scholarly journals P278 Real-world experience with an IL-17A blocker in biologic-naïve and biologic-experienced radiographic and non-radiographic axSpA patients

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Nicola Booth ◽  
Julie Hill ◽  
Soyi Liu Leage ◽  
Christophe Sapin ◽  
Elizabeth Holdsworth ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Median Duration ◽  
Real World ◽  
Treatment Duration ◽  
Axial Spondyloarthritis ◽  
Activity Index ◽  
Loading Dose ◽  
Median Treatment ◽  
Median Treatment Duration

Abstract Background In Europe, IL-17A blocker secukinumab is approved for ankylosing spondylitis (AS). The label dose is 150mg: loading dose regimen at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. 300mg dose is not indicated for AS. Secukinumab is not yet approved for non-radiographic axial spondyloarthritis (nr-axSpA). Objectives: Describe real-world dose utilization of an IL-17A blocker among axial spondyloarthritis (axSpA) patients with radiographic (AS) and nr-axSpA. Methods Descriptive, cross-sectional survey of physicians managing axSpA (France, Germany, Italy, Spain, UK, Austria & Australia). At the time of survey (April-August 2019), only secukinumab was approved. Physicians completed patient record forms for their next 7 consulting patients currently treated with or discontinued secukinumab, recording demographics, disease activity (Bath Ankylosing Spondylitis Disease Activity Index, BASDAI), Ankylosing Spondylitis Disease Activity Score, ASDAS) and treatment history. Results 275 rheumatologists and 4 orthopedists provided data for 2,101 patients: 1,509 (1151 AS; 358 nr-axSpA) currently receiving secukinumab and 592 (385 AS; 207 nr-axSpA) secukinumab discontinuers. Mean age was 45.1years (45.8 AS; 43.2 nr-axSpA), 64.4% were male (68.8% AS, 52.4% nr-axSpA), and mean time diagnosed was 5.3years (5.9 AS; 3.8 nr-axSpA). 50.5% (48.4% AS; 55.9% nr-axSpA) of patients were receiving secukinumab as their first biologic, 48.4% biologic-experienced. 94.1% (93.9% AS; 94.3% nr-axSpA) of all users were treated beyond loading dose phase of secukinumab; 8.8% dose up-titrated from 150mg to 300mg. Of patients currently receiving secukinumab maintenance, median treatment duration was 44.4weeks (n = 1249). 71.5% (71.4% AS; 72.3% nr-axSpA) received 150mg monthly, 28.5% received a dose outside label (23.7% on 300mg). For discontinuers who reached maintenance phase, median treatment duration was 20.0weeks (n = 547). 38.7% (37.4% AS; 41.3% nr-axSpA) of secukinumab discontinuers received a dose outside label (33.9% on 300mg). 30.5% (28.8% AS; 36.1% nr-axSpA) of biologic-experienced patients received secukinumab 300mg. The utilization of secukinumab 300mg in biologic-experienced discontinuers was 36.9% and higher than in current biologic-experienced users (28.0%). At initiation of secukinumab 150mg, 95.1% and 90.7% of patients had BASDAI≥4 (n = 593) and ASDAS≥2.1 (n = 129), respectively. For those continuing, after a median duration of 42.3weeks, 31.7% (30.4% AS; 35.7% nr-axSpA) had BASDAI≥4 and 30.2% (27.8% AS; 37.5% nr-axSpA) ASDAS≥2.1. At initiation of secukinumab 300mg, 93.1% and 96.4% had BASDAI≥4 (n = 173) and ASDAS≥2.1 (n = 28), respectively. For those continuing, after median duration of 51.9weeks, 42.2% (38.2% AS; 54.8% nr-axSpA) had BASDAI≥4 and 57.1% (52.4% AS; 71.4% nr-axSpA) ASDAS≥2.1. Conclusion In the real-world, secukinumab discontinuation occurred after 20.0weeks, despite approximately one third being treated with secukinumab 300mg. For those remaining on secukinumab, up to 30% used outside-label doses (higher in biologic-experienced patients). Secukinumab is not universally prescribed for the approved indication or at the recommended dose. There is a suggestion that not all patients receiving a higher dose achieve low disease activity. Disclosures N. Booth: Grants/research support; Research was funded by eli-lilly and company. Other; Employed by Adelphi Real World. J. Hill: Other; Employed by Eli Lilly and company. S. Leage: Other; Employed by Eli Lilly and company. C. Sapin: Other; Employed by Eli Lilly and company. E. Holdsworth: Other; Employed by Adelphi Real World. S. Antonelli: Other; Employed by Eli Lilly and company.

scholarly journals SAT0364 DATA TO BE COLLECTED FOR AN OPTIMAL MANAGEMENT OF AXIAL SPONDYLOARTHRITIS IN DAILY PRACTICE: PROPOSAL FROM AN EVIDENCE BASED AND CONSENSUAL APPROACHES

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1129.1-1129
Author(s):  
A. Baillet ◽  
X. Romand ◽  
A. Pfimlin ◽  
M. Dalecky ◽  
M. Dougados
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Axial Spondyloarthritis ◽  
Activity Index ◽  
Disease Activity Index ◽  
Daily Practice ◽  
Evidence Based ◽  
Periodic Review ◽  
Grade Scale

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

scholarly journals AB0669 PARTICULARITIES OF TUNISIAN FEMALE AXIAL SPONDYLOARTHRITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1629.2-1629
Author(s):  
K. Ben Abdelghani ◽  
Y. Gzam ◽  
A. Fazaa ◽  
S. Miladi ◽  
K. Ouenniche ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Axial Spondyloarthritis ◽  
Activity Index ◽  
Age At Onset ◽  
Disease Onset ◽  
Disease Activity Index ◽  
Reactive Protein ◽  
Significant Difference ◽  
The Mean

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

scholarly journals Real-world evidence of TNF inhibition in axial spondyloarthritis: can we generalise the results from clinical trials?

2020 ◽  
Vol 79 (7) ◽  
pp. 914-919 ◽  
Author(s):  
Gareth T Jones ◽  
Linda E Dean ◽  
Ejaz Pathan ◽  
Rosemary J Hollick ◽  
Gary J Macfarlane
Keyword(s):  
Clinical Trials ◽  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Treatment Response ◽  
Real World ◽  
Axial Spondyloarthritis ◽  
British Society ◽  
Symptom Duration ◽  
Clinical Records ◽  
Trial Participants

Management guidelines assume that results from clinical trials can be generalised, although seldom is data available to test this assumption. We aimed to determine the proportion of patients commencing tumour necrosis factor inhibition (TNFi) who would have been eligible for relevant clinical trials, and whether treatment response differs between these groups and the trials themselves. The British Society for Rheumatology Biologics Register for Ankylosing Spondylitis (BSRBR-AS) recruited a real-world cohort of TNFi-naïve spondyloarthritis patients with data collection from clinical records and patient questionnaires. Participant characteristics were extracted from trials identified from a recent Health Technology Assessment of TNFi for ankylosing spondylitis/non-radiographic axial spondyloarthritis. Descriptive statistics were used to determine the differences, including treatment response, between BSRBR-AS participants who would/would not have been eligible for the clinical trials and with trial participants. Among 2420 BSRBR-AS participants, those commencing TNFi (34%) had shorter symptom duration (15 vs 22 years) but more active disease (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 6.4 vs 4.0; Bath Ankylosing Spondylitis Disease Functional Index (BASFI) 6.2 vs 3.8). Of those commencing TNFi, 41% met eligibility criteria for ≥1 of fourteen relevant trials; they reported higher disease activity (BASDAI 6.9 vs 6.1) and poorer function (BASFI 6.6 vs 6.0). 61.7% of trial participants reported a positive treatment response, vs 51.3% of BSRBR-AS patients (difference: 10.4%; 95% CI 4.4% to 16.5%). Potential eligibility for trials did not influence treatment response (difference 2.0%; -9.4% to 13.4%). Fewer patients in the real world respond to TNFi than is reported in the trial literature. This has important implications for the generalisability of trial results, and the cost-effectiveness of TNFi agents.

scholarly journals Sexual Quality of Life in Patients with Axial Spondyloarthritis in the Biologic Treatment Era

2019 ◽  
Vol 46 (9) ◽  
pp. 1075-1083 ◽  
Author(s):  
Kari Hansen Berg ◽  
Gudrun Elin Rohde ◽  
Anne Prøven ◽  
Esben Esther Pirelli Benestad ◽  
Monika Østensen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Axial Spondyloarthritis ◽  
Activity Index ◽  
Statistical Tests ◽  
Linear Regression Analysis ◽  
Biologic Treatment ◽  
Sexual Quality Of Life

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.

scholarly journals Predictors of Loss of Remission and Disease Flares in Patients with Axial Spondyloarthritis Receiving Antitumor Necrosis Factor Treatment: A Retrospective Study

2016 ◽  
Vol 43 (8) ◽  
pp. 1541-1546 ◽  
Author(s):  
Ennio Lubrano ◽  
Fabio Massimo Perrotta ◽  
Maria Manara ◽  
Salvatore D’Angelo ◽  
Olga Addimanda ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Axial Spondyloarthritis ◽  
Residual Disease ◽  
Activity Index ◽  
Inactive Disease ◽  
Disease Flare ◽  
Asas Criteria ◽  
Disease Reactivation ◽  
Necrosis Factor

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.

Fatigue in Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis: Analysis from a Longitudinal Observation Cohort

2015 ◽  
Vol 42 (12) ◽  
pp. 2354-2360 ◽  
Author(s):  
Mohamed Bedaiwi ◽  
Ismail Sari ◽  
Arane Thavaneswaran ◽  
Renise Ayearst ◽  
Nigil Haroon ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Axial Spondyloarthritis ◽  
Acute Phase Proteins ◽  
Activity Index ◽  
Health Assessment ◽  
Disease Activity Index ◽  
Common Symptom ◽  
Severe Fatigue ◽  
Fatigue Severity

Objective.In this study, we aimed to address the prevalence of fatigue, its associated factors, and the effect of tumor necrosis factor inhibitors (TNFi) on this subgroup of patients in a large axial spondyloarthritis (axSpA) cohort.Methods.The study included 681 patients [ankylosing spondylitis (AS) and nonradiographic axSpA (nr-axSpA)]. The Fatigue Severity Scale (FSS) and the Bath AS Disease Activity Index question 1 (BASDAI Q1) indices were used for fatigue assessment. Severe fatigue was defined as an FSS ≥ 4 or a BASDAI Q1 ≥ 5. Disease activity, function, and quality of life (QoL) measures were recorded. Patients who had been treated with TNFi were identified, and baseline and followup data were analyzed.Results.Of the cohort, 67.3% had severe fatigue, and the prevalence was similar between AS (67.2%) and nr-axSpA (68.2%). Severely fatigued patients tended to have higher disease activity scores, increased acute-phase proteins, and decreased QoL measures. TNFi therapy was associated with improvement in disease activity, and although this treatment led to significantly decreased fatigue scores, this reduction was not optimal in the majority of patients with 80% continuing to have severe fatigue according to their posttreatment scores. Health Assessment Questionnaire, mean scores of BASDAI Q5 and Q6, and BASDAI enthesitis were independent predictors of fatigue severity.Conclusion.Fatigue is a common symptom in axSpA, and the burden of fatigue among patients with nr-axSpA is similar to that seen in AS. While biologics are effective in improving disease activity, their effect on fatigue is more limited. In axSpA, fatigue remains unresponsive to TNFi in nearly 80% of patients.

Efficacy of TNFα blockers in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis: a meta-analysis

2014 ◽  
Vol 74 (6) ◽  
pp. 1241-1248 ◽  
Author(s):  
Johanna Callhoff ◽  
Joachim Sieper ◽  
Anja Weiß ◽  
Angela Zink ◽  
Joachim Listing
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Effect Size ◽  
Axial Spondyloarthritis ◽  
Activity Index ◽  
Meta Analysis ◽  
Disease Activity Index ◽  
Effect Sizes ◽  
Double Blind ◽  
Mixed Effect

ObjectivesThis meta-analysis investigates the efficacy of tumour necrosis factor α (TNFα) blockers versus placebo for the treatment of ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).MethodsA systematic literature search was conducted independently by two reviewers. Double-blind randomised controlled trials (RCTs) investigating the efficacy of adalimumab, certolizumab, etanercept, golimumab or infliximab in approved dosages in comparison with placebo were included. The use of concomitant non-steroidal antirheumatic drugs was allowed. The outcome parameters were improvement in disease activity and function measured by the Bath AS disease activity index (BASDAI), Bath AS functional index (BASFI) and ASAS40 response. The effect sizes of the changes in BASDAI/BASFI between TNFα blocker and placebo comparator groups were calculated. Mixed effect models were applied separately for RCTs with AS and nr-axSpA patients and differences between those groups were evaluated in a joint model.Results20 studies with data from 3096 patients were included in the analysis: 15 studies with AS patients, four with nr-axSpA patients and one with both. For AS patients, TNFα blockers showed better efficacy than placebo for BASDAI (effect size 1.00), BASFI (effect size 0.67) and ASAS40 response (OR 4.7). For nr-axSpA patients, the differences were smaller (effect sizes 0.73, 0.57; OR 3.6). However, after adjustment for the year of publication as a proxy for disease severity, no differences in the effect sizes between the AS and nr-axSpA trials were observed.ConclusionsCompared with placebo, TNFα blockers improve disease activity and functional capacity clinically meaningful for both AS and nr-axSpA patients.

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