Lower Persistence of Biologics Observed Among Women vs Men With PsA

At initiation of biologic therapy, women vs men with psoriatic arthritis (PsA) have more severe disease and a lower persistence of treatment, according to study findings published in Rheumatology (Oxford).

Research has shown that men and women with PsA experience different magnitudes of response to and retention of biologic disease-modifying antirheumatic drug (bDMARD) treatment, including tumor necrosis factor (TNF) inhibitors.

The investigators sought to determine whether patients with PsA have sex-based differences at baseline, and to explore whether these variations are observed in response to and retention of biologics in individuals receiving treatment with the interleukin (IL)-12/IL-23 inhibitor ustekinumab or a TNF inhibitor in routine clinical practice.

The multinational, prospective, real-world, observational, noninterventional PsABio cohort study (ClinicalTrials.gov Identifier: NCT02627768) was conducted among patients with PsA who received ustekinumab or a TNF inhibitor as first-, second-, or third-line therapy.

Data were collected from participants at baseline, then at every 6 months up to
3 years. Disease activity, treatment persistence, safety, and patient-reported outcome measures were compared among men and women with PsA.

The study included a baseline set, which included all eligible participants with baseline data available and no major protocol deviations; a safety set, which included all participants with baseline data available, along with an additional set of participants; an effectiveness set-1, which included all eligible patients from the baseline set with any effectiveness follow-up data up to 12 months; an effectiveness set-2, which was based on a prior effectiveness set that included 2 patients fewer; and “remainer” patient groups, which included all groups that remained on initial therapy (ustekinumab or TNF inhibitor) at 12 months.

Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) scores and minimal and very low (MDA/VLDA, respectively) criteria were evaluated.

Data were collected on the presence of dactylitis, enthesitis, nail psoriasis, and psoriasis skin involvement; the EuroQoL-5 Dimension (EQ-5D; regarding mobility, self-care, usual activities, pain/discomfort, and anxiety/depression); and the Fibromyalgia Rapid Screening Tool (FiRST).

A total of 991 participants were included in the study, with 929 (512 women) in the baseline set and 895 (439 initiating ustekinumab and 456 initiating a TNF inhibitor) in the effectiveness set-1. The mean age among women was 50.2 years compared with 48.7 years among men. The mean duration of disease at baseline was 6.7 years in women and 6.9 years in men.

Results of the study showed that a greater percentage of women vs men reported a FiRST score of at least 5 (42.7% vs 24.4%, respectively), which was indicative of chronic widespread pain. Women were also more likely to exhibit enthesitis and polyarticular disease, whereas men were more likely to exhibit oligoarticular disease, dactylitis, and psoriasis that affected greater than 10% of their body surface.

At baseline, women vs men had worse scores in the following assessments of disease activity:

• Mean cDAPSA score: 32.3 vs 26.8, respectively
• Mean HAQ-DI score: 1.3 vs 0.93, respectively
• Mean EQ-5D VAS score: 48.6 vs 53.8, respectively
• Total Psoriatic Arthritis Impact of Disease-12 (PsAID-12) score: 6.0 vs 5.1, respectively

Although participants of both sexes exhibited improvements in clinical outcomes at 6 and 12 months vs baseline, women vs men reported less marked disease improvement. The percentage of participants who attained MDA, including VLDA, at 6 and 12 months were 21.0% and 33.7% in women and 43.1% and 55.5% in men, respectively. Of note, the percentage of participants who reached cDAPSA LDA, which included remission, at 6 and 12 months were 43.8% and 57.8% in women and 66.0% and 80.3% in men, respectively.

Further, women compared with men had a significantly lower rate of treatment persistence (P <.001).

Limitations of the study were noted. The results were generated from a post hoc analysis and no strict medication protocol was determined, with the selection of bDMARDs determined independently by participants’ rheumatologist.

According to the investigators, “These real-world data from PsABio on [sex] differences suggest that, at the start of biologic treatment, [women] have a worse clinical picture of PsA than [men].”

“A better understanding of the mechanisms underlying these differences may improve therapeutic management in [women] with PsA,” they concluded.

Disclosure: This research was supported by Janssen. Multiple study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.