Optimizing Clinical Outcomes in Rheumatoid Arthritis: Strategies for Improving Adherence. Reactions From the Patient Perspective—A Discussion With Advocate, Kelly Young ^a,b

by Christina J. Ansted, MPH, CCMEP

a. Creator and Writer, Rheumatoid Arthritis Warrior (.com) Website; President and Founder, Rheumatoid Patient Foundation; Consultant, RA Patient Insight, LLC

b. Correspondence to Ms. Young can be directed to kelly@rawarrior.com or relayed via Twitter handle @rawarrior

Introduction

On November 16, 2011, CME Outfitters broadcasted a live and on-demand CME activity entitled Optimizing Clinical Outcomes in Rheumatoid Arthritis: Strategies for Improving Adherence.¹ The goals of this activity were to:
• Educate clinicians on the most common causes of suboptimal treatment adherence
• Improve physician-patient communication about treatment
• Raise expertise in designing and implementing patient-concordant, multimodal treatment plans that support long-term adherence
• Teach strategies for integrating evidence-based objective measures into clinical practice.

Course directors predicted that achievement of these goals would improve treatment adherence and ultimately outcomes for patients with rheumatoid arthritis (RA).¹

In an effort to bridge the gap between physician and patient perspectives on the quality of care for patients with rheumatoid arthritis, CME Outfitters invited a well-respected patient advocate to view the broadcast, provide her input, and discuss insights she gleaned from living with RA herself for several years, as well as from her interaction with thousands of other patients, caregivers, and researchers. This article will attempt to summarize and highlight the most salient points of that discussion.

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Discussion of Activity by Learning Objective

Learning Objective #1

"Articulate the most common causes of low treatment adherence among patients with RA, and more effectively and proactively communicate with patients about the long-term risks of treatment nonadherence."¹

Faculty presenters in the activity clearly defined adherence (the extent to which a patient takes medications as prescribed by a provider²) in contrast to persistence or medication possession ratio (MPR). They then moved on to discuss that adherence rates in rheumatoid arthritis are suboptimal and that only one-third of RA patients reported that they never fail to take their medication, i.e., that only two-thirds of patients are therefore adherent to medication.³ Faculty members also discussed the various factors that can affect adherence (e.g., demographic, clinical, environmental, and psychological), and proceeded to talk about the various barriers to adherence, which included poor patient-provider communication and substandard patient and physician interactions within the health care system.¹

Kelly Young, creator of and writer at RA Warrior.com added, "Stopping medication due to adverse events is not the same as non-adherence. The issues related to adverse events should be considered independently because better 'provider-patient communication,' better 'insurance coverage,' 'simpler treatment regimens,' or 'improved job satisfaction' will not address adverse events." Ms. Young, while drawing attention to the 2009 van den Bemt study to assess adherence rates with self-report measures in a large random population and to identify potential risk factors for non-adherence,⁴ commented, "The results of this study support the position that it is improper to generalize about non-adherence in patients with RA instead of actually addressing individual treatment questions." Activity faculty members made reference to this concept in discussion related to how to empower patients in the management of both their disease and their medication regimen. "RA is a disease that we have to manage together with the patient," said Jennifer L. Barton, MD, Assistant Adjunct Professor of Medicine, Division of Rheumatology at the University of California, San Francisco in San Francisco, California. Allan Gibofsky, MD, JD, FACP, FCLM, Professor of Medicine and Public Health at the Weill Medical College of Cornell University and Attending Rheumatologist at the Hospital for Special Surgery in New York, New York, was moderator for the activity; he went on to say, "We [clinicians] have to move away from this concept of "physician paternalism," to "patient autonomy." And there [are] extensive data suggesting that autonomy works better than paternalism, in terms of outcomes." Martin J. Bergman, MD, FACR, FACP, concurs: "After I've made the diagnosis [of RA], very often I'll talk with the patient and have a family meeting, because the family has to know. It's [about] involving everybody, and bringing them into the room, and addressing their questions as well." van den Bemt and colleagues stated, "32% – 40% of patients did not adhere to their DMARD prescription [a number that correlates exactly with the percentage of patients whose cases are unresponsive to DMARDs]. As none of the possible risk factors was strongly related to adherence, no general risk factor seems to be powerful enough as a possible screening tool or target for adherence-improving interventions. This implies that nonadherence barriers should be assessed on an individual basis."⁴ Ms. Young confirms the point that non-adherence must be addressed on an individual basis because there is no general risk factor for it, and further explains, "It is more logical to assume that a large percentage of those patients [who do not adhere to treatment] did not find the treatment efficacious, which has obvious implications on adherence. Strategies to influence adherence with treatments that are non-efficacious will continue to be problematic." In addition, a 2011 study by van den Bemt concluded, "Making the rheumatologist aware of a patient's medication use and adherence did not change adherence or patients' beliefs about medication."⁵ This finding identifies the fact that effective support for adherence is needed for individual patients with RA.

Faculty members also discussed "unnecessarily high levels of disease activity" and "poor disease control" as long-term risks of treatment non-adherence.¹ Ms. Young added two additional issues. She said, "It is unclear what long-term risks could result from non-adherence [to] symptom-treating medications (e.g., NSAIDs, corticosteroids, or muscle relaxers). Patients are aware that these medications carry long-term risks of their own, as well as [possible] short-term side effects, but are not clear on the impact [of these medications] on disease progression." In addition, she said, "Disease treatments are only moderately effective in most patients [e.g., 20% reach ACR70; 17% reach no higher than ACR50; 29% reach no higher than ACR20; and 34% are non-responders].^6,7 The disease itself is heterogeneous, with half of patients experiencing a periodic, waxing and waning disease activity pattern, often referred to as 'flares.' This flaring pattern compounded by a 50% improvement level in 44% of patients with RA, results in a 'grey area' for efficacy; and efficacy is so important. It is extremely difficult to determine whether adherence to disease treatments necessarily improves long-term outcomes."

In regards to provider-patient communication, Ms. Young commented, "patients need to understand, 'What is the purpose of this treatment?' and 'Why do I take the medications I take?'" There is a significant difference between treatment of symptoms and treatment of the disease. Medications for symptoms and medications for disease treatment are separate topics that need to be addressed separately. She said, "Patients should have a different level of control with symptom medications than they do with treatment medications. And they have to be discussed in separate conversations. For example, NSAIDS treat the symptoms, not the disease. This is an important point that patients need to recognize." Similarly, "patients must be aware of the long-term side effects of treatment and be able to manage the 'risk portfolio' of not only their medications but [also] their disease." She says that there is a discrepancy between nonadherence because treatments have limited efficacy, and because patients are simply not taking their medications. "RA is complicated, and there are differences at so many levels. But, most important [to know] is that patients may likely stop taking medications because [they feel that, for them] the medications don't help." From the patient perspective this begs the question, "why would patients continue to take a medication with limited efficacy, and which may cause side effects?"

Learning Objective #2

"Devise an assessment plan that applies evidence-based models, strategies, and objective measures, and use these to routinely monitor and improve adherence to a therapeutic regimen in patients with RA."¹

In discussing effective disease management strategies, faculty members stressed the importance of measuring disease activity across time (i.e., with tight control), accelerating treatment for uncontrolled disease, and supporting adherence to treatment. These are strategies that they said "are not being done in traditional RA management."8-10 Faculty members also stated "there is no tool to measure adherence to treatment. However, one could argue that measuring disease activity is a de facto measure of adherence."1 Ms. Young comments, "Adherence is complicated in RA. Disease activity is not [exclusively] a measure of non-adherence, it [can be] evidence that the disease is not well controlled."

In stark contrast to the physician goal of achieving remission, Ms. Young is firmly of the opinion that "remission is rare." She reiterates that "only 20% of patients with RA reach 70% improvement, and the improvement is always temporary,^[11,12] and that only 44% of patients with RA even reach the 50% improvement level, while a full third of patients do not respond to medications at all (i.e., are 'non-responders')."^[6,7]

Tools to measure disease activity include the ACR 20/50/70 response criteria, which refers to a composite improvement of 20%/50%/70% in swollen joint count and tender joint count—where both joint counts are based on an assessment of 28 or more joints—as well as three or more of the following measures:

Other tools include the Modified Disease Activity Scores (DAS-28 ESR) that includes 28-joint counts; the Simplified Disease Activity Index (SDAI); the Clinical Disease Activity Index (CDAI); and patient-reported outcome (PRO) measures on a Multi-Dimensional Health Assessment Questionnaire (MDHAQ), which can be compiled into the Routine Assessment of Patient Index Data 3 (RAPID3) score, which includes the three PRO measures from the ACR Core Data Set: physical function, pain, and global estimate.

The expert faculty panel also underscored the point that treatment may need to be adjusted at 3 – 6 months,¹ Ms. Young commented, "That's the 'cutting edge,' and it's just not being done in average clinical practice." Ms. Young provided a startling, real-world example of the fact that patients are often kept on the same medication for a minimum of 6 months, and typically for up to 2 years. "In my personal experience, I was on the same biologic therapy for 2.5 years without being evaluated. And was told by my rheumatologist, 'you have a systemic disease. We can't x-ray your whole body.' I had to change rheumatologists before I could change my medication."

Ms. Young appreciated the emphasis on monitoring and measuring of disease activity and the use of PRO tools; she also stated clearly that neither is done with frequency in most patients with RA: "Treatment adjustments do not occur at the short intervals mentioned by the panelists (e.g., three months). Favored measures of disease activity [among rheumatologists] are acute-phase reactants and [a] 'gestalt' approach—doctors [rheumatologists] feel that they can get to the same point with gestalt that they can with measuring)—both of which are inadequate and may account for the discordance that has been repeatedly documented between patient and clinician assessment in RA." This point was corroborated in a study by Kahn and colleagues to assess the determinants of patients' and physicians' global assessments (PTGL and MDGL, respectively) of rheumatoid arthritis activity and factors associated with discordance among them. Study results showed that "nearly 36% of patients had discordance in RA activity assessment from [that of] their physicians."¹³ Investigators also highlighted the importance of "sensitivity to the 'disease experience' of patients, particularly pain and fatigue, as warranted for effective care of RA."¹³ Ms. Young says, "physicians are not usually asking patients about their disease activity. And the physician perception of disease activity is [therefore] much less than what the disease activity actually is because they are not measuring." Ms. Young uses the concept of a joint exam as an example: "There is no joint exam, no RAPID, and no HAQ. Physicians will glance at the top of the patient's hands, and maybe ask, 'How is your morning stiffness?' But, swelling is not only on the top of the hands, or the front of the knee. Visits are short and the focus is on prescriptions, an unfortunate necessity given physician time constraints."

Additionally, Ms. Young made the points that physicians are not monitoring for adherence, adding that "adherence is not a major focus for doctors," and that "physicians are also not looking at trends, e.g., liver profiles." However, she is not without hope. "If routine, appropriate monitoring were to occur, and treatment adjustments were successfully made, efficacy would likely be increased, which would improve adherence. Again, efficacy is central to adherence, more than pillboxes or manipulation of a patient's social support system," she said.

Learning Objective #3

"Select targeted, pharmacological and nonpharmacological therapies for RA within individualized management plans that are in concordance with patients' needs."¹

In discussing treatment strategies for the management of RA, faculty members highlighted both pharmacologic (i.e., NSAIDs, glucocorticoid joint injections, and low-dose systemic steroids for controlling symptoms; and early initiation of DMARD therapy to retard disease progression) and nonpharmacologic modalities (e.g., education of the patient and his or her family; and physical and occupational therapy).^14,15 Faculty members also elaborated on the nonpharmacologic treatment modalities by providing examples such as weight loss if the patient is overweight; physical and/or occupational therapy, especially for the patient who is compromised with activities of daily living; aerobic and strength-training exercise to improve joint mobility, fitness, function, and psychological well-being; and, where necessary, assistive devices for activities of daily living and joint protection.^14,16

Ms. Young adds a critical point here, saying, "There are no nonpharmacologic treatments that slow disease activity, progression, or joint erosion. Not exercise, movement, or heat therapy. All they do is make the patient more comfortable." Ms. Young feels strongly that nonpharmacologic therapies should be described to patients as adjuncts to treatment, not a treatment for their disease.^[17] According to Ms. Young, "Nothing a person does or doesn't do causes a flare. Patients need to seek treatment, be treated early and aggressively, and can't waste time relying upon things that will not help their RA. […] If anything," she adds, "patients with RA tend to be people who were previously very active and who are trying to maintain their health. We want to do as much as we can do. And patients are trying everything they can."

The concept of treating early and aggressively certainly did not escape the attention of the faculty members, who emphasized the importance of a "treatment window" and of "treating to target" (i.e., early diagnosis and start of DMARD therapy; setting a precise goal or target; continuous measurement of disease activity with validated instruments; and adjusting treatment according to both the assessment of disease activity and clinical judgment).^18,19 The faculty members conceded that this method of practice represents a paradigm shift in the treatment of RA.¹ Ms. Young does support this concept in principle; and she did take this idea a bit farther, stating, "Individualized management plans and treatment to target are definitely part of a paradigm shift in RA treatment that has taken place in very recent years with respect to leading rheumatologists. However, these ideas have not been put into practice with the general population of RA patients." She continues, saying that the "window of treatment" concept may not be realistic. RA disease activity occurs in the body over a span of years (1 – 10) before treatment is received.^20-24 "To truly get to a 'window of treatment,' we have to identify people with very early RA (VERA)." Ms. Young also raised the issue that most primary care physicians (PCPs) are unaware of what RA is and how to look for it. In a 2009 article on early treatment of rheumatoid arthritis as an elusive goal, Ms. Young wrote, "Early treatment of RA is not possible without early diagnosis. [However,] ignorance of early RA is pervasive in the general public and may not be much better among general practitioners (GPs). There are no clear criteria that can be used by GPs to identify early RA. Commonly, patients are screened using [sedimentation] rate or rheumatoid factor, both of which are poor indicators of early RA."²⁵ In addition, she writes that physicians are often skeptical about what they cannot see. "Skepticism is not unique to RA; doctors have to treat several so-called 'invisible illnesses.' The same bizarre presentation that causes early RA patients to fear seeking a diagnosis can confuse a GP also. It is understandable that unless they are trained otherwise, doctors may look with skepticism upon the collection of complaints of a patient with early RA. Unfortunately, the skepticism of a trusted primary care physician can cause shame in a patient, which will lead to further delay in diagnosis."²⁵ The problem she says also stems from a lack of education to old and new physicians alike. "Most primary care physicians believe that RA is not a serious disease. Furthermore, most medical students know nothing about RA; they need to be able to identify it."

According to Ms. Young, patients and their providers seem to have wildly discordant perspectives of what RA treatment can really achieve. "RA is a serious disease where efficacy is not very high. It's hard for patients to believe that early treatment can improve disease control. But, many physicians have unrealistic expectations for [outcomes of] RA and the medications, believing that 'most people get better.' Most people do not get better. Biologics don't always work. And perhaps of greatest concern is the assumption that 'all is ok' because when they [rheumatologists] saw the patient, there was no swelling." An overarching principle of the Treat-to-Target (T2T)¹⁸ recommendations warrants mention here:

The directive is clear—"communicate with your patients." In the face of imperfect treatments and inconsistent management strategies, physicians must take the time to involve their patients in the development of therapeutic plans, including garnering from the patient perspective what therapies may or may not be working and what changes may be apparent as a result of disease progression.

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What Can Be Done to Change Physician Performance and Practice?

So in the end we are left with the questions of "What now?" and "What can we do to improve the care of patients with rheumatoid arthritis?" Ms. Young's first and immediate recommendation is to have patients involved not only in their care, but also in education to physicians. "Patients need to be involved in medical education so that we can increase knowledge about RA and advance care," Ms. Young said. It's a critical point, and one that merits consideration. The goal of CME is ultimately to improve patient care and outcomes from disease management, and yet the piece most often missing in the development of education for physicians are the patient perspectives of what is "really being done," and "what is really needed."

Perhaps Ms. Young summarized needs best when she said, "Tell patients that our best hope is [in] treating early and aggressively. Don't give up." Nevertheless, before physicians can evaluate and monitor patients for adherence and disease activity, they must first evaluate and monitor their own performance and begin to implement strategies that can help individualize the care of their patients with RA and truly affect outcomes and quality of life in a way that patients can stand behind.

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Clinical Connections

• Stopping medication because of adverse events is not the same as non-adherence
  • The issues related to adverse events should be considered independently
• Medications for symptoms and medications for RA disease treatment need to be addressed separately
• RA treatment may need to be adjusted (i.e., patients should be evaluated) at 3 – 6 months
• Monitor and measure RA disease activity using validated assessments and PRO tools
  • Ask patients about their disease activity
  • Monitor trends, e.g., liver profiles
• Nonpharmacologic therapies should be described to patients as adjuncts to treatment, not as treatment for their disease
• Primary care physicians need to be better informed of common symptoms of early RA²⁵
• Communicate with your patients!
  • The treatment of rheumatoid arthritis must be based on shared decision-making between the patient and the rheumatologist

Recommended Review Articles on Geriatric Depression Assessment

• CME Outfitters Live and On Demand: Optimizing Clinical Outcomes in Rheumatoid Arthritis: Strategies for Improving Adherence
• Kelly Young: “20 Rheumatoid arthritis patient facts I learned from RA patients”
• Kelly Young: “2 Reasons monitoring rheumatoid arthritis matters”
• Kelly Young: “How rheumatoid arthritis pain affects women’s lives”

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Post-Compass Questions™

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References

1. Gibofsky A, Barton JL, Bergman MJ. CMEO Live and On Demand: Optimizing Clinical Outcomes in Rheumatoid Arthritis: Strategies for Improving Adherence. CME Outfitters Website. http://www.cmeoutfitters.com/cmea.asp?ID=619. Published November 16, 2011. Accessed November 29, 2011.

2. Brus H, van de Laar M, Taal E, Rasker J, Wiegman O. Compliance in rheumatoid arthritis and the role of formal patient education. Semin Arthritis Rheum. 1997;26(4):702-710. PMID: 9062951.

3. Garcia-Gonzalez A, Richardson M, Garcia Popa-Lisseanu M, et al. Treatment adherence in patients with rheumatoid arthritis and systemic lupus erythematosus. Clin Rheumatol. 2008;27(7):883-889. PMID: 18185905.

4. van den Bemt BJ, van den Hoogen FH, Benraad B, Hekster YA, van Riel PL, van Lankveld W. Adherence rates and associations with nonadherence in patients with rheumatoid arthritis using disease modifying antirheumatic drugs. J Rheumatol. 2009;36(10):2164-2170. PMID: 19723906.

5. van den Bemt BJ, den Broeder AA, van den Hoogen FH, et al. Making the rheumatologist aware of patients' non-adherence does not improve medication adherence in patients with rheumatoid arthritis. Scand J Rheumatol. 2011;40(3):192-196. PMID: 20977385.

6. Singh JA, Christensen R, Wells GA, et al. Biologics for rheumatoid arthritis: an overview of Cochrane reviews. Cochrane Database Syst Rev. 2009;(4):CD007848. PMID: 19821440.

7. Young K. New way to report response in RA clinical trials? Rheumatoid Arthritis Warrior Website. http://rawarrior.com/new-way-to-report-response-in-rheumatoid-arthritis-clinical-trials/. Published August 23, 2011. Accessed November 29, 2011.

8. Grigor C, Capell H, Stirling A, et al. Effect of a treatment strategy of tight control for rheumatoid arthritis (the TICORA study): a single-blind randomised controlled trial. Lancet. 2004;364(9430):263-269. PMID: 15262104.

9. Goekoop-Ruiterman YP, de Vries-Bouwstra JK, Allaart CF, et al. Clinical and radiographic outcomes of four different treatment strategies in patients with early rheumatoid arthritis (the BeSt study): a randomized, controlled trial. Arthritis Rheum. 2005;52(11):3381-3390. PMID: 16258899.

10. Harrington JT. The uses of disease activity scoring and the physician global assessment of disease activity for managing rheumatoid arthritis in rheumatology practice. J Rheumatol. 2009;36(5):925-929. PMID: 19369466.

11. Bartelds GM, Krieckaert CL, Nurmohamed MT, et al. Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during long-term follow-up. JAMA. 2011;305(14):1460-1468. PMID: 21486979.

12. Rendas-Baum R, Wallenstein GV, Koncz T, et al. Evaluating the efficacy of sequential biologic therapies for rheumatoid arthritis patients with an inadequate response to tumor necrosis factor-alpha inhibitors. Arthritis Res Ther. 2011;13(1):R25. PMID: 21324169.

13. Khan NA, Spencer HJ, Abda E, et al. Determinants of discordance in patient's and physician's rating of rheumatoid arthritis disease activity. Arthritis Care Res (Hoboken). November 2, 2011. [Epub ahead of print]. PMID: 22052672.

14. American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis: 2002 update. Arthritis Rheum. 2002;46(2):328-346. PMID: 11840435.

15. van Everdingen AA, Jacobs JW, Siewertsz Van Reesema DR, Bijlsma JW. Low-dose prednisone therapy for patients with early active rheumatoid arthritis: clinical efficacy, disease-modifying properties, and side effects: a randomized, double-blind, placebo-controlled clinical trial. Ann Intern Med. 2002;136(1):1-12. PMID: 11777359.

16. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum. 2000;43(9):1905-1915. PMID: 11014340.

17. Calabrese LH, Gibofsky A, Rigby WFC. CMEO Live and On Demand: Optimizing Care of Patients with Rheumatoid Arthritis: A Focus on Diagnosis, Combination Therapy, and Outcomes-Based Care. CME Outfitters Website. http://www.cmeoutfitters.com/cmea.asp?ID=568. Published August 10, 2011. Accessed December 12, 2011.

18. Smolen JS, Aletaha D, Bijlsma JW, et al. Treating rheumatoid arthritis to target: recommendations of an international task force. Ann Rheum Dis. 2010;69(4):631-637. PMID: 20215140.

19. de Wit MP, Smolen JS, Gossec L, van der Heijde DM. Treating rheumatoid arthritis to target: the patient version of the international recommendations. Ann Rheum Dis. 2011;70(6):891-895. PMID: 21478190.

20. Kokkonen H, Mullazehi M, Berglin E, et al. Antibodies of IgG, IgA and IgM isotypes against cyclic citrullinated peptide precede the development of rheumatoid arthritis. Arthritis Res Ther. 2011;13(1):R13. PMID: 21291540.

21. Harel M, Shoenfeld Y. Predicting and preventing autoimmunity, myth or reality? Ann N Y Acad Sci. 2006;1069:322-345. PMID: 16855160.

22. Kapetanovic MC, Lindqvist E, Algulin J, et al. Early changes in bone mineral density measured by digital X-ray radiogrammetry predict up to 20 years radiological outcome in rheumatoid arthritis. Arthritis Res Ther. 2011;13(1):R31. PMID: 21345204.

23. Deane KD, Norris JM, Holers VM. Preclinical rheumatoid arthritis: identification, evaluation, and future directions for investigation. Rheum Dis Clin North Am. 2010;36(2):213-241. PMID: 20510231.

24. Young K. Predicting rheumatoid arthritis. Rheumatoid Arthritis Warrior Website. http://rawarrior.com/predicting-rheumatoid-arthritis/. Published March 2, 2011. Accessed November 29, 2011.

25. Young K. Early treatment of rheumatoid arthritis is an elusive goal. HCPLive Website. http://www.hcplive.com/articles/early_treatment_of_RA. Published December 7, 2009. Accessed November 29, 2011.

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