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ISPRM 2021: New Ipsen Analysis Highlights Potential Treatment Gap in Adults Living With Spasticity

2021-06-11 01:00 ET - News Release

  • Ipsen analyzed data held in two large U.S. medical insurance databases, amounting to over 15 million patients, including nearly 1.3 million people living with active spasticity1
  • Despite being a recommended first-line treatment, only 3-4% of eligible adults living with active spasticity were treated with botulinum neurotoxin type A (BoNT-A)1
  • These data comprise one of 13 abstracts that Ipsen is presenting at the virtual ISPRM 2021 Congress


PARIS -- (Business Wire)

Regulatory News:

Ipsen (Euronext: IPN; ADR: IPSEY) announced findings from a new U.S. healthcare database analysis to assess the current treatment patterns of adults living with spasticity in a real-life setting. The analysis focused on the proportion of people living with active spasticity who received botulinum neurotoxin type A (BoNT-A) treatment.1 The abstract, Analysis of US Commercial Claims to Understand Patient Treatment Pathways in Spasticity,is being presented during the International Society of Physical and Rehabilitation Medicine (ISPRM) 2021 Congress, which is taking place virtually between 12-15 June 2021.1

Spasticity is usually caused by damage to the parts of the brain or spinal cord that control voluntary movement, leading to a change in the balance of signals between the nervous system and the muscles, which results in increased activity in the muscles.2,3 When injected into specific muscles of people living with movement disorders, BoNT injections cause temporary muscle relaxation, which can ease symptoms and aid rehabilitation.4 BoNT-A injections are considered as a recommended first-line treatment for adults living with spasticity in several countries, including the U.S.5

Ipsen analyzed data from two large U.S. commercial claims databases: IBM Watson’s MarketScan® and the IQVIA Anonymous Longitudinal Patient Data (APLD) database:

  • A total of 4,974,859 records were accessed in the MarketScan® database, and 10,685,964 records in the IQVIA database.1
  • Spasticity was identified from the two sources using International Classification of Disease (ICD) codes for spastic conditions (e.g., monoplegia, diplegia, hemiplegia and contracture).1
  • This revealed 126,465 and 1,151,127 people living with spasticity in the MarketScan® and IQVIA databases, respectively.1
  • In the MarketScan® database, only 5,111 people living with spasticity (4%) were treated with BoNT-A. In the IQVIA database, an even smaller percentage were treated with BoNT-A (31,176 patients, 3%).1

Isabelle Bocher-Pianka, Chief Patient Affairs Officer at Ipsen, commented: “Real-world studies help us better understand the patient’s medical journey and their unmet needs. While effective treatment of spasticity requires a multidisciplinary approach, which may involve a combination of exercise, physical therapy, medication, or surgery, it is concerning to see that many people living with spasticity in the U.S. are not receiving a recommended first-line treatment. The pandemic has been disruptive to the management of spasticity; these new data have, however, put a spotlight on the broader issues in the treatment of this condition that pre-date the pandemic.”

“We need to address barriers to treatment and find innovative ways to address the access issues in the treatment of this debilitating condition,” said Dr. Alberto Esquenazi, Sheerr Gait and Motion Analysis Laboratory, MossRehab, U.S. “Despite being a recommended first-line treatment, these data highlight a significant disconnect between the patient journey and the guidelines, since BoNT-A is only used for a small proportion of people living with spasticity in the U.S. and this is likely to be true in other parts of the world.”

“At Ipsen, we are fully committed to improving health outcomes for people living with debilitating neurological disorders,” said Dr. Andreas Lysandropoulos, Vice President, Head of Global Medical Affairs Neuroscience at Ipsen. “Poor control of spasticity can result in the breakthrough of painful symptoms such as muscle stiffness, spasms and involuntary contractions, which means the person living with spasticity may find it difficult to walk or perform certain tasks. These data show there is an urgent need to build on these findings and gather further insights into the underlying reasons for this disconnect.”

Follow Ipsen on Twitter via @IpsenGroup and keep up to date with ISPRM 2021 news and updates by using the hashtag #ISPRM2021.

About the databases

MarketScan® holds healthcare data on approximately ~8% of the U.S. population insured commercially or as part of the national Medicare program. IQVIA is derived from electronic healthcare claims data generated as part of the normal reimbursement process and covers 50% of the U.S. population. All database records were de-identified and fully compliant with U.S. patient confidentiality requirements.

About spasticity

Spasticity is estimated to affect more than 12 million people worldwide.6 It is a condition in which certain muscles are continuously contracted causing stiffness or tightness of the muscles, which can interfere with normal movement, gait and speech.2 Spasticity is usually caused by damage to the parts of the brain or spinal cord that control voluntary movement, leading to a change in the balance of signals between the nervous system and the muscles which results in increased activity in the muscles.2,3 Spinal cord injury, multiple sclerosis, cerebral palsy, stroke, brain or head trauma and metabolic diseases can all cause spasticity.2 Spasticity is experienced by approximately 34% of stroke survivors within 18 months following a stroke.7

Ipsen

Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology, Neuroscience and Rare Disease; it also has a well-established Consumer Healthcare business. With Total Sales of over €2.5bn in FY 2020, Ipsen sells more than 20 medicines in over 115 countries, with a direct commercial presence in more than 30 countries. The Company’s research and development efforts are focused on its innovative and differentiated technological platforms located in the heart of leading biotechnological and life-science hubs: Paris-Saclay, France; Oxford, U.K.; Cambridge, U.S.; Shanghai, China. Ipsen has c.5,700 colleagues worldwide and is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com.

Forward-looking statements

The forward-looking statements, objectives and targets contained herein are based on the Group’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect the Group’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words "believes", "anticipates" and "expects" and similar expressions are intended to identify forward-looking statements, including the Group’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by the Group. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising product in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. The Group must face or might face competition from generic products that might translate into a loss of market share. Furthermore, the Research and Development process involves several stages each of which involves the substantial risk that the Group may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Group cannot be certain that favorable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned. There can be no guarantees a product will receive the necessary regulatory approvals or that the product will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Group's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Group’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The Group also depends on third parties to develop and market some of its products which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to the Group’s activities and financial results. The Group cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of the Group’s partners could generate lower revenues than expected. Such situations could have a negative impact on the Group’s business, financial position or performance. The Group expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. The Group’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to the Group’s 2020 Registration Document, available on ipsen.com.

References

  1. Lamontagne A. et al. ISPRM 2021. Analysis of US Commercial Claims to Understand Patient Treatment Pathways in Spasticity. Poster No. EP04-58
  2. American Association of Neurological Surgeons. Spasticity. Available from: https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Spasticity. Accessed: June 2021
  3. American Association of Neurological Surgeons. Movement Disorders. Available from: https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Movement-Disorders. Accessed: June 2021
  4. Field M. et al. AbobotulinumtoxinA (Dysport®), OnabotulinumtoxinA (Botox®), and IncobotulinumtoxinA (Xeomin®) Neurotoxin Content and Potential Implications for Duration of Response in Patients. Toxins (Basel). 2018 Dec; 10(12): 535. doi: 10.3390/toxins10120535
  5. Simpson D. et al. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Practice Guideline. Neurology. 2016 May 10;86(19):1818-26. doi: 10.1212/WNL.0000000000002560.
  6. John Hopkins Medicine. Spasticity. Available from: https://www.hopkinsmedicine.org/health/conditions-and-diseases/spasticity Accessed: June 2021
  7. Kuo C. Post-stroke Spasticity: A review of epidemiology, pathophysiology, and treatments. Int J Gerontol 2018;12:280-284.

 

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Source: Ipsen

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