- Tofacitinib (Xeljanz) is associated with increases in low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) among patients with psoriatic arthritis (PsA), but lipid ratios remained unchanged.
- Hypertension adverse events and major cardiovascular events (MACE) were slightly elevated, consistent with other PsA treatments.
Why this matters
- Findings suggest that tofacitinib is not associated with increased cardiovascular risk.
- Pooled analysis of 2 phase 3 placebo-controlled trials (OPAL Broaden and OPAL Beyond) and 1 long-term extension trial (OPAL Balance).
- Tofacitinib was given at doses of 5 or 10 mg twice daily plus conventional synthetic disease-modifying antirheumatic drugs.
- Funding: Pfizer Inc.
- Increases from baseline (range, 9%-14%) in mean percentage of both LDL-C and HDL-C:
- LDL-C increased 9.2% and 14.0% at 5- and 10-mg doses at 3 months, respectively.
- HDL-C increased 10.0% and 14.0%, respectively.
- LDL-C and HDL-C increases stabilized by month 6.
- No meaningful changes were observed in 2 key lipid ratios: LDL-C/HDL-C and total cholesterol/HDL-C.
- 7.4% of patients had hypertension-related adverse events (incidence rate [IR] per 100 patient-years, 4.81; 95% CI, 3.65-6.22) vs 2.1% of placebo-treated.
- 0.6% had MACE (IR, 0.24; 95% CI, 0.05-0.70), 2 fatal, vs 0% of placebo-treated.
- Overall extent of exposure to placebo was less than tofacitinib.