Background/Purpose: This study assessed the occurrence of adverse events of serious infections, herpes zoster, and opportunistic infection during concomitant treatment with GCs and after GC tapering in patients with GCA receiving UPA or PBO in the SELECT-GCA trial.

Methods: Patients in this analysis from SELECT-GCA1 were diagnosed with new-onset or relapsing GCA, had previous exposure to ≥40 mg prednisone (or equivalent) daily, and were on a baseline prednisone dose of ≥20 mg daily. Kaplan-Meier method was used to analyze adverse events through week 52, presented as time to first event (patients with no events were censored at the end of the study period). Event rates were calculated for data from patients with ≥1 event of the same type.

Results: Baseline characteristics of the treatment groups were similar.1 Baseline GC doses for UPA were: 20 mg (30%, n=95); 30 mg (22%, n=70); 40 mg (29%, n=91); 50 mg (10%, n=32); 60 mg (9%, n=28). Baseline GC doses were similarly distributed for PBO: 20 mg (27%, n=30); 30 mg (26%, n=29); 40 mg (28%, n=31); 50 mg (14%, n=16); 60 mg (5%, n=6). Rates of serious infections were lower with both doses of UPA than PBO through week 52 (UPA7.5, 7.9 [95% CI: 3.2, 16.3]; UPA15, 7.9 [4.3, 13.2]; PBO 12.7 [6.6, 22.2] events per 100 patient-years [E/100 PY]). Herpes zoster, a known risk for JAK inhibitors including UPA, had higher rates with UPA15 vs PBO (7.3 [95% CI: 3.9, 12.5] E/100 PY vs 4.2 [1.2, 10.9] E/100 PY) or UPA7.5 (4.5 [1.2, 11.6] E/100 PY). Rates of opportunistic infections were low in all groups, although numerically higher in the UPA15 group compared to PBO (2.2 [95% CI: 0.6, 5.8] E/100 PY vs 1.1 [0, 5.9] E/100 PY); no opportunistic infections were reported for UPA7.5. In UPA-treated patients, rates of serious infections were comparable across during the GC-taper period (difference ≤ week 26 for UPA – PBO: 0.3 [95% CI: -5.8, 6.4] and -0.3 [-5.4, 4.8] E/100 PY for UPA7.5 and UPA15. Rates of serious infections were lower in the post-taper period with UPA7.5 or UPA15 relative to PBO (treatment difference from > week 26 to week 52: UPA7.5, -5.1 [95% CI: -12.1, 1.9] and UPA15, -4.6 [-11.1, 2.0] E/100 PY). Rates of herpes zoster were similar in UPA-treated patients during the GC taper (treatment difference for UPA – PBO: UPA7.5, -3.1 [95% CI: -7.8, 1.6] and UPA15, 1.4 [-4.0, 6.8] E/100 PY) and post-GC taper (treatment difference: 3.4 [95% CI: -0.4, 7.2] and 1.7 [-0.2, 3.6] E/100 PY). Of the 4 opportunistic infections in UPA15, 3 events occurred during the GC taper and 1 occurred post-taper.

Conclusion: The rate of serious infection through 52 weeks was lower in patients treated with UPA combined with a 26-week GC taper versus PBO with a 52-week GC taper, with rates lower with UPA relative to PBO after tapering GCs in the UPA groups. The decrease in serious infection rates during the GC-free phase suggests GC use may contribute to the risk of serious infections. GC tapering did not appear to affect the occurrence of HZ in the UPA groups. These results support the use of UPA15 with a standardized approach to GC tapering to reduce GC burden in older populations with an elevated infection risk.References:1. Blockmans D, et al. N Engl J Med. 2025 Apr 2. doi: 10.1056/NEJMoa2413449.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/impact-of-glucocorticoid-tapering-in-giant-cell-arteritis-analysis-from-the-select-gca-trial/