scholarly journals Rapid improvement in spinal pain in patients with axial spondyloarthritis treated with secukinumab: primary results from a randomized controlled phase-IIIb trial

2021 ◽  
Vol 13 ◽  
pp. 1759720X2110514
Author(s):  
Denis Poddubnyy ◽  
Effie Pournara ◽  
Agnieszka Zielińska ◽  
Asta Baranauskaite ◽  
Alejandro Muñoz Jiménez ◽  
...  

Background: This study aimed to evaluate the efficacy and safety of secukinumab 150 mg compared with placebo in the management of spinal pain and disease activity in patients with axial spondyloarthritis (axSpA) at Week 8 and up to Week 24. Methods: Patients ( n = 380) with active axSpA were randomized (3:1) to secukinumab 150 mg (Group A) or placebo (Group B). At Week 8, patients from Group A with an average spinal pain score <4 were defined as responders and were re-assigned to secukinumab 150 mg (Arm A1); whereas non-responders were re-randomized to secukinumab 150/300 mg (Arm A2/A3). Patients from Group B were re-randomized (1:1) to secukinumab 150/300 mg (Arm B1/B2). Results: At Week 8, the odds of achieving an average spinal pain score of <4 were significantly higher for patients on secukinumab 150 mg than for patients on placebo (odds ratio (OR): 1.89; 95% confidence interval (CI): 1.08–3.33; p = 0.0264). Further reductions in spinal pain were observed across treatment groups up to Week 24. Pronounced improvements were also observed in other disease activity measurements, such as Bath Ankylosing Spondylitis Disease Activity Index and Ankylosing Spondylitis Disease Activity Score. Responders from Group A showed the highest improvements for all measured parameters of spinal pain compared with the other arms. No new or unexpected safety signals were observed. Conclusion: Secukinumab provided rapid and significant improvement in spinal pain at Week 8 which was sustained or increased further up to Week 24 in patients with axSpA. Trial Registration: ClinicalTrials.gov: NCT03136861. Registered May 2, 2017.

2021 ◽  
Author(s):  
Siliang Man ◽  
Liang Zhang ◽  
Tao Bian ◽  
Hongchao Li ◽  
Zhuyi Ma ◽  
...  

Abstract Background. The aim is to test the reliability and validity of the Hip Inflammation MRI Scoring System (HIMRISS) in assessing hip involvement of AS patients at different stages of the bath ankylosing spondylitis radiology index (BASRI-hip) scoring system.Methods. Fifty-two outpatients with ankylosing spondylitis(AS) were included in this study. The subjects’ data includes demographics, clinical characteristics, disease activity score, and functional index. Based on the Harris hip scoring (HHS) of involved hip and BASRI-hip score, we devided these patients into no hip involvement group(HHS≥80 and BASRI≤1)(Group A), mild hip involvement subgroup (BASRI=2 or BASRI≤1 and HHS≤79) (Group B) and moderate to advanced hip involvement subgroup (BASRI≥3) (Group C). Data was analyzed statistically by SPSS software.Results. In total of 44 patients (88 hips), group A consisted of 21 hips, group B consisted of 42 hips and group C consisted of 25 hips. The test-retest intraclass correlation coefficients (ICCs) in four raters were 0.955~0.977 and interrater ICC was 0.993. HIMRISS correlated moderately with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (r=0.540, p<0.001), the Bath ankylosing spondylitis functional index (BASFI) (r=0.581, p<0.001), ASDAS-ESR (r=0.604, p<0.001) and Ankylosing Spondylitis Disease Activity Score(ASDAS)- C reactive protein (CRP) (r=0.575, p<0.001). HIMRISS in group B and C was significantly higher than that in group A: 29.38(17.00,40.94)vs 14.50(11.38,22.25), p=0.009; 38 (31.13,64.38)vs 14.50(11.38,22.25), p<0.001.Conclusions. HIMRISS applied to patients with AS demonstrated a satisfactory reliability, which means it is a reliable quantitive assessment tool for evaluating early hip involvement in patients with AS.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 726.1-726
Author(s):  
M. Lorenzin ◽  
A. Ortolan ◽  
M. S. Chimenti ◽  
A. Marchesoni ◽  
E. Lubrano ◽  
...  

Background:Axial Spondyloarthritis (axSpA) can be distinguished in radiographic axSpA (r-axSpA) and non-radiographic (nr-axSpA). Secukinumab (SEC) is a novel treatment for axSpA, but data from real-life are still missing.Objectives:1)to evaluate the effectiveness and safety of a wide cohort of axSpA patients on SEC followed in 8 Italian Rheumatologic centers for 24-months;2)to compare the features and disease-activity indices of SEC-treated axSpA patients subdivided in naïve biological drugs (group A) and in TNF-inhibitors failure patients (group B).Methods:Consecutive patients with active axSpA (diagnosis according Assessment of SpondyloArthritis International Society ASAS criteria), who started SEC treatment, were evaluated prospectively.Data on disease characteristics, previous/ongoing treatments and imaging were collected. Disease-activity/functional/clinical scores and biochemical values were recorded at baseline (T0), at 6 (T6), 12 (T12), and 24 (T24) months. Effectiveness was evaluated over-time with descriptive statistics. Anova (Kruskal Wallis) and generalized linear models were used to compare variables over-time. Infections,adverse events were collected.Results:One-hundred-seven patients [49.53% men; median age 49years; median treatment duration 18.5years] were enrolled;53(49.53%) had HLA-B27, 47.66% were r-axSpA and 52.34% nr-axSpA. Signs of sacroiliitis were present on MRI in 97 (90.65%) and X-rays in 51 (47.66%). SEC was prescribed as first line biologic treatment in 32 (29.9%) patients and as second or more line biological treatment in 75 (70.1%) patients (Figure 1). In all population significant decrease was achieved in:Visual Analogue Scale of pain and general-health; Leeds Enthesitis Index;Health Assessment Questionnaire modified for spondyloarthritis (HAQ-s);Bath Ankylosing Spondylitis Functional Index (BASFI);C-reactive protein. Bath Ankylosing Spondylitis Metrology Index and Erythrocyte-sedimentation-rate not significantly decreased. Effectiveness was associated to an improvement in Ankylosing Spondylitis disease activity score (ASDAS) [T0=3.4 (2.9-3.9) vs T24=1.9 (1.2-2.7);p=0.02] and in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [T0=6.6 (5.0-7.8) vs T24=3.2 (2.0-5.0);p=0.03].At T0 group B had a longer disease duration (p=0.04),a greater prevalence of peripheral arthritis (p=0.02),enthesitis (p=0.04) and psoriasis (p=0.05) and was mostly male (p=0.05),while no significant difference was observed for functional and disease-activity indices and signs of sacroiliitis on MRI/X-rays. At T24 group A showed better physical functioning and lower disease activity compared to group B [HAQs A vs. B=0.1(0.0-0.5) vs 0.3(0.1-0.8); BASFI A vs B=1.6(0.8-4.8) vs 4.0(2.5-4.6); BASDAI A vs B=2.2(1.0-3.8) vs 3.9(2.7-5.0);ASDAS A vs B=1.3(1.0-2.2) vs 2.1(1.6-2.9)].After T24 of treatment 70.2% of Group A and 68.4% of Group B had a low disease activity,accordingly to ASDAS<2.1. Twenty-three patients (21.5%) stopped the treatment during the follow-up mainly because of primary (7) or secondary loss of efficacy (9).Only 7 patients suspended SEC because of adverse events.A low number of episodes of mild infections (19) occurred;SEC was instead permanently discontinued in 4 cases for:oral refractory mucositis (2);recurrent aphthosis (1);recurrent broncopneumoniae (1).The retention rate at t24 was good in the whole population (73%).Survival curves for Group A and B were similar (log-rank test=0.81;p=0.69).Conclusion:In a real-life clinical setting,SEC was safe and effective in axSpA, as shown by a significant decrease of BASDAI and ASDAS over a 24-months follow-up.Disclosure of Interests:Mariagrazia Lorenzin: None declared, Augusta Ortolan: None declared, Maria Sole Chimenti: None declared, Antonio Marchesoni Grant/research support from: AM has received honoraria and speaker fees from Abbvie, Pfizer, MSD, UCB, Novartis, Janssen, Eli-Lilly., Ennio Lubrano: None declared, Leonardo Santo Speakers bureau: Speaker from Jansen, Novartis, Pfizer, UCB, MSD, Sanofi, Angelo Semeraro: None declared, Carlo Salvarani: None declared, Nicolò Girolimetto: None declared, Emanuela Praino: None declared, Giulia Lavinia Fonti: None declared, Rosario Foti: None declared, Antonio Carletto: None declared, Andrea Doria Grant/research support from: ADhas received honoraria and speaker fees from Novartis, Abbvie, Pfizer, MSD, Janssen., Roberta Ramonda Grant/research support from: RR has received honoraria and speaker fees from Novartis, Abbvie, Pfizer, MSD, Janssen.


2021 ◽  
Vol 13 ◽  
pp. 1759720X2110337
Author(s):  
Iván Ferraz-Amaro ◽  
Javier Rueda-Gotor ◽  
Fernanda Genre ◽  
Alfonso Corrales ◽  
Ricardo Blanco ◽  
...  

Background: Axial spondyloarthritis (axSpA) patients are known to have a higher prevalence of several comorbidities, including, among others, an increased risk of atherosclerosis, hypertension, dyslipidemia, and diabetes. The purpose of the present study was to determine whether the sum of traditional cardiovascular (CV) risk factors is related to disease characteristics, such as disease activity, in patients with axSpA. Methods: A cross-sectional study that encompassed 804 patients with axSpA was conducted. Patients were assessed for the presence of five traditional CV risk factors (diabetes mellitus, dyslipidemia, hypertension, obesity, and smoking status), and disease activity measurements. A multivariable regression analysis was performed to evaluate whether the number of classic CV risk factors was independently associated with specific features of the disease, to include disease activity. Results: A multivariable analysis showed that Ankylosing Spondylitis Disease Activity Score–C reactive protein (ASDAS-CRP) activity score was significantly higher in patients with 1 [beta coefficient 0.3 (95% confidence interval (CI) 0.1–0.5), p = 0.001] and ⩾2 [beta coefficient 0.5 (95% CI 0.3–0.7), p = 0.000] CV risk factors compared with those without CV risk factors. Similarly, patients with 1 [OR 2.00 (95%CI 0.99–4.02), p = 0.053] and ⩾2 [OR 3.39 (95%CI 1.82–6.31), p = 0.000] CV risk factors had a higher odds ratio for the presence of high disease activity compared with the zero CV category. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) activity score was significantly associated with the number of CV risk factors, being higher in patients with more CV risk factors. These relationships showed a CV risk factor-dependent effect being beta coefficients and ORs higher for the effect of ⩾2 over 1 CV risk factor. Conclusion: Among patients with axSpA, as the number of traditional CV risk factors increased, disease activity similarly increases in an independent manner.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1129.1-1129
Author(s):  
A. Baillet ◽  
X. Romand ◽  
A. Pfimlin ◽  
M. Dalecky ◽  
M. Dougados

Background:Standardization of clinical practice has been proven to be effective in management of chronic diseases. This is particularly true at the time where the concept of treat to target is becoming more and more important in the field of axial spondyloarthritis (ax-SpA).Objectives:To propose a list of variables to be collected at the time of the diagnosis and over the follow-up of patients with axial spondyloarthritis (ax-SpA) for an optimal management in daily practice.Methods:The process comprised (1) the evaluation of the interest of 51 variables proposed for the assessment of axSpA via a systematic literature research, (2) a consensus process involving 78 hospital-based or office-based rheumatologists, considering the collection of the variable in a 4 grade scale from ”potentially useful” to “mandatory”, (3) a consensus on optimal timeline for periodic assessment of the selected variables on a 5 grade scale from “at each visit” to “never to be re-collected”.Results:The systematic literature research retrieved a total of 14,133 abstracts, of which 213 were included in the final qualitative synthesis. Concerning the data to be collected at the time of the diagnosis and during follow-up, we proposed to differentiate the results based on a) the way of collection of the variables (e.g. questionnaires by the patient, interview by the physician, physical examination, investigations) b) the usefulness these variables in daily practice based on the opinion of the rheumatologists ” c) the optimal timeline between 2 evaluations of the variable based on the opinion of the rheumatologists. In the initial systematic review, symptoms of heart failure history of inflammatory bowel disease, psoriasis or uveitis, patient global visual analogic scale, spine radiographs, modified Schöber test, coxo-femoral rotations, swollen joint count, urine strip test, BASDAI and ASDAS global scores were considered very useful and nocturnal back pain/morning stiffness, sacro-iliac joints radiographs and CRP were considered mandatory (Figure 1). Timeline between 2 evaluations of variables to collect in the periodic review are summarized inFigure 2.Figure 1.Core sets of items to collect and report in the systematic review in axial spondyloarthritis management in daily practice ASDAS=Ankylosing Spondylitis Disease Activity Score, BASDAI=Bath Ankylosing Spondylitis Disease Activity Index, BASFI=Bath Ankylosing Spondylitis Functionnal Index, BASMI=Bath Ankylosing Spondylitis Metrology Index, CRP=C Reactive Protein, CT=computerized tomography, FIRST=Fibromyalgia Rapid Screening Tool, HLA=Human Leukocyte Antigen, MRI=Magnetic resonance imaging, PET=positron emission tomography.Figure 2.Periodic review timeline of variables to collectASDAS=Ankylosing Spondylitis Disease Activity Score, BASDAI=Bath Ankylosing Spondylitis Disease Activity Index, Spondylitis Metrology Index, CRP=C Reactive Protein, IBD = inflammatory bowel diseases, PRO = Patient Reported OutcomesConclusion:Using an evidence-based and an expert consensus approaches, this initiative defined a core set of variables to be collected and reported at the time of the diagnosis and during follow-up of patients with ax-SpA in daily practice.Acknowledgments:this study has been conducted in two parts: the first one (evidence-based) was conducted thanks to a support from Abbvie France. AbbVie did not review the content or have influence on this manuscript. The second part of this initiative (consensus) has been conducted thanks to a support from the scientific non-profit organization: Association de Recherche Clinique en RhumatologieDisclosure of Interests:Athan Baillet Consultant of: Athan BAILLET has received honorarium fees from Abbvie for his participation as the coordinator of the systematic literature review, Xavier Romand Consultant of: Xavier ROMAND has received honorarium fees from Abbvie, Arnaud Pfimlin Consultant of: Arnaud PFIMLIN has received honorarium fees from Abbvie, Mickael Dalecky Consultant of: Mickael DALECKY has received honorarium fees from Abbvie, Maxime Dougados Grant/research support from: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma, Speakers bureau: AbbVie, Eli Lilly, Merck, Novartis, Pfizer and UCB Pharma


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1629.2-1629
Author(s):  
K. Ben Abdelghani ◽  
Y. Gzam ◽  
A. Fazaa ◽  
S. Miladi ◽  
K. Ouenniche ◽  
...  

Background:Axial spondyloarthritis (ax-SpA) is a chronic rheumatic disease that mainly affects men. However, the female form of ax-SpA remains insufficiently studied.Objectives:The aim of this study was to determine the clinical characteristics, the disease activity and the functional impact of female ax-SpA in comparison with male ax-SpA.Methods:This is a retrospective study including patients diagnosed with ax-SpA fulfilling the criteria of the Assessment of SpondyloArthritis international Society (ASAS) 2009.Clinical parameters, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), Bath ankylosing spondylitis disease activity index (BASDAI) and Bath ankylosing spondylitis functional index (BASFI) were compared between groups of female and male ax-SpA.Results:Two hundred ax-SpA patients were included with 31% of female (n=62) and a mean age of 43,3 ± 11,2 years.The mean age at onset of symptoms was 31,8 ± 8,9 years for women and 25,3 ± 9,1 years for men (p <0,0001). The mean age at diagnosis was 36,4 ± 9,6 years for women and 31,7 ± 10,4 years for men (p = 0,003). Ax-SpA with juvenile onset was noted in 1,7% of women and 12,1% of men (p = 0,02). Male ax-SpA were significantly more smokers (46.8% vs 5.4%; p <0.001). The mean duration of morning stiffness was 11,3 ± 9,2 minutes for women versus 21,6 ± 19,3 minutes for men (p = 0,005).The mean ESR was 42,4 ± 29,8 mm for women and 28,3 ± 23,4 mm for men (p = 0,001). Radiographic sacroiliitis was present in 69,3% of women versus 84,7% of men (p = 0,01). The use of anti-TNF alpha was less frequent in women (29% vs 48,5%; p = 0,01).Our study didn’t found a statistically significant difference in peripheral manifestations, extraarticular manifestations, CRP, BASDAI and BASFI between the two groups.Conclusion:Female ax-SpA seems to have a better prognosis than male with older age in disease onset, less inflammation, less radiographic sacroiliitis and less use of biological treatments.References:[1]Rusman T, et al. Curr Rheumatol Rep. 2018; 20(6).[2]Siar N, et al. Curr Rheumatol Rev. 2019;Disclosure of Interests:None declared


2019 ◽  
Vol 46 (9) ◽  
pp. 1075-1083 ◽  
Author(s):  
Kari Hansen Berg ◽  
Gudrun Elin Rohde ◽  
Anne Prøven ◽  
Esben Esther Pirelli Benestad ◽  
Monika Østensen ◽  
...  

Objective.To examine the relationship between demographics, disease-related variables, treatment, and sexual quality of life (SQOL) in men and women with axial spondyloarthritis (axSpA).Methods.AxSpA patients were consecutively recruited from 2 rheumatology outpatient clinics in southern Norway. A broad spectrum of demographics, disease, treatment, and QOL data were systematically collected. SQOL was assessed using the SQOL-Female (SQOL-F) questionnaire (score range 18–108). Appropriate statistical tests were applied for group comparison, and the association between independent variables and SQOL-F was examined using multiple linear regression analysis.Results.A total of 360 (240 men, 120 women) axSpA patients with mean age 45.5 years and disease duration 13.9 years were included. Seventy-eight percent were married/cohabiting, 26.7% were current smokers, 71.0% were employed, 86.0% performed > 1-h exercise per week, and 88.0% were HLA-B27–positive. Mean (SD) values for disease measures were C-reactive protein (CRP) 8.5 (12.1) mg/l, Bath Ankylosing Spondylitis Disease Activity Index 3.1 (2.1), Bath Ankylosing Spondylitis Global Score (BAS-G) 3.8 (2.5), Bath Ankylosing Spondylitis Functional Index 2.7 (2.2), and Health Assessment Questionnaire 0.6 (0.5). The proportion of patients using nonsteroidal antiinflammatory drugs was 44.0%, synthetic disease-modifying antirheumatic drugs (DMARD) 5.0%, and biologic DMARD 24.0%. Mean (SD) total sum score for SQOL was 76.6 (11.3). In multivariate analysis, female sex, increased body mass index, measures reflecting disease activity (BAS-G and CRP), and current biologic treatment were independently associated with a lower SQOL.Conclusion.Our data suggest that inflammation in patients with axSpA even in the biologic treatment era reduces SQOL.


2016 ◽  
Vol 43 (8) ◽  
pp. 1541-1546 ◽  
Author(s):  
Ennio Lubrano ◽  
Fabio Massimo Perrotta ◽  
Maria Manara ◽  
Salvatore D’Angelo ◽  
Olga Addimanda ◽  
...  

Objective.The aim of this study was to evaluate rate and predictive factors of loss of remission and disease flare in patients with axial spondyloarthritis (axSpA) receiving antitumor necrosis factor (anti-TNF) treatment.Methods.In this retrospective multicenter study, patients with axSpA, according to the Assessment of Spondyloarthritis international Society (ASAS) criteria, treated with adalimumab, etanercept, or infliximab with a minimum followup of 12 months and satisfying the ASAS partial remission criteria and/or Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease were studied. Disease flare was defined as a Bath Ankylosing Spondylitis Disease Activity Index score > 4.5 or ASDAS score > 2.5 on at least 1 occasion.Results.One hundred seventy-four patients with axSpA were studied. After a median [interquartile range (IQR)] followup of 4 years (2–6), 37 patients (21.2%) experienced a loss of remission and 28 (16.1% of the whole study group) a disease flare. Median (IQR) duration of remission in patients who lost this status was 1 year (0.625–2). Higher median erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) values, continuous nonsteroidal antiinflammatory drug (NSAID) use, and an ASDAS-CRP ≥ 0.8 during the remission period were significantly associated with both loss of remission and disease flare. At the multivariate analysis, continuous NSAID intake (OR 4.05, 95% CI 1.4–11.74, p = 0.010) and ESR > 15 (OR 2.90, 95% CI 1.23–6.82, p = 0.015) were the only factors predictive of disease reactivation.Conclusion.In this study, loss of remission and disease flares occurred, respectively, in about 21% and 16% of the patients with axSpA who achieved a state of remission while receiving anti-TNF therapy. Residual disease activity was associated with disease reactivation.


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