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