Ankylosing Spondylitis Disease Activity Score Research Articles

Long-term clinical outcomes of certolizumab pegol treatment in non-radiographic axial spondyloarthritis stratified by baseline MRI and CRP status

ObjectiveThere is a paucity of data on long-term clinical responses in patients with non-radiographic axial spondyloarthritis (nr-axSpA) based on their baseline objective signs of inflammation such as MRI or C-reactive...

Comparative characteristics of axial spondyloarthritis and psoriatic arthritis with axial involvement

Objective – to compare clinical characteristics of patients with axial spondyloarthritis (axSpA)/ankylosing spondylitis (AS) and with axial psoriatic arthritis (axPsA).Subjects and methods. 100 patients were examined: 45 – with axSpA/AS (group 1), 55 – with axPsA (group 2). Patients of group 1 were included according to axSpA/AS criteria, patients of group 2 – according to CASPAR (ClASsification criteria for Psoriatic ARthritis) criteria, and having axial involvement (axPsA). Axial involvement was detected in case of radiologically significant sacroiliitis (bilateral grade ≥2 or unilateral grade ≥3) or active MRI sacroiliitis, or ≥1 syndesmophyte(s) of the cervical and/or lumbar spine. Patients were evaluated for presence of inflammatory back pain (IBP) by ASAS (Assessment of Spondyloarthritis International Society) criteria.Results and discussion. Patients of group 1 were younger (p<0.001), more often HLA-B27 positive (p<0.001), had more IBP (p=0.001). Patients of group 2 had older age (>40 years) at back pain onset (p<0.001), more often peripheral arthritis (p<0.001), dactylitis (p=0.004), and skin psoriasis (p<0.001). Nail psoriasis was found only in group 2 patients (p<0.001). Group 1 patients had more often heel enthesitis (p=0.005). Group 2 patients had worse axial disease activity scores: BASDAI (Bath Ankylosing Spondylitis Disease Activity Index; p=0.006) and ASDAS-СRP (Ankylosing Spondylitis Disease Activity Score with C-reactive protein level determination; р<0.001); and worse patient reported outcomes: BASFI (Bath Ankylosing Spondylitis Functional Index; p=0.004), patients’ pain (p=0.005) and patients’ global assessments (p=0.036). Patients of group 2 had more syndesmophytes of the lumbar (р=0.009) and cervical (р=0.007) spine. Only in group 2 patients, chunky “non-marginal” syndesmophytes were found (in 32.1%), as well as spinal lesions without sacroiliitis (in 20.0%). Patients of group 2 had more joint erosions (р=0.001), osteolysis (р=0.015), juxta-articular bone formation (р<0.001) and joint ankyloses (р=0.02). All patients of group 1 and only 80% of group 2 (р=0.003) met ASAS criteria for axSpA. AxSpA/AS and axPsA seem to be two different diseases. In our cohort of patients, axPsA patients had worse disease status compared to axSp and AS.

Sex-specific disparities in disease activity scores among patients with axial spondyloarthritis and their implications for evaluating the response to tumor necrosis factor alpha inhibitor therapy

BackgroundWe aimed to investigate whether there are sex differences in disease activity measures among patients with axial spondyloarthritis (axSpA) and to determine any potential impact on the assessment of treatment responses to tumor necrosis factor alpha inhibitors (TNFi).MethodsUsing the Korean College of Rheumatology Biologics and Targeted Therapy (KOBIO) registry data, we compared sex differences in changes in the Bath Ankylosing Spondylitis Disease Activity Score (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) levels at baseline and one year after TNFi initiation in patients with axSpA.ResultsThis study included 1,753 patients with axSpA who started or changed TNFi, of whom 1,343 (76.6%) were male. At baseline, the mean BASDAI and ASDAS scores of all patients were 5.98 and 3.6, respectively. The BASDAI changes between baseline and the one-year follow-up were independently associated with sex (\U0001d6fd = 0.343, p = 0.011), whereas ASDAS was not (\U0001d6fd = 0.079, p = 0.235). When judging the effect of TNFi at one-year of treatment, male patients were more likely to be assessed as effective by the BASDAI-based criterion (ΔBASDAI ≥ 50% or ≥ 2; OR 1.700, 95% CI 1.200–2.406), while the ASDAS-based criterion (ΔASDAS ≥ 1.1) showed no significant difference between sexes (OR 0.993, 95% CI 0.678–1.455), after adjusting for other baseline characteristics.ConclusionsThe changes in disease activity before and after TNFi use were significantly different between sexes when measured by BASDAI, but not ASDAS. TNFi treatment effects may be interpreted differently between sexes depending on the disease activity measure used.

[Clinical value of high frequency ultrasound in the diagnosis of hip joint involvement in patients with ankylosing spondylitis].

To analyze the correlation between hip joint musculoskeletal ultrasound score and ankylosing spondylitis (AS) disease activity, as well as to investigate the value of high frequency ultrasound in the assessment of hip joint involvement in AS. The clinical data of 244 patients with AS who were treated in the rheumatology department of from March 2019 to March 2022 were retrospectively analyzed. Among them, there 174 males and 70 females, aged from 19 to 58 years old with an average of (34.22±9.49) years old;the disease duration of AS patients ranged from 8 months to 26 years, with an average of (13.68±4.04) years.The 244 patients were divided into disease group (83 cases) and control group (161 cases) based in the presence of hip joint involuement. According to the the disease activity, patients in the disease group were further categorezed into active phase (45 cases) and stable phase (38 cases). The ultrasound scores of patients in the active and stable phases of the disease group and the control group were compared. Relevant factors of hip joint involvement in AS patients were analyzed, and analyze the correlation between ultrasound score and Bath ankylosing spondylitis disease activity score index(BASDAI), Bath ankylosing spondylitis functional index(BASFI), visual analogue score of pain (VAS), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and the correlation between hip joint capsule score and tendon attachment end score and BASDAI, BASFI, VAS, CRP and ESR. The hip joint capsule score(3.06±1.12), femoral head score(1.45±0.43), tendon attachment end score(3.28±1.30) and total ultrasound score(6.65±2.31) of the disease group were higher than those of the control group(1.51±0.48)、(0.66±0.27)、(1.61±0.53)、(3.81±1.44)scores (P<0.05). Multifactor Logstic regression analysis showed that the course of disease, hip joint capsule score and total ultrasound score were independent risk factors for hip involvement in AS patients.The hip capsule score (3.65±1.22)and total ultrasound score(8.28±2.33) in the active phase of the disease group were higher than those in the stable phase (2.48±1.04)、( 6.82±1.96)scores(P<0.05). The hip joint capsule score and total ultrasonic score of AS patients were positively correlated with BASDAI, BASFI, VAS, CRP, and ESR (P<0.05, P<0.01).The score of tendon attachment end was positively correlated with CRP (P<0.05). The score of joint capsule effusion in AS patients was positively correlated with BASDAI, BASFI and VAS (P<0.05, P<0.01). The synovial blood flow score was positively correlated with BASDAI, VAS, CRP and ESR (P<0.05, P<0.01). The synovial thickening score was positively correlated with BASDAI, BASFI, VAS, CRP and ESR (P<0.05, P<0.01). There was no correlation between the score of tendon attachment end and BASDAI, BASFI, VAS, CRP and ESR. There is a correlation between hip joint ultrasonic score of hip joint and clinical indexes in AS patients.Hip joint capsule score and total ultrasonic score were independent risk factors for hip involvement in AS patients. High frequency ultrasound exhibits clinical value in the diagnosis of hip joint involvement in AS patients.

E068 Achievement of low disease activity over 52 weeks in patients with active axial spondyloarthritis on bimekizumab treatment: results from the phase 3 studies BE MOBILE 1 and BE MOBILE 2

Abstract Background/Aims The recommended treatment target for axial spondyloarthritis (axSpA) is remission/low disease activity (LDA) according to Ankylosing Spondylitis Disease Activity Score (ASDAS) levels (ASDAS&amp;lt;2.1); however, remission is difficult to achieve for many patients. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) remains commonly used in clinical practice to assess disease activity, although limited data exist to validate cut-offs. Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A. BKZ has demonstrated consistent and sustained efficacy up to Week (Wk)52 in the BE MOBILE 1 and 2 phase 3 studies, including achievement of LDA according to ASDAS by &amp;gt; 50% of patients with non-radiographic (nr-)axSpA and radiographic (r-)axSpA. Here, we report achievement of LDA, as assessed by either ASDAS&amp;lt;2.1, BASDAI&amp;lt;4, or both, to Wk52 with BKZ across the spectrum of axSpA in two phase 3 studies. Methods BE MOBILE 1 (NCT03928704) and BE MOBILE 2 (NCT03928743) comprised a 16-wk placebo (PBO)-controlled and 36-wk maintenance period. BE MOBILE 1 (nr-axSpA) patients met Assessment of SpondyloArthritis international Society (ASAS) classification criteria and had objective inflammation (MRI and/or elevated C-reactive protein). BE MOBILE 2 (r-axSpA) patients met modified New York and ASAS classification criteria. All patients had active disease (BASDAI≥4 and spinal pain≥4 [BASDAI item 2]) at baseline. Patients were randomised to subcutaneous BKZ 160 mg every 4 weeks (Q4W) or PBO. Patients randomised to PBO switched to BKZ from Wk16 (‘PBO/BKZ-switchers’). The proportion of patients that achieved LDA to Wk52, as defined by either ASDAS&amp;lt;2.1, BASDAI&amp;lt;4, or both, are presented (non-responder imputation). Results Overall, 254 patients with nr-axSpA (BKZ: 128/PBO: 126) and 332 with r-axSpA (BKZ: 221/PBO: 111) were randomised. Most had high (ASDAS≥2.1-≤3.5) or very high (ASDAS&amp;gt;3.5) disease activity at baseline (nr-axSpA: BKZ: 99.2%/PBO: 97.6%; r-axSpA: BKZ: 98.6%/PBO: 100%). At Wk16, a greater proportion of BKZ vs PBO-treated patients achieved ASDAS&amp;lt;2.1 (nr-axSpA: BKZ: 46.1%/PBO: 19.8%; r-axSpA: BKZ: 42.1%/PBO: 17.1%), BASDAI&amp;lt;4 (nr-axSpA: BKZ: 52.3%/PBO: 31.7%; r-axSpA: BKZ: 55.7%/PBO: 41.4%) and both (nr-axSpA: BKZ: 43.8%/PBO: 19.0%; r-axSpA: BKZ: 41.6%/PBO: 17.1%). Results were sustained/improved across continuous BKZ-treated patients and PBO/BKZ-switchers to Wk52, with achievement of ASDAS&amp;lt;2.1 (nr-axSpA: BKZ: 53.9%/switchers: 47.6%; r-axSpA: BKZ: 50.2%/switchers: 61.3%), BASDAI&amp;lt;4 (nr-axSpA: BKZ: 60.2%/switchers: 54.0%; r-axSpA: BKZ: 65.6%/switchers: 68.5%) and both (nr-axSpA: BKZ: 49.2%/switchers: 45.2%; r-axSpA: BKZ: 49.8%/switchers: 58.6%). Achievement of BASDAI&amp;lt;4 was consistently higher than ASDAS&amp;lt;2.1, regardless of treatment arm. Conclusion Across the full axSpA disease spectrum, BKZ resulted in rapid achievement of LDA vs PBO to Wk16, as assessed by ASDAS&amp;lt;2.1, BASDAI&amp;lt;4, or both; improvements continued to Wk52. Most patients achieving ASDAS&amp;lt;2.1 also achieved BASDAI&amp;lt;4. These data suggest ASDAS&amp;lt;2.1 is a more stringent criterion for LDA, relevant for consideration of BKZ in the context of a potential treat-to-target approach for axSpA in daily practice. Disclosure X. Baraliakos: Consultancies; AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, Novartis, Pfizer and UCB Pharma ; grant/research support from: Novartis and UCB Pharma. Member of speakers’ bureau; AbbVie, BMS, Chugai, Eli Lilly, Galapagos, MSD, Novartis, Pfizer and UCB Pharma. Other; Paid instructor for: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, MSD, Novartis, Pfizer and UCB Pharma. S. Ramiro: Grants/research support; AbbVie, Galapagos, MSD, Novartis, Pfizer and UCB Pharma; Consultant for AbbVie, Eli Lilly, Novartis, Pfizer, Sanofi and UCB Pharma. M. Magrey: Consultancies; AbbVie, BMS, Eli Lilly, Novartis, Pfizer and UCB Pharma. Grants/research support; AbbVie, BMS and UCB Pharma. M. Rudwaleit: Consultancies; AbbVie, Eli Lilly, Novartis and UCB Pharma. Member of speakers’ bureau; AbbVie, Boehringer Ingelheim, Chugai, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma. N. Haroon: Consultancies; AbbVie, Eli Lilly, Janssen, Novartis and UCB Pharma. C. Fleurinck: Other; Employees of UCB Pharma. U. Massow: Other; Employees of UCB Pharma. N. de Peyrecave: Other; Employees of UCB Pharma. T. Vaux: Other; Employees of UCB Pharma. H. Marzo-Ortega: Consultancies; AbbVie, Biogen, Eli Lilly, Janssen, Moonlake, Novartis, Pfizer, Takeda and UCB Pharma. Honoraria; AbbVie, Biogen, Eli Lilly, Janssen, Moonlake, Novartis, Pfizer, Takeda and UCB Pharma. Grants/research support; Janssen, Novartis and UCB Pharma. V. Navarro-Compán: Consultancies; AbbVie, Eli Lilly, Galapagos, MoonLake, MSD, Novartis, Pfizer and UCB Pharma. Member of speakers’ bureau; AbbVie, Eli Lilly, Fresenius Kabi, Janssen, MSD, Novartis, Pfizer and UCB Pharma. Grants/research support; AbbVie and Novartis.

P167 Bimekizumab achieved sustained improvements in efficacy outcomes in patients with axial spondyloarthritis, regardless of prior tumour necrosis factor inhibitor treatment: week 52 pooled results from the phase 3 studies BE MOBILE 1 and BE MOBILE 2

Abstract Background/Aims Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL17A. In the phase 3 BE MOBILE 1 and 2 studies, BKZ treatment resulted in rapid and sustained improvements in efficacy outcomes through 52 weeks (wks) in patients with active nonradiographic axial spondyloarthritis (nr-axSpA) and radiographic (r)axSpA (i.e., ankylosing spondylitis [AS]). Here, we assess the efficacy of BKZ in tumour necrosis factor inhibitor (TNFi)-naïve or -inadequate responder (IR) patients with active nr-axSpA and raxSpA through Wk52. Methods In BE MOBILE 1 (nr-axSpA; NCT03928704) patients met Assessment of SpondyloArthritis international Society (ASAS) classification criteria and in BE MOBILE 2 (r-axSpA; NCT03928743) patients fulfilled modified New York and ASAS criteria. Patients were randomised to receive subcutaneous BKZ 160mg every 4wks (Q4W) or placebo (PBO) then BKZ 160mg Q4W from Wk16. This post-hoc analysis reports pooled mean efficacy data, including disease activity, MRI inflammation, physical function, and quality of life (QoL), through Wk52, stratified by TNFi status (naïve/IR). TNFi-IR patients were defined as those who experienced intolerance, or IR, to prior treatment given at an approved dose for ≥12wks. Results This pooled analysis included 505 TNFi-naïve and 81 TNFi-IR patients. 302/505 (59.8%) TNFi-naïve and 47/81 (58.0%) TNFi-IR patients were randomised to BKZ. Higher proportions of BKZ-randomised patients vs PBO achieved Wk16 ASAS40 (TNFinaïve: 46.0% vs 23.2%, TNFi-IR: 44.7% vs 14.7%; multiple imputation) and AS Disease Activity Score (ASDAS) &amp;lt;2.1 or low disease activity (47.9% vs 20.3%, 30.2% vs 15.6%; observed case). In continuous BKZ-treated patients, responses increased to Wk52 (ASAS40: 59.9%, 55.3%; ASDAS&amp;lt;2.1: 62.0%, 54.1%). Greater reductions from baseline in ASDAS-CRP and MRI inflammation by Wk16 were achieved with BKZ vs PBO in both TNFi-naïve/-IR patients; in continuous BKZ-treated patients this was sustained or further improved through 52wks. Comparable improvements in physical function, nocturnal spinal pain and ASQoL were observed through 52wks with BKZ in TNFinaïve/-IR patients (Table). Conclusion Across the full axSpA disease spectrum, BKZ treatment resulted in clinically relevant improvements in key efficacy outcomes vs PBO, including suppression of inflammation and improvements in physical function and QoL, regardless of prior TNFi exposure. Improvements were sustained to Wk52. Disclosure M. Magrey: Consultancies; AbbVie, BMS, Eli Lilly, Novartis, Pfizer and UCB Pharma. Grants/research support; AbbVie, BMS and UCB Pharma. M. Van de Sande: Consultancies; AbbVie, Novartis and UCB Pharma. Member of speakers’ bureau; Janssen, Novartis and UCB Pharma. Grants/research support; Eli Lilly, Novartis and UCB Pharma. M. Breban: Consultancies; Novartis and UCB Pharma. Grants/research support; MSD. F. Van den Bosch: Consultancies; AbbVie, Amgen, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer and UCB Pharma. Member of speakers’ bureau; AbbVie, Amgen, Janssen, Merck, Novartis, Pfizer and UCB Pharma. C. Fleurinck: Other; Employee of UCB Pharma. U. Massow: Other; Employee of UCB Pharma. N. de Peyrecave: Other; Employee of UCB Pharma. T. Vaux: Other; Employee of UCB Pharma. X. Baraliakos: Consultancies; AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, Novartis, Pfizer and UCB Pharma. Member of speakers’ bureau; AbbVie, BMS, Chugai, Eli Lilly, Galapagos, MSD, Novartis, Pfizer and UCB Pharma. Grants/research support; Novartis and UCB Pharma. Other; Paid instructor for AbbVie, BMS, Chugai, Eli Lilly, Galapagos, MSD, Novartis, Pfizer and UCB Pharma. H. Marzo-Ortega: Consultancies; AbbVie, Biogen, Eli Lilly, Janssen, Moonlake, Novartis, Pfizer, Takeda and UCB Pharma. Honoraria; AbbVie, Biogen, Eli Lilly, Janssen, Moonlake, Novartis, Pfizer, Takeda and UCB Pharma. Grants/research support; Janssen, Novartis and UCB Pharma.

BASDAI versus ASDAS in evaluating axial involvement in patients with psoriatic arthritis: a pooled analysis of two phase 3 studies

Abstract Objective In the absence of axial psoriatic arthritis (axPsA)-specific tools, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) are used to assess axial symptoms in patients with PsA. Here, we assessed the performance of BASDAI and ASDAS in patients with PsA. Methods Patients with active PsA in DISCOVER-1 and DISCOVER-2 (ClinicalTrials.gov: NCT03162796 and NCT03158285, respectively) with or without axPsA but with available baseline BASDAI information were analyzed; those with investigator-identified axial symptoms and imaging-confirmed sacroiliitis comprised the axPsA cohort. Correlations between BASDAI/ASDAS and clinical variables were assessed with Pearson’s coefficient (r). Longitudinal effects of enthesitis (Leeds Enthesitis Index [LEI]), swollen joint count (SJC), and presence versuss absence of axPsA on BASDAI/ASDAS (normalized 0–10 scale) were analyzed with mixed models for repeated measures. Results At baseline in the axPsA (n = 312) and non-axPsA (n = 124) cohorts, BASDAI scores showed no or weak correlation with SJC (0.18–0.20), tender joint count (0.12–0.29), LEI (–0.04–0.24), and physician global assessment (0.35–0.43); moderate correlation with fatigue (both –0.56); and strong correlation with patient global assessment of disease activity (0.62–0.69) and patient-reported pain (0.66–0.70). Similar correlations were observed for ASDAS. Axial involvement versuss noninvolvement was associated with higher BASDAI/ASDAS scores (all β ≥ 0.5), without differences between instruments; longitudinal associations between SJC (β  ≤ 0.06)/LEI (β  ≤ 0.19) and BASDAI/ASDAS were clinically unimportant. Conclusion BASDAI and ASDAS performed similarly in patients with active PsA and axial involvement, independent of peripheral disease involvement, supporting their performance in assessing axial disease activity. Clinical Trial Registration Trials are registered at ClinicalTrials.gov (NCT03162796 and NCT03158285).

Clinical value of the Patient Global Assessment with Ankylosing Spondylitis: A cross-sectional study.

To analyze the factors associated with the overall patient condition and explore the clinical value of the Patient Global Assessment (PGA) index for assessing the disease state in patients with Ankylosing Spondylitis (AS). This cross-sectional study used a standardized questionnaire to record the basic information of patients with AS. The collected data included the Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-reactive protein (CRP), ASDAS-erythrocyte sedimentation rate (ESR), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), PGA, and other clinical indicators. Statistical analysis was performed using SPSS 25.0 software, and the scale was assessed for retest reliability and structural validity. The Kruskal-Wallis H test and Spearman or Pearson correlation analysis were used to analyze the factors influencing PGA scores. The receiver operator characteristic (ROC) curve was used to identify the cutoff value of the PGA for predicting disease activity in AS. The patient age, disease duration, family history, and history of ocular inflammation significantly differed between PGA groups (P < .05). The median PGA was significantly lower in patients with disease remission than in those with disease activity (P < .01). The various clinical indexes significantly differed between PGA groups (P < .01). The PGA was significantly correlated with various clinical indicators (P < .01). The area under the ROC curve (AUC) for disease activity based on the ASDAS-CRP was 0.743 (P < .01) with a PGA cutoff value of 1.38; the AUC for disease activity based on the BASDAI was 0.715 (P < .01) with a PGA cutoff value of 1.63. The PGA was significantly correlated with patient-reported outcomes, disease activity, function, and psychological status, and may indicate the level of inflammation in patients with AS. A PGA of around 1.5 indicates disease activity.

ASDAS-CRP and ASDAS-ESR cut-offs for disease activity states in axial spondyloarthritis - Are they interchangeable?

Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP) is recommended over erythrocyte sedimentation rate (ASDAS-ESR) to assess disease activity in axial spondyloarthritis (axSpA). Although ASDAS-CRP and ASDAS-ESR are not interchangeable, the same disease activity cut-offs are used for both. We aimed to estimate optimal ASDAS-ESR values corresponding to the established ASDAS-CRP cut-offs (1.3, 2.1 and 3.5) and investigate the potential improvement of level of agreement between ASDAS-ESR and ASDAS-CRP disease activity states when applying these estimated cut-offs. We used data from axSpA patients initiating a tumour necrosis factor inhibitor from nine European registries. ASDAS-ESR cut-offs were estimated using the Youden index. Level of agreement between ASDAS-ESR and ASDAS-CRP disease activity states was compared against each other. In 3,664 patients, mean ASDAS-CRP was higher than ASDAS-ESR at both baseline (3.6 and 3.4, respectively) and aggregated follow-up at 6, 12, or 24 months (1.9 and 1.8, respectively). The estimated ASDAS-ESR values corresponding to the established ASDAS-CRP cut-offs were 1.4, 1.9 and 3.3. By applying these cut-offs, the proportion of discordance between disease activity states according to ASDAS-ESR and ASDAS-CRP decreased from 22.93% to 19.81% in baseline data but increased from 27.17% to 28.94% in follow-up data. We estimated the optimal ASDAS-ESR values corresponding to the established ASDAS-CRP cut-off values. However, applying the estimated cut-offs did not increase the level of agreement between ASDAS-ESR and ASDAS-CRP disease activity states to a relevant degree. Our findings did not provide evidence to reject the established cut-off values for ASDAS-ESR.

Drug Survival, Effectiveness and Safety of Secukinumab in Axial Spondyloarthritis up to 4 Years: A Real-Life Single Center Experience.

(1) Objective: The main aims of our study were to explore the drug survival and effectiveness of secukinumab in patients with axial spondyloarthritis (axSpA). (2) Methods: We underwent a retrospective analysis of consecutive axSpA treated with secukinumab as a first line of biologics or at switch in a biologic-experienced population. Efficacy data, indicating improvement in inflammation parameters (such as C-reactive protein and erythrocyte sedimentation rate) and disease activity scores (such as Ankylosing Spondylitis Disease Activity Score [ASDAS-CRP], Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]), and patient-reported outcomes (pain), were assessed at 6, 12, 24, 36 and 48 months. The drug survival rate, dropout rate and discontinuation reasons (efficacy versus safety) of secukinumab were assessed in subgroup analysis (axSpA with and without exposure to biologics). (3) Results: In total, 46 patients were exposed to the IL-17A inhibitor secukinumab. The drug survival for axSpA patients 59.7% at 12 months and 31.3% at 24 months. There were no statistically significant differences in the median drug survival between biologic-naïve versus biologic-experienced subgroups. (4) Conclusions: Secukinumab has demonstrated effectiveness and safety in treating a cohort of axSpA patients in real-world settings, with a notable retention rate of the drug.

The cost-effectiveness of a bimekizumab versus IL-17A inhibitors treatment-pathway in patients with active axial spondyloarthritis in Scotland

Objective To estimate the cost-effectiveness of a treatment-pathway initiated with bimekizumab, a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F and IL-17A, in patients with axial spondyloarthritis (axSpA) compared with IL-17Ai's, ixekizumab, and secukinumab, from the NHS Scotland perspective. Methods The axSpA treatment-pathway was modeled using a decision tree followed by a lifetime Markov model. The pathway included first- and second-line biologic disease-modifying antirheumatic drugs (bDMARD), followed by best supportive care (bDMARD, nonbiologic). Bimekizumab followed by any bDMARD (“BKZ”) was compared with IL-17Ai’s: secukinumab 150 mg followed by a blend (“SEC”) of dose up-titration to secukinumab 300 mg and any bDMARD, or ixekizumab followed by any bDMARD (“IXE”). Transition to the next therapy was triggered by Bath Ankylosing Spondylitis Disease Activity Index-50% (BASDAI50) non-response or any-cause discontinuation. A published network meta-analysis provided efficacy data. EuroQoL-5-dimensions utilities were derived by mapping from Ankylosing Spondylitis Disease Activity Score. Costs included disease management (linked to functional limitations), biologics acquisition (list prices), administration and monitoring (NHS 2021/22). Discounting was 3.5%/year. Probabilistic results from patients with non-radiographic axSpA and ankylosing spondylitis were averaged to reflect the axSpA disease spectrum. Scenario and sensitivity analyses were performed. Results The incremental cost-effectiveness ratio (ICER) of BKZ was £24,801/quality-adjusted life-year (QALY) vs. SEC (95% credible interval £24,163–£25,895). BKZ had similar costs (Δ -£385 [−£15,239–£14,468]) and QALYs (Δ 0.039 [−0.748–0.825]) to IXE, with £1,523 (£862–£2,222) net monetary benefit. Conclusions remained unchanged in most scenarios. Results’ drivers included BASDAI50 response rate and disease management cost. Limitations Results were based on list prices. Data concerning up-titration to secukinumab 300 mg was scarce. Conclusions The bimekizumab treatment-pathway represents a cost-effective option across the axSpA disease spectrum in Scotland. Bimekizumab is cost-effective compared to a secukinumab-pathway that includes dose up-titration, and has similar costs and QALYs to an ixekizumab-pathway.

Association of clinical response criteria and disease activity levels with axial spondyloarthritis core domains: results from two phase 3 randomised studies, BE MOBILE 1 and 2

ObjectiveTo assess how achievement of increasingly stringent clinical response criteria and disease activity states at week 52 translate into changes in core domains in patients with non-radiographic (nr-) and radiographic...

Assessment of the endothelial glycocalyx state in patients with axial spondyloarthritis associated with Crohn’s disease

BACKGROUND: Epithelial barrier dysfunction, including their permeability increment, is supposed to be a pathogenetic link in the development of various immunoinflammatory diseases, including Crohn’s disease and axial spondyloarthritits. Endothelial permeability regulation is provided by both intercellular contacts and endothelial glycocalyx. AIM: To study the microcirculatory state by measuring the endothelial glycocalyx thickness in patients with axial spondyloarthritits associated with Crohn’s disease. To identify an association between the endothelial glycocalyx thinning and the epithelial permeability severity in patients with Crohn’s disease, axial spondyloarthritits and their combination. MATERIALS AND METHODS: 12 patients with axial spondyloarthritits associated with Crohn’s disease (group A), 22 patients with idiopathic axial spondyloarthritits (group B), 24 patients with Crohn’s disease (group C) and 16 healthy individuals (group D) were examined. The endothelial glycocalyx thickness was assessed in the sublingual region using dark-field microscopy. Fecal calprotectin and fecal zonulin was studied. RESULTS: A statistically significant increase in the perfused boundary region high flow was found (p = 0.001), as well as the MicroVascular Health Score (p = 0.004) in group A compared with the control. In Group A, a positive correlation between perfused boundary region high flow and scores Ankylosing Spondylitis Disease Activity Score, Bath Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Metrology Index 10 (p 0.05) was found; perfused boundary region 5–9 mµ correlated positively with the fecal calprotectin (p = 0.007). Perfused boundary region high flow measurement provides 77.1% accuracy for correct classification of axial spondyloarthritits associated with Crohn’s disease and idiopathic axial spondyloarthritits (p = 0.010). In group C, a positive correlation between fecal zonulin and perfused boundary region 5–9 mµ, 10–19 mµ, 5–25 mµ (p 0.05) was also found. CONCLUSIONS: The findings suggest that the patients with axial spondyloarthritits associated with Crohn’s disease have endothelial glycocalyx impairment; the detection of these abnormalities may be useful in assessing the disease integral activity and in the differential diagnosis of axial spondyloarthritits associated with Crohn’s disease and idiopathic axial spondyloarthritits. Further studies of microcirculation will allow better understanding of spondyloarthritis and inflammatory bowel diseases pathogenesis and improve the management of patients with these diseases.

Different Therapeutic Response to Anti-TNF Drugs in Patients with Axial Spondyloarthritis Depending on Their Clinical Profile: An Unsupervised Cluster Analysis.

Background: The objectives were as follows: (a) to identify, among patients with axial spondyloarthritis (axSpA), "clusters" of patients based on the presence of peripheral and extra-musculoskeletal manifestations (EMMs) and (b) to compare the effectiveness of the first anti-TNF drugs across the different clusters after 6 months of follow-up. Methods: An observational and retrospective study of 90 axSpA patients naïve to bDMARDs was conducted. An unsupervised cluster analysis using the "k-means" technique was performed using variables of peripheral and EMMs. Baseline clinical and sociodemographic characteristics were evaluated, and the response to anti-TNF treatment (considering responders as those with an improvement ≥1.1 for the Ankylosing Spondylitis Disease Activity Score (ASDAS) or ≥2.0 for the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)) was compared across the clusters after 6 months of follow-up. Results: Two clusters were identified: cluster 1 (n = 14), with a higher prevalence of peripheral manifestations, inflammatory bowel disease (IBD), and HLA-B27-positive status, and a lower prevalence of uveitis in comparison with cluster 2 (n = 76). Patients from cluster 1 experienced a more pronounced absolute improvement in ASDAS and BASDAI indices after 6 months. The percentage of responders after 6 months of follow-up was superior in cluster 1 compared to cluster 2 (85.7% vs. 48.7%, p = 0.011). Conclusion: This study suggests the existence of two clinical profiles in axSpA patients according to the peripheral and EMMs, with higher rates of anti-TNF effectiveness after 6 months in those with a greater presence of peripheral features.

Comparative Effectiveness of Tofacitinib and Adalimumab in Axial Spondyloarthritis: A Real-World Clinical Context Multicenter Study.

Tofacitinib, an oral Janus kinase inhibitor, is a putative choice in the treatment of axial spondyloarthritis (AxSpA). The objective of this study was to compare the effectiveness and tolerability of tofacitinib with adalimumab, in AxSpA, in a real-world clinical setting. In this multicentric medical records review study, adult patients with active AxSpA treated with either tofacitinib 5 mg twice daily or adalimumab 40 mg subcutaneously fortnightly were recruited. Effectiveness was measured with Ankylosing Spondylitis Disease Activity Score (ASDAS) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Drug-cost analysis was calculated with Incremental Cost-Effectiveness Ratio (ICERdrug). Among the 266 patients, 135 were treated with tofacitinib and 131 with adalimumab (follow-up: 6.5 ± 1.6 months). Mean improvement of BASDAI (3.39 ± 0.09 vs. 3.14 ± 1.16, respectively) and that of ASDAS (1.78 ± 0.68 vs. 2.07 ± 2.08, respectively) were comparable between the adalimumab and tofacitinib groups. A higher proportion of patients achieved BASDAI50 response in the second (49.5% vs. 31.6%) and fourth month (83.9% vs. 62.8%) and ASDAS low disease activity in the fourth month (71.6% vs. 47.9%) in the adalimumab group. All disease activity measurements were similar by the sixth month in both groups. A higher proportion of patients in the tofacitinib group than in the adalimumab group required change in therapy (14.8% vs. 7.6%, respectively). ICERdrug for adalimumab compared with tofacitinib was US $188.8 per patient in the adalimumab group for each person-month with BASDAI <4. Tofacitinib showed comparable effectiveness with adalimumab in patients with AxSpA at the sixth month, despite lesser response in the initial months, with favorable ICERdrug.

Can serum granulocyte-macrophage colony-stimulating factor and CCL17 levels be a marker of disease activation in spondyloarthritis?

Objectives: The aim of this cross-sectional study was to investigate if serum levels of granulocytemacrophage colony-stimulating factor (GM-CSF) and CC chemokine ligand 17 (CCL17) correlate with disease activity in axial spondyloarthritis (axSpA) and peripheral spondyloarthritis (pSpA) patients. Patients and methods: The cross-sectional study was conducted with 80 individuals (48 females, 32 males; mean age: 47.7±11.5) between March 2021 and September 2021. Of the participants, 20 were axSpA, 20 were pSpA, and 20 were active rheumatoid arthritis patients, and the remaining 20 were healthy controls. Age, sex, body mass index, disease duration, comorbid diseases, smoking status, medical treatments, C-reactive protein (CRP) level and human leukocyte antigen B27 (HLA-B27) positivity were recorded. Serum GM-CSF and CCL17 levels were analyzed by ELISA. Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP) was used to evaluate the disease activity of patients with spondyloarthritis. Functional status of spondyloarthritis patients was evaluated by Bath Ankylosing Spondylitis Functional Index (BASFI). Results: While the serum GM-CSF levels were similar in the axSpA and pSpA groups, they were significantly higher than the healthy control group (p=0.021 and p=0.009, respectively). There was a significant correlation between GM-CSF levels and ASDAS-CRP (r=0.545, p=0.013) and BASFI (r=0.546, p=0.013) in the axSpA group. In active axSpA patients, the cut-off value for GM-CSF was 15.89 pg/mL (sensitivity 50%, specificity 100%). No differences were detected in serum CCL17 levels among the groups. Conclusion: The results suggest that serum GM-CSF levels may be used as a new marker for the evaluation of disease activity in axSpA, and GM-CSF might be a therapeutic target.

The relationship between clinical parameters and ultrasonographic enthesitis assessment in patients with spondyloarthritis

Objectives: The study aimed to evaluate the role of ultrasonographic assessment of enthesitis in patients with spondyloarthritis (SpA) in terms of disease activity, functionality, and quality of life. Patients and methods: Ninety SpA patients (57 males, 33 females; mean age: 37.5±9.7 years; range, 18 to 60 years) were included in cross-sectional study between November 2016 and January 2017. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath Ankylosing Spondylitis Functional Index (BASFI), Short Form-12 (SF-12), and Ankylosing Spondylitis Quality of Life (ASQoL) were utilized for clinical evaluation. The clinical evaluation of enthesitis was performed with the Spondyloarthritis Research Consortium of Canada (SPARCC) and Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) via an algometer calibrated to 4 kg/cm2 of pressure. Ultrasound evaluation was performed according to Madrid Sonographic Enthesitis Index (MASEI). A total of 2,610 entheseal sites were examined clinically, and 1,080 were assessed ultrasonographically. Results: A significant proportion of enthesitis (463/1,080) was detected on ultrasonographic evaluation but not with clinical enthesitis score (MASES and SPARCC). Although ultrasonographic entheseal evaluation detected enthesitis in at least one enthesis of all patients, 35 of the patients had no enthesitis with clinical examination. The sites most frequently involved in the entheses were the proximal patellar tendon and Achilles tendon. The MASEI score did not correlate with the MASES, SPARCC, BASDAI, SF-12, and ASQoL but moderately correlated with the C-reactive protein (CRP) level (r=0.348), ASDAS-CRP (r=0.294), and BASFI score (r=0.244). Conclusion: The association of ultrasonography scores with CRP levels and ASDAS-CRP indicates that ultrasonography is effective in detecting inflammation. The MASEI score weakly correlates with functionality but not with quality of life. Ultrasonographic evaluation is invaluable and merits to be incorporated into SpA disease scoring system.

Comparison of Ankylosing Spondylitis Disease Activity Score and Bath Ankylosing Spondylitis Disease Activity Index tools in assessment of axial spondyloarthritis activity.

Axial spondyloarthritis (axSpA) is an inflammatory joint disease, in which the dominant symptom is inflammatory back pain. It affects approximately 1% of the population, with a higher incidence in males. Spinal pain associated with spondyloarthritis is referred to as inflammatory back pain. In clinical practice, it is extremely important to be able to assess the activity of inflammatory back diseases and to select appropriate treatment and monitor the therapy. Currently, two main tools are used for assessment of the activity of axial spondyloarthritis: BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) and ASDAS (Ankylosing Spondylitis Disease Activity Score). The BASDAI is a tool used for years for assessment of disease activity, determining eligibility for treatment, and making decisions about continuation of therapy. Since BASDAI depends entirely on patient self-assessment, it is considered less objective than the ASDAS index. In turn, the latter includes not only answers to questions provided by the patient but also a parameter of inflammation such as erythrocyte sedimentation rate or C-reactive protein (CRP). Additionally, increasing numbers of studies report advantages of the ASDAS index over BASDAI. Moreover, as indicated by ASAS/EULAR (Assessment in Spondyloarthritis International Society/European Alliance of Associations for Rheumatology) 2022, ASDAS, especially ASDAS-CRP is the preferred tool for assessment of the activity of axSpA, whereas BASDAI is used only when the evaluation of the ASDAS is not possible. This paper presents the definition and symptoms of axSpA and reviews the latest research on ASDAS and BASDAI, with emphasis on the objectivity of the ASDAS assessment also presenting the doubts and limitations concerning this tool.

Flare prediction after tapering the dose of tumour necrosis factor inhibitors in patients with axial spondyloarthritis: A nationwide cohort study.

To develop a model for predicting flares after tapering the dose of tumour necrosis factor inhibitors (TNFi) in patients with axial spondyloarthritis (axSpA). Data were obtained from the Korean College of Rheumatology Biologics and Targeted Therapy Registry. In total, 526 patients who received the standard-dose TNFi for at least 1 year and tapered their dose were included in the derivation cohort. The main outcome was a flare occurrence defined as an Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP) score of ≥ 2.1 after 1 year of TNFi tapering. The final prediction model was validated using an independent cohort. Among 526 patients, 127 (24.1%) experienced flares. The final prediction model included negative human leucocyte antigen B27 (β = 1.088), inflammatory back pain (β = 1.072), psoriasis (β = 1.567), family history of SpA (β = 0.623), diabetes mellitus (β = 1.092), TNFi tapering by ≥ 50% of the standard-dose (β = 0.435), ASDAS-CRP at tapering (β = 1.029), and Bath Ankylosing Spondylitis Functional Index score at tapering (β = 0.194) as covariates. It showed an excellent discrimination performance (AUC = 0.828). According to the predictive risk, patients were classified into three groups (low-, intermediate-, and high-risk). The probabilities of flares in these groups were 4.5%, 18.1%, and 61.8%, respectively. The performance of the model in the validation cohort was also comparable. The established prediction model accurately predicted the risk of flares after TNFi dose tapering in patients with axSpA using eight simple clinical parameters, which could be helpful to select appropriate patients for tapering their TNFi without flare in daily clinical practice.

Clinical and ultrasonographic enthesitis assessment before and after anti-tumor necrosis factor treatment in patients with spondyloarthritis.

This study aimed to clinically and ultrasonographically evaluate enthesitis in patients with spondyloarthritis (SpA) and to determine enthesitis response to anti-tumor necrosis factor (TNF) treatment. Thirty-one SpA patients (22 males, 9 females; mean age: 39.4±10.9 years; range, 22 to 60 years) who started anti-TNF treatment due to their high disease activity were included in the cross-sectional prospective study between May 2017 and January 2018. Ankylosing Spondylitis Disease Activity Score, Bath Ankylosing Spondylitis Disease Activity Index, Ankylosing Spondylitis Quality of Life Questionnaire, Bath Ankylosing Spondylitis Functional Index, and Bath Ankylosing Spondylitis Metrology Index were recorded. Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) and Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score were utilized for clinical enthesitis evaluation. Patients were ultrasonographically evaluated in accordance with the Madrid Sonographic Enthesitis Index (MASEI) by a blinded sonographer. Patients were clinically and ultrasonographically assessed at baseline and in the third month after the treatment. In the initial evaluation, 24 (77.42%) of the patients had clinical enthesitis, and 30 (96.77%) of the patients had ultrasonographic enthesitis. After anti-TNF treatment, MASES, SPARCC, MASEI-structure, MASEI-thickness, MASEI-bursitis, MASEI-Doppler, MASEI-inflammatory, and MASEI-total scores significantly decreased (p<0.05). There was no significant change in MASEI-damage, MASEI-erosion, and MASEI-calcification scores following the therapy (p>0.05). Anti-TNF treatment may improve clinical and ultrasonographic enthesitis, particularly inflammatory changes. Erosions and calcifications may not ameliorate after three months of anti-TNF treatment.