GRAPPA Guidelines for PsA: Considerations

1. GRAPPA Guidelines for PsA: Considerations GRAPPA 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” Institute of Medicine • More data needed on prognostic factors (e.g.for peripheral arthritis, oligoarticular vs polyarticular; erosive vs non-erosive, +/- other features such as axial, skin, entheses, etc) to optimize stratification • PsA multifaceted: How appropriate is extrapolation of efficacy/safety data, and hence treatment guidelines, from similar conditions (psoriasis, AS, RA, etc)? Can we borrow aspects of screening, stratification, monitoring? • Guideline exigency driven by introduction of novel immunomodulatory therapies, and their expense; with sensitivity to local factors, cultural differences, economics, etc • Systematic review of available evidence has been performed and published; J Rheumatol July 2006

2. 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

3. How to Use a Clinical Practice Guideline.Hayward et al (evidenced based working group). JAMA 1995;274:570-4 & 1630-2. • Are the results of the study valid? • - Were all important options and outcomes clearly specified? • - Was an explicit and sensible process used to identify, select and combine the evidence? To consider the value of different outcomes? • - Is the guideline likely to account for important recent developments? • - Has the guideline been subject to peer review and testing? • What were the results? • - Are practical, clinically important recommendations made? • - How strong are the recommendations? • - What is the impact of uncertainty associated with the evidence and the values used in the guidelines? • III. Will the results help me in caring for my patients? • - Is the primary objective consistent with your objective • - Are the recommendations applicable to your patients? See also …Shiffman et al; Ann Intern Med 2003; 139:493

4. 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

5. Attributes of Systematically Developed Guidelines • Validity: How closely is the guideline linked to the available evidence? • Reliability: Would a different group of developers derive similar guidelines with the same evidence? • Reproducibility: Would different care-givers interpret and apply the guidelines similarly in similar contexts • Clarity: Are the guidelines unambiguous and precise? • Documentation: Is the method of development transparent and clearly stated? • Multidisciplinary: Did the developers represent more than one clinical orientation towards the clinical problems being addressed?

6. PsA Treatment Guidelines Proposal Committees Peripheral arthritis SystematicReviews Guideline development and consensus by committees and patients Skin & Nails Vote by GRAPPA Axial Dx Dactylitis Enthesitis

7. Committees • Peripheral Arthritis • E Soriano, N Mchugh, P Mease, F Behrens, M Lebwohl • Skin & Nails • H Boehneke, A Gottlieb, B Strober. D Fiorentino • Axial • P Nash. J Zochling, D Gladman • Dactylitis • P Helliwell, P Healy • Enthesitis • K de Vlam. A Adebadjo

8. Treatment Guideline Model Peripheral arthritis (# joints, pain, function, location, damage, etc) + skin and/or nails (severity. location, QOL) + axial disease (pain, function, QOL) + dactylitis (pain, location, function) + enthesitis (pain, location, function)

9. Peripheral Arthritis Skin Enthesitis Dactylitis Spine Mild ·1-3 tender and/or swollen joints ·No erosive disease on plain film ·Function not significantly impaired <3% BSA None None ·No sign or symptoms of spinal inflammation ·Normal Schoeber score and normal AP pelvis form Moderate ·5+ tender/swollen joints ·Normal x-rays but Oligoarticularor polyarticular disease that interferes w/ normal function ·Or less than 5 T/S joints but with erosions or JSN on x-ray >3% And <10% BSA 1-3 entheseal sites inflamed 1-3 inflamed digits Inflammatory back pain with a normal AP pelvis film Severe ·>5 tender /swollen joints w/ evidence of joint damage on exam ·Arthritis mutilans ·Oligo-or polyarticular disease that limits ADLs >10% BSA ·>3 sites ·Entheseal involvement in foot that prevents ambulation ·Tendon rupture ·>3 inflamed digits ·Evidence of ankylosis in a dactylitic joint Symptomatic inflammatory back pain with radiographic changes on plain film