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 P257 Real-world evidence of TNF inhibition in axial spondyloarthritis: can we generalise the results from clinical trials?

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Gareth T Jones ◽  
Linda E Dean ◽  
Ejaz Pathan ◽  
Gary J Macfarlane
Keyword(s):  
Clinical Trials ◽  
Treatment Response ◽  
Real World ◽  
Financial Support ◽  
World Population ◽  
Research Support ◽  
Trial Participants ◽  
Tnf Inhibition ◽  
Grant Holder

Abstract Background The development and utility of management guidelines assumes that clinical trial findings are generalisable. Seldom is data available to test this. We aimed to determine, in the British Society for Rheumatology Biologics Register for Ankylosing Spondylitis (BSRBR-AS), the proportion of patients commencing TNF inhibition (TNFi) that would/would not have been eligible for clinical trials that led to TNFi treatment guidelines, and whether treatment response differed between the trials and this real-world population. Methods Biologic-naïve spondyloarthritis patients were recruited from across Great Britain. Data was obtained from clinical records, and participants completed postal questionnaires. Participant characteristics were extracted from the placebo-controlled randomised trials in the NICE Health Technology Assessment: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis (TA383). Descriptive statistics were used to examine differences, including treatment response (ASAS-20), between BSRBR-AS participants who would/would not have been eligible for the clinical trials, and the trial participants. Results 816/2420 (34%) BSRBR-AS participants were commencing TNFi. They were younger (mean age 44 versus 50yrs) with shorter disease duration (15 versus 22yrs), more active disease (BASDAI 6.4 versus 4.0), and poorer function (BASFI 6.2 versus 3.8). Fourteen clinical trials were identified. Compared to trial populations, fewer BSRBR-AS participants were male (67% versus 71%; difference: -4.1% (95%CI: -7.8%, -0.4%)) and fewer were HLA-B27 positive (76% versus 82%; difference: -6.6% (-10.6%, -2.6%)). BSRBR-AS participants were 6yrs older than trial participants, with longer symptom duration. They reported similar disease activity (BASDAI: 6.4 versus 6.2; difference 0.2 (-0.3, 0.7)), although significantly poorer function (BASFI: 6.2 versus 5.1; difference 1.1 (0.5, 1.8)) and spinal mobility (BASMI: 4.2 versus 3.3; difference 1.0 (0.8, 1.1)). Only 333 (41%) of BSRBR-AS participants commencing TNFi would have been eligible for any of the relevant trials. Ten trials reported ASAS20 response criteria, and 864/1401 participants reported a positive treatment response (61.7%). Follow-up data was available for 318 (39%) BSRBR-AS participants, of whom 163 (51.3%) achieved an ASAS20 treatment response (difference: 10.4% (4.4%, 16.5%)). There was no difference in ASAS20 response between those who would/would not have been eligible for clinical trials (50% versus 52%; difference 2.0% (-9.4%, 13.4%)). Conclusion In this real-world population, although the likelihood of meeting response criteria was unrelated to factors determining trial eligibility, the proportion of patients responding to TNFi was lower than in the clinical trial literature. Could this be explained by selection bias? Although fewer BSRBR-AS participants provided follow-up data than in the clinical trials, to account for the observed difference participants lost to follow-up would have to be one-third more likely to achieve ASAS20 response than those who provided follow-up data. We believe this is unlikely. These findings have important implications for the generalisability of trial results, and also for the cost-effectiveness of TNFi agents. Disclosures G.T. Jones: Grants/research support; GTJ is/was a grant holder for research funded by Pfizer, AbbVie, UCB and Celgene., GTJ is/was involved in research that received financial support from Novartis. L.E. Dean: Grants/research support; LED is/was involved in research that received financial support from Pfizer, AbbVie, UCB and Novartis. E. Pathan: None. G.J. Macfarlane: Grants/research support; GJM is/was a grant holder for research funded by Pfizer, AbbVie, UCB and Celgene., GJM is/was involved in research that received financial support from Novartis.

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 THU0395 EFFICACY OF IXEKIZUMAB ON DISEASE ACTIVITY AND QUALITY OF LIFE IN PATIENTS WITH ACTIVE NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS AND OBJECTIVE SIGNS OF INFLAMMATION, STRATIFIED BY BASELINE CRP/SACROILIAC JOINT MRI STATUS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 432-433
Author(s):  
W. P. Maksymowych ◽  
H. Marzo-Ortega ◽  
M. Ǿstergaard ◽  
L. S. Gensler ◽  
J. Ermann ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Treatment Group ◽  
Disease Activity ◽  
Sacroiliac Joint ◽  
Axial Spondyloarthritis ◽  
Physical Component Score ◽  
Research Support ◽  
Advisory Boards ◽  
Sf 36 ◽  
Active Sacroiliitis

Background:Ixekizumab (IXE), a high-affinity anti-interleukin-17A monoclonal antibody, is effective in patients (pts) with active non-radiographic axial spondyloarthritis (nr-axSpA), who had elevated C-reactive protein (CRP) and/or active sacroiliitis on magnetic resonance imaging (MRI).1Objectives:To determine if disease activity and patient-reported outcomes at Week 16 were similar between groups after stratifying pts by CRP/sacroiliac joint (SIJ) MRI status at baseline.Methods:COAST-X (NCT02757352) included pts with active nr-axSpA and objective signs of inflammation, i.e. presence of sacroiliitis on MRI (Assessment of Spondyloarthritis International Society [ASAS]/ Outcome Measures in Rheumatology criteria) or elevation of serum CRP (>5.0 mg/L). Pts were randomized 1:1:1 to receive subcutaneous 80 mg IXE every 4 weeks (Q4W) or Q2W, or placebo (PBO). Depending on the baseline values of CRP and MRI SIJ (Spondyloarthritis Research Consortium of Canada [SPARCC] score), pts in the intent-to-treat population (N=239) were divided into 3 subgroups (CRP >5 and MRI ≥2; CRP ≤5 and MRI ≥2; CRP >5 and MRI <2). Logistic regression analysis with treatment, subgroup, and treatment-by-subgroup interaction was used to detect treatment group differences in ASAS40, Ankylosing Spondylitis Disease Activity Score (ASDAS) <2.1 (low disease activity), and Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) responses at Week 16. Analysis of covariance model with baseline value, treatment, subgroup, and treatment-by-subgroup interaction was used to detect the treatment group difference in change from baseline in Short Form-36 physical component score (SF-36 PCS).Results:The proportion of pts achieving ASAS40 (primary endpoint), ASDAS <2.1, and BASDAI50 (secondary endpoints) was higher in IXE treatment groups compared to PBO at Week 16 (Figure 1). The response rates in IXE-treated subjects were higher in all subgroups (CRP >5 and MRI ≥2; CRP ≤5 and MRI ≥2; CRP >5 and MRI <2) without consistent differences in efficacy between the subgroups. Similarly, pts in the IXE groups showed improvement in SF-36 PCS scores (secondary endpoint) versus pts on PBO at Week 16 (Figure 2).Conclusion:Pts with active nr-axSpA and objective signs of inflammation at baseline who were treated with IXE showed an overall improvement in the signs and symptoms of the disease. The efficacy was not different between pts with both elevated CRP and active sacroiliitis on MRI and pts with either elevated CRP or active sacroiliitis on MRI.References:[1]Deodhar A, et al.Lancet.2020.Disclosure of Interests:Walter P Maksymowych Grant/research support from: Received research and/or educational grants from Abbvie, Novartis, Pfizer, UCB, Consultant of: WPM is Chief Medical Officer of CARE Arthritis Limited, has received consultant/participated in advisory boards for Abbvie, Boehringer, Celgene, Eli-Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, UCB, Speakers bureau: Received speaker fees from Abbvie, Janssen, Novartis, Pfizer, UCB., Helena Marzo-Ortega Grant/research support from: Janssen, Novartis, Consultant of: Abbvie, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, UCB, Speakers bureau: Abbvie, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Takeda, UCB, Mikkel Ǿstergaard Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Merck, and Novartis, Consultant of: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, Lianne S. Gensler Grant/research support from: Pfizer, Novartis, UCB, Consultant of: AbbVie, Eli Lilly, GSK, Novartis, UCB, Joerg Ermann Grant/research support from: Boehringer-Ingelheim, Pfizer, Consultant of: Abbvie, Eli Lilly, Janssen, Novartis,Pfizer, Takeda, UCB, Atul Deodhar Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, David Sandoval Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Rebecca Bolce Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Andris Kronbergs Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Soyi Liu Leage Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Gabriel Doridot Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Vladimir Geneus Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Ann Leung: None declared, David Adams Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Martin Rudwaleit Consultant of: AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma

scholarly journals Potential relation of cardiovascular risk factors to disease activity in patients with axial spondyloarthritis

2021 ◽  
Vol 13 ◽  
pp. 1759720X2110337
Author(s):  
Iván Ferraz-Amaro ◽  
Javier Rueda-Gotor ◽  
Fernanda Genre ◽  
Alfonso Corrales ◽  
Ricardo Blanco ◽  
...  
Keyword(s):  
Risk Factors ◽  
Risk Factor ◽  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Axial Spondyloarthritis ◽  
Multivariable Analysis ◽  
Activity Score ◽  
Increased Risk ◽  
Activity Measurements ◽  
Beta Coefficient

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.

scholarly journals THU0378 DO COMORBIDITIES DECREASE THE FIRST TNF-INHIBITOR RETENTION AND TREATMENT RESPONSE IN AXIAL SPONDYLOARTHRITIS PATIENTS? DATA FROM TURKBIO

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 422-423
Author(s):  
Y. Erez ◽  
A. Karakas ◽  
S. B. Kocaer ◽  
T. Yüce İnel ◽  
S. Gulle ◽  
...  
Keyword(s):  
Disease Activity ◽  
Treatment Response ◽  
Axial Spondyloarthritis ◽  
Cerebrovascular Event ◽  
Tnf Inhibitor ◽  
Drug Survival ◽  
Drug Retention ◽  
Significant Difference ◽  
Baseline Characteristics ◽  
The Impact

Background:The frequency of comorbidities has increased in spondyloarthritis patients compared to the general population. The effect of comorbidities on tumour necrosis factor alpha inhibitor (TNFi) drug retention and treatment response has not been well evaluated.Objectives:The purpose of this study to assess the impact of comorbidities on the first TNFi drug survival and treatment response in patients with axial spondyloarthritis (axSpA) registered in theTURKBIOdatabase.Methods:In this study, the frequency of comorbidities, disease activity scores at baseline and month 6 and drug retention were recorded in AxSpA patients iniating first TNFi treatment between 2011 and 2019. Kaplan Meier plot and log rank tests were used for drug survival analysis. Cox regression analysis with HR was performed to evaluate the correlation between comorbidities and drug survival.Results:There were 2428 patients with AxSpA (39.3% female) who used their first TNFi during the study period. Among them, a total of 770 (31%) had at least one comorbid disease. Hypertension was the most common comorbidity (9.7%), followed by the affective disorders (8%) and chronic lung disease (5.8%). The baseline characteristics of patients are shown in Table 1.The presence of any comorbidity did not impact the first TNFi retention (Figure 1). When comorbidities were analysed seperately, we found that only history of cerebrovascular event was negatively associated with drug retention rate (HR: 6.9, p:0.008). There was no statistically significant difference in Bath AS Disease Activity Index 50% (BASDAI50) response between patients with and without comorbidity at 6 months. Less axSpA patients with comorbidity achieved a ASDAS score ≤ 2.1 compared to patients without comorbidity at 6 months.Table 1.Baseline Characteristics of PatientsRadiographic Spondyloarthritis, n (%)2318 (95.5)Female, n(%)954 (39.3)Age, year42.2±11.8Age at diagnosis, years32.5± 11.3Age at initial TNFi, years39.4 ± 11.1Symptom duration, years9.7± 7.5Time to initial TNFi, years7±6.8HLA-B27- positivity, n (%)1144 (47.1)Smokers, n (%)1068 (44)Baseline BASDAI35.5±22.2Baseline ASDAS-CRP2.8±1.1Baseline CRP (mg/L)15.7±24.4VAS global patient46.6±28.7-Quantitative variables are presented as mean ± SD, and qualitative variables are presented as frequency and percentage-ASDAS-CRP, Ankylosing Spondylitis Disease Activity Score using C-reactive protein VAS, visual analogue scaleConclusion:The results of this study demonstrated that the presence of previous cerebrovascular event decreased the first TNFi survival in patients with axSpA. It also suggested that comorbidities might decrease TNFi treatment response.Disclosure of Interests:None declared

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 POS0959 DIAGNOSTIC DELAY IN AXIAL SPONDYLOARTHRITIS: RESULTS FROM THE NATIONAL EARLY INFLAMMATORY ARTHRITIS AUDIT

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 744.1-744
Author(s):  
M. Russell ◽  
F. Coath ◽  
M. Yates ◽  
K. Bechman ◽  
S. Norton ◽  
...  
Keyword(s):  
Inflammatory Arthritis ◽  
Clinical Characteristics ◽  
Axial Spondyloarthritis ◽  
Diagnostic Delay ◽  
British Society ◽  
Standards Of Care ◽  
Symptom Duration ◽  
Research Support ◽  
England And Wales ◽  
Early Inflammatory Arthritis

Background:Diagnostic delay is a significant problem in axial spondyloarthritis (axSpA), and there is a growing body of evidence showing that delayed axSpA diagnosis is associated with worse clinical, humanistic and economic outcomes.1 International guidelines have been published to inform referral pathways and improve standards of care for patients with axSpA.2,3Objectives:To describe the sociodemographic and clinical characteristics of newly-referred patients with axSpA in England and Wales in the National Early Inflammatory Arthritis Audit (NEIAA), with rheumatoid arthritis (RA) and mechanical back pain (MBP) as comparators.Methods:The NEIAA captures data on all new patients over the age of 16 referred with suspected inflammatory arthritis to rheumatology departments in England and Wales.4 We describe baseline sociodemographic and clinical characteristics of axSpA patients (n=784) recruited to the NEIAA between May 2018 and March 2020, compared with RA (n=9,270) and MBP (n=370) during the same period.Results:Symptom duration prior to initial rheumatology assessment was significantly longer in axSpA than RA patients (p<0.001), and non-significantly longer in axSpA than MBP patients (p=0.062): 79.7% of axSpA patients had symptom durations of >6 months, compared to 33.7% of RA patients and 76.0% of MBP patients; 32.6% of axSpA patients had symptom durations of >5 years, compared to 3.5% of RA patients and 24.6% of MBP patients (Figure 1A). Following referral, median time to initial rheumatology assessment was longer for axSpA than RA patients (36 vs. 24 days; p<0.001), and similar to MBP patients (39 days; p=0.30). The proportion of axSpA patients assessed within 3 weeks of referral increased from 26.7% in May 2018 to 34.7% in March 2020; compared to an increase from 38.2% to 54.5% for RA patients (Figure 1B). A large majority of axSpA referrals originated from primary care (72.4%) or musculoskeletal triage services (14.1%), with relatively few referrals from gastroenterology (1.9%), ophthalmology (1.4%) or dermatology (0.4%).Of the subset of patients with peripheral arthritis requiring EIA pathway follow-up, fewer axSpA than RA patients had disease education provided (77.5% vs. 97.8%; p<0.001), and RA patients reported a better understanding of their condition (p<0.001). HAQ-DI scores were lower at baseline in axSpA EIA patients than RA EIA patients (0.8 vs 1.1, respectively; p=0.004), whereas baseline Musculoskeletal Health Questionnaire (MSK-HQ) scores were similar (25 vs. 24, respectively; p=0.49). The burden of disease was substantial across the 14 domains comprising MSK-HQ in both axSpA and RA (Figure 1C).Conclusion:We have shown that diagnostic delay remains a major challenge in axSpA, despite improved disease understanding and updated referral guidelines. Patient education is an unmet need in axSpA, highlighting the need for specialist clinics. MSK-HQ scores demonstrated that the functional impact of axSpA is no less than for RA, whereas HAQ-DI may underrepresent disability in axSpA.References:[1]Yi E, Ahuja A, Rajput T, George AT, Park Y. Clinical, economic, and humanistic burden associated with delayed diagnosis of axial spondyloarthritis: a systematic review. Rheumatol Ther. 2020;7:65-87.[2]NICE. Spondyloarthritis in over 16s: diagnosis and management. 2017.[3]van der Heijde D, Ramiro S, Landewe R, et al. 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis. 2017;76(6):978-91.[4]British Society for Rheumatology. National Early Inflammatory Arthritis Audit (NEIAA) Second Annual Report. 2021.Acknowledgements:The National Early Inflammatory Arthritis Audit is commissioned by the Healthcare Quality Improvement Partnership, funded by NHS England and Improvement, and the Welsh Government, and carried out by the British Society for Rheumatology, King’s College London and Net Solving.Disclosure of Interests:Mark Russell Grant/research support from: UCB, Pfizer, Fiona Coath: None declared, Mark Yates Grant/research support from: UCB, Abbvie, Katie Bechman: None declared, Sam Norton: None declared, James Galloway Grant/research support from: Abbvie, Celgene, Chugai, Gilead, Janssen, Lilly, Pfizer, Roche, UCB, Jo Ledingham: None declared, Raj Sengupta Grant/research support from: AbbVie, Biogen, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Karl Gaffney Grant/research support from: AbbVie, Biogen, Cellgene, Celltrion, Janssen, Lilly, Novartis, Pfizer, Roche, UCB.

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

THU0399 HOW DO TNF-ALPHA-INHIBITORS IN MEDICAL HISTORY AFFECT PATIENT REPORTED OUTCOMES AND RETENTION IN ANKYLOSING SPONDYLITIS PATIENTS TREATED WITH SECUKINUMAB IN REAL WORLD? - GERMAN AQUILA STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 436-437
Author(s):  
U. Kiltz ◽  
J. Brandt-Juergens ◽  
P. Kästner ◽  
E. Riechers ◽  
D. Peterlik ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Treatment Outcomes ◽  
Medical History ◽  
Physical Functioning ◽  
Real World ◽  
Interim Analysis ◽  
Retention Rates ◽  
Research Support ◽  
Kaplan Meier

Background:Secukinumab (SEC), a fully human monoclonal antibody that selectively inhibits interleukin 17A, is approved for treatment of patients with ankylosing spondylitis (AS). However, there is lack of real-world evidence on SEC treatment outcomes, disease activity, physical functioning and on its retention, especially in anti-tumor necrosis factor (anti-TNF) naïve patients and patients pretreated with different anti-TNFs in medical history.1Objectives:The aim of this interim analysis is to evaluate SEC treatment outcomes on disease activity, physical functioning and retention rates in AS patients stratified by number of anti-TNFs (naive, 1 or ≥2) in medical history.Methods:AQUILA is an ongoing, multi-center, non-interventional study. AS and psoriatic arthritis patients treated with SEC in daily practice are enrolled and observed from baseline (BL, d0 or d1 of study start) up to week 52 according to clinical routine. Real-world effectiveness of SEC was assessed prospectively and analyzed as observed. Here, we report interim results of SEC effectiveness on different treatment outcomes in AS patients by means of validated questionnaires such as patient´s global assessment (PGA), Bath Ankylosing Disease Activity Index (BASDAI), and Assessment of Spondyloarthritis Health Index (ASAS-HI). In addition, retention rates (time from study inclusion until premature SEC treatment discontinuation) were assessed through Kaplan-Meier plots. This interim analysis focuses onanti-TNF naïveand AS patients treated with1 anti-TNFor≥2 anti-TNFsin medical history. Wilcoxon tests were conducted to show significant differences between the subgroups.Results:At BL, 311 AS patients were included; 72 (23.2%) of them received SEC already for more than 1 day up to more than 6 months before BL. Most AS patients were anti-TNF-experienced (71.1%): 82 (26.4%) and 139 (44.7%) AS patients had 1 or ≥2 prior anti-TNF treatments, respectively. BL scores for PGA, BASDAI and ASAS-HI were similar between the different anti-TNF subgroups. Constant improvement was shown in all parameters from BL up to week 52, irrespective of prior anti-TNF treatment (PGA-anti-TNF naïve: 5.9 to 3.5, PGA-1 anti-TNF:6.1 to 4.2 and PGA-≥2 anti-TNFs:6.7 to 5.1; BASDAI-anti-TNF naïve: 5.3 to 3.4, BASDAI-1 anti-TNF:5.5 to 3.7 and BASDAI-≥2 anti-TNFs:5.7 to 4.7). However, overall better improvement was observed inanti-TNF naïvepatients, as seen by the example of ASAS-HI (Fig. 1). Between 30% and 40% of patients prematurely discontinued SEC treatment in the subgroups1 anti-TNFand≥2 anti-TNFs, respectively, while only about 20% did so in theanti-TNF naïveAS patients (Fig. 2).Conclusion:SEC has shown to improve disease activity, physical functioning and QoL in anti-TNF-naïve and pretreated AS patients in a real-world setting. The benefits of SEC were numerically more distinct in anti-TNF-naïve patients. Moreover, SEC demonstrated high retention rate, particularly in anti-TNF-naïve patients, thereby confirming previously reported real-world data on SEC from EuroSpA research collaboration network.2References:[1]Glintborg B, et al, Ann Rheum Dis 2013;72:1149-55; 2. Michelsen B, et al, Arthritis Rheumatol 2019:71(suppl10) #1822Disclosure of Interests:Uta Kiltz Grant/research support from: AbbVie, Amgen, Biogen, Novartis, Pfizer, Consultant of: AbbVie, Biocad, Eli Lilly and Company, Grünenthal, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Novartis, Pfizer, Roche, UCB, Jan Brandt-Juergens: None declared, Peter Kästner Consultant of: Chugai, Novartis, Elke Riechers Grant/research support from: AbbVie, Chugai, Lilly, Janssen, Novartis, Pfizer, Roche, UCB, Consultant of: AbbVie, Chugai, Novartis, UCB, Daniel Peterlik Employee of: Novartis Pharma GmbH, Hans-Peter Tony Consultant of: AbbVie, Astra-Zeneca, BMS, Chugai, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, SanofiFigure 1.Change of health in AS patients treated with SEC stratified by anti-TNF pretreatmentFigure 2.SEC treatment retention depending on anti-TNF pretreatment (Kaplan-Meier plot)

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