Anterior uveitis in patients with spondyloarthritis treated with secukinumab or tumour necrosis factor inhibitors in routine care: does the choice of biological therapy matter?

BACKGROUND: The effect of interleukin 17-inhibitors on anterior uveitis (AU) in spondyloarthritis (SpA) is poorly understood. This study aimed to compare the risk of AU during treatment with secukinumab versus tumour necrosis factor inhibitors (TNFi). METHODS: Patients with SpA starting secukinumab or a TNFi 2015 through 2018 were identified in the Swedish Rheumatology Quality Register. Occurrence of AU was identified based on diagnosis codes in outpatient ophthalmology care in the National Patient Register. The main outcomes were crude rates of AU-diagnoses per 100 patient-years, and adjusted HRs for AU, during treatment, in patients without AU during the year before treatment start (in order to reduce confounding by indication). HRs were adjusted for age, sex, history of AU and patient global assessment of disease activity. RESULTS: Based on 4851 treatment starts (456 secukinumab; 4395 any TNFi), the rate of AU-diagnoses per 100 patient-years was 6.8 (95% CI 5.2 to 8.7) for secukinumab. Among the TNFi, the rate varied from 2.9 (95% CI 2.1 to 3.7) for infliximab and 4.0 (95% CI 3.3 to 4.9) for adalimumab to 7.5 (95% CI 6.7 to 8.4) for etanercept. The adjusted HRs for first AU (adalimumab as reference) were: secukinumab 2.32 (95% CI 1.16 to 4.63), infliximab 0.99 (95% CI 0.49 to 1.96), etanercept 1.82 (95% CI 1.13 to 2.93), golimumab 1.59 (95% CI 0.90 to 2.80) and certolizumab 1.12 (95% CI 0.44 to 2.83). Sensitivity analyses confirmed the pattern of higher AU rates with secukinumab and etanercept versus monoclonal TNFi. CONCLUSION: As used in clinical practice in SpA, secukinumab appears to be associated with a higher risk of AU, compared with the monoclonal TNFi and a similar risk compared with etanercept.

Comparative effectiveness of two adalimumab biosimilars in 1318 real-world patients with inflammatory rheumatic disease mandated to switch from originator adalimumab: nationwide observational study emulating a randomised clinical trial.

OBJECTIVES: In 2018, a nationwide mandatory switch from originator to biosimilar adalimumab was conducted in Denmark. The available biosimilar was GP2017 (Hyrimoz) in Eastern regions and SB5 (Imraldi) in Western regions. We aimed to assess the comparative effectiveness of GP2017 versus SB5 in patients with rheumatoid arthritis (RA)/psoriatic arthritis (PsA)/axial spondyloarthritis (AxSpA). METHODS: Observational cohort study based on the DANBIO registry with geographical cluster pseudo-randomisation, analysed by emulating a randomised clinical trial. Main outcome was adjusted 1-year treatment retention (Cox regression). Furthermore, 6 months' remission rates (logistic regression), reasons for withdrawal and back-switching to originator were investigated (overall and stratified by indication). RESULTS: Overall, of 1570 eligible patients, 1318 switched and were included (467 RA/321 PsA/530 AxSpA); 623 (47%) switched to GP2017, 695 (53%) to SB5. Baseline characteristics of the two clusters were largely similar, but some differences in registration practice were observed. The combined 1-year retention rate for the two biosimilars was 89.5%. Compared with SB5, estimated risk of withdrawal for GP2017 was lower (HR 0.60; 95% CI 0.42 to 0.86) and 6 months' remission rate was higher (OR 1.72; 95% CI 1.25 to 2.37). Stratified analyses gave similar results (statistically significant for RA). During 1 year, 8.5% and 12.9% withdrew GP2017 and SB5, respectively (primarily lack of effect and adverse events), of whom 48 patients (3.6%) back-switched. CONCLUSION: This head-to-head comparison of GP2017 versus SB5 following a mandatory switch from the originator indicated differences in effectiveness in routine care. This may reflect a true difference, but other explanations, for example, differences in excipients, differences between clusters and residual confounding cannot be ruled out.

Tumor Necrosis Factor Inhibitors Reduce Spinal Radiographic Progression in Patients With Radiographic Axial Spondyloarthritis: A Longitudinal Analysis From the Alberta Prospective Cohort.

OBJECTIVE: To investigate whether tumor necrosis factor inhibitors (TNFi) impact spinal radiographic progression in patients with axial spondyloarthritis (SpA) and whether this is coupled to their effect on inflammation. METHODS: Patients with axial SpA fulfilling the modified New York criteria were included in a prospective cohort (the ALBERTA Follow Up Research Cohort in Ankylosing Spondylitis Treatment). Spine radiographs, performed every 2 years for up to 10 years, were scored by 2 central readers, using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). The indirect effect of TNFi on mSASSS was evaluated with generalized estimating equations by testing the interaction between TNFi and Ankylosing Spondylitis Disease Activity Score (ASDAS) at the start of each 2-year interval (t). If significant, the association between ASDAS at t and mSASSS at the end of the interval (t+1) was assessed in 1) patients treated with TNFi at all visits, 2) patients treated with TNFi at some visits, and 3) patients who were never treated with TNFi. In addition, the association between TNFi at t and mSASSS at t+1 (adjusting for ASDAS at t) was also tested (direct effect). RESULTS: In total, 314 patients were included. A gradient was seen for the effect of ASDAS at t on mSASSS at t+1 (interaction P = 0.10), with a higher progression in patients never treated with TNFi (ß = 0.41 [95% confidence interval (95% CI) 0.13, 0.68]) compared to those continuously treated (ß = 0.16 [95% CI 0.00, 0.31]) (indirect effect). However, TNFi also directly slowed progression, as treated patients had on average an mSASSS 0.85 units lower at t+1 compared to untreated patients (ß = -0.85 [95% CI -1.35, -0.35]). CONCLUSION: Our findings indicate that TNFi reduce spinal radiographic progression in patients with radiographic axial SpA, which might be partially uncoupled from their effects on inflammation as measured by the ASDAS.

Association between comorbidities and disease activity in axial spondyloarthritis: results from the BSRBR-AS.

OBJECTIVE: Whether comorbidities influence disease activity assessment in axial SpA (axSpA) is unclear. Comorbidities inflate DAS28 in rheumatoid arthritis through the patient global score. We examined whether axSpA disease activity measures are differentially affected, and whether comorbidities inflate the AS disease activity score (ASDAS) through the patient global component. METHODS: We used baseline data from the British Society for Rheumatology Biologics Register for AS, including 14 physician diagnosed comorbidities. Linear models were used to compare disease activity (BASDAI, spinal pain, ASDAS) and ESR/CRP according to comorbidity count, adjusted for age, gender, BMI, smoking, socioeconomic status, and education. The same models were used to examine whether the patient global score was associated with comorbidities, additionally adjusting for other ASDAS components. RESULTS: The number of participants eligible for analysis was 2043 (67% male, mean age 49 years); 44% had at least one comorbidity. Each additional comorbidity was associated with higher BASDAI by 0.40 units (95% CI: 0.27, 0.52) and spinal pain by 0.53 (95% CI: 0.37, 0.68). Effect size for ASDAS (0.09 units; 95% CI: 0.03, 0.15) was not clinically significant. ESR and CRP were not associated with comorbidity count. Depression, heart failure and peptic ulcer were consistently associated with higher disease activity measures, but not CRP/ESR. Patient global was associated with comorbidity count, but not independently of other ASDAS components (P = 0.75). CONCLUSION: Comorbidities were associated with higher patient reported disease activity in axSpA. Clinicians should be mindful of the potential impact of comorbidities on patient reported outcome measures and consider additionally collecting ASDAS when comorbidities are present.

Impact of the COVID-19 pandemic on the disease course of patients with inflammatory rheumatic diseases: results from the Swiss Clinical Quality Management cohort.

OBJECTIVES: To investigate whether the transient reduction in rheumatology services imposed by virus containment measures during the COVID-19 pandemic was associated with disease worsening in axial spondyloarthritis (axSpA), rheumatoid arthritis (RA) or psoriatic arthritis (PsA). METHODS: Patient-reported disease activity assessed during face-to-face visits and/or via a smartphone application were compared between three periods of each 2 months duration (before, during and after the COVID-19-wave) from January to June 2020 in 666 patients with axSpA, RA and PsA in the Swiss Clinical Quality Management cohort. RESULTS: The number of consultations dropped by 52%, whereas the number of remote assessments increased by 129%. The proportion of patients with drug non-compliance slightly increased during the pandemic, the difference reaching statistical significance in axSpA (19.9% vs 13.2% before the pandemic, p=0.003). The proportion of patients with disease flares remained stable (<15%). There was no increase in mean values of the Bath Ankylosing Disease Activity Index, the Rheumatoid Arthritis Disease Activity Index-5 and the Patient Global Assessment in patients with axSpA, RA and PsA, respectively. CONCLUSION: A short interruption of in-person patient-rheumatologist interactions had no major detrimental impact on the disease course of axSpA, RA and PsA as assessed by patient-reported outcomes.

Axial involvement in patients with early peripheral spondyloarthritis: a prospective MRI study of sacroiliac joints and spine.

OBJECTIVES: To assess axial involvement on MRI in early peripheral spondyloarthritis (pSpA) and to evaluate whether axial inflammation predicts relapse on treatment withdrawal. METHODS: Fifty-six patients with early, active, newly diagnosed pSpA underwent MRI of the sacroiliac joints (SIJs) and spine prior to golimumab initiation. At sustained clinical remission of pSpA, treatment was withdrawn and a second MRI was performed. Bone marrow oedema (BME) was scored by three readers according to the Spondyloarthritis Research Consortium of Canada (SPARCC) method. Scores were compared with an axial spondyloarthritis cohort (Belgian Arthritis and Spondylitis cohort). Structural lesions were assessed using a similar method. Furthermore, fulfilment of the Assessment of Spondyloarthritis International Society (ASAS) definition of a positive MRI for sacroiliitis was assessed. Spinal images were evaluated for BME and structural lesions using the Canada-Denmark MRI spine scoring system by two readers. RESULTS: Thirty-six per cent showed SIJ BME at baseline, all fulfilling the ASAS definition of sacroiliitis. No association with back pain was found. Twenty-one per cent displayed SIJ structural lesions. Spinal BME was limited: the median inflammation scores were low and no patients had ≥5 inflammatory corner lesions. On clinical remission, a significant decrease in SIJ SPARCC scores was detected. On clinical remission, no significant differences in SIJ SPARCC scores were noted between patients relapsing and those maintaining remission after treatment discontinuation. CONCLUSION: In patients with early pSpA, a surprisingly high prevalence of sacroiliitis on MRI was observed; SPARCC scores decreased significantly on tumour necrosis factor inhibition. Residual inflammation on MRI was not predictive of relapse of peripheral manifestations. No relevant inflammatory spinal involvement was detected. Collectively, our findings suggest a higher inflammatory burden in patients with early pSpA than anticipated.

Is fibromyalgia frequency increasing in axial spondyloarthritis? Association with fibromyalgia and biological therapies.

Fibromyalgia (FM) is known a common painful syndrome and its frequency is increased in inflammatory rheumatic diseases. We aimed to assess FM frequency in axial spondyloarthritis (AxSpA) patients and age- and sex-matched healthy controls with the 2011 ACR FM criteria. We evaluated the association between receiving biologic disease-modifying antirheumatoid drugs (bDMARD) and presence of FM. 127 patients with Ax-SpA and 73 age- and sex-matched controls were included. Individuals were assessed according to modified 2011 ACR diagnostic criteria for FM. The pain was evaluated by visual analog scale (VAS). Disease activity was assessed by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activation Score (ASDAS). Spinal limitation, quality of life, and functionality were assessed. Drug therapies were noted. AxSpA and control group had similar FM rates. 43 (33.9%) patients in AxSpA group and 22 (30.1%) patients in control group had FM diagnosis (p = 0.589). Age, gender, BMI, and CRP values were similar in the AxSpA patients with and without FM, while global VAS and ASDAS scores were higher in patients with FM. Biologic DMARD use was higher in the AxSpA patients with FM; however, the difference was not statistically significant. In conclusion, FM frequency does not increase in AxSpA patients as compared to healthy controls. FM awareness is one of the key points to determine the appropriate treatment due to the influence on disease activity.

Quantifying and predicting the effect of anti-TNF therapy on axSpA-related fatigue: results from the BSRBR-AS registry and meta-analysis.

OBJECTIVES: Effective management of axial spondyloarthritis (axSpA)-related fatigue is a major unmet clinical need. Anti-TNF therapy may reduce fatigue levels, although any effect has yet to be definitively quantified and predictors of any such improvements are unknown. METHODS: The British Society of Rheumatology Register in Axial Spondyloarthritis (BSRBR-AS) prospectively recruited axSpA patients across the UK. Changes in fatigue levels (measured using the Chalder Fatigue Scale) >1 year were compared between those starting anti-TNF therapy at the time of recruitment and those not. Differences between treatment groups were adjusted using propensity score matching. Results were meta-analysed with the extant literature to calculate pooled estimates. Then, among those BSRBR-AS anti-TNF commencers with clinically relevant fatigue, baseline predictors of response were investigated. RESULTS: Of the 998 BSRBR-AS recruits with complete fatigue data, 310 were anti-TNF commencers. At 1-year follow-up, the former group reported a mean fatigue change of -2.6 (95% CI -4.1, -1.9) points while the latter reported a mean worsening of fatigue by 0.2 points. Following propensity score adjustment, those commencing anti-TNF therapy reduced fatigue by 3.0 points compared with those not. Of those with significant fatigue and commencing anti-TNF, poor sleep quality at baseline predicted fatigue improvement. In the meta-analysis, including 1109 subjects, treatment with anti-TNF therapy resulted in a significant improvement in fatigue [Standardized mean difference (SMD) = 0.36, 95% CI 0.15, 1.56]. CONCLUSION: Anti-TNF therapy results in a significant but modest reduction in fatigue amongst axSpA patients, with those reporting poor sleep quality most likely to report improvement. Effective management will likely require additional approaches.

Traditional Chinese medicine (TCM) collaborative care for patients with axial spondyloarthritis (AcuSpA): protocol for a pragmatic randomized controlled trial.

BACKGROUND: Axial spondyloarthritis (AxSpA) is a chronic disease which results in fatigue, pain, and reduced quality of life (QoL). Traditional Chinese medicine (TCM), especially acupuncture, has shown promise in managing pain. Although a TCM collaborative model of care (TCMCMC) has been studied in cancer, there are no randomized controlled trials investigating TCM in AxSpA. Therefore, we will conduct a pragmatic trial to determine the clinical effectiveness, safety, and cost-effectiveness of TCMCMC for patients with AxSpA. We define TCMCMC as standard TCM history taking and physical examination, acupuncture, and TCM non-pharmacological advice and communications with rheumatologists in addition to usual rheumatologic care. The purpose of this paper is to describe the rationale for and methodology of this trial. METHODS/DESIGN: This pragmatic randomized controlled trial will recruit 160 patients who are diagnosed with AxSpA and have inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs). Simple randomization to usual rheumatologic care or the intervention (TCMCMC) with a 1:1 allocation ratio will be used. Ten 30-min acupuncture sessions will be provided to patients assigned to the TCMCMC arm. All participants will continue to receive usual rheumatologic care. The primary endpoint - spinal pain - will be evaluated at week 6. Secondary endpoints include clinical, quality of life, and economic outcome measures. Patients will be followed up for up to 52 weeks, and adverse events will be documented. DISCUSSION: This trial may provide evidence regarding the clinical effectiveness, safety, and cost-effectiveness of a TCMCMC for patients with AxSpA. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03420404 . Registered on 14 February 2018.

Enthesitis detection by ultrasound: where are we now?

Over the last 25 years, ultrasound has been used to evaluate involvement at the entheses in spondyloarthritis (SpA) and psoriatic arthritis (PsA). Several studies have been reported indicating its value in detecting active inflammation at entheseal sites using both gray scale and Doppler findings. This review explores the recent literature and appraises the current knowledge and the unmet needs of enthesitis detection by ultrasound in the management of both SpA and PsA.

[Asociación de la composición corporal total con la fuerza del tronco, el dolor y la discapacidad en pacientes con espondiloartrosis lumbar]. / The association of total body composition with trunk strength, pain and disability in patients with lumbar osteoarthritis.

INTRODUCCIÓN: Las alteraciones en la composición corporal total podrían influir sobre la fuerza, el dolor y la discapacidad en pacientes con espondiloartrosis lumbar. OBJETIVO: Analizar la asociación de la composición corporal total con la fuerza muscular del tronco, el dolor y la discapacidad en pacientes con espondiloartrosis lumbar. MÉTODO: Estudio piloto en mayores de 50 años con dolor crónico de espalda baja y espondiloartrosis lumbar. Se excluyeron pacientes con diabetes mellitus, depresión, ansiedad, artropatías inflamatorias, fracturas vertebrales, escoliosis, cirugías de columna, cardiopatías, hipertensión arterial, radiculopatía o claudicación neurogénica. Se recolectaron datos sobre tiempo de evolución, composición corporal (masa grasa y muscular total), fuerza del tronco (isocinesia), dolor (escala numérica verbal) y discapacidad (Roland Morris). Análisis estadístico con U de Mann-Whitney y correlaciones de Spearman. RESULTADOS: 27 pacientes (18 mujeres y 9 hombres) con edad de 58.59 ± 6.98 años. La masa muscular total se asoció con el dolor (rho: -0.63, p = 0.001) y con la fuerza del tronco (flexores rho: -0.42, p = 0.02; extensores rho: -0.50, p = 0.007), sin correlación con la discapacidad. No se encontró correlación de la masa grasa con ninguna de las variables. CONCLUSIÓN: La disminución de la masa muscular se asocia con el dolor, pero no con la discapacidad, en pacientes con espondiloartrosis lumbar. BACKGROUND: Variations in body composition among patients with lumbar osteoarthritis may influence pain and disability and muscle strength. OBJECTIVE: To analyze the relationship between body composition with pain, disability and muscle strength, in patients with lumbar osteoarthritis. METHODS: Pilot study in patients older than 50 years of age, with chronic low back pain and lumbar osteoarthritis, who agreed to participate through informed consent. We excluded patients with diabetes mellitus, depression, anxiety, inflammatory arthropathies, vertebral fractures, idiopathic scoliosis, spinal surgery, heart disease or hypertension, radiculopathy or neurogenic claudication. Data on evolution time, body composition (total body fat and muscle mass), trunk strength, pain (numerical rating scale), and disability (Roland Morris questionnaire) were collected. Mann-Whitney U-test and Spearman correlations were performed. RESULTS: 27 patients (18 women and 9 men) aged 58.59 ± 6.98 years. Negative correlations between muscle mass with pain (rho: −0.63, p = 0.001) and strength (flexors rho: −0.42, p = 0.02; extensors rho: −0.50, p = 0.007) were found, without correlation with disability. No correlations of fat mass with pain or disability were found. CONCLUSION: Decreased of muscle mass were associated with higher pain scores without influencing the disability in patients with lumbar osteoarthritis..

Shifting the focus - the primary role of IL-23 in psoriasis and other inflammatory disorders.

Insights into the pathophysiology of autoimmune inflammatory diseases including psoriasis have advanced considerably in recent years, and in parallel, so too have the available treatment options. Current clinical paradigms for the treatment of psoriasis have evolved to include targeted biologic therapies, starting with tumour necrosis factor-alpha (TNF-α) inhibitors and later, agents targeting interleukin (IL)-12/23 and IL-17. The most recent evidence suggests that IL-23 might be an even more potent target for the effective treatment of psoriasis and other autoimmune inflammatory disorders. This review will describe recent developments leading to the current understanding of the key role of IL-23 as a 'master regulator' of autoimmune inflammation and the clinical evidence for agents that specifically target this modulator in the context of treating psoriasis, spondyloarthropathy and inflammatory bowel disease.

The problem in differentiation between psoriatic-related polyenthesitis and fibromyalgia.

The recognition of the primacy of enthesitis in animal models of spondyloarthritis and the prevalence of clinically occult enthesopathy in psoriatic subjects and of persistent joint pain in PsA subjects who have ostensibly good reduction of joint swelling under biological therapy has highlighted the potential impact of polyenthesitis in psoriatic disease. In daily practice, the formal demonstration of enthesitis is challenging for the following reasons: the relatively avascular nature of enthesis, often leading to the absence of overt clinical inflammatory signs; the frequent lack of elevation of inflammatory markers; and finally, the limitations of current imaging techniques to provide supportive evidence for inflammation in these areas. Consequently, enthesitis may present as widespread pain indistinguishable from FM or may emerge as the dominant feature after successful biological therapy for suppression of synovitis. The unmet needs in the differentiation between FM and enthesitis in psoriatic disease patients are highlighted and critically evaluated in this article.

Co-Occurrence and Characteristics of Patients With Axial Spondyloarthritis Who Meet Criteria for Fibromyalgia: Results From a UK National Register.

OBJECTIVE: To estimate the proportion of patients with axial spondyloarthritis (SpA) in a UK national biologics registry who met criteria for fibromyalgia (FM), and to delineate the characteristics of these patients. METHODS: Two cohorts of patients are prospectively recruited from across 83 centers in the UK for the British Society for Rheumatology Biologics Register in Ankylosing Spondylitis (BSRBR-AS). All patients are required to meet Assessment of SpondyloArthritis international Society (ASAS) criteria for axial SpA. Patients are either newly starting biologic therapy (biologics cohort) or are naive to treatment with biologic agents (non-biologics cohort) at the time of recruitment, and all patients are followed up prospectively. At recruitment and follow-up, clinical information and measurements are recorded while patients complete the 2011 research criteria for FM and assessments of the level of disease activity and work impact. RESULTS: Of the patients registered in the BSRBR-AS, 1,504 (68% male) were eligible for the current analysis, of whom 311 (20.7%) met the 2011 research criteria for FM. Prevalence of FM was similar between patients who fulfilled the modified New York criteria for AS (19.7%) and those who fulfilled ASAS imaging criteria but not the modified New York criteria (25.2%); however, among those who fulfilled only the ASAS clinical criteria, the prevalence of FM was lower (9.5%). Patients who met FM criteria reported significantly worse disease activity, function, global severity scores, and quality of life, and were more likely to have moderate or severe levels of mood disorder and clinically important fatigue. Patients who met FM criteria reported experiencing work impairment around half their working time. Meeting FM criteria was not related to elevated C-reactive protein levels or most extraspinal manifestations, but was associated with a higher likelihood of having received biologic therapy. CONCLUSION: Developing management approaches that would address the significant unmet clinical needs of the 1 in 5 patients with axial SpA who meet criteria for FM should be a research priority.

Mechanisms, impact and prevention of pathological bone regeneration in spondyloarthritis.

PURPOSE OF REVIEW: To discuss different aspects of new bone formation in patients with spondyloarthritis based on emerging data from clinical trials, prospective cohort studies and translational laboratory investigations. RECENT FINDINGS: New bone formation potentially leading to ankylosis of the spine and sacroiliac joints remains an important concern for patients with axial spondyloarthritis. New therapeutic strategies, in particular targeting of interleukin-17, have emerged in addition to the antitumor necrosis factor drugs, but we still fail to fully understand the mechanisms of structural disease progression. A new paradigm is developing in which sustained and effective suppression of inflammation likely inhibits this structural disease progression. Biomechanical factors, in particular changes in bone microarchitecture in the vertebrae, and the need for core stability could provide a new framework to understand the relationship between bone remodeling and inflammation and to develop long-term strategies. SUMMARY: New bone formation leading to ankylosis remains a hallmark of axial spondyloarthritis and should be further investigated. The clinical data that progressively become available support the concept that effective and sustained therapy will be beneficial for the patients not only in short-term, but also in long-term outcomes.

Exploring the relationship between demographic and disease-related variables and perceived effect of health status on sexual activity in patients with axial spondyloarthritis: associations found only with non-disease variables.

OBJECTIVE: To explore the relationship between demographic and disease-related variables and the perceived effect of health status on sexual activity in patients with axial spondyloarthritis (ax-SpA). METHOD: The study assessed 379 ax-SpA patients consecutively recruited from two rheumatology outpatient clinics. Data collection included information on demographics, markers and measures of ax-SpA disease, treatment, comorbidity, and health-related quality of life (HRQoL) using the Short Form-36. The perceived effect of health status on sexual activity was assessed using question 15 in the HRQoL instrument 15D. RESULTS: The mean age of the patients was 45.6 years, 66.5% were men, 87.3% were human leucocyte antigen-B27 positive, and mean disease duration was 13.9 years. A total of 312 patients (82.3%) reported their health status to have no/little effect and 17.7% patients reported their health status to have a large negative effect on their sexual activity. In univariate analysis, increased body mass index (BMI), smoking, alcohol consumption, unemployed status, low physical activity, comorbidities, and higher disease activity (Bath Ankylosing Spondylitis Questionnaire), impaired body movement and lower HRQoL were associated with a large effect on sexual activity. In adjusted analyses, only female gender, high BMI, current smoking, and low HRQoL showed significant associations. CONCLUSION: Approximately 20% of ax-SpA patients reported a large negative effect on their sexual activity. Female gender, high BMI, current smoking, and reduced HRQoL were associated with health status having a large effect on sexual activity, whereas no measures reflecting ax-SpA disease showed an independent association.

Evaluation of whether extremely high enthesitis or Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores suggest fibromyalgia and confound the anti-TNF response in early non-radiographic axial spondyloarthritis.

OBJECTIVES: Differentiating between pain from spondyloarthritis (SpA) and pain from fibromyalgia is challenging. We evaluated patients with non-radiographic axial SpA (nr-axSpA) to determine the percentage of patients with extremely high enthesitis and/or Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores, the relationship between extreme scores and depression, and the effect of extreme scores on treatment outcomes with etanercept. METHODS: Patients with nr-axSpA received double-blind etanercept 50 mg or placebo weekly and were divided into those who did vs did not have extreme scores at baseline. Extreme scores were defined as the highest quintile for enthesitis score (≥6), and/or scores ≥8 on three of five BASDAI items (excluding morning stiffness duration). Depression was assessed with the Hospital Anxiety and Depression Scale, depression subscale (HADS-D) and medication use. Week 12 outcomes included Assessment of SpondyloArthritis (ASAS) 40 and ASAS partial remission. RESULTS: At baseline, 35/213 (16.4%) patients met extreme enthesitis criteria, 31 (14.6%) met extreme BASDAI criteria, 12 (5.6%) met both, and 135 (63.4%) met neither. More patients with extreme scores than without met the HADS-D definition of depression: 35/68 (51.5%) vs. 27/118 (22.9%), p<0.0001. For patients with vs. without extreme scores who received etanercept, no significant difference existed in week 12 ASAS 40: 13/41 (31.7%) vs. 21/60 (35.0%), respectively, or ASAS partial remission: 8/41 (19.5%) vs. 19/60 (31.7%). CONCLUSIONS: Extreme enthesitis and/or BASDAI scores were associated with measurements of depression, but did not affect week 12 ASAS 40 or ASAS partial remission.

Fatigue contributes to work productivity impairment in patients with axial spondyloarthritis: a cross-sectional UK study.

OBJECTIVES: To determine factors associated with absenteeism, presenteeism, work productivity loss (WPL), and daily activity impairment in UK patients with AxSpA using standardised measures. METHODS: 490 patients with AxSpA completed (1) Work Productivity and Impairment questionnaire (WPAI), providing measures for absenteeism, presenteeism, WPL and daily activity impairment, and (2) BASDAI, BASFI, BASMI, Jenkins Sleep scale, Patient Global Assessment disease activity (PGA), back pain night and anytime, EQ-5D for mobility, self-care, daily activities, pain/discomfort, anxiety/depression, EQ-VAS Health State Today, FACIT fatigue, for health-related disease factors. Multivariate linear and logistic regression determined associations between WPAI measures and health-related factors. RESULTS: 301(61%) patients provided WPAI measurements, 76% were male, 87% HLA-B27+. Mean (SD) WPAI scores for absenteeism were 5.1%(19.2), presenteeism 22%(24.3), WPL 23.2%(25.7), activity impairment 34.8%(27.3). Absenteeism was associated with higher fatigue levels and more likely in patients with nrAxSpA. Presenteeism and WPL were both associated higher fatigue levels, BASDAI, and BASFI respectively. Daily activity impairment was associated with higher fatigue levels, BASFI, PGA, EQ-VAS, and smoking. CONCLUSIONS: Work productivity and impairment are associated with fatigue, disease activity, and functional ability in UK patients with AxSpA. The strong association of fatigue with all work measures as well as with daily activity impairment emphasises the need to better understand the impact of fatigue on patients' quality of life. Improving fatigue may help to optimise work status.