Abstract
Objectives
To determine whether novel follow-up regimen, remote monitoring or patient-initiated care, are non-inferior to usual care in maintaining low disease activity, in patients with axial spondyloarthritis (axSpA).
Methods
Randomized, controlled, three-armed, parallel-group, open-label, non-inferiority trial. Patients with axSpA in low disease activity on stable treatment with tumour necrosis factor inhibitor (TNFi), recruited from a Norwegian outpatient clinic. Patients were randomly allocated 1:1:1 to Remote Monitoring, Patient-initiated Care, or Usual Care (control group), with 18 months follow-up. Primary outcome was mean probability of axSpA Disease Activity Score (ASDAS)<2.1, compared between groups at 6, 12, and 18 months, with 15% non-inferiority margin. Secondary outcomes included other measures of disease activity, physical function, patient satisfaction, change of medication, resource use, and adverse events.
Results
Of 243 patients enrolled patients, 235 completed the study (Remote Monitoring=75, Patient-initiated Care=79, Usual Care=81). At the 6-, 12-, and 18-months assessments, 90% or more patients in all three groups had ASDAS<2.1. The estimated difference of probability of ASDAS<2.1 was: Usual Care vs. Remote Monitoring was -4.1% (97.5% CI, -9.9 to 1.8), Usual care vs. Patient-initiated Care -1.1% (97.5% CI, -7.2 to 4.9), and Remote Monitoring vs. Patient-initiated Care 2.9% (95% CI, -1.5 to 7.4). Health providers’ resource use was lowest in Patient-initiated Care, other secondary outcomes were comparable.
Conclusions
In patients with axSpA in low disease activity and on stable treatment with TNFi, follow-up with Remote Monitoring or Patient-initiated Care was non-inferior to usual care in maintaining low disease activity, supporting the implementation of novel follow-up strategies.
Trial registration: ClinicalTrials.gov Identifier: NCT050317
To determine whether novel follow-up regimen, remote monitoring or patient-initiated care, are non-inferior to usual care in maintaining low disease activity, in patients with axial spondyloarthritis (axSpA).
Methods
Randomized, controlled, three-armed, parallel-group, open-label, non-inferiority trial. Patients with axSpA in low disease activity on stable treatment with tumour necrosis factor inhibitor (TNFi), recruited from a Norwegian outpatient clinic. Patients were randomly allocated 1:1:1 to Remote Monitoring, Patient-initiated Care, or Usual Care (control group), with 18 months follow-up. Primary outcome was mean probability of axSpA Disease Activity Score (ASDAS)<2.1, compared between groups at 6, 12, and 18 months, with 15% non-inferiority margin. Secondary outcomes included other measures of disease activity, physical function, patient satisfaction, change of medication, resource use, and adverse events.
Results
Of 243 patients enrolled patients, 235 completed the study (Remote Monitoring=75, Patient-initiated Care=79, Usual Care=81). At the 6-, 12-, and 18-months assessments, 90% or more patients in all three groups had ASDAS<2.1. The estimated difference of probability of ASDAS<2.1 was: Usual Care vs. Remote Monitoring was -4.1% (97.5% CI, -9.9 to 1.8), Usual care vs. Patient-initiated Care -1.1% (97.5% CI, -7.2 to 4.9), and Remote Monitoring vs. Patient-initiated Care 2.9% (95% CI, -1.5 to 7.4). Health providers’ resource use was lowest in Patient-initiated Care, other secondary outcomes were comparable.
Conclusions
In patients with axSpA in low disease activity and on stable treatment with TNFi, follow-up with Remote Monitoring or Patient-initiated Care was non-inferior to usual care in maintaining low disease activity, supporting the implementation of novel follow-up strategies.
Trial registration: ClinicalTrials.gov Identifier: NCT050317
| Original language | English |
|---|---|
| Journal | Annals of the Rheumatic Diseases |
| Publication status | Accepted/In press - 18 Apr 2025 |
Keywords
- spondyloarthritis
- health care
- randomized controlled trial
- inflammatory joint disease
- remote care
- self management