Persistence and effectiveness of the IL-12/23 pathway inhibitor ustekinumab or tumour necrosis factor inhibitor treatment in patients with psoriatic arthritis: 1-year results from the real-world PsABio Study

Abstract

ObjectiveWe evaluated real-world treatment persistence and effectiveness at 1 year following initiation of IL-12/23 inhibitor ustekinumab or a tumour necrosis factor inhibitor (TNFi) for psoriatic arthritis (PsA).MethodsPsABio (NCT02627768), a prospective, observational study, followed patients with PsA prescribed first-line to third-line ustekinumab or TNFi. Drug persistence, effectiveness (achievement of clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) low disease activity (LDA)/remission and minimal disease activity/very low disease activity (MDA/VLDA)), and safety were assessed every 6 months. In addition to descriptive statistics, propensity score (PS)-adjusted comparisons across cohorts were performed.ResultsAt 1 year, overall persistence was similar in the ustekinumab (n=317/438, 72.4%) and TNFi (n=321/455, 70.5%) groups. PS-adjusted HR (95% CI) for stopping/switching ustekinumab versus TNFi was 0.82 (0.60; 1.13). cDAPSA LDA (including remission)/remission was achieved in 55.9%/22.1% of ustekinumab-treated and 67.1%/31.7% of TNFi-treated patients; PS-adjusted ORs (95% CI) were 0.80 (0.57; 1.10) for cDAPSA LDA and 0.73 (0.49; 1.07) for remission. MDA/VLDA was achieved in 34.2%/11.9% of ustekinumab-treated and 43.1%/12.6% of TNFi-treated patients; PS-adjusted ORs (95% CI) were 0.89 (0.63; 1.26) for MDA and 0.90 (0.54; 1.49) for VLDA. The safety profiles were similar in both groups.ConclusionIn the real-world PsABio Study, after 1 year of treatment, although unadjusted persistence was numerically slightly higher for ustekinumab versus TNFi and unadjusted effectiveness was numerically slightly higher for TNFi versus ustekinumab, the PS-adjusted comparisons demonstrated comparable overall persistence, effectiveness and safety for both modes of action in PsA.

Long-term effectiveness and persistence of ustekinumab and TNF inhibitors in patients with psoriatic arthritis: final 3-year results from the PsABio real-world study

“…The similarity in drug persistence observed here for ustekinumab and TNFi, after 3 years of follow-up, is consistent with our findings from the 1-year analysis 24. Previously it was shown that female sex, older age, chronic widespread pain, depression, high number of comorbidities and later line of bDMARD treatment reduce persistence 15 24 33 34.…”

“…Patients on ustekinumab monotherapy (without MTX) and those on TNFi+MTX combination therapy persisted longer than patients on ustekinumab+MTX combination therapy and those on TNFi monotherapy, respectively. That patients on ustekinumab monotherapy persisted longer than those on TNFi monotherapy, is consistent with our 1-year results 24. This may be due to several reasons: patients treated with a TNFi may more frequently develop neutralising antidrug antibodies, especially without MTX co-therapy, but with ustekinumab the risk of such antidrug antibodies is described as minimal 39.…”

“…Real-world and randomised controlled trial data on comparisons between treatments with different modes of action are lacking in PsA 22. The 6-month and 1-year data from the PsABio cohort study of ustekinumab and TNFi treatment in patients with PsA indicated that later line of treatment, female sex and comorbidities as well as high baseline clinical disease activity and chronic widespread pain were shown to negatively influence treatment response 23 24. Here, we present the final 3-year data on persistence, clinical effectiveness and safety from the PsABio study, aiming to provide a long-term perspective on these important clinical aspects.…”

Uptake and effectiveness of newer biologic and targeted synthetic disease-modifying antirheumatic drugs in psoriatic arthritis: results from five Nordic biologics registries

“…One RCT of the JAKi tofacitinib in PsA also included adalimumab as an active comparator, suggesting numerically similar effect sizes 7. Further, a substantial number of observational studies have attempted comparisons of effectiveness in routine care across several different drug classes 8–15. Within the Nordic countries, we have previously shown similar treatment retention and 6-month response in patients with PsA treated with secukinumab and adalimumab 16…”

The role of IL‐23 and the use of IL‐23 inhibitors in psoriatic arthritis

“…However, the best therapeutic approach for treating enthesitis in PsA remains unclear. In the PsABio real-world multicentre observational study, outcomes and persistence at 6-month and 1 year were similar for ustekinumab and TNF-inhibitors in PsA (Gossec et al, 2022;Smolen et al, 2021).…”