– ASLeap trial to evaluate impact of increasing the dose of Cosentyx (secukinumab) to 300 mg in patients who do not achieve symptom remission after 16 weeks of treatment with the approved dose of 150 mg
– Additional exploratory analysis to investigate sleep disturbance, fatigue and daytime activity, some of the most common concerns for patients with ankylosing spondylitis(1, 2)
– Enrollment expected to begin January 2018(1)
EAST HANOVER, NJ, USA I December 7, 2017 I Novartis announced today the initiation of 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 US Clinical Development and Medical Affairs, Novartis Pharmaceuticals Corporation. “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
The study is expected to begin enrollment in January 2018 and aims to enroll approximately 270 patients at 70 centers in the United States. More information can be found at www.clinicaltrials.gov.
About the ASLeap Study
The ASLeap study design includes an initial 16 week open-label period (Treatment Period 1), followed by a randomized, double-blind, parallel-group period (Treatment Period 2). During the initial 16 weeks of the trial, all patients will receive open-label 150 mg Cosentyx. At Week 16, based on whether patients have met the definition of ASDAS inactive disease, patients will be placed into one of the following three groups for the remaining 36 weeks of the trial: Responders, patients who achieve ASDAS inactive disease (total score <1.3) at both Week 12 and Week 16, will enter Treatment Period 2 and continue receiving blinded Cosentyx 150 mg through Week 48. Inadequate Responders, patients who are not in inactive disease status, defined as an ASDAS total score of ≥1.3, at both Week 12 and Week 16, will enter Treatment Period 2 and be randomized (1:1, double-blinded) to Cosentyx 300 mg or Cosentyx 150 mg through Week 48. Non-responders, patients who exhibit no change or an increase (worsening) from baseline in total ASDAS score at either Week 12 or Week 16, will complete the study at Week 16.
The study population will consist of male and female patients, ≥18 years of age with a clinical diagnosis of moderate to severe AS fulfilling the Modified New York criteria for AS despite previous or current NSAIDs/non-biologic DMARDs and/or anti-TNFα therapy. Patients must have active AS, as measured by the following: total BASDAI ≥4 on a scale of 0-10 at baseline, spinal pain as measured by BASDAI question #2 ≥4 on a scale of 0-10 at baseline, and total back pain as measured by visual analog scale (VAS) ≥40mm (0-100 mm) at baseline. 1
About ankylosing spondylitis (AS)
Ankylosing spondylitis (AS) is a painful and often progressively debilitating disease, caused by spine inflammation that can result in irreversible damage.4 Up to 70% 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% of patients do not respond well to standard of care biologic medicines, and there have been few therapeutic options for those people.7
About Cosentyx (secukinumab) and interleukin-17A (IL-17A)
Cosentyx is a fully human monoclonal antibody (mAB) that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor.8,9
Cosentyx is the only IL-17a antagonist approved for the treatment of adults with active ankylosing spondylitis. Cosentyx is approved in more than 70 countries, which includes the European Union countries and the US. Cosentyx is also approved for the treatment of PsA and pustular psoriasis in Japan.10
In addition, Cosentyx is approved in more than 75 countries for the treatment of moderate to severe plaque psoriasis, which includes the European Union countries, Japan, Switzerland, Australia, the US and Canada. In Europe, Cosentyx is approved for the first-line systemic treatment of moderate to severe plaque psoriasis in adult patients.11 In the US, Cosentyx is approved as a treatment for moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy (light therapy).9
To date, more than 100,000 patients worldwide have been prescribed Cosentyx in the post-marketing setting across all indications.12 In addition, 2017 marks 10 years since the first patient visit in a clinical trial with Cosentyx.12
INDICATIONS
Cosentyx is a human interleukin-17A antagonist indicated for the treatment of:
- moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy
- adults with active psoriatic arthritis (PsA)
- adults with active ankylosing spondylitis (AS)
The approved dosage for the treatment of AS is 150 mg.
About Novartis
Located in East Hanover, NJ Novartis Pharmaceuticals Corporation is an affiliate of Novartis which provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2016, the Group achieved net sales of USD 48.5 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 121,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis
For Novartis multimedia content, please visit www.novartis.com/news/media-library
For questions about the site or required registration, please contact media.relations@novartis.com
* Actiwatch® is a registered trademark of Mini-Mitter Co. Inc.
References
- Novartis Data on file. Clinical Trial Protocol CAIN457FUS06. November 2017.
- 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.
- 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.
- 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.
- 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.
- Dean LE, Jones GT, MacDonald AG, et al. Global prevalence of ankylosing spondylitis. Rheumatology (Oxford). 2014;53(4):650-7.
- Dougados M, Baeten D. Spondyloarthritis. Lancet. 2011; 377(9783):2127-37.
- McInnes, IB, Mease, PJ, Kirkham, B, et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet. 2015; 386, No. 9999; p1137–1146.
- Cosentyx [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2017
- Pharmaceuticals and Medical Devices Agency. Review Report. Available at: http://www.pmda.go.jp/files/000216877.pdf . Accessed August 10, 2017.
- Cosentyx Summary of Product Characteristics. Novartis Europharm Limited. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003729/human_med_001832.jsp&mid=WC0b01ac058001d124. Last accessed August 2017.
- Novartis Data on file. Number of Patients Prescribed Cosentyx. May 2017.
SOURCE: Novartis
Post Views: 23
– ASLeap trial to evaluate impact of increasing the dose of Cosentyx (secukinumab) to 300 mg in patients who do not achieve symptom remission after 16 weeks of treatment with the approved dose of 150 mg
– Additional exploratory analysis to investigate sleep disturbance, fatigue and daytime activity, some of the most common concerns for patients with ankylosing spondylitis(1, 2)
– Enrollment expected to begin January 2018(1)
EAST HANOVER, NJ, USA I December 7, 2017 I Novartis announced today the initiation of 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 US Clinical Development and Medical Affairs, Novartis Pharmaceuticals Corporation. “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
The study is expected to begin enrollment in January 2018 and aims to enroll approximately 270 patients at 70 centers in the United States. More information can be found at www.clinicaltrials.gov.
About the ASLeap Study
The ASLeap study design includes an initial 16 week open-label period (Treatment Period 1), followed by a randomized, double-blind, parallel-group period (Treatment Period 2). During the initial 16 weeks of the trial, all patients will receive open-label 150 mg Cosentyx. At Week 16, based on whether patients have met the definition of ASDAS inactive disease, patients will be placed into one of the following three groups for the remaining 36 weeks of the trial: Responders, patients who achieve ASDAS inactive disease (total score <1.3) at both Week 12 and Week 16, will enter Treatment Period 2 and continue receiving blinded Cosentyx 150 mg through Week 48. Inadequate Responders, patients who are not in inactive disease status, defined as an ASDAS total score of ≥1.3, at both Week 12 and Week 16, will enter Treatment Period 2 and be randomized (1:1, double-blinded) to Cosentyx 300 mg or Cosentyx 150 mg through Week 48. Non-responders, patients who exhibit no change or an increase (worsening) from baseline in total ASDAS score at either Week 12 or Week 16, will complete the study at Week 16.
The study population will consist of male and female patients, ≥18 years of age with a clinical diagnosis of moderate to severe AS fulfilling the Modified New York criteria for AS despite previous or current NSAIDs/non-biologic DMARDs and/or anti-TNFα therapy. Patients must have active AS, as measured by the following: total BASDAI ≥4 on a scale of 0-10 at baseline, spinal pain as measured by BASDAI question #2 ≥4 on a scale of 0-10 at baseline, and total back pain as measured by visual analog scale (VAS) ≥40mm (0-100 mm) at baseline. 1
About ankylosing spondylitis (AS)
Ankylosing spondylitis (AS) is a painful and often progressively debilitating disease, caused by spine inflammation that can result in irreversible damage.4 Up to 70% 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% of patients do not respond well to standard of care biologic medicines, and there have been few therapeutic options for those people.7
About Cosentyx (secukinumab) and interleukin-17A (IL-17A)
Cosentyx is a fully human monoclonal antibody (mAB) that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor.8,9
Cosentyx is the only IL-17a antagonist approved for the treatment of adults with active ankylosing spondylitis. Cosentyx is approved in more than 70 countries, which includes the European Union countries and the US. Cosentyx is also approved for the treatment of PsA and pustular psoriasis in Japan.10
In addition, Cosentyx is approved in more than 75 countries for the treatment of moderate to severe plaque psoriasis, which includes the European Union countries, Japan, Switzerland, Australia, the US and Canada. In Europe, Cosentyx is approved for the first-line systemic treatment of moderate to severe plaque psoriasis in adult patients.11 In the US, Cosentyx is approved as a treatment for moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy (light therapy).9
To date, more than 100,000 patients worldwide have been prescribed Cosentyx in the post-marketing setting across all indications.12 In addition, 2017 marks 10 years since the first patient visit in a clinical trial with Cosentyx.12
INDICATIONS
Cosentyx is a human interleukin-17A antagonist indicated for the treatment of:
- moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy
- adults with active psoriatic arthritis (PsA)
- adults with active ankylosing spondylitis (AS)
The approved dosage for the treatment of AS is 150 mg.
About Novartis
Located in East Hanover, NJ Novartis Pharmaceuticals Corporation is an affiliate of Novartis which provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2016, the Group achieved net sales of USD 48.5 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 121,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis
For Novartis multimedia content, please visit www.novartis.com/news/media-library
For questions about the site or required registration, please contact media.relations@novartis.com
* Actiwatch® is a registered trademark of Mini-Mitter Co. Inc.
References
- Novartis Data on file. Clinical Trial Protocol CAIN457FUS06. November 2017.
- 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.
- 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.
- 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.
- 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.
- Dean LE, Jones GT, MacDonald AG, et al. Global prevalence of ankylosing spondylitis. Rheumatology (Oxford). 2014;53(4):650-7.
- Dougados M, Baeten D. Spondyloarthritis. Lancet. 2011; 377(9783):2127-37.
- McInnes, IB, Mease, PJ, Kirkham, B, et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet. 2015; 386, No. 9999; p1137–1146.
- Cosentyx [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2017
- Pharmaceuticals and Medical Devices Agency. Review Report. Available at: http://www.pmda.go.jp/files/000216877.pdf . Accessed August 10, 2017.
- Cosentyx Summary of Product Characteristics. Novartis Europharm Limited. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003729/human_med_001832.jsp&mid=WC0b01ac058001d124. Last accessed August 2017.
- Novartis Data on file. Number of Patients Prescribed Cosentyx. May 2017.
SOURCE: Novartis
Post Views: 23
