scholarly journals ASessment in Ankylosing Spondylitis (ASAS) international working group: a model for psoriatic arthritis and psoriasis?

2005 ◽  
Vol 64 (suppl_2) ◽  
pp. ii108-ii109 ◽  
Author(s):  
D van der Heijde
Keyword(s):  
Psoriatic Arthritis ◽  
Ankylosing Spondylitis ◽  
Working Group ◽  
International Working Group ◽  
Group A

Proposal for Levels of Evidence Schema for Validation of a Soluble Biomarker Reflecting Damage Endpoints in Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis, and Recommendations for Study Design

2009 ◽  
Vol 36 (8) ◽  
pp. 1792-1799 ◽  
Author(s):  
WALTER P. MAKSYMOWYCH ◽  
OLIVER FITZGERALD ◽  
GEORGE A. WELLS ◽  
DAFNA D. GLADMAN ◽  
ROBERT LANDEWÉ ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Longitudinal Study ◽  
Psoriatic Arthritis ◽  
Ankylosing Spondylitis ◽  
Study Design ◽  
Validation Studies ◽  
Working Group ◽  
Statistical Strength ◽  
Levels Of Evidence ◽  
Longitudinal Study Design

Objective.At OMERACT 8 a framework for levels of evidence was proposed for the validation of biomarkers as surrogate outcome measures. We aimed to adapt this scheme in order to apply it in the setting of soluble biomarkers proposed to replace the measurement of damage endpoints in rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). We also aimed to generate consensus on minimum standards for the design of longitudinal studies aimed at validating biomarkers.Methods.Before the meeting, the Soluble Biomarker Working Group prepared a preliminary framework and discussed various models for association and prediction related to the statistical strength domain. In addition, 3 Delphi exercises addressing longitudinal study design for RA, PsA, and AS were conducted within the working group and members of the Assessments in SpondyloArthritis International Society (ASAS) and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). This formed the basis for discussions among OMERACT 9 participants.Results.The proposed framework was accepted by consensus. In the study design domain a requirement for both prospective observational studies and randomized controlled trials (RCT) in different drug classes was noted. A template for determining the level of statistical strength was proposed. The addition of a new domain on biomarker assay performance was considered essential, and participants suggested that for any biomarker this domain should be addressed first, i.e., before starting clinical validation studies. Participants agreed on most elements of a longitudinal study design template. Where consensus was lacking the working group has drafted solutions that constitute a basis for prospective validation studies.Conclusion.The OMERACT 9 Soluble Biomarker Group has successfully formulated a levels of evidence scheme and a study design template that will provide guidance to conduct validation studies in the setting of soluble biomarkers proposed to replace the measurement of damage endpoints in RA, PsA, and AS.

scholarly journals Assessment in Ankylosing Spondylitis International Working Group/Spondylitis Association of America recommendations for conducting clinical trials in ankylosing spondylitis

2005 ◽  
Vol 52 (2) ◽  
pp. 386-394 ◽  
Author(s):  
D�sir�e van der Heijde ◽  
Maxime Dougados ◽  
John Davis ◽  
Michael H. Weisman ◽  
Walter Maksymowych ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Ankylosing Spondylitis ◽  
Working Group ◽  
International Working Group

scholarly journals FRI0284 EFFECTIVENESS AND SAFETY OF SECUKINUMAB IN NAÏVE OR TNF-INHIBITORS FAILURE PSORIATIC ARTHRITIS PATIENTS IN REAL LIFE: A 24-MONTHS PROSPECTIVE MULTICENTER STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 730.1-730
Author(s):  
M. Lorenzin ◽  
A. Carletto ◽  
R. Foti ◽  
M. S. Chimenti ◽  
A. Semeraro ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Ankylosing Spondylitis ◽  
Adverse Events ◽  
Disease Activity ◽  
Real Life ◽  
Tnf Inhibitors ◽  
Significant Difference ◽  
Group A ◽  
Group B

Background:Secukinumab (SEC) is a novel treatment for psoriatic arthritis (PsA),but data from real life are still missing.Objectives:1)to evaluate the effectiveness and safety of a wide cohort of PsA patients on SEC followed in 7 Italian rheumatologic centers for 24 months;2)to compare the features and disease activity indices of SEC-treated PsA patients subdivided in naïve biological drugs (group A) and in TNF-inhibitors (TNFi) failure patients (group B).Methods:Consecutive patients with moderate-severe PsA,who begun SEC treatment were evaluated prospectively.Data on disease characteristics,previous and ongoing treatments,comorbidities and duration of follow-up were collected.Disease activity,functional and clinimetric scores and biochemical values were recorded at baseline (t0),at 6 (t6),12 (t12),and 24 (t24) months.Anova (Kruskal Wallis) and generalized linear models were used to compare variables over time.Infections and adverse events were also collected.Results:PsA345patients [38.84% men;mean age 52.9 (11.27) years] were enrolled;mean treatment duration was 18.53 (9.97) years.SEC was prescribed as first line biologic treatment in 133 (38.55%) patients and as second or more line biological treatment in 212 (61.45%) patients. Enthesitis was present as a prominent manifestation in 61.44% of patients (Figure 1).In all population significant decrease in tender/swollen joints;Visual Analogue Scale of pain (VASp) and general health (VASgh);Psoriasis Area Severity Index (PASI);Leeds Enthesitis Index (LEI);number of dactylitis;Health Assessment Questionnaire modified for spondyloarthritis (HAQ-S);Bath Ankylosing Spondylitis Disease Activity Index (BASDAI);Bath Ankylosing Spondylitis Functional Index (BASFI);C-reactive protein (CRP) was achieved.Effectiveness of all PsA patients was associated to an improvement in Ankylosing Spondylitis disease activity score (ASDAS) [t0=3.45 (0.69) vs t24=1.48 (0.23);p<0.01] and in Disease Activity in PsA (DAPSA) [t0=29.52 (12.56) vs t24=11.41 (7.63);p<0.001].At t0group Bhad a more erosive (p=0.04) and polyarticular pattern (p=0.04),a longer disease duration (p=0.001),a greater prevalence (p=0.04) of psoriasis and dactylitis (p=0.01),a higher PASI score (p=0.01),while no significant difference was observed for uveitis,inflammatory bowel diseases,enthesitis.At t24group Ashowed better physical functioning and lower disease activity compared togroup B[HAQs A vs B=0.03 (0.16) vs 0.69 (0.73);BASDAI A vs B=2.37 (0.66) vs 4.27 (2.33);ASDAS A vs B=1.4 (0.62) vs 1.99 (0.86);CRP A vs B=2.03 (1.94) vs 3.11 (1.55) mg/L;DAPSA A vs B=7.03 (3.57) vs 12.41 (8.05)].After t24 of treatment 74.6% ofGroup Aand 72.8% ofGroup Barticular had an inactive\low disease activity (MDA),accordingly to ASDAS and DAPSA respectively.Forty-three patients (12.46%) stopped the treatment during the follow-up mainly because of primary or secondary loss of efficacy (29 and 24, respectively).Only 14 patients suspended SEC because of adverse events (of which 9 for reactions at site of injection).A low number of episodes of mild infections (16) occurred;SEC was instead permanently discontinued in 7 cases for:oral refractory mucositis (3);recurrent aphthosis (2);diverticulitis (2).The retention rate at t24 was good in the whole population.Interestingly no differences were found betweenGroup AandB(p=0.815).Conclusion:In a real life clinical setting,SEC was safe and effective in PsA. as shown by a significant decrease of DAPSA and ASDAS over a 24-months follow up.Disclosure of Interests:Mariagrazia Lorenzin: None declared, Antonio Carletto: None declared, Rosario Foti Consultant of: lilly, sanofi, MSD, Janssen, Abbvie, BMS, celgene, roche, Speakers bureau: lilly, sanofi, MSD, Janssen, Abbvie, BMS, celgene, roche, Maria Sole Chimenti: None declared, Angelo Semeraro: None declared, Luisa Costa: None declared, Leonardo Santo: None declared, Elena Fracassi: None declared, Ilaria Montanari: None declared, Mara Felicetti: None declared, Giulia Lavinia Fonti: None declared, Francesco Caso: None declared, Andrea Doria Consultant of: GSK, Pfizer, Abbvie, Novartis, Ely Lilly, Speakers bureau: UCB pharma, GSK, Pfizer, Janssen, Abbvie, Novartis, Ely Lilly, BMS, Augusta Ortolan: None declared, Roberta Ramonda Speakers bureau: Novartis, Celgene, Janssen, Pfizer, Abbvie, Lilly

MDS-Patienten mit stabiler Erkrankung profitieren von kontinuierlicher Azacitidin- Therapie

2010 ◽  
Vol 01 (04) ◽  
pp. 161-162
Author(s):  
Günter Springer
Keyword(s):  
Working Group ◽  
International Working Group ◽  
American Society

Patienten mit Myelodysplastischem Syndrom (MDS) und Krankheitsstabilisierung (SD) als erstes Ansprechen haben unter kontinuierlicher Behandlung mit Azacitidin (Vida-za®) gute Aussichten, noch ein Ansprechen gemäß Kriterien der International Working Group (IWG) und dadurch einen Überlebensvorteil zu erreichen. Zu diesem Ergebnis kam eine auf dem Kongress der American Society of Oncology (ASCO) vorgestellte Analyse der Zulassungsstudie AZA-001.

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