Cardiovascular risk of advanced IBD therapies: 43 studies, and no clear answer either way

The edition in brief

A meta-analysis of 43 studies published between 2002 and 2024 - 36 randomised trials including nine long-term follow-ups, and seven observational studies - looked for a cardiovascular signal from advanced therapies in inflammatory bowel disease. Placebo-controlled trials showed a non-significant trend towards lower major adverse cardiovascular event risk (odds ratio 0.60, 95% CI 0.24 to 1.51). Class estimates ran from 0.35 for IL-12/IL-23 inhibitors to 3.04 for anti-TNF agents, none significant and all with intervals wide enough to include substantial benefit and substantial harm. Observational data reversed the anti-TNF picture entirely, suggesting lower risk (odds ratio 0.29, 95% CI 0.21 to 0.40). The honest summary is that the question is open. The FDA sweep carries an ongoing Class II recall of premixed intravenous pantoprazole, 80 mg in 100 mL, for manufacturing deviations - a supply issue rather than a drug safety finding, but one that matters on a ward where the infusion is reached for during an upper gastrointestinal bleed. A supplement to an adalimumab biosimilar application has also been approved, with contents unspecified. A meta-analysis of four randomised paediatric cohorts, 3282 participants, found higher seroconversion at one month (odds ratio 3.05, 95% CI 1.88 to 4.96) and higher antibody concentrations with one hepatitis A vaccine strain over another, with comparable adverse events - on surrogate immunogenicity outcomes, in cohorts concentrated in one country.