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Glucocorticoid use with Xeljanz does not affect clinical, radiographic efficacy
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In an analysis of six phase 3 studies, the use of glucocorticoids with Xeljanz in patients with rheumatoid arthritis did not appear to affect clinical or radiographic efficacy, according to findings published in the Journal of Rheumatology.
Christina Charles-Schoeman, MD, MS, associate professor of medicine at the University of California, Los Angeles, and colleagues also concluded that methotrexate taken with glucocorticoids tended to inhibit radiographic progression more than methotrexate alone.
“This was the first study to evaluate the efficacy of tofacitinib with and without glucocorticoids in a large phase 3 RA clinical developmental program,” Charles-Schoeman told Healio Rheumatology.
According to the researchers, Xeljanz (tofacitinib, Pfizer) is an oral Janus kinase inhibitor for the treatment of RA.
“No difference in efficacy was noted between patients receiving tofacitinib with and without glucocorticoids,” Charles-Schoeman said. “However, these results must be considered in the context of the studies performed — in particular, the patients studied had active disease on glucocorticoids at baseline before they were started on tofacitinib.”
To study to effect of glucocorticoid use on the efficacy outcomes in patients with RA who are also receiving tofacitinib and/or methotrexate, or conventional synthetic DMARD, the researchers conducted a posthoc analysis of six phase 3 studies. Among the 3,200 patients who were treated with tofacitinib, 39.3% received tofacitinib monotherapy, 60.7% received tofacitinib plus conventional synthetic DMARD and 55.2% received concomitant glucocorticoids.
Endpoints included the American College of Rheumatology 20/50/70 response rates, as well as low disease activity as defined by the Clinical Disease Activity Index (CDAI) and remission — defined as CDAI of 2.8 or less. The researchers also included changes from baseline in CDAI, the 28-joint count Disease Activity Score–erythrocyte sedimentation rate, Health Assessment Questionnaire–Disability Index, pain visual analog scale and modified total Sharp score.
According to the researchers, ACR20/50/70 response rates, as well as rates of CDAI low disease activity and remission, and improvements in CDAI, Disease Activity Score–erythrocyte sedimentation rate, Health Assessment Questionnaire–Disability Index and pain visual analog scale with tofacitinib were generally similar with or without glucocorticoids in monotherapy and combination therapy studies. Glucocorticoid use did not appear to affect radiographic progression in patients who were methotrexate-naive and treated with tofacitinib. Methotrexate along with glucocorticoids appeared to inhibit radiographic progression to a numerically greater degree than methotrexate alone, the researchers found.
“Due to the known risks of glucocorticoids including increased risk of serious infections, it is important to study the efficacy of RA therapeutics such as tofacitinib with and without concomitant glucocorticoids,” Charles-Schoeman said. “Further research would be needed in the form of a randomized clinical trial to definitively characterize the efficacy and safety of glucocorticoids in conjunction with tofacitinib.” – by Jason Laday
Disclosure: Charles-Schoeman reports receiving research grants and consulting fees from Pfizer Inc.
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