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Of 13 the Axial Spa Public Comment Was Posted on the ACR Website The Axial SpA Public Comment was posted on the ACR website Monday, May 13, 2013. The announcement was emailed to ACR membership on Tuesday, May 14. As of June 4, 24 responses were received. The public comment period closed on the morning of Tuesday, June 4. 1. Tracy Brenner, Clinical Staff Rheumatologist Indiana University Health Physicians/ Dept. Rheumatology Nothing to disclose Comment: Thank you for your email regarding the development of recommendation for the management of axial spondyloarthritis, including ankylosing spondylitis, and children with the enthesitis‐related arthritis form of juvenile idiopathic arthritis. I am both a practicing rheumatologist as well as a mother with a 10 year old son with Crohn's related spondyloarthropathy (diagnosed at 7 years old). As a physician and mother, I think two important issues to cover are the following: 1. Prognosis for children diagnosed with enthesitis‐related arthritis and/or IBD related spondyloarthropathy. The general risk factors are clear including concern for overall morbidity and mortality but it would be helpful to have more statistics regarding these issues (e.g. CVD, long term use of methotrexate, long term use of biologics with initiation of therapy in the pediatric years, etc). I realize some of this is available, certainly, but continued observance is warranted. 2. Question of risk vs. benefit regarding use of Remicade with young male patients (documented ages were 12‐early 20's) with Crohn's related SPA as this group seems to represent a rare, but unfortunate correlation to the largely fatal hepatosplenic T cell lymphoma. I have asked the pharmaceutical company for the numbers of male juvenile patients treated with Remicade but they stated those numbers are not available. Thank you for your consideration. I truly appreciate your time and effort in this endeavor. If there is any way I can help please let me know. 2. Lisa Suter, Assistant Professor Yale School of Medicine Disclosure: I am a member of the ACR Quality Measurement Subcommittee Comment: I have reviewed the proposed plan for developing management guidelines for the spondyloarthropathies and agree with the proposed approach. Publication bias is a significant concern in this kind of analysis. I recommend the work group consider the following approaches to addressing publication bias in their project: 1. Use rigorous methods to identify preliminary and unpublished data through contact with experts and study authors; 2. Create funnel plots (of effect estimates versus sample size) and use Egger’s test to assess the asymmetry within the funnel plots (eg, if significant asymmetry is identified, suggesting publication bias, one could use the “trim and fill” approach to estimate upper and lower boundaries around the summary estimate to account for the potential publication bias); 3. Estimate the number of null studies needed to alter the study findings; 4. Cross‐reference the published and available literature against funded clinical trials registered at www.ClinicalTrials.gov in order to partially assess funded trials that have not been published (as negative studies are more likely to never be published). Page 1 of 13 3. Eric Matteson, Consultant Mayo Clinic Nothing to disclose Comment: Looks like an excellent plan. One further question to consider is whether it is worthwhile to screen/evaluate patients with AS for the lung disease that some develop. 4. Brandt Groh, Pediatric Rheumatology Division Chief Penn State Children's Hospital Nothing to disclose Comment: Regarding children presenting with enthesitis in advance of arthritis, I think it would be useful to know if there is enough literature/experience to support US examination as a diagnostic modality. This question is particularly relevant in teenage girls who walk the fine line between enthesitis versus fibromyalgia discomfort. 5. Robert Colbert, Senior Investigator NIAMS/NIH Nothing to disclose Comment: The inclusion of children with spondyloarthritis is important, but restricting the process to 'ERA' only is too limiting. The majority of children with spondyloartrhtis will fall into three ILAR categories: 1. ERA, 2. psoriatic arthritis, and 3. undifferentiated arthritis (ILAR categories) 6. Jinoos Yazdany (QOC member) UCSF Nothing to disclose Comment: The scope of the project is too broad. The precedent is for ACR projects of this nature to be much more narrowly focused to make the final product clear, and also for feasibility reasons. I see at least four or five separate guidelines in what the authors propose: treatment in adults (analogous to RA treatment recommendations); treatment in kids (analogous to JIA recommendations); measurement of disease activity in clinical practice (analogous to RADAM paper); treatment of co‐morbidities (analogous to projects such as GIOP recommendations).I am afraid the authors have proposed something that is far too ambitious and will have difficulty completing the scope of work with the resources available. My recommendation is to eliminate all of the topics except treatment recommendations in adult patients. 7. Robert Inman UHN Nothing to disclose Comment: I would suggest including health‐related QOL as a primary treatment target, and I would use the term spinal osteotomy (rather than thoracic kyphoplasty) in the outline. Page 2 of 13 8. Liana Fraenkel, Associate Professor of Medicine (QOC member) Yale University Nothing to disclose Comment: The authors have developed an extremely comprehensive plan to provide the membership with information for the management of axial spondyloarthritis. The scope of domains proposed, however, may be overly ambitious. Concerns are the: 1. Feasibility of examining 90 PICO questions. 2. Difficulty of leveraging relevant expertise for the breadth of domains described. 3. Inclusion of some items which may be less relevant to the practicing rheumatologist (example immediate post‐op care). 4. Likelihood of 90 PICO questions being translated into a practical/manageable set of recommendations. 9. Carol Oatis, Professor (QOC member) Arcadia University Nothing to disclose Comment: The proposed project is important and I am particularly enthusiastic about the focus on rehabilitation issues in the Axial SpA project. The authors have identified very important issues which would benefit from a synthesis of the evidence. That said, I have two concerns regarding the plan. I am very concerned by the number of overall topics proposed for the projects as well as the number of specific PICO questions. The topical areas and specific questions are all important. But I believe it is impossible to accomplish all of this in a timely manner. Timeliness is essential in guidelines. I believe it would be much better to focus on no more than two areas, perhaps pharmacology and rehabilitation and let the other areas wait for another project. My second area of concern is that despite a large focus on rehabilitation with its large number of PICO questions, there is only one rehabilitation expert (a PT) on the panel. While that individual is certainly well qualified to participate, I believe if you are focusing on rehabilitation you need at least three rehab experts with a minimum of two PT’s. 10. Frank Vasey, Rheumatologist Essential Health Nothing to disclose Comment: After a career studying these conditions, I think more attention should be paid to understanding the intracellular mishandling of bacteria. My own research argues psoriatic arthritis is reactive arthritis to streptococci. This work by RT‐PCR was recently confirmed and extended to staphylococci in psoriasis by Barbara Baker a London dermatologist. The 20 fold increase in the prevalence of psoriasis in inflammatory bowel disease argues gram positive bacteria possibly enterococci are critical to the clinical expression of IBD arthritis. This is supported by Balfour Sartor's IL‐10 deficient rat studies. When rats were raised germ free, no colitis, with enterococci and adhesive invasive E Coli, colitis occurs. These observations raise the question of the role of antibiotics in the treatment of spondyloarthritis, as shown by John Carter, in curing some patients with reactive arthritis to chlamydia with prolonged Azithromax. A paper from India claimed benefit for psoriatic arthritis patients in an open label study with q 3 weekly Page 3 of 13 bicillin IM. Group A streptococci remain 100% sensitive to penicillin. In view of the cost differential between TNF blockers and penicillin, this deserves study especially in patients with psoriatic arthritis and guttate psoriasis. 11. Mark Figgie, Professor (Axial SpA voting panel member) Hospital for Special Surgery Disclosure: ethicon‐ research grantmedtronic‐ honorariummekanika‐ stock Comment: Regarding surgical treatment: 1. Should we also consider other joints (i.e. knees) or just restrict this to total hips? 2. Is it better to use cemented or cementless devices in AS? 3. If radiation therapy is used to prevent heterotopic ossification, what dosage? Pre‐ or post‐op? 4. If hip replacement and spinal osteotomy are to be performed, which should be done first? 12. John Healey, Chief of Orthopaedic Surgery Memorial Sloan Kettering Cancer Center Disclosure: Trustee, Orthopaedic Research and Education Foundation Trustee, Musculoskeletal Transplant Foundation President, Musculoskeletal Tumor Society Board Member, past president Association of Bone and Joint Surgeons Associate Editor Clinical Orthopaedics and Related Research Member American Academy of Orthopaedic Surgeons: 1) Council on Research and Quality; 2)
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