# Remote monitoring or patient-initiated care in axial spondyloarthritis: A threearmed randomized controlled noninferiority trial Authors

Inger Jorid Berg, Eirik Kristianslund, Anne Therese Tveter, Joseph Sexton, Gunnstein Bakland, Laure Gossec, Sarah Hakim, Gary Macfarlane, Ellen Moholt, Sella Aarrestad Provan, et al.

► To cite this version:

Inger Jorid Berg, Eirik Kristianslund, Anne Therese Tveter, Joseph Sexton, Gunnstein Bakland, et al.. Remote monitoring or patient-initiated care in axial spondyloarthritis: A threearmed randomized controlled noninferiority trial Authors. Annals of the Rheumatic Diseases, 2025, 84 (7), pp.1140-1150. 10.1016/j.ard.2025.04.019 . hal-05441102

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# Remote monitoring or patient-initiated care in axial spondyloarthritis: A three-armed randomized controlled non-inferiority trial

## Authors

Inger Jorid Berg<fnref n="1" />, Eirik K Kristianslund<fnref n="1" />, Anne Therese Tveter<fnref n="1" />,<fnref n="2" />, Joseph Sexton<fnref n="1" />, Gunnstein Bakland<fnref n="3" />,<fnref n="4" />, Laure Gossec<fnref n="5" />,<fnref n="6" />, Sarah Hakim<fnref n="1" />, Gary J Macfarlane<fnref n="7" />, Ellen Moholt<fnref n="1" />, Sella Aarrestad Provan<fnref n="1" />,<fnref n="8" />, Emil E Kvernberg Thomassen<fnref n="1" />, Annette de Thurah<fnref n="9" />,<fnref n="10" />, Espen A. Haavardsholm<fnref n="1" />,<fnref n="11" />, Siri Lillegraven<fnref n="1" />, Nina Osteras<fnref n="1" />,<fnref n="11" />

**Correspondence to:** Inger Jorid Berg; ingerjoridberg@gmail.com

**Keywords:** spondyloarthritis, health care, randomized controlled trial, inflammatory joint disease, remote care, self-management

Manuscript word count: 3341

<footnote n="1">¹Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, PO Box 23 Vinderen, NO-0319 Oslo, Norway</footnote>

<footnote n="2">²Department of Rehabilitation Science and Health Technology, Oslo Metropolitan University, PO Box 4 St Olavs plass, NO-0130 Oslo, Norway</footnote>

<footnote n="3">³Department of Rheumatology, University Hospital of North Norway, PO Box 100, N-9038 Tromsø Norway</footnote>

<footnote n="4">⁴Institute of Clinical Medicine, Faculty of Health Sciences, UiT The Arctic University of Tromsø, PO Box 6050 Stakkevollan, NO-9037 Tromsø, Norway</footnote>

<footnote n="5">⁵Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, 27 rue Chaligny, 75571 Paris, France</footnote>

<footnote n="6">⁶AP-HP, Pitié-Salpêtrière hospital, Rheumatology department, 91-105, Bd de l'Hôpital, 75013 Paris, France</footnote>

<footnote n="7">⁷Aberdeen Centre for Arthritis and Musculoskeletal Health (Epidemiology Group), University of Aberdeen, Aberdeen, United Kingdom AB25 2ZD</footnote>

<footnote n="8">⁸Section for Public Health, Inland Norway University of Applied Sciences, P.O. Box 400, NO-2418 Elverum, Norway</footnote>

<footnote n="9">⁹Department of Rheumatology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99 DK-8200 Aarhus N, Denmark</footnote>

<footnote n="10">¹⁰Department of Clinical Medicine, Aarhus University, Palle Juul-Jensens Boulevard 99 DK-8200 Aarhus N, Denmark</footnote>

<footnote n="11">¹¹Faculty of Medicine, University of Oslo, P.O box 1078 Blindern, NO-0316 OSLO, Norway</footnote>
# 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
Introduction

Patients with chronic diseases receiving follow-up in specialist healthcare services usually have
regular pre-scheduled face-to-face visits. Such follow-up is time-consuming for patients and
resource-demanding for the healthcare services. Digital health technologies enable novel follow-up
strategies such as remote monitoring of patient-reported outcomes (PROs) and sensor data,¹² which
may identify patients who need assessments or adjustments of treatment.³ Patient-initiated care
represents another alternative follow-up strategy, where patients are instructed to contact their
healthcare provider if symptoms increase or adverse events occur.⁴ Thus, both remote monitoring
and patient-initiated care may represent more targeted and efficient use of healthcare resources,
compared to regular pre-scheduled follow-up. However, the effectiveness and safety of such novel
strategies should be evaluated before implementation.⁵

Axial spondyloarthritis (axSpA) is a chronic inflammatory joint disease with a prevalence of 0.3-1.4%, and onset typically in the third decade of life.⁶ The disease is characterized by inflammation of sacroiliac joints and spine, back pain and stiffness, and may result in structural bone changes that reduce spinal mobility.⁶ ⁷ First-line medical treatment are non-steroidal anti-inflammatory drugs (NSAIDs). Some patients progress to disease-modifying anti-rheumatic drugs, usually tumour necrosis factor inhibitors (TNFi), and receive long-term follow-up in the specialist healthcare with assessments of treatment efficacy.⁷⁻⁹ Monitoring of disease activity at least twice a year under supervision of a rheumatologist is recommended.¹⁰ Patients are usually offered regular pre-scheduled visits, but with an opportunity to request additional visits if they experience worsening. Research has shown that rheumatologists considered 34% of the pre-scheduled visits for axSpA patients to be unnecessary,¹¹ and that patients with axSpA were interested in alternative follow-up strategies.¹² ¹³ However, only an observational study and a recently published randomized controlled trial (RCT) on remote monitoring of patients with axSpA have been conducted, indicating favourable effects of remote monitoring.¹⁴ ¹⁵ Thus, more research on the effectiveness, user satisfaction, safety, and resource utilization of novel follow-up strategies in axSpA is needed.¹⁶

The present study assessed whether either remote monitoring or patient-initiated care were non-inferior to usual care follow-up in maintaining low disease activity over 18 months in patients with axSpA. Secondary objectives included evaluation of other measures of disease activity, self-reported physical function, patient satisfaction, change of medication, resource use, and adverse events in the two novel follow-up strategies, compared to usual care over time.
# Methods

## Study design and participants

The Remote Monitoring in Axial Spondyloarthritis (ReMonit) study was a single-centre, three-armed, parallel group, randomized, controlled, open-label trial that evaluated the non-inferiority of two different follow-up strategies, compared to usual care follow-up over 18 months, for patients with axSpA (NCT050317).<sup>17</sup> The study was conducted at a single outpatient rheumatology clinic in a Norwegian hospital and in compliance with the Declaration of Helsinki and the International Conference on Harmonization Guidelines for Good Clinical Practice.<sup>18</sup>

Two patient research partners from the REMEDY patient advisory board participated as part of the study organization (SH, TG). The patient research partners provided input on the relevance of the research question, the feasibility of the study design and study logistics from a patient perspective, and written information to patients. They participated in meetings with the study organization throughout the study, and one (SH) is a co-author of this manuscript.

The study protocol (online supplemental file 1) was approved by the Regional Committee for Medical Research Ethics South East Norway (REC south-east 229187). All patients provided a written informed consent prior to inclusion. The study was conducted and analysed according to the protocol and statistical analyses plan (online supplemental file 1 and 2).

Eligible patients were adults (>18 years) with axSpA fulfilling the Assessment of SpondyloArthritis International Society criteria.<sup>19</sup> Patients were required to have used a stable dose of TNFi for the past six months, and have low disease activity, defined as Axial Spondyloarthritis Disease Activity Score (ASDAS) <2.1.<sup>20-23</sup> Full inclusion and exclusion criteria are listed in online supplemental file 3. The patients were recruited by rheumatologists during outpatient visits.

Baseline data collection included demographics, e-health literacy,<sup>24</sup> lifestyle, disease characteristics, measures of disease activity and function, medication used for axSpA, and patient satisfaction with care.

## Randomization

Patients were randomized 1:1:1 to one of the three groups after eligibility was confirmed. A statistician and a secretary, not involved in patient screening or enrolment, provided a computer-generated block randomization list (random block size of 6, 9, or 12 patients) and prepared sealed, opaque envelopes containing information on group allocation. The study nurse or study coordinator informed patients about their group assignment and the designated intervention. Patients and treating clinicians were not blinded to group allocation, but the statistician programming the statistical analyses was blinded.

## Interventions

The interventions were the follow-up strategy between baseline visit and study-end visit at 18 months post-randomization; either remote monitoring or patient-initiated care.

The patients in Remote Monitoring or Patient-initiated Care had no pre-scheduled visits between baseline and study-end. In Remote Monitoring, patients reported PROs monthly via a smartphone application, MyDignio.<sup>25</sup> The following was reported: (i) Patient Global Assessment of Disease activity (PGA) on numerical rating scale (NRS): 0-10 (worst), and (ii) whether they experienced a flare (significant worsening of disease-related symptoms). If patients scored PGA≥3 or reported “yes” or
“uncertain” to the flare question, they were asked to additionally complete the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questionnaire.²⁶ A rheumatology nurse monitored the PROs daily on the web-platform, Dignio Prevent. If BASDAI score was ≥4, the nurse received an alert (“yellow flag”), contacted the patients by phone and assessed the need for a visit.

Patients allocated to Patient-initiated Care self-monitored their symptoms and could contact a rheumatology nurse if they experienced significant symptom worsening or adverse events. They also reported the same PROs as the Remote Monitoring group in the MyDignio app every 3rd month, but they were informed that this reporting was for research only and would not be monitored.

The control group received usual care follow-up with pre-scheduled face-to-face visits, at the hospital every 6th month. These visits were undertaken by a rheumatology nurse under supervision by a rheumatologist.

If patients in any of the three groups experienced a minor disease worsening, they could initiate or intensify treatment with NSAIDs at the dosage they had used previously. All patients were encouraged to contact the rheumatology nurse if they experienced significant disease worsening or adverse events, either by phone or through a messaging system in the MyDignio app (only Remote Monitoring and Patient-initiated Care). The nurse assessed the need of a visit with a rheumatologist.

## Outcomes

The primary endpoint was low disease activity, defined as ASDAS<2.1 evaluated at 6-, 12-, and 18-months. ASDAS was calculated from four PROs (NRS 0-10, 10=very severe): back pain, joint pain/swelling, duration of morning stiffness, and PGA during the last week in addition to C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR). ASDAS<sub>CRP</sub> was the preferred measure.²³

Most secondary endpoints were evaluated at 6, 12, and 18 months and are in detail described in online supplemental file 4. The secondary endpoints included measures of disease activity: ASDAS as continuous measure, ASDAS<1.3,²¹ ASDAS increase ≥0.9,²⁷ BASDAI,²⁶ CRP, ESR, PGA, general pain, joint pain, back pain, morning stiffness severity, and fatigue. Number of tender and swollen joints were evaluated at 18 months. Secondary endpoints included measures of function; Bath Ankylosing Spondylitis Functional Index,²⁸ activity impairment,²⁹ sleep disturbance due to pain,³⁰ and overall health.³¹ ³² Patients also reported on satisfaction with care.³³ Medication was assessed by number of patients switching or stopping TNFi during the study (only evaluated at 18 months), use of NSAIDs, other analgesics, and corticosteroids. Number of hospital-visits and brief contacts by phone between patients and healthcare providers were registered throughout the study as a measure of healthcare providers’ resource use. Adverse events and serious adverse events were reported at study-end at 18 months or at early study termination, and were coded according to the Medical Dictionary of Regulatory Activities, version 3.0.

## Populations available for analyses

All enrolled patients were included in baseline analyses. The full analyses set included patients with at least one assessment of the primary outcome at 6, 12, or 18 months. The per-protocol set included patients who were adherent to the allocated follow-up regimen with no major protocol deviation (online supplemental file 5). The primary analysis was performed in the full analysis set, and repeated in the per-protocol set as a sensitivity analysis. The risk of non-adherence to study protocol was considered to be unequal between the study groups as the patients in the Remote Monitoring had to report PROs on a regular basis.

## Statistical analyses
Using data from the ongoing NOR-DMARD study,³⁴ we estimated the probability of a patient satisfying ASDAS<2.1 at a single visit to be around 88% in the Usual Care group. We required at least 80% power to conclude that either one or both of Remote Monitoring or Patient-initiated Care were non-inferior to Usual Care, using a non-inferiority margin of 15%. The non-inferiority margin of 15%, was considered as a clinically meaningful difference based on a combination of statistical reasoning and clinical judgement after thorough discussions between the clinicians and biostatisticians in the project group. Assuming no differences between the groups, we estimated that 74 patients in each group would suffice. Anticipating drop-out, we aimed for a group size of 80 patients.

The primary analysis was performed using mixed effect logistic regression. The model included randomization group, baseline ASDAS and their interactions with time (categorical) as covariates, in addition to patient level random intercepts. The estimates of the probability of ASDAS<2.1 for each group were formed by averaging across the timepoint specific estimates of the probability that a patient satisfied ASDAS<2.1. Their standard errors and that of the corresponding risk differences were estimated using subject level bootstrapping, which were then used to form normal-based confidence intervals (CIs). The analyses assumed that missing values of ASDAS were missing at random. Hence, missing values were not imputed.

The non-inferiority of Remote Monitoring vs. Usual Care was assessed using a two-sided 97.5% CI for the between-group difference of the probability of ASDAS<2.1, and conducted if the CI ruled out differences in excess of 15% in favour of Usual Care. The same approach was used for assessing the non-inferiority of Patient-initiated Care vs. Usual Care. The non-inferiority of Patient-initiated Care vs. Remote Monitoring would only be assessed (using a 95% CI) if both these strategies were shown to be non-inferior to Usual Care, giving a family-wise error rate of 2.5%.

Sensitivity analyses were performed in the per-protocol set; with adjustment for additional baseline characteristics (age, gender, and TNFi treatment duration); with an updated ASDAS definition;³⁵ and multiple imputation in combination with logistic regression estimated using the GEE approach.

Secondary continuous and binary endpoints were analysed in a similar to the primary analysis. Outcomes assessed at a single time point (ASDAS increase>0.9, tender and swollen joints) were treated likewise but without random intercepts and time interactions. Patients' satisfaction, medication, healthcare providers' resource use, and adverse events were summarized using descriptive statistics.

All analyses, were prespecified in the statistical analysis plan (supplement 1), and carried out using Stata version 16 (StataCorp) and R version 4.0.3 (R Foundation).
# Results

## Study Participants

In total 243 of 346 screened patients were enrolled into the study between September 2021 and June 2022, and the final visit was in January 2024. Patients were randomly allocated to; Remote Monitoring n=80; Patient-initiated Care n=81; or Usual Care, n=82 (figure 1). Mean age was 43 years (SD 12), 183 (75%) were male, and mean ASDAS was 1.0 (SD 0.5) at baseline, with balanced baseline characteristics between the groups (table 1). Excluded patients had similar age, gender, and disease activity to the enrolled patients, but a higher proportion of the enrolled patients had education at university level and were in paid work as compared to excluded patients (online supplemental table S1). Of the 243 enrolled patients, one did not meet the inclusion criteria, two withdrew soon after inclusion, and five were lost to follow-up, leaving 235 patients in the full analyses set (figure 1). Eight patients had a major protocol deviation; six in Remote Monitoring, one in Patient-initiated Care, and one in Usual Care, leaving 227 patients in the per-protocol set.

## Primary Endpoint

In all three groups, and at each of the 6-, 12-, and 18-months assessments, ≥90% of patients had ASDAS<2.1, with minimal differences between the groups (figure 2). The estimated difference in the probability of ASDAS<2.1 between Usual Care and Remote Monitoring was -4.1% (97.5% CI -9.9 to 1.8), between Usual Care and Patient-initiated Care; -1.1% (97.5% CI -7.2 to 4.9). Both analyses supported the conclusion of non-inferiority, and hence the difference in the probability of ASDAS<2.1 between Remote Monitoring and Patient-initiated Care was assessed; 2.9% (95% CI -1.5 to 7.4) (figure 2). Sensitivity analyses showed confirmatory results (online supplemental table S2).

## Secondary outcomes

Analyses of secondary endpoints on disease activity and self-reported physical function showed similar results across groups (figure 3, online supplemental table S3 and S4). This was also the case for patient satisfaction, with ≥90% reporting to be "satisfied" or "very satisfied" (figure 3, online supplemental table S5). At 18 months, less than 10% had switched or stopped TNFi, with no group differences. There were only small differences between groups in the use of NSAIDs, other analgesics, and steroids throughout the study (table 2).

The number of extra visits were similar in all follow-up groups, but the total number of visits were higher in Usual Care due to the pre-scheduled visits every 6th month. There were more brief contacts by phone in Remote Monitoring than in Usual Care and Patient-initiated Care, but a substantial proportion of these contacts were the nurse calling patients due to a PRO-related "yellow flag" in the remote monitoring platform (figure 3). Number of adverse events were similar across groups (table 3, online supplemental file 6). There were few serious adverse events, and none led to study discontinuation.
Discussion

In the present ReMonit study, Remote Monitoring and Patient-initiated Care were non-inferior follow-up strategies in maintaining low disease activity compared to Usual Care follow-up in patients with axSpA. Furthermore, Patient-initiated Care was non-inferior to Remote Monitoring. There were no differences across groups for patient satisfaction or change of TNFi medication, but there were fewer visits and brief contacts by phone in the Patient-initiated Care. There were few serious adverse events, and none led to study discontinuation.

Previous research on alternative follow-up strategies of axSpA is limited. In an observational study, using a mobile health tool for axSpA was associated with lower disease activity or inactive disease, and a lower need for hospital visits. ¹⁴ A recent Dutch RCT compared the combination of remote monitoring and patient-initiated care with usual care, demonstrating non-inferiority in disease activity at the 12 months follow-up. ¹⁵ In this study, patients in the intervention group were remotely monitored at 6 months, while those in the control group received follow-up at the discretion of their rheumatologist. An important difference between the Dutch study and the present ReMonit study is that the ReMonit study distinctly evaluated remote monitoring and patient-initiated care in separate groups. This design allowed the ReMonit study to compare the independent effects of these two follow-up strategies, ultimately showing that patient-initiated care was non-inferior to remote monitoring. Moreover, the ReMonit study featured more frequent remote monitoring and an extended follow-up time period, both of which are crucial for implementation in clinical practice. A few RCTs among patients with other inflammatory joint diseases have compared remote monitoring of PROs or patient-initiated care to usual care, and most studies reported similar results on disease activity for remote monitoring or patient-initiated care vs. usual care. ³⁶⁻³⁹ A meta-analyses indicated a favourable effect on disease activity of remote monitoring compared to usual care with regular clinic visits, but the effect-size was small. ³⁷

The similarities between the three groups in primary and secondary outcomes on disease activity suggests that disease worsening is likely to be detected regardless of follow-up strategy. We found a similar low frequency of change in TNFi treatment across the groups, indicating that patients who needed change of treatment were recognized to the same extent irrespective of the follow-up strategy. Since the use of NSAIDs and analgesics did not increase in any of the follow-up groups, we can assume that patients experiencing disease worsening sought evaluation of their medical treatment at the outpatient clinic. The observed lack of difference in use or change of medication is probably also related to the low frequency of disease worsening episodes in the study sample.

Reduction of healthcare providers' resource use is important to achieve sustainable follow-up care. In the present study, there were more visits in the Usual Care group, and Remote Monitoring had more brief contacts by phone. Fewer visits in the intervention groups is in line with the Dutch RCT on patients with axSpA. ¹⁵ Correspondingly, studies on patients with rheumatoid arthritis followed by remote monitoring or patient-initiated care showed less face-to-face visits compared to usual care. ³⁶
³⁷ Similar to the results of the present study, one study found a higher number of nurse telephone contacts in the remote monitoring group compared to usual care. ⁴⁰ While monitoring of disease activity at least twice a year under supervision of a rheumatologist has been recommended, ¹⁰ the results of the present study indicate that monitoring could be done as infrequent as at 18-month intervals. Moreover, the present study shows no additional benefit of remote monitoring over patient-initiated care.
Since the present study only included patients with axSpA in low disease activity and on stable medication, caution should be exercised when generalizing the findings. However, a large proportion (>50%) of patients with axSpA have low disease activity,⁴¹ and implementation of less resource-intensive, effective, and safe follow-up strategies would be beneficial for the society, healthcare sector, and patients. The lower resource-use in patient-initiated care can liberate time for healthcare providers to care for patients with high disease activity or more complex diseases, and thus facilitate more targeted use of healthcare resources in rheumatology. This may also be relevant for other fields of medicine.

From an environmental perspective, less resource-intensive follow-up is favourable, by reducing the carbon footprint. When RCTs demonstrate equivalent clinical outcomes, we should recommend the low-carbon alternative.⁴² Reducing patient travelling through remote healthcare services can significantly decrease emissions,⁴³ but use of technology may increase energy use related to collection, storage and processing data.⁴⁴ Patient-initiated care reduces patient travelling and additionally diminishes need for technology and staff resources, making it likely to be the follow-up in our trial with lowest environmental impact. By adopting this follow-up regime, healthcare systems enhance efficiency and contribute to environmental sustainability.

## Strengths and limitations

The strengths of this study include the RCT design with comparison of two novel follow-up strategies to conventional follow-up over a long time period, as well as a comprehensive data collection. This study has some limitations. First, there may be a selection bias as patients motivated for an alternative follow-up would be more likely to participate. Hence, the results regarding patient satisfaction may be overestimated in the intervention groups. However, very few patients declined to participate, which reduces the effect of a possible selection bias. Second, this study was open-labelled and most of the outcomes were PROs, which may have been affected by patients' enthusiasm for their allocated follow-up and bias their reporting of the outcomes. Both the primary outcome ASDAS, which in addition to PROs include an objective measure, CRP, and treatment discontinuation of TNFi can be regarded as semi-objective outcomes, and may reduce such bias. Third, reporting of adverse events at the ultimate study visit was susceptible to recall bias, especially in the intervention groups. However, serious adverse events were reported in all three groups, indicating that we managed to capture information about serious adverse events also from patients in groups without regular visits.

## Conclusion

Among patients with axSpA in low disease activity and on stable medication, follow-up with Remote Monitoring or Patient-initiated Care were non-inferior to usual care in maintaining low disease activity, which supports implementation of remote monitoring or patient-initiated care. Patient-initiated care was the least resource-intensive follow-up for healthcare providers. Further research on alternative follow-up strategies for patients with higher disease activity is warranted.
# Key messages

**What is already known on this topic:**

Follow-up of patients with chronic diseases, traditionally offered as regular pre-scheduled face-to-face visits, is time-consuming for patients and resource-demanding for the healthcare services.

Novel follow-up strategies such as remote monitoring or patient-initiated care may allow for targeted and efficient use of healthcare resources, but the knowledge is limited on the effectiveness of these follow-up regimen.

**What this study adds:**

Both remote monitoring and patient-initiated follow-up were non-inferior to usual care in maintaining low disease activity in patients with axial spondyloarthritis.

Patient-initiated care was the least resource intensive follow-up for healthcare providers.

**How this study might affect research, practice or policy:**

Patients with axial spondyloarthritis in low disease activity can be managed either by remote monitoring or patient-initiated care as alternatives to usual care with pre-scheduled follow-up.
## Figures

<caption>**Figure 1** Flow of the participants in the ReMonit study</caption>

*Patients with no assessment of the primary endpoint during follow-up

†Completed less than 50% of the monthly PROs and not completed a monthly PRO at least once between baseline and the 6-month, once between the 6- and the 12-month, and once between the 12- and the 18-month follow-ups; or less than two assessments of the primary endpoint at either 6, 12, or 18 months

‡Less than two assessments of the primary endpoint at either 6, 12 or 18 months

§Less than two assessments of the primary endpoint at either 6, 12 or 18 months, and not attended at prescheduled visits at neither the 6- nor the 12-month follow-up

<caption>**Figure 2** Probability of low disease activity with different follow-up strategies</caption>

ASDAS=Axial Spondyloarthritis Disease Activity Score

Crude values and proportions of patient with ASDAS<2.1 at 6, 12- and 18-months follow-up and adjusted comparisons between the follow-up arms, analysed by mixed effect logistic regression. The randomization group and baseline ASDAS assessment, as well as their interactions with time (categorical), were included as covariates, in addition to patient specific random intercepts.

<caption>**Figure 3** Secondary outcomes, disease activity, patient satisfaction, number of visits and brief contacts by phone</caption>

Panel a: Boxplot of disease activity over time measured by Axial Spondyloarthritis Disease Activity Score.

Panel b: Boxplot of disease activity over time measured by C-reactive protein.

Panel c: Bar graphs of Patient satisfaction at study-end at 18 months, five-point response options ranging from “Very satisfied” to “Very dissatisfied”, presented as percentage of patients.

Panel d: Bar graphs of Hospital visits and brief contacts by phone as measures of healthcare providers' resource use. Unscedueled visits are extra appointments in all follow-up groups, and Scedueled visits are pre-scedueled visits, only for the Usual Care group. Brief contacts by phone were patient initiated in all three follow-up groups, i.e., the patients called the healthcare provider. Flagged Brief contacts by phone was when the rheumatology nurse called a patient in Remote Monitoring due to a high patient-reported BASDAI score (yellow flag) indicated in the remote monitoring platform.
Tables

<table><caption>**Table 1.** Baseline characteristics of the study population</caption><thead><tr><th></th><th>Remote<br>Monitoring<br>(n=80)</th><th>Patient-initiated<br>Care<br>(n=81)</th><th>Control Group<br>(n=82)</th></tr></thead><tbody><tr><td><strong>Demographics</strong></td><td></td><td></td><td></td></tr><tr><td>Age, mean (SD), min-max, years</td><td>42 (12), 22-70</td><td>45 (10), 26-78</td><td>44 (13), 21-76</td></tr><tr><td>Males, No. (%)</td><td>62 (78)</td><td>62 (77)</td><td>59 (72)</td></tr><tr><td>Education at university level, No. (%)</td><td>69 (86)</td><td>59 (73)</td><td>68 (84)</td></tr><tr><td>Paid work, No. (%)</td><td>70 (88)</td><td>71 (88)</td><td>73 (89)</td></tr><tr><td>E-health literacy*, mean (SD)</td><td>3.5 (0.4)</td><td>3.3 (0.5)</td><td>3.4 (0.4)</td></tr><tr><td><strong>Lifestyle</strong></td><td></td><td></td><td></td></tr><tr><td>Body mass index, mean (SD), kg/m<sup>2</sup></td><td>24.2 (3.2)</td><td>26.3 (4.4)</td><td>25.1 (5.4)</td></tr><tr><td>Smoking, No. (%)</td><td>3 (4)</td><td>1 (1)</td><td>3 (4)</td></tr><tr><td><strong>Disease Characteristics</strong></td><td></td><td></td><td></td></tr><tr><td>Disease duration, from diagnosis, mean (SD), years</td><td>13.2 (10.5)</td><td>13.4 (9.1)</td><td>14.4 (12.1)</td></tr><tr><td>Symptom duration, mean (SD), years</td><td>19.5 (12.1)</td><td>19.4 (10.5)</td><td>20.2 (12.9)</td></tr><tr><td>Sacroiliitis, No. (%)</td><td>74 (93)</td><td>77 (95)</td><td>77 (94)</td></tr><tr><td>HLA-B27, No. (%)</td><td>75 (94)</td><td>77 (95)</td><td>74 (90)</td></tr><tr><td>Peripheral involvement ever, No. (%)</td><td></td><td></td><td></td></tr><tr><td>Arthritis</td><td>30 (38)</td><td>43 (53)</td><td>39 (48)</td></tr><tr><td>Enthesitis</td><td>6 (8)</td><td>15 (19)</td><td>10 (12)</td></tr><tr><td>Dactylitis</td><td>4 (5)</td><td>4 (5)</td><td>2 (2)</td></tr><tr><td>Extra musculoskeletal manifestations ever, No. (%)</td><td></td><td></td><td></td></tr><tr><td>Uveitis</td><td>29 (36)</td><td>26 (32)</td><td>27 (33)</td></tr><tr><td>Psoriasis</td><td>8 (10)</td><td>12 (15)</td><td>7 (9)</td></tr><tr><td>Inflammatory bowel disease</td><td>7 (9)</td><td>4 (5)</td><td>9 (11)</td></tr><tr><td><strong>Disease activity</strong></td><td></td><td></td><td></td></tr><tr><td>ASDAS, mean (SD)</td><td>1.0 (0.5)</td><td>1.0 (0.5)</td><td>1.0 (0.4)</td></tr><tr><td>BASDAI, mean (SD)</td><td>1.3 (1.1)</td><td>1.3 (1.2)</td><td>1.3 (1.0)</td></tr><tr><td>CRP, median (IQR), mg/L</td><td>1 (1-2)</td><td>1 (1-2)</td><td>1 (1-2)</td></tr><tr><td>ESR, median (IQR), mm/h</td><td>5 (2-9)</td><td>5 (2-7)</td><td>5 (3-11)</td></tr><tr><td>PGA†, mean (SD)</td><td>1.7 (1.8)</td><td>1.5 (1.9)</td><td>1.4 (1.1)</td></tr><tr><td>General pain†, mean (SD)</td><td>1.3 (1.2)</td><td>1.2 (1.2)</td><td>1.3 (1.1)</td></tr><tr><td>Back pain†, mean (SD)</td><td>1.4 (1.3)</td><td>1.6 (1.7)</td><td>1.5 (1.4)</td></tr><tr><td>Joint pain†, mean (SD)</td><td>1.2 (1.2)</td><td>1.0 (1.2)</td><td>1.3 (1.2)</td></tr><tr><td>Morning stiffness severity†, mean (SD)</td><td>1.5 (1.4)</td><td>1.2 (1.3)</td><td>1.5 (1.4)</td></tr><tr><td>Fatigue†, mean (SD)</td><td>1.9 (2.1)</td><td>1.9 (2.0)</td><td>1.9 (1.8)</td></tr><tr><td>Peripheral disease activity, No. (%)</td><td></td><td></td><td></td></tr><tr><td>Patients with swollen joints</td><td>0 (0)</td><td>0 (0)</td><td>0 (0)</td></tr><tr><td>Patients with tender joints</td><td>3 (4)</td><td>2 (3)</td><td>3 (4)</td></tr><tr><td>Patients with heel enthesitis</td><td>1 (1)</td><td>0 (0)</td><td>0 (0)</td></tr><tr><td><strong>Functional status</strong></td><td></td><td></td><td></td></tr><tr><td>BASFI, mean (SD)</td><td>0.8 (0.9)</td><td>0.7 (1.0)</td><td>0.7 (1.0)</td></tr><tr><td>Activity impairment, mean (SD)</td><td>1.1 (1.5)</td><td>1.1 (1.5)</td><td>0.9 (1.0)</td></tr><tr><td>Sleep disturbances due to pain, No. (%)</td><td>17 (21)</td><td>18 (22)</td><td>10 (12)</td></tr><tr><td>Overall health (EQ-5D-5L), mean (SD)</td><td>80 (13)</td><td>78 (16)</td><td>80 (13)</td></tr></tbody></table>
<table><caption>**Table 1.** Baseline characteristics of the study population, continued</caption><thead><tr><th></th><th>Remote<br>Monitoring<br>(n=80)</th><th>Patient-initiated<br>Care<br>(n=81)</th><th>Control Group<br>(n=82)</th></tr></thead><tbody><tr><td>Medication used for axSpA, No. (%)</td><td></td><td></td><td></td></tr><tr><td>Infliximab</td><td>10 (13)</td><td>8 (10)</td><td>18 (22)</td></tr><tr><td>Etanercept</td><td>33 (41)</td><td>27 (33)</td><td>23 (28)</td></tr><tr><td>Adalimumab</td><td>31 (39)</td><td>39 (48)</td><td>37 (45)</td></tr><tr><td>Golimumab</td><td>3 (4)</td><td>3 (4)</td><td>1 (1)</td></tr><tr><td>Certolizumab pegol</td><td>3 (4)</td><td>4 (5)</td><td>3 (4)</td></tr><tr><td>DMARDs (not TNFi)</td><td>2 (3)</td><td>4 (5)</td><td>3 (4)</td></tr><tr><td>NSAIDs</td><td>30 (38)</td><td>27 (33)</td><td>24 (29)</td></tr><tr><td>Analgesics, not NSAIDs</td><td>14 (18)</td><td>21 (26)</td><td>15 (18)</td></tr><tr><td>Corticosteroids</td><td>2 (3)</td><td>4 (5)</td><td>0 (0)</td></tr><tr><td>Patient satisfaction with care, No. (%)</td><td></td><td></td><td></td></tr><tr><td>Very satisfied</td><td>58 (73)</td><td>62 (77)</td><td>64 (78)</td></tr><tr><td>Satisfied</td><td>21 (26)</td><td>18 (22)</td><td>18 (22)</td></tr><tr><td>Both satisfied and dissatisfied</td><td>1 (1)</td><td>1 (1)</td><td>0 (0)</td></tr><tr><td>Dissatisfied</td><td>0 (0)</td><td>0 (0)</td><td>0 (0)</td></tr><tr><td>Very dissatisfied</td><td>0 (0)</td><td>0 (0)</td><td>0 (0)</td></tr></tbody></table>

ASDAS, Axial Spondyloarthritis Disease Activity Score; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; CRP, C-Reactive Protein; DMARD, Disease Modifying Anti Rheumatic Drugs; EQ-5D-5L, Euro Quality of Life 5 dimensions 5 levels; ESR, Erythrocyte Sedimentation Rate; HLA, human leucocyte antigen; NSAIDs, Non-Steroidal Anti-Inflammatory Drugs; PGA, patient global assessment of disease activity: SD, standard deviation; TNFi, Tumour Necrosis Factor inhibitor

<footnote>*Range 1-4, 4 is best score</footnote>

<footnote>†Measured on NRS 0-10 (0=none, 10=very severe)</footnote>
<table><caption>**Table 2** Use of medication for axial spondyloarthritis throughout the study</caption><thead><tr><th>Medication</th><th>Remote Monitoring (n=75)</th><th>Patient-initiated Care (n=79)</th><th>Usual Care (n=81)</th></tr></thead><tbody><tr><td>TNFi stopped or switched to another TNFi</td><td></td><td></td><td></td></tr><tr><td>18 months</td><td>2 (2)</td><td>3 (4)</td><td>4 (5)</td></tr><tr><td>Use of NSAIDs</td><td></td><td></td><td></td></tr><tr><td>Baseline</td><td>27 (36)</td><td>27 (34)</td><td>25 (31)</td></tr><tr><td>6 months</td><td>28 (38)</td><td>32 (42)</td><td>22 (27)</td></tr><tr><td>12 months</td><td>26 (36)</td><td>31 (40)</td><td>28 (35)</td></tr><tr><td>18 months</td><td>30 (42)</td><td>25 (33)</td><td>25 (32)</td></tr><tr><td>Use of analgesics, not NSAIDs*</td><td></td><td></td><td></td></tr><tr><td>Baseline</td><td>13 (17)</td><td>21 (27)</td><td>15 (19)</td></tr><tr><td>6 months</td><td>22 (29)</td><td>21 (27)</td><td>21 (26)</td></tr><tr><td>12 months</td><td>20 (27)</td><td>26 (33)</td><td>20 (25)</td></tr><tr><td>18 months</td><td>19 (27)</td><td>14 (18)</td><td>21 (27)</td></tr><tr><td>Use of corticosteroids</td><td></td><td></td><td></td></tr><tr><td>Baseline</td><td>2 (3)</td><td>7 (9)</td><td>4 (5)</td></tr><tr><td>6 months</td><td>3 (4)</td><td>5 (6)</td><td>7 (9)</td></tr><tr><td>12 months</td><td>4 (5)</td><td>3 (4)</td><td>1 (1)</td></tr><tr><td>18 months</td><td>4 (6)</td><td>0 (0)</td><td>3 (4)</td></tr></tbody></table>

Values are numbers (%).

*According to the statistical analyses plan, we planned to calculate NSAIDs score,⁴⁵ but the data collected on the amount of NSAIDs used was inaccurate and this analysis was left out.

NSAID, Non-Steroidal Anti-Inflammatory Drugs; TNFi, Tumour Necrosis Factor inhibitor
<table><caption>**Table 3** Adverse Events, reported at 18 months.</caption><thead><tr><th>Adverse Events</th><th>Remote Monitoring (n=75)</th><th>Patient-initiated Care (n=79)</th><th>Control Group (n=81)</th></tr></thead><tbody><tr><td>Individuals with Adverse events</td><td>26 (33)</td><td>27 (33)</td><td>25 (31)</td></tr><tr><td>Total number of Adverse events</td><td>38</td><td>36</td><td>33</td></tr><tr><td><strong>Adverse events reported three times or more</strong></td><td></td><td></td><td></td></tr><tr><td>Upper respiratory tract infection</td><td>1</td><td>5</td><td>3</td></tr><tr><td>Lower respiratory tract infection</td><td>0</td><td>3</td><td>1</td></tr><tr><td>Rash</td><td>1</td><td>1</td><td>2</td></tr><tr><td>Uveitis</td><td>2</td><td>0</td><td>2</td></tr><tr><td>Borrelia burgdorferi infection</td><td>0</td><td>1</td><td>2</td></tr><tr><td>Chest pain</td><td>1</td><td>2</td><td>0</td></tr><tr><td>Disc herniation</td><td>2</td><td>1</td><td>0</td></tr><tr><td>Elevated liver enzymes</td><td>1</td><td>1</td><td>1</td></tr><tr><td>Essential hypertension</td><td>2</td><td>0</td><td>1</td></tr><tr><td><strong>Serious adverse events*</strong></td><td></td><td></td><td></td></tr><tr><td>Individuals with serious adverse events</td><td>5 (6)</td><td>2 (3)</td><td>1 (1)</td></tr><tr><td>Total number of serious adverse events†‡</td><td>6</td><td>2</td><td>1</td></tr></tbody></table>

Values are numbers (%).

*The serious adverse events term included any untoward medical occurrence that resulted in death, was immediately life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital birth anomaly/defect, or as significant medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above.

†The serious adverse events were: 1 case of pericarditis, endometritis postpartum, palpitations, femur fracture, myocardial infarction, gastrointestinal bleeding, neutropenia after initiation of sulfasalazine, hypomagnesemia.

‡None of the serious adverse events led to study discontinuation or death.
Acknowledgments

We thank all the participating patients, and are grateful for the time and efforts spent in the project.
We also thank patient representative Tale Gjøvik for her contribution in designing the study and to
Jostein Arnesen for administrative support.

Authors contribution:

Conceptualization: All authors.

Data curation: IJB, NO, JS.

Formal analyses: JS.

Funding acquisition: IJB, NO.

Investigation: IJB, NO, EEKT, EM, EEK, SAP.

Methodology: All authors.

Project administration: NO.

Resources: IJB, NO, EM, EKK, SAP, JS.

Supervision: EAH, SL.

Writing - original draft: IJB, NO, JS.

Writing – review & editing: All authors

IJB, NO, and JS had full access to all of the data in the study and take responsibility for the integrity of
the data and the accuracy of the data analysis.

IJB and NO are responsible for the overall content as guarantors.

The corresponding author attests that all listed authors meet authorship criteria and that no others
meeting the criteria have been omitted.

Funding sources

This work was funded from South-Eastern Norway Regional Health Authority (funding number
2021062). The funder 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.

Competing interests

LG has reported research grants: AbbVie, Biogen, Lilly, Novartis, UCB; consulting fees: AbbVie, Amgen, BMS, Celltrion, Janssen, Lilly, MSD, Novartis, Pfizer, Stada, UCB; non-financial support: AbbVie, Amgen, Biogen, Janssen, MSD, Pfizer, UCB, all disclosures outside the submitted work. GB as reported speakers fee Johnson&Johnson.
No other disclosures were reported.

Patient and public involvement

Two patient research partners from the REMEDY patient advisory board participated as part of the study organization (Sarah Hakim, Tale Gjøvik). The patient research partners provided input on the relevance of the research question, the feasibility of the study design and study logistics from a patient perspective, and written information to patients. They participated in meetings with the study organization throughout the study, and one (SH) is a co-author of this manuscript.

Patient consent for publication

Not applicable
## Ethics approval

The study involves human participants and was conducted in compliance with the Declaration of Helsinki and the International Conference on Harmonization Guidelines for Good Clinical Practice. The study protocol was approved by the Regional Committee for Medical Research Ethics South East Norway (REC south-east 229187). All patients provided an informed written consent before participation.

## Data availability statement

A de-identified 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.

## Data linking

Not applicable

## ORCID iDs

Inger Jorid Berg 0000-0002-8605-5488
Eirik K Kristianslund 0000-0002-4963-3285
Anne Therese Tveter 0000-0003-1701-9835
Gunnstein Bakland 0000-0003-2613-5176
Laure Gossec 0000-0002-4528-310X
Sarah Hakim 0009-0006-3567-0313
Gary J Macfarlane 0000-0003-2322-3314
Ellen Moholt 0000-0002-4987-4863
Sella Aarrestad Provan 0000-0001-5442-902X
Emil E Kvernberg Thomassen 0000-0003-2075-999X
Annette de Thurah 0000-0003-0103-4328
Espen A. Haavardsholm 0000-0002-5893-1698
Siri Lillegraven 0000-0003-3615-0134
Nina Osteras 0000-0001-8602-342X

## Supplements

Supplemental file 1 Protocol

Supplemental file 2 Statistical Analyses Plan

Supplemental file 3 Eligibility criteria

Supplemental file 4 Secondary outcomes

Supplemental file 5 Analyses populations

Supplemental file 6 Adverse event summary

Supplemental Table S1 Baseline characteristics of selected variables based on participation status

Supplemental Table S2 Sensitivity analyses of primary endpoint, comparisons of adjusted probability of ASDAS<2.1
Supplemental Table S3 Secondary outcomes, disease activity and function, crude values

Supplemental Table S4 Secondary outcomes, disease activity and function, adjusted comparisons between the follow-up strategies

Supplemental Table S5 Patient satisfaction with care
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