medwireNews: The increased risk for herpes zoster in rheumatoid arthritis (RA) patients taking tofacitinib is further doubled with the concomitant use of glucocorticoids, show real-world data for more than 8000 patients.
The additional use of methotrexate did not confer a further risk, however, reported Jeffrey Curtis (University of Alabama, Birmingham, USA), presenting the findings at the 2018 ACR/ARHP Annual Meeting in Chicago, Illinois, USA.
Curtis and colleagues found that younger age, being male, and vaccination with the live virus zoster vaccine were associated with a lower risk for herpes zoster, which they say “may suggest a role for newer vaccination strategies in at-risk RA patients.”
For the study, which has also been published in Arthritis Care and Research, a total of 8030 RA patients initiating treatment with the Janus kinase (JAK) inhibitor tofacitinib between 2011 and 2016 were identified based on ICD9/10 codes from the MarketScan and Medicare databases, and provided 5811 person–years for analysis. The patients were aged an average of approximately 60 years and 83.3% were women.
In total, 222 patients developed herpes zoster. For those taking tofacitinib alone the crude rate of herpes zoster was 3.7 per 100 person–years, which the researchers note is higher than previously published rates in patients taking biologics of between 1.7 and 2.7 per 100 person–years.
The rate of herpes zoster in patients taking tofacitinib and additional methotrexate was 3.4 per 100 person–years, which did not differ significantly from that seen in patients taking tofacitinib alone. By contrast, patients taking additional glucocorticoids (without methotrexate) had a significant twofold higher rate, at 6.0 per 100 person–years.
“Our results add to the growing body of literature [surrounding] the risk for [herpes zoster] association with JAK inhibition and other risk factors in RA patients,” the team comments.
After adjusting for multiple risk factors, glucocorticoid exposure was associated with a significant 96% increased risk for herpes zoster with older age and female sex being other contributing factors, increasing the risk by 11% (per 5-year increment) and 43%, respectively. Receiving the live zoster vaccine protected against herpes zoster, reducing the risk by 40%, although there was only a trend towards significance.
Commenting on this at the meeting, Curtis acknowledged that “in general US rheumatologists are quite anxious and nervous about using a live virus vaccine in people on biologics or targeted therapies,” adding that they tend not to give it because of safety concerns.
However, Curtis went on to announce that together with his team he is conducting a randomized pragmatic trial and of 600 people with RA or other indications for anti-TNF therapy given live virus vaccine so far, none have developed varicella.
But he thinks that until these trial data are available and there are maybe some label changes, rheumatologists “will be cautious and conservative about using a live virus vaccine for anyone on a biologic or targeted therapy like tofacitinib.”
By Lucy Piper
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