PSOLAR results show no patterns of cardiovascular events

February 4, 2014

Recent reports on results from the Psoriasis Longitudinal Assessment and Registry (PSOLAR) study show there are no distinct patterns of major adverse cardiovascular events (MACE), and there are limited rates of malignancy, overall.

 

Recent reports on results from the Psoriasis Longitudinal Assessment and Registry (PSOLAR) study show there are no distinct patterns of major adverse cardiovascular events (MACE), and there are limited rates of malignancy, overall.

Results of the PSOLAR study were revealed in a poster presentation at MauiDerm 2014 last week.

“PSOLAR is a multicenter, longitudinal, observational study evaluating long-term safety and clinical outcomes for patients receiving (or eligible to receive) treatment for psoriasis with biologics and/or conventional systemic agents,” according to the reports.

One report that analyzed MACE among the 11,900 patients enrolled in PSOLAR (as of Aug. 23, 2012), found that a total of 57 MACE occurred across biologic treatment groups. Of those, 20 of the MACE were reported among patients who initiated a new biologic.

Of the 20 patients who had MACE after initiating a new biologic treatment, the breakdown of reported MACE per treatment is as follows:

  • Adalimumab - 10/1121 (0.89 percent)

  • Etanercept - 3/468 (0.64 percent)

  • Infliximab - 3/250 (1.20 percent)

  • Ustekinumab - 4/1576 (0.25 percent)

“Further analyses adjusting for demographic features, CV risk factors and biologic exposure are planned,” the report stated.

Another recent report from PSOLAR also looked at the 11,900 patients enrolled in the study as of Aug. 23, 2012. This report examined the accrual of malignancies excluding nonmelanoma skin cancers in study patients. Of the study’s patients, the rates of malignancies excluding nonmelanoma skin cancers for the following treatments are as follows:

  • Ustekinumab - 0.53 events per 100 patient years of observation

  • Infliximab/golimumab - 0.70 per 100 patient years of observation

  • Other biologics (almost exclusively etanercept/adalimumab) - 0.68 per 100 patient years of observation

  • Nonbiologic therapy - 0.83 per 100 patient years of observation

  • Overall - 0.68 per 100 patient years of observation

“Due to channeling of therapy, there may be differences in subgroup characteristics,” the report states. “Formal comparison will require statistical modeling to adjust for patients characteristics and risks, including consideration of multiple treatments.”

Unadjusted rates in ustekinumab-treated patients tended to be lower than other treatment groups, despite the rules of event attribution, that report stated.

“These are preliminary results - PSOLAR will follow patients for up to eight years, providing additional data over time,” the report stated. “PSOLAR is a powerful resource for tracking safety events of interest among patients eligible to receive systemic therapies.”