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After patients with granulomatosis with polyangiitis (GPA) achieve remission, the use of low-dose prednisone (5 mg/day) prevents more disease relapses over 6 months than being fully off prednisone, but only among patients treated with a non-rituximab-based regimen. With either 5 or 0 mg/day of prednisone, the risk for a major relapse is very low.

After reaching GPA remission, continuing low-dose glucocorticoids or discontinuing them are standards of care. The efficacy and safety of these strategies were compared in the multicenter, open-label, randomized-controlled, phase 3 TAPIR (NCT01933724) trial by Prof. Peter Merkel, from the University of Pennsylvania, and colleagues. The participants (n=144) were randomly assigned 1:1 to tapering glucocorticoids down to 5 or 0 mg/day for 6 months or until relapse.

At enrollment, GPA had to be in remission and the glucocorticoid dose was 5–10 mg/day. After tapering to 5 mg/day, participants were randomly assigned to 5 mg/day for 6 months (n=73) or to taper off to 0 mg/day within 4 weeks (n=71). The primary outcome was the physician’s decision to increase the glucocorticoid dose due to GPA relapse by month 6. Just over half (54%) of participants received rituximab during the trial.

In the glucocorticoid 5 mg/day group, 4.2% had a relapse versus 15.5% in the 0 mg/day group (OR 4.22; 95% CI 1.1–15.8; P=0.0227). Prof. Merkel said that among rituximab users, there was no between-group difference in relapse rate (P=0.667). Time to relapse was significantly shorter in the 0 mg/day group (P=0.026). There were no differences in change in patient-reported outcomes. Of six serious AEs, five occurred in the 0 mg/day group and one in the 5 mg/day group (P=0.492).

Prof. Merkel stressed the importance of these results for clinical practice. “For patients treated with rituximab, fully tapering off glucocorticoids is reasonable to consider as the first approach,” he said. “For patients not treated with rituximab, low-dose prednisone may prevent some minor relapses; but fully tapering off prednisone presents little risk for increasing the rate of major relapses.”

Medical writing support was provided by Michiel Tent

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