Lipid profile changes in patients with chronic inflammatory arthritis treated with biologics and tofacitinib in randomized clinical trials: A systematic review and meta-analysis
Systemic inflammation, reflected by high levels of C-reactive protein and the erythrocyte sedimentation rate, has been identified as an independent risk factor for cardiovascular disease, the most important cause of death in RA and SpA. Studies with TNF antagonists have given contradictory results on cardiovascular risk. As such, this systemic literature search aimed to analyse lipid changes in RA and SpA subjects treated with biologics or tofacitinib in randomized clinical trials.
The search identified 4527 articles (RCTs, ACR/EULAR abstracts and FDA documents), of which, 25 articles were selected for the analysis; nine articles, one abstract and two FDA documents were analysed for TNF antagonists, seven for tofacitinib and six for tocilizumab. Meta-analyses were performed to assess changes in the lipid profile, defined as the percentage of patients with high lipid levels or average increase or mean percentage increase (from baseline) in the total cholesterol, LDL and HDL cholesterol and triglycerides.
Results showed that moderate changes in lipids were seen in RA patients treated with tocilizumab and tofacitinib but not with TNF antagonists. Compared to placebo, tocilizumab treatment showed significant hypercholesterolemia, increased HDL and increased LDL cholesterol. Tofacitinib was also associated with increased levels of HDL and LDL in RA patients, compared to placebo, but no significant effect was seen in patients treated with TNF antagonists. Whether these changes relate to the control of inflammation or an independent mechanism of action remains to be determined.