Background/Purpose: Power Doppler ultrasound (PDUS) is a sensitive non-invasive imaging tool to visualize a wide range of articular and periarticular inflammation in psoriatic arthritis (PsA).^1,2 ULTIMATE (NCT02662985) is the first large RCT that used ultrasound with Global OMERACT ultrasound synovitis score (GLOESS) as the primary endpoint, to demonstrate early benefits of secukinumab on synovitis in patients with PsA through 12 weeks.³ Here we report the responsiveness of ultrasound on synovitis and enthesitis, clinical efficacy, and safety of secukinumab up to 52 weeks.

Methods: This was a 52-week study with a 12-week double-blind placebo-controlled treatment followed by 12-week open-label treatment and 6-month open-label extension treatment in all patients. Detailed study design and eligibility criteria have been reported previously.^3,4 Synovitis and ultrasound enthesitis response were measured by GLOESS and Global OMERACT enthesitis Score (Definitions 1 and 2)⁴ at patient level, respectively. Other assessments across key PsA manifestations of joints (ACR responses), enthesitis, (SPARCC), skin (PASI responses), dactylitis (LDI) and physical function (HAQ-DI) were also evaluated. Data are presented as observed.

Results: A total of 166 patients were enrolled, of which 90% (75/83) of secukinumab and 83% (69/83) of placebo-secukinumab participants completed 52 weeks. A continued improvement in GLOESS was observed in both secukinumab and placebo-secukinumab group after switch to active therapy at Week 12 through Week 52 (Figure 1). A similar trend of improvement in Global OMERACT enthesitis score (Definition 1 and 2) was observed up to 52 weeks in both groups (Figure 2). Sustained clinical response rates were observed across multiple facets of disease and physical function up to 52 weeks in both secukinumab and placebo-secukinumab groups (Table). There were no new or unexpected safety findings.

Conclusion: ULTIMATE demonstrated the responsiveness of ultrasound on both synovitis and enthesitis outcomes in PsA supporting its use in clinical trials, and confirmed the rapid and continued benefits of secukinumab through 52 weeks. Sustained efficacy was also observed across key clinical PsA manifestations with a safety profile consistent with previous reports.

References:
1. D’Agostino MA and Coates LC. J Rheumatol 2019;46:337–9
2. Uson J, et al. Rheumatol Clin 2018;14:27–35
3. D’Agostino MA, et al. Arthritis Rheumatol 2020;72 (suppl 10)
4. Boers M et al. Ann Rheum Dis 2021;80:314

Figure 1: Mean change from baseline in GLOESS by treatment up to Week 52

Figure 2: Mean change from baseline Global OMERACT enthesitis score up to Week 52

Table: Clinical efficacy outcomes at Week 52 (Extension period)

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/ultrasound-demonstrates-continued-improvement-in-psoriatic-arthritis-synovitis-and-enthesitis-with-secukinumab-52-week-results-from-a-phase-iii-study/