According to the researchers, a “direct association regarding the long-term effect of TCZ treatment on [cardiovascular disease] cannot be determined, given that the time during placebo treatment was limited in these trials; therefore, no robust comparison of [major adverse cardiovascular events] risk in placebo-treated patients is possible.”
Inflammatory Burden & Risk
Drs. Liao and Solomon, in commenting about the Rao research in their editorial, said that the statistical power of the study to determine that total cholesterol and LDL levels at Week 24 were not associated with an increased risk of CV events was “limited.”
Dr. Solomon
In an interview, Dr. Solomon, professor of medicine at Harvard Medical School and chief of the Section of Clinical Sciences and Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham & Women’s Hospital in Boston, elaborated on that comment. “There are decades of literature telling us that total cholesterol and LDL levels are bad,” he says. “One should not come away from this paper thinking that you shouldn’t have a concern about the cholesterol issue or that with a response to tocilizumab that patients are safe from the cardiovascular standpoint. That’s an overreach.”
Dr. Liao, assistant professor at the Harvard Medical School and a rheumatologist at Brigham & Women’s Hospital, says that Rao and colleagues examined the association between a change in lipids; for example, an increase in LDL between baseline and 24 weeks, with a CV event occurring after 24 weeks. The mean duration of TCZ treatment in the study was 1.8 years.
“The authors had only a mean of approximately 1.3 years to assess whether the changes in lipids for patients on tocilizumab were related to CV risk in any way,” she says. “Even in populations at high risk for CVD, when assessing for a link between lipids and CV risk, you would either need more follow-up time or more people than were in the study.”
