Reliability of a consensus-based ultrasound definition and scoring for enthesitis in spondyloarthritis and psoriatic arthritis: an OMERACT US initiative

2018 ◽  
Vol 77 (12) ◽  
pp. 1730-1735 ◽  
Author(s):  
Peter V Balint ◽  
Lene Terslev ◽  
Philippe Aegerter ◽  
George Arthur Willem Bruyn ◽  
Isabelle Chary-Valckenaere ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Psoriatic Arthritis ◽  
Doppler Signal ◽  
Kappa Statistics ◽  
Stepwise Approach ◽  
The Us ◽  
Definition Of ◽  
Low Prevalence

ObjectivesTo evaluate the reliability of consensus-based ultrasound (US) definitions of elementary components of enthesitis in spondyloarthritis (SpA) and psoriatic arthritis (PsA) and to evaluate which of them had the highest contribution to defining and scoring enthesitis.MethodsEleven sonographers evaluated 40 entheses from five patients with SpA/PsA at four bilateral sites. Nine US elementary lesions were binary-scored: hypoechogenicity, thickened insertion, enthesophytes, calcifications, erosions, bone irregularities, bursitis and Doppler signal inside and around enthesis. Kappa statistics were used to evaluate reliability. Sonographers were also asked to state which lesions can be considered as inflammatory or structural and should be included in the final definition of enthesitis. Only the lesions, scored as present in at least 75% of the entheses considered as having an enthesitis, were included in the final definition.ResultsThe prevalence of detected lesions was quite low except for enthesophytes (55%) and bone irregularities (54%). Reliability ranged from poor to good (the lowest for thickened enthesis (kappa 0.1 (95% CI 0 to 0.7)) and the highest for enthesophytes (kappa 0.6 (95% CI 0.5 to 0.7)). When adjusted for low prevalence, kappa values increased for all lesions, with the best result observed for detecting Doppler signal at insertion (0.9) and for bursitis (0.8). The US components included in the final definition were hypoechogenicity, increased thickness at enthesis, erosions and calcifications/enthesophytes and Doppler signal at insertion.ConclusionBy using a consensus-based stepwise approach, a final reliable US score and definition of enthesitis in SpA/PsA were produced. Further studies are sought for implementing this score in clinical trials and practice.

scholarly journals Pulmonary exacerbation in adults with bronchiectasis: a consensus definition for clinical research

2017 ◽  
Vol 49 (6) ◽  
pp. 1700051 ◽  
Author(s):  
Adam T. Hill ◽  
Charles S. Haworth ◽  
Stefano Aliberti ◽  
Alan Barker ◽  
Francesco Blasi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Working Group ◽  
Exercise Tolerance ◽  
Research Collaboration ◽  
Round Table ◽  
Consensus Definition ◽  
The Us ◽  
Sputum Volume ◽  
Definition Of

There is a need for a clear definition of exacerbations used in clinical trials in patients with bronchiectasis. An expert conference was convened to develop a consensus definition of an exacerbation for use in clinical research.A systematic review of exacerbation definitions used in clinical trials from January 2000 until December 2015 and involving adults with bronchiectasis was conducted. A Delphi process followed by a round-table meeting involving bronchiectasis experts was organised to reach a consensus definition. These experts came from Europe (representing the European Multicentre Bronchiectasis Research Collaboration), North America (representing the US Bronchiectasis Research Registry/COPD Foundation), Australasia and South Africa.The definition was unanimously approved by the working group as: a person with bronchiectasis with a deterioration in three or more of the following key symptoms for at least 48 h: cough; sputum volume and/or consistency; sputum purulence; breathlessness and/or exercise tolerance; fatigue and/or malaise; haemoptysis AND a clinician determines that a change in bronchiectasis treatment is required.The working group proposes the use of this consensus-based definition for bronchiectasis exacerbation in future clinical research involving adults with bronchiectasis.

scholarly journals POS1066 IS ENTHESITIS A SONOGRAPHIC BIOMARKER OF DISEASE SEVERITY IN PSORIATIC ARTHRITIS? THE LINK BETWEEN ULTRASOUND ENTHESEAL ABNORMALITIES AND PERIPHERAL JOINT EROSIVE DAMAGE

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 811.2-812
Author(s):  
G. Smerilli ◽  
E. Cipolletta ◽  
G. M. Destro Castaniti ◽  
A. DI Matteo ◽  
M. DI Carlo ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Severity ◽  
Healthy Subjects ◽  
Structural Damage ◽  
Bone Erosion ◽  
Doppler Signal ◽  
P Value ◽  
Bone Erosions ◽  
The Us ◽  
The Impact

Background:Enthesitis is one of the hallmark of psoriatic arthritis (PsA). Ultrasound (US) accurately detects morphostructural abnormalities indicative of entheseal inflammation and structural damage. Interestingly, in a recent study, US-detected entheseal pathology appeared to be a potential marker of disease severity, being associated with higher radiographic score of structural damage at peripheral joint level. (1) However, a sub-analysis of the impact of each elementary finding of US enthesitis was not performed. Moreover, some US entheseal abnormalities (hypoechogenicity, thickening and calcification/enthesophyte) have been described as frequent findings in healthy subjects and patients with dysmetabolic conditions, undermining their specificity. (2) Thus, we hypothesized that their role as a sonographic biomarker of joint disease severity could be questioned.Objectives:The main aim of the present study was to explore the association between the US elementary findings of enthesitis defined by OMERACT [i.e. hypoechogenicity, thickening, Doppler signal, calcification/enthesophyte and bone erosion at enthesis] (3) and the presence of US-detected joint bone erosions in patients with PsA.Methods:Consecutive patients with PsA (CASPAR criteria) were included in this cross-sectional single-centre study. The scanning protocol included bilateral assessment of the main entheses of the lower limbs [plantar fascia, quadriceps, patellar (proximal and distal) and Achilles tendons]. The presence of US joint bone erosions was investigated in the following areas: 2nd and 5th metacarpophalangeal (MCP) joints, ulnar head and 5th metatarsophalangeal (MTP) joint, bilaterally, as well as the most inflamed joint at the physical examination. The US examination was carried out with a 6-18 MHz probe. Univariate and multivariate logistic analysis were performed to identify predictors of US joint bone erosions.Results:A total of 74 PsA patients were enrolled. The mean disease duration was 7.9±8.0 years. Joint bone erosions were found in 36/75 patients (48.0%), and in 71/600 joints (11.8%), most frequently in the 5th MTP joint (in 26/75 patients, 34.7%). The univariate analysis showed that entheseal bone erosions [odds ratio (OR) 27.1, 95% confidence interval (CI) 3.3-220.2, p value <0.01] and Doppler signal (OR 3.5, 95% CI 1.3 - 9.4, p value 0.01) were associated with joint bone erosions. Only entheseal bone erosions remained significantly associated with joint bone erosions in the multivariate analysis (Table 1).Table 1.Multivariate regression analysis: predictive value of the entheseal US findings for the presence of joint bone erosions.OR (95% CI)P valueHypoechogenicity0.5 (0.1-3.4)0.45Thickening2.2 (0.6-8.3)0.27Doppler signal3.2 (0.9-10.8)0.06Calcification/enthesophyte1.1 (0.1-11.2)0.99Entheseal bone erosion24.2 (2.7-216.2)<0.01Conclusion:Entheseal bone erosion and, to a lesser extent, Doppler signal, were the only entheseal abnormalities correlated with the presence of US-detected joint bone erosions, representing potential sonographic biomarkers of disease severity in PsA.References:[1]Polachek A, Cook R, Chandran V, Gladman DD, Eder L. The association between sonographic enthesitis and radiographic damage in psoriatic arthritis. Arthritis Res Ther 2017; 15;19:189.[2]Balint PV, Terslev L, Aegerter P, Bruyn GAW, Chary-Valckenaere I, Gandjbakhch F, et al. Reliability of a consensus-based ultrasound definition and scoring for enthesitis in spondyloarthritis and psoriatic arthritis: An OMERACT US initiative. Ann Rheum Dis 2018; 77(12):1730-5.[3]Di Matteo A, Filippucci E, Cipolletta E, Martire V, Jesus D, Musca A, et al. How normal is the enthesis by ultrasound in healthy subjects? Clin Exp Rheumatol 2020;38:472-8.Disclosure of Interests:Gianluca Smerilli: None declared, Edoardo Cipolletta: None declared, Giulia Maria Destro Castaniti: None declared, Andrea Di Matteo: None declared, Marco Di Carlo: None declared, Erica Moscioni: None declared, Francesca Francioso: None declared, Walter Grassi Speakers bureau: W.G. has received speaking fees from AbbVie, Celgene, Grünenthal, Pfizer and UCB Pharma., Emilio Filippucci Speakers bureau: E.F. has received speaking fees from Abbvie, BMS, Janssen, Lilly, MSD, Novartis, Roche, Pfizer, UCB Pharma.

Validity of the modified RECIST criteria and EORTC PET criteria evaluated based on the pathologic findings for patients with resectable malignant pleural mesothelioma

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e11639-e11639
Author(s):  
T. Mimura ◽  
H. Watanabe ◽  
T. Yamanaka ◽  
M. Satouchi ◽  
M. Okada
Keyword(s):  
Clinical Trials ◽  
Malignant Pleural Mesothelioma ◽  
Surrogate Endpoint ◽  
Kappa Statistics ◽  
Pleural Mesothelioma ◽  
European Organization ◽  
Pathologic Findings ◽  
Modified Recist ◽  
Definition Of ◽  
Measurable Lesion

e11639 Background: The unique growth pattern of malignant pleural mesothelioma (MPM) presents challenges for clinical investigators evaluating the responses to chemotherapy, which is an important surrogate endpoint for patient benefit, particularly in clinical trials. In patients with resectable MPM, multicenter clinical trials of neoadjuvant chemotherapy followed by extrapleral pneumonectomy (EPP) and subsequent radiotherapy have been attempted around the world. The applicability of modified RECIST based on the findings on CT images and EORTC (European Organization for Research and Treatment of Cancer) criteria based on the findings on FDG-PET images to resectable MPM would be challenging and significant, but their validity has never been examined. Methods: Between May 2006 and November 2008, 13 consecutive patients with resectable pathologically proven MPM were included in this study. All were initially treated with combination chemotherapy including cisplatin. EPP was successfully performed in all the patients. In addition to modified RECIST (CR vs PR vs SD vs PD), FDG uptake by the tumor on PET was also evaluated according to the EORTC PET criteria (CMR vs PMR vs SMD vs PMD). Also, pathologic findings (NT; no viable tumor vs MR; minimal residual vs GR; gross residual) were reviewed. Results: According to modified RECIST, in which the definition of measurable lesions is ≥10mm in diameter, 7 of the 13 patients investigated had no measurable lesion. Even when the definition of measurable lesions was changed to ≥5mm, 2 patients had no measurable lesion and 4 had only one lesion. In regard to the response, 4 of 11 patients with any measurable lesions were classified as PR, and 7 were classified as SD, while 8 patients were classified as PMR and 3 were classified as SMD according to the PET findings. Eight patients were classified as GR and 5 as MR. Kappa statistics suggested potential variation between the CT response and the pathologic findings (κ=0.214, 95% CI=-0.377 ∼ 0.806) and between the PET response and the pathologic findings (κ=0.286, 95% CI=-0.049 ∼ 0.620). Conclusions: Our data raise doubts about the validity of applying the modified RECIST criteria as well as EORTC PET criteria to resectable MPM. No significant financial relationships to disclose.

Holism, Chinese Medicine and Systems Ideologies: Rewriting the Past to Imagine the Future

2018 ◽  
Author(s):  
Volker Scheid
Keyword(s):  
Eighteenth Century ◽  
Chinese Medicine ◽  
Medical Humanities ◽  
Science And Technology Studies ◽  
Human Beings ◽  
The Past ◽  
Starting Point ◽  
The Us ◽  
Shared Objective ◽  
Definition Of

This chapter explores the articulations that have emerged over the last half century between various types of holism, Chinese medicine and systems biology. Given the discipline’s historical attachments to a definition of ‘medicine’ that rather narrowly refers to biomedicine as developed in Europe and the US from the eighteenth century onwards, the medical humanities are not the most obvious starting point for such an inquiry. At the same time, they do offer one advantage over neighbouring disciplines like medical history, anthropology or science and technology studies for someone like myself, a clinician as well as a historian and anthropologist: their strong commitment to the objective of facilitating better medical practice. This promise furthermore links to the wider project of critique, which, in Max Horkheimer’s definition of the term, aims at change and emancipation in order ‘to liberate human beings from the circumstances that enslave them’. If we take the critical medical humanities as explicitly affirming this shared objective and responsibility, extending the discipline’s traditional gaze is not a burden but becomes, in fact, an obligation.

HELIOTHERAPY IN THE TREATMENT OF PSORIATIC ARTHRITIS

2018 ◽  
Vol 28 (2) ◽  
pp. 483-487
Author(s):  
Snezhina Georgieva ◽  
Dilyana Zvezdova
Keyword(s):  
Psoriatic Arthritis ◽  
Clinical Picture ◽  
Local Therapy ◽  
Severe Form ◽  
Climatic Conditions ◽  
Joint Disease ◽  
Immune Mediated ◽  
Social Comfort ◽  
Pigment Type ◽  
Definition Of

Psoriatic arthritis is an inflammatory joint disease associated with psoriasis vulgaris, with routinely negative rheumatoid factors and the absence of rheumatoid nodules. This is an immune-mediated disease, according to generally accepted definition of Wright and Moll from 1973. American Association against Rheumatism classified psoriatic arthritis as an independent disease in 1964. Psoriatic arthritis is a single disease with a varied clinical picture. It belongs to the group of seronegative spondyloarthropathies with which there are general clinical features. It is believed that similar mechanisms determine the onset of psoriasis and psoriatic arthritis. The clinical picture includes various clinical forms that damage the peripheral and sacroiliac joints, spine, internal organs. The treatment of psoriatic arthritis is directed simultaneously to the influence of skin and joint changes. Purpose: Our study aims to summarize our long-standing experience in the treatment of psoriatic arthritis with heliotherapy. Subject of observation: Monitoring includes 132 patients with moderate and severe form of psoriasis treated at the sanatorium in town of Pomorie for 5 years in the period 2001-2006. Results and discussion: 132 patients with psoriasis with no effect on the local therapy and have proven psoriatic arthritis were selected. In our climatic conditions, heliotherapy is appointed during the warm half-year. Sun treatment was conducted under the conditions of a healing beach, which had shielding, radiation-protective devices. In patients with erythema - pigment and pigment type skin reactivity begins with 1-2 bioadoses reached to 8-10 biodoses, carried out in the area of overcomfort. Conclusion: The studies demonstrated that heliotherapy combined with medications significantly improves the prognosis of patients with this disease. The ultimate success would mean overcoming the frequent depression conditions, better survival and social comfort for patients with psoriatic arthritis.

scholarly journals Animal and Human Vaccines against West Nile Virus

Pathogens ◽  
2020 ◽  
Vol 9 (12) ◽  
pp. 1073
Author(s):  
Juan-Carlos Saiz
Keyword(s):  
Clinical Trials ◽  
West Nile Virus ◽  
Vaccine Development ◽  
Phase Iii ◽  
West Nile ◽  
Specific Therapy ◽  
Phase Iii Clinical Trials ◽  
Neuroinvasive Disease ◽  
The Us ◽  
The Status

West Nile virus (WNV) is a widely distributed enveloped flavivirus transmitted by mosquitoes, which main hosts are birds. The virus sporadically infects equids and humans with serious economic and health consequences, as infected individuals can develop a severe neuroinvasive disease that can even lead to death. Nowadays, no WNV-specific therapy is available and vaccines are only licensed for use in horses but not for humans. While several methodologies for WNV vaccine development have been successfully applied and have contributed to significantly reducing its incidence in horses in the US, none have progressed to phase III clinical trials in humans. This review addresses the status of WNV vaccines for horses, birds, and humans, summarizing and discussing the challenges they face for their clinical advance and their introduction to the market.

scholarly journals AB0809 HOW WELL ARE BIOLOGICS RETAINED IN PSORIATIC ARTHRITIS - A REAL WORLD STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1706.1-1706
Author(s):  
I. Jawad ◽  
M. K. Nisar
Keyword(s):  
Clinical Trials ◽  
Psoriatic Arthritis ◽  
Real World ◽  
Biologic Therapy ◽  
Health Economy ◽  
Nice Guidelines ◽  
Drug Survival ◽  
Gi Symptoms ◽  
Conventional Dmards ◽  
Significant Difference

Background:Biologics have led to a sea change in the management of psoriatic arthritis (PsA) with unprecedented improvement in the signs, symptoms and radiographic damage, resulting in improvement in functionality and quality of life. However longitudinal data for their retention and tolerability is sparse.Objectives:Our objective was to evaluate real-world biologic therapy duration and reasons for discontinuing treatment.Methods:We conducted a retrospective analysis of our PsA electronic register from 1994 up to and including April 2019 at our university teaching hospital. We had access to full patient records including details on co-morbidities, drugs and disease management.Results:335 patients were identified with PsA. 58% of them were female with mean age of 46 yr (13-81). 113 (33.7%) patients had been treated with a biologic with 105 (93%) continuing at the time of analysis. 60 individuals were prescribed combination therapy with DMARDs. Mean age was 43.3 years (13-81) with 56% women. The biologics sample was ethnically diverse including 80% White Caucasian patients, 17% Asian and others (3%). Significant co-morbidities included cardiovascular disease (18.6%) and diabetes (4.4%). Eight different biologics were in use with adalimumab being the most prescribed (67%).35 (30.9%) patients had stopped biologics at some point with 76 episodes of cessation. 6% of our sample had discontinued two or more biologic treatments. The mean duration before biologic therapy was discontinued was 18.2 months (8 days to 9.5 years), which was almost twice as long as the average period before discontinuing a DMARD (9.9 months). Main reasons for stopping treatment included 23% each due to GI symptoms, neurological causes, cutaneous symptoms and other side effects. The remaining 8% reported fatigue as the reason for stopping therapy.Conclusion:To our knowledge this is the first dedicated retrospective review of a large real world PsA cohort comparing drug survival and tolerability of biologics against DMARDs. Biologic therapies are well tolerated in psoriatic arthritis. There is no significant difference amongst various modes of action. Over a quarter of the patients discontinue the drug owing to intolerance with mean drug survival of 18 months. In contrast nearly two-thirds were intolerant of DMARDs and stopped within ten months. Thus both the rate and duration of biologic retention is significantly better than conventional DMARDs. This has significant economic impact as NICE guidelines require an adequate trial of two DMARDs for six months prior to advanced therapy. However, this approach is unlikely to be cost effective as the disease progresses whilst patients struggle with DMARDs prescription and thus delay biologics which are more likely to be tolerated and retained longer. Hence there is an urgent need to review NICE guidelines to allow earlier employment of biologics in the treatment paradigm with significant benefits to both patients and the health economy.Disclosure of Interests:Issrah Jawad: None declared, Muhammad Khurram Nisar Grant/research support from: Muhammad Nisar undertakes clinical trials and received support (including attendance at conferences, speaker fees and honoraria) from Roche, Chugai, MSD, Abbvie, Pfizer, BMS, Celgene, Novartis and UCB, Consultant of: Muhammad Nisar undertakes clinical trials and received support (including attendance at conferences, speaker fees and honoraria) from Roche, Chugai, MSD, Abbvie, Pfizer, BMS, Celgene, Novartis and UCB, Speakers bureau: Muhammad Nisar undertakes clinical trials and received support (including attendance at conferences, speaker fees and honoraria) from Roche, Chugai, MSD, Abbvie, Pfizer, BMS, Celgene, Novartis and UCB

scholarly journals Adverse events of special interest in clinical trials of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and psoriasis with 37 066 patient-years of tofacitinib exposure

RMD Open ◽  
2021 ◽  
Vol 7 (2) ◽  
pp. e001595
Author(s):  
Gerd R Burmester ◽  
Peter Nash ◽  
Bruce E Sands ◽  
Kim Papp ◽  
Lori Stockert ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Ulcerative Colitis ◽  
Clinical Trials ◽  
Psoriatic Arthritis ◽  
Adverse Events ◽  
Special Interest ◽  
Phase 1 ◽  
Incidence Rates ◽  
Study Data ◽  
System Organ Class

ObjectivesTo analyse adverse events (AEs) of special interest across tofacitinib clinical programmes in rheumatoid arthritis (RA), psoriatic arthritis (PsA), ulcerative colitis (UC) and psoriasis (PsO), and to determine whether the incidence rates (IRs; unique patients with events per 100 patient-years) of these events are consistent across diseases.MethodsThe analysis included data from patients exposed to ≥1 dose of tofacitinib in phase 1, 2, 3 or 3b/4 clinical trials and long-term extension (LTE) studies (38 trials) in RA (23 trials), PsA (3 trials), UC (5 trials) and PsO (7 trials). All studies were completed by or before July 2019, except for one ongoing UC LTE study (data cut-off May 2019). IRs were obtained for AEs of special interest.Results13 567 patients were included in the analysis (RA: n=7964; PsA: n=783; UC: n=1157; PsO: n=3663), representing 37 066 patient-years of exposure. Maximum duration of exposure was 10.5 years (RA). AEs within the ‘infections and infestations’ System Organ Class were the most common in all diseases. Among AEs of special interest, IRs were highest for herpes zoster (non-serious and serious; 3.6, 1.8, 3.5 and 2.4 for RA, PsA, UC and PsO, respectively) and serious infections (2.5, 1.2, 1.7 and 1.3 for RA, PsA, UC and PsO, respectively). Age-adjusted and sex-adjusted mortality ratios (weighted for country) were ≤0.2 across cohorts.ConclusionsThe tofacitinib safety profile in this analysis was generally consistent across diseases and with longer term follow-up compared with previous analyses.

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