Impact of the time of initiation and line of biologic therapy on the retention rate of secukinumab in axial spondyloarthritis (axSpA): data from the French multicentre retrospective FORSYA study.

OBJECTIVE: To compare the 1-year retention rate of secukinumab in axial spondyloarthritis (axSpA) and its predisposing factors with regard to its time of initiation (eg, right after or remotely from its launch). METHODS: Study design: Retrospective multicentre French study of patients with axSpA. Study periods: Two cohorts were evaluated regarding the time of initiation of secukinumab: cohort 1 (C1)-between 16 August 2016 and 31 August 2018-and cohort 2 (C2)-between 1 September 2018 and 13 November 2020. STATISTICAL ANALYSIS: The 1-year retention rate of secukinumab was estimated using the Kaplan-Meier method, and the log-rank test was used to compare the retention curves of the two cohorts. Preselected factors (eg, disease characterristics, line and time of secukinumab initiation) of secukinumab retention at 1 year were analysed by univariate and multivariate Cox model regression. RESULTS: In total, 906 patients in C1 and 758 in C2 from 50 centres were included in the analysis. The 1-year retention rate was better in C2 (64% (61%-68%)) vs C1 (59% (55%-62%)) (HR=1.19 (1.02-1.39); p=0.0297). In the multivariate analysis, the line of biologic therapy was the single predictive factor of the 1-year retention rate of secukinumab picked up in both cohorts, with a better retention rate when prescribed as first-line biologic therapy. CONCLUSION: The better secukinumab retention rate remotely from its launch is explained by its use at an earlier stage of the disease, suggesting a change in the behaviour of prescribing physicians. Our results emphasise the relevance of iterative evaluations of routine care treatments.

Patients with radiographic axial spondylarthritis have an impaired dietary intake-a cross-sectional study with matched controls from northern Sweden.

BACKGROUND: Radiographic axial spondyloarthritis (r-axSpA) is one of the most common chronic inflammatory rheumatic diseases, affecting about 0.2% of the Swedish population. Adequate nutritional intake is essential for maintaining physiological functions. A poor diet increases the risk of developing conditions such as obesity, osteoporosis, and/or atherosclerosis. Diet quality is also theorized to affect systemic inflammation. Dietary habits in patients with r-axSpA are largely unknown. The aims of this study were to assess dietary nutrient intake in r-axSpA patients and examine whether it differs compared to persons without r-axSpA. METHODS: r-axSpA patients (modified NY criteria) at the rheumatology clinic in Region Västerbotten, northern Sweden, were invited to take part in the Backbone study which investigates disease severity and comorbidities. In total, 155 patients were included. Nutritional intake was assessed by the semi-quantitative food frequency questionnaire MiniMeal-Q. Controls were collected from the Swedish CArdioPulmonary bioImage Study (n = 30,154), a study that invited participants 50-64 years of age by random selection from the Swedish population register. Out of the 155 r-axSpA patients, 81 were in the same age span. Four controls were identified for each patient, matched on age (± 1 year), sex, and geographic location. Data on dietary intake was available for 319 controls. Statistical comparisons of dietary intake between patients with r-axSpA and controls were done by exact conditional logistic regression analysis, adjusted for country of birth, educational level, single household, weight, smoking status, and energy intake. RESULTS: Patients had a comparatively significantly higher energy intake from carbohydrates, a lower fiber density, and a lower intake of marine omega-3 fatty acids. Furthermore, intake of vitamins D, E, and K as well as selenium, folate, calcium, magnesium, phosphorus, potassium, vitamin A, and ß-carotene (a precursor of vitamin A and marker of vegetable and fruit intake) was significantly lower among patients compared to controls. CONCLUSIONS: Our results suggest that r-axSpA patients have an impaired dietary intake. Notably, intake was lower in several nutrients theorized to have anti-inflammatory properties (fiber density, marine-omega-3 fatty acids, vitamin D, and selenium). We further propose that nutrition screening might be incorporated into the management of r-axSpA patients.

Physical therapy in patients with rheumatoid arthritis and axial spondyloarthritis: the patients' perspective.

OBJECTIVE: To assess the duration, frequency, and content of individual physical therapy (PT) in patients with rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA). METHOD: In this cross-sectional study, an electronic questionnaire aimed at people with RA and axSpA was distributed through various communication channels of the Dutch Arthritis Foundation. It comprised questions on sociodemographic and health characteristics, received PT (currently and/or in the past year) and, if applicable, its duration, frequency, and content (active exercises, manual treatment, physical modalities, and/or counselling/education). RESULTS: The study included 257 and 94 patients with self-reported diagnoses of RA and axSpA, of whom 163 (63%) and 77 (82%) currently or had recently received individual PT. The duration of individual PT was long-term (> 3 months) in 79% of RA and 83% of axSpA patients, with an average frequency of once per week in most. Although active exercises and counselling/education were each reported by ≥ 73% of the patients with RA and axSpA who received long-term individual PT, passive treatment modalities were also often offered (≥ 89%), in particular massage, kinesiotaping, and/or passive mobilization. The same pattern was seen in patients receiving short-term PT. CONCLUSION: The majority of patients with RA and axSpA received PT currently or in the past year, usually individually, long-term, and at a frequency of once a week. Although active exercises and education are recommended in guidelines, passive treatment options that are not advised were relatively often reported. An implementation study to identify barriers and facilitators regarding adherence to clinical practice guidelines seems warranted.

Sleep behaviour differs in women and men with psoriatic arthritis and axial spondyloarthritis with impact on quality of life and depressive symptoms.

OBJECTIVES: Axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) may have a profound impact on sleep and health-related quality of life. The aim of this study was to assess sleep quality and quality of life and determine associated factors in patients treated with spondyloarthritides (SpA). METHODS: Cross-sectional questionnaire-based assessment of sleep behaviour, quality of life, functional impairment and depression (Regensburg Insomnia Scale, WHO Quality of Life questionnaire, Funktionsfragebogen Hannover questionnaire, Beck Depression Inventory II, Patient health questionnaire 9) and retrospective medical chart analysis of a monocentric cohort of 330 patients with SpA (n=168 PsA and n=162 axSpA). RESULTS: 46.6% of patients with SpA demonstrated abnormal sleep behaviour. Linear regression models showed HLA-B27 positivity, Bath Ankylosing Spondylitis Disease Activity Index, depressive symptoms, functional capacity and disease duration to be predictive of insomnia symptoms in axSpA, respectively, depressive symptoms, female sex and Disease Activity Score 28 in patients with PsA. Patients with unrestful sleep had a significantly reduced health-related quality of life (p<0.001) as well as significantly more depressive symptoms (p<0.001). Satisfaction with health was rated significantly lower (p<0.001), indicating poor sleep as a burden on general well-being.In particular, female patients had a significantly worse sleep quality with a prolonged sleep latency (p=0.009), increased sleep disturbances (p=0.014) and unrestful sleep (p<0.001) as well as a reduced physical and mental health-related quality of life (p=0.015, p<0.001) and more depressive symptoms (p=0.015). CONCLUSION: Despite treatment, many patients with SpA demonstrate abnormal sleep behaviour with symptoms of insomnia and a reduced quality of life with significant differences between male and female patients. An interdisciplinary and holistic approach may be needed to address unmet needs.

Effects of synbiotic supplementation on regulatory T cells' response in patients with axial spondyloarthritis: a randomized double-masked placebo-controlled trial.

This study was conducted on samples from patients enrolled in a randomized double-masked placebo-controlled trial on the effect of synbiotic supplementation on the IL-17/IL-23 pathway and disease activity in patients with axial spondyloarthritis (axSpA) to investigate the effects of synbiotic supplementation on regulatory T (Treg) cells' response in these patients. Forty-eight axSpA patients were randomized to take one synbiotic capsule or placebo daily for 12 weeks. Treg cell proportion, gene expression of forkhead box protein P3 (Foxp3), microRNA (miRNA)-25, miRNA-106b, miRNA-146a, interleukin (IL)-10, and transforming growth factor (TGF)-ß as well as serum IL-10 and TGF-ß levels were assessed before and after the trial. Thirty-eight patients (19 in each group) completed the trial. The proportion of Treg cells (P < 0.001), the gene expression of FoxP3 (P < 0.001), IL-10 (P = 0.001), TGF-ß (P < 0.001), and miRNA-146a (P < 0.001) and serum IL-10 (P = 0.003) and TGF-ß (P = 0.002) levels significantly increased compared to the baseline in the synbiotic group. Additionally, a significant reduction in the gene expression of miRNA-25 (P < 0.001) and miRNA-106b (P < 0.001) was observed in the synbiotic group. Significant between-group differences were observed in the proportion of Treg cells (P = 0.024) and the gene expression of FoxP3 (P = 0.010), IL-10 (P = 0.002), TGF-ß (P = 0.016), miRNA-25 (P = 0.008), miRNA-106b (P = 0.001), and miRNA-146a (P = 0.010). Differences in the serum levels of IL-10 and TGF-ß between the groups were not significant. As a conclusion, synbiotic supplementation could modulate Treg cells' response in axSpA patients and thus can be promising as an adjunctive therapy. Additional investigations would help in further clarifying the subject.

Tapering biologics in axial spondyloarthritis: A systematic literature review.

INTRODUCTION: The emergence of biologics has improved the management of patients with rheumatic disease, mainly with spondyloarthritis (SpA). Sustained remission has become a reachable goal thanks to the treat to target strategy. Contrary to rheumatoid arthritis, data on biologic optimization among SpA patients in remission is scarce and still a subject of debate. The main objective of this systematic review was to provide the most up-to-date published literature regarding biologic tapering in axial spondyloarthritis. METHODS: This systematic review followed the preferred reporting items for systematic reviews guidelines. Original articles from Pubmed and Scopus, published until December 20th 2021, and tackling tapering strategies of the biologics in patients with axial SpA were included RESULTS: Fourteen studies met the inclusion criteria. They were published between 2008 and 2020. The most studied molecules were Etanercept (ETN) (n = 13), Infliximab (IFX) (n = 6), Adalimumab (ADA) (n = 5), certolizumab pegol (CZP) (n = 2), Golimumab (n = 1) and ETN biosimilar. There are no studies published regarding anti-IL 17 tapering strategy. Patient-tailored dose reduction of anti TNF-α agents was successful in preserving stable low disease activity in most of the studies with remission rates ranging between 20.2 % and 93.7 %. Complete treatment discontinuation is associated with a high risk of flares. CONCLUSION: To conclude, published data indicate that a progressive tapering strategy for anti TNF-α therapy is successful among axial SpA in sustained remission. However, further studies with more homogenized tapering strategies are needed in order to ascertain the specific implication of each subset for a better holistic approach.

Achievement rate and predictive factors of the recommended therapeutical target in patients with axial spondyloarthritis who remain on biological therapy: a prospective cohort study in Spain.

OBJECTIVES: To determine the frequency of sustained remission (R) or low diseas activity (LDA) in patients with axial spondyloarthritis (axSpA) undergoing long-term biological therapy and to analyse predictive factors for achieving these outcomes. DESIGN: Prospective, observational cohort study. SETTING: Spanish hospital. PARTICIPANTS: Patients with axSpA who initiated biological treatment between 2003 and 2017. INTERVENTION: Assessment of demographic and clinical characteristics at the beginning of treatment and disease activity every 6 months up to a maximum of 2 years. MAIN OUTCOME MEASURES: Disease activity was measured by Ankylosing Spondylitis Disease Activity Score (ASDAS) and Bath Ankylosing Spondylitis Disease Activity Index and C reactive protein (BASDAI&CRP). Sustained R was defined as ASDAS<1.3 and/or BASDAI <2 and normal CRP while sustained LDA was defined as ASDAS <2.1 and/or BASDAI <4 and normal CRP on at least three consecutive visits. RESULTS: In total 186 patients (66.1% men and 75.3% with radiographic sacroiliitis) were included. Overall, 76.8% of patients achieved ASDAS R/LDA (R53.2%/LDA23.6%) in at least one visit. Forty per cent (R17.6%/LDA22.4%) of the patients fulfilled the sustained ASDAS R/LDA state, whereas only 30.8% maintained this status (R14.8%/LDA15.9%) according to BASDAI&CRP. In the multivariate analysis, male sex (OR=4.01), younger age at the beginning of biological therapy (OR=0.96) and an HLA*B27 positive status (OR=4.30) were associated with achieving sustained ASDAS R/LDA. CONCLUSIONS: In clinical practice, around one-third of patients on biological disease-modifying antirheumatic drugs achieve a sustained R/LDA status, but these rates drop to less than one in five when targeting remission, preventing the use of the latter as a feasible target. Male sex, HLA*B27 positivity and younger age at the beginning of biological therapy are the main predictors for achieving sustained R/LDA.

Similarities and differences between non-radiographic and radiographic axial spondyloarthritis: The patient perspective from the Spanish atlas.

AIM: Although non-radiographic axial spondyloarthritis (EspAax-nr) is well understood within health institutions, being considered along with radiographic EspAax (EspAax-r) as part of the same disease spectrum, patient understanding is unknown. The aim is to describe the patient's knowledge of the EspAax-nr entity. METHODS: Atlas 2017, promoted by the Spanish Federation of Spondylarthritis Associations (CEADE), aims to comprehensively understand the reality of EspAax patients from a holistic approach. A cross-sectional on-line survey of unselected patients with self-reported EspAax diagnosis from Spain was conducted. Participants were asked to report their diagnosis. Socio-demographic, disease characteristics and patient-reported outcomes (PROs) were compared between those patients self-reporting as EspAax-nr and EspAax-r. RESULTS: 634 EspAax patients participated. Mean age 45.7±10.9 years, 50.9% female and 36.1% university-educated. 35 (5.2%) self-reported as EspAax-nr. Compared to EspAax-r patients, those with EspAax-nr were more frequently women (48.6% vs 91.4%, p<0.001), had longer diagnostic delay (10.1±8.9 vs 8.5±7.6 years), higher psychological distress (GHQ-12: 7.5±4.9 vs 5.6±4.4) and similar degree of disease activity (BASDAI: 5.7±2.1 vs 5.7±2.0), and unemployment rates (20.0% vs 21.6%). 20.0% of EspAax-nr received biologics vs 36.9% of EspAax-r, p=0.043. Visits to the rheumatologist in the past year were similar in both groups (3.8±4.5 vs 3.2±3.8), while GP visits were much higher within EspAax-nr (8.0±10.7 vs 4.9±13.3 p=0.003). CONCLUSION: For the first time, EspAax-nr characteristics and PROs have been analyzed from the patient's perspective. Both groups reported similar trends with the exception of EspAax-nr being more frequently women, younger, having longer diagnostic delay and lower use of biologic therapy.

Treatment of back pain in active axial spondyloarthritis with serial locoregional water-filtered infrared A radiation: A randomized controlled trial.

BACKGROUND: Axial spondyloarthritis (axSpA) is an inflammatory rheumatic disease primarily affecting the axial skeleton. OBJECTIVE: To evaluate the short-term effects of locoregional water-filtered infrared A radiation (sl-wIRAR) in the treatment of lower back pain in patients with axSpA. METHODS: Patients with active axSpA with non-steroidal anti-inflammatory drug (NSAID) therapy undergoing a 7-day multimodal rheumatologic complex treatment in an in-patient setting were eligible. Patients were randomly assigned to the intervention group (IG) receiving sl-wIRAR treatment of the back (2 treatments/day for 30 min each for 6 days) or to the control group (CG) receiving no treatment. Primary outcome was a between-group difference in pain after sl-wIRAR therapy measured on a numeric rating scale (NRS) (0 = no pain, 10 = worst pain). Secondary outcomes included an assessment of i) the onset and development of analgesic effects and an evaluation of whether sl-wIRAR ii) improved axSpA-specific well-being and iii) influenced serum cytokine levels. RESULTS: Seventy-one patients were enrolled, completed the trial and were analyzed (IG: 36 patients, CG: 35 patients). In the IG, there was a statistically significant change (p< 0.0005) in pain level [NRS] (1.6 ± 1.9 [5; 2]) from baseline (4.1 ± 2.4 [0; 8]) to trial completion (2.6 ± 2.0 [0; 7]) and a significant difference to the CG (p= 0.006). In the IG there was a significant improvement in axSpA-specific well-being (BAS-G) (p= 0.006). A physiologically relevant change in serum cytokine levels could not be observed. CONCLUSION: sl-wIRAR treatment can be useful in the treatment of patients with active axSpA as it leads to a rapid reduction of pain.

Axial Spondyloarthritis in the Chiropractic Care Setting: A Systematic Literature Review.

ABSTRACT: Diagnosis of axial spondyloarthritis (axSpA), an immune-mediated inflammatory disease, is commonly associated with chronic inflammatory back pain (IBP) and often occurs years after initial onset of clinical symptoms. Recognition of IBP is important for timely referral of patients with suspected axSpA to a rheumatologist. Patients with all types of back pain are treated in chiropractic care, but the proportion of patients with undiagnosed axSpA is unknown. This systematic literature review investigated the presence of axSpA in patients treated by chiropractors and identified the chiropractor's role in axSpA diagnosis, referral, and management. A PubMed search was conducted using the following search strings: "chiropract*" AND ("sacroiliac" OR "back pain" OR "spondyloarthritis" OR "ankylosing spondylitis"); English language, since 2009; and (chiropractic OR chiropractor) AND (ankylosing spondylitis OR axial spondyloarthritis), with no date limits. Of 652 articles identified in the searches, 27 met the inclusion criteria. Although back pain was identified as a common reason for patients seeking chiropractic care, there was no mention of axSpA, ankylosing spondylitis, or the distinction between mechanical and IBP. Data from relevant articles suggested that the majority of patients seeking chiropractic care have lower back pain, whereas no articles reported axSpA in this patient population. The near absence of any identified articles on axSpA in chiropractic care may be due to underrecognition of axSpA, resulting in delayed rheumatology referral and appropriate management. Better awareness and increased use of validated screening tools could reduce diagnostic delay of axSpA in chiropractic care.

Disease activity outcome measures are only available in half of the electronic medical files of patients with axial spondyloarthritis followed in an outpatient clinic: the results of an audit of a tertiary-care rheumatology department.

Current recommendations for management of patients with axial spondyloarthritis (axSpA) include regular collection of validated disease activity outcomes. This study aimed at evaluating the proportion of patients for whom validated outcome measures were available on their electronic medical reports (EMR), and the factors associated with the presence of such information on the EMR. We performed a cross-sectional monocentric observational study, including patients with an axSpA diagnosis who attended an outpatient visit between February, 2018 and February, 2019. Patients (demographics, disease characteristics, treatment) and physician characteristics (age, gender) and the disease activity outcome measures (BASDAI, CRP and ASDAS, and the items allowing to calculate them) were retrieved from the EMR. The proportion of patients in which disease activity outcome measures were available in the EMR was calculated, and the association between the presence of such outcomes and patients and physician's characteristics was evaluated. 320 EMR of axSpA patients seen in the outpatient clinic were examined. Among them, 131 (41%) and 123 (38.4%) had a BASDAI + CRP and an ASDAS reported, respectively, but at least one was available in 178 (55.6%) of the EMR. The most frequently reported disease activity items were duration of morning stiffness (n = 230, 72%) and CRP (n = 224, 70%). Only previous participation on a systematic holistic review was independently associated with a reported disease activity outcome. Thus, implementation of recommendations with regard to regularly collecting disease activity outcome measures is not optimal. The participation in educational programs including self-assessment educational programs might be a key to improve such implementation.