Remote monitoring or patient-initiated care in axial spondyloarthritis

Inger Jorid  Berg; Eirik Klami Kristianslund; Anne Therese Tveter; Joseph Sexton; Gunnstein Bakland; Laure Gossec; Sarah Hakim; Gary Macfarlane; Ellen Moholt; Sella Aarrestad Provan; Emil Eirik Kvernberg  Thomassen; Annette De Thurah; Espen A Haavardsholm; Siri Lillegraven; Nina Østerås

doi:10.1016/j.ard.2025.04.019

Remote monitoring or patient-initiated care in axial spondyloarthritis

Inger Jorid Berg^* (Corresponding Author)
, Eirik Klami Kristianslund
, Anne Therese Tveter
, Joseph Sexton
, Gunnstein Bakland
, Laure Gossec
, Sarah Hakim
, Gary Macfarlane
, Ellen Moholt
, Sella Aarrestad Provan
, Emil Eirik Kvernberg Thomassen
, Annette De Thurah
, Espen A Haavardsholm
, Siri Lillegraven
, Nina Østerås

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

2 Citations (Scopus)

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

Original language	English
Pages (from-to)	1140-1150
Number of pages	11
Journal	Annals of the Rheumatic Diseases
Volume	84
Issue number	7
Early online date	4 Jul 2025
DOIs	https://doi.org/10.1016/j.ard.2025.04.019
Publication status	Published - Jul 2025

Data Availability Statement

A deidentified patient data set can be made available to researchers upon reasonable request. The data will only be made available after submission of a project plan outlining the reason for the request and any proposed analyses. The data sharing will have to be approved by the ReMonit project group and may require a data access agreement to be signed.

Funding

This work was funded from South-Eastern Norway Regional Health Authority (funding number 2021062), and The Research Council of Norway (funding number 328657). The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Funders	Funder number
South-Eastern Norway Regional Health Authority	2021062
The Research Council of Norway	328657

Keywords

spondyloarthritis
health care
randomized controlled trial
inflammatory joint disease
remote care
self management

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Berg_etal_ARD_Remote_Monitoring_Or_VoR
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)
Final published version, 1.25 MBLicence: CC BY-NC-ND

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Berg, I. J., Kristianslund, E. K., Tveter, A. T., Sexton, J., Bakland, G., Gossec, L., Hakim, S., Macfarlane, G., Moholt, E., Provan, S. A., Thomassen, E. E. K., De Thurah, A., Haavardsholm, E. A., Lillegraven, S., & Østerås, N. (2025). Remote monitoring or patient-initiated care in axial spondyloarthritis. Annals of the Rheumatic Diseases, 84(7), 1140-1150. https://doi.org/10.1016/j.ard.2025.04.019

Berg, IJ, Kristianslund, EK, Tveter, AT, Sexton, J, Bakland, G, Gossec, L, Hakim, S, Macfarlane, G, Moholt, E, Provan, SA, Thomassen, EEK, De Thurah, A, Haavardsholm, EA, Lillegraven, S & Østerås, N 2025, 'Remote monitoring or patient-initiated care in axial spondyloarthritis', Annals of the Rheumatic Diseases, vol. 84, no. 7, pp. 1140-1150. https://doi.org/10.1016/j.ard.2025.04.019

@article{6184932cae2d4ad09e8f522a1ff09dda,

title = "Remote monitoring or patient-initiated care in axial spondyloarthritis",

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{\textquoteright} 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 ",

keywords = "spondyloarthritis, health care, randomized controlled trial, inflammatory joint disease, remote care, self management",

author = "Berg, \{Inger Jorid\} and Kristianslund, \{Eirik Klami\} and Tveter, \{Anne Therese\} and Joseph Sexton and Gunnstein Bakland and Laure Gossec and Sarah Hakim and Gary Macfarlane and Ellen Moholt and Provan, \{Sella Aarrestad\} and Thomassen, \{Emil Eirik Kvernberg\} and \{De Thurah\}, Annette and Haavardsholm, \{Espen A\} and Siri Lillegraven and Nina {\O}ster{\aa}s",

year = "2025",

month = jul,

doi = "10.1016/j.ard.2025.04.019",

language = "English",

volume = "84",

pages = "1140--1150",

journal = "Annals of the Rheumatic Diseases",

issn = "0003-4967",

publisher = "BMJ Publishing Group",

number = "7",

}

TY - JOUR

T1 - Remote monitoring or patient-initiated care in axial spondyloarthritis

AU - Berg, Inger Jorid

AU - Kristianslund, Eirik Klami

AU - Tveter, Anne Therese

AU - Sexton, Joseph

AU - Bakland, Gunnstein

AU - Gossec, Laure

AU - Hakim, Sarah

AU - Macfarlane, Gary

AU - Moholt, Ellen

AU - Provan, Sella Aarrestad

AU - Thomassen, Emil Eirik Kvernberg

AU - De Thurah, Annette

AU - Haavardsholm, Espen A

AU - Lillegraven, Siri

AU - Østerås, Nina

PY - 2025/7

Y1 - 2025/7

N2 - 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

AB - 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

KW - spondyloarthritis

KW - health care

KW - randomized controlled trial

KW - inflammatory joint disease

KW - remote care

KW - self management

UR - https://www.scopus.com/pages/publications/105005945969

U2 - 10.1016/j.ard.2025.04.019

DO - 10.1016/j.ard.2025.04.019

M3 - Article

SN - 0003-4967

VL - 84

SP - 1140

EP - 1150

JO - Annals of the Rheumatic Diseases

JF - Annals of the Rheumatic Diseases

IS - 7

ER -

Remote monitoring or patient-initiated care in axial spondyloarthritis

Abstract

Data Availability Statement

Funding

Keywords

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