Background/Purpose: Dactylitis is a key and frequent clinical manifestation of psoriatic arthritis (PsA)¹ associated with significant disease burden and impaired function.^2–3 Randomized controlled trials designed to evaluate the impact of biologics on resolution of dactylitis are limited.³ We report results of a post hoc analysis evaluating the effect of secukinumab (SEC) on PsA patients with dactylitis, from the FUTURE 5 trial (NCT02404350).⁴

Methods: FUTURE 5 is a randomized, double-blinded, placebo-controlled, 2-year phase 3 trial in patients with active PsA. Patients (aged ≥18 years) were randomized 2:2:2:3 to s.c. SEC 300 mg or 150 mg with loading dose (LD), 150 mg without loading dose (NL) or placebo. All groups received SEC or placebo at baseline, weeks (wks) 1, 2 and 3 and then every 4 wks from Wk 4. Exploratory efficacy analysis at Wks 16 and 52 included time to resolution of dactylitis by dactylitis severity, proportion of patients with resolution of dactylitis, ACR 20/50 response and Psoriasis Area and Severity Index (PASI) 90.

Results: Of the 996 patients in the trial, 389 (39%) had dactylitis (SEC 150 mg NL [N=103], 150 mg LD [N=80], 300 mg LD [N=82], and placebo [N=124]). The mean (SD) tender joint count, swollen joint count and dactylitis count at baseline was: 24.0 (17.0), 14.5 (11.4) and 4.1 (4.16) and 19.1 (14.8), 9.5 (8.5) and 0, respectively, in patients with (N=389) and without (N=607) dactylitis at baseline. Higher presence of enthesitis, hsCRP and skin disease were also observed in the dactylitis subset. Median time to resolution of dactylitis (days) [95% CI] in patients on SEC 150 mg NL, 150 mg LD, and 300 mg LD, was 85 [61.0, 113.0], 85 [57.0, 119.0] and 57 [30.0, 85.0], respectively. A higher proportion of SEC treated patients achieved resolution of dactylitis, ACR 20/50 and PASI90 responses vs. placebo at Wk16 with further improvements through Wk 52 (Table 1). Resolution of dactylitis based on the number of dactylitis count at baseline (≤2 and ≥3) are shown in Table 2. SEC 300 mg LD was associated with a faster time to resolution of dactylitis and higher ACR50 and PASI90 responses compared to SEC 150 mg.

Conclusion: A higher level of disease burden was observed in patients with dactylitis compared to patients without dactylitis. SEC 300 mg was associated with a faster time to resolution of dactylitis, higher resolution of dactylitis irrespective of severity and higher responses on skin and joints.

References

1. Coates, et al. Arthritis Rheumatol. 2016;68:1060–
2. Taylor, et al Arthritis Rheum. 2006;54:2665–
3. Gladman, et al; J Rheumatol. 2013; 40:1357–59.
4. Mease, et al. Ann Rheum Dis. 2018;77:890–97.

Table 1. Efficacy outcomes in patients with baseline dactylitis (observed data)

Table 2. Efficacy outcomes in patients with dactylitis at baseline ≤ 2 and ≥ 3 (observed data)

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/secukinumab-in-the-treatment-of-dactylitis-in-patients-with-psoriatic-arthritis-post-hoc-analysis-results-from-a-randomized-phase-3-trial/