Abstract
BACKGROUND: The psoriatic arthritis (PsA) Observational Study of Persistence of Treatment (PRO-SPIRIT) assesses effectiveness and persistence of real-world PsA treatments. Ixekizumab (IXE) is an interleukin (IL)-17A inhibitor (i) (IL-17Ai), approved for the treatment of adult PsA. METHODS: The aim of this predefined interim analysis was to report baseline characteristics along with early (3-month) descriptive and comparative real-world effectiveness in patients with PsA prescribed with advanced treatment including IL-17Ai; IXE or secukinumab (SEC), IL-12/23i, IL-23i, tumour necrosis factor (TNFi) or Janus kinase (JAKi). RESULTS: 1192 patients across 6 countries were analysed. At baseline, patients receiving IXE had longer disease duration and higher previous biological/targeted-synthetic disease-modifying antirheumatic drugs experience than patients starting TNFi and SEC 150, and less concomitant conventional-synthetic DMARD use than TNFi and JAKi. Comparative analyses at 3 months showed that: (a) versus TNFi, IXE exhibited similar improvement in clinical Disease Activity in PsA (cDAPSA) but significantly greater improvement in body surface area affected by psoriasis (BSA) and global assessments (physician GA, patient GA (PatGA)); (b) versus IL-12/23i and IL-23i (pooled), IXE showed significantly greater improvement in cDAPSA and PatGA; (c) IXE was as fast as JAKi in improving joint disease activity. Ad hoc analysis indicated that more patients with active psoriasis (BSA ≥3%) achieved minimal disease activity with IXE than JAKi or IL-12/23i. The responses to SEC varied by dosage. CONCLUSIONS: This study confirms the rapid 3-month effectiveness of IXE on joint disease activity-as fast as TNFi and JAKi (cDAPSA), and exceeding IL-12/23i and IL-23i-along with clear benefits to skin.
Original language | English |
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Article number | e004318 |
Journal | RMD Open |
Volume | 10 |
Issue number | 3 |
Early online date | 20 Sept 2024 |
DOIs | |
Publication status | Published - 20 Sept 2024 |
Data Availability Statement
Data are available on reasonable request. Eli Lilly and Company provides access to all individual participant data collected duringthe trial, after anonymisation, with the exception of pharmacokinetic or geneticdata. Data are available to request 6 months after the indication studied hasbeen approved in the USA and EU and after primary publication acceptance,whichever is later. No expiration date of data requests is currently set once dataare made available. Access is provided after a proposal has been approved by anindependent review committee identified for this purpose and after receipt of asigned data sharing agreement. Data and documents, including the study protocol,statistical analysis plan, clinical study report, blank or annotated case report forms,will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at www.vivli.org.Keywords
- arthritis, psoriatic
- health-related quality of life
- interleukin-17
- patient reported outcome measures
- tumor necrosis factor inhibitors
ASJC Scopus subject areas
- Rheumatology
- Immunology and Allergy
- Immunology