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Guselkumab resolves enthesitis in most PsA patients

Jairia Dela Cruz
28 Apr 2021

Treatment with the selective interleukin (IL)-23 inhibitor guselkumab results in the clearance of enthesitis for many psoriatic arthritis (PsA) patients, with the resolution maintained through month 12, as shown by pooled data from two phase III trials.

At week 24, resolution rates were markedly different between the guselkumab and placebo groups, in favour of the former, according to a team of investigators led by Dr Dennis McGonagle of the Leeds Biomedical Research Centre, University of Leeds in the UK. 

“Enthesitis resolution was associated with achieving important patient outcomes,” McGonagle said.

Even though patients with more severe inflammation of the entheses had lower rates of resolution, he noted, the beneficial effect of guselkumab on other disease domains was consistent and independent of the presence of enthesitis at baseline.

McGonagle and colleagues synthesized data from 381 patients who have or have not previously taken one or more tumour necrosis factor inhibitors (TNFis; DISCOVER-1) and from 739 biologic-naïve patients (DISCOVER-2). Participants had been assigned to treatment with guselkumab 100 mg every 4 weeks (Q4W) or every 8 weeks (Q8W) or placebo. After 24 weeks, those on placebo switched to guselkumab 100 mg every 4 weeks.

More than half (65 percent) of the overall population had enthesitis, which was assessed using Leeds Enthesitis Index (LEI), at baseline. They exhibited slightly more swollen and tender joints, systemic inflammation, and impaired physical function than patients without enthesitis.

Guselkumab Q4W and Q8W performed better than placebo at clearing pre-existing enthesitis at week 24, with the respective resolution rates of 45 percent, 50 percent, and 29 percent (p=0.0301 for both comparisons). [Rheumatology 2021;doi:10.1093/rheumatology/keab285]

Enthesitis resolution rates continued to rise through week 52, where 58 percent of guselkumab-treated patients combined achieved resolution. These included patients with mild (LEI=1; 70–75 percent), moderate (LEI=2; 69–73 percent), or severe (LEI=3–6; 42–44 percent) enthesitis at baseline.

As previously pointed out, a lot more patients with resolved enthesitis on guselkumab at week 24 achieved minimal disease activity at week 52 as opposed to those with unresolved enthesitis (42 percent vs 17 percent).

The efficacy of biologics approved for PsA in treating enthesitis have been shown in previous studies, although it is difficult to compare due to differences in study designs, measurement tools, and data analyses, according to McGonagle.

“Based on the central role of IL-23 in enthesitis, it is not surprising that results of comparative studies of PsA patients with enthesitis showed both ustekinumab (anti-IL-12/23 agent) and ixekizumab (anti-IL-17 agent acting downstream of IL-23) to be more effective than a TNFi in treating enthesitis,” he said. [Ann Rheum Dis 2017;76:79-87; Semin Arthritis Rheum 2019;48:632-637]

“These limited active comparator data, together with the findings reported here and those recently reported for anti-IL-17 agents, support the central role of the IL-23 and IL-17 pathways in PsA enthesitis pathogenesis and may inform treatment choices for PsA patients with enthesitis,” the investigator added. [Arthritis Res Ther 2019;21:38; Arthritis Res Ther 2019;21:266]

McGonagle highlighted the importance of effectively treating the key PsA manifestation, saying that enthesitis may also be a progenitor of the structural joint damage seen in PsA. “Indeed, the presence and extent of enthesitis have demonstrated positive associations with greater peripheral and axial joint damage, impaired quality of life and function, sleep disturbance, and patient-reported pain.” [Semin Arthritis Rheum 2018;48:35-43; Arthritis Care Res 2017;69:1685-1691; Int J Rheum Dis 2017;20:1212-1218; Arthritis Care Res 2017;69:1692-1699]

Additional studies are warranted, especially those investigating whether targeting the IL-23 p19-subunit is superior to inhibition of TNF and IL-17 in treating PsA patients with enthesitis, according to the investigator.

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Most Read Articles
Pearl Toh, 3 days ago
Not only does the CGRP* inhibitor galcanezumab show sustained efficacy in migraine patients, long-term treatment does not come with excess cardiovascular (CV) risk, according to studies presented at the AAN 2021 Annual Meeting.
01 Apr 2021
Migraine and headache are common ailments of people living in the modern era. Dr Jon Marshall of The Singapore Headache and Migraine Clinic shares his insights with Pearl Toh on how to manage migraine and headache using non-pharmaceutical strategies, with a focus on the manual medicine approach.
Tristan Manalac, 4 days ago
Visceral fat area is the strongest indicator of mobility disability among obese, community-dwelling, older adults, according to a recent Singapore study.
3 days ago
In a webinar held on 27 March 2021, paediatric endocrinology nurses Karen Blair, Kate Davies, and Siti Zarina Yaakop shared insights and clinical experience based on their frontline roles in caring for patients with central precocious puberty (CPP) and supporting their family members.