axial involvement
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2021 ◽  
pp. 247553032110638
Author(s):  
Saman Darabian ◽  
Maziar Badii ◽  
Jan P. Dutz ◽  
Jonathan Chan

Objectives: This study aims to evaluate clinical responses in patients with active psoriatic arthritis who, despite secukinumab 300 mg subcutaneous monthly, are switched to ixekizumab 80 mg subcutaneous every four weeks. Methods: We conducted a chart review of adult patients with psoriatic arthritis treated at one clinical center. We identified all patients with active inflammatory arthritis who were switched from secukinumab to ixekizumab. Baseline demographics such as disease duration, age, gender, number of previous DMARDs, and previous time on secukinumab were collected. We collected clinical outcome data such as tender and swollen joint count, enthesitis based on SPARCC score, dactylitis, psoriasis severity, CRP, and BASDAI if axial involvement was present. Results: Eight of 10 patients were included in the analysis. Most patients were female, average age 62 years old, and had been on secukinumab for an average of 79 weeks. Twelve weeks following switch to ixekizumab, 6/8 had improvement in tender joint count, 6/8 improved in swollen joint count, 2/2 had resolution of enthesitis, 4/4 had resolution of dactylitis, 5/6 had improvement in psoriasis severity, 1 patient had absolute improvement of 2.3 in BASDAI, and 7/8 had improvement in the CRP level. Conclusions: Patients with active psoriatic arthritis despite treatment with secukinumab may still have a clinical response following treatment with another anti-IL17 agent. Larger studies will be required to confirm this finding, and studies which emphasize dactylitis and enthesitis outcomes will be needed as most patients did not have activity in these domains.


BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e048647
Author(s):  
Fabian Proft ◽  
Murat Torgutalp ◽  
Burkhard Muche ◽  
Valeria Rios Rodriguez ◽  
Maryna Verba ◽  
...  

IntroductionPsoriatic arthritis (PsA) is an inflammatory disease characterised by synovitis, enthesitis, dactylitis and axial involvement. The prevalence of axial involvement ranges from 25% to 70% in this patient group. Treatment recommendations for axial PsA were mainly extrapolated from guidelines for axial spondyloarthritis, and the main treatment options are non-steroidal anti-inflammatory drugs and biological disease-modifying antirheumatic drugs (tumour necrosis factor, IL-17 and IL-23 inhibitors). Tofacitinib was approved for the treatment of PsA and its efficacy on axial inflammation has been demonstrated in a phase II study of ankylosing spondylitis (AS). This prospective study aims to evaluate the efficacy of tofacitinib in reducing inflammation in the sacroiliac joints (SIJs) and spine on MRI in patients with axial disease of their PsA presenting with active axial involvement compatible with axial PsA.Methods and analysesThis is a randomised, double-blind, placebo-controlled, multicentre clinical trial in patients with axial PsA who have evidence of axial involvement, active disease as defined by a Bath AS Disease Activity Index score of ≥4 and active inflammation on MRI of the SIJs and/or spine as assessed by and independent central reader. The study includes a 6-week screening period, a 24-week treatment period, which consist of a 12-week placebo-controlled double-blind treatment period followed by a 12-week active treatment period with tofacitinib for all participants, and a safety follow-up period of 4 weeks. At baseline, 80 subjects shall be randomised (1:1) to receive either tofacitinib or matching placebo for a 12-week double-blind treatment period. At week 12, an MRI of the whole spine and SIJs will be performed to evaluate the primary study endpoint.Ethics and disseminationThe study will be performed according to the ethical principles of the Declaration of Helsinki and the German drug law. The independent ethics committees of each centre approved the ethical, scientific and medical appropriateness of the study before it was conducted.Trial registration numberNCT04062695; ClinicalTrials.gov and EudraCT No: 2018-004254-22; European Union Clinical Trials Register.


2021 ◽  
pp. jrheum.211043
Author(s):  
Laura C. Coates ◽  
William Tillett

Spondyloarthritis (SpA) is recognized as an overarching spectrum of disease characterized by axial SpA (axSpA), peripheral arthritis, enthesitis, and dactylitis. Despite significant overlap, patients are often characterized as having predominantly peripheral or axial involvement.


2021 ◽  
Vol 12 ◽  
Author(s):  
Qing Han ◽  
ZhaoHui Zheng ◽  
Qiang Liang ◽  
Kui Zhang ◽  
FengFan Yang ◽  
...  

ObjectiveInjections of proteoglycan aggrecan (PGA) have been reported to induce axial spondyloarthritis (ax-SpA) in BALB/c mice. It is considered to be a model for radiographic ax-SpA. However, evaluation of the extent of axial disease by histopathological assessment of every intervertebral space is labor-intensive. The objective of our paper is to test the feasibility of Micro Computed Tomography (Micro-CT) in rapidly enumerating the number of intervertebral spaces affected in each mouse.MethodsArthritis was induced in BALB/c mice by intraperitoneal injections of PGA. Involvement of several spinal segments, and selected sacroiliac and hip joints were evaluated by histopathology. The involvement of all intervertebral spaces, sacroiliac and hip joints was evaluated by Micro-CT.ResultsBALB/c mice injected with PGA developed histopathology of SpA-like axial lesions, including spondylitis, sacroiliac joint arthritis and hip joint arthritis. Micro-CT allowed us to clearly enumerate the number of lesions in each mouse.ConclusionMicro-CT allows quantitative assessment of the extent of axial involvement in PGA-induced mouse spondylitis. This can be a useful tool in assessing therapeutic interventions.


2021 ◽  
Vol 10 (13) ◽  
pp. 2845
Author(s):  
Ivan Giovannini ◽  
Alen Zabotti ◽  
Carmelo Cicciò ◽  
Matteo Salgarello ◽  
Lorenzo Cereser ◽  
...  

The frequent involvement of the spine and sacroiliac joint has justified the classification of psoriatic arthritis (PsA) in the Spondyloarthritis group. Even if different classification criteria have been developed for PsA and Spondyloarthritis over the years, a well-defined distinction is still difficult. Although the majority of PsA patients present peripheral involvement, the axial involvement needs to be taken into account when considering disease management. Depending on the definition used, the prevalence of axial disease may vary from 25 to 70% in patients affected by PsA. To date, no consensus definition has been reached in the literature and the definition of axial involvement in PsA has varied from isolated sacroiliitis to criteria used in ankylosing spondylitis. This article reviews the unmet needs in the clinical and radiological assessment of axial PsA, reporting the various interpretations of axial involvement, which have changed over the years. Focusing on both imaging and clinical standpoints, we reported the prevalence of clinical and radiologic features, describing the characteristics of axial disease detectable by X-rays, magnetic resonance imaging, and PET-CT, and also describing the axial symptoms and outcome measures in patients affected by axial disease.


Author(s):  
Denis Poddubnyy ◽  
Deepak R. Jadon ◽  
Filip Van den Bosch ◽  
Philip J. Mease ◽  
Dafna D. Gladman

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 754-755
Author(s):  
E. Gubar ◽  
Y. Korsakova ◽  
E. Loginova ◽  
S. Glukhova ◽  
T. Korotaeva ◽  
...  

Background:Limited data are available on retention rates of biologic therapy in psoriatic arthritis (PsA) patients (pts) with axial involvement. It has been shown that in the subset of pts with prevalent axial involvement (AS versus PsA and AxSpA versus PsA) a longer duration of anti-TNF-α-therapy was observed as compared to peripheral arthritis [1].Objectives:To compare retention rates of biologic therapy in PsA pts with and without axial involvement in routine clinical practice.Methods:731 pts with PsA according to CASPAR criteria were included in the study. Data were collected from 43 rheumatology clinics over various regions of the Russian Federation. Among the pts, 243 (33.0%) (M/F 132/111) were given biologic therapy. Pts’ age 45.9±12.8 years (yrs), disease duration 8.6±6.5 yrs. Pts underwent standard clinical examination of PsA activity and were split into two groups (gr.), with and without axial PsA (axPsA): axPsA(+) and axPsA(-). Pts in the axPsA(+) gr. had inflammatory back pain by ASAS criteria and/or radiographic sacroiliitis (SI) (unilateral grade≥3 or bilateral grade≥2) and/or active MRI SI and/or typical of axPsA changes of the cervical and/or lumbar spine (marginal/paramarginal syndesmophytes, ankylosis of the facet joints). Pts in the axPsA(-) gr. had only peripheral arthritis. The axPsA(+) gr. included 143 (58.8%) pts, the axPsA(-) gr. 100 (41.2%) pts. 163 (67.1%) pts were treated with TNF inhibitors (TNF-i), 80 (32.9%) pts with interleukin inhibitors (IL-i): 55 pts with Ustekinumab, 25 pts with Secukinumab. During the TNF-i treatment courses Infliximab was given to 34 pts, Adalimumab to 53 pts, Etanercept to 36 pts, Golimumab to 27 pts and Certolizumab Pegol to 8 pts. The observation period lasted 12 months. Treatment retention rates were analyzed using Kaplan-Meier curves and the log-rank test.Results:Analysis of the treatment retention rates revealed statistically significant differences between the axPsA(+) and the axPsA(-) grs. After 12 months of observation, 72.9% of pts in the axPsA(-) gr. continued receiving biologic therapy, while in the axPsA(+) gr. only 53.1% of pts (р=0.0027) received it. The same kind of differences in anti-TNF therapy were found between the axPsA(-) gr. and the axPsA(+) gr.: 82.2% and 62.3% pts respectively (р=0.011) continued receiving TNF-i after 12 months. However no statistically significant differences were found between the two grs. in the treatment retention rates of IL-i therapy: after 12 months of observation 55.5% of axPsA(-) pts and 37% of axPsA(+) pts (р=0.086) continued receiving IL-i.Conclusion:In routine clinical practice, retention rates of biologic therapy were found to be worse in PsA pts with axial involvement. In clinical practice, TNF-i are prescribed twice as often than IL-i. However, considering the need of personalized therapy, in case of axPsA the use of IL-i is preferable because their treatment retention rates don’t depend on axial involvement.References:[1]M. Fabbroni et al. Mediators of Inflammation, 2014.Retention rates of biologic therapy. Differences between axPsA(+) and axPsA(-) pts are statistically significant (р=0.00265, log rank test).Disclosure of Interests:None declared.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 798-799
Author(s):  
A. Deodhar ◽  
D. D. Gladman ◽  
R. Bolce ◽  
D. Sandoval ◽  
S. Y. Park ◽  
...  

Background:Many patients with psoriatic arthritis (PsA) experience back pain and stiffness, which may suggest axial involvement [1]. The prevalence of axial involvement in PsA varies between 25-70% [2]. Ixekizumab (IXE), a monoclonal antibody with high affinity for IL17-A, has been studied in Phase 3 trials in patients with PsA (SPIRIT-P1 [Biologic-naïve; NCT01695239] and SPIRIT-P2 [Inadequate response or intolerant to 1 or 2 TNF inhibitors (TNFi); NCT02349295]) [3] [4].Objectives:To determine the efficacy of IXE up to 52 weeks (Wks) in reducing axial symptoms in patients with active PsA presenting with symptoms suggestive of axial involvement.Methods:This post-hoc analysis included data from two subpopulations of patients with PsA (pooled SPIRIT-P1 and -P2). Symptoms suggestive of axial involvement were defined as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Q2 (back pain) ≥4, and an average of Q5 + Q6 (intensity and duration of morning stiffness in the spine) ≥4 at baseline. Patients included in the sensitivity analysis subgroup 1 were, in addition to the above-mentioned overall analysis criteria, <45 years of age, while patients included in sensitivity analysis subgroup 2 were aged <45 but also had elevated C-reactive protein (CRP) (> 5 mg/l) at baseline. Efficacy of IXE was analysed using BASDAI questions, total BASDAI, mBASDAI (without Q3), and Ankylosing Spondylitis Disease Activity Score (ASDAS) change from baseline, as well as BASDAI50 response and Short-Form-36 physical component summary (SF-36 PCS) improvement, at Wks 16, 24 and 52. Treatment comparison was done using logistic regression for BASDAI50, and analysis of covariance (ANCOVA) model for other endpoints. Missing data for binary and continuous endpoints were imputed by non-responder imputation and modified baseline observation carried forward (mBOCF), respectively.Results:A total of 313 patients (placebo (PBO), N=151; IXE Q4W, N=162) met the overall analysis inclusion criteria. Baseline values for BASDAI and ASDAS related endpoints were balanced across treatment arms (Table 1). Improvement in axial symptoms were significantly greater in patients treated with IXE compared to PBO at Wks 16 and 24 (Figure 1. next page) Improvement in quality of life (QoL) measures (SF-36 PCS) were also significantly greater in patients treated with IXE compared to PBO at Wks 16 and 24 (Table 1). Similar results were observed for patients < 45 years, and in patients < 45 years with CRP > 5 mg/l at baseline (sensitivity analysis, data not shown).Table 1.Baseline values and change from baseline (mBOCF) in the overall analysis population at Wks 16, 24 and 52 for BASDAI and ASDAS related endpoints in patients with PsA and axial pain. Data presented as mean (SD) unless otherwise specified. ‡p<0.001 vs PBO.Conclusion:IXE is effective in reducing axial symptoms and improving QoL in patients with active PsA presenting with symptoms suggestive of axial involvement.References:[1]Yap KS. Ann Rheum Dis. 2018;77(11)[2]Feld J. Nat Rev Rheumatol. 2018;14[3]Orbai A. Clin Exp Rheumatol. 2020[online][4]Genovese MC. Rheumatol. 2018;57(11)Figure 1.Change from baseline (mBOCF) in BASDAI and ASDAS related endpoints in patients with PsA and axial pain in the overall analysis population. Data presented as mean (SD). ‡p<0.001 vs PBO.Acknowledgements:Edel Hughes, an employee of Eli Lilly and Company, provided editorial and writing support.Disclosure of Interests:Atul Deodhar Speakers bureau: Janssen, Novartis, Pfizer, Paid instructor for: Boeheringer Ingelheim, Pfizer, Consultant of: AbbVie, Amgen, Boeheringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, Glaxo Smith Kline, Janssen, Novartis, Pfizer, UCB, Grant/research support from: AbbVie, Eli Lilly, Glaxo Smith Kline, Novartis, Pfizer, UCB, Dafna D Gladman Consultant of: Abbvie, Amgen, BMS, Galapagos, Gilead, Eli Lilly, Janssen, Novartis, Pfizer, UCB, Grant/research support from: Abbvie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, UCB, Rebecca Bolce Shareholder of: Employee and shareholder of Eli Lilly and Company, Employee of: Employee and shareholder of Eli Lilly and Company, David Sandoval Shareholder of: Eli Lilly and Company, Employee of: Currently employed by Eli Lilly and Company, So Young Park Shareholder of: Eli Lilly & Company, Employee of: Eli Lilly & Company, Soyi Liu Leage Shareholder of: Owns Lilly shares (company producing drug/devices for use in rheumatology), Employee of: Employee of Eli Lilly and Company, Peter Nash Speakers bureau: Honoraria for lectures on behalf Abbvie, BMS, Celgene, Roche, Sanofi, Lilly, Novartis, Janssen, Pfizer, Boehringer, Samsung, Consultant of: Advice on behalf Abbvie, BMS, Celgene, Roche, Sanofi, Lilly, Novartis, Janssen, Pfizer, Boehringer, Samsung, Grant/research support from: Research funding for clinical trials on behalf Abbvie, BMS, Celgene, Roche, Sanofi, Lilly, Novartis, Janssen, Pfizer, Boehringer, Samsung, Denis Poddubnyy Speakers bureau: AbbVie, Bristol-Myers Squibb, Lilly, MSD, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Biocad, Gilead, GlaxoSmithKline, Eli Lilly, MSD, Novartis, Pfizer, Samsung Bioepis, and UCB, Grant/research support from: AbbVie, Eli Lilly, MSD, Novartis, and Pfizer.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 24.2-25
Author(s):  
C. López-Medina ◽  
S. Chevret ◽  
A. Moltó ◽  
J. Sieper ◽  
M. T. Duruöz ◽  
...  

Background:Patients with a diagnosis of Spondyloarthritis (SpA) and Psoriatic Arthritis (PsA) may have predominant axial or peripheral symptoms, and the frequency and distribution of these symptoms may determine the clinical diagnosis by the rheumatologist (“clinical clusters”). Clustering analysis represents an unsupervised exploratory analysis which tries to identify homogeneous groups of cases (“statistical clusters”) without prior information about the membership for any of the cases.Objectives:To identify “statistical clusters” of peripheral involvement according to the specific location of these symptoms in the whole spectrum of SpA and PsA (without prior information about the diagnosis of the patients), and to evaluate whether these “statistical clusters” are in agreement with the “clinical clusters”.Methods:Cross-sectional and multicentre study with 24 participating countries. Consecutive patients considered by their treating rheumatologist as suffering from either PsA, axial SpA (axSpA) or peripheral SpA (pSpA) were enrolled. Four different cluster analyses were conducted: the first one using information about the specific location from all the peripheral musculoskeletal manifestations (i.e., peripheral arthritis, enthesitis and dactylitis), and thereafter a cluster analysis for each peripheral manifestation individually. Multiple correspondence analyses and k-means clustering methods were used. Distribution of peripheral manifestations and clinical characteristics were compared across the different clusters.Results:4465 patients were included in the analysis. Two clusters were found with regard to the location of all the peripheral manifestations (Fig. 1). Cluster 1 showed a low prevalence of peripheral manifestations in comparison with cluster 2; however, when peripheral involvement appeared in cluster 1, this was mostly represented by arthritis of hip, knee and ankle, as well as enthesitis of the heel. Patients from cluster 1 showed a higher prevalence of males (63% vs 44%), HLA-B27 positivity (69% vs 38%) and axial involvement (80% vs 52%), as well as more frequent diagnosis of axSpA (66% vs 21%) and more frequently fulfilling the ASAS axSpA criteria (69% vs. 41%). Patients from cluster 2 showed a higher prevalence of psoriasis (63% vs 25%), a more frequent diagnosis of PsA (61% vs 19%), and they fulfilled more frequently the peripheral ASAS (26% vs 11%) and the CASPAR criteria (57% vs 19%).Figure 1.Distribution of the peripheral involvement across clustersThree clusters were found with regard to the location of the peripheral arthritis. Clusters 2 and 3 showed a high prevalence of peripheral joint disease, although this was located more predominantly in the lower limbs in cluster 2, and in the upper limbs in cluster 3. Cluster 1 showed a higher prevalence of males, HLA-B27 positivity, axial involvement, a lower presence of psoriasis, a more frequent diagnosis of axSpA and fulfilling the ASAS axSpA criteria in comparison with clusters 2 and 3, respectively. Clusters 2 and 3 showed a higher prevalence of enthesitis and dactylitis in comparison with cluster 1, a more frequent diagnosis of PsA and fulfillment of the CASPAR criteria.Information about the location of enthesitis exhibited three groups: cluster 1 showed a very low prevalence of enthesitis, while cluster 2 and 3 showed a high prevalence of enthesitis, with a predominant involvement of axial enthesis in cluster 2 and peripheral enthesitis in cluster 3.Finally, the analysis of dactylitis also exhibited three clusters that showed a very low prevalence of dactylitis, predominantly toes and predominantly fingers involvement, respectively.Conclusion:These results suggest the presence of heterogeneous patterns of peripheral involvement in SpA and PsA patients without clearly defined groups, confirming the clear overlap of these peripheral manifestations across the different underlying diagnoses.Acknowledgements:This study was conducted under the umbrella of ASAS with unrestricted grant of Abbvie, Pfizer, Lilly, Novartis, UCB, Janssen and Merck.Disclosure of Interests:None declared


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