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Facing Up to Reality: The Patient Perspective on Unmet Need in RA

Facing Up to Reality: The Patient Perspective on Unmet Need in RA . Andrea Rubbert-Roth Senior Physician, Medical Department, University of Cologne, Cologne, Germany. Do Patient ’ s and Physician ’ s Perspective Really Differ?.

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Facing Up to Reality: The Patient Perspective on Unmet Need in RA

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  1. Facing Up to Reality: The Patient Perspective on Unmet Need in RA Andrea Rubbert-Roth Senior Physician, Medical Department, University of Cologne, Cologne, Germany

  2. Do Patient’s and Physician’s Perspective Really Differ? • Rheumatologists’ assessments of their patients physical function was discrepant with the patients’ assessment in about 35% of cases1-2 • Assessment of patients with chronic diseases often focuses on ‘process’ (improvement of ESR or articular index) rather than on ‘outcome’ (such as improvement in health status)3 Specific goals due to patients’ requirements i.e. piano player, playing golf 1. Berkanovic, et al, 1995 2. Kwoh, et al. 20013. Fries,et al. 1993

  3. The Impact of Arthritis on Daily Life • RA has a major impact on various aspects of daily life Rating of mental health outcome measures Ranking for being most important patients/physicians - Feeling of being in control 42% (21%) - Cognitive function, decision making 22% (33%) - Feelings of being happy 18% (31%) Social life - Working at a job, around the house 62% (84%) - Seeing family and friends 29% (7%) Kwoh/Ibrahim, et al. 2001

  4. Maintenance of current status appears to be the patient priority • 64% patients would not change therapy as long as their condition would not getting worse • Most RA patients satisfied with their current therapy even many with high disease activity and impaired functional status • Main reason for reluctance to change is the satisfaction with current disease control Wolfe and Michaud. Arthritis Rheum 2007;56:2135-2142

  5. The Patient’s View and Concerns • Aim for social, psychological and physical well-being • Fear for the future and physical dependence • Development of anger, anxiety and depression • Work loss depending on job and lack of specific support • Deficits in social activities and skills leading to disruption of social life

  6. How to Obtain the Patient’s Perception More Objectively • Apply outcome assessment tests that show • adequate validity and reliability • technique must be able to detect a clinically meaninful change • Health status measures in arthritis • HAQ • SF-36 • Functionality is increasingly being recognised as an important outcome parameter

  7. Patient Reported Outcome Measures • Patient-reported measures may be more sensitive to treatment effect than are physician reported outcome measures1 • Physicians should assign greater importance to patient reported measures in both clinical trials as well as in daily practice 1. Cohen, et al. Rheumatology 2004

  8. Percentage changes Patient Reported Measures Are as Sensitive to Change As Physician-reported Outcomes: Results from 4 Trials of Adalimumab Relative efficiency of ACR core set components based on percentage change ARMADA DE011 DE019 STAR Pincus, et al. J Rheumatol. 2006;33:2146-52

  9. HAQ During the Course of RA • 50% of patients show impaired functionality during the course of disease (HAQ Disability Index): • moderate after 2 years (HAQ of 1) • severe after 6 years (HAQ of 2) • very severe after 10 years (HAQ of 2.5) Wolfe & Cathey. J Rheumatol 1991;18:1298-1306 Wolfe & Hawley. J Rheumatol 1998;2108-2117

  10. Annual Costs of RA Correlate to the Increase in Disability 50 45 40 35 5-Yr Costs/Patient (US $ x1000) 30 After Disability* 25 20 15 10 5 0 0.0 0.5 1.0 1.5 2.0 2.5 3.0 HAQ Fries. Ann Rheum Dis 1999;58(Suppl 1):I86-I89 * Hospitalisation, surgery, long-term care. Pre-biologics era

  11. REFLEX: Proportion of Patients with clinically relevant improvement in function at 6 months (ITT) Clinically relevant improvement defined as fall in HAQ score of >0.25

  12. REFLEX Study: Changes in SF-36 Mental HealthComponents at 24 Weeks Mental health p<0.0001 Change in SF-36 score Cohen, et al. Arthritis Rheum 2006;54:2793-2806

  13. REFLEX Study: Changes in SF-36 Physical Components at 24 Weeks Physical health p<0.0001 Change in SF-36 score Cohen, et al. Arthritis Rheum 2006;54:2793-2806

  14. Mean change in SF-36 Quality of Life is Maintained or Further Improved With Repeat Rituximab Treatment Courses Prior TNF inhibitor exposure population Mean change in mental and physical components of the SF-36 at 24 weeks* *Versus original baseline Tak, et al. Ann Rheum Dis 2006;65(Suppl. II):503

  15. Fatigue in RA (I) • Besides pain, fatigue is the most frequently reported symptom in RA patientsRelates to pain, poor sleep, inflammation and anaemia • Different from ‘normal fatigue’ ‘overwhelming, uncontrollable’ ‘sudden onset, exhausting nature’ • Most patients do not discuss ‘fatigue’ with their physician and believe they have to manage it • Fatigue is rarely regarded as a treatment target

  16. Fatigue in RA (II) • Fatigue in RA patients strongly correlates to: • quality of life, work dysfunction • Patients with higher levels of fatigue • visit rheumatologists more frequently 1 • have higher annual costs of care • missed more work days 2 • Improvement of fatigue in patients with RA and Crohn’s disease when using TNF inhibitors 3 1. Belza, et al. 1993 2. Singh, et al. 2003 3. Moreland,et al. 2006; Minderhout, et al. 2007

  17. Placebo (n=201) Rituximab 1000 mg x 2 (n=298) Change of minimal clinical significance p<0.0001 REFLEX Study: Change in Fatigue(FACIT-F) at 24 Weeks After the First Course FACIT-F = Functional Assessment of Chronic Illness Therapy-Fatigue Cohen, et al. Arthritis Rheum 2006;54:2793-2806

  18. Patient’s Frequently Asked Questions • Shortness of trials versus duration of disease • Experience in patients like myself (comorbidities) • Difficulty in understanding a new drug mechanism • Difficulty to define a realistic treatment goal • New technologies create more treatment options • How to best decide on an individual treatment • Are there predictive parameters for efficacy? • Are there predictive parameters for safety? • How is this during the long-term? • Economic aspects may be considered

  19. Summary • Patient-centred outcomes are important in assessing new therapies, especially in those with new mechanisms of action • From a patient‘s perspective, fatigue is the second most important outcome after pain • Rituximab improves fatigue and functional status with regard to both mental and physical components

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