POS0974 IMPROVEMENT IN THE DIAGNOSTIC DELAY OF AXIAL SPONDYLOARTHRITIS, RESULTS FROM REAL WORLD DATA

Background:Diagnostic delay is a major challenge in axial spondyloarthritis (axSpA) with an extended interval of 8-10 years in Europe and 14 years in the United States between symptom onset and disease diagnosis (1, 2).Objectives:To assess the delay in the diagnosis of axSpA over time in a real world axSpA cohort diagnosed in the last 3 decades and to evaluate factors associated with this delay.Methods:A cohort of axSpA patients was recruited from a national multicenter registry of inflammatory arthritis. This cohorts’ demographic, clinical and diagnostic variables were studied. The diagnostic delay was defined as the time interval between the year of first symptom and year of diagnosis. The mean and median diagnostic delay were calculated. A survival analysis was performed evaluating the association between the demographic, clinical and diagnostic variables on the diagnostic delay.Results:Of the 373 axSpA patients in the registry, 198 (47%) are men. Ankylosing spondylitis fulfilling New York criteria was diagnosed in 73% of the patients. HLA-B*27 positivity was found in 64% of patients. The majority of the patients (63%) reported symptom onset between the age of 21-45, 21% before the age of 21 and 16% after the age of 45. Nine percent were diagnosed before the age of 21, 28% between 21-30, 23% between 31-40, 21% between 41-50 and 18% after the age of 50. One hundred and ten patients were diagnosed before 2000, 133 between 2001-2009 and 130 between 2010-2020. The mean and median delay in diagnosis was 9.1, 6 (±8.4) years when diagnosed before 2000, 5, 4 (±4.1) years when diagnosed 2001-2009, and 2, 1 (±1.5) years when diagnosed 2010-2020, respectively (graph 1). The only variable which was found to be associated with a shorter delay was the interval between symptom onset and first rheumatology consult: HR of 5.86 (4.3-8, p<0.001) if the rheumatology visit was within the first year of symptoms, HR 3.5 (2.4-5, p<0.001) if assessed 2-3 years after symptom onset. Additionally, age <21 at symptom onset was associated with a shorter delay (p=0.005). Sex, type of axSpA (radiographic vs. non radiographic axSpA), level of education, and HLA-B*27 positivity were not associated with a delay in diagnosis.Conclusion:Delay in axSpA diagnosis has significantly improved in this real-world cohort during the last decade. The most significant factor associated with a faster diagnosis was the time of the first rheumatology consult relative to symptom onset. Increasing the awareness of disease manifestations and early referral to a rheumatology service can improve the diagnosis delay of axSpA.References:[1]Sorensen J, Hetland ML, all departments of rheumatology in D. Diagnostic delay in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis: results from the Danish nationwide DANBIO registry. Ann Rheum Dis. 2015;74(3):e12.[2]Deodhar A, Mittal M, Reilly P, Bao Y, Manthena S, Anderson J, et al. Ankylosing spondylitis diagnosis in US patients with back pain: identifying providers involved and factors associated with rheumatology referral delay. Clin Rheumatol. 2016;35(7):1769-76.Graph 1.The improvement in the delay in diagnosis of axial spondyloarthropathy over the last 3 decadesDisclosure of Interests:None declared.

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AB0664 DIAGNOSIS DELAY IN ANKYLOSING SPONDYLITIS PATIENTS IN EGYPT: FACTORS, SOCIOECONOMIC AND CLINICAL OUTCOME

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.5003 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1627.2-1627

Author(s):

F. I. Abdelrahman ◽

M. Mortada

Keyword(s):

Ankylosing Spondylitis ◽

Social Life ◽

Activity Index ◽

Diagnostic Delay ◽

Disease Activity Index ◽

Diagnosis Delay ◽

Functional Index ◽

Delay In Diagnosis ◽

Significant Difference ◽

The Mean

Background:Ankylosing spondylitis (AS) is a destructive inflammatory disease which was reported to have the longest diagnostic delay among the inflammatory rheumatic disease. This lag period have a great impact on the clinical outcome and socioeconomic state of the patients. With the advent of tumor necrosis factor-α (TNF-α) inhibitors, early diagnosis in AS has become important(1).Objectives:to evaluate the period from symptom onset to diagnosis of AS in Egyptian patients and to examine possible reasons for delayed diagnosis and its impact on the economic and social life of the patients.Methods:The study included 87 AS patients diagnosed according to the Assessment of Spondyloarthritis international Society (ASAS) criteria (2). A face-to-face interview was applied to take medical history, and a questionnaire that contains some clinical aspects of disease was used. Diagnosis delay was described as the gap between first AS symptom and correct diagnosis of AS. Clinical and functional assessment of axial SpA measured by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI). The direct medical cost during years of delay (including costs of medical consultations, medications, investigations, physiotherapy and surgical treatment) had been estimated by Egyptian pound.Results:The study included 87 AS patients with mean age (30.03±8.3), 70 male (80.5%) and 17 female (19.5%).Mean delay in diagnosis was(5.7 ±4.9) years. Mean of diagnostic delay for patient diagnosed before 2010 is (14±4.4) and that of patients diagnosed after 2010 is (3.5±1.8) with significant difference between both (p value<0.0001). The main cause of delay was incorrect diagnosis as follow degenerative disc disease (43/87, 49.4%), non-specific back pain (31/87, 35.6%), rheumatoid arthritis (10/87,11.5%), rheumatic fever (2/87, 2.3%) and tuberculosis of spine (1/87, 1.1%). The mean of the medical visits was (6±5.4). Most incorrect initial diagnoses were made by orthopedicians (57.9%), followed by neurologists (22.2%) followed by rheumatologist (10%) and general phyisicians (9.9%). Absence of extra-articular manifestations, negative family history and juvenile age are significantly associated with diagnostic delay. Delay in diagnosis is significantly associated with higher disease activity index(BASDAI), functional index (BASFI), and damage index(BASMI). The mean of the costs during years of delay is (15671.3±546.1) with the mean of cost per each year delay (660.9±6.6) with high significant association between the cost and longer delay in diagnosis (<0.0001). Regarding work ability, we found that(32.2%) are fit for work, unfit (29.9%), partially fit (37.9%) with high significant difference between ability of work and shorter delay. Regarding social effect, 40.2 % of patients developed negative effect on social life with significant association to diagnostic delay (0.004).Conclusion:Our study confirmed the importance of early diagnosis of AS due to its impact on patient’s health outcome and socioeconomic state.We recommend to increase the awareness about the disease among healthcare professionals in our region.References:[1]Sykes M. et al: Diagnostic delay in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis; Ann Rheum Dis.2015;74:e44.[2]Rudwaleit M. et al: The development of Assessment of Spondyloarthritis international Society classification criteria for axial spondyloarthritis; Ann Rheum Dis, 68 (2009), pp.777-783.Disclosure of Interests:None declared

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High Probability of Long Diagnostic Delay in Coronavirus Disease 2019 Cases with Unknown Transmission Route in Japan

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17228655 ◽

2020 ◽

Vol 17 (22) ◽

pp. 8655

Author(s):

Tsuyoshi Ogata ◽

Hideo Tanaka

Keyword(s):

Symptom Onset ◽

Odds Ratio ◽

High Probability ◽

Adjusted Odds Ratio ◽

Diagnostic Delay ◽

Regression Analyses ◽

Factors Associated ◽

The Mean ◽

Diagnostic Delays ◽

Pcr Test

Long diagnostic delays (LDDs) in patients with coronavirus disease 2019 (COVID-19) might decrease the effectiveness of patient isolation in reducing subsequent transmission. We assumed that direction of government considerably increased probability of LDD among COVID-19 cases with unknown exposure in Japan. This study aimed to investigate association of route of case detection and proportion of LDD of COVID-19 in Japan. We included confirmed COVID-19 patients with symptom onset between the ninth and eleventh week in 2020, in 6 prefectures of Japan. LDD was defined as the duration between COVID-19 symptom onset and confirmation ≥6 days. We used multivariable logistic regression analyses to elucidate factors associated with LDD. The mean diagnostic delay for 364 cases was 6.3 days. Proportion of LDD was 38% for cases with known exposure, and 65% for cases with unknown exposure. The probability of LDD in cases with unknown exposure was significantly higher than that for known exposure cases (adjusted odds ratio: 2.38, 95% confidence interval: 1.354–4.21). Early PCR test after symptom onset, strengthening of PCR test capacity, and investigations to study impact of high proportion of LDD in cases without known exposure might be necessary.

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AB0725 FACTORS ASSOCIATED WITH RADIOGRAPHIC SPINAL INVOLVEMENT IN SPONDYLOARTHRITIS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.4372 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1657.2-1657

Author(s):

M. Slouma ◽

S. Rahmouni ◽

R. Dhahri ◽

I. Gharsallah ◽

N. Boussetta ◽

...

Keyword(s):

Ankylosing Spondylitis ◽

Disease Activity ◽

Structural Damage ◽

Disease Duration ◽

Diagnostic Delay ◽

Cross Sectional Study ◽

Cross Sectional ◽

Positive Correlation ◽

Factors Associated ◽

The Mean

Background:Spondyloarthritis (SpA) is characterized by significant radiographic changes in the spine. The structural spine damage can be assessed using several scorings such as the Bath AS Radiology Index (BASRI) and the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS).Objectives:We aimed to identify factors associated with structural damage in the spine using these scores.Methods:We conducted a cross-sectional study including patients with SpA diagnosed according to the assessment of Spondyloarthritis International Society criteria.To assess the radiographic involvement of the spine, we used the mSASSS, the BASRI-spine (BASRI-S), the BASRI-lumber (BASRI-L) and the BASRI-cervical (BASRI-C).Disease activity was assessed using the BASDAI and ASDAS-CRP.Results:Among the 112 patients, 72.32% were men. The mean age was 43.78 ± 12,91 years. The mean age at diagnosis was 37.8 ± 13.45 years. The diagnostic delay of 37,8 ± 46 months.Forty-nine patients were smockers (43.8%).The mean BASDAI score and ASDAS–CRP score were 4.04 ± 1.99 and 3.30 ± 0.87.The mean ESR and CRP were 36.21 ± 27 (mm/H) and 31.28 ± 47.25 mg/LThe mean BASRI-S was 3,99 ± 21,96 and the mean mSASSS was 10,26 ± 15,41.Twenty-five patients (22.3%) had non-radiographic axial SpA.Men had higher BARSI-L (1.36 vs 0.7, p= 0.045) and BASRI-S (4.3 vs 3.09; p=0.047) than women.Moreover, smokers’ patients had higher mSASSS (14.07 vs 7.02; p=0.031), BASRI-C (1.23 vs 0.62; p=0.031), and BASRI-S (4.82 vs 3.35; p= 0.009) than nonsmokers’ patients.A positive correlation was noted between age and BASRI-C (r= 0.260, p=0.012). There was no correlation between age at the onset of SpA and structural spine damage.We found a positive correlation between disease duration and the following scores: BASRI-C (r=0.245, p=0.018) and BASRI-S (r=0.274, p=0.003).Patients with non-radiographic axial SpA had lower mSASSS (4.05 vs 12.14; p=0.034), BASRI-s (1.2 vs 4.9; p< 10-3), and BASRI-L (0.42 vs 1.4; p=0.003) than patients with radiographic axial SpA.There was no correlation between the radiographic index and BASDAI and ASDAS-CRP.Conclusion:We confirmed previous observations that male gender, smoking and disease duration are associated with structural damage in the spine [1].However, CRP and other inflammatory biomarkers were not associated with radiographic evidence of spine involvement.As observed in previous studies, the radiographic spine damage did not correlate with disease activity (BASDAI) [1].References:[1]Sari I, Haroon N. Radiographic Progression in Ankylosing Spondylitis: From Prognostication to Disease Modification. Curr Rheumatol Rep. 2018 Nov 8;20(12):82.Disclosure of Interests:None declared

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Determinants of diagnostic delay in axial spondyloarthritis: an analysis based on linked claims and patient-reported survey data

Rheumatology ◽

10.1093/rheumatology/kez090 ◽

2019 ◽

Vol 58 (9) ◽

pp. 1634-1638 ◽

Cited By ~ 25

Author(s):

Imke Redeker ◽

Johanna Callhoff ◽

Falk Hoffmann ◽

Hildrun Haibel ◽

Joachim Sieper ◽

...

Keyword(s):

Linear Regression ◽

Symptom Onset ◽

Linear Regression Analysis ◽

Diagnostic Delay ◽

International Classification Of Diseases ◽

Hla B27 ◽

Health Insurance Data ◽

Factors Associated ◽

Patient Reported ◽

The Mean

Abstract Objectives The objective of this study was to assess the current diagnostic delay in axial SpA (axSpA) and to analyse factors associated with it. Methods A stratified sample of subjects with a diagnosis of axSpA (International Classification of Diseases, 10th Revision code M45) was drawn from health insurance data in Germany and was questioned on disease-related, lifestyle and socio-economic characteristics. The diagnostic delay was calculated as the time from back pain onset until a diagnosis of axSpA. A multivariable linear regression analysis was performed to explore factors associated with the diagnostic delay. Results Among 1677 patients with axSpA included in the analysis, the mean diagnostic delay was 5.7 years (median 2.3). Of those, 407 patients were diagnosed in 1996–2005 and 484 patients in 2006–2015. The mean diagnostic delay was not substantially different in both periods: 6.3 years (median 2.6) and 7.4 (2.7), respectively. Multivariable linear regression revealed that female sex [β = 1.85 (95% CI 1.06, 2.65)], negative HLA-B27 status [β = 3.61 (95% CI 2.07, 5.14)], presence of psoriasis [β = 1.40 (95% CI 0.08, 2.73)] and younger age at symptom onset [β = 1.91 (95% CI 1.53, 2.29)] were factors associated with a longer diagnostic delay. Conclusion The diagnostic delay in axSpA is still unacceptably long. Patients who are female, young at symptom onset, HLA-B27 negative or have psoriasis have a longer diagnostic delay. Specific referral strategies might be necessary in order to decrease the diagnostic delay in patients presenting with these characteristics.

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Younger age of onset and uveitis associated with HLA-B27 and delayed diagnosis in Thai patients with axial spondyloarthritis

Scientific Reports ◽

10.1038/s41598-021-93001-5 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Naphruet Limsakul ◽

Praveena Chiowchanwisawakit ◽

Parichart Permpikul ◽

Yubolrat Thanaketpaisarn

Keyword(s):

Regression Analysis ◽

Multiple Regression Analysis ◽

Axial Spondyloarthritis ◽

Age At Onset ◽

Delayed Diagnosis ◽

Musculoskeletal Symptom ◽

Hla B27 ◽

Delay In Diagnosis ◽

Factors Associated ◽

Younger Age

AbstractTo identify characteristics associated with HLA-B27, and to identify factors associated with delayed diagnosis in Thai patients with axial spondyloarthritis (axSpA). This cross-sectional study included Thai patients were diagnosed with axSpA by a rheumatologist at Siriraj Hospital. Clinical data were collected. Regression analyses were employed to identify factors associated with study outcomes. Of total 177 patients, 127 (72%) were positive HLA-B27. Uveitis [Odds ratio (OR) 4.0], age at onset of the first musculoskeletal symptom of ≤ 28 years [OR 3.5], female [OR 0.4], and psoriasis [OR 0.4] were significantly associated with HLA-B27 in multiple regression analysis. Those with positive HLA-B27 had less spinal flexibility. Elevated C-reactive protein (p = 0.012) was associated with shorter delay in diagnosis, while uveitis (p < 0.001) and younger age at onset of the first symptom (p = 0.002) were associated with longer delay in diagnosis in multiple regression analysis. Younger age at onset of the first musculoskeletal symptom and uveitis were associated with HLA-B27 and delayed diagnosis in axSpA patients. Young people with musculoskeletal symptom and uveitis should be referred to a rheumatologist to rule out or make a timely diagnosis of axSpA.

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AB0669 PARTICULARITIES OF TUNISIAN FEMALE AXIAL SPONDYLOARTHRITIS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.6203 ◽

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

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AB0490 IMPACT OF SPONDYLOARTHRITIS ON WORK PRODUCTIVITY: A REAL LIFE STUDY

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.1079 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 1272.1-1272

Author(s):

M. Ben Majdouba ◽

S. Boussaid ◽

S. Rekik ◽

S. Jemmali ◽

H. Ajlani ◽

...

Keyword(s):

Ankylosing Spondylitis ◽

Age At Onset ◽

Productivity Loss ◽

Diagnostic Delay ◽

Work Productivity ◽

Symptomatic Treatment ◽

Work Outcomes ◽

Joint Involvement ◽

The Mean

Background:Work productivity of patients with spondyloarthritis is frequently affected by their disease.Objectives:We aim to identify disease-related factors associated with poor work productivity in patients with spondyloarthritis.Methods:A cross-sectional study was performed in patients with spondyloarthritis. Data on disease characteristics were collected as well as specific indices: Visual analogue scale (VAS) for fatigue and pain, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP), Bath Ankylosing Spondylitis Functionnel Index (BASFI) and Bath Ankylosing Spondylitis Metrology Index (BASMI). EuroQol-5D (EQ5D) was used to assess health-related quality of life. Work productivity was assessed by the Work Productivity and Activity Impairment scale (WPAI:SpA). Factors associated with presenteeism, absenteeism and work productivity loss were evaluated.Results:One hundred patients were enrolled (73 men and 27 women); mean age was 43.68 ± 10.3 years. Fifty nine percent of patients were employed, 26% were off work and 15% were retired of which 8% were in early retirement. Sixty seven percent of patients had ankylosing spondylitis, 17% had rheumatism associated with inflammatory bowel disease and 16% had psoriatic rheumatism. The average disease duration was 12.24 ± 8.73 years. Mean age at onset was 33.2 ± 10 years [18-59]. The average diagnostic delay was 2.41 ± 3 years; it was more than five years in 17% of cases. Sacroiliac pain has been noted in 69 patients, lumbar or cervical stiffness in 78 patients and peripheral joint involvement in 18 cases. Thirty one percent of patients had hip joint involvement and 49% had extra-articular manifestation. Fifty percent had inflammatory biological syndrome, 63% were treated with anti-TNFα and 58% needed symptomatic treatment regularly. The mean fatigue and pain VAS was respectively 5.58 ± 2.5 and 5.56 ± 2.9. The mean BASDAI was 4.4 ± 2.4, the average BASFI was 4.6 ± 2.7 and the average ASDAS-CRP was 2.77 ± 1.18. The mean BASMI was 4.4 ± 2.8. The mean EQ5D score was 0.485 ± 0.378. Among employed patients, mean absenteeism, presenteeism and work productivity loss was 21.8 ± 33.13%, 42 ± 32% and 46.5 ± 35.31%, respectively. These work outcomes were correlated to diagnostic delay ≥ 2 years (p<0.03), peripheral joint involvement (p=0.006), psoriasis (p=0.02), inflammatory biological syndrome (p<0.001), need of symptomatic treatment (p=0.001), fatigue and pain VAS ≥ 4 (p<0.001), BASDAI ≥ 4 (p<0.001), ASDAS-CRP ≥ 2.1 (p<0.001), BASFI ≥ 4 (p<0.001), BASMI ≥ 4 (p=0.002) and low EQ5D score (p<0.001). Work productivity loss was in addition correlated to age at onset < 25 years (p=0.03).Conclusion:Active disease, reduced physical function and poorer quality of life are associated with reduced work productivity. Early diagnosis and good disease management especially fatigue and pain can potentially improve work outcomes in patients with spondyloarthritis.Disclosure of Interests:None declared.

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Abstract 1122‐000142: Safety and Efficacy of Surpass Streamline for Intracranial Aneurysms: A Multicenter US Real‐World Experience (SESSIA)

Stroke: Vascular and Interventional Neurology ◽

10.1161/svin.01.suppl_1.000142 ◽

2021 ◽

Vol 1 (S1) ◽

Author(s):

Juan Vivanco‐Suarez ◽

Alan Mendez‐Ruiz ◽

Farooqui Mudassir ◽

Cynthia B Zevallos ◽

Milagros Galecio‐Castillo ◽

...

Keyword(s):

Real World ◽

Intracranial Aneurysms ◽

The United States ◽

Chromium Alloy ◽

Cobalt Chromium ◽

Anterior Circulation ◽

Safety And Efficacy ◽

Post Marketing ◽

The Mean

Introduction : Flow diversion has established itself as standard treatment of wide complex intracranial aneurysms (IA). Its recognition has been validated with positive occlusion rates and favorable clinical outcomes. The Surpass Streamline (SS) flow diverter (FD) is a braided cobalt/chromium alloy implant with 72 or 96 wires approved by the FDA in 2018. The aim of this study is to determine the safety and efficacy of the SS in a post‐marketing large US cohort. Methods : We performed a multicenter, retrospective study for consecutive patients treated with the SS FD for IA between January 2018 and June 2021 in the United States. Inclusion criteria for participants were: 1. Adults (≥ 18 years) and 2. Treatment with SS FD for IA. Primary safety end point was a major ipsilateral stroke (increase in National Institutes of Health Stroke Scale Score of ≥ 4) or neurological death within 12 months. Primary efficacy was assessed using the 3‐point Raymond‐Roy (RR) occlusion scale on digital subtraction angiography (DSA) at 6‐12‐month follow‐up. Results : A total of 276 patients with 313 aneurysms were enrolled. The median age was 59 years and 199 (72%) were females. The most common comorbidities included hypertension in 156 (57%) subjects followed by hyperlipidemia in 76 (28%) patients. One hundred and twenty‐two (44%) patients were asymptomatic while subarachnoid hemorrhage was present in only 10 (4%) patients. A total of 143 (46%) aneurysms were left‐sided. Aneurysms were located as follows: 274 (88%) were in the anterior circulation with paraophthalmic being the most common in 120 (38%) followed by petrocavernous ICA in 81 (26%); 33 (11%) aneurysms were located in the posterior circulation with basilar trunk being the most common in 14 (5%). The mean maximum aneurysm dome width was 5.77 ± 4.7 mm, neck width 4.22 ± 3.8 mm and dome to neck ratio was 1.63 ± 1.3 mm. The mean number of SS FD implanted per aneurysm was 1.06 (range 1–3) with more than one SS FD implanted in 21 (7%) aneurysms. Modified Rankin Scale (mRS) of 0–2 was present in 206/213 (97%) patients at 6–12 month follow‐up. The complete aneurysm occlusion (RR 1) rate was 145/175 (83%) among subjects who had angiographic follow‐up at 6–12 months. Major stroke and death was encountered in 7 (2%) and 5 (1.8%) of the patients respectively. Conclusions : Our data represent the largest real‐world study using SS FD. These results corroborate its post‐marketing safety and efficacy for the treatment of intracranial aneurysms showing more favorable rates to the initial experience during SCENT trial.

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OR30-01 Real-World Minimed™ 670G System Use and Glycemic Outcomes of Pediatric and Adult Individuals Living with Type 1 Diabetes (T1D) in the United States

Journal of the Endocrine Society ◽

10.1210/jendso/bvaa046.1708 ◽

2020 ◽

Vol 4 (Supplement_1) ◽

Author(s):

Robert Alan Vigersky ◽

Michael Stone ◽

Pratik Agrawal ◽

Alex Zhong ◽

Kevin Velado ◽

...

Keyword(s):

Glycemic Control ◽

Real World ◽

Adult Population ◽

Age Groups ◽

The United States ◽

System Use ◽

System Data ◽

The Mean ◽

The Impact ◽

The U.S

Abstract Introduction: The MiniMed™ 670G system was FDA-approved in 2016 for adults and adolescents ≥14yrs, and in 2018 for children ages 7-13yrs with T1D. Since then, use of the system has grown to over 180,000 people in the U.S. The glycemic control benefits of real-world MiniMed™ 670G system Auto Mode use in the U.S. were assessed. Methods: System data (aggregated five-minute instances of sensor glucose [SG]) uploaded from March 2017 to July 2019 by individuals (N=118,737) with T1D and ≥7yrs of age who enabled Auto Mode were analyzed to determine the mean % of overall time spent <54mg/dL/<70mg/dL (TBR); between 70-180mg/dL (TIR); and >180mg/dL/>250mg/dL (TAR). The impact of Auto Mode was further assessed in a sub-group of individuals (N=51,254) with, at least, 7 days of SG data for both Auto Mode turned ON and turned OFF. The % of TIR, TBR and TAR, and the associated glucose management indicator (GMI) were evaluated for the overall OFF (2,524,570 days) and ON (6,308,806 days) periods, and across different age groups. Results: System data TIR was 71.3%; TBR was 0.4% and 1.9%, respectively; and TAR was 26.8% and 6.2%, respectively. User-wise data of Auto Mode OFF versus ON showed a mean of 70.3% of the time spent in Auto Mode, that TIR increased from 60.9% to 69.9%; and that both TBR and TAR decreased. For those 7-13yrs (N=1,417), TIR increased from 48.7% to 61.5%; TBR increased from 0.5% to 0.6% and from 2.0% to 2.2%, respectively; and TAR decreased from 49.3% to 36.3% and from 20.5% to 13.0%, respectively. For those 14-21yrs (N=4,194), TIR increased from 51.0% to 61.5%; TBR decreased from 0.7% to 0.6% and from 2.3% to 2.0%, respectively; and TAR decreased from 46.7% to 36.5% and from 18.5% to 12.5%, respectively. For those ≥22yrs (N=45,643), TIR increased from 62.2% to 70.9%; TBR decreased from 0.7% to 0.5% and from 2.6% to 1.9%, respectively; and TAR decreased from 35.2% to 27.3% and from 9.9% to 6.3%, respectively. The mean GMI decreased by 0.23% (overall), 0.48% (7-13yrs), 0.35% (14-21yrs), and 0.22% (≥22yrs), respectively, with Auto Mode ON versus OFF. Discussion: In over 6 million days of real-world MiniMed™ 670G system Auto Mode use in the U.S., TIR of a large pediatric and adult population with T1D improved by 9% compared to when Auto Mode was OFF, which was comparable to or exceeded the TIR observed in the smaller pivotal trials. These results further support outcomes of the pivotal trials and increased glycemic control with system use.

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

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2019-216841 ◽

2020 ◽

Vol 79 (7) ◽

pp. 914-919 ◽

Cited By ~ 3

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.

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