Secukinumab has Early and Sustained Efficacy on Enthesitis in Patients with Psoriatic Arthritis
Secukinumab provided early and sustained resolution of enthesitis in patients with psoriatic arthritis based on post hoc analysis pooled data from the FUTURE trial.
Secukinumab (Cosentyx, Novartis) has shown early and sustained efficacy on enthesitis in patients with psoriatic arthritis (PsA) regardless of whether they received tumor necrosis factor inhibitors, according to a study published in BioMed Central.
Enthesitis is inflammation of the entheses, the site where ligaments or tendons insert into the bones. Common locations for enthesitis include the bottom of the feet, the Achilles tendons, and the places where ligaments attach to the ribs, spine, and pelvis.2
Patients with enthesitis are known to have worse outcomes than patients without enthesitis. Using pooled data from the FUTURE 2 and 3 studies, a research team explored the use of secukinumab to limit enthesitis in patients with PsA.1
FUTURE was a phase 3 randomized, double-blind, placebo-controlled multicenter study that analyzed the 24- to 52-week efficacy, safety, and tolerability of subcutaneous secukinumab in prefilled syringes. Researchers used the Leeds Enthesitis Index (LEI) that consists of 6 sites: bilateral Achilles tendon insertions, medial femoral condyles, and lateral epicondyles of the humerus. Tenderness at each site is quantified by a number scale: 0 means nontender and 1 means tender.4
The post hoc analyses included the resolution of enthesis count (EC=0), median time to first resolution of enthesitis, and shift analysis of baseline EC (1, 2, or 3-6) to full resolution (FR) stable (similar or reduction of EC), or worse (EC > baseline).1
Sixty-five percent (466/712) of patients had baseline enthesitis. In the overall population, FR was achieved as early as week 16 in 65% (300 mg) and 56% (150 mg) versus 44% in the placebo group, with further improvements to 91% (300 mg) and 88% (150 mg) at week 104. The majority (89%) of patients without enthesitis at baseline maintained their status at week 104.3
In patients with EC of 1 or 2, shift analysis from baseline to week 24 showed that more patients achieved FR with secukinumab 300 mg and 150 mg versus placebo, whereas no difference between secukinumab and placebo was shown in patients with more severe symptoms with an EC of 3 to 6. Improvements in efficacy outcomes were similar in patients with or without enthesitis treated with secukinumab 300 mg.1
Secukinumab provided early and sustained resolution of enthesitis in patients with PsA over 2 years, the study authors noted.1 Secukinumab 300 mg provided higher resolution than 150 mg in patients with more severe baseline EC and showed similar overall efficacy in patients with or without enthesitis.
- Coates, L.C., Wallman, J.K., McGonagle, D. et al. Secukinumab efficacy on resolution of enthesitis in psoriatic arthritis: pooled analysis of two phase 3 studies. Arthritis Res Ther 21, 266 (2019) doi:10.1186/s13075-019-2055-z. Accessed January 8, 2020.
- Classification of Psoriatic Arthritis. National Psoriasis Foundation. https://www.psoriasis.org/psoriatic-arthritis/classification-of-psoriatic-arthritis. Accessed January 8, 2020.
- Efficacy at 24 Weeks with long-term safety, tolerability, and efficacy up to 5 years of secukinumab in patients of active psoriatic arthritis (FUTURE 2). Clinical Trials website. Published December 19, 2012. https://clinicaltrials.gov/ct2/show/study/NCT01752634. Accessed January 8, 2020.
- Healy, PJ. Leeds Enthesitis Index (LEI). Published in 2008. eProvide website. https://eprovide.mapi-trust.org/instruments/leeds-enthesitis-index. Accessed January 8, 2020.