Prevalence of sleep disturbance and the association between poor disease control in people with ankylosing spondylitis within the Australian clinical setting (ASLEEP study): a real-world observational study using the OPAL dataset

Abstract Introduction Sleep disturbance and fatigue are commonly reported in ankylosing spondylitis (AS) but specific prevalence and the relationship to disease control are unknown. Method This retrospective non-interventional observational study of data from the OPAL dataset included patients with AS (ICD code M45, M45.0 or M08.1), aged 18 to 95 years and had completed ≥ 1 sleep questionnaire between 1 January 2019 and 30 September 2020. The prevalence of insomnia and obstructive sleep apnoea were assessed using the Insomnia Severity Index (ISI) and Multivariate Apnoea Prediction Index (MAPI), respectively. Propensity score (PS) matching based on sex, age and symptom duration increased comparability between patients administered tumour necrosis factor inhibitors (TNFi) and interleukin 17A inhibitors (IL-17Ai). Results Four hundred ninety-five patients were included. The mean ISI total score in the overall population was 8.6 ± 6.2. Self-reported moderate or severe clinical insomnia was present in 16% and 3.2% of patients, respectively. The mean MAPI score was 0.4 ± 0.3, self-reported apnoea was identified in 31.5% of patients and the mean FACIT-Fatigue score was 36.1 ± 10.7. In the PS matched population, the only treatment-related difference was the mean MAPI score (IL-17Ai 0.4 ± 0.3 and TNFi 0.3 ± 0.2, p = 0.046). Those with poor disease control (BASDAI ≥ 4) were more likely (odds ratio [OR] 7.29, 95% CI 2.37 to 22.46, p = 0.001) to have a greater severity of insomnia symptoms than those with good disease control. Conclusion In this real-world AS cohort, poor disease control was associated with sleep disturbance. Little difference in sleep disturbance was observed between biologic TNFi and IL-17Ai treatment. Key Points • Sleep disturbance and fatigue are common in patients with ankylosing spondylitis.• In our real-world cohort, self-reported apnoea was reported in one-third of patients; and one in five patients reported moderate to severe insomnia.• Those with poor disease control were more likely to experience greater sleep disturbance than those with good disease control.

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AB1346-HPR REAL-WORLD EFFECTIVENESS AND PERCEIVED USEFULNESS OF SYMPTOM CHECKERS IN RHEUMATOLOGY: INTERIM REPORT FROM THE PROSPECTIVE MULTICENTER BETTER STUDY

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.1604 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1961.1-1961

Author(s):

J. Knitza ◽

J. Mohn ◽

C. Bergmann ◽

E. Kampylafka ◽

M. Hagen ◽

...

Keyword(s):

Diagnostic Accuracy ◽

Real World ◽

Search Engines ◽

Correct Diagnosis ◽

Perceived Usefulness ◽

Symptom Duration ◽

Research Support ◽

Link Type ◽

The Mean ◽

Research Grant

Background:Symptom checkers (SC) promise to reduce diagnostic delay, misdiagnosis and effectively guide patients through healthcare systems. They are increasingly used, however little evidence exists about their real-life effectiveness.Objectives:The aim of this study was to evaluate the diagnostic accuracy, usage time, usability and perceived usefulness of two promising SC, ADA (www.ada.com) and Rheport (www.rheport.de). Furthermore, symptom duration and previous symptom checking was recorded.Methods:Cross-sectional interim clinical data from the first of three recruiting centers from the prospective, real-world, multicenter bETTeR-study (DKRS DRKS00017642) was used. Patients newly presenting to a secondary rheumatology outpatient clinic between September and December 2019 completed the ADA and Rheport SC. The time and answers were recorded and compared to the patient’s actual diagnosis. ADA provides up to 5 disease suggestions, Rheport calculates a risk score for rheumatic musculoskeletal diseases (RMDs) (≥1=RMD). For both SC the sensitivity, specificity was calculated regarding RMDs. Furthermore, patients completed a survey evaluating the SC usability using the system usability scale (SUS), perceived usefulness, previous symptom checking and symptom duration.Results:Of the 129 consecutive patients approached, 97 agreed to participate. 38% (37/97) of the presenting patients presented with an RMD (Figure 1). Mean symptom duration was 146 weeks and a mean number of 10 physician contacts occurred previously, to evaluate current symptoms. 56% (54/96) had previously checked their symptoms on the internet using search engines, spending a mean of 6 hours. Rheport showed a sensitivity of 49% (18/37) and specificity of 58% (35/60) concerning RMDs. ADA’s top 1 and top 5 disease suggestions concerning RMD showed a sensitivity of 43% (16/37) and 54% (20/37) and a specificity of 58% (35/60) and 52% (31/60), respectively. ADA listed the correct diagnosis of the patients with RMDs first or within the first 5 disease suggestions in 19% (7/37) and 30% (11/37), respectively. The average perceived usefulness for checking symptoms using ADA, internet search engines and Rheport was 3.0, 3.5 and 3.1 on a visual analog scale from 1-5 (5=very useful). 61% (59/96) and 64% (61/96) would recommend using ADA and Rheport, respectively. The mean SUS score of ADA and Rheport was 72/100 and 73/100. The mean usage time for ADA and Rheport was 8 and 9 minutes, respectively.Conclusion:This is the first prospective, real-world, multicenter study evaluating the diagnostic accuracy and other features of two currently used SC in rheumatology. These interim results suggest that diagnostic accuracy is limited, however SC are well accepted among patients and in some cases, correct diagnosis can be provided out of the pocket within few minutes, saving valuable time.Figure:Acknowledgments:This study was supported by an unrestricted research grant from Novartis.Disclosure of Interests:Johannes Knitza Grant/research support from: Research Grant: Novartis, Jacob Mohn: None declared, Christina Bergmann: None declared, Eleni Kampylafka Speakers bureau: Novartis, BMS, Janssen, Melanie Hagen: None declared, Daniela Bohr: None declared, Elizabeth Araujo Speakers bureau: Novartis, Lilly, Abbott, Matthias Englbrecht Grant/research support from: Roche Pharma, Chugai Pharma Europe, Consultant of: AbbVie, Roche Pharma, RheumaDatenRhePort GbR, Speakers bureau: AbbVie, Celgene, Chugai Pharma Europe, Lilly, Mundipharma, Novartis, Pfizer, Roche Pharma, UCB, David Simon Grant/research support from: Else Kröner-Memorial Scholarship, Novartis, Consultant of: Novartis, Lilly, Arnd Kleyer Consultant of: Lilly, Gilead, Novartis,Abbvie, Speakers bureau: Novartis, Lilly, Timo Meinderink: None declared, Wolfgang Vorbrüggen: None declared, Cay-Benedict von der Decken: None declared, Stefan Kleinert Shareholder of: Morphosys, Grant/research support from: Novartis, Consultant of: Novartis, Speakers bureau: Abbvie, Novartis, Celgene, Roche, Chugai, Janssen, Andreas Ramming Grant/research support from: Pfizer, Novartis, Consultant of: Boehringer Ingelheim, Novartis, Gilead, Pfizer, Speakers bureau: Boehringer Ingelheim, Roche, Janssen, Jörg Distler Grant/research support from: Boehringer Ingelheim, Consultant of: Boehringer Ingelheim, Paid instructor for: Boehringer Ingelheim, Speakers bureau: Boehringer Ingelheim, Peter Bartz-Bazzanella: None declared, Georg Schett Speakers bureau: AbbVie, BMS, Celgene, Janssen, Eli Lilly, Novartis, Roche and UCB, Axel Hueber Grant/research support from: Novartis, Lilly, Pfizer, Consultant of: Abbvie, BMS, Celgene, Gilead, GSK, Lilly, Novartis, Speakers bureau: GSK, Lilly, Novartis, Martin Welcker Grant/research support from: Abbvie, Novartis, UCB, Hexal, BMS, Lilly, Roche, Celgene, Sanofi, Consultant of: Abbvie, Actelion, Aescu, Amgen, Celgene, Hexal, Janssen, Medac, Novartis, Pfizer, Sanofi, UCB, Speakers bureau: Abbvie, Aescu, Amgen, Biogen, Berlin Chemie, Celgene, GSK, Hexal, Mylan, Novartis, Pfizer, UCB

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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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Validity of the Use of Wrist and Forehead Temperatures in Screening the General Population for COVID-19: A Prospective Real-World Study

Iranian Journal of Public Health ◽

10.18502/ijph.v49is1.3670 ◽

2020 ◽

Author(s):

Ge CHEN ◽

Jiarong XIE ◽

Guangli DAI ◽

Peijun ZHENG ◽

Xiaqing HU ◽

...

Keyword(s):

General Population ◽

Observational Study ◽

Electric Vehicle ◽

Real World ◽

Prospective Observational Study ◽

Real Life ◽

High Fever ◽

Tympanic Temperature ◽

Infrared Thermometer ◽

The Mean

Background: We aimed to compare the accuracy of individuals’ wrist and forehead temperatures with their tympanic temperature under different circumstances. Methods: We performed a prospective observational study in a real-life population in Ningbo First Hospital in China. We consecutively recorded individuals’ wrist and forehead temperatures in Celsius (°C) using a noncontact infrared thermometer (NCIT). We also measured individuals’ tympanic temperature using a tympanic thermometer (IRTT) and defined fever as a tympanic temperature of ≥37.3 °C. Results: We enrolled 528 participants, including 261 indoor and 267 outdoor participants. We grouped the outdoor participants into four groups according to their means of transportation to the hospital: by foot, by bicycle/electric vehicle, by car, or as a passenger in a car. Under different circumstances, the mean difference in the forehead measurement ranged from -1.72 to -0.56 °C across groups, and that in the wrist measurement ranged from -0.96 to -0.61°C. Both measurements had high fever screening abilities in indoor patients. (Wrist: AUC 0.790; 95% CI: 0.725-0.854, P<0.001; forehead: AUC 0.816; 95% CI: 0.757-0.876, P <0.001). The cut-off value of the wrist measurement for detecting a tympanic temperature of ≥37.3 °C was 36.2 °C, with 86.4% sensitivity and 67.0% specificity, and the best threshold for the forehead measurement was 36.2 °C, with 93.2% sensitivity and 60.0% specificity. Conclusion: Wrist measurements are more stable than forehead measurements under different circumstances. Both measurements have favorable fever screening abilities in indoor patients. The cut-off values were both 36.2 °C.

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AB0724 IS THERE A LINK BETWEEN RADIOGRAPHIC SACROILIITIS AND HIP INVOLVEMENT IN SPONDYLOARTHRITIS?

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.4321 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1656.2-1657

Author(s):

S. Rahmouni ◽

M. Slouma ◽

R. Dhahri ◽

I. Gharsallah ◽

N. Boussetta ◽

...

Keyword(s):

New York ◽

Ankylosing Spondylitis ◽

Structural Damage ◽

Multivariable Analysis ◽

Diagnostic Delay ◽

Symptom Duration ◽

Sacroiliac Joints ◽

Cross Sectional ◽

Significant Difference ◽

The Mean

Background:Hip involvement is a common feature in spondyloarthritis (SpA). Whether the hip is part of the axial or appendicular skeletal is still a matter of discussion.Objectives:We aimed to assess the relationship between sacroiliitis, spinal and hip involvement in SpA.Methods:Patients with SpA diagnosed according to the assessment of Spondyloarthritis International Society criteria were included in this retrospective cross-sectional study.The modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) and the Bath Ankylosing Spondylitis Radiology Index-spine (BASRI-s) were used to assess the radiographic involvement of the spine.The sacroiliac joints were scored according to the modified New York criteria.Radiological hip involvement was scored using the Bath Ankylosing Spondylitis Radiology Index hip (BASRI-h).Patients were divided into two groups: G0 including patients without hip involvement and G1 patients with hip involvement.Results:We included 112 patients with a sex ratio of 2.4. The average SpA symptom duration was 9.33 ± 8.93 years. The diagnostic delay was 42.92 ± 52 months.Radiographic hip involvement was noted in 39.28% of cases. It was bilateral in 31 patients (70.4%). The total number of coxitis was 75. Severe and moderate hip involvement (BASRI-h ≥ 3) affected 21 hips. The most common radiographic pattern was early coxitis (n=31, 41.3%) followed by the destructive form (n=22, 29.3%, mimicking-osteoarthritis form (n=15, 20%), condensing form (n=5, 6.6%) and ankylosing form (n=2, 2%).Radiographic sacroiliitis was noted in 75.8% of patients. It was bilateral in 91.7% of cases. Among the 161 sacroiliac joints fulfilling the m-New-york criteria, 32.9% had grade 4 and 37.2% had grade 3.The mean mSASSS was 10.26 ± 15. The mean BASRI-t, BASRI-C, and BASRI-L were 3.99 ± 2.9, 0.89 ± 1.3, and 1.1 ± 1.3 respectively.Radiographic sacroiliitis was more common in patients with hip involvement (G1) (90.9% vs 68.2%, p=0.00). Patients in G1 had higher mSASSS (15.78 ± 18.24 vs 6.29 ± 11.85, p=0.01), BASRI-L (1.73±1.46 vs 0.75 ± 1.131, p=0.009), and BASRI-s (5.46 ± 3.02 vs 3.19 ± 2.46, p< 10-3) than patients in G2. There was no significant difference between the two groups regarding the BASRI-C.Multivariable analysis revealed that radiographic sacroiliitis was associated with hip involvement (OR=14.81, 95%, [1.1-198], p=0.042).When comparing patients with severe and moderate hip involvement (BASRI-h ≥ 3) and those with mild involvement, we didn’t find significant differences regarding BASRIs, BASR-L, BASRI-c, mSASSS, and sacroiliac involvement.Conclusion:As reported in previous studies [1], we concluded that structural axial lesions were higher in patients with coxitis. Structural damage to the sacroiliac joint in SpA was predictive of hip involvement.We suggest that sacroiliitis, spinal and hip involvement are part of the same spectrum.References:[1]Chen H-A, Chen C-H, Liao H-T, Lin Y-J, Chen P-C, Chen W-S, et al. Factors associated with radiographic spinal involvement and hip involvement in ankylosing spondylitis. Semin Arthritis Rheum. 2011;40 (6):552-8Disclosure of Interests:None declared

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Tazarotene/Betamethasone Dipropionate Cream in Patients with Plaque Psoriasis: Results of a Prospective, Multicenter, Observational Study

Dermatology ◽

10.1159/000511891 ◽

2020 ◽

pp. 1-8

Author(s):

Chunxia He ◽

Hongzhong Jin ◽

Xiguang Liu ◽

Fengming Hu ◽

Litao Zhang ◽

...

Keyword(s):

Observational Study ◽

Real World ◽

Plaque Psoriasis ◽

Adverse Reactions ◽

Response Rates ◽

The Body ◽

Betamethasone Dipropionate ◽

Efficacy And Safety ◽

Local Skin ◽

The Mean

Background: Topical agents are still the mainstay for the treatment of mild-to-moderate plaque psoriasis, in which fixed combinations play an important role. Tazarotene/betamethasone dipropionate (Taz/BD) cream is a novel fixed combination approved for treating plaque psoriasis in China, but its efficacy and safety have not been verified in a real-world environment. Objectives: The primary objective was to investigate the efficacy and safety of Taz/BD cream in treating plaque psoriasis. The secondary objectives were to assess its relapse after discontinuation and the efficacy and safety profiles during retreatment. Methods: A prospective, multicenter, large-scale observational study was conducted. Adult patients with chronic plaque psoriasis involving <20% of the body surface area were enrolled. Taz/BD cream was applied once daily for 4 weeks. Patients who achieved ≥90% improvement in the Psoriasis Area and Severity Index (PASI) from baseline to week 4 were followed up to investigate relapse after drug withdrawal. Relapsed patients underwent another 4-week treatment. Results: In total, 2,299 eligible patients were enrolled, and 2,095 patients (91.1%) completed the 4-week study. The mean PASI improvement at week 4 was 53.7%, and the PASI 50/75 response rates were 62.5 and 26.8%, respectively. The mean PASI reduction in plaque induration, desquamation and erythema were 58.3, 61.0 and 40.0%, respectively (p < 0.001). Adverse reactions occurred in 445 patients (20.8%) at week 4. The most frequently reported adverse reactions were local skin irritation, including pruritus (10%), pain (6.7%), erythema (6.1%) and desquamation (1.8%). During the post-treatment period, 47 patients (24.0%) relapsed within 8 weeks after drug discontinuation. Forty-five patients were retreated for another 4 weeks, and the PASI 50/75 response rates were 72.7 and 40.9%, respectively. There were no unexpected safety signals during retreatment. Conclusion: Taz/BD cream is effective and well tolerated in treating mild-to-moderate plaque psoriasis under near real-world conditions and demonstrates efficacy and safety during retreatment.

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Radiologic Changes in the Symphysis Pubis of Male Patients with Ankylosing Spondylitis

The Journal of Rheumatology ◽

10.3899/jrheum.150711 ◽

2015 ◽

Vol 43 (2) ◽

pp. 330-334 ◽

Cited By ~ 1

Author(s):

Bon San Koo ◽

Yoonah Song ◽

Kyung Bin Joo ◽

Seunghun Lee ◽

Tae-Hwan Kim

Keyword(s):

Ankylosing Spondylitis ◽

Disease Duration ◽

Clinical Findings ◽

Symphysis Pubis ◽

University Hospital ◽

Symptom Duration ◽

Normal Score ◽

Male Patients ◽

The Mean ◽

Subchondral Sclerosis

Objective.We aimed to evaluate the involvement of the symphysis pubis in patients with ankylosing spondylitis (AS), and to assess the correlations between symphysis pubis changes and clinical findings.Methods.We retrospectively evaluated a total of 222 male patients with AS who underwent pelvic and cervical/lumbar spine radiography at the Hanyang University Hospital for Rheumatic Diseases from August 2004 to February 2014. Radiographs were examined by 2 experienced radiologists, and radiographic damage was scored as follows: 0 (no damage), 1 (subtle irregularity and/or subchondral sclerosis), 2 (erosion), 3 (partial ankylosis), and 4 (total ankylosis). We evaluated the patients’ clinical characteristics and analyzed their correlations with radiographic symphysis pubis changes.Results.The mean patient age was 30.5 ± 8.3 years and mean disease duration was 7.1 ± 4.6 years; 105 patients (47.3%) exhibited radiologic damage in the symphysis pubis. Moreover, 75, 28, 0, and 2 patients had scores of 1, 2, 3, and 4, respectively. When comparing the normal (score 0) and abnormal (score 1–4) symphysis pubis groups, the latter had a longer symptom duration (10.1 ± 7.0 vs 7.6 ± 5.8 yrs, p = 0.004) and higher modified Stoke Ankylosing Spondylitis Spine Score (mSASSS; 18.6 ± 17.0 vs. 14.3 ± 13.4, p = 0.038). Moreover, a significant correlation was noted between the radiographic symphysis pubis damage score and mSASSS (r2 = 0.147, p = 0.029).Conclusion.Among male patients with AS, 47.3% exhibited symphysis pubis involvement. Moreover, a correlation was observed between the radiographic symphysis pubis and spine changes.

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

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.1802 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 753.1-753

Author(s):

J. Feld ◽

O. Elkayam ◽

A. Druyan ◽

T. Reitblat ◽

A. Balbir-Gurman ◽

...

Keyword(s):

Ankylosing Spondylitis ◽

Real World ◽

Symptom Onset ◽

Axial Spondyloarthritis ◽

Diagnostic Delay ◽

The United States ◽

Delay In Diagnosis ◽

Factors Associated ◽

The Mean ◽

Diagnostic Variables

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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The Pattern of Use, Effectiveness, and Safety of Gadoteric Acid (Clariscan) in Patients Undergoing Contrast-Enhanced Magnetic Resonance Imaging: A Prospective, Multicenter, Observational Study

Contrast Media & Molecular Imaging ◽

10.1155/2021/4764348 ◽

2021 ◽

Vol 2021 ◽

pp. 1-8

Author(s):

Won-Jin Moon ◽

Young Ah Cho ◽

Seok Hahn ◽

Hye Min Son ◽

Sung Koo Woo ◽

...

Keyword(s):

Nervous System ◽

Image Quality ◽

Observational Study ◽

Real World ◽

Diagnostic Confidence ◽

Multicenter Observational Study ◽

Contrast Enhanced ◽

Subgroup Analyses ◽

The Mean ◽

Prospective Multicenter Observational Study

Objective. Contrast-enhanced MR (CE-MR) imaging is often required to improve lesion detection and characterization and to increase diagnostic confidence. This study aimed to evaluate the safety and effectiveness, as well as the use pattern, of the macrocyclic gadolinium-based contrast agent Clariscan in real-world clinical practice in Korea. Materials and Methods. This was a prospective, multicenter, observational study of patients undergoing CE-MR as part of routine clinical care at 6 university hospitals in Korea. Effectiveness was evaluated by determining diagnostic confidence and image quality; safety evaluation included the adverse event (AE) expression rate. Subgroup analyses were conducted by body regions of diagnosis (musculoskeletal, nervous system, others) and in pediatric patients (aged ≤7 years). Results. From October 2019 to September 2020, 1,376 subjects were included in the study. The mean volume of Clariscan used was 0.26 mL/kg (0.13 mmol/kg). In the overall study population and in each subgroup, diagnostic confidence increased after contrast enhancement with Clariscan. Overall, image quality was excellent in 72.5% of subjects and good-to-adequate in 27.2%. Clariscan was well tolerated (14 AEs occurred in 10 subjects); all AEs were of mild severity. Subgroup analyses showed that the mean dose of Clariscan used was ≥0.1 mmol/kg for nervous system-related diagnoses (e.g., brain) and ≤0.1 mmol/kg for musculoskeletal and pediatric-related diagnoses. All musculoskeletal and pediatric examinations were provided with a smaller package of 5 mL Clariscan. By body region of MR examination, the most common region was the nervous system in 69.0%, musculoskeletal system in 13.6%, and reproductive system in 4.9%. Conclusions. This study confirmed the use pattern of Clariscan and its excellent effectiveness and safety in the real-world clinical environment in Korea. The small-dose package indicated the possibility of increasing the convenience and efficiency of drug use.

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Improvement of Disease Management and Cost Effectiveness in Chinese Patients with Ankylosing Spondylitis Using a Smart-phone Management System: A Prospective Cohort Study (Preprint)

10.2196/preprints.12372 ◽

2018 ◽

Author(s):

Xiaojian Ji ◽

Yiwen Wang ◽

Yingpei Ma ◽

Zhengyuan Hu ◽

Siliang Man ◽

...

Keyword(s):

Ankylosing Spondylitis ◽

Disease Management ◽

Mobile Health ◽

Real World ◽

Management System ◽

Smart Phone ◽

Chinese Patients ◽

Inactive Disease ◽

Management Tool ◽

Symptom Duration

BACKGROUND Ankylosing spondylitis (AS) is a chronic disease that mainly affects the axial skeleton, leading to decreased mobility, function, and quality of life. With the advent of mobile health (mHealth) technologies, it is now possible to create more economical, sustainable, and user-friendly communication and health monitoring systems to improve the effectiveness of patient care and to gather real-world clinical data for clinical research. OBJECTIVE To introduce “smart-phone Spondyloarthritis Management System” (SpAMS), an interactive mobile health (mHealth) tool, specifically designed for longitudinal disease management and prospective ankylosing spondylitis (AS)/spondyloarthritis (SpA) and to evaluate the clinical profile of Chinese (AS) patients. METHODS SpAMS integrates the patient’s portal and the physician’s portal in a cell phone application. By using SpAMS, Chinese Ankylosing Spondylitis Prospective Imaging Cohort (CASPIC) was launched from April 2016. All patients fulfilled the 1984 modified New York criteria. Patient self-assessments were completed online at baseline and at every subsequent clinic visit. Physician-reported assessments and treatment regimens were recorded by rheumatologists during each visit. RESULTS In total, 1201 AS patients [mean (SD) age, 30.6 (8.7) years; male, 82.6%] were recruited. The mean (SD) disease duration was 8.4 (6.1) years. A history or current symptoms suggestive of acute anterior uveitis (AAU), psoriasis, and inflammatory bowel disease (IBD) were observed in 21.0%, 3.7%, and 9.4% of the patients, respectively. AAU and IBD were found significantly more in patients with a symptom duration > 10 years (31.1%, 12.5%, respectively). At the baseline visit, the most commonly used medications were non-steroidal anti-inflammatory drugs (NSAIDs) (98.2%). Patients using tumor necrosis factor inhibitors (TNFi) accounted for 20.8% of enrolled patients. Additionally, 66.4% of patients used conventional synthetic disease-modifying anti-rheumatic drugs (DMARDs). At baseline, the percentage of patients with inactive disease (ID)/low disease activity (LDA) was 57.2%, and this value improved significantly to 79.2% after a mean follow-up of 13.3 (5.9) months. Compared with relapsed patients, new achievers of ID/LDA underwent more online patient assessments (P < .001). By solving problems in SpAMS, 29.1% of clinic visits were unnecessary and therefore time had been saved. At least an average of 5.3 hours and 327.4 RMB per person spent on traffic was saved through SpAMS. The saved traffic expenses were equal to 16% of the Chinese monthly disposable personal income. CONCLUSIONS SpAMS is a time- and cost-saving disease management tool, helping AS patients perform self-management and providing valuable data to clinicians. This is the first nationwide real-world study of AS patients in China who use mHealth technology, and our results contribute significantly to characterizing the clinical profiles of Chinese patients with AS.

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A 12-month, prospective, observational study of ranibizumab in treatment-naïve Taiwanese patients with neovascular age-related macular degeneration: the RACER study

BMC Ophthalmology ◽

10.1186/s12886-020-01715-3 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Wen-Chuan Wu ◽

Jiann-Torng Chen ◽

Ching-Yao Tsai ◽

Chien-Liang Wu ◽

Cheng-Kuo Cheng ◽

...

Keyword(s):

Observational Study ◽

Macular Degeneration ◽

Real World ◽

Prospective Observational Study ◽

Age Related Macular Degeneration ◽

Intravitreal Ranibizumab ◽

Age Related ◽

Treatment Naïve ◽

The Mean ◽

Prescribing Information

Abstract Background The current National Health Insurance scheme in Taiwan reimburses 3 initial plus 4 additional injections of ranibizumab 0.5 mg for eligible patients with neovascular age-related macular degeneration (nAMD). The Ranibizumab AMD Clinical Efficacy in Real-world practice (RACER) study aimed to observe the effectiveness of ranibizumab injections under this reimbursement system. Methods RACER was a 12-month, prospective, observational study conducted in treatment-naïve, adult Taiwanese patients with nAMD. Patients received intravitreal ranibizumab 0.5 mg injections in adherence with local prescribing information. Results Of 161 patients enrolled, 114 (70.8%) completed the 12-month study. Overall, patients received a mean (standard deviation [SD]) of 4.3 (1.7) ranibizumab injections. The mean (SD, [95% confidence interval], P value) gain in best-corrected visual acuity (BCVA) from baseline at Month 3 was 5.2 (12.2, [3.1, 7.3] letters, P < 0.0001) and at Month 12 was 3.4 (15.4, [0.2–6.6] letters, P = 0.0352). Mean central retinal thickness also decreased from baseline at Months 3 and 12 (both P < 0.001). In subgroup analyses, better treatment outcomes at Months 3 and 12 were observed among patients who received a loading dose and those who had a shorter duration of nAMD at baseline. Adverse events were reported in 58.4% of patients; most (94.4%) were mild-to-moderate in severity and 98.8% were deemed unrelated to study treatment. Conclusions Treatment with ranibizumab 0.5 mg resulted in significant improvements in visual outcomes among treatment-naïve Taiwanese patients with nAMD. Early treatment and frequent dosing in the real-world setting may be the key to achieving better outcomes.

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