Quality of Life changes in participants of the SEISMIC Extension Trial in the Treatment of Signs and Symptoms of Endogenous Cushing's Syndrome

Program: Abstracts - Orals, Featured Poster Presentations, and Posters
Session: MON 290-291-Endocrine Nursing
Monday, June 17, 2013: 1:45 PM-3:45 PM
Expo Halls ABC (Moscone Center)

Poster Board MON-290
Daphne T Adelman*1, Simone Howell2 and Patricia S Via3
1Northwestern University, Chicago, IL, 2Corcept Therapeutics, Dallas, TX, 3McGuire Veterans Affairs Med Ctr, Richmond, VA
Introduction: Endogenous Cushing’s syndrome (CS) is a debilitating and rare multisystem disorder. Previous studies site poor quality of life (QoL) for people with CS: rates of up to 85% for fatigue/weakness, 80% disruption in family relations, 63% have concerns about physical appearance, 63% emotional instability, 56% school/work performance difficulties, 49% cognitive decline, 32% depression, and 12% sleep problems are reported. 1,2 The goal of this study was to assess QoL changes in SEISMIC Extension Trial participants [An Open Label Extension Study of the Efficacy and Safety of mifepristone in the Treatment of the Signs and Symptoms of Endogenous Cushing’s Syndrome]

Methods: The SEISMIC Trial was a multicenter 24-week open label study of 50 patients (PTS) with persistent or recurring CS.3  Of the 50 PTS who completed the SEISMIC Trial, 30 PTS continued in the long term extension study following a 6 week medication washout period. Santos and Webb, et al, developed a 12-item CushingsQoL (CQoL) instrument designed and validated specifically to assess QoL in patients suffering from endogenous CS. 4,5 Twenty-three of 30 subjects consented to the CQoL at the 3 months study visit following extension study entry.  The survey was administered twice via a single 20-minute phone interview conducted by an independent endocrine nurse practitioner. The survey compared item scores before SEISMIC study and during the most recent 4 week period on study drug.

Results: Scoring was calculated as % change over baseline. Domain scores were assessed on a 1-5 point ordinal scale, with higher scores representing improved QoL. Total composite score (n=23) improved by 52% compared to baseline and was highly Statistically Significant (SS) (p<0.001). SS % improvements were seen in the following domains: 86%  bruising(p= 0.037), 74% socialization( p<0.001),  73% physical appearance(p<0.001),  59%  sleep(p=0.001),  54%  mood swings(p=0.005),  52%  wound healing(p= 0.002),  50% desire for leisure activities(p<0.001),  45%  illness impact on activities of daily living(p= 0.027), 45%  worries about future health(p= 0.027), 44%  pain(p= 0.037) and 44% confidence(p= 0.003).

Conclusion: PTS completing the disease-specific CQoL survey demonstrated significant improvement in overall composite and multiple domain scores of the CQoL. Chronic treatment of CS with mifepristone has shown improved measures in QoL.

1. Gotch PM, Cushing‘s syndrome from the patient’s perspective.  Endocrinology and Metabolism Clinics of North America  1994  23  607- 617.  2. Nieman LK, Biller BM, Findling JW, Newell-Price J, Savage M, Setewart P & Montori VM. The diagnosis of Cushing’s syndrome: an Endocrine Society Clinical Practice Guideline. Journal of Clinical Endocrinology and Metabolism 2008 93 1526–1540   3. Fleseriu M, Biller BMK, Findling JW, Molitch ME, et al. Mifepristone, a glucocorticoid receptor antagonist, produces clinical and metabolic benefits in patients with Cushing’s syndrome. J Clin Endocrinol Metab 2012; 97 2039-2049   4. Webb SM, Badia X, Barahona MJ, Colao A, Strasburger CJ, Tabarin A, van Aken MO, Pivonello R, Stalla G, Lamberts SW & Glusman JE. Evaluation of health-related quality of life in patients with Cushing’s syndrome with a new questionnaire. European Journal of Endocrinology 2008 158 623–630   5. Santos A,  Resmini E, Martı´nez-Mombla´n M, Crespo I, Valassi E, Roset M, Badia X and Webb S.  Psychometric performance of the CushingQoL questionnaire in conditions of real clinical practice. European Journal of Endocrinology (2012) 167 337–342 ISSN 0804-4643

Disclosure: SH: Employee, Corcept. Nothing to Disclose: DTA, PSV

*Please take note of The Endocrine Society's News Embargo Policy at http://www.endo-society.org/endo2013/media.cfm

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