Improvement in patient-reported outcomes and work productivity following 3-year ustekinumab or tumour necrosis factor inhibitor treatment in patients with psoriatic arthritis: results from the PsABio real-world study.

Abstract

BACKGROUND:

To evaluate the real-world effect of the IL-12/23 inhibitor ustekinumab or of a tumour necrosis factor inhibitor (TNFi) on patient-reported outcomes (PRO) and their association with effectiveness endpoints in psoriatic arthritis (PsA) patients over 3 years.

METHODS:

In PsABio (NCT02627768), a prospective, observational study, patients with PsA that were prescribed first- to third-line ustekinumab or a TNFi, and remained on that drug for 3 years, were analysed for change in baseline in PROs (EuroQol-5 dimensions health state VAS [EQ-5D VAS], 12-item Psoriatic Arthritis Impact of Disease questionnaire [PsAID-12; range 0-10], Work Productivity and Activity Impairment for Psoriatic Arthritis questionnaire [WPAI; results expressed as a percentage for each domain]), and the association between PROs and WPAI with effectiveness endpoints, clinical disease activity index for psoriatic arthritis (cDAPSA), low disease activity (LDA)/remission, minimal disease activity (MDA) and very low disease activity (VLDA).

RESULTS:

In 437 patients (mean age 49.1 years, 47.8% female), at 3 years, ustekinumab and TNFi treatment led to comparable improvements in EQ-5D VAS; mean change from baseline (95% confidence intervals [CI]) was 11.0 (6.5; 15.4) and 18.9 (14.0; 23.9), respectively. Both groups improved PsAID-12 after 3 years; mean change from baseline (95% CI) was -2.9 (-3.2; -2.5) and -3.5 (-3.9; -3.2), respectively. At baseline, due to their PsA, TNFi-treated patients had lower work productivity compared to ustekinumab-treated patients; mean productivity reduction (95% CI) was 58.8 [52.4; 65.2] and 43.3 [35.6; 51.1]. Over 3 years, TNFi-treated patients had a greater improvement in work productivity compared to ustekinumab-treated patients, ultimately leaving work productivity to be comparable between groups; mean improvement (95% CI) was 44.5% (38.4; 50.6) and 24.9% (15.8; 34.0), respectively. A similar trend was observed in activity impairment. Patients in both treatment groups who achieved effectiveness endpoints, cDAPSA LDA/remission, MDA, and VLDA had greater improvement in PROs and WPAI than patients who did not achieve these endpoints.

CONCLUSIONS:

At 3 years, improvements in PROs following ustekinumab or TNFi treatment were generally comparable; however, TNFi-treated patients achieved a greater improvement in work productivity, although this group started from a lower baseline. Achievement of effectiveness endpoints, independent of treatment group, also improved PROs.

TRIAL REGISTRATION:

ClinicalTrials.gov, NCT02627768. Registered on 11 December 2015.

• Authors: Laure Gossec, Stefan Siebert, Paul Bergmans, Kurt de Vlam, Elisa Gremese, Beatríz Joven-Ibáñez, Tatiana V Korotaeva, Frederic Lavie, Wim Noël, Michael T Nurmohamed, Petros P Sfikakis, Mohamed Sharaf, Elke Theander, Josef S Smolen
• Journal: Arthritis research & therapy (Arthritis Res Ther) Vol. 25 Issue 1 Pg. 109 (06 23 2023) ISSN: 1478-6362 [Electronic] England
• PMID: 37353788 (Publication Type: Observational Study, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2023. The Author(s).

Chemical References

• Ustekinumab
• Tumor Necrosis Factor Inhibitors
• Antirheumatic Agents

Topics

• Humans
• Female
• Middle Aged
• Male
• Ustekinumab (therapeutic use)
• Arthritis, Psoriatic (drug therapy)
• Tumor Necrosis Factor Inhibitors (therapeutic use)
• Prospective Studies
• Patient Reported Outcome Measures
• Treatment Outcome
• Antirheumatic Agents (therapeutic use)
• Severity of Illness Index