Pooled phase III data with Xeljanz shows changes that could correlate with CV risk in psoriatic arthritis .- Pfizer

To investigate the CV risk factors and major adverse cardiovascular events (MACE) in patients with active Psoriatic Arthritis (PsA) receiving Xeljanz (tofacitinib) 5 or 10 mg twice daily, from Pfizer, plus conventional synthetic disease-modifying antirheumatic drugs, data were pooled from two Phase III studies (OPAL Broaden [NCT01877668] and OPAL Beyond [NCT01882439]) and one ongoing long-term extension (OPAL Balance [NCT01976364]). The outcomes recorded include fasting lipid levels, blood pressure (BP), hypertension-related adverse events (AEs; including �hypertension�, �high blood pressure�, and �increased blood pressure�), and MACE.

Overall, 783 tofacitinib-treated patients were included. Percentage increases from baseline in low-density and high-density lipoprotein cholesterol levels (LDL-c and HDL-c, respectively) ranged from 9-14% for tofacitinib 5 and 10 mg at 3 and 6 months; no meaningful changes in LDL-c/HDL-c or total cholesterol/HDL-c ratios were observed. BP remained stable over 24 months. Fifty-eight (7.4%) patients had hypertension-related AEs; none were fatal (incidence rate [IR] per 100 patient-years: 4.81; 95% confidence interval [CI]: 3.65-6.22). Five (0.6%) patients had MACE (IR: 0.24; 95% CI: 0.05-0.70); two were fatal. In conclusion, the study shows that serum lipid level increases at month 3 following tofacitinib treatment in PsA were consistent with observations in rheumatoid arthritis and psoriasis. The incidence rate of hypertension-related AEs and MACE was low; long-term follow-up is ongoing.