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Changes in Lipid Levels and Incidence of Cardiovascular Events Following Tofacitinib Treatment in Patients with Psoriatic Arthritis: A Pooled Analysis Across Phase 3 and Long-Term Extension Studies

Author

Gladman DD1, Charles-Schoeman C2, McInnes IB3, Veale DJ4, Thiers B5, Nurmohamed M6, Graham D7, Wang C7, Jones T8, Wolk R7, Demasi R8. Arthritis Care Res (Hoboken). 2019 May 21. doi: 10.1002/acr.23930. [Epub ahead of print]

Author Information

1 Department of medicine, krembil research institute, toronto western hospital, Toronto, Canada.

2 University of california, los angeles, CA, USA.

3 university of glasgow, Glasgow, UK.

4 ST. Vincent's university hospital and university college dublin, Dublin, Ireland.

5 Medical university of south Carolina, Charleston, SC, USA.

6 Amsterdam rheumatology & immunology center / vu university medical center & reade, Amsterdam, The Netherlands.

7 Pfizer Inc, Groton, CT, USA.

8 Pfizer Inc, Collegeville, PA, USA.

Abstract

OBJECTIVE: 

The risk of cardiovascular (CV) disease is higher in patients with psoriatic arthritis (PsA) versus the general population. Tofacitinib is an oral Janus kinase inhibitor for the treatment of PsA. As tofacitinib increases circulating lipid levels in some patients, we evaluated CV risk factors and major adverse cardiovascular events (MACE) in patients with active PsA receiving tofacitinib 5 or 10 mg twice daily plus conventional synthetic disease-modifying antirheumatic drugs.

METHODS: 

Data were pooled from two Phase 3 studies (OPAL Broaden [NCT01877668] and OPAL Beyond [NCT01882439]) and one ongoing long-term extension (OPAL Balance [NCT01976364]; data cut-off January 2017; database not locked). Outcomes included fasting lipid levels, blood pressure (BP), hypertension-related adverse events (AEs; including 'hypertension', 'high blood pressure', and 'increased blood pressure'), and MACE.

RESULTS: 

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.

CONCLUSION: 

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.