Ankylosing Spondylitis Disease Activity Score Research Articles

Association between serum uric acid concentration and radiographic axial spondylarthritis: a cross-sectional study of 202 patients.

Association between serum uric acid concentration and radiographic axial spondylarthritis: a cross-sectional study of 202 patients.

Sustained low functional impairment in axial spondyloarthritis (axSpA): which are the primary outcomes that should be targeted to achieve this?

ObjectivesTo (i) determine whether sustained disease activity states, as measured by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS), impact function, and (ii) evaluate characteristics predicting sustained low functional impairment in a prospective axial spondyloarthritis (axSpA) cohort.MethodsBiologic Treatment Registry Across Canada (BioTRAC) was a multi-center, prospective registry that collected real-world data on axSpA patients receiving infliximab or golimumab between 2006 and 2017. Generalized estimating equations (GEE) were used to test baseline characteristics, treatment, and duration (at 6 and 12 months vs. only at 6 or 12 months vs. neither) of low BASDAI (< 3), ASDAS-inactive disease (ID)(< 1.3), and ASDAS-low disease activity (LDA) in predicting sustained low Bath Ankylosing Spondylitis Functional Index (BASFI)(< 3) between 12 and 18 months. The adjusted impact of achieving low disease state at 6 and/or 12 months on BASFI at 18 months was analyzed by generalized linear models.ResultsEight hundred ten patients were enrolled. 33.7%, 13.4%, and 24.7% achieved sustained low BASDAI, ASDAS-ID, and ASDAS-LDA, respectively. In univariable GEE of baseline variables, age and baseline BASDAI, BASFI, and ASDAS significantly predicted sustained low BASFI. In multivariable GEE, sustained low BASDAI (p < 0.001), low BASDAI only at 6 or 12 months (p = 0.001), and baseline BASFI (p < 0.001) were the only predictors of sustained low BASFI. Sustained ASDAS-ID (p = 0.040) and ASDAS-LDA (p < 0.001) were also predictors when forced into the model. Similar results were obtained when evaluating the BASFI score at 18 months.ConclusionSustained BASDAI < 3 may be a valid and feasible target for a treat-to-target strategy in axSpA having function as treatment goal.

The effects of supervision on the outcomes of exercise training in patients with ankylosing spondylitis: A single-blind randomized controlled trial.

Exercise training is crucial for managing ankylosing spondylitis. We evaluated the effects of exercise with different levels of supervision on clinical outcomes in patients with ankylosing spondylitis. We performed a single-blind randomized controlled trial in a university outpatient clinic. Overall, 45 (31 men) patients with ankylosing spondylitis were randomly allocated to 3 groups. The mean (SD) for age and disease duration were 39.3 (9.3) and 8.4 (7.8) years. The primary outcome was chest expansion in cm, and the secondary outcomes were the index scores of 5 standard questionnaires. For each participant, adalimumab 40 mg/0.8 mL/2 wk was injected and a 3-session exercise program per week for 1 month was prescribed. Controls received a pamphlet on the exercise program. Another group received the pamphlet and underwent a 2-hour training session. The supervised group received the pamphlet, and the 2-hour training, and completed the program by attending each exercise session in the clinic. Within-group analysis showed significant improvement in chest expansion (P = 0.016) and all subjective or objective questionnaire scores (all P < 0.001) for the full-supervised group. Between-group analysis implied best outcomes for chest expansion (P = 0.046), Ankylosing Spondylitis Disease Activity Score (P < 0.001), Bath Disease Activity (P = 0.010), and Metrology (P = 0.002) Indices for ankylosing spondylitis. The group with 2-hour training experienced an improvement in some indices, and the control group did not show significant changes in the outcomes. We recommend the prescription of a supervised training program instead of in-home exercises for patients with ankylosing spondylitis.

P134 Efficacy of Upadacitinib on Psoriatic Arthritis with Axial Involvement Defined by Investigator Assessment and PRO-Based Criteria: Results from two Phase 3 Studies

P134 Efficacy of Upadacitinib on Psoriatic Arthritis with Axial Involvement Defined by Investigator Assessment and PRO-Based Criteria: Results from two Phase 3 Studies

P187 Safety and efficacy of ixekizumab treatment in patients with axial spondyloarthritis: 3-year results from the COAST programme

Abstract Background/Aims Ixekizumab (IXE) has demonstrated efficacy at week (wk) 16 which was maintained through 2 years (yrs) and was associated with a consistent safety profile in patients (pts) with r- and nr-axSpA, who are bDMARD-naïve and TNFi-experienced. We aimed to report safety and efficacy from the COAST programme at 3 yrs: 1 yr of the originating studies (COAST-V/W/X) and 2 yrs of COAST-Y. Methods COAST-Y (NCT03129100) is the phase 3, long-term extension study of the 3 originating studies COAST-V/W/X. Pts continued with the dose received at the end of the originating trial at week (wk) 52, either with 80 mg IXE every 4 wks (Q4W) or every 2 wks (Q2W). Pts assigned to adalimumab (ADA) or placebo (PBO) were re-randomised to IXE Q4W or Q2W at wk 16 in COAST-V and -W. Pts who received PBO for 52 wks in COAST-X were switched to IXE Q4W to continue in COAST-Y. Starting at wk 116 (wk 64 of COAST-Y), pts receiving IXE Q4W could have their dose escalated to Q2W based on investigator's opinion. This analysis focused on pts receiving ≥1 dose of IXE Q4W, observed data while on IXE Q2W dose escalation are excluded. Continuous data are summarised as observed. Safety data while on IXE were analysed for pts who received ≥1 dose of IXE; observed data while on PBO or ADA are excluded. Results A total of 932 pts received ≥1 dose of IXE, 414 received ≥1 dose of IXE Q4W, and 562/932 (60%) pts completed 3 yrs of follow-up (PBO→IXE Q4W, 63/119 (53%); ADA→IXE Q4W, 29/44 (66%); and IXE Q4W→IXE Q4W, 114/251(45%)). Through 3 yrs, the most frequently reported treatment-emergent adverse events were infections [incidence rate (IR) 25.7/100 patient years (PY)] and injection site reactions [IR 7.4/100 PY], the majority of which were mild/moderate in severity. Serious adverse events were reported at an IR of 4.8/100 PY, of which osteoarthritis was the most frequent at 0.4/100 PY. A total of 3 deaths were reported among all pts who received ≥1 dose of IXE [IR 0.1/100 PY]. For all patients, baseline disease activity (Ankylosing Spondylitis Disease Activity Score; ASDAS) was high. A similar improvement in disease activity through 3 yrs was confirmed across additional efficacy endpoints. Conclusion This analysis in COAST-Y demonstrated that the safety profile is consistent with the established safety profile, with no new safety signals observed. Patients on IXE Q4W had sustained improvement through 3 years. Disclosure A. Deodhar: Consultancies; A. Deodhar has served as a speaker and/or consultant for: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Galapagos NV, GlaxoSmithKline, Janssen, Novartis, Pfizer, and UCB Pharma. D. Poddubnyy: Shareholder/stock ownership; D. Poddubnyy has served as a speaker and/or consultant for: AbbVie, BIOCAD, Bristol Myers Squibb, Eli Lilly and Company, Gilead Sciences, GlaxoSmithKline, Janssen, Merck Sharp &amp; Dohme, Novartis, Pfizer, Samsung Bioepis, and UCB Pharma. Grants/research support; D.P. has received grant and/or research support from: AbbVie, Eli Lilly and Company, Merck Sharp &amp; Dohme, Novartis, and Pfizer. P. Rahman: Consultancies; P. Rahman has served as a speaker for: Abbott, AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Janssen, Novartis, and Pfizer. Grants/research support; P.R. has received grant and/or research support from: Janssen and Novartis. R. Bolce: Shareholder/stock ownership; R. Bolce is an employee and shareholder of: Eli Lilly and Company. S. Liu Leage: Shareholder/stock ownership; S. Liu-Leage is an employee and shareholder of: Eli Lilly and Company. A. Kronbergs: Shareholder/stock ownership; A. Kronbergs is an employee and shareholder of: Eli Lilly and Company. C. Johnson: Shareholder/stock ownership; C. Johnson is an employee and shareholder of: Eli Lilly and Company. A. Leung: Corporate appointments; A. Leung is an employee of: Syneos Health; and a contractor for: Eli Lilly and Company. D. van der Heijde: Consultancies; D. van der Heijde has served as a consultant for: AbbVie, Bayer Pharmaceuticals, Bristol Myers Squibb, Cyxone, Eisai, Eli Lilly and Company, Galapagos NV, Gilead Sciences, GlaxoSmithKline, Janssen, Novartis, Pfizer, and UCB Pharma. Other; D. van der Heijde is the director of: Imaging Rheumatology BV. A. Kiprianos (Non-author Presenter): Shareholder/stock ownership; A. Kiprianos is an employee and shareholder in Lilly.

Efficacy and safety of upadacitinib in patients with active psoriatic arthritis and axial involvement: results from two phase 3 studies

BackgroundThe objective of this post-hoc analysis was to assess the efficacy and safety of upadacitinib in psoriatic arthritis (PsA) patients with axial involvement.MethodsPost-hoc analysis of SELECT-PsA 1 and SELECT-PsA 2 in patients randomized to upadacitinib 15 mg (UPA15), placebo (switched to UPA15 at week 24), or adalimumab 40 mg (ADA; SELECT-PsA 1 only). Axial involvement was determined by investigator judgement (yes or no; based on the totality of available clinical information, such as duration and characteristics of back pain, age of onset, and previous lab investigations and imaging, if available) alone, or investigator judgement and patient-reported outcome (PRO)-based criteria (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] ≥ 4 and BASDAI Q2 ≥ 4). Efficacy outcomes that describe axial disease activity, including BASDAI endpoints, such as change from baseline in the overall BASDAI score or proportion of patients achieving BASDAI50 (≥ 50% improvement from baseline), as well as Ankylosing Spondylitis Disease Activity Score (ASDAS) endpoints, such as mean change from baseline in overall ASDAS or proportion of patients achieving ASDAS inactive disease or low disease activity, were evaluated at weeks 12, 24, and 56, with nominal P-values shown. Treatment-emergent adverse events (TEAEs) are summarized through week 56.Results30.9% of patients in SELECT-PsA 1 and 35.7% in SELECT-PsA 2 had axial involvement by investigator judgement alone; 22.6% (SELECT-PsA 1) and 28.6% (SELECT-PsA 2) had axial involvement by investigator judgement and PRO-based criteria. Greater proportions of patients achieved BASDAI50 with UPA15 versus placebo using either criterion, and versus ADA using investigator judgement alone, at week 24 in SELECT-PsA 1 (investigator alone: UPA15, 59.0%, placebo, 26.9%, P < 0.0001, ADA, 44.1%, P = 0.015; investigator and PRO-based: UPA15, 60.4%, placebo, 29.3%, P < 0.0001, ADA, 47.1%, P = 0.074), with comparable findings in SELECT-PsA 2. Similar results were observed with UPA15 for additional BASDAI and ASDAS endpoints at weeks 12 and 24, with improvements maintained at week 56. Rates of TEAEs were generally similar across sub-groups irrespective of axial involvement status.ConclusionsPsA patients with axial involvement determined by predefined criteria showed greater BASDAI and ASDAS responses with UPA15 versus placebo, and numerically similar/greater responses versus ADA. Safety results were generally comparable between patients with or without axial involvement.Trial registrationClinicalTrials.gov: SELECT-PsA 1, NCT03104400; SELECT-PsA 2, NCT0310437.

Interferon-alpha 1 expression indicates the disease activity and response of patients with ankylosing spondylitis to anti-TNF-α treatment.

This study aimed to investigate whether interferon-alpha 1 (IFNA1) is predictive of Ankylosing spondylitis (AS) progression and treatment response to Tumour necrosis factor inhibitors (TNFis). Data of 50 AS patients receiving TNFi for 24 weeks were retrospectively analysed. AS patients who reached the Assessment of Spondyloarthritis International Society 40 response at the W24 were classified as responders to TNFi treatment; otherwise, they were classified as nonresponders. Human fibroblast-like synoviocytes (HFLS) isolated from AS patients (AS-HFLS) were used for in vitro validation. When the IFNA1 expression level was used to diagnose AS patients, an area under the curve of 0.895 was yielded (P < .001). Pearson correlation analysis showed negative correlations between IFNA1 expression, C-reactive protein (CRP) level, Bath AS Disease Activity Index scores, AS Disease Activity Score with CRP, and the production of inflammatory cytokines. An increased IFNA1 expression level was found to be associated with a better treatment response to TNFi. IFNA1 overexpression could protect HFLS against inflammatory response in the setting of AS. Blood IFNA1 deficiency is correlated with inflammatory cytokine production and disease activity and is indicative of unsatisfied response to TNFi treatment in AS patients.

Biopsychosocial factors should be considered when evaluating central sensitization in axial spondyloarthritis.

To identify the determinants of central sensitization (CS) in patients with axial spondyloarthritis (axSpA). Central Sensitization Inventory (CSI) was used to determine CS frequency. Disease-related variables including Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP/-ESR), Maastricht Ankylosing Spondylitis Enthesitis Score (MASES), Bath Ankylosing Spondylitis Functional Index (BASFI), Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) and Numeric Rating Scale (NRS)GLOBAL were assessed. Biopsychosocial variables were evaluated by the Multidimensional Scale of Perceived Social Support (MSPSS), Brief Illness Perception Questionnaire (B-IPQ), Hospital Anxiety and Depression Scale (HADS) and subscales for Anxiety (HADS-A) and Depression (HADS-D), and Jenkins Sleep Evaluation Scale (JSS). To determine the predictors of the development and severity of CS, multiple linear and logistic regression analyses were performed. The frequency of CS was 57.4% in the study population (n = 108). CSI score was correlated with the duration of morning stiffness, BASDAI, ASDAS-CRP, ASDAS-ESR, NRSGLOBAL, BASFI, MASES, ASOoL, JSS, HADS, and B-IPQ total scores (ρ ranged from 0.510 to 0.853). Multiple regression analysis indicated that BASDAI (OR: 10.44, 95% CI: 2.65-41.09), MASES (OR: 2.47, 95% CI: 1.09-5.56) and HADS-A (OR: 1.62, 95% CI: 1.11-2.37) were independent predictors of the development of CS. Additionally, higher NRSGLOBAL, JSS, HADS-D, and HADS-A scores appeared to determine the severity of CS. This study confirms that worse disease activity, more enthesal involvement, and anxiety independently predict the development of CS. Additionally, higher patient-perceived disease activity, sleep impairment and poor mental health significantly contribute to the severity of CS.

The Long-Term Effects of Short-Period Adalimumab Biosimilar Usage in Ankylosing Spondylitis.

Background Cost and drug toxicity frequently deter the long-term use of anti-tumor necrosis factor (TNF) agents in ankylosing spondylitis (AS). Therefore, this study was conducted to observe long-term relief after the short-term administration of an anti-TNF agent. Methodology A one-year, prospective, interventional, uncontrolled, single-center trial was conducted. There were 50 patients with symptomatic active chronic AS who received rheumatology therapy and were anti-TNF naive. Every two weeks, 40 mg of standard biosimilar adalimumab (Bs-ADA, Exemptia™) was administered subcutaneously for six injections (10 weeks) or to continue with standard follow-up if they did not achieve an Assessment in Ankylosing Spondylitis Response Criteria (ASAS 20) index response by week 12. Standard indicators (Assessment Spondyloarthritis International Society/ASAS and Bath) were used to evaluate progress. In addition, TNF-alpha, interleukin (IL)-6, and IL-17 were tested using a commercially available enzyme-linked immunosorbent assay kit from Bio Legend (Bengaluru, India). Results Patients experienced early and significant improvement in pain, non-steroidal anti-inflammatory drugs (NSAIDs) requirement, function, and several indices (ASAS 20 and 40, ASAS partial remission, Bath Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Functional Index, Ankylosing Spondylitis Disease Activity Score) after discontinuing injections. At weeks 12 and 48, 84% and 52% of patients showed ASAS 20 improvement, with 34% and 24% showing ASAS partial remission. Over half of the patients continued to improve and provided proof of concept. Conclusions In difficult-to-treat AS, a 10-week course of biosimilar adalimumab demonstrated significant early improvement that often lasted for 24 weeks. This unconventional method proved to be economically appealing. It merits further confirmation and acceptance, especially in resource-constrained contexts.

Current health resources required for the management of ankylosing spondylitis in developing areas of China.

Current health resources required for the management of ankylosing spondylitis in developing areas of China.

Influence of Sex on Early Axial Spondyloarthritis: A Six-Year Longitudinal Analysis From a Large National Cohort.

The objective was to determine sex differences in disease outcomes in recent axial spondyloarthritis (SpA) over time. We analyzed the first 6 years of follow-up of the prospective French multicenter DESIR cohort. Patients analyzed had <3 years of disease, were naive to disease-modifying antirheumatic drugs, and fulfilled the Assessment of SpondyloArthritis international Society classification criteria for axial SpA. Disease activity (Ankylosing Spondylitis Disease Activity Score [ASDAS] using the C-reactive protein [CRP] level), patient global assessment (PtGA), CRP level, and radiographic sacroiliitis were compared between men and women (self-reported sex) by linear and logistic mixed-effects models.Models were created for trajectories of disease activity over 6 years in men and women, using k-means. Of 494 patients analyzed (mean ± SD age 31.9 ± 7.5 years, symptoms duration 20.7 ± 11.7 months), 50.4% were men. Over 6 years of follow-up, both men and women showed clear improvements in ASDAS-CRP, PtGA, and CRP level. Women had higher ASDAS-CRP and PtGA over time compared to men (both P < 0.0001) with overall similar CRP levels (P=0.089), whereas structural damage increased more in men (P < 0.0001). One-third of both men (33%) and women (34%) belonged to persistent high/very high disease activity trajectories, but ASDAS-CRP was globally higher in women in these trajectories. In early axial SpA, clinical outcomes (disease activity and symptoms) were worse in women than men over 6 years of follow-up, whereas CRP was similar and structural damage was more frequent in men. Although similarly distributed, disease activity scores were higher in women in high/very high disease activity trajectories. Sex appears to be an important contextual factor in axial SpA.

The electronic medical record management systems may improve monitoring and control of disease activity in patients with ankylosing spondylitis

To investigate the impact of an electronic medical record management system (EMRMS) on disease activity and the frequency of outpatient visits among patients with ankylosing spondylitis (AS). We identified 652 patients with AS who were followed up for at least 1 year before and after the first Ankylosing Spondylitis Disease Activity Score (ASDAS) assessment and compared the number of outpatient visits and average visit time within 1 year before and after the initial ASDAS assessment. Finally, we analyzed 201 patients with AS who had complete data and received ≥ 3 continuous ASDAS assessments at an interval of 3 months, and we compared the results of the second and third ASDAS assessments with those of the first. The number of annual outpatient visits increased after ASDAS assessment (4.0 (4.0, 7.0) vs. 4.0 (4.0, 8.0), p < 0.001), particularly among those with a high initial disease activity. The average visit time was reduced within 1 year after ASDAS assessment (6.4 (8.5, 11.2) vs. 6.3 (8.3, 10.8) min, p = 0.073), especially among patients whose with an inactive disease activity was < 1.3 (ASDAS C-reactive protein (CRP) 6.7 (8.8, 11.1) vs. 6.1 (8.0, 10.3) min, p = 0.033; ASDAS erythrocyte sedimentation rate (ESR) 6.4 (8.7, 11.1) vs. 6.1 (8.1, 10.0) min, p = 0.027). Among patients who received at least three ASDAS assessments, the third ASDAS-CRP tended to be lower than the first (1.5 (0.9, 2.1) vs. 1.4 (0.8, 1.9), p = 0.058). The use of an EMRMS increased the frequency of ambulatory visits among AS patients with high and very high disease activity and reduced the visit time among those with an inactive disease. Continual ASDAS assessments may help control the disease activity of patients with AS.

Characterisation of gut microbiota composition in patients with axial spondyloarthritis and its modulation by TNF inhibitor treatment

ObjectiveTo assess whether gut microbiota composition is associated with patient characteristics and may have predictive value on the response to TNF inhibitor (TNFi) treatment in axial spondyloarthritis (AxSpA).MethodsThe study involved...

Ixekizumab therapy following secukinumab inadequate response in psoriatic arthritis: a case series focusing on axial disease.

There are limited data regarding cycling between interleukin-17 (IL-17) inhibitors in psoriatic arthritis (PsA). We aimed to report the efficacy of an IL-17 inhibitor (ixekizumab-IXE) after inadequate response (IR) of another one (secukinumab-SEC) in patients with PsA. Case series of PsA patients who received IXE after SEC-IR in four rheumatology centers between 1/9/2021 and 1/9/2022 were included. Peripheral arthritis was assessed with disease activity in psoriatic arthritis score (DAPSA) and skin involvement with body surface area (BSA). Axial disease was defined as having both imaging and clinical features and its activity was measured with the ankylosing spondylitis disease activity score (ASDAS). Twenty-four patients (54.2% female, mean [SD] age: 51.6 [14.1]) who were SEC-IR and received IXE either immediately (n = 11) or after ≥ 1 interposed biologic disease modifying anti-rheumatic drug (bDMARD) (n = 13) were included. Patients were followed on IXE for a mean [SD] period of 9.6 [4.9] months. Among patients with peripheral arthritis (n = 24), the mean [SD] DAPSA decreased from 22.8 [8.6] to 13.6 [7.8] during follow-up (p = 0.0001) with 62.5% of patients showing improvement in the DAPSA disease activity categories. For patients with axial involvement (n = 16), a clinically meaningful improvement (Δ ≥ 1.1 in ASDAS) was noted in 50% (8/16), while dactylitis and enthesitis resolution was observed in 60% (3/5) and 83% (5/6) of patients, respectively. Regarding psoriasis, the mean [SD] BSA of involved skin decreased from 8.7 [8.7] to 2.4 [3.3] (p = 0.001). In this case series, treatment with IXE after inadequate response to another IL-17 inhibitor (SEC) was efficacious in a real-world setting in patients with PsA, including axial disease.

The Efficacy and Safety of Subcutaneous Ixekizumab for the Treatment of Axial Spondylarthritis: A Systematic Review and Meta-Analysis.

Axial spondylarthritis (axSpA) is a progressive inflammatory condition that is treated with various management options. Interleukin-17A (IL-17A)inhibitors are a novel therapeutic option that demonstrates both efficacy and safety. This systematic review and meta-analysis evaluated the effectiveness of ixekizumab and its safety compared to a placebo. Medline, ScienceDirect, EBSCO, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched. We included randomized control trials (RCTs) that assessed the efficacy and safety of ixekizumab versus the placebo. The GRADE (Gradingof Recommendations, Assessment, Development, and Evaluations) assessment was utilized to evaluate the certainty of evidence. The revised Cochrane risk of bias tool for randomized trials was used to assess the risk of bias. Four RCTs (n=1016) met the eligibility criteria. All included studies had a low risk of bias. Significant improvements in the Assessment of Spondylarthritis International Society response for 40% improvement (ASAS40) (RR = 2.39, 95% CI 1.72-3.31, P < 0.01, I2 = 23%), Ankylosing Spondylitis Disease Activity Score (ASDAS) (SMD= -9.28 95% CI -12.31- (-6.25), P < 0.01, I2=97%), andSpondylarthritis Research Consortium of Canada (SPRACC score) (SMD= -5.82 95% CI -7.16- (-4.47), P < 0.01, I2=94%) were noted in comparison to placebo. Regarding safety, there was an insignificant increase in risk for serious adverse events (SAEs) (RR = 1.19, 95% CI 0.45-3.14, P = 0.73, I2 = 0%). Additionally, significant nonserious adverse events (NSAEs) (RR = 1.54, 95% CI 1.19-1.99, P = 0.001, I2 = 0%) were noted for the ixekizumab arm. No mortality events were detected in both arms. Ixekizumab, which demonstrates significant improvement in all efficacy endpoints, is a promising management option for axSpA patients who fail non-steroidal anti-inflammatory drugs (NSAIDs) therapy. However, the significant risk of developing adverse events hinders its utilization. More high-quality RCTs with larger sample sizes and prolonged follow-up periods are warranted to further assess this treatment option.

Long-Term Safety and Efficacy of Ixekizumab in Patients With Axial Spondyloarthritis: 3-year Data From the COAST Program.

To report safety and efficacy of ixekizumab (IXE) from the COAST program at 3 years, including 1 year from the originating studies (COAST-V, COAST-W, and COAST-X), and 2 years from COAST-Y. In COAST-Y, patients continued with the dose received at the end of the originating study at week 52: 80 mg IXE either every 4 weeks (Q4W) or every 2 weeks (Q2W). Placebo-treated patients from COAST-X received IXE Q4W in COAST-Y. Starting at week 116 (week 64 of COAST-Y), patients receiving IXE Q4W could be escalated to Q2W. Safety for patients receiving ≥ 1 dose of IXE and efficacy for patients receiving ≥ 1 dose of IXE Q4W was assessed. Data are summarized as observed. For the 932 patients who received ≥ 1 dose of IXE (Q2W or Q4W) through 3 years, treatmentemergent adverse events (TEAEs) occurred at an incidence rate (IR) of 38.0 per 100 patient-years (PYs). The most frequently reported were infections (IR 25.7 per 100 PYs) and injection site reactions (IR 7.4 per 100 PYs); the majority of TEAEs were mild or moderate in severity. In total, 7.1% of TEAEs led to discontinuation (IR 3.1 per 100 PYs). All patient groups receiving IXE Q4W assessed through 3 years saw sustained improvements in Ankylosing Spondylitis Disease Activity Score, clinically important improvement, and other efficacy end points. The 3-year safety profile of IXE in the COAST program is consistent with the previously established long-term safety profile. IXE Q4W provided sustained improvement of disease activity in patients who received treatment through 3 years. (ClinicalTrials.gov: NCT02696785 [COAST-V], NCT02696798 [COAST-W], NCT02757352 [COAST-X], and NCT03129100 [COAST-Y]).

Predictors of long-term functional outcomes of juvenile idiopathic arthritis-enthesitis-related arthritis: a single centre experience.

Long-term functional outcomes in enthesitis-related arthritis (ERA) is limited from developing countries. We assessed the clinical and genetic factors that predicted the long-term functional outcome in ERA. Patients with ERA having ≥5 years of disease and >16 years of age were included in this cross-sectional study. Data on clinical features within 6 months of disease onset was collected from hospital records. Bath indices, HAQ Disability Index (HAQ-DI) and World Health Organization's Quality of Life (WHO-QOL) were assessed at last visit. Poor functional outcome (PFO) was defined as BASFI > 1.5 or HAQ-DI > 1. Persistent disease activity (PDA) was defined as BASDAI ≥ 4. Endoplasmic reticulum aminopeptidase 1 (ERAP1) and IL-23 receptor single nucleotide polymorphism genotyping was performed with the TaqMan method and HLA-B27 by PCR. One hundred and eighty-one patients [170 male, median (interquartile range) age of disease onset 12.5 (10-15) years, disease duration 7 (5-11) years] were recruited. There was a delay in diagnosis of 3 (1-5) years. The median Ankylosing Spondylitis Disease Activity Score (ASDAS)-ESR, BASDAI, HAQ-DI and BASFI at inclusion were 2.6 (1.8-3.6), 2.6 (1-5.2), 0.5 (0-0.5) and 1.6 (0.3-3.2), respectively. BASFI and HAQ-DI correlated with ASDAS-ESR, ASDAS-CRP and WHO-QOL-BREF. Those with PFO (n = 98) had a longer delay in diagnosis (4 vs 2 years, P < 0.001), lower prevalence of arthritis at onset [odds ratio (OR) = 0.3; 95% CI: 0.1, 0.8], higher prevalence of ERAP1 (rs27044) allele C (OR = 7.2; 95% CI: 1.5, 33.7) and higher disease activity currently. Delay in diagnosis (OR = 1.2; 95% CI: 1.08, 1.4) was the sole predictor of PFO in multivariate analysis. One-third of patients had PDA. Tarsitis at disease onset was the sole predictor of PDA (OR = 2.3; 95% CI: 1.009, 5.4). PFO was seen in one-half of JIA-ERA in the long-term and was associated with active disease with delay in diagnosis as its sole predictor.

Effectiveness and safety of generic tofacitinib in spondyloarthritis: A real-world retrospective analysis from India.

Clinical trial evidence demonstrates the efficacy of tofacitinib in ankylosing spondylitis and psoriatic arthritis (PsA). Real-world data from spondyloarthritis (SpA) patients are scarce; there are few reports of its effectiveness and safety from low- to middle-income countries like India, despite its widespread usage. This was a retrospective analysis of clinical and laboratory records of 100 patients with SpA prescribed generic tofacitinib from a single center in Mumbai, India. Disease activity was measured using the Ankylosing Spondylitis Disease Activity Score C-Reactive Protein (ASDAS-CRP) in all patients, along with disease-specific outcome measures in the subgroups. We used paired t test for response to tofacitinib. We compared Δ ASDAS-CRP in patients with active peripheral arthritis and in patients without. We defined clinical tofacitinib failure as the physician's decision to change or add a disease-modifying antirheumatic drug (DMARD), and performed logistic regression to identify factors associated with tofacitinib failure. Among 100 patients (71 male, median age 42.5 years), 57 had axial SpA, 10 had peripheral SpA, 4 had inflammatory bowel disease-SpA and 29 had PsA. One-third had received biologic DMARDs previously. Patients received tofacitinib for a median of 192 days. There was a significant improvement in ASDAS-CRP in all types of SpA. Patients with active peripheral arthritis had a significantly greater fall in ASDAS-CRP. There were no serious adverse events, 19 patients had mild COVID-19; no patient had tuberculosis. Ten patients had tofacitinib failure; no baseline parameter could predict failure. In the real-world setting, generic tofacitinib showed good effectiveness and tolerable safety profile in Indian patients with SpA.

Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomised controlled trials

ObjectivesAxial spondyloarthritis (axSpA) is a complex disease with diverse manifestations, for which new treatment options are warranted. BE MOBILE 1 (non-radiographic (nr)-axSpA) and BE MOBILE 2 (radiographic axSpA (r-axSpA)) are...

Prevalence and Associated Factors of Facet Joint Ankylosis in Patients With Axial Spondyloarthritis.

To investigate the prevalence of facet joint ankylosis in the whole spine in axial spondyloarthritis (axSpA) using low-dose computed tomography (LDCT), and to identify factors associated with facet joint ankylosis. Whole spine LDCT images from 161 patients with axSpA were examined, and the presence of facet joint ankylosis was assessed (right and left, C2-S1) by 2 readers. Facet joint ankylosis was scored from 0 to 46. Structural damage of vertebral body was assessed using CT Syndesmophyte Score (CTSS). Factors associated with ankylosed facet joint scores for the whole spine were identified using a generalized linear model with a negative binomial distribution. Seventy-nine patients (49%) and 70 patients (43%; reader 1 and reader 2, respectively) had ≥ 1 ankylosed facet joint. Facet joint ankylosis was most common in the thoracic spine. The mean score of facet joint ankylosis for the whole spine was 6.6 (SD 11.2) in reader 1 and 4.2 (SD 8.4) in reader 2. Whole spine facet joint ankylosis score positively correlated with Ankylosing Spondylitis Disease Activity Score (ASDAS) and CTSS. In multivariable analysis, the ankylosed facet joint score was associated with ASDAS, sacroiliitis, CTSS, and a history of uveitis in both readers. Uveitis history, ASDAS, and CTSS were associated with whole spine facet joint ankylosis score in subgroup analysis of only radiographic axSpA. The prevalence of ankylosed facet joints is high in axSpA, especially in the thoracic segment. The whole spine ankylosed facet joint score is significantly associated with a history of uveitis, ASDAS, sacroiliitis, and syndesmophyte score.