Rapid improvement in spinal pain in patients with axial spondyloarthritis treated with secukinumab: primary results from a randomized controlled phase-IIIb trial

Abstract

Background: This study aimed to evaluate the efficacy and safety of secukinumab 150 mg compared with placebo in the management of spinal pain and disease activity in patients with axial spondyloarthritis (axSpA) at Week 8 and up to Week 24. Methods: Patients ( n = 380) with active axSpA were randomized (3:1) to secukinumab 150 mg (Group A) or placebo (Group B). At Week 8, patients from Group A with an average spinal pain score <4 were defined as responders and were re-assigned to secukinumab 150 mg (Arm A1); whereas non-responders were re-randomized to secukinumab 150/300 mg (Arm A2/A3). Patients from Group B were re-randomized (1:1) to secukinumab 150/300 mg (Arm B1/B2). Results: At Week 8, the odds of achieving an average spinal pain score of <4 were significantly higher for patients on secukinumab 150 mg than for patients on placebo (odds ratio (OR): 1.89; 95% confidence interval (CI): 1.08–3.33; p = 0.0264). Further reductions in spinal pain were observed across treatment groups up to Week 24. Pronounced improvements were also observed in other disease activity measurements, such as Bath Ankylosing Spondylitis Disease Activity Index and Ankylosing Spondylitis Disease Activity Score. Responders from Group A showed the highest improvements for all measured parameters of spinal pain compared with the other arms. No new or unexpected safety signals were observed. Conclusion: Secukinumab provided rapid and significant improvement in spinal pain at Week 8 which was sustained or increased further up to Week 24 in patients with axSpA. Trial Registration: ClinicalTrials.gov: NCT03136861. Registered May 2, 2017.

Efficacy and safety of biological DMARDs: a systematic literature review informing the 2022 update of the ASAS-EULAR recommendations for the management of axial spondyloarthritis

“…The frequency of AAU, IBD and psoriasis in RCTs (and OLE/LTE) of patients treated with TNFi and IL-17i was overall low and comparable to those of the placebo arm (online supplemental tables S5.1−S5.9, S5.22−S5.30). 17 19 24 26–28 30 32–35 38 51–62 One observational study at low RoB conducted in a large Swedish registry (Swedish Rheumatology Quality Register, SRQ) found an increased risk of first on-treatment AAU with etanercept use compared to adalimumab (HR 3.89 (1.85–8.06)) and infliximab (HR 1.99 (1.23–3.22)) use in those without recent AAU 63. These findings were confirmed in another observational study within the same registry 64.…”

“…In total, 14 placebo-controlled trials assessed the efficacy of IL-17i (Table 2, Supplementary Tables S3.37-S3.66). [25][26][27][28][29][30][31][32][33][34][35][36][37][38] Patients with r-axSpA on secukinumab showed greater improvement compared to placebo in two phase III trials (ASAS20 58.1-60.5% versus 36.6-36.8%, low/unclear RoB). 25,27 Another phase III trial at low RoB saw numerically higher response rates for secukinumab compared to placebo in patients with r-axSpA, although results were not statistically significant (ASAS20 59.5-61.5% versus 47.0%) (Table 3).…”

“…The frequency of AAU, IBD and psoriasis in RCTs (and OLE/LTE) of patients treated with TNFi and IL17i was overall low and comparable to those of the placebo arm (Supplementary Tables S5.1-S5.9, S5.22-S5.30). 16,18,23,[25][26][27]29,[31][32][33][34]37,[50][51][52][53][54][55][56][57][58][59][60][61] One observational study at low RoB conducted in a large Swedish registry (SRQ) found an increased risk of first on-treatment AAU with etanercept use compared to adalimumab (HR 3.89 [1. .06]) and infliximab (HR 1.99 [1.…”