COLORADO BONE & JOINT NEWSLETTER

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1 COLORADO BONE & JOINT NEWSLETTER A publication of Colorado Center for Arthritis & Osteoporosis, PLLC Copyright 2012 VOLUME 4, ISSUE 1 SPRING 2013 W. Edwards Deming, the father of systems thinking and the continuous improvement process, once said, The most important things can t be measured. Certainly this is true in medicine. The ability to show compassion, to effectively communicate with patients and even to accurately and efficiently reach a diagnosis defy quantification. Having acknowledged these limitations in assessing the quality of medical care, we at CCAO nevertheless strive to assess the important components of medical care that can be measured. It is only in this way that we can understand our current level of performance and thus continue to improve in our ability to provide quality and efficient medical care to our patients. As part of our continuous improvement process, one of our goals in 2012 was to implement a meaningful objective measure of quality in our provision of medical MEASURING QUALITY AT CCAO: RHEUMATOID ARTHRITIS by Jeffrey D. Perkins, MD PhD services. This past September, we set in place the first of a planned series of clinical performance measures. In this issue of the Quarterly, we are excited to share with our colleagues our baseline performance data. This performance measure focuses on the treatment of patients with rheumatoid arthritis, the most common autoimmune rheumatic disease. We based our criteria on those presented by the rheumatologists of Geisinger Clinic at the November 2011 ACR convention (ACR 2011, abstract 755). The six components of this measure are all evidence-based, and are directly related to the ability to improve function and prevent joint damage, or to safely use antirheumatic drugs. The original Geisinger model included 9 discrete components. We excluded three of these (related to influenza vaccine and lipid assessment and management), since these measures are more applicable to a multispecialty environment. In the Table, we present the baseline data on our RA quality measure, alongside the baseline data from Gesinger. The importance of DMARD treatment in RA is universally accepted. Ideally, every patient with active RA should be on one or more DMARDs. Our baseline data indicated 93% compliance with this goal for all RA patients and almost 99% compliance with Table Clinical Quality Measure for Rheumatoid Arthritis: CCAO vs. Geisinger Clinic CCAO Geisinger RA on DMARD 93% 85% Active RA on DMARD 99% 90% RA with CDAI measured 94% 61% RA with remission or low dz activity 77% 28% PD if on a biologic agent 94% 73% RA with Pneumococcal vaccine* 64% 54% *For CCAO data, assumes all RA patients on DMARD are appropriate candidates this goal for active RA patients. One key to assessing the efficacy of RA disease control is the use of a standardized, validated measure of disease activity. CDAI (clinical disease activity index) is such a validated measure. CDAI combines the results of a standardized 28- joint exam with both physician and patient global assessments to produce a composite measure. It can be calculated at the time of service and allows categorization of disease activity into remission or low, medium or high activity. Maintaining RA in remission or low disease activity has been strongly correlated with inhibition of joint damage and maintenance of function in multiple patient populations. We decided to use CDAI as our primary RA disease activity measure in 2010, and have been striving to measure a CDAI as part of routine care for all of our RA patients since then. In the 6 month period from March 9 to September , we documented disease activity with a CDAI on over 93% of our RA patients. Of the patients with RA in whom a CDAI was documented, over 77% were in remission or had low disease activity. Virtually all DMARDs are immunosuppressive to some degree. Evidence-based recommendations to improve the safety of DMARD treatment include checking a PPD on patients on most biologic DMARDs and providing pneumococcal vaccination to all patients on immunosuppressive DMARDs. Our baseline data Inside this issue: Ankylosing Spondylitis 2 Osteoporosis Screening Interval 3 Infection and Anti-TNF Drugs 4 About Us 5

2 Page 2 COLORADO BONE & JOINT QUARTERLY MEASURING QUALITY IN RA (Continued from page 1) reveal at 94% compliance with the PPD recommendation and at least a 64% compliance with the pneumococcal vaccine recommendation. As can be seen from the Table, our baseline data exceeds that of Geisninger Clinic in every component. It should be not- ed that the Geisinger Clinic has been held out as a national model of quality, efficient medical care by President Obama and other national leaders. While we are understandably proud of the results of our baseline analysis of quality management of RA, our main goal in implementing this measure was to help us in further improving our care. Dr. Joe Lutt will be spearheading our improvement efforts in the management of our RA population in He will also be leading our efforts to develop clinical quality measures relating to other common diseases and management situations. As we proceed with implementation of our clinical quality program, we will keep you apprised of our progress. ANKYLOSING SPONDYLITIS: PREVENTING SPINAL FUSION by Jill Gibson, MD When ankylosing spondylitis (AS) affects the axial skeleton, it manifests in two major ways. First, the inflammation that occurs leads to significant axial pain and stiffness, as well as to systemic effects such as fatigue and anemia. These inflammatory effects usually occur early in the course of disease, years prior to overt radiographic effects. Second, over the course of years to decades, a subset of AS patients can develop syndesmophyte formation, ultimately leading to irreversible fusion of part or all of the spine. The inflammatory and fusion aspects of this...studies to date fail to show that anti-tnf agents slow progression of spinal fusion in AS. disease are not closely coupled, and both contribute independently to decreased function and quality of life. Nonsteroidal anti-inflammatory drugs (NSAIDs) have been the mainstay of AS therapy for many decades. Until very recently, these drugs were thought to only improve inflammatory symptoms, without any effect on the process of spinal fusion. Anti-TNF medications have been an important addition to the treatment of AS. These biologic drugs have been shown to decrease pain, stiffness and inflammation associated with AS, often dramatically. Their ability to alleviate symptoms caused by inflammation is typically much more potent than that of NSAIDs. Thus, there has been a shift in the last decade away from long-term NSAID use and toward anti-tnf therapy in AS. However, while anti-tnf drugs have been shown to have potent diseasemodifying effects in rheumatoid arthritis (RA), studies to date fail to show that anti-tnf agents slow progression of spinal fusion in AS. Whether this is due to true lack of disease-modifying effects in AS, or to a long lag time between initiation of TNF blocking therapy and radiographic demonstration of a diseasemodifying effect is still debated. However, even if there is an effect on spinal fusion in the long-term, the lack of a disease-modifying effect in the early years of therapy has been disappointing. This has led to a re-examination of the possible long-term role of NSAIDs in AS treatment....accumulating evidence has pointed to an ability of NSAIDs to interfere with the process of spinal fusion. In recent years, despite their reputation as symptom only medications, accumulating evidence has pointed to an ability of NSAIDs to interfere with the process of spinal fusion. This is in marked contrast to their use in RA, where it is clear that these drugs have no significant protective effect in the realm of joint damage or deformity. In a study by Wanders et al in 2005, the authors showed small differences in radiographic progression between those patients taking continuous NSAIDs versus on-demand NSAIDs. The findings of this study have now been confirmed in two studies published this year. Kroon et al found that in patients with elevated markers of inflammation (ESR and CRP), the use of continuous NSAIDs was associated with a reduced rate of radiographic progression over a two year period. This was not seen in patients with normal markers of inflammation, nor was there any impact for patients with elevated disease activity index scores.

3 Page 3 VOLUME II, ISSUE 1 SPINAL FUSION IN ANKYLOSING SPONDYLITIS (Continued from page 2) Similar findings were published by Poddubnny et al in another two year study. This study also found reduced radiographic progression in patients with an elevated CRP taking continuous NSAIDS over on-demand NSAIDs. In addition they found similar results in patients with baseline syndesmophytes, a strong risk factor for radiographic progression over time. There was no benefit in patients with non-radiographic axial spondyloarthropathy. In light of this recent evidence, we are starting to reconsider whether long-term NSAIDs should be a part of AS therapy, even if inflammatory symptoms are wellcontrolled with anti-tnf agents. Such a role for chronic NSAIDs will need to be weighed against the patient s baseline risk of spinal fusion and the possible gastroin- testinal, renal and cardiovascular effects of long-term NSAID therapy. It is unclear why NSAIDs may affect the radiographic progression of AS when anti- TNF medications do not appear to do so. Genome-wide association studies have found a genetic association between AS and a prostaglandin receptor. Since NSAIDs are known to reduce prostaglandin synthesis, this genetic association may be the beginnings of an explanation for why this class of drugs appear to block spinal fusion. Further investigation will be needed to fully understand the mechanism of this NSAID effect, and to understand which groups of patients may most benefit from this effect. References Haroon N, Kim T, Inman R. NSAID and radiographic progression in ankylosing spondylitis: Bagging big game with small arms? Ann Rheum Dis 2012; 71: Kroon F, Landewe R, Dougados M, Van Der Heijde D. Continuous NSAID use reverts the effects of inflammation on radiographic progression in patients with ankylosing spondylitis. Ann Rheum Dis 2012; 71: Poddubnny D, Rudwaleit M, Haibel H, et al. Effect of non-steroidal antiinflammatory drugs on radiographic spinal progression in patients with axial sponyloarthritis: results from the German Spondyloarthritis Inception Cohort. Ann Rheum Dis 2012; 71: BONE DENSITY SCREENING INTERVAL FOR POST-MENOPAUSAL WOMEN by Jeffrey D. Perkins, MD PhD Current guidelines for screening for osteoporosis have for some time recommended bone mineral density (BMD) testing with dual-energy xray absorptiometry (DXA) scans for women over the age of 65. However, there is no recommendation for the frequency of DXA scans. The US Preventive Services Task Force stated in 2001: Because of limitations in the precision of testing, a minimum of 2 years may be needed to reliably measure a change in BMD; however, longer intervals may be necessary to improve fracture risk prediction. While this statement provides a minimum interval based on inherent limitations of DXA technology, it does not comment on the clinically appropriate interval. In absence of specific guidelines, a common practice in many communities has developed of rescreening postmenopausal women every two years. A recent published study has called this common practice into question. A large prospective study by Gourlay, M, et al. was published in the New England Journal of Medicine in January and attempts to addresses the issue of repeat DXA screening interval in postmenopausal women. This study included 4957 women, 67 years of age or older, with normal BMD (T-score femoral neck and A recent published study has called [the common practice of rescreening postmenopausal women with repeat DXA scans every 2 years] into question. total hip or higher) or osteopenia (T-score, to -2.49). This was a US based study and 99% of study participants were white. The primary outcome measure was the estimated intervals for 10% of participants to make the transition from normal BMD or osteopenia to osteoporosis, without clinically-apparent fracture occurring and before initiation of treatment for osteoporosis. The investigators adjusted the data for several risk factors for osteoporosis, including BMI, age, estrogen use, previous fracture, smoking, previous use of glucocorticoids and RA. The results of this study are summarized in the Table (see following page). For women with normal BMD (T-score -1.0), the adjusted estimated time for 10% to progress to osteoporosis was 16.8 years. This time was similar for women with mild osteopenia (Tscore to -1.49), at 17.3 years. On the other hand, the estimated time for 10% of women with moderate osteopenia (T-score -1.5 to ) to progress to osteoporosis was 4.7 years. Finally, the 10% progression time was 1.1 years for women with advanced osteopenia (Tscore -2.0 to -2.49) was 1.1 years. The covariates that seemed to influence the results were age, estrogen use and BMI. The time for transition from osteopenia to osteoporosis was longer with younger age, higher BMI and prior estrogen use.

4 Page 4 COLORADO BONE & JOINT QUARTERLY SCREENING INTERVAL FOR POST-MENOPAUSAL OSTEOPOROSIS Table. Interval Between Baseline Testing and the Development of Osteoporosis in 10% of Study Participants, According to the Result of Baseline Testing [from NEJM 366: ] Results of Baseline Test Interval Between Baseline Testing and Development of Osteoporosis (years) Unadjusted Adjusted Normal BMD 17.4 ( ) 16.8 ( ) Mild Osteopenia 16.5 ( ) 17.3 ( ) Moderate Osteopenia 4.6 ( ) 4.7 ( ) Advanced Osteopenia 1.0 ( ) 1.1 ( ) There were several limitations to this study. It did not take into account the risk of fracture predicted by the multivariate FRAX model a procedure that has come into common use recently and is currently recommended by the National Osteoporosis Foundation when determining which patients with osteopenia should be treated. However, it did adjust for some of the variables that are included in a FRAX score. Also, the relatively homogeneous population in this study limits the ability to generalize these findings to other populations. Despite these limitations, the study included a large cohort of women followed over a long period of time, and the results provide us with some important data to consider when deciding when to rescreen women whose initial DXA does not show osteoporosis. (Continued from page 3) The factors that were not significant were any fracture after 50 years of age, current smoking, use of glucocorticoids and history of rheumatoid arthritis. The results of this study are interesting and may help clinicians to determine an appropriate rescreening interval. The common practice of screening all postmenopausal women every 2 years with repeat DXA regardless of their T-score and risk factors for osteoporosis may be unnecessary. For women with normal BMD or mild osteopenia and without other risk factors for osteoporosis, a significantly longer rescreening interval seems appropriate. On the other hand, for women who fall into the category of advanced osteopenia, BMD screening every 2 years seems more appropriate as these women may transition to osteoporosis within that time frame. References Screening for osteoporosis: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med 2011; 154: Gourlay, M, et al. Bone-Density Testing Interval and Transition to Osteoporosis in Older Women. N Engl J Med 2012; 366: The benefit of the biologic medications, such as the TNF inhibitors, for rheumatoid arthritis (RA) is well established. In early RA, nearly half of patients can achieve a state of clinical remission after starting an anti-tnf agent, and all studies have revealed a significant slowing of radiographic damage, which is strongly associated with future disability. The inflammatory bowel disease THE RISK FOR HOSPITALIZATION FOR INFECTION AFTER STARTING TNF ANTAGONISTS by Joseph R. Lutt, MD (IBD), psoriasis, and spondyloarthritis (SpA) populations have also shown amazing results with these agents. There continues to be concerns and questions regarding the short- and long-term safety of these potent medications, however. A study reported in JAMA fairly recently addressed one of these issues: the risk of serious infections. This was a retrospective cohort study utilizing multiple US databases, including Medicaid, Medicare, and Kaiser Permanente. Patients with RA, IBD, and psoriasis/spa who were receiving their first prescription for an anti-tnf agent were followed for up to 1 year to determine the probability of hospitalization for serious infections. The comparator group included patients taking nonbiologic regimens, such as methotrexate, sulfasalazine, hydroxycholorquine, leflunomide, and azathioprine. More than 10,000 RA, 2,323 IBD, and 3,215 psoriasis/spa patients were identified. About 20% of the patients were 65 years old or older. Of the 1172 serious (Continued on page 5)

5 Page 5 VOLUME II, ISSUE 1 Exposures RA IBD Table. Risk of Serious Infection [from JAMA 306: ] Adjusted Hazard Ratios (95% CI) Anti-TNF 1.05 ( ) No prednisone 1 (reference) >0-<5 mg/d 1.32 ( ) 5-10 mg/d 1.78 ( ) >10 mg/d 2.95 ( ) Anti-TNF 1.10 ( ) No prednisone 1 (reference) >0-<5 mg/d 1.09 ( ) 5-10 mg/d 0.93 ( ) >10 mg/d 1.38 ( ) Psoriasis/SpA Anti-TNF 1.06 ( ) No prednisone 1 (reference) >0-<5 mg/d 1.15 ( ) 5-10 mg/d 2.01 ( ) >10 mg/d 2.77 ( ) (Continued from page 4) infections identified, 53% were related to skin and soft tissue infections and pneumonia....the anti-tnf groups were not at greater risk for serious infection. Prednisone was the only variable that was associated with a greater probability of serious infection. Somewhat surprisingly, after adjusting for multiple variables (age, gender, disease activity/systemic inflammation, comorbidities, etc.) the anti-tnf groups were not at greater risk for serious infections. Prednisone was the only variable that was associated with a greater probability of serious infection. Even daily doses of less than 5mg increased the risk significantly in the RA population (see table). Additionally, infliximab (Remicade) had greater rates of serious infection than etanercept (Enbrel) and adalimumab (Humira). While multiple randomized, controlled trials have shown an increased rate of serious infections with the anti-tnf agents, this retrospective study of thousands of real world patients is certainly reassuring that, at most, this increase is probably small. The treatment of patients with inflammatory autoimmune diseases is individualized, and we have all seen patients for whom the chronic use of prednisone is the least bad option. The potential side effects of prednisone, especially at high doses, are well known and are one of the primary reasons rheumatologists are willing to recommend starting potentially toxic and expensive biologic agents. This study highlights the significant effect of even low-dose prednisone on the risk of infection and is a good reminder of the vigilance that is necessary when caring for these patients. Reference Grijalva, CG, et al. Initiation of TNF Antagonists and the Risk of Hospitalization for Infection in Patients With Autoimmune Diseases. JAMA. 2011;306: ABOUT US Colorado Center for Arthritis and Osteoporosis has provided expert, compassionate care for patients with arthritis, autoimmune connective tissue disease and osteoporosis since 1998 to the residents of Boulder County, with offices in Boulder and Longmont. In 2009, we undertook a significant expansion in order to improve access to rheumatology and metabolic bone services for residents of the northern and western Denver metropolitan area. We are now seeing patients in our Broomfield location near the intersection of Wadsworth/287 and US-36, as well as in our new Wheat Ridge location on the Lutheran Hospital campus. Drs. Jeff Perkins, Joe Lutt, Theresa Tran, Shiraz Moinuddin and Jill Gibson are all Board Certified in internal medicine and rheumatology. They offer a full range of rheumatology and bone health services. Services offered by CCAO include consultation and disease management services in the areas of rheumatology and metabolic bone disease, and infusion centers at all of our locations. In addition, we offer bone densitometry (DXA) at our Longmont location. We strive to serve our patients and referring physicians by providing prompt and convenient access to our services. Patients can generally be seen for an initial consultation in 1 to 2 weeks and urgent cases can be accommodated in 1 to 2 business days. Our physicians are readily available by phone to give advice to our colleagues in the areas of rheumatology and metabolic bone disease. P l e a s e v i s i t u s o n l i n e a t or us at office@ccao.net. We d love to hear from you!

6 WELCOME DR. CHAUDHARY! This summer, CCAO will be significantly expanding its Wheat Ridge and Broomfield offices. We are excited to welcome Prateek Chaudhary, DO! Dr. Prateek Chaudhary received his medical and public health degrees from University of North Texas Health Science Center at Fort W o r t h. H e completed his internal medicine residency at The University of Texas Medical School in Houston and his rheumatology fellowship at Duke University Medical Center in Durham, NC. He is board certified in internal medicine and board eligible in rheumatology. He will be joining CCAO in August and will see patients in our Wheat Ridge and Broomfield offices. CCAO Offices Longmont 1551 Professional Lane Suite 235 Longmont, CO Boulder th Street Suite 201 Boulder, CO Broomfield 2095 W. 6th Ave. Suite 106 Broomfield, CO Wheat Ridge 3555 Lutheran Pkwy. Suite 360 Wheat Ridge, CO Estes Park Estes Park Medical Center Specialty Clinic Phone: (720) Toll free: (877) Fax: (720) office@ccao.net Web: C O L O R A D O C E N T E R F O R A R T H R I T I S & O S T E O P O R O S I S, P L L C 1551 Professional Lane Suite 235 Longmont, CO RETURN SERVICE REQUESTED PRE-SORT STD US POSTAGE PAID PERMIT NO. 418 LONGMONT, CO «AddressBlock»