Real-world Actemra data show lower rate of some SAEs vs. clinical trials in RA

August 12, 2015

A study of tocilizumab (Actemra) in the treatment of rheumatoid arthritis (RA) found that the number of serious adverse events (SAEs) found in postmarketing data were similar to other populations from clinical trials and epidemiology data.

A study of tocilizumab (Actemra) in the treatment of rheumatoid arthritis (RA) found that the number of serious adverse events (SAEs) found in postmarketing data were similar to other populations from clinical trials and epidemiology data. Tocilizumab is a first-in-class drug for RA with a different mechanism of action (MAO) targeting IL-6 receptors.

Related: Actemra gets break through therapy designation for scleroderma

The findings were published in Seminars in Arthritis and Rheumatism. The study also found that the overall rate of SAEs of interest in the real world were lower than those observed in clinical trials (especially with regard to gastrointestinal perforation).

These analyses support the safety of Actemra in real-world use for those living with RA, according to study author Jeffrey Curtis, MD. 

In this analysis, Dr Curtis and colleagues took a novel and comprehensive approach to compare safety event rates from tocilizumab global post-marketing safety database, tocilizumab registrational clinical trials (including placebo-controlled and long-term extensions), and an insurance claims database for the comparator anti-TNF population.

Related:Rheumatoid arthritis drug may benefit atopic dermatitis patients

“This post-marketing pharmacovigilance data showed comparable safety of tocilizumab to anti-TNF agents and helps us further understand the long-term benefit risk for tocilizumab with an alternative MOA in real-world clinical practice,” said Dr Curtis, professor at the University of Alabama at Birmingham, Division of Clinical Immunology and Rheumatology.

Similar rates were observed for SAEs of interest between patients treated with tocilizumab and anti-TNF therapies.

 

NEXT: 5 take-aways from the study and 5 things formulary managers should know

 

Dr Curtis offers 5 take-aways from this study:

  • This has been one of the most comprehensive safety evaluations of tocilizumab to-date.

  • Analysis showed similar SAE rates for tocilizumab compared to anti-TNF agents within 3 data sources (SAEs of interests were serious hepatic events, serious GI perforations, serious myocardial infarction, and serious stroke).

  • Clinical trials are limited by the number of patients and enrollment criteria, and may not be representative of real-world heterogeneous treatment populations. This analysis uses an integrated approach in which post-marketing pharmacovigilance data was analyzed to improve understanding of a treatment's safety profile beyond clinical trials.

  • Although post-marketing and claims data are valuable for outcomes analysis, they have inherent limitations expected for real-world reporting practices.

  • Ongoing safety evaluations and pharmacovigilance efforts are under way to monitor the long-term safety of tocilizumab.

In addition, there are 5 things formulary managers must know about RA:

  • The pathogenesis of RA is heterogeneous, mediated by a number of different cytokines; therefore, access to biologic therapies with differing mechanisms of action is important to allow for individualized treatment.

  • The primary treatment goal for the management of RA is to achieve low disease activity or remission; however, individual treatment goals depend on a number of factors, including disease progression, patient preference and comorbidities.

  • Careful consideration should be given to therapies with data supporting their use as monotherapy in MTX-intolerant or MTX-inadequate responders, as approximately one-third of all patients on biologics take them as monotherapy.

  • Approximately 30% to 40% of patients have inadequate responses or intolerance to anti-TNF agents in studies up to 30 weeks. Alternative therapies that target other pathways may help patients achieve treatment goals.

  • Similar to the course of other chronic diseases, RA drug therapy has advanced to encompass a wider variety of agents with varying mechanisms of action. Access to different therapeutic options is important for patients with poor prognosis and high disease activity.