New GSK Multi-country Survey Reveals Need for Improved Awareness Around Long-term Impact and Appropriate use of Corticosteroids in SLE Management

SAN DIEGO and LONDON, November 6, 2017 /PRNewswire/ --

Findings from a new multi-country GSK survey, released today to coincide with the 2017 American College of Rheumatology/Association for Rheumatology Health Professionals Annual Meeting (ACR/AHRP), reveal that patients with systemic lupus erythematosus (SLE) often self-manage their corticosteroid medication without the consent of their HCP (89% rheumatologists and some Internal Medicine physicians in EU4 countries). With varied treatment approaches and no universally accepted guidelines in SLE, the EnABLE survey[1] was designed to provide an insight into discrepancies in current approaches to management between HCPs and patients and identify barriers to improved patient care.

Results from EnABLE highlight an opportunity for increased awareness on appropriate corticosteroid use and a more proactive approach to the management of SLE. More than a third of HCPs surveyed (37%) did not agree that long-term treatment/management was as important as immediate symptoms when caring for persistently active SLE patients. Survey feedback also indicated that only ~40% of rheumatologists are aware that SLE leads to organ damage in 30-50% of patients within 5 years of diagnosis.

This was reflected in HCPs' attitudes towards the use of corticosteroids in managing the symptoms of SLE, with most accepting doses far exceeding the recommended clinical threshold. Similarly, more than half (53%) of patients surveyed said they rely heavily on corticosteroids to get through difficult periods of lupus and 69% did not believe that their HCP went beyond treating symptoms to fully manage all aspects of their persistently active SLE.

"For many people, lupus can be managed successfully with early diagnosis and expert medical care; but a balance needs to be struck - between treating symptoms as they evolve and proactively reducing underlying disease activity and preventing flares - if the risk of long-term organ damage is to be reduced," said Dr Alex Liakos, Global Medical Affairs, GSK.

One of the key challenges in the management of SLE is reducing the impact of the disease whilst minimising damage from the toxicity and side effects of some standard treatments.[1] Although the long-term use of corticosteroids is associated with irreversible organ damage,[2],[3] around a third of SLE patients in EnABLE reported upping oral corticosteroid dosage and frequency without the consent of their HCP, on average making increases as many as six times in a year. However HCPs underestimated the scale of this patient self-management, predicting that only 15-20% of their patients independently increased corticosteroid dosage or frequency.

The survey revealed that 58% of HCPs define high dose corticosteroids as 20mg/day or higher, markedly above the recommended clinical threshold of 7.5mg/day*.[2],[3] In fact, the majority considered 10mg/day to be a low dose for patients with SLE**. In addition, although reductions of as little as 1 mg/day in mean corticosteroid dose lower the estimated risk of future organ damage,[2] most HCPs (61%) reported that they did not plan to alter their corticosteroid use and 8% expected to increase it in patients with persistently active disease.

"These results highlight the need for better education around the appropriate use of corticosteroids and the long-term impact of the disease, particularly given that half of patients suffer irreversible organ damage within five years of being diagnosed," concluded Dr Alex Liakos. "EnABLE suggests that taking a more holistic, proactive approach to treating the disease would improve the overall outcomes for people with SLE."

To support patient care, GSK has prepared several US and Global patient-focused resources called UsinLupus.com [http://www.UsinLupus.com ] and Living with Lupus. To support HCPs, GSK has created TalkSLE.com. They are designed to educate and equip the lupus community with the relevant tools to take a more holistic approach to disease management.

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1. EnABLE (Exploration iNto Attitudes and Behaviour in the Lupus Experience) *Clinical threshold defined as 7.5mg/day in survey ** HCPs defined short term as 5.5 weeks and long term as 13.4 weeks

About EnABLE Survey 

EnABLE (Exploration iNto Attitudes and Behaviour in the Lupus Experience) is a major multi-country survey of attitudes and behaviours among patients with SLE and healthcare professionals (HCPs) who treat the condition, supported by GSK. EnABLE was conducted by Cello Health Insight, a healthcare market research agency.

Research was carried out in two phases:


- The qualitative phase involved a total of 22 patients from the US, Italy and
Spain. It consisted of a combination of small focus groups and in-depth
face-to-face/telephone interviews carried out from March - April 2017
- The quantitative phase involved 261 active SLE patients and 311 HCPs (89%
rheumatologists and some Internal Medicine physicians in EU4 countries) from the US,
Europe, Japan and Brazil. Research interviews were conducted May - June 2017.


Although the study represented a robust sample size overall, some markets have base sizes lower than N= 30. In addition, the survey was carried out in an uncontrolled setting and only looked at certain aspects of SLE management. As a result, caution should be taken when interpreting these results as they are directional only.

About systemic lupus erythematosus (SLE) 

SLE is the most common form of lupus, affecting approximately 70 percent of an estimated 5 million people with lupus worldwide. It is a chronic, incurable autoimmune disease producing autoantibodies that can attack almost any system in the body. With symptoms such as extreme fatigue, painful or swollen joints, unexplained fever, skin rashes and kidney problems, SLE is unpredictable and life-changing. Although the underlying disease is always present, symptoms can erupt, or flare, without warning, making it difficult for patients to plan and manage their everyday lives.

GSK - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit http://www.gsk.com.

References 

1. Lopez R, Davidson JE, Beeby MD, Egger PJ, Isenberg DA. Lupus disease activity and the risk of subsequent organ damage and mortality in a large lupus cohort. Rheumatology (Oxford) 2012 Mar;51(3):491-8.  

2. Al Sawah S, Zhang X, Zhu B, et al. Effect of corticosteroid use by dose on the risk of developing organ damage over time in systemic lupus erythematosus-the Hopkins Lupus Cohort. Lupus Science & Medicine 2015;2:e000066. doi:10.1136/lupus-2014- 000066. 

3. Ruiz-Irastorza G, Danza A and Khamashta M. Glucocorticoid use and abuse in SLE. Rheumatology 2012;51:11451153 doi:10.1093/rheumatology/ker410.  

CONTACT: Emily Bunting, +44(0)20-8047-5502, (London), Anna Padula, +1-215-760-2928, (Philadelphia)

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