Novartis initiates study evaluating impact of higher dosing of Cosentyx in patients with ankylosing spondylitis.
Novartis Pharmaceuticals Corporation will initiate the ASLeap trial in patients with ankylosing spondylitis (AS), evaluating the effect of changing to a higher dose (300 mg) of Cosentyx (secukinumab) in patients who do not achieve symptom remission after treatment with Cosentyx 150 mg for 16 weeks.
The primary endpoint of ASLeap is to determine the difference between Cosentyx 300 mg and Cosentyx 150 mg at Week 52 based on the proportion of subjects achieving inactive disease status based on the Ankylosing Spondylitis Disease Activity Score (ASDAS).1
“An important goal of ankylosing spondylitis treatment is to provide as much symptom relief as possible for patients living with this debilitating disease,” said Marcia Kayath, head of U.S. clinical development and medical affairs at Novartis. “While Cosentyx 150 mg has shown clinically significant results in treating a majority of patients with AS, we want to investigate whether some patients may benefit from a higher dose. We hope that the results of the ASLeap study will help provide physicians with important information about how best to manage these patients.”
An exploratory analysis will also assess sleep disturbance and daytime activity in patients with AS, as measured by the use of a wearable motion biosensor, an Actiwatch* device, which is a medical device resembling a wristwatch used to collect detailed information on sleep and physical activity.
Patients with AS report chronic and extensive sleep disturbance due to pain and stiffness during the night.2 In AS patients, poor quality sleep is strongly correlated with increased pain, fatigue, lower quality of life, higher depressed mood, higher disease activity, and reduced physical function.3
Ankylosing spondylitis is a painful and often progressively debilitating disease, caused by spine inflammation that can result in irreversible damage.4 Up to 70 percent of patients who go on to develop severe AS will form spinal fusions (where the bones grow together) over 10 to 15 years, which significantly reduces mobility.5
People in their teens and twenties, particularly males, are affected most often. Family members of those with AS are at higher risk.4,6 Approximately 20-40 percent of patients do not respond well to standard of care biologic medicines, and there have been few therapeutic options for those people.7
The study is expected to begin enrollment in January 2018 and aims to enroll approximately 270 patients at 70 centers in the United States.
* Actiwatch is a registered trademark of Mini-Mitter Co. Inc.
1 Novartis Data on file. Clinical Trial Protocol CAIN457FUS06. November 2017.
2 Leverment S, Clarke E, Wadeley A, Sengupta R. Prevalence and factors associated with disturbed sleep in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis: a systematic review. Rheumatology International. 2016;37(2):257-271.
3 Batmaz I, Sarıyıldız MA, Dilek B, Bez Y, Karakoç M, Çevik R. Sleep quality and associated factors in ankylosing spondylitis: relationship with disease parameters, psychological status and quality of life. Rheumatology International. 2012;33(4):1039-1045.
4 Schett et al. Structural damage in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: traditional views, novel insights gained from TNF blockade, and concepts for the future. Arthritis Res Ther. 2011;13:S4.
5 Barkham N, Kong K O, Tennant A, et al. The unmet need for anti-tumour necrosis factor (anti-TNF) therapy in ankylosing spondylitis. Rheumatology. 2005;44:1277–1281.
6 Dean LE, Jones GT, MacDonald AG, et al. Global prevalence of ankylosing spondylitis. Rheumatology (Oxford).2014;53(4):650-7.
7 Dougados M, Baeten D. Spondyloarthritis. Lancet. 2011; 377(9783):2127-37.
(Source: Novartis Pharmaceuticals Corporation)
Filed Under: Drug Discovery