Real-world retention rate, effectiveness, and safety of netakimab in the treatment of patients with ankylosing spondylitis: Two-year results of the real word evidence LIBRA study

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Under real-world clinical practice together with indices for assessing disease activity and the effectiveness of therapy, drug retention provides critical information on efficacy, safety, compliance and convenience of use.The aim – to obtain data on the safety of netakimab (NTK) in a population of patients with ankylosing spondylitis (AS), including various somatic diseases, as well as to assess retention on therapy during 2 years of observation in real word clinical practice.Materials and methods. Patients were recruited for the study from August 2020 to December 2021 at 23 centers in the Russian Federation. The study included 137 patients who were prescribed netakimab therapy before enrollment. Clinical and medical history data for the first visit were entered retrospectively, and following visits at 12, 24, 52, 76, 104 weeks of therapy were collected within the study. The average age of the patients 42,3 y. O., 34.3% of them with previous biologics therapy.Results. Median observation period was 104 weeks (range 1–137 weeks). At the end of the analyzed period (104 weeks of therapy), 85,5% [95% confidence interval (95% CI): 79.7–91.8] of patients continued treatment with Netakimab. Retention on NTK therapy was slightly better in “bio-naïve” vs patients who received biologics earlier: 88.7% (95% CI: 82.3–95.5) and 78.9% (95% CI: 67.5–92.2), respectively, without significant differences between groups (p=0.16). 21 (15.3%) patients withdrew from study before visit 6. The main end of study reasons was lost to follow-up – 7 (5.1%) patients, and treatment inefficacy – 6 (4.4%) patients. The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) and ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score with C-reactive protein) showed statistically significant decreases from baseline: by three times during the first 3 months of therapy and two times decrease during the first year of treatment. This trend continued in the second year of treatment, although with a lower rate of reduction. By week 104 of therapy, 52.9% (95% CI: 47.3–58.4) reached low disease activity (1.3≤ASDAS<2.1), 21.3% (95% CI: 12.8–29.8) had inactive disease (ASDAS<1.3). Netakimab was well tolerated by patients: AEs, related to therapy according to the investigator’s opinion, were reported in 8 (6.0%) patients.Conclusions. In real-world clinical practice, 85.5% of patients continued treatment with Netakimab at the end of 104 weeks. By 104 weeks 74% patients had low disease activity or inactive disease. Netakimab was well tolerated by most of patients.

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  • 10.1136/annrheumdis-2019-eular.6442
AB0716 ESTABLISHMENT OF BASDAI CUT-OFFS FOR THE DISEASE ACTIVITY STATES BASED ON ASDAS CUT-OFFS IN TAIWANESE ANKYLOSING SPONDYLITIS PATIENTS
  • Jun 1, 2019
  • Annals of the Rheumatic Diseases
  • Hsin-Hua Chen + 12 more

AB0716 ESTABLISHMENT OF BASDAI CUT-OFFS FOR THE DISEASE ACTIVITY STATES BASED ON ASDAS CUT-OFFS IN TAIWANESE ANKYLOSING SPONDYLITIS PATIENTS

  • Abstract
  • 10.1136/annrheumdis-2012-eular.891
AB0891 Correlation of ASDAS and BASDAI with disease activity in axial spondyloarthritis
  • Jun 1, 2013
  • Annals of the Rheumatic Diseases
  • J.L Rosales Alexander + 4 more

AB0891 Correlation of ASDAS and BASDAI with disease activity in axial spondyloarthritis

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  • 10.1136/annrheumdis-2014-eular.3931
FRI0141 Rapid3 in 90 Korean Patients with Ankylosing Spondylitis Yields Similar Information to BASDAI and Asdas, with Greater Feasibility for Busy Clinical Settings
  • Jun 1, 2014
  • Annals of the Rheumatic Diseases
  • S.-H Park + 4 more

FRI0141 Rapid3 in 90 Korean Patients with Ankylosing Spondylitis Yields Similar Information to BASDAI and Asdas, with Greater Feasibility for Busy Clinical Settings

  • Abstract
  • 10.1136/annrheumdis-2012-eular.922
AB0922 Disease activity assessment in ankylosing spondylitis: Basdai or asdas?
  • Jun 1, 2013
  • Annals of the Rheumatic Diseases
  • Y.L.E Au + 5 more

AB0922 Disease activity assessment in ankylosing spondylitis: Basdai or asdas?

  • Research Article
  • 10.1177/1759720x231201714
The predictability of ASDAS on drug survival in patients with ankylosing spondylitis on biologic therapy: data from the KOBIO registry.
  • Jan 1, 2023
  • Therapeutic Advances in Musculoskeletal Disease
  • Jinhyun Kim + 5 more

The Ankylosing Spondylitis (AS) Disease Activity Score (ASDAS) is largely used for assessing disease activity in patients with AS. We aimed to investigate the predictability of ASDAS on drug survival in patients with low Bath AS Disease Activity Index (BASDAI) during biologic therapy. Using data from multi-center, prospective, observational prospective cohort, Korean College of Rheumatology Biologics and Targeted Therapy (KOBIO) registry. The study population consisted of patients enrolled in the KOBIO registry from December 2012 to December 2018. The baseline demographic data and variables such as extra-articular manifestations, HLA-B27 positivity, family history of spondyloarthritis, ASDAS C-reactive protein (CRP), BASDAI, and Bath AS Functional Index scores were collected from the database. The disease activity indices were followed yearly after initiating a tumor necrosis factor (TNF) inhibitor (TNFi). Disease activities were defined as high (ASDAS-CRP ⩾ 2.1, BASDAI ⩾ 4) and low (ASDAS-CRP < 2.1, BASDAI < 4). Data from 1773 patients were analyzed. Among 269 patients with low BASDAI at baseline, 151 (56.1%) patients had high ASDAS-CRP, yet in 142 patients with low ASDAS-CRP at baseline, only 24 (16.9%) patients had a high BASDAI. High ASDAS-CRP captured more patients who had initiated or switched to a TNFi than those with high BASDAI (92.5% versus 84.8%, respectively, p < 0.001). Moreover, among AS patients with low BASDAI after 1 year of therapy, drug persistence in the following year was significantly lower in patients with high ASDAS than in those with low ASDAS (68.7% versus 82.5%, p < 0.001). ASDAS-CRP not only has its advantages over BASDAI in assessing disease activity but also low ASDAS-CRP at 1 year can be a marker of long-term drug survival of TNFi therapy.

  • Research Article
  • Cite Count Icon 37
  • 10.1097/jim.0000000000000095
Elevated Serum Levels of Calprotectin (Myeloid-Related Protein 8/14) in Patients With Ankylosing Spondylitis and Its Association With Disease Activity and Quality of Life
  • Aug 1, 2014
  • Journal of Investigative Medicine
  • Pelin Oktayoglu + 5 more

BackgroundCalprotectin is one of the major leukocyte S100 proteins showing both calcium binding and antimicrobial characteristics. The serum level of calprotectin is markedly elevated in patients with inflammatory bowel disease,...

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  • Cite Count Icon 21
  • 10.1007/s10067-012-2056-7
A simplified version of Ankylosing Spondylitis Disease Activity Score (ASDAS) in patients with ankylosing spondylitis
  • Aug 16, 2012
  • Clinical Rheumatology
  • Fernando A Sommerfleck + 4 more

This study aimed to develop a simplified version of the Ankylosing Spondylitis Disease Activity Score (ASDAS). The study included consecutive patients with ankylosing spondylitis according to modified New York and/or Assessment in Ankylosing Spondylitis 2009 criteria. Sociodemographic data and characteristics of the disease (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), and Ankylosing Spondylitis Quality of Life (ASQoL)) and erythrocyte sedimentation rate (ESR) were collected. ASDAS simplified version (SASDAS) was calculated as the simple linear sum of the five components of ASDAS which include: patient global assessment using visual analogue scale, back pain (BASDAI question no. 2), peripheral pain and swelling (BASDAI question no. 3), morning stiffness (BASDAI question no. 6), and ESR in millimeters per hour, divided by 10 so as to make it equivalent to the other scale's components. Eighty-six patients were included: 69 (80.2 %) were men with a median age of 46 years and median disease duration of 19 years. SASDAS showed an excellent correlation with the ASDAS (r = 0.93). SASDAS also showed a good correlation with night pain (r = 0.60), global pain (r = 0.69), ASQoL (r = 0.70), BASFI (r = 0.75), and BASDAI (r = 0.96). Using ASDAS cut-off values previously suggested, the corresponding cut-off values for SASDAS were as follows: from 0 to 7.8 (inactive disease), from 7.9 to 13.8 (moderate disease activity), from 13.9 to 27.6 (high disease activity), and above 27.6 (very high disease activity) with optimum sensitivity and specificity. SASDAS showed an excellent correlation with conventional clinical measures of disease activity, and it can be easily calculated and is simple to use in daily clinical practice.

  • Research Article
  • Cite Count Icon 29
  • 10.1007/s00296-014-3168-y
Discriminant validity of the Ankylosing Spondylitis Disease Activity Score (ASDAS) in patients with non-radiographic axial spondyloarthritis and ankylosing spondylitis: a cohort study.
  • Nov 4, 2014
  • Rheumatology International
  • Erkan Kilic + 3 more

The aim of this study was to assess discriminant validity of Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-reactive protein (-CRP) and ASDAS-erythrocyte sedimentation rate (-ESR) and to compare with The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as clinical tools for the measurement of disease activity in patients with non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS). Also, the cut-off values for ASDAS-CRP in nr-axSpA and AS is revisited. Patients with axSpA were recruited from Erciyes Spondyloarthritis Cohort (ESPAC) and were assessed for disease activity, quality of life and functional measures. The discriminatory ability of ASDAS-CRP and ASDAS-ESR was assessed using standardized mean differences and receiver operating characteristic (ROC) curves analysis. Optimal cut-off values for disease activity scores were calculated. Two hundred and eighty-seven patients with axSpA (nr-axSpA:132, AS:155) were included in this study. Two ASDAS versions and BASDAI had good correlations with patient's and physician's global assessment in both groups. Discriminatory ability of ASDAS-CRP, ASDAS-ESR and BASDAI were similar in patients with nr-axSpA and AS when the patients were assigned into low and high disease activity according to the ASAS partial remission, patient's and physician's global assessment scores (based on the comparison of ROC curves). ASDAS cut-off values are quite similar between groups indicating that ASDAS-CRP works similarly well in nr-axSpA and AS. The performance of ASDAS to discriminate low and high disease activity and cut-off values are quite similar in patients with AS and non-radiographic axial SpA.

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  • 10.28982/josam.7887
Value of ischemia-modified albumin in ankylosing spondylitis
  • Sep 19, 2023
  • Journal of Surgery and Medicine
  • Nurdan Orucoglu Yildirim + 2 more

Background/Aim: Ankylosing spondylitis (AS) is a chronic inflammatory illness with a poorly known pathogenesis. Current biomarkers that are used to estimate inflammation are normal in some patients despite having active disease. Recent studies have revealed that oxidative stress may have a role in AS and that there is a close relationship between oxidative stress and inflammation. Ischemia-modified albumin (IMA) is a promising new biomarker for oxidative stress. Thus, the aim of this study was to assess IMA levels and their relationship with disease activity and other inflammatory markers in patients with AS. Methods: This prospective case-control study included 48 patients with AS and 25 healthy controls (HCs). The measured serum levels of IMA, interleukin (IL)-17, and IL-23 were compared between patients with AS and the HC group. We also analyzed the correlation between IMA and disease activity, acute phase reactants, and HLA-B27 positivity. The Ankylosing Spondylitis Disease Activity Score with C-Reactive Protein (ASDAS-CRP) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) were used to determine disease activity. Results: There was no difference in serum IMA levels between the AS and HC groups (25.08 [20.49-46.83] vs. 29.89 [29.89-42.0], P=0.146). Only IL-23 was significantly higher in patients with AS (10.81 [7.25-14.06] vs. 7.95 [6.85-10.46], P=0.039). Furthermore, there was no correlation between IMA and IL-23, IL-17, CRP, ESR, BASDAI, or ASDAS-CRP (r=-0.079, P=0.593; r=-0.043, P=0.771; r=-0.018, P=0.906; r=0.047, P=0.751; r=0.281, P=0.053; r=0.162, P=0.271). There was no significant difference between IMA, IL-17, and IL-23 levels in patients with low disease activity (BASDAI &lt;4, ASDAS-CRP &lt;2.1) and high disease activity (BASDAI ≥4, ASDAS-CRP ≥2.1) (BASDAI: P=0.146, P=0.303, P=0.071, and ASDAS-CRP: P=0.451, P=0.410, P=0.324, respectively). There was no difference in IMA levels between HLA-B27-positive patients and HLA-B27-negative patients (P=0.070). Conclusion: Although oxidative stress has been suggested to play a role in AS pathogenesis, we did not find an increase in serum levels of IMA, an oxidative stress biomarker, in patients with AS. Our results suggest that IMA may not be a reliable indicator of inflammation. Further research is needed to determine whether IMA may have a role as a biomarker in AS.

  • Research Article
  • Cite Count Icon 22
  • 10.3389/fmed.2022.856654
The BASDAI Cut-Off for Disease Activity Corresponding to the ASDAS Scores in a Taiwanese Cohort of Ankylosing Spondylitis
  • May 16, 2022
  • Frontiers in Medicine
  • Yi-Hsing Chen + 15 more

ObjectivesThe Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) has been widely utilized to evaluate disease activity in patients with ankylosing spondylitis (AS) by an arbitrary cut-off of ≥4 to indicate high disease activity and initiate biological therapy. The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a new composite index to assess AS disease activity states that have been defined and validated. ASDAS ≥2.1 was selected as a criterion to start biological therapy. The purpose of this study was to estimate the corresponding BASDAI and ASDAS cut-off in a Taiwanese AS cohort.MethodsFrom November 2016 to October 2018, we assessed the ASDAS and the BASDAI regularly and recorded demographic data for 489 AS patients in Taichung Veterans General hospital (TCVGH) using an electronic patient-reported data system linked to electronic medical records. We used receiver operating characteristic curves with Youden's J statistic to determine the BASDAI values that correspond to ASDAS disease activity cut-offs (i.e., 1.3, 2.1, and 3.5).ResultsIn our population, the best trade-off BASDAI values corresponding to ASDAS -C-reactive protein (CRP) 1.3, 2.1, and 3.5 were 2.1, 3.1, and 3.7, respectively. The optimal BASDAI values corresponding to ASDAS-erythrocyte sedimentation rates 1.3, 2.1, and 3.5 were 2.0, 2.6, and 4.8, respectively.ConclusionWe propose a revised BASDAI cut-off based on our data, as BASDAI scores are commonly used globally. A more reasonable, lower BASDAI cut-off to initiate or change biological therapy will bring us closer to better decisions to treat AS patients.

  • Abstract
  • Cite Count Icon 1
  • 10.1136/annrheumdis-2016-eular.5468
AB0710 Platelet Distribution Width as An Adjunctive Inflammatory Marker in Patients with Ankylosing Spondylitis
  • Jun 1, 2016
  • Annals of the Rheumatic Diseases
  • S.-J Byun + 4 more

AB0710 Platelet Distribution Width as An Adjunctive Inflammatory Marker in Patients with Ankylosing Spondylitis

  • Abstract
  • 10.1136/annrheumdis-2022-eular.4224
AB0864 A nomogram model combining inflammatory factors and MRI radiomics to assess the disease activity of the patients with axSpA in a prospective study
  • May 23, 2022
  • Annals of the Rheumatic Diseases
  • L Ye + 6 more

BackgroundClinical and magnetic resonance imaging (MRI) disease activity score (DAS) are measuring different aspects of axial spondyloarthritis (axSpA), they are essential in disease activity assessment. The radiomics was on facilitating...

  • Abstract
  • 10.1136/annrheumdis-2015-eular.2310
SAT0238 Gender-Attributable Differences in Outcome of Ankylosing Spondylitis: Long-Term Results from the Outcome in Ankylosing Spondylitis International Study
  • Jun 1, 2015
  • Annals of the Rheumatic Diseases
  • C Webers + 8 more

SAT0238 Gender-Attributable Differences in Outcome of Ankylosing Spondylitis: Long-Term Results from the Outcome in Ankylosing Spondylitis International Study

  • Research Article
  • 10.14412/1996-7012-2025-5-62-68
Efficacy and safety of 24-week therapy with a monoclonal antibody to TRBV9+ T lymphocytes (seniprutug) in patients with ankylosing spondylitis: real-world data
  • Oct 18, 2025
  • Modern Rheumatology Journal
  • E A Vasilenko + 4 more

In April 2024, the first biologic agent (seniprutug) selectively targeting CD8+ T lymphocytes bearing the TRBV9 segment was approved. This novel mechanism of action potentially affects the initial immunopathologic cascade in HLA-B27-associated ankylosing spondylitis (AS). During 2024, seniprutug therapy was initiated in 9 patients with AS in the European part of Russia.Objective. To evaluate the efficacy and safety of seniprutug in patients with AS at 12 and 24 weeks (3 and 6 months) in real-world clinical practice.Material and methods. Nine patients with AS were included: 7 men (77.8%) and 2 women (22.2%); mean age 37.3±12.6 years. AS was diagnosed according to ASAS (2009) and the modified New York criteria (1984). Active sacroiliitis on magnetic resonance imaging (MRI) was present in 8 patients (88.9%); spondylitis in at least one spinal segment in 7 (77.8%), with bone-marrow edema (MRI-confirmed spondylitis) in 6 (66.7%). Baseline disease activity was high: Ankylosing Spondylitis Disease Activity Score (ASDAS) 3.83±0.53; Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 5.7±2.01; inflammatory markers were elevated: C-reactive protein (CRP) 49.6±36.7 mg/L (&gt;5 mg/L in 8 patients) and erythrocyte sedimentation rate (ESR) 56.4±28.5 mm/h (&gt;15 mm/h in all patients). Intravenous seniprutug infusions were administered at weeks 0 and 12. Complete 12- and 24-week follow-up data were available for all 9 patients by September 2025.Results and discussion. At week 12, 8 from 9 patients reported subjective improvement. Mean activity scores decreased: ASDAS to 2.57±0.94 and BASDAI to 3.41±1.17. CRP and ESR declined to 26.79±46.35 mg/L and 25.7±29 mm/h, respectively; normalization of laboratory indices occurred in 55.6% of patients. Low disease activity by ASDAS and BASDAI was recorded in 33.3% and 77.8% of cases, respectively. At week 24, 8 of 9 patients (88.9%) achieved ASAS40 response; mean ASDAS was 1.59±0.21 and BASDAI 1.75±0.81. Mean reductions were ΔASDAS (weeks 0–24) 2.42±0.75 and ΔBASDAI (weeks 0–24) 4.24±2.0. In all patients completing follow-up, inflammatory markers markedly decreased (CRP 3.4±2.3 mg/L; ESR 11.6±7.2 mm/h). One non-responder was switched to an alternative biologic DMARD.Conclusion. This first real-world study demonstrates significant clinical and laboratory improvement in AS patients treated with seniprutug. The 24-week data support the potential of this approach to modulate the pathogenic cascade in HLA-B27-associated AS and justify further evaluation in larger cohorts.

  • Research Article
  • Cite Count Icon 22
  • 10.1097/rhu.0000000000000277
Routine Assessment of Patient Index Data (RAPID3) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Scores Yield Similar Information in 85 Korean Patients With Ankylosing Spondylitis Seen in Usual Clinical Care
  • Sep 1, 2015
  • Journal of Clinical Rheumatology
  • Sung-Hoon Park + 5 more

BackgroundDisease-specific ankylosing spondylitis (AS) indices, including BASDAI (Bath AS Disease Activity Index), BASFI (Bath AS Functional Index), ASDAS (AS Disease Activity Score), and BASMI (Bath AS Metrology Index), are widely used in clinical trials and in some clinical settings, but not in most routine care. Laboratory tests usually are the only quantitative measures included in routine care of AS patients, but often are poorly informative. Routine Assessment of Patient Index Data 3 (RAPID3) on a Multidimensional Health Assessment Questionnaire (MDHAQ) is feasible and informative in many rheumatic diseases.ObjectiveThe aim of this study was to compare RAPID3 to BASDAI, BASFI, ASDAS, and BASMI in a cross-sectional analysis of 85 Korean AS patients collected in routine care.MethodsMDHAQ/RAPID3, BASDAI, and BASFI were completed by patients, and ASDAS and BASMI assessed by health professionals. Indices and individual measures were compared using correlations, cross tabulations, scatter plots, and κ statistics.ResultsRAPID3 scores were correlated significantly with BASDAI (ρ = 0.82) and ASDAS-ESR (erythrocyte sedimentation rate) (ρ = 0.76), at levels similar to the correlation of BASDAI with ASDAS-ESR (ρ = 0.81). All 21 patients with BASDAI scores of 4 or greater, indicating active AS, were among 39 patients who had RAPID3 scores of greater than 12, indicating high severity, whereas 79% of 33 patients with ASDAS of greater than 1.3, indicating high activity, had RAPID3 high severity.ConclusionsRAPID3 gives similar information to BASDAI and ASDAS in AS patients, in this limited cross-sectional study from 1 setting. Ankylosing spondylitis–specific measures are needed for clinical trials, but poorly feasible in most busy clinical settings. The MDHAQ/RAPID3 offers pragmatic quantitative clinical assessment of AS patients in routine care.

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