FRI0332 Factors Affecting The Attitudes of Patients with Systemic Lupus Erythematosus Regarding Potential Clinical Trial Participation
Authors: J. Braverman, S. Lops, E. Felicione, C. Wagner
Journal: Annals of the Rheumatic Diseases (2016)

<h3>Background</h3> Systemic Lupus Erythematosus (SLE) is an autoimmune disorder affecting skin, joints, kidneys, brain, and other organs<sup>1</sup>. Recruiting participants for SLE clinical trials may be challenging for several reasons including patients9 concerns that medications may exacerbate their condition or cause side effects<sup>2</sup>. <h3>Objectives</h3> To address challenges of recruiting patients with SLE into clinical trials, we conducted a survey study to: (1) explore patients9 satisfaction with their current treatment; (2) assess participants9 motivations to switch to a new treatment; and (3) identify the characteristics of patient who indicated a willingness to participate in a clinical trial. <h3>Methods</h3> 259 members of an online patient network aged 18–77 (mean age = 47; 96% female, 78% white) with SLE completed an online survey about their experience and attitudes. The data was collected within 7 days. We used the Chi-square test to analyze the distribution of categorical variables; two sample t-tests to compare group means and Pearson r correlation to identify the association between continuous variables. <h3>Results</h3> 60% of SLE patients report being at least “somewhat satisfied” with their current treatment; 74% name worsening symptoms as an important factor for changing medications. Those patients (36%) who said they were motivated to change to a new treatment reported a slightly more severe daily impact of SLE (mean = 3.6 on a scale 1: not at all – 5 very much) than patients who did not see new treatment availability as a reason to change their current medication (SLE impact mean = 3.3; t(258)=2.49; p&lt;0.01). 29% say knowing that a trial drug has never been tested before will increase the likelihood of their participation in the trial. The correlation analyses revealed slight, but statistically significant association between this favorable view of novel drug trials and higher number of treatments, frequency of healthcare utilization, and lupus daily impact (r ranged 0.13–0.22, p&lt;0.03). The disease-related factors positively associated with likelihood of clinical trial participation are SLE daily impact (r=0.26, p&lt;0.03), headaches (χ<sup>2</sup>=14.06, p&lt;0.01), and pain (χ<sup>2</sup>=8.8, p&lt;0.05); the treatment-related factors are burden of treatment, frequency of flares, frequency of healthcare utilization, number of medications (r ranged 0.14–0.18, p&lt;0.03), and use of pain medications (χ<sup>2</sup>=12.6, p&lt;0.05). <h3>Conclusions</h3> Investigators and clinical trial coordinators may achieve a higher recruitment and retention rate by targeting: 1) patients whose SLE symptoms are under poor control and who therefore frequently utilize the healthcare system rather than patients with low disease activity or stable disease; and 2) those patients who are experiencing more pain and headaches and more frequently using pain medications. <h3>References</h3> Odds of Persistently Positive Antiphospholipid Antibodies. J Rheumatol. 2013;40(1):30–33. van Vollenhoven RF. Challenges and opportunities in SLE clinical trials.Curr Opin Rheumatol. 2013 Sep;25(5):606–15. <h3>Disclosure of Interest</h3> J. Braverman Grant/research support from: Janssen Research and Development, LLC, S. Lops Employee of: Janssen Research and Development, LLC, E. Felicione Employee of: Janssen Research and Development, LLC, C. Wagner Employee of: Janssen Research and Development, LLC