In patients taking tofacitinib, major adverse cardiac events (MACE) occur more frequently in patients with a high baseline 10-year atherosclerotic cardiovascular disease (ASCVD) risk, compared with a low risk, according to study findings published in the Journal of Crohn’s and Colitis.
Patients experiencing inflammatory bowel disease (IBD) often experience ASCVD at higher rates, compared with those without chronic inflammatory conditions. Researchers conducted a study to assess the cardiovascular risk of taking tofacitinib in patients with ulcerative colitis (UC).
Data was collected from 5 studies:
- The Phase 2 induction study (ClinicalTrials.gov Identifier: NCT00787202);
- The Phase 3 induction studies (OCTAVE Induction 1 and 2 [ClinicalTrials.gov Identifier: NCT01465763, NCT01458951]);
- The Phase 3 maintenance study (OCTAVE Sustain [ClinicalTrials.gov Identifier: NCT01458574]);
- The open-label, long-term extension study (OCTAVE Open [ClinicalTrials.gov Identifier: NCT01470612]).
The researchers conducted a post hoc analysis using this data. Myocardial infarction (MI), stroke, or cardiovascular death were considered MACE. Causes for cardiovascular death included acute MI, sudden cardiac death, stroke, heart failure, heart procedures, cardiovascular hemorrhage, and peripheral artery disease.
In the UC OCTAVE clinical program, 1,157 participants took at least 1 dose of tofacitinib. The median treatment duration was 623 days (range, 1-2850 days) with a total tofacitinib exposure of 2814.4 patient-years (PY). In this study population, 45 (4%) patients had prior ASCVD.
Among patients without a history of ASCVD, there was a higher average baseline 10-year ASCVD risk score in those with MACE, compared to those without (13.5% vs 2.5%, respectively).
After MACE adjudication, 8 (0.7%) of 1,124 patients reported MACE (incidence rate [IR], 0.28; 95% CI, 0.12-0.54). The IR for MACE was 0.95 (95% CI, 0.02-5.27]) in patients with prior ASCVD.
In patients without prior ASCVD, the incidence rate of MACE was 1.81 (95% CI, 0.05-10.07) for high, 1.54 (95% CI, 0.42-3.95) for intermediate, 0.09 (95% CI, 0.01-0.32) for low baseline 10-year ASCVD risk.
For patients experiencing MACE, 5 (71.4%) out of 7 patients had at least a 1% increase in 10-year ASCVD risk scores when compared with their scores at baseline. This increase in risk resulted in escalation to a more severe risk category for 2 patients (28.6%).
“Future prospective studies should take a multi-ethnic approach and be comprised of large registries that would allow a distinction between the influence of pre-existing ASCVD risks from therapy-inferred changes, which may be cardioprotective in some patients,” study authors wrote.
Study limitations include a short median treatment duration, some studies lacking an active comparator, and a potential lack of generalizability to some patient groups.
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
This article originally appeared on Gastroenterology Advisor
Schreiber S, Rubin DT, Ng SC. Major adverse cardiovascular events by baseline cardiovascular risk in patients with ulcerative colitis treated with tofacitinib: data from the OCTAVE clinical programme. J Crohns Colitis. July 4, 2023. doi:10.1093/ecco-jcc/jjad104