In patients with psoriatic arthritis (PsA), ustekinumab and tumor necrosis factor inhibitors (TNFi) show comparable effectiveness and persistence; however, ustekinumab vs TNFi results in lower rates of adverse events (AEs), according to study results published in Annals of the Rheumatic Diseases.
Real-world data comparing treatments with different mechanisms of action are lacking in patients with PsA.
Researchers sought to assess the real-world persistence and effectiveness of the interleukin (IL)-12/23 inhibitor ustekinumab compared with a TNFi over a period of 3 years.
Participants enrolled in the PsABio (ClinicalTrials.gov Identifier: NCT02627768) study received treatment with first- to third-line ustekinumab or a TNFi. Persistence, long-term effectiveness, and safety were evaluated every 6 months. Achievement of clinical Disease Activity Index for PSA (cDAPSA) low disease activity (LDA)/remission and minimal disease activity/very LDA (MDA/VDA) were used to assess efficacy.
Study participants included adults who were initiating treatment with ustekinumab or any approved TNFi (including biosimilars) as first-, second-, or third-line therapy.
Persistence was defined as the time between initiation of a first in-study biologic disease-modifying antirheumatic drug (bDMARD) until the last dose plus 1 dispensing interval or stop/switch to another bDMARD, whichever happened first.
A total of 991 individuals were enrolled between December 2015 and June 2018 at 92 different sites in Belgium, France, Greece, Italy, the Netherlands, the Russian Federation, Spain, and the UK. Among these participants, 57 were ineligible and were thus excluded from the study.
Overall, 934 patients were included in the safety analysis — 459 in the ustekinumab group and 475 in the TNFi group. Among these individuals, 14 discontinued participation in the study because of the COVID-19 pandemic. Of the 934 patients, 895 (439 in the ustekinumab group and 456 in the TNFi group) had baseline and follow-up effectiveness data available up to 3 years and were included in the effectiveness analysis.
Among the 895 participants, 44.7% were men. The mean patient age was 49.8 years. At 3 years, the percentage of patients who continued to receive their initial treatment was similar in the ustekinumab and the TNFi groups (49.9% and 47.8%, respectively). Following adjustment for baseline imbalances, no difference was observed in the risk of stopping/switching with ustekinumab vs TNFi (hazard ratio [HR], 0.87; 95% CI, 0.68-1.11).
In the overall population, cDAPSA LDA/remission was attained in 58.6%/31.4% of participants who received ustekinumab vs 69.8%/45.0% of those who received TNFi (adjusted odds ratio [OR], 0.89; 95% CI, 0.63-1.26 for cDAPSA LDA and OR, 0.72; 95% CI, 0.50-1.05 for remission).
MDA/VLDA was attained in 41.4%/19.2% of those in the ustekinumab group vs 54.2%/26.9% of those in the TNFi group (adjusted OR, 0.79; 95% CI, 0.55-1.14 for MDA and OR, 0.69; 95% CI, 0.45-1.05 for VLDA). A greater percentage of participants who received TNFi achieved effectiveness outcomes.
Although patients in both treatment groups had good long-term safety profiles, participants who received ustekinumab reported lower rates of AEs than those who received TNFi. The rate of infections was also lower with ustekinumab vs TNFi.
The study authors concluded, “In line with our study results, patients with high levels of skin involvement, and in whom [methotrexate] use is contraindicated, may be attractive candidates for treatment with ustekinumab rather than TNFi.”
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