics when drawing causal inferences from observational data: lessons from a multi-database evaluation of the risk of non-infectious uveitis among patients exposed to Remicade^®.

ABSTRACT:

Background

Autoimmune disorders have primary manifestations such as joint pain and bowel inflammation but can also have secondary manifestations such as non-infectious uveitis (NIU). A regulatory health authority raised concerns after receiving spontaneous reports for NIU following exposure to Remicade^®, a biologic therapy with multiple indications for which alternative therapies are available. In assessment of this clinical question, we applied validity diagnostics to support observational data causal inferences.

Methods

We assessed the risk of NIU among patients exposed to Remicade^® compared to alternative biologics. Five databases, four study populations, and four analysis methodologies were used to estimate 80 potential treatment effects, with 20 pr

SUBMITTER: Weaver J 

PROVIDER: S-EPMC11681708 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature