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Natural disease progression in finger osteoarthritis : results from a 10 year follow-up cohort

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Title:

Natural disease progression in finger osteoarthritis: results from a 10 years follow up cohort.

T. Vanhaverbeke*1, L. Pardaens*1, R. Wittoek2,3

1 Faculty of Medicine and Health sciences, Ghent University, Ghent, Belgium

2 Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium

3 Rheumatology, Ghent University Hospital, Ghent, Belgium

* shared first authorship

Corresponding author:

Prof. Dr. Ruth Wittoek MD, PhD

C. Heymanslaan 10 B-9000 Ghent Belgium

+32 9 332 05 82

e-mail: Ruth.Wittoek@UGent.be

Category of submission: article

Running title: Disease progression in finger OA

Key words: hand osteoarthritis, radiography, disease progression, functional outcome measures Word count: 3195

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Abstract

Objectives: Limited evidence is available about long term natural disease progression in hand osteoarthritis (HOA). The objective is to study natural radiographic and clinical disease progression in HOA after longer follow up (i.e. 10 years) and to identify predictors for progression.

Methods: At baseline (T0), 270 patients with HOA were included in the Belgian HOA register. The majority (84.8%) was female and the mean age was 62.9 years. A total of resp. 154 (57%) and 106 (39.3%) patients consented to follow up (FU) after approximately five (T1) and ten years (T2).

Clinical and functional outcome measures were collected. Hand radiographs were taken and scored according to the anatomical phase scoring system.

Results: At T2, the majority of the patients (73.3%) showed any radiographic progression compared to T0. Remodelling was most frequently seen and new erosive joints rather rarely. FIHOA (0-30) and AUSCAN function (0-90) increased over time resp. 8.8 to 9.9 (p=0.017) and 39.3 to 41.9 (p=0.035) after T2. VAS pain (0-100) did not change (40.2 to 38.6 from T0 to T2 (p=0.656)). Univariate and multivariate logistic regression retained baseline soft tissue swelling (OR resp. 8.20;8.76), higher levels of pain (OR resp. 4.08;4.30) and number of baseline erosive joints (OR resp. 31.82;30.02) as significant predictors for radiographic progression.

Conclusions: Significant radiographic progression is seen over time in HOA. While pain remains similar after ten years, functional status does decline. Patients with soft tissue swelling, high levels of pain and already erosive disease at baseline are prone to progress over time.

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Introduction

Hand osteoarthritis (HOA) is a highly prevalent disease, especially among women and the elderly (1, 2). The disease is rather heterogeneous and several subtypes have been recognized (3). Especially the erosive HOA, characterized by joint swelling, inflammation and radiographic central erosions (4), can result in substantial pain and disability (5-7).

Although several longitudinal studies have been undertaken (8-13), not much is known about the natural course of HOA in terms of radiographic and clinical evolution. Moreover, most of these studies have been rather limited in follow up (FU). One study, where the disease course in HOA was studied over a period of six years, suggested that clinical changes are unrelated to radiographic changes (8). Knowledge about natural disease progression and its risk factors of clinical or radiographic progression could guide the needs of therapeutical interventions, which are currently rather limited to symptomatic treatments (14).

Previous data published on the five-year FU of the Belgian HOA cohort showed that presence of swollen joints is the main risk factor for radiographic disease progression (15). Imaging based longitudinal studies also supported this and showed that both sonographic signs of inflammation (i.e., gray scale synovitis, effusion and/or Power Doppler signal) (10, 11, 16), MRI synovitis and bone marrow lesions (12) were associated with radiographic progression after FU of two to five years.

Moreover, ultrasound-detected osteophytes do predict radiographic and clinical progression of HOA after five years (13).

The aim of this study is to investigate the natural clinical and radiographic disease progression in HOA after ten years, compare the radiographic progression between baseline (T0) and five years (T1), T0 and ten years (T2) and identify risk factors for radiographic and clinical disease progression.

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Patients and methods Study design and subjects

Consecutive patients were recruited from secondary and tertiary Belgian rheumatology practices and included in the Belgian HOA cohort (n=270), which is a prospective observational cohort, set up between May 2007 and January 2010. Selection criteria, baseline demographic, clinical and radiographic data are described elsewhere (6). In brief, baseline mean disease duration was 10.1 years, 60% of patients suffered from erosive HOA with mean number of 1.4 joints (of 18) per patient. T1 took place between January and May 2014 (15). One hundred and fifty-four patients were seen at T1 (Supplementary file 1). All patients from T0 were invited for T2 after approximately ten years. Results reported here are originated from the T2 visit and compared to T0 and T1.

From 2007, 9 patients had died, 78 patients were lost to FU and 77 patients dropped out due to other medical issues (n=15), mobility problems (n=26), loss of interest (n=27) and family- or work-related issues (n=9). Hundred and six patients consented and T2 took place between September and December 2018. One patient was excluded from the analysis for patient reported outcome measurements (PROMs) due to Alzheimer’s disease, but included for analyses concerning physician reported outcomes and radiographic outcomes (Supplementary file 1). Written informed consent from all participants and approval from the local Ethical Committee were already available.

Clinical assessments, grip strength and PROMs

Similar clinical assessments were performed and PROMs were collected at T2 as at T0 and T1 (6). In short, presence of tenderness upon palpation and soft tissue swelling of all metacarpophalangeal (MCP), proximal interphalangeal (PIP) and distal interphalangeal (DIP) joints of both hands were assessed. Presence of tenderness and soft tissue swelling were defined on patient level if at least one joint was resp. painful or swollen. Grip strength of both hands was measured separately. All patients had three attempts for each hand and the maximum score of the dominant hand was withheld for further analysis.

Patients were asked to complete a Visual Analogue Scale (VAS) to indicate the level of pain in both hands during the last forty-eight hours (range: 0-100 mm with 0: no pain and 100: most extreme pain).

A cut-off for VAS was set on 33 mm, to compare patients with mild pain to those with moderate to high pain (17). The Functional Index for Hand Osteoarthritis (FIHOA) and the Australian/Canadian Osteoarthritis Hand Index (AUSCAN) were completed by the patients. For AUSCAN function (0-90), the cut-off change between T2 and T0 was set on 7.2, based on the minimal clinically important improvement (MCII) in HOA for AUSCAN function (18). Since MCII for FIHOA (0-30) is missing in literature, a cut-off was set on 1.8, implying that a patient is showing significantly more disability compared to baseline when the change in FIHOA is higher than 1.8 over ten years. This cut-off was

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chosen in analogy to the cut-off of AUSCAN. The cut-off was lowered due to the smaller range in the FIHOA questionnaire.

According to the functional impairment over time, patients were divided into two categories:

detetioration and non-deterioration. As 73.5% of the patients were categorised into the same category by FIHOA change or AUSCAN function change, deterioration was defined as FIHOA change higher than 1.8 or AUSCAN change higher than 7.2 between T0 and T2.

Radiographic assessments

Radiographs of both hands were taken unless collected within six months prior to the visit and were scored according to the scoring system for HOA by Verbruggen and Veys (19). This method identifies six different phases in a joint: ‘N’, normal; ‘S’ characterized by joint space narrowing, small- ossification centres and/or osteophytes; ‘J’ partial or total disappearance of the joint space; ‘E’

showing manifest erosions and destruction of the subchondral plate; ‘R’ showing remodelling signs with repair of the subchondral bone plate and reappearance of the joint space. Rarely ‘F’, a form of ankylosis, is seen.

Radiographs were scored independently by two readers (TV, LP) after intensive training. Inter- and intra-observer reliability were determined by Cohen’s kappa coefficient (κ). Both intra-observer (0.82 and 0.83) and inter-observer reliability (0.78) were excellent. Radiographic scoring was done blinded to clinical data and examination chronology. Discrepancies between readers in radiographic phase (except N and S) were adjudicated by a third independent reviewer (RW), this concerned 1.31% of the joints.

For logistic regression, patients were defined as radiographical, erosive progressor, when two or more joints progressed to another phase within the scoring system between T0 and T2, except for the change from N to S. Although being important from a clinical or pathogenetic viewpoint, the latter changes were considered to be non relevant in the context of erosive progression. The longer interval between consecutive radiographic assessments required a more stringent definition of progression.

Statistical analysis

Descriptive analysis was performed. Means and standard deviations (SD) were calculated for continuous variables and frequencies and percentages for categorical variables. To exclude potential transfer bias, participants were compared to the drop-out population by using the Mann-Whitney U test. The two populations were compared for differences in VAS pain, disease duration, total FIHOA and AUSCAN function between T0 and T2.

Longitudinal analyses were performed for clinical outcomes, grip strength, PROMs and radiographic outcomes from T0 to T2. The Wilcoxon matched pairs signed ranks test was used for this analysis.

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The Mann-Whitney U test was used to compare radiographic progressors to non-progressors and deteriorators to non-deteriorators. Univariate and multivariate logistic regression was performed to identify prognostic factors for radiographic and functional progression (dependent variable). The exploratory variables included in the multiple regression model had p-value<0.20 on univariate analysis. Stepwise logistic regression analysis was used. Goodness of fit of the model was assessed by Nagelkerke R-square and Hosmer and Lemeshow Test. Wald test was interpreted to assess the effect of an individual predictor while controlling other predictors. Stepwise, interaction terms were added to increase the predictive power of the model.The following independent variables were selected: sex (F/M), presence of tenderness (yes/no), presence of soft tissue swelling (yes/no), baseline VAS pain (>

33 mm or ≤ 33 mm), disease duration (years), BMI and number of baseline E joints for radiographic progression. Age was not included since highly correlated with disease duration and the latter being more of relevance. Age at onset (years), sex (F/M), grip strength (kg), baseline presence of tenderness (yes/no), baseline FIHOA or AUSCAN, and number of baseline R joints were selected for the prediction model of functional progression.

For all statistical analysis, IBM SPSS Statistics 25 was used. All hypotheses were tested two-tailed.

The level of significance (α) is 0.05. The results are defined as significant if the p-value is less than 0.05 (p-value < 0.05). The 95% confidence intervals (95%CI) of the odds ratios (OR) are reported for each logistic regression (OR [(95%CI]).

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Results

Comparison between participants and dropouts

The two populations of participants and dropouts did not differ statistically significant in disease duration, VAS pain, FIHOA and AUSCAN function.

Demographic data

A total of 106 patients, eighty-nine women (84%) and seventeen (16%) men were present at T2. The mean age was 70.5 years and the mean disease duration was 19 years at T2. Other demographic data are shown in Table 1.

Natural clinical disease course

The number of tender joints decreases significantly over a period of ten years (p=0.035) while the number of swollen joints increased (p<0.001) (Table 1). The maximal grip strength of the dominant hand decreases after ten years (p<0.001). In addition, hand functionality of patients, both measured by FIHOA and AUSCAN function, deteriorates significantly after ten years (resp. p=0.017 and p=0.035), although the mean difference over ten years is very small, resp. 1.45 and 4.51. Controversially, pain, measured by VAS and AUSCAN subdomain, decreases only numerically over ten years without reaching statistical significance (resp. p=0.656 and p=0.073). The mean difference of VAS pain and AUSCAN subdomain pain over ten years is resp. -1.16 and -1.84.

Natural radiographic disease course

In total, radiographs of 1908 IP joints were obtained of which seven joints could not be scored due to amputation, arthrodesis or bad alignment on the radiograph. On joint level, 419 of the 1901 joints (22%) showed radiographic progression over ten years: there was a significant decrease in mean number of N joints and E joints (p<0.001). Controversially, patients showed a significant increase of R joints (p<0.001) (Table 1). The majority of patients (73.3%) showed any radiographic progression compared to T0. Remodelling being most common. Incident new erosive joints occurred very rarely.

Predictors of radiographic progression

Demographic data, PROMs and clinical outcomes of radiographic progressors and non-progressors are shown in Table 2.

On univariate analysis, radiographic progression was significantly associated with several baseline variables (Table 3). In particular, presence of baseline soft tissue swelling, higher levels of pain on VAS and higher number of baseline erosive joints were more present in patients with radiographic progression after ten years. Presence of tender joints at baseline was seen more in the radiographic

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progressors than in non-progressors, although not significantly. BMI, disease duration nor female gender were significantly higher in progressors.

Stepwise logistic regression analysis retained baseline presence of soft tissue swelling, higher levels of pain and number of baseline erosive joints as significant predictors. All OR, 95%CI and p-values are shown in Table 3.

Predictors of functional progression

After a mean FU 9.7 years, 59% of the patients showed functional deterioration. The overall mean change between T0 and T2 was 4.52 (SD= 19.91) for AUSCAN function and 1.45 (SD= 5.49) for FIHOA. Deteriorators had significantly higher amounts of pain, defined by both VAS pain and AUSCAN pain (resp. p=0.02 and p=0.001). Other demographic, clinical data and PROMs are shown in Supplementary file 2. Although the Goodness-of-fit statistics of the suggested prediction model was acceptable, no significant predictors could be retained and data suggested regression to the mean for functional outcomes (Supplementary file 3).

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Discussion

In this present study, it was shown that the majority of patients (>70%) with HOA showed any radiographic progression after ten year of FU, mostly being remodelling and more frequently in the first years of FU. Because of the long interval between consecutive imaging, incident new, erosive joints were rather rare but due to the natural progression of the anatomical phases, as described by Verbruggen and Veys, lots of erosive phases must have preceded the remodelled joints (9). Presence of soft tissue swelling, baseline erosive joints and moderate to high pain were found to be the strongest predictors of radiographic progression after ten years. Although much radiographic progression is present, after ten years of FU, the level of pain did not seem to increase anymore over time in our population with a mean disease duration of already 18 years, but still maintaining a mean VAS pain of 39/100, emphasizing a considerable ongoing burden of disease. Knowing that VAS pain has been shown to be sensitive to change over time in several interventional trials in HOA (20), these data are in line with previous results showing that clinical changes and radiographic changes are unrelated in HOA (8). Hence this suggests that our patients seem to have adapted to the pain intensity or tolerate a certain level of pain.

On the other hand, disability increased, with outcome measures of functional impairment (i.e, FIHOA and AUSCAN) and also grip strength worsened significantly over time. In a previous study (8), high baseline self-reported pain, functional limitations and high number of painful joints were associated with increasing functional impairment. No significant predictors for functional progression could be retained here due to regression to the mean in our data.

Only few observational studies in HOA studying clinical risk factors for natural disease progression are available. Earlier results from the five year FU data of this cohort already identified the importance of baseline soft tissue swelling as important predictor for further radiographic progression (15).

Several imaging based studies confirmed the importance of US and MRI synovitis as risk factors for radiographic progression (10, 12, 16).

Clinical observed soft tissue swelling seems to be a good indicator for inflammation, and its role as predictor for radiographic progression is found to be consistent over time. Moreover, it has been shown to be reliable (data not shown). In this cohort of advanced HOA, the presence of soft tissue swelling is increasing over time while the number of remodelled joints is also increasing. If remodelling is associated with more soft tissue swelling and what soft tissue swelling exactly reflects is not clear yet. Soft tissue swelling in HOA could be more chronic synovial proliferation instead of intra-articular effusion like in chronic rheumatoid arthritis. Other imaging techniques such as MRI and US can provide answers to this question. However, since the clinical assessment is a good and sustainable predictor for radiographic progression, it is an easy and accessible manner to select patients for future treatments. Patients with inflammation are the ones that are preference candidates

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for future targeted therapies.The radiographic erosive subtype is known as the more inflammatory subset of HOA with higher clinical burden (21). Although at baseline, more than 60% of patients showed signs of erosive disease, development of new erosive joints remained rather rare in this cohort.

The number of normal and erosive joints per patient significantly reduced after ten years (from 5.0 to 2.0 for ‘N’ and 1.5 to 0.2 for ‘E’ joints, respectively) at the cost of remodelled joints (from 1.5 to 5.1).

This might suggest that the erosive subtype is a temporarily phenomenon within the spectrum.

The strength of this study is its long FU period: this cohort of HOA patients is the first that has been followed for ten years and where patient underwent identical clinical and radiographic examinations.

Since no effective treatments have become available in the meantime, the natural disease history is being studied and not confounded by any treatment interventions.

This study has a few limitations. First, at baseline, the mean disease duration was already ten years, illustrating that this cohort is an advanced HOA group instead of reflecting early HOA. It might be advocated that an earlier HOA cohort is more relevant for seeking risk factors that, by preference, are modifiable in order to prevent additional burden of disease. Other risk factors towards progression might be present in the earlier stages of the disease.

Second, the drop out rate is rather high, although no statistical differences in baseline clinical nor demographic data were present between patients who dropped out and patients who were present at T2. The high drop out rate is not surprisingly due to the higher age of the participants and more logistic problems in terms of mobility. Only few cognitive impairments were present and a small percentage of patients died.

Third, research on the natural disease course and development of effective treatment options is seriously hampered by the lack of good classification criteria. Comparisons of hand, finger and thumb base OA incidence and prevalence across studies or over time have been difficult to accomplish.

Currently, more insights are available on physiopathology and possible predictors of several subtypes in HOA: thumb base OA is considered a more mechanically driven disease whether IP joint OA, and especially the erosive type, is considered a more inflammatory one (22). At the inception of this cohort, these insights were not yet available hence distinction was not sufficiently made to account for these differences in later analyses. It becomes more clear now that different predictors for progression might be present according to the subtype studied. Solitary thumb base OA is rather rare in our cohort and could not be isolated as a subgroup to study.

Fourth, no other radiographic OA scoring systems besides the anatomical phase scoring system were used to assess the structural progression because these do not include a possibility to detect erosive progression.

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Disease activity in HOA reflects more than only radiographic progression, pain and/or functional impairment. The true definition of disease activity is yet unknown, but it is clear that it includes several domains and even several aspects within a domain. Investigation of composite scores is warranted, and may lead to development of a joint or disease activity score such as in rheumatoid artritis and spondyloarthritis. This might help to study the disease and predictors for disease progression.

Future research aiming to identify predictors for disease progression in HOA should preferentially include early HOA patients: imaging modalities such as MRI and ultrasonoraphy need to be included to identify these patients before conventional radiographs show advanced lesions.

In conclusion, the burden of disease in HOA remains high even after longer disease duration.

Radiographic progression towards remodelling is seen in the majority of patients. The highest rate for progression is seen in the beginning of the disease. This underlines the need for more sensitive tools to identify early HOA. Baseline presence of soft tissue swelling, higher levels of pain and number of baseline erosive joints are confirmed to be the strongest risk factors for radiographic progression here, underlining the need to treat these patients preferentially with future targeted therapies in early stages of development.

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Ethics and consent

This study was conducted with the approval of the local ethics committee, University Hospital Ghent, De Pintelaan 185, 9000 Ghent, Belgium. The procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000.

Acknowledgments

The authors wish to thank the patients who participated in the study.

Funding details

The study was supported by a grant from “Fonds voor Wetenschappelijk Reuma Onderzoek (FWRO)”.

Conflict of interest None.

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Tables

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Table 1. Demographic and clinical characteristics of patients at T0, T1 and T2.

Variable T0 (n=270) T1 (n=154) T2 (n=106) p-value

(comparison T0 and T2)

Demographic data

Sex (no. % female) 84.8% 86.4% 84% 1.00

Age at time of assessment (years) 62.9 ± 8.0 67.7 ± 7.2 70.5 ± 6.5 <0.001

Disease duration (years) 10.1 ± 7.0 15.7 ± 6.3 18.9 ± 5.7 <0.001

BMI (kg/m2) 25.7 ± 3.9 26.1 ± 4.9 0.049

Clinical outcomes and patient performed outcome

Tender (total no. of tender IP joints; range 0-18) 3.1 ± 3.4 4.8 ± 3.8 2.3 ± 3.5 0.035 Soft tissue swelling (total no. of swollen IP joints;

range 0-18) 1.4 ± 1.8 2.6 ± 2.7 3.6 ± 2.9 <0.001

Grip strength (kg) 19.0 ± 9.0 15.9 ± 8.3 15.8 ± 8.0 <0.001

Patient reported outcome measures*

FIHOA total (range 0-30) 8.8 ± 6.5 9.8 ± 6.5 9.9 ± 6.8 0.017

AUSCAN total (range 0-150) 63.5 ± 32.3 62.4 ± 30.9 64.0 ± 32.6 0.514

AUSCAN pain (range 0-50) 19.6 ± 10.9 17.2 ± 10.8 17.4 ± 10.6 0.073

VAS pain (range 0-100) 40.2 ± 25.1 33.3 ± 28.2 38.6 ± 27.2 0.656

AUSCAN function (0-90) 39.3 ± 21.3 40.2 ± 20.0 41.9 ± 22.0 0.035

AUSCAN stiffness (range 0-10) 4.6 ± 2.5 4.5 ± 2.6 4.7 ± 2.8 0.510

Radiographic outcomes

N joints (total no. of N joints within patient; range

0-18) 5.0 ± 4.3 2.1 ± 2.8

2.0 ± 2.8 <0.001 S joints (total no. of S joints within patient; range 0-

18) 9.2 ± 4.2 10.3 ± 4.1

10.1 ± 4.4 0.073

J joints (total no. of J joints within patient; range 0-

18) 0.5 ± 0.9 0.2 ± 0.5 0.4 ± 0.9 0.311

E joints (total no. of E joints within patient; range

0-18) 1.4 ± 1.7 0.2 ± 0.6 0.2 ± 0.5 <0.001

R joints (total no. of R joints within patient; range

0-18) 1.5 ± 2.6 5.0 ± 4.5

5.1 ± 4.3 <0.001 F joints (total no. of F joints within patient; range 0- 0.1 ± 0.5 0.2 ± 0.7 0.2 ± 0.7 0.031

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Values shown are mean ± standard deviation; except where indicated differently.

All p-values are tested two-tailed at a level of p< 0.05. All p-values lower than 0.05 in bold.

*n=105 in population present at T2, one patient’s data was excluded due to Alzheimer’s disease

FIHOA= Functional Hand Index for Hand Osteoarthritis; AUSCAN Osteoarthritis Hand Index= Australian Canadian Osteoarthritis Hand Index;

VAS= visual analogue scale; IP joints= interphalangeal joints; all 18 joints in the patient’s hands were examined;

Grip strength= maximum grip strength of the dominant hand

Table 2. Demographic and clinical characteristics of radiographic progressors and non- progressors at T2.

Variable Progressors*

(n=74)

Non-progressors*

(n=27) p-value

Demographic data

Sex (no. % female) 86.5 77.8 0.291

BMI (kg/m2) 26.2 ± 5.2 25.6 ± 3.4 0.456

Age at third assessment ( years) 70.3 ± 6.5 70.8 ± 6.6 0.785

PROMs

VAS 39.7 ± 26.8 31.3 ± 28.0 0.170

FIHOA total (range 0-30) 11.2 ± 6.3 5.6 ± 6.5 <0.001

AUSCAN pain (range 0-50) 18.1 ±10.7 13.9 ± 9.9 0.028

AUSCAN stiffness (range 0-10) 4.7 ± 2.8 4.5 ± 3.0 0.684

AUSCAN function (range 0-90) 43.3 ± 20.3 33.6 ± 24.3 0.017

AUSCAN total (range 0-150) 66.1 ± 31.3 51.9 ± 33.7

Clinical outcomes

Tender (total no. of tender IP joints; range 0-18) 2.8 ± 3.9 0.8 ± 1.6 0.002

Soft tissue swelling (total no. of swollen IP joints; range 0-18) 3.7 ± 3.1 3.5 ± 2.5 0.981

Grip strength (kg) 14.8 ± 7,8 18.3 ± 7.9 0.010

Radiographic outcomes

Total no. of progressive IP joints (range 0-18) 5.9 ± 3.01 0.3 ± 0.4 Values shown are mean ± standard deviation; except where indicated differently.

All p-values are tested two-tailed at a level of p< 0.05. All p-values lower than 0.05 in bold.

*Progressor defined as the presence of two or more joints with radiographic progression.

1 n=70 due to one or more joints which were not scorable (prostheses, amputation…).

VAS= Visual Analogue Scale; AUSCAN Osteoarthritis Hand Index= Australian Canadian Osteoarthritis Hand Index; FIHOA=

Functional Hand Index for Hand Osteoarthritis; IP joints= interphalangeal joints; all 18 joints in the patient’s hands were examined;

(18)

Grip strength= maximum grip strength of the dominant hand

(19)

Table 3. Univariate and multivariate logistic regression for radiographic progression after 10 years.

Baseline variable Univariate analysis Multivariate analysis*

Odds Ratio [95% Confidence Interval] p-value Odds Ratio [95% Confidence Interval] p-value

Sex (female vs. male) 1.33 [0.30; 5.83] 0.706 -

Disease duration (>5 years) 1.07 [0.95; 1.19] 0.257 -

BMI (kg/m2) 1.03 [0.94; 1.14] 0.511 -

Presence of soft tissue swelling (0/1) 8.20 [4.35; 4.10] 0.002 8.76 [3.22;18.64] 0.002

VAS pain (>33mm) 4.08 [1.25; 13.34] 0.002 4.30 [1.09; 9.99] 0.047

Presence of tenderness (0/1) 3.19 [1.69; 14.63] 0.013 0.53 [0.13; 2.16] 0.375

Total E joints 31.82 [0.00; 116.36] 0.006 30.02 [0.00; 108.37] 0.001

* included variables: presence of soft tissue swelling, presence of tenderness, VAS pain, total E joints baseline VAS= Visual Analogue Scale

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