medwireNews: Concomitant use of glucocorticoids (GC) is unlikely to alter the efficacy of the Janus kinase (JAK) inhibitor tofacitinib among patients with rheumatoid arthritis (RA), results of a post-hoc analysis suggest.
Oral GC are often taken by RA patients “[t]o rapidly control pain and inflammation while awaiting the effects of other disease-modifying antirheumatic drug (DMARD) treatments,” with many guidelines recommending “the use of GC in combination with DMARD, with GC being tapered as soon as is clinically feasible,” explain the study authors.
Eustratios Bananis (Pfizer Inc., New York, USA) and fellow researchers analyzed data from the six phase III ORAL trials analyzing clinical outcomes of RA patients treated with tofacitinib alone or in combination with conventional DMARDs versus methotrexate or placebo. Trial participants who were receiving GC treatment prior to enrollment continued to receive a stable dose throughout the studies.
In all, 3200 of 4067 patients from the six trials were treated with tofacitinib at a dose of 5 mg or 10 mg twice daily. In the two monotherapy studies, 46.5% of 956 patients in ORAL Start and 57.4% of the 610 ORAL Solo participants received concomitant GC treatment, at a mean dose range of 6.2–8.3 mg/day.
And in the four combination therapy studies – ORAL Scan, ORAL Standard, ORAL Sync, and ORAL Step – 58.1% of 2501 patients received GC at a mean dose range of 6.1–6.3 mg/day.
The researchers found that the proportion of tofacitinib-treated patients who responded to treatment, achieved low disease activity or remission, and experienced improvements in disability was “generally similar” among those who did and did not receive concomitant GC therapy.
For example, in ORAL Start, 67.4% of patients treated with tofacitinib 5 mg plus GC and 75.1% of those who did not receive GC achieved at least a 20% improvement in ACR criteria (ACR20) at month 6. Similarly, in the ORAL Solo study, ACR20 responses at month 3 were achieved by 57.6% and 62.8% of patients given tofacitinib 5 mg with and without GC, respectively, and a corresponding 53.8% and 57.0% achieved the same endpoint when data from the combination therapy studies were pooled.
Furthermore, GC use “did not appear to affect radiographic progression” in methotrexate-naïve, tofacitinib-treated patients, say the researchers, although they note that ORAL Start was the only included study that reported measures of radiographic progression.
Bananis and team caution that the results of their post-hoc analysis “should be considered exploratory” and that patients enrolled in the ORAL studies had active RA despite GC treatment, meaning that the results may not be generalizable to those starting GC at the same time as DMARDs.
And they conclude in The Journal of Rheumatology: “Further research, in the form of a randomized clinical trial evaluating efficacy in tofacitinib-treated GC-naive patients with RA, with or without concomitant oral GC of varying dose, would be needed to definitively characterize the efficacy and safety profile of tofacitinib in combination with GC.”
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