Session Type: Late-Breaking Abstract Session
Session Time: 11:15AM-11:30AM
Background/Purpose: Little is known about glucocorticoid-sparing agents in giant cell arteritis (GCA) except for IL-6 inhibition. Secukinumab (SEC) has shown significant improvements in the signs and symptoms of IL-17A driven medical conditions such as plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis.1,2 It has a favorable long-term safety profile.1,2 TitAIN is the first randomized controlled trial investigating the potential efficacy, safety, and tolerability of SEC in GCA patients.
Methods: This phase 2, randomized, double-blind, placebo-controlled, multicenter, proof-of-concept trial enrolled patients (aged ≥50 years) with new onset (diagnosed within 6 weeks of baseline) or relapsing (diagnosed >6 weeks from baseline) GCA, naïve to biological therapy. Patients were randomized (1:1) to SEC 300 mg or placebo initially administered weekly (5 doses) and every 4 weeks thereafter through Week 48 (last dose), in combination with a 26-week prednisolone taper regimen starting from baseline. The proportion of GCA patients in sustained remission until Week 28 was the primary endpoint assessed by a Bayesian analysis of the posterior distribution with non-responder imputation. Other key endpoints included the proportion of GCA patients in sustained remission until Week 52 (based on study data with non-responder imputation) and time to first GCA flare after baseline.
Results: Out of 52 randomized patients (SEC, n=27; placebo, n=25), 71.2% (n=37) completed study treatment (SEC, 81.5%; placebo, 60.0%). Overall, 42 (80.8%) patients had new onset GCA and 10 (19.2%) patients had relapsing GCA at baseline. The proportion (posterior median with 95% credibility interval) of GCA patients in sustained remission until Week 28 was higher with SEC, 70.1% (51.6%-84.9%), than with placebo, 20.3% (12.4%-30.0%); odds ratio (posterior median with 95% credibility interval), 9.31 (3.54-26.29) (Figure 1a). Until Week 52, the proportion (95% confidence interval) of GCA patients in sustained remission were 59.3% (38.8%-77.6%) in SEC group and 8.0% (1.0%-26.0%) in placebo group (Figure 1b). The median (95% confidence interval) time to first GCA flare after baseline was not reached for GCA patients treated with SEC and was 197.0 (101.0-280.0) days for placebo (Figure 2). Overall, treatment-emergent adverse events (AEs) occurred in 98.1% (SEC vs placebo, 100.0% vs 96.0%) and serious AEs in 32.7% (SEC vs placebo, 22.2% vs 44.0%) patients. Two patients in each SEC and placebo group had AEs that led to study drug discontinuation and 1 patient in each group had AEs that led to death (not treatment-related). There were no new or unexpected safety signals identified with SEC treatment.
Conclusion: SEC demonstrated a higher sustained remission rate along with longer time to first GCA flare versus placebo through 52 weeks in patients with GCA. This proof-of-concept phase 2 study supports the further development of SEC as a potential treatment in combination with a 26-week glucocorticoid taper for patients with GCA.
- Mease PJ, et al. ACR Open Rheumatol. 2020;2(1):18-25
- Baraliakos X, et al. RMD Open 2019;5:e001005
To cite this abstract in AMA style:Venhoff N, Schmidt W, Bergner R, Rech J, Unger L, Tony H, Mendelson M, Sieder C, Maricos M, Thiel J. Secukinumab in Giant Cell Arteritis: A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase 2 Trial [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/secukinumab-in-giant-cell-arteritis-a-randomized-parallel-group-double-blind-placebo-controlled-multicenter-phase-2-trial/. Accessed January 28, 2023.
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