MACE risk higher with tofacitinib vs TNFi in patients with RA, ASCVD

In the treatment of patients with rheumatoid arthritis (RA) and atherosclerotic cardiovascular disease (ASCVD), the use of tofacitinib confers an increased risk of major adverse cardiovascular events (MACE) than tumour necrosis factor inhibitors (TNFi), according to a post hoc analysis of ORAL Surveillance.

In ORAL Surveillance, 4,362 RA patients were randomized to receive tofacitinib 5 mg two times per day (n=1,455), tofacitinib 10 mg two times per day (n=1,456), or TNFi (n=1,451). Of these, 3,111 (71.3 percent) patients completed the trial and 2,745 (62.9 percent) completed treatment. A total of 640 (14.7 percent) patients had a history of ASCVD.

Patients with vs without a history of ASCVD were more likely to be older, male, past smokers, and have a history of diabetes mellitus, hypertension, or hyperlipidaemia. Over a median follow-up of 4.0 years, MACE, myocardial infarction, and sudden cardiac death occurred more frequently among tofacitinib- than TNFi-treated patients.

In the group of patients with a history of ASCVD, MACE occurred more frequently with tofacitinib 5 and 10 mg than with TNFi (8.3 percent and 7.7 percent vs 4.2 percent; combined tofacitinib: hazard ratio [HR], 1.98, 95 percent confidence interval [CI], 0.95–4.14; p=0.059).

In the group of patients without a history of ASCVD, there was no increased risk of MACE detected with  tofacitinib 5 and 10 mg vs TNFi (2.4 percent and 2.8 percent vs 2.3 percent; HR, 1.03, 95 percent CI, 0.62–1.73 and HR, 1.25, 95 percent CI, 0.76–2.07, respectively).