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” IOM 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: To start, we can begin with a base case of a patient with peripheral arthritis 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? Determine most appropriate outcome measures (signs/symptoms, structural integrity, QOL/functional status) Guideline exigency driven by introduction of novel immunomodulatory therapies, and their expense; with sensitivity to local factors, cultural differences, economics, etc

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? Absence of studies for certain 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” (e.g. MTX When there is no data, what is the role of “expert” opinion? How can treatment approaches to divergent aspects of PsA (skin, joints, enthesitis, dactylitis, spondylitis) with various levels of activity) be optimally synthesized? GRAPPA PsA Treatment Guidelines

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

How to Use a Clinical Practice Guideline. Hayward et al (evidenced based working group). JAMA 1995;274:570-4 & I.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? II.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

Peripheral ArthritisSki n EnthesitisDactylitisSpine 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 Moderat e  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  Evidenc e of ankylosis in a dactylitic joint Symptomatic inflammatory back pain with radiographic changes on plain film

Choices of Therapies: Considerations Medical –disease activity (“mild-moderate-severe”) –disease severity / prognosis –treatment options risk / benefit QOL Patient Preferences (how to value?) Contextual –social / cultural –financial