Propensity score (PS)-adjusted comparisons between treatment of psoriatic arthritis (PsA) with ustekinumab vs a tumor necrosis factor inhibitor (TFNi) showed equivalent overall persistence, effectiveness, and safety, according to study findings published in Annals of the Rheumatic Diseases.
The real-world, prospective, observational, multinational PsABio study (ClinicalTrials.gov identifier: NCT02627768) was conducted among patients with PsA treated with first-line to third-line ustekinumab or a TNFi, per their rheumatologist’s recommendation. Researchers sought to evaluate real-world treatment persistence and effectiveness at 1 year after initiation of the interleukin-12/23 inhibitor ustekinumab or a TNFi in patients with PsA. Study duration was up to 3 years, with follow-up occurring twice annually.
The current 1-year analysis reported on the following: (1) comparative drug persistence data; (2) extended effectiveness outcomes with respect to attainment of low disease activity (LDA) or remission via use of the clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) definitions and minimal disease activity/very low disease activity (MDA/VLDA), along with patient-reported 12-item Psoriatic Arthritis Impact of Disease measure; and (3) safety data. Treatment persistence was defined as the time between initiation of a biologic disease-modifying antirheumatic drug (bDMARD) until the last dose plus 1 dispensing interval or stop/switch to another bDMARD, or study withdrawal.
Between December 2015 and June 2019, a total of 991 participants were enrolled at 92 sites in Belgium, France, Greece, Italy, the Netherlands, the Russian Federation, Spain, and the United Kingdom. For the 1-year analysis, a total of 893 participants were included in the effectiveness analysis set (438 in the ustekinumab group vs 455 in the TNF inhibitor group) and 927 participants were included in the safety set (457 in the ustekinumab group vs 470 in the TNF inhibitor group).
Results of the study showed that at 1 year, overall persistence was similar between the ustekinumab group (72.4%; 317 of 438 participants) and in the TNF inhibitor group (70.5%; 321 of 455 participants). The PS-adjusted hazard ratio for stopping/switching ustekinumab vs a TNF inhibitor was 0.82 (95% CI, 0.60-1.13).
Further, cDAPSA LDA (including remission)/remission was attained in 55.9%/22.1% of ustekinumab-treated participants compared with 67.1%/31.7% of TNFi-treated participants. The PS-adjusted odds ratios (ORs) were 0.80 (95% CI, 0.57-1.10) for cDAPSA LDA and 0.73 (95% CI, 0.49-1.07) for remission.
Those who attained MDA/VLDA comprised 34.2%/11.9% of the ustekinumab group and 43.1%/12.6% of the TNF inhibitor group. The PS-adjusted ORs were 0.89 (95% CI, 0.63-1.26) for MDA compared with 0.90 (95% CI, 0.54-1.49) for VLDA. The safety profiles were similar in the 2 treatment groups.
A major limitation of the study was the fact that the comparison between the treatment cohorts needed to be based on PS adjustment, not on randomization, because of a probable selection bias in treatment selection.
The study authors concluded that 1-year results from the PsABio Study provide real-world evidence on factors that may impact selection of therapy and help to inform treatment decisions in clinical practice.
Disclosure: Some of the study authors have declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
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. Ann Rheum Dis. 2022;81(6):823-830. doi:10.1136/annrheumdis-2021-221640