Horizon Pharma on Wednesday announced a collaboration with the Alliance for Lupus Research (ALR) to study RAYOS (prednisone) delayed-release tablets in systemic lupus erythematosus (SLE).
SLE is a chronic autoimmune disease that causes inflammation and pain in the joints and muscles as well as overall fatigue.
Jeffrey D. Kent, M.D., FACG, senior vice president, medical affairs and outcomes research, Horizon Pharma plc said that despite advances in SLE therapies, sustained control of disease activity is limited to a small fraction of patients.
He said further said that Prednisone was the steroid most commonly prescribed for lupus and given the unique delayed-release mechanism of RAYOS, the company was excited to partner with the Alliance for Lupus Research to further explore its potential in the disease.
According to Horizon, the first study planned as part of the collaboration, RAYOS Inhibits Fatigue in Lupus Erythematosus (RIFLE), will investigate the effect of RAYOS on the fatigue experienced by lupus erythematosus patients, a common symptom of the disease.
RIFLE is an investigator-initiated, randomized, double-blind, active comparator, cross-over study, Horizon says, in which patients will be randomized to receive either prednisone for three months or RAYOS at 10 p.m. for three months, and then switched to the alternative medication for an additional three months. Furthermore, approximately 62 patients across 25 sites will be enrolled in the United States.
In addition, the company says that the primary endpoint will assess fatigue as measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Horizon says, a 13-question survey to be completed by study participants that focuses on the daily fatigue experienced in patients with chronic illnesses.
“This study presents an opportunity to explore the debilitating fatigue associated with SLE — one of the most common symptoms that can decrease quality of life and increase risk of work disability and associated healthcare costs,” said Kenneth M. Farber, president of the Alliance for Lupus Research.
“Through this study we hope to uncover another treatment option that may improve outcomes for SLE patients.”
Secondary and exploratory endpoints of the study
Horizon further explained in its press release that the secondary and exploratory endpoints of the study would include measurement of fatigue according to the Fatigue Severity Scale (FSS).
The FSS scale is a 9-item questionnaire related to how fatigue interferes with certain activities; the SF-36 short-form health survey, which determines overall physical and mental health.
That is determined by assessments of overall quality of life and morning stiffness; an evaluation of the activity of lupus using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), British Isles Lupus Activity Group(BILAG), Systemic Lupus Activity Questionnaire (SLAQ), British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) and the SF 14.
Horizon noted that the trial would be carried out by the ALR-founded and supported Lupus Clinical Investigators Network (LuCIN) that was formed to specifically carry out this kind of trial to explore new treatments that might make life better for patients with lupus.
As explained by Horizon, it is part of its new program to identify and test drugs and treatments that address the concerns of lupus patients.
“More than three fourths of lupus patients experience fatigue, which is often debilitating. This is one of the first trials to address that problem in a scientifically rational way,” Horizon has concluded.
RAYOS, known as LODOTRA in Europe, is a proprietary delayed-release formulation of low-dose prednisone.