New Study Shows Rheumatoid Arthritis Patients Report Need for Improvement in Subcutaneous Therapy Delivery Devices

Merck & Co., Inc.An overwhelming majority of rheumatoid arthritis (RA) patients are not completely satisfied with their current subcutaneous treatment devices, according to recent survey results presented at the European League Against Rheumatism's (EULAR) 2010 Annual European Congress of Rheumatology. Findings showed that between 78 and 90 percent of surveyed RA patients reported that they disliked at least one aspect of administering their subcutaneous injection.

The RAISE Patient Device Handling Survey was developed to gain a better understanding of RA patients' perspectives and concerns regarding the characteristics and use of their subcutaneous treatment administration devices. Although more than half of the surveyed patients found their autoinjectors easy to use, more than one third of the patients admitted that they were unsure if they were administering their treatments correctly. Thirty-six percent of the patient responders reported pain and burning upon injection, and approximately 10 percent have admittedly skipped a treatment because of the severity of injection pain. In addition, between seven and 10 percent had given thought to skipping treatment for the same reason.

Patients surveyed felt the most important characteristics of autoinjector devices were the location of the autoinjector button, ease-of-use, comfortable to hold and simple to learn. In addition, patients frequently reported that they desire a means for determining whether their treatment was delivered correctly.

"The survey results revealed some concerns rheumatoid arthritis patients have with their current autoinjectors, and demonstrate the need for further improvement in the design and development of self-treatment devices," said Iain McInnes, FRCP, Ph.D., FRSE, Head of Division of Immunology, Infection and Inflammation, Professor of Experimental Medicine, Glasgow Biomedical Research Centre, Glasgow, Scotland and lead investigator. "As clinicians, we need to work closely with our patients to discuss and address these specific concerns that are often not apparent during regular consultations."

Meeting a Critical Need in Patients with Rheumatoid Arthritis
Results from a Delphi initiative, which looked at the critical roles nurses play in the management and treatment of RA patients, were also presented at the EULAR 2010 Annual European Congress of Rheumatology. The findings showed that topics such as quality-of-life and personal well-being are not always addressed by physicians due to time constraints or general level-of-comfort in discussing these issues. Consequently, as nurses spend substantially more time with each patient than the physician in most European and Canadian practices, they are more likely to initiate conversations on these topics and address important emotional and social issues related to diagnosis and treatment.

The results also suggest that while doctors are more likely to recommend a particular therapy, nurses play a crucial part in determining the patients' readiness and understanding of the treatment, and are responsible for educating the patient on treatment side-effects, efficacy, and administration. Additionally, nurses are responsible for monitoring the safety of the treatment and the patients' progress.

"The outcomes of this initiative suggest that nurses play an essential role in satisfying an often unmet need in the treatment and management of patients with rheumatoid arthritis, especially in the area of patient education," said Terri Lupton, RN, CCRP, Rheumatology Central Triage, Calgary Health Region, Alberta, Canada and participant in the Delphi initiative. "To better improve total patient care, we need to further examine how we can customize patient education given each patient requires various levels of individual support and treatment information."

About The RAISE Patient Device Handling Survey
The RAISE Patient Device Handling Survey evaluated 425 patients using either adalimumab (n=299) or etanercept (n=126) subcutaneous autoinjectors for at least two months to treat moderate-to-severe RA. Eligible patients were at least 18 years of age and from Canada, France, Germany or the United Kingdom. Survey questions assessed patients' opinions of their pre-filled delivery devices and evaluated their concerns regarding the device itself and the injection.

Twenty percent of patients surveyed identified the pain caused by the needle prick as one of their least favorite aspects of self-injection. In addition, between two and 16 percent of patients reported that they accidently triggered their injector and wasted a dose of medication.

About the Delphi Nurse Initiative
A modified Delphi method (a consensus-generating process reflecting anonymous expert opinion and counsel) with two rounds of questionnaires was developed and refined by a steering committee of three nurses. An international group of 12 nurses with extensive clinical or research experience in the management and treatment of patients with moderate-to-severe RA completed the questionnaires and attended a follow-up panel discussion to explore unmet needs and issues in which a consensus had not yet been reached.

Prior to the in-person meeting, all responses remained anonymous and confidential. Panel discussion topics focused on understanding the physical and emotional needs of RA patients and included the nurse's role as caregiver, assessor of treatment outcomes and disease status, and provider of information.

About Rheumatoid Arthritis
Rheumatoid arthritis is a chronic and debilitating disease that affects approximately 300,000 people in Canada, 1.3 million people in the United States and more than three million people in Europe. Signs and symptoms of RA include pain, stiffness and motion restriction in multiple joints. Because RA is a progressive disease, it can cause permanent joint deformity and severe disability if not diagnosed early or if initial treatment is delayed. RA can occur at any age, but is most common in adults 30-50 years old and is two to three times more prevalent in women than in men. The cause of RA is unknown, although genetic factors may contribute to the disease.

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