Efficacy of a tight-control and treat-to-target strategy in axial spondyloarthritis: results of the open-label, pragmatic, cluster-randomised TICOSPA trial.

OBJECTIVES: To compare the benefits of a tight-control/treat-to-target strategy (TC/T2T) in axial spondyloarthritis (axSpA) with those of usual care (UC). METHODS: Pragmatic, prospective, cluster-randomised, controlled, open, 1-year trial (NCT03043846). 18 centres were randomised (1:1). Patients met Axial Spondylo Arthritis International Society (ASAS) criteria for axSpA, had an Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥2.1, received non-optimal treatment by non-steroidal anti-inflammatory drugs and were biologic-naive. INTERVENTIONS: (1) TC/T2T: visits every 4 weeks and prespecified strategy based on treatment intensification until achieving target (ie, ASDAS <2.1); (2) UC: visits every 12 weeks and treatment at the rheumatologist's discretion. MAIN OUTCOME: Percentage of patients with a ≥30% improvement on the ASAS-Health Index (ASAS-HI). Other efficacy outcomes and adverse events were recorded. A health economic evaluation was performed. STATISTICAL ANALYSIS: Two-level mixed models were used to estimate efficacy outcomes. Cost-effectiveness was assessed by the incremental cost per quality-adjusted life-year (QALY) gained for TC/T2T versus UC. RESULTS: 160 patients were included (80/group). Mean (SD) age was 37.9 (11.0) years and disease duration was 3.7 (6.2) years; 51.2% were men. ASDAS at inclusion was 3.0 (0.7), and ASAS-HI was 8.6 (3.7). ASAS-HI improved by ≥30% in 47.3% of the TC/T2T arm and in 36.1% of those receiving UC (non-significant). All secondary efficacy outcomes were more frequent in the TC/T2T arm, although not all statistically significant. Safety was similar in both arms. From a societal perspective, TC/T2T resulted in an additional 0.04 QALY, and saved €472 compared with UC. CONCLUSION: TC/T2T was not significantly superior to UC for the primary outcome, while many secondary efficacy outcomes favoured it, had a similar safety profile and was favourable from a societal health economic perspective. TRIAL REGISTRATION NUMBER: NCT03043846.

Social Role Participation and Satisfaction With Life: A Study Among Patients With Ankylosing Spondylitis and Population Controls.

OBJECTIVE: Participation in society of persons with chronic diseases receives increasing attention. However, little is known about which components of participation are most relevant to life satisfaction. This study examines the association between several aspects of social role participation and satisfaction with life (SWL) in patients with ankylosing spondylitis (AS) compared to population controls. METHODS: In a cross-sectional study, participants completed the Social Role Participation Questionnaire (SRPQ) and SWL scale. The SRPQ assesses several dimensions of participation (importance, satisfaction with performance, and satisfaction with time and physical difficulty) in 11 roles representing 3 domains (interpersonal relations, leisure, and work). For individuals with AS and controls, the association between role domains and SWL was examined using linear regression for each participation dimension separately, in the total and the employed population, adjusting for age, sex, education, and income. RESULTS: A total of 246 AS patients (mean ± SD age 51 ± 12 years, 62% males, mean ± SD disease duration 17 ± 12 years) and 510 controls (mean ± SD age 42 ± 15 years, 70% males) were included. AS patients were more frequently (extremely) dissatisfied with life (17.9% versus 8.6%; P < 0.05). In the total and the employed population, less physical difficulty and higher satisfaction with interpersonal relations and leisure were associated with higher SWL, and this was somewhat stronger in patients than in controls (P < 0.1). In employed controls, but not in employed patients, satisfaction with work was independently associated with SWL. CONCLUSION: These findings highlight the importance of supporting persons with AS in ameliorating social role participation, particularly in areas like close relationships and leisure activities, which are typically ignored when treating AS.

Incorporating assessment of the cervical facet joints in the modified Stoke ankylosing spondylitis spine score is of additional value in the evaluation of spinal radiographic outcome in ankylosing spondylitis.

BACKGROUND: To aim was to investigate the additional value of incorporating the de Vlam cervical facet joint score in the modified ankylosing spondylitis (AS) spine score (mSASSS) for the evaluation of spinal radiographic outcome in AS. METHOD: Baseline and 4-year radiographs from 98 consecutive patients from the Groningen Leeuwarden AS (GLAS) cohort, who had AS treated with TNF-α inhibitors, were scored by two readers; the vertebral bodies were assessed according to the mSASSS (0-72) and cervical facet joints (C2-C7) were assessed according to the method of de Vlam (0-15). The combined AS spine score (CASSS) was calculated as the sum of both total scores (range 0-87) and compared with the original mSASSS according to three aspects of the Outcome Measures in Rheumatology Clinical Trials (OMERACT) filter: feasibility, discrimination, and truth. RESULTS: Feasibility: the CASSS was calculated in 91% of the patients. No additional radiographs were necessary and the assessment took only a few extra minutes. Discrimination: both scoring methods had excellent inter-observer reliability (intra-class correlation coefficient (ICC) status scores >0.99, progression scores 0.92). Incorporating the cervical facet joints did not result in an increase in measurement error. The CASSS detected more patients with definite damage (61% vs. 57%) and definite progression (55% vs. 48%). Truth: higher CASSS scores at baseline and higher progression scores were seen in 41 (46%) and 22 (25%) patients, respectively. Cervical rotation correlated better with cervical CASSS than with cervical mSASSS (Spearman's rho = 0.68 vs. 0.59). CONCLUSIONS: The CASSS is a relevant and easy modification of the mSASSS. It captures more patients with AS who have spinal radiographic damage and progression, which is of great additional value in the evaluation of radiographic outcome in this heterogeneous and overall slowly progressing disease.

Development and Validation of a Short Form of the Social Role Participation Questionnaire in Patients with Ankylosing Spondylitis.

OBJECTIVE: The Social Role Participation Questionnaire (SRPQ) assesses the influence of health on 11 specific roles and 1 general role along 4 dimensions. In this study, a shortened version of the SRPQ (s-SRPQ) was developed in patients with ankylosing spondylitis (AS) to facilitate data collection in clinical studies and practice. METHODS: Using data from 246 patients with AS and population controls, the fit of each role to the different participation dimensions, the contribution of each role to the measurement precision, and the correlation between dimensions were evaluated using item response theory. Representation of the 3 participation chapters of the International Classification of Functioning, Disability, and Health was ensured. Reliability of each dimension of both versions of the SRPQ was compared by correlating scores to the Medical Outcomes Study Short Form-36 (SF-36) and the Satisfaction With Life Scale (SWLS), and by comparing ability to discriminate between patients and controls and between patients with low and high disease activity (Bath Ankylosing Spondylitis Disease Activity Index ≥ 4). RESULTS: The s-SRPQ, which assesses participation across 6 social roles along 2 dimensions (physical difficulty and satisfaction with performance), was proposed. Both dimensions of the s-SRPQ were highly reliable (r ≥ 0.86) and were shown to have construct validity as indicated by a similar pattern of correlations with the SF-36 and SWLS as the original SRPQ dimensions. Both versions discriminated well between patients and controls and between patients with high versus low disease activity (relative validity ≥ 0.72). CONCLUSION: The s-SRPQ retains the measurement properties of the original SRPQ and seems useful for measuring the effect of AS on participation.

Social Role Participation in Patients With Ankylosing Spondylitis: A Cross-Sectional Comparison With Population Controls.

OBJECTIVE: Participation in social roles for persons with chronic disease is important for their quality of life, but interpretation of the data on participation is difficult in the absence of a benchmark. This study aimed to compare social role participation in patients with ankylosing spondylitis (AS) to population controls using the Social Role Participation Questionnaire (SRPQ). METHODS: There were 246 AS patients and 510 population controls who completed the SRPQ, which assesses participation in 11 roles (with scores ranging 1-5) across 4 dimensions (importance, satisfaction with performance, satisfaction with time, and physical difficulty), and additionally ranked their 3 most important roles. The ranking of role importance, the SRPQ dimension scores, and the gap between importance and satisfaction with performance of roles were compared between patients and controls. RESULTS: Patients (62% male; mean ± SD age 51 ± 12 years) and controls (70% male; mean ± SD 42 ± 15 years) ranked intimate relationships, relationships with children/stepchildren/grandchildren, and employment as the most important roles. Compared to controls, patients gave higher scores on the SRPQ to importance (3.75 versus 3.43), but reported lower satisfaction with performance (3.19 versus 3.58) and greater physical difficulty (3.87 versus 4.67) (P ≤ 0.05 for all). The largest differences in gaps between importance and satisfaction with performance for patients compared to controls were seen in the physical leisure, hobbies, and traveling and vacation categories, in which patients assigned higher importance but reported especially low satisfaction. CONCLUSION: As society places increasing emphasis on individual responsibility to participate fully in social roles, the current data suggest that health care providers should pay more attention to participation restrictions experienced by patients with AS.

Assessment of fatigue in patients with ankylosing spondylitis: a psychometric analysis.

OBJECTIVES: To investigate whether the single-item fatigue question of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Multidimensional Fatigue Inventory (MFI) are appropriate instruments to measure fatigue in ankylosing spondylitis (AS); to identify factors that influence fatigue in AS; and to assess how fatigue in all its aspects is associated with quality of life in AS. METHODS: A total of 812 patients with AS were included. Patients completed questionnaires on disease activity (BASDAI), functional ability (Bath Ankylosing Spondylitis Functional Index [BASFI]), global well-being (Bath Ankylosing Spondylitis Global Score [BAS-G]), overall perceived health (EuroQoL visual analog scale), and quality of life (Ankylosing Spondylitis Quality of Life questionnaire, and Short Form 36 [SF-36]). Patients were dichotomized into a F+ group (fatigue = major symptom) if the BASDAI fatigue score was > 5.0 and a F- group (fatigue = minor symptom) if the fatigue score was < 5.0. Reproducibility was assessed with intraclass correlation coefficients, and responsiveness was calculated according to 3 different methods. Logistic regression analysis was used to determine which factors were associated with fatigue. Multiple regression analysis was used to investigate whether fatigue contributes in explaining quality of life. RESULTS: Fifty-three percent of the patients were assigned to the F+ group. They scored significantly worse compared with the F- group with respect to each dimension of the MFI and to all other questionnaires studied (all P < 0.001). The BASDAI fatigue question, as well as each separate dimension of the MFI, showed moderate to good reproducibility (0.57-0.75) and responsiveness (0.23-0.96). Fatigue was, in the opinion of the patients, highly associated with pain (70% of patients) and stiffness (54% of patients). Logistic regression analysis showed that scores on BASDAI, BASFI, BAS-G, and mental health status (SF-36) were independently associated with fatigue (R(2) = 0.52). Multiple regression analysis showed that scores on the BASDAI fatigue question were significantly associated with quality of life. With the 5 MFI dimensions as explanatory variables, different aspects of fatigue were associated with different domains of quality of life. CONCLUSIONS: Fatigue as a major symptom of AS can effectively be measured with either a single-item question on the intensity of fatigue or with the MFI. The MFI, however, provides more insight into specific dimensions of fatigue. Fatigue appears to be associated with the level of disease activity, functional ability, global well-being, and mental health status. In addition, fatigue negatively influences different aspects of quality of life.