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  string(147) "Identifying the optimal target for Psoriatic Arthritis: a retrospective analysis to identify which target best predicts improved long term outcomes"
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  string(699) "International Recommendations have suggested using a 'treat to target' approach in psoriatic arthritis (PsA) (1).  The TIght COntrol of PsA (TICOPA) trial showed this can improve disease activity, function and quality of life (2).  However there are several targets that could be used and the best has not yet been determined.  PsA is a heterogeneous condition, with potentially important involvement across multiple domains of disease. We wish to use trial data to explore which targets are associated with the best long term outcome for patients in terms of x-ray damage to joints and functional ability.  Then the best target can be implemented in practice, and lead to improved patient outcomes."
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  string(67) "Retrospective analysis of outcome measures using existing data sets"
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      ["p_pers_pr_affil"]=>
      string(34) "University of California San Diego"
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      string(9) "Helliwell"
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      string(19) "University of Leeds"
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      string(19) "University of Leeds"
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  string(41) "National Institute of Health Research, UK"
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      string(210) "NCT00265096 - A Multicenter, Randomized, Double-blind, Placebo controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Psoriatic Arthritis"
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  ["property_scientific_abstract"]=>
  string(1372) "Background: Treating to target in PsA has been recommended internationally but multiple potential targets exist and the optimal target has not been identified.

Objective: To use retrospective analysis of data to examine 16 variations of 5 outcome measures that could serve as targets for therapy investigating which has the best prognostic value for long term function and structural damage outcomes in PsA.

Study design: Retrospective analysis comparing patients achieving different targets to establish which target has the best prognostic value for function and structural damage progression.

Participants: observed data from randomized patients with PsA in the GO-REVEAL trial with non-missing MDA and/or radiographic data at weeks 14, 24, 52, 104, 148, 196, and 256.

Main outcome measures: Change in function (health assessment questionnaire), structural damage, quality of life (SF-36) and productivity at week 256.

Statistical analysis: proportions achieving targets will be compared and residual disease activity quantified.  Logistic regression will look for baseline predictors of achieving the targets and analyses of variance will compare the outcomes including radiographic damage, HAQ, SF-36 and patient global for participants achieving different targets either never, >2 and >3 timepoints (>38 and 90 weeks respectively)."
  ["project_brief_bg"]=>
  string(2822) "Treat to target recommendations for SpA,  published in 2013 and drafted by expert consensus(3) stated that in PsA, the target of treatment should be remission or inactive disease.  In some cases an alternative target of low or minimal disease activity was considered to be appropriate.  At that time, no definitions of remission or inactive disease existed and the only validated target available was the minimal disease activity (MDA) criteria for PsA(4).  The MDA criteria have been validated in numerous trial datasets(5-7) and were used in the only treat to target study in PsA to date(2).  Since that time, other potential targets for both remission and low disease activity have been developed including cut offs for the Disease Activity in PsA (DAPSA) score(8, 9) (10). In addition, some proposals have been made with preliminary work on alternative versions of the MDA criteria(11). These include:

?	addressing the requirement for either 6 or 7 of the 7 criteria to be met (rather than the original 5)

?	MDA joints which requires that the two joint cut offs are met (tender and swollen joints ? 1) along with an additional 3 of the 5 remaining measures

?	MDA skin where the skin cut off is met, plus 4 of the remaining 6 measures

?	MDA joints and skin where the joint and skin measures are met plus 2 of the remaining 4 measures.

It was also stated in these recommendations that a normalisation of a measure of systemic inflammation such as C-reactive protein should also be included in the definition of remission(12).  CRP is not included in the MDA criteria and it is not clear what the addition of this requirement adds to the criteria, but this has not been explored.

Also since these recommendations were published, the first treat to target trial in PsA (the TICOPA study), using the MDA criteria as the target, has been presented and published(2).  As we work towards translating the evidence based treat to target strategy into clinical practice, it would be ideal to recommend just one target for remission/inactive disease and low/minimal disease activity to ease education of physicians and feasibility in practice.  However there is little data comparing these outcome measures and the potential consequences to patients of these targets.

Data from clinical trials in PsA are a unique source of information that is complete enough to allow calculation of the DAPSA scores, PASDAS, CPDAI, GRACE and the different MDA criteria.  This will also allow us to evaluate the criteria in a subpopulation with active skin disease.  By looking at the proportion of patients achieving these various criteria and their prognostic overall patient impact, we should be able to provide further evidence towards choosing optimal targets and optimizing patient outcomes."
  ["project_specific_aims"]=>
  string(902) "The aim of this project is identify an evidence-based optimal treatment target for PsA that can be recommended for future trials and clinical practice.

The hypothesis is that differences between the definitions of remission, low and minimal disease activity will translate into differences in long term outcomes for patients.  This will help us to identify an optimal target for therapy.

Our first objective is to examine compare different measures of remission or very low disease activity that may be appropriate for patients with a shorter duration of disease and less baseline joint damage so that these can be utilised in newly diagnosed patients.  Our second objective is to compare different measures of minimal and low disease activity that may act as an alternative target in those with more established disease or pre-existing damage where remission may not be a realistic goal."
  ["project_study_design"]=>
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  ["project_research_methods"]=>
  string(257) "These post-hoc analyses of the GO-REVEAL trial will utilize observed data from randomized patients with non-missing MDA and/or radiographic data at weeks 14, 24, 52, 104, 148, 196, and 256, time points at which data were available to analyze the MDA status."
  ["project_main_outcome_measure"]=>
  string(214) "The main outcome will be change in health assessment questionnaires (HAQ) at week 256.  This will be defined as change in score from baseline to week 256 and will be used as our key long term outcome in this study."
  ["project_main_predictor_indep"]=>
  string(752) "The MDA includes : tender joint count (TJC) ?1; swollen joint count (SJC) ?1; Psoriasis Activity and Severity Index (PASI) ?1; patient pain visual analogue score (VAS) ?15 mm; patient global disease activity VAS ?20 mm; health assessment questionnaire score ?0.5; and ?1 tender entheseal points.

Six variations of MDA will be tested.  Achieving at least 5, 6 or all 7 of the 7 variables.  Also definitions requiring 5 variables but with either or both peripheral arthritis and skin activity mandated.

The disease activity in PsA (DAPSA) score = TJC + SJC + Pt VAS (cm) + Pt pain (cm) +CRP (mg/dl).  The clinical DAPSA = TJC + SJC + Pt VAS (cm) + Pt pain (cm).  Remission is ?4 for both and low disease activity is ?14 and 13 respectively."
  ["project_other_variables_interest"]=>
  string(522) "The PsA disease activity score (PASDAS) score is calculated as 0.18 x ?physician global VAS + 0.159 x ?patient global VAS - 0.253 x ?Short form 36 physical component score (SF36-PCS) + 0.101 x ln (SJC+1) + 0.048 x ln (TJC+1) + 0.23 x ln (Leeds enthesitis index (LEI) +1) + 0.37 x ln (tender dactylitis count+1) + 0.102 x ln (C reactive protein (CRP)+1).  Low and very low disease activity are 3.2 and 1.9.

The GRAPPA Composite index (GRACE) score is calculated using desirability functions.  Low disease activity is"
  ["project_stat_analysis_plan"]=>
  string(1568) "The following targets will be tested

1.	MDA 5 of 7 variables

2.	MDA 6 of 7 variables

3.	MDA 7 of 7 variables

4.	MDA joints

5.	MDA skin

6.	MDA joints and skin

7.	DAPSA remission

8.	cDAPSA remission

9.	DAPSA low disease activity

10.	cDAPSA low disease activity

11.	PASDAS low disease activity

12.	PASDAS very low disease activity

13.	CPDAI low disease activity

14.	CPDAI very low disease activity

15.	GRACE low disease activity

16.	GRACE very low disease activity

Proportions achieving the targets will be compared at a group and individual level.  For those meeting the targets, residual disease activity will be quantified using descriptive analysis including values of systemic inflammatory response.

The endpoints at >2 and >3 consecutive time points (>38 and 90 weeks), based on a previous publication(7), provide a reasonable number of patients for analysis in a clinically meaningful and sustained timeframe. 

Logistic regression analyses will assess the effect of baseline characteristics on achievement of the targets, including HAQ DI score, MTX use, patient global, PsA duration, joint counts, and CRP level.

Analyses of variance will compare outcomes of interest including changes from baseline to week 256 in the PsA-modified Sharp/van der Heijde score (SHS), HAQ DI score, SF-36, productivity score, PASI score, and patient global for different target categories including: never;  >2 and >3 consecutive time points."
  ["project_timeline"]=>
  string(384) "Application submitted to YODA	       August 2016

Approval from YODA	                       September 2016

Project start date (receipt of data)	1st October 2016

Analysis completion date	                 31st December 2016

Draft manuscript completed and submitted for publication	1st April 2017

Results reported to YODA	                 1st April 2017"
  ["project_dissemination_plan"]=>
  string(1139) "The dissemination will be via two main outputs.  Firstly we anticipate an original research paper reporting the findings that would also be submitted in abstract form.  Given the timelines above, we plan to submit an abstract summarising the data to the European League Against Rheumatology (EULAR) for their deadline for submissions of 31st January 2017.  We believe that the manuscript would be of high interest to those in the field of PsA and would plan to submit for publication in the Annals of the Rheumatic Diseases or Arthritis Care and Research.

Secondly, this data will inform an ongoing project within the Group for Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) to form an expert international consensus on the optimal target for treatment in PsA.  This data will contribute to the ongoing project (with data from other studies) and this will form the basis of an expert consensus meeting where opinions of rheumatologists, dermatologists and patient research partners will be sought with an aim of producing a recommendation paper supporting translation of this trial evidence into routine clinical practice."
  ["project_bibliography"]=>
  string(2881) "
1. Gossec L, Smolen JS, Ramiro S, de Wit M, Cutolo M, Dougados M, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2016;75(3):499-510.

2. Coates LC, Moverley AR, McParland L, Brown S, Navarro-Coy N, O’Dwyer JL, et al. Effect of tight control of inflammation in early psoriatic arthritis (TICOPA): a UK multicentre, open-label, randomised controlled trial. Lancet. 2015;386(10012):2489-98.

3. Smolen JS, Braun J, Dougados M, Emery P, Fitzgerald O, Helliwell P, et al. Treating spondyloarthritis, including ankylosing spondylitis and psoriatic arthritis, to target: recommendations of an international task force. Ann Rheum Dis. 2014;73(1):6-16.

4. Coates LC, Fransen J, Helliwell PS. Defining minimal disease activity in psoriatic arthritis: a proposed objective target for treatment. Ann Rheum Dis. 2010;69(1):48-53.

5. Coates LC, Schentag C, Lee K, Chandran V, Cook RJ, Gladman DD. Achieving minimal disease activity criteria decreases progression of joint damage in psoriatic arthritis. Ann Rheum Dis. 2009;68 (3):137 (abstract).

6. Coates LC, Schentag CT, Lee K, Chandran V, Cook RJ, Gladman DD. Frequency and predictors of minimal disease activity in an observational psoriatic arthritis cohort. Ann Rheum Dis. 2009;68 (3):137 (abstract).

7. Kavanaugh A, van der Heijde D, Beutler A, Gladman D, Mease P, Krueger GG, et al. Radiographic Progression of Patients With Psoriatic Arthritis Who Achieve Minimal Disease Activity in Response to Golimumab Therapy: Results Through 5 Years of a Randomized, Placebo-Controlled Study. Arthritis Care Res (Hoboken). 2016;68(2):267-74.

8. Nell-Duxneuner VP, Stamm TA, Machold KP, Pflugbeil S, Aletaha D, Smolen JS. Evaluation of the appropriateness of composite disease activity measures for assessment of psoriatic arthritis. Ann Rheum Dis. 2010;69(3):546-9.

9. Schoels M, Aletaha D, Funovits J, Kavanaugh A, Baker D, Smolen JS. Application of the DAREA/DAPSA score for assessment of disease activity in psoriatic arthritis. Ann Rheum Dis. 2010;69(8):1441-7.

10. Schoels MM, Aletaha D, Alasti F, Smolen JS. Disease activity in psoriatic arthritis (PsA): defining remission and treatment success using the DAPSA score. Ann Rheum Dis. 2016;75(5):811-8.

11. Coates LC, Helliwell PS. Defining Low Disease Activity States in Psoriatic Arthritis using Novel Composite Disease Instruments. J Rheumatol. 2016;43(2):371-5.

12. Schoels MM, Braun J, Dougados M, Emery P, Fitzgerald O, Kavanaugh A, et al. Treating axial and peripheral spondyloarthritis, including psoriatic arthritis, to target: results of a systematic literature search to support an international treat-to-target recommendation in spondyloarthritis. Ann Rheum Dis. 2014;73(1):238-42.
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