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Guidelines Mission Statement

GRAPPA PsA Treatment Guidelines. Guidelines Mission Statement. “To develop guidelines, based upon the best scientific evidence, for the optimal treatment of patients with psoriatic arthritis (PsA).”

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Guidelines Mission Statement

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  1. GRAPPA PsA Treatment Guidelines Guidelines Mission Statement “To develop guidelines, based upon the best scientific evidence, for the optimal treatment of patients with psoriatic arthritis (PsA).” Guidelines: “Systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances” IOM

  2. GRAPPA PsA Treatment Guidelines Considerations Relevant to Guideline Creation in PsA • PsA may follow heterogeneous, variable clinical course • More research needed on important prognostic factors (e.g. oligo vs poly) to allow optimal stratification • PsA multifaceted (axial/periph joints, skin, etc): Work is progressing on classification criteria (CASPAR) • How appropriate is extrapolation of efficacy/safety data from similar conditions (psoriasis, AS, RA, etc)? • Determine most appropriate outcome measures (signs/symptoms, structural integrity, QOL/functional status) • Guideline exigency driven by introduction of novel immunomodulatory therapies

  3. GRAPPA PsA Treatment Guidelines If Guidelines Are Based on Best Available Evidence, How Do We Handle: • When “state of the art” outstrips peer-reviewed published medical literature? • That quality of newer studies is superior to older studies? • The variable diagnostic criteria / outcomes in trials? • The absence of studies for certain accepted therapies (e.g. steroids)? • The absence of head-to-head trials? • Aphorism: “The absence of evidence of an effect is not equivalent to evidence of absence of an effect” When there is no data, what is the role of “expert” opinion?

  4. GRAPPA PsA Treatment Guidelines Methods • Determine areas of interest for obtaining data (axial disease, peripheral arthritis, skin, enthesitis, dactylitis) • Formulate questions for the systematic review; for the different manifestations (and based on disease characteristics…) • What is the effect of a given therapy on clinical manifestations (including signs/symptoms, QOL/Fx, structural integrity)? What is the effect size • What is the effect of a given therapy as regards safety? What is the effect size? • Systematic literature review; excerpting data • Identify key areas for research (i.e. lacking data) • Re-assemble into unifying guideline

  5. Peripheral Arthritis Axial Disease Dactylitis Enthesitis Initiate Therapy NSAIDs, IA steroids, DMARDs (MTX, CsA, SSZ, LEF), Biologics (anti-TNF) Initiate Therapy NSAID PT Biologics (anti-TNF) Initiate Therapy NSAID Injection Biologics (anti-TNF) Initiate Therapy NSAID Injection Biologics (anti-TNF) GRAPPA PsA Treatment GuidelinesEstablish Diagnosis of Psoriatic Arthritis Skin and Nail Disease Initiate Therapy Topicals PUVA/UVB DMARDs (MTX,CsA,etc) Biologics (anti-TNF, etc) Reassess Response to Therapy and Toxicity

  6. GRAPPA PsA Treatment Guidelines Methods After considerations of relevant characteristics of PsA, the best available evidence is collected, graded and utilized to formulate recommendations. An important task is the identification of areas lacking sufficient data to support recommendations. In an attempt to produce guidelines of the highest quality, as guidelines are developed, we will adhere to the Conference on Guideline Standardization recommendations.1 1Shiffman et al; Ann Intern Med 2003; 139:493

  7. GRAPPA PsA Treatment Guidelines MethodsPrinciples of Systemic Review of Published Medical Literature • Review addresses a focused clinical question • Literature search strategy is explicit and reproducible • Literature review is comprehensive • Criteria for selection of articles for review are described • Criteria for selection of patients/patient groups w/in each article for analysis are described • Criteria for outcome assessments of patients/patient groups are defined • Articles and patients are assessed by multiple reviewers using a standard form; differences of interpretation resolved by consensus • Assembled data are quantitatively assessed1 1 Ann Intern Med 1997; 126: 376-80

  8. GRAPPA PsA Treatment Guidelines GRAPPA is using a systematic review of the literature, including languages other than English, using established principles for such reviews.1 Retrieved articles are graded according to the categories of evidence suggested by the Agency for Health Care Policy Research (AHCPR). Categories Include: 1A Evidence from meta-analysis of randomized controlled trials (RCT) 1B Evidence from one or more RCTs 2A Evidence from 1 or more controlled trials (without randomization) 2B Evidence obtained through other well-designed studies (quasi-experimental) 3 Evidence from non-experimental studies (e.g. comparative, correlation or case-control) 4 Expert committee opinions, clinical experience 1 Cook et al; Ann Intern Med 1997: 126:376

  9. GRAPPA PsA Treatment Guidelines When the best evidence is extracted from published literature, recommendations are graded accordingly: Grade A: Based on category 1 evidence Grade B: Category 2 evidence Grade C: Category 3 evidence Grade D: Category 4 evidence

  10. GRAPPA PsA Treatment Guidelines Effect Size x1-xc = d spooled d = Cohen’s d effect size x = Mean (average of treatment or comparison conditions) s = Standard deviation

  11. GRAPPA PsA Treatment Guidelines Reporting Clinical Practice Guidelines(Conference on Guideline Standardization COGs) Overview material Method for Synthesizing Evidence Focus Prerelease Review Goal Update Plan Users/Setting Definitions Target Populations Recommendations, Rationale Developer Potential Benefits, Harms Funding Source/Sponsor Algorithm Evidence Collection Implementation Considerations Recommended Grading Criteria

  12. GRAPPA PsA Treatment Guidelines

  13. GRAPPA PsA Treatment Guidelines Evidence Presentations • Peripheral Arthritis– Enrique Soriano • Axial Involvement – Peter Nash • Skin – Souyma Reddy • Enthesitis – Chris Ritchlin • Dactylitis – Philip Helliwell Questions – Discussion and Voting

  14. Peripheral Arthritis Axial Disease Dactylitis Enthesitis Initiate Therapy NSAIDs, IA steroids, DMARDs (MTX, CsA, SSZ, LEF), Biologics (anti-TNF) Initiate Therapy NSAID PT Biologics (anti-TNF) Initiate Therapy NSAID Injection Biologics (anti-TNF) Initiate Therapy NSAID Injection Biologics (anti-TNF) GRAPPA PsA Treatment GuidelinesEstablish Diagnosis of Psoriatic Arthritis Skin and Nail Disease Initiate Therapy Topicals PUVA/UVB DMARDs (MTX,CsA,etc) Biologics (anti-TNF, etc) Reassess Response to Therapy and Toxicity

  15. GRAPPA PsA Treatment Guidelines Combining the evidence into Guidelines: Values / Process • Cost / Availability • Patient Preference • Political Combining: Decision analyses etc.

  16. Evidence based? treatment algorithm for Peripheral PsA Polyarthritis Oligoarthritis Monoarthritis ? Early DMARDs SSZ (A); LFN (A); MTX (B), CyA (B) NSAIDs (A) +/- IA corticosteroids (D) Adequate therapeutic trial of 2 DMARDs ? ? Respond Anti TNF alpha Positive Response Failed Response

  17. 1. Will GRAPPA guidelines be focused on reimbursement or treatment?

  18. 2. Can we “borrow” evidence from AS (or other diseases, such as RA, Osteo or Psoriasis) when there is anabsence of data in PsA? (what do we do when there is no direct evidence from PsA? Look at RCTs in RA/AS; look at eminence rather than evidence data? Is level A evidence from other diseases more relevant than expert opinion in PsA when there is no data for PsA?)

  19. 3. Do we only count skin data from PsA clinical trials or can we include assessment from psoriasis trials?

  20. 4. Given that PsA trials tend to be few in number, is it appropriate to borrow safety databases from other diseases to help assess safety of these compounds, including effect size?

  21. 5. What influence, if any, should the presence or severity of bone and/or cartilage damage as evidenced on X-ray have concerning therapeutic choices?

  22. 6. Should treatment guidelines be separate for polyarticular vs. olioarticular? What if only 1 or 2 joints are involved but the involvement is severe (i.e., extensive osteolysis or ankylosis)? What about patients who have SAPHO?

  23. 7. What measures should we use to assess Rx response (PsARC, modified ACR, DAS28, or other measures)? What data should be collected and what outcome measures should be used in the clinic and in clinical trials?

  24. 8. What are the holes in our evidence that prevents us from addressing issues of guidelines appropriately?

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