Certain biologic therapies for psoriasis do not appear to increase risk for cardiovascular problems

August 23, 2011, JAMA and Archives Journals

Although some preliminary reports have indicated an increased risk of major adverse cardiovascular events with the use of certain biologic therapies to treat chronic plaque psoriasis, an analysis of previous studies finds no significant difference in the rate of these events among patients who received these medications compared to patients who received placebo, according to an article in the August 24/31 issue of JAMA.

In the past decade, important new findings have emerged linking , including psoriasis, with chronic and a subsequent increase in . It has been proposed that control of inflammation could help reduce cardiovascular illness, according to background information in the article. There have been preliminary reports of an excess number of major adverse (MACEs [a composite end point of , cerebrovascular accident, or ]) in randomized controlled trials (RCTs) of psoriasis patients treated with anti-IL-12/23 agents, and a small amount of events reported from studies of anti-tumor necrosis factor alpha (TNF-α) agents for the treatment of psoriasis.

Caitriona Ryan, M.B., B.A.O., B.Ch., of the Baylor Research Institute, Dallas, and colleagues conducted a meta-analysis to evaluate a possible association between biologic therapies for chronic plaque psoriasis (CPP; the most common form of psoriasis, characterized by well-defined patches of red raised skin) and MACEs. The researchers indentified for inclusion in the analysis 22 of monotherapy studies (with safety outcome data for MACE) of anti-IL-12/23 agents (ustekinumab and briakinumab) and anti-TNF-α agents (adalimumab, etanercept and infliximab) in adults. The total number of participants in these studies was 10,183 patients. The primary outcome that was measured was a MACE during the placebo-controlled phase of treatment in patients receiving at least 1 dose of study agent or placebo.

During the placebo-controlled phases of the anti-IL-12/23 studies, 10 of the 3,179 patients treated with these therapies had a MACE compared with no events in the 1,474 patients treated with placebo. In studies of anti-TNF-α agents, 1 of the 3,858 patients receiving these agents had a MACE compared with 1 of the 1,812 treated with placebo.

"This meta-analysis did not show a significant increase in the risk of MACEs associated with the use of anti-lL-12/23 agents. Limitations of this study, however, prevent us from determining whether these drugs expose psoriasis patients to increased cardiovascular risk. Access to patient-level data for these studies was not granted by any of the study sponsors, which precluded the use of a more statistically robust time-to-event analysis. The small number of MACEs that occurred in placebo-controlled phases of these studies and the limited duration of the placebo-controlled phases reduce the power of this meta-analysis to detect a change in risk," the authors write.

The researchers add that this analysis highlights the inherent limitations of placebo-controlled, clinical trials to reliably interpret the significance of rare events given their current design. "Although RCTs are currently the criterion standard for measuring clinical efficacy in psoriasis therapies, these studies are designed to detect differences in the severity of psoriasis in response to therapy over short periods of treatment and are often underpowered and of too short duration to detect rare or long-term adverse events. Careful consideration of these issues is warranted to best serve patients in these studies and those who are treated once drugs are approved."

Explore further: Common rheumatoid arthritis and psoriasis medications are associated with reduced diabetes risk

More information: JAMA. 2011;306[8]:864-871.

Related Stories

Common rheumatoid arthritis and psoriasis medications are associated with reduced diabetes risk

June 21, 2011
Individuals with systemic inflammatory conditions, such as rheumatoid arthritis (RA) and psoriasis, experience a 1.5 to 2-fold increased rate of cardiovascular disease. Previous research suggests that inflammation and insulin ...

Recommended for you

Creation of synthetic horsepox virus could lead to more effective smallpox vaccine

January 19, 2018
UAlberta researchers created a new synthetic virus that could lead to the development of a more effective vaccine against smallpox. The discovery demonstrates how techniques based on the use of synthetic DNA can be used to ...

Study ends debate over role of steroids in treating septic shock

January 19, 2018
The results from the largest ever study of septic shock could improve treatment for critically ill patients and save health systems worldwide hundreds of millions of dollars each year.

New approach could help curtail hospitalizations due to influenza infection

January 18, 2018
More than 700,000 Americans were hospitalized due to illnesses associated with the seasonal flu during the 2014-15 flu season, according to federal estimates. A radical new approach to vaccine development at UCLA may help ...

Zika virus damages placenta, which may explain malformed babies

January 18, 2018
Though the Zika virus is widely known for a recent outbreak that caused children to be born with microencephaly, or having a small head, and other malformations, scientists have struggled to explain how the virus affects ...

Certain flu virus mutations may compensate for fitness costs of other mutations

January 18, 2018
Seasonal flu viruses continually undergo mutations that help them evade the human immune system, but some of these mutations can reduce a virus's potency. According to new research published in PLOS Pathogens, certain mutations ...

Study reveals how MRSA infection compromises lymphatic function

January 17, 2018
Infections of the skin or other soft tissues with the hard-to-treat MRSA (methicillin-resistant Staphylococcus aureus) bacteria appear to permanently compromise the lymphatic system, which is crucial to immune system function. ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.