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One-year results from the PsABio study provide evidence on factors that may impact treatment selection and decisions in clinical practice.
In patients with psoriatic arthritis (PsA), the IL-12/23 inhibitor ustekinumab (Stelara, Janssen) and tumor necrosis factor inhibitors (TNFi) showed similar persistence, efficiency, and safety after 1 year of treatment, according to data from a real-world observational study, published in Annals of the Rheumatic Diseases.1
“These 1-year results from the PsABio study provide real-world evidence on factors which may impact treatment selection and help inform treatment decisions in clinical practice,” Laure Gossec, MD, PhD, professor of rheumatology at Sorbonne Université in Paris, France, and colleagues, stated. Patients “were more likely to remain on ustekinumab than TNFi when extensive skin disease was present and when methotrexate was not used as concomitant treatment…Women had lower treatment persistence with both treatments versus men, indicating they may require more comprehensive multidimensional therapy.”
Many randomized controlled trials have demonstrated efficacy and safety of biologics in PsA, but real-world comparison trials, particularly over the long term, are lacking. The PsABio real-world observational study has provided comparative data on ustekinumab and TNFi in PsA treatment over 6 months and indicated similar efficacy. This 1-year analysis looked at persistence, the primary outcome, as well as clinical effectiveness, and safety.
The study followed 991 patients with PsA prescribed first-line to third-line ustekinumab or TNFi. Drug persistence, effectiveness and safety were assessed every 6 months. For the effectiveness and safety analyses, 893 and 927 patients were included. Effectiveness was measured by the 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). Propensity score (PS)-adjusted comparisons were also performed.
At 1-year, drug persistence was similar in the ustekinumab (72.4%) and TNFi (70.5%) groups. PS-adjusted HR (95% CI) for stopping/switching ustekinumab versus TNFi was 0.82 (0.60; 1.13). For efficiency, cDAPSA LDA (including remission)/remission was achieved in 55.9%/22.1% of patients treated with ustekinumab and 67.1%/31.7% of those treated with TNFi; 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 patients treated with ustekinumab and 43.1%/12.6% of treated with TNFi; 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.
“This study has confirmed the strong impact of treatment line, gender and baseline extent of skin disease on persistence and demonstrated the effectiveness of ustekinumab or TNFi-based treatments in PsA, not only on physician-derived but also patient-reported outcomes, such as disease impact,” investigators concluded.
The final 3-year data from the PsABio study may provide further insights.
Gossec L, Siebert S, Bergmans P, et al. 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 [published online ahead of print, 2022 Feb 24]. Ann Rheum Dis. doi:10.1136/annrheumdis-2021-221640