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  1. AU="Hoepken, Bengt"
  2. AU="Crossman, Kerryn"
  3. AU="Mendonça, Halysson B"
  4. AU="Rodenstein, Daniel Oscar"
  5. AU="Csont, Tamás"
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  15. AU=Falagas M E
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  17. AU=Kacar Mark AU=Kacar Mark
  18. AU="Schaup, Rebecca Michaela"
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  20. AU="Tekin, Nur"
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  30. AU="Eing, Lorenz"
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  32. AU="Chapuis, J"
  33. AU="Berta, László"
  34. AU="Barzilay, Regina"
  35. AU="Schmidt, Michael Rahbek"
  36. AU=Tack J
  37. AU="Oh, Hye Min"
  38. AU=Gaffen Sarah L AU=Gaffen Sarah L
  39. AU="Schmitt, Christine"
  40. AU="McKay, Jackie"
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  42. AU="Desai, Urja"
  43. AU="Chini, Maria Giovanna"
  44. AU="Xiao, Difei"
  45. AU="Ryan, Chris"
  46. AU="Omar Bazighifan"
  47. AU="Corominas Galbany, Jordi"
  48. AU=Fox Norma E
  49. AU="Hamilton, Shelia M"
  50. AU="Nichols, J Wylie"
  51. AU="Pesce R."
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  53. AU="Imran, Aqeel"
  54. AU="Sharma, Yashoda"
  55. AU="Kosai, Jordyn"
  56. AU="Aroca Ferri, María"
  57. AU="Laba, Stephanie"
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  1. Artikel: Achievement of higher thresholds of clinical responses and lower levels of disease activity is associated with improvements in workplace and household productivity in patients with axial spondyloarthritis.

    Rudwaleit, Martin / Machado, Pedro M / Taieb, Vanessa / de Peyrecave, Natasha / Hoepken, Bengt / Gensler, Lianne S

    Therapeutic advances in musculoskeletal disease

    2023  Band 15, Seite(n) 1759720X231189079

    Abstract: Background: Patients with active axial spondyloarthritis (axSpA) exhibit more absences and lower levels of productivity in the workplace and household than the general population, which can improve upon treatment.: Objectives: The objective of this ... ...

    Abstract Background: Patients with active axial spondyloarthritis (axSpA) exhibit more absences and lower levels of productivity in the workplace and household than the general population, which can improve upon treatment.
    Objectives: The objective of this study is to determine the long-term impact of achieving different levels of clinical response or disease activity on workplace and household productivity in patients with axSpA.
    Design: RAPID-axSpA (NCT01087762) was a 204-week phase III trial evaluating the safety and efficacy of certolizumab pegol (CZP) in adult patients with active axSpA.
    Methods: The impact of axSpA on workplace and household productivity was evaluated using the validated arthritis-specific Work Productivity Survey. Outcomes included the percentage of patients achieving Assessment of SpondyloArthritis International Society (ASAS) response and Ankylosing Spondylitis Disease Activity Score (ASDAS) thresholds. This post hoc study used a generalised estimating equations model to determine the association between the threshold of clinical response achieved and patient productivity.
    Results: Of 218 CZP-randomised patients, 65.1% completed week 204. At baseline, 72.0% were employed outside the home. Of the patients who were unemployed, 42.6% were unable to work due to arthritis. Achievement of higher treatment response thresholds, such as clinical remission, was associated with fewer days affected by workplace absenteeism (ASAS-partial remission: 4.0 days, ASAS40: 8.6 days, ASAS20 but not reaching ASAS40 response: 29.4 days, ASAS20 non-response: 69.2 days; ASDAS-inactive disease: 5.0 days, ASDAS-low disease activity: 15.6 days, ASDAS-high disease activity: 32.7 days, ASDAS-very high disease activity: 93.4 days). Similar associations were found for workplace presenteeism, and household absenteeism and presenteeism.
    Conclusions: Over 4 years, achievement of higher clinical response thresholds and lower levels of disease activity was associated with fewer cumulative days affected by absenteeism or presenteeism, with clinical remission associated with the greatest improvements in productivity. This highlights the importance of targeting these thresholds to limit the burden of axSpA on society and on patients' daily lives.
    Sprache Englisch
    Erscheinungsdatum 2023-08-30
    Erscheinungsland England
    Dokumenttyp Journal Article
    ZDB-ID 2516075-8
    ISSN 1759-7218 ; 1759-720X
    ISSN (online) 1759-7218
    ISSN 1759-720X
    DOI 10.1177/1759720X231189079
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  2. Artikel ; Online: Long-term clinical outcomes of certolizumab pegol treatment in non-radiographic axial spondyloarthritis stratified by baseline MRI and CRP status.

    Rudwaleit, Martin / Deodhar, Atul / Bauer, Lars / Gensler, Lianne / Hoepken, Bengt / Kumke, Thomas / Auteri, Simone Emanuele / Kim, Mindy / Maksymowych, Walter

    RMD open

    2024  Band 10, Heft 2

    Abstract: Objective: There 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 protein (CRP) levels. This study ...

    Abstract Objective: There 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 protein (CRP) levels. This study reports clinical outcomes up to 3 years of the C-axSpAnd trial, including safety follow-up extension (SFE) from Weeks 52 to 156, stratified by patients' baseline MRI and CRP status.
    Methods: C-axSpAnd (NCT02552212) was a phase 3, multicentre study that evaluated certolizumab pegol (CZP) in patients with active nr-axSpA who had active sacroiliitis on MRI and/or elevated CRP. In this post hoc analysis, efficacy outcomes are reported to Week 156 of C-axSpAnd for patients stratified according to their MRI and CRP status at Week 0 (MRI+/CRP-, MRI-/CRP+ and MRI+/CRP+).
    Results: Across all outcome measures, including major improvement in Ankylosing Spondylitis Disease Activity Score (ASDAS-MI) and Assessment of SpondyloArthritis international Society criteria ≥40% response (ASAS40), outcomes were generally sustained in SFE patients from Week 52 to Week 156. MRI+/CRP+ patients showed numerically higher or comparable responses relative to MRI-/CRP+ and MRI+/CRP- patients at Weeks 52 and 156; however, all three subgroups demonstrated substantial improvements from Week 0 (in CZP-randomised patients, ASDAS-MI at Week 156 [observed case]: MRI+/CRP+: 73.1%, MRI-/CRP+: 52.2%, MRI+/CRP-: 30.4%; ASAS40: MRI+/CRP+: 76.9%, MRI-/CRP+: 62.5%, MRI+/CRP-: 65.2%).
    Conclusions: In patients with nr-axSpA and objective signs of inflammation, long-term clinical outcomes achieved after 1 year were generally sustained at 3 years across MRI+/CRP+, MRI-/CRP+ and MRI+/CRP- subgroups.
    Mesh-Begriff(e) Humans ; Certolizumab Pegol/therapeutic use ; Magnetic Resonance Imaging ; C-Reactive Protein/analysis ; C-Reactive Protein/metabolism ; Male ; Female ; Adult ; Treatment Outcome ; Axial Spondyloarthritis/drug therapy ; Axial Spondyloarthritis/etiology ; Middle Aged ; Biomarkers ; Severity of Illness Index
    Chemische Substanzen Certolizumab Pegol (UMD07X179E) ; C-Reactive Protein (9007-41-4) ; Biomarkers
    Sprache Englisch
    Erscheinungsdatum 2024-05-09
    Erscheinungsland England
    Dokumenttyp Journal Article ; Research Support, Non-U.S. Gov't ; Clinical Trial, Phase III ; Multicenter Study ; Randomized Controlled Trial
    ZDB-ID 2812592-7
    ISSN 2056-5933 ; 2056-5933
    ISSN (online) 2056-5933
    ISSN 2056-5933
    DOI 10.1136/rmdopen-2023-003884
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  3. Artikel ; Online: Predictors of long-term clinical response in patients with non-radiographic axial spondyloarthritis receiving certolizumab pegol.

    Maksymowych, Walter P / Kumke, Thomas / Auteri, Simone E / Hoepken, Bengt / Bauer, Lars / Rudwaleit, Martin

    Arthritis research & therapy

    2021  Band 23, Heft 1, Seite(n) 274

    Abstract: Background: Identification of predictive clinical factors of long-term treatment response may contribute to improved management of non-radiographic axSpA (nr-axSpA) patients. This analysis aims to identify whether any baseline characteristics or Week 12 ...

    Abstract Background: Identification of predictive clinical factors of long-term treatment response may contribute to improved management of non-radiographic axSpA (nr-axSpA) patients. This analysis aims to identify whether any baseline characteristics or Week 12 clinical outcomes in nr-axSpA patients with elevated C-reactive protein (CRP) and/or sacroiliitis on magnetic resonance imaging (MRI) enrolled in the C-axSpAnd study are predictive of achieving clinical response after 1 year of certolizumab pegol (CZP).
    Methods: C-axSpAnd (NCT02552212) was a phase 3, multicentre study, including a 52-Week double-blind, placebo-controlled period. Enrolled patients were randomised to CZP 200 mg Q2W or placebo. Predictors of Week 12 (CZP group only) and Week 52 clinical response were identified using a multivariate stepwise logistic regression analysis. Response variables included Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI), Assessment of SpondyloArthritis International Society 40% response (ASAS40), Bath Ankylosing Spondylitis Disease Activity Index 50% response (BASDAI50) and ASDAS inactive disease (ASDAS-ID). Predictive factors assessed included demographic and baseline characteristics and clinical outcomes at Week 12. A p-value <0.05 was required for forward selection into the model and p ≥0.1 for backward elimination. Missing data or values collected after switching to open-label treatment were accounted for using non-responder imputation. Sensitivity analyses accounted for patients with changes in non-biologic background medication.
    Results: Of 317 enrolled patients, 159 and 158 were randomised to CZP and placebo, respectively. Younger age and male sex were identified as predictors of Week 12 response across all assessed efficacy outcomes in CZP-treated patients. Consistent predictors of Week 52 response, measured by ASDAS-MI, ASAS40 and BASDAI50, included human leukocyte antigen (HLA)-B27 positivity and sacroiliitis on MRI at baseline. MRI positivity was also predictive of achieving ASDAS-ID at Week 52. Sensitivity analyses were generally consistent with the primary analysis. In placebo-treated patients, no meaningful predictors of Week 52 response were identified.
    Conclusions: In this 52-Week, placebo-controlled study in nr-axSpA patients with elevated CRP and/or active sacroiliitis on MRI at baseline, MRI sacroiliitis and HLA-B27 positivity, but not elevated CRP or responses at Week 12, were predictive of long-term clinical response to CZP. Findings may support rheumatologists to identify patients suitable for TNFi treatment.
    Trial registration: ClinicalTrials.gov, NCT02552212 . Registered on 15 September 2015.
    Mesh-Begriff(e) Certolizumab Pegol/therapeutic use ; Double-Blind Method ; Humans ; Male ; Sacroiliitis ; Spondylarthritis/diagnostic imaging ; Spondylarthritis/drug therapy ; Spondylitis, Ankylosing ; Treatment Outcome
    Chemische Substanzen Certolizumab Pegol (UMD07X179E)
    Sprache Englisch
    Erscheinungsdatum 2021-10-29
    Erscheinungsland England
    Dokumenttyp Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 2107602-9
    ISSN 1478-6362 ; 1478-6354
    ISSN (online) 1478-6362
    ISSN 1478-6354
    DOI 10.1186/s13075-021-02650-4
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  4. Artikel ; Online: Certolizumab pegol treatment in axial spondyloarthritis mitigates fat lesion development: 4-year post-hoc MRI results from a phase 3 study.

    Baraliakos, Xenofon / Kruse, Sebastian / Auteri, Simone E / de Peyrecave, Natasha / Nurminen, Tommi / Kumke, Thomas / Hoepken, Bengt / Braun, Jürgen

    Rheumatology (Oxford, England)

    2022  Band 61, Heft 7, Seite(n) 2875–2885

    Abstract: Objectives: Fat lesions (FLs) on MRI T1 sequences are considered to be early indicators of structural spinal progression in axial spondyloarthritis (axSpA) patients. In this post-hoc analysis from RAPID-axSpA, we assess whether tumour necrosis factor ... ...

    Abstract Objectives: Fat lesions (FLs) on MRI T1 sequences are considered to be early indicators of structural spinal progression in axial spondyloarthritis (axSpA) patients. In this post-hoc analysis from RAPID-axSpA, we assess whether tumour necrosis factor inhibitor (TNFi) treatment over 4 years impacts FLs in spinal vertebral edges (VEs) of patients with axSpA.
    Methods: In RAPID-axSpA (NCT01087762), a 4-year, phase 3 randomized trial, participants were randomized to certolizumab pegol (CZP; 400 mg loading dose at Weeks 0/2/4 then 200/400 mg every 2/4 weeks) or placebo (PBO) at baseline; PBO-randomized participants switched to CZP at Week 16/24 (denoted PBO-randomized/CZP). Spinal MRI scans were taken at Weeks 0, 12, 48, 96 and 204. Changes in proportions of VEs with FLs are reported as odds ratios (ORs) between time points.
    Results: Overall, 136 participants (CZP: 89, PBO-randomized/CZP: 47) had a baseline and ≥1 post-baseline MRI. The OR (95% confidence interval) vs baseline of FLs was higher in PBO-randomized/CZP vs CZP-randomized participants at Weeks 48 [3.35 (2.16-5.19) vs 1.45 (1.07-1.97)], 96 [2.62 (1.77-3.88) vs 1.84 (1.36-2.48)] and 204 [2.55 (1.59-4.06) vs 1.71 (1.23-2.37)]. Across 204 weeks, FLs increased more in VEs with baseline inflammation [Week 204 OR: 4.84 (2.56-9.18)] than those without [OR: 1.15 (0.78-1.71)]. VEs in which inflammation was resolved by Week 12 had lower FL prevalence at Weeks 48, 96 and 204 compared with VEs with unresolved inflammation.
    Conclusions: Early and sustained suppression of inflammation mitigates the risk of long-term FL development in the spine in study participants with axSpA evaluated over 4 years.
    Trial registration: ClinicalTrials.gov, https://clinicaltrials.gov, NCT01087762.
    Mesh-Begriff(e) Antirheumatic Agents/therapeutic use ; Axial Spondyloarthritis ; Certolizumab Pegol/therapeutic use ; Double-Blind Method ; Humans ; Inflammation/drug therapy ; Magnetic Resonance Imaging ; Spondylarthritis/diagnostic imaging ; Spondylarthritis/drug therapy ; Treatment Outcome
    Chemische Substanzen Antirheumatic Agents ; Certolizumab Pegol (UMD07X179E)
    Sprache Englisch
    Erscheinungsdatum 2022-04-04
    Erscheinungsland England
    Dokumenttyp Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 1464822-2
    ISSN 1462-0332 ; 1462-0324
    ISSN (online) 1462-0332
    ISSN 1462-0324
    DOI 10.1093/rheumatology/keab841
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  5. Artikel ; Online: Validation of the Ankylosing Spondylitis Quality of Life assessment tool in patients with non-radiographic axial spondyloarthritis.

    Hoepken, Bengt / Serrano, Daniel / Harris, Kristina / Hwang, Mark C / Reveille, John

    Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation

    2020  Band 30, Heft 3, Seite(n) 945–954

    Abstract: Purpose: To evaluate the psychometric performance of the Ankylosing Spondylitis Quality of Life (ASQoL) scale in patients with non-radiographic axial spondyloarthritis (nr-axSpA) to assess its appropriateness as an outcome measure in future clinical ... ...

    Abstract Purpose: To evaluate the psychometric performance of the Ankylosing Spondylitis Quality of Life (ASQoL) scale in patients with non-radiographic axial spondyloarthritis (nr-axSpA) to assess its appropriateness as an outcome measure in future clinical studies.
    Methods: Patients with active axSpA from a Phase III, randomized, double-blind, placebo-controlled trial (RAPID-axSpA, NCT01087762) were included (N = 325). Modified New York (mNY) classification criteria were used to classify patients as having ankylosing spondylitis or nr-axSpA; those with nr-axSpA were further categorized based on objective signs of inflammation. Psychometric properties of the ASQoL were assessed/documented using a mixture of modern psychometric methods and classical test theory methods. These included exploratory factor analysis and item response theory models to assess the domain structure, test the utility of a single domain relative to subdomains, assess bias, and generate statistics to guide an empirical scoring algorithm. The reliability and validity of scores were evaluated via internal consistency, test-retest reliability, concurrent validity, and known-groups validity. Score responsiveness was assessed via anchor-based clinically meaningful change, supplemented with empirical cumulative distribution function visualizations.
    Results: The ASQoL data were defined by four domains. However, a four-domain solution was found to be inferior to a bifactor solution in which the four domains were included within a total domain. Scoring statistics supported a unit-weighted total score. Within the nr-axSpA population with objective signs of inflammation, the ASQoL mean score had adequate reliability, validity, and ability to detect clinically meaningful change.
    Conclusions: Our findings suggest that the ASQoL is an appropriate outcome measure in interventional clinical trials in patients with nr-axSpA.
    Mesh-Begriff(e) Adult ; Aged ; Double-Blind Method ; Female ; Humans ; Male ; Middle Aged ; Outcome Assessment, Health Care ; Psychometrics/methods ; Quality of Life/psychology ; Reproducibility of Results ; Spondylarthritis/complications ; Spondylitis, Ankylosing/epidemiology ; Young Adult
    Sprache Englisch
    Erscheinungsdatum 2020-10-31
    Erscheinungsland Netherlands
    Dokumenttyp Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial
    ZDB-ID 1161148-0
    ISSN 1573-2649 ; 0962-9343
    ISSN (online) 1573-2649
    ISSN 0962-9343
    DOI 10.1007/s11136-020-02686-0
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  6. Artikel ; Online: Effectiveness and Safety of Certolizumab Pegol in Axial Spondyloarthritis in a Real-World Setting in Greece: A Sub-Analysis of the Prospective Non-Interventional CIMAX Cohort Study.

    Katsifis, Gkikas / Theodoridou, Athina / Bounas, Andreas / Georgiou, Panagiotis / Sfikakis, Petros / Fragiadaki, Kalliopi / Dimitroulas, Theodoros / Mole, Evangelia / Bauer, Lars / Kumke, Thomas / Hoepken, Bengt

    Mediterranean journal of rheumatology

    2022  Band 33, Heft Suppl 1, Seite(n) 162–172

    Abstract: Objectives: We report the effectiveness and safety of certolizumab pegol (CZP) treatment in a real-world Greek axial spondyloarthritis (axSpA) population, including patients with radiographic (r-axSpA) and non-radiographic (nr-axSpA) disease.: Methods! ...

    Abstract Objectives: We report the effectiveness and safety of certolizumab pegol (CZP) treatment in a real-world Greek axial spondyloarthritis (axSpA) population, including patients with radiographic (r-axSpA) and non-radiographic (nr-axSpA) disease.
    Methods: We performed a sub-analysis of the Greek cohort from CIMAX (NCT02354105), a multicentre, non-interventional cohort study that prospectively investigated CZP treatment in patients with axSpA. The primary outcome was change from baseline (CfB) in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) to Week 52.
    Results: Across 12 sites in Greece, 126 patients (r-axSpA: 91; nr-axSpA: 35) received ≥1 dose of CZP and were included in the Safety Set (SS), with 120 patients (r-axSpA: 86; nr-axSpA: 34) included in the Full Analysis Set (FAS). The mean (standard deviation [SD]) CfB in BASDAI at Week 52 was -3.8 (2.0) in the overall axSpA population, with numerically greater improvements observed for nr-axSpA patients compared with r-axSpA (nr-axSpA: -4.2 [2.1]; r-axSpA: -3.7 [2.0]). Improvements in the axSpA population, including r-axSpA and nr-axSpA subpopulations, were observed in key secondary and additional outcomes at Week 52. Overall, 14.3% (18/126) of patients in the axSpA population experienced ≥1 adverse event (AE). There were no serious AEs or deaths reported during the study.
    Conclusions: Patients with r-axSpA and nr-axSpA treated with CZP in clinical practice in Greece showed improvements in disease activity and key symptoms. CZP treatment may therefore help address the substantial health burden associated with axSpA in Greece.
    Sprache Englisch
    Erscheinungsdatum 2022-04-15
    Erscheinungsland Greece
    Dokumenttyp Case Reports
    ZDB-ID 3019943-8
    ISSN 2529-198X ; 2459-3516
    ISSN (online) 2529-198X
    ISSN 2459-3516
    DOI 10.31138/mjr.33.1.162
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  7. Artikel: Certolizumab Pegol Treatment in Patients with Axial-Spondyloarthritis-Associated Acute Anterior Uveitis: a Narrative Review.

    van der Horst-Bruinsma, Irene E / Robinson, Philip C / Favalli, Ennio G / Verbraak, Frank D / Kim, Mindy / Kumke, Thomas / Bauer, Lars / Hoepken, Bengt / Deodhar, Atul

    Rheumatology and therapy

    2022  Band 9, Heft 6, Seite(n) 1481–1497

    Abstract: Background: Acute anterior uveitis (AAU) affects up to 40% of patients with axial spondyloarthritis (axSpA). An effective treatment for patients with axSpA that reduces the risk of AAU flares while also targeting axial symptoms is therefore highly ... ...

    Abstract Background: Acute anterior uveitis (AAU) affects up to 40% of patients with axial spondyloarthritis (axSpA). An effective treatment for patients with axSpA that reduces the risk of AAU flares while also targeting axial symptoms is therefore highly desirable. Tumor necrosis factor inhibitors (TNFis) have been shown effective for treatment of axSpA and AAU occurrence, with guidelines conditionally recommending treating patients with axSpA and associated AAU with TNFi monoclonal antibodies. To date, most available data on the impact of TNFis on AAU in axSpA are from observational, open-label studies without parallel comparator arms. However, there is a growing body of evidence describing the impact of the TNFi certolizumab pegol (CZP) on the incidence of axSpA-associated AAU.
    Objective: Our objective was to collate data pertaining to the impact of CZP in axSpA-associated AAU in patients across the full axSpA spectrum.
    Methods: Data were obtained from four industry-supported phase 3 and 4 clinical trials (C-VIEW, C-axSpAnd, C-OPTIMISE, and RAPID-axSpA). To supplement these data, a targeted literature review was performed through searches of MEDLINE, Embase, and reference lists.
    Results: Available data from 1467 patients from the C-VIEW, C-axSpAnd, C-OPTIMISE, and RAPID-axSpA trials show CZP to be effective in AAU in patients across the full axSpA spectrum, reducing AAU flares when compared with placebo or pretreatment period. No differences in AAU outcomes were reported when stratified by axSpA subgroup age or sex. The targeted literature review identified six further studies of CZP in spondyloarthritis-associated AAU, only one of which was specific to axSpA.
    Conclusion: CZP was effective in reducing AAU incidence in clinical trials with patients with axSpA. The targeted literature review, however, highlighted that there remains a paucity of data beyond these trials. Data from comparative studies would further enhance the body of evidence on the effects of CZP in patients with axSpA who develop AAU.
    Sprache Englisch
    Erscheinungsdatum 2022-09-30
    Erscheinungsland England
    Dokumenttyp Journal Article ; Review
    ZDB-ID 2783278-8
    ISSN 2198-6584 ; 2198-6576
    ISSN (online) 2198-6584
    ISSN 2198-6576
    DOI 10.1007/s40744-022-00486-1
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  8. Artikel ; Online: Long-term safety and clinical outcomes of certolizumab pegol treatment in patients with active non-radiographic axial spondyloarthritis: 3-year results from the phase 3 C-axSpAnd study.

    van der Heijde, Désirée / Gensler, Lianne S / Maksymowych, Walter P / Landewé, Robert / Rudwaleit, Martin / Bauer, Lars / Kumke, Thomas / Kim, Mindy / Auteri, Simone Emanuele / Hoepken, Bengt / Deodhar, Atul

    RMD open

    2022  Band 8, Heft 1

    Abstract: Background: 52-week results from C-axSpAnd demonstrated the safety and efficacy of certolizumab pegol (CZP) in patients with active non-radiographic axial spondyloarthritis (nr-axSpA) and objective signs of inflammation (sacroiliitis on MRI and/or ... ...

    Abstract Background: 52-week results from C-axSpAnd demonstrated the safety and efficacy of certolizumab pegol (CZP) in patients with active non-radiographic axial spondyloarthritis (nr-axSpA) and objective signs of inflammation (sacroiliitis on MRI and/or elevated C-reactive protein levels). Long-term safety and clinical outcomes, including MRI assessments, are evaluated up to 3 years for CZP-treated patients with nr-axSpA.
    Methods: C-axSpAnd was a phase 3 study comprising a 1-year double-blind, placebo-controlled period and 2-year open-label safety follow-up extension (SFE). At baseline, 317 patients were randomised 1:1 to placebo or CZP 200 mg every 2 weeks. Patients completing the double-blind phase who enrolled into the SFE received open-label CZP for an additional 104 weeks. Long-term safety and clinical outcomes are reported to Week 156. Continuous outcomes are presented as observed case (OC) and dichotomous outcomes as OC and with non-responder imputation.
    Results: 243/317 (76.7%) patients entered the SFE, during which 149 (61.3%) experienced ≥1 treatment-emergent adverse event (TEAE); 15 (3.3/100 patient-years) experienced serious TEAEs. Continuous outcome scores (including Ankylosing Spondylitis Disease Activity Score [ASDAS]: 1.8; Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]: 2.7) at Week 52 were maintained at Week 156 (ASDAS: 1.8; BASDAI: 2.6) for the initial CZP-randomised group. Mean SPARCC MRI sacroiliac joint inflammation scores for these patients decreased at Week 52 (baseline: 7.6; Week 52: 1.7), remaining low at Week 156 (2.4).
    Conclusions: CZP treatment was well tolerated up to 3 years, with no new safety signals versus previous reports. Clinical outcomes achieved after 1 year were sustained to 3 years.
    Trial registration number: NCT02552212.
    Mesh-Begriff(e) Axial Spondyloarthritis ; Certolizumab Pegol/adverse effects ; Humans ; Sacroiliitis ; Spondylarthritis/diagnostic imaging ; Spondylarthritis/drug therapy ; Treatment Outcome
    Chemische Substanzen Certolizumab Pegol (UMD07X179E)
    Sprache Englisch
    Erscheinungsdatum 2022-03-16
    Erscheinungsland England
    Dokumenttyp Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 2812592-7
    ISSN 2056-5933 ; 2056-5933
    ISSN (online) 2056-5933
    ISSN 2056-5933
    DOI 10.1136/rmdopen-2021-002138
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  9. Artikel ; Online: Certolizumab Pegol Efficacy in Patients With Non-Radiographic Axial Spondyloarthritis Stratified by Baseline MRI and C-Reactive Protein Status: An Analysis From the C-axSpAnd Study.

    Robinson, Philip C / Maksymowych, Walter P / Gensler, Lianne S / Hall, Stephen / Rudwaleit, Martin / Hoepken, Bengt / Bauer, Lars / Kumke, Thomas / Kim, Mindy / de Peyrecave, Natasha / Deodhar, Atul

    ACR open rheumatology

    2022  Band 4, Heft 9, Seite(n) 794–801

    Abstract: Objective: Tumor necrosis factor inhibitors (TNFi) are an effective treatment for non-radiographic axial spondyloarthritis (nr-axSpA). To be eligible, however, many authorities require patients with nr-axSpA to show active sacroiliitis on magnetic ... ...

    Abstract Objective: Tumor necrosis factor inhibitors (TNFi) are an effective treatment for non-radiographic axial spondyloarthritis (nr-axSpA). To be eligible, however, many authorities require patients with nr-axSpA to show active sacroiliitis on magnetic resonance imaging (MRI) and/or an elevated C-reactive protein (CRP) level, possibly resulting in a perception that patients with nr-axSpA without both factors have only low responses to TNFi treatment. We evaluated clinical responses to certolizumab pegol (CZP) in patients with nr-axSpA stratified by baseline MRI/CRP status.
    Methods: C-axSpAnd was a phase 3, multicenter study on CZP in adult patients with active nr-axSpA and objective signs of inflammation. This analysis assessed efficacy of CZP over the 52-week randomized, double-blind, placebo-controlled period in patients stratified into subgroups based on the presence of active sacroiliitis on MRI and CRP level at baseline.
    Results: CZP-treated patients across all MRI/CRP subgroups achieved clinical responses greater than placebo. Across outcome measures, CZP-treated MRI+/CRP+ patients demonstrated the greatest clinical responses, but substantial improvements were also observed in CZP-treated MRI+/CRP- and MRI-/CRP+ patients. Ankylosing Spondylitis Disease Activity Score Major Improvement response rates at week 52 among CZP-treated patients (75.6% MRI+/CRP+; 47.5% MRI-/CRP+; and 29.7% MRI+/CRP-) were higher than rates in placebo groups (range: 3.9%-12.5%). Assessment of SpondyloArthritis international Society 40% response, Bath Ankylosing Spondylitis Disease Activity Index, and Bath Ankylosing Spondyloarthritis Functional Index had similar response patterns, although differences between the CZP-treated MRI/CRP subgroups were smaller. Clinical responses among CZP-treated patients were also observed in additional subgroups, including those with low Spondyloarthritis Research Consortium of Canada MRI sacroiliac joint inflammation scores and those with normal baseline CRP levels.
    Conclusion: Our findings indicate that CZP treatment benefits patients with nr-axSpA across MRI+/CRP+, MRI-/CRP+, and MRI+/CRP- subgroups.
    Sprache Englisch
    Erscheinungsdatum 2022-06-22
    Erscheinungsland United States
    Dokumenttyp Journal Article
    ISSN 2578-5745
    ISSN (online) 2578-5745
    DOI 10.1002/acr2.11469
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  10. Artikel: Reduction of anterior uveitis flares in patients with axial spondyloarthritis on certolizumab pegol treatment: final 2-year results from the multicenter phase IV C-VIEW study.

    van der Horst-Bruinsma, Irene E / van Bentum, Rianne E / Verbraak, Frank D / Deodhar, Atul / Rath, Thomas / Hoepken, Bengt / Irvin-Sellers, Oscar / Thomas, Karen / Bauer, Lars / Rudwaleit, Martin

    Therapeutic advances in musculoskeletal disease

    2021  Band 13, Seite(n) 1759720X211003803

    Abstract: Introduction: Acute anterior uveitis (AAU), affecting up to 40% of patients with axial spondyloarthritis (axSpA), risks permanent visual deficits if not adequately treated. We report 2-year results from C-VIEW, the first study to prospectively ... ...

    Abstract Introduction: Acute anterior uveitis (AAU), affecting up to 40% of patients with axial spondyloarthritis (axSpA), risks permanent visual deficits if not adequately treated. We report 2-year results from C-VIEW, the first study to prospectively investigate certolizumab pegol (CZP) on AAU in patients with active axSpA at high risk of recurrent AAU.
    Patients and methods: C-VIEW (NCT03020992) was a 104-week (96 weeks plus 8-week safety follow-up), open-label, multicenter study. Eligible patients had active axSpA, human leukocyte antigen-B27 (HLA-B27) positivity and a history of recurrent AAU (⩾2 AAU flares in total; ⩾1 in the year prior to baseline). Patients received CZP 400 mg at weeks 0, 2 and 4, then 200 mg every 2 weeks to week 96. The primary efficacy endpoint was the AAU flare event rate during 96 weeks' CZP
    Results: Of 115 enrolled patients, 89 initiated CZP (male: 63%; radiographic/non-radiographic axSpA: 85%/15%; mean disease duration: 9.1 years); 83 completed week 96. There was a significant 82% reduction in AAU flare event rate during CZP
    Conclusion: CZP treatment significantly reduced AAU flare event rate in patients with axSpA and a history of AAU, indicating CZP is a suitable treatment option for patients at risk of recurrent AAU.
    Trial registration clinicaltrialsgov: NCT03020992, URL: https://clinicaltrials.gov/ct2/show/NCT03020992.
    Sprache Englisch
    Erscheinungsdatum 2021-03-29
    Erscheinungsland England
    Dokumenttyp Journal Article
    ZDB-ID 2516075-8
    ISSN 1759-7218 ; 1759-720X
    ISSN (online) 1759-7218
    ISSN 1759-720X
    DOI 10.1177/1759720X211003803
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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