Ipsen (Euronext: IPN; ADR: IPSEY) today announced that results from its Neurosciences portfolio are the subject of eight oral presentations at the World Congress for Neurorehabilitation (WCNR 2018). The presentations focus on improvements in care for patients with spasticity and spasticity management with abobotulinumtoxinA (Dysport®). The meeting takes place in Mumbai, India, February 7-10, 2018.
“Ipsen has a very strong presence at WCNR 2018 with eight abstracts accepted as oral presentations, and we look forward to reporting these important data on spasticity management with Dysport®. We are notably pleased to present the first milestone in one of the largest patient-centred spasticity management observational studies, ULIS-III which has enrolled over 1,000 patients to be followed up for two years. These presentations demonstrate the commitment of Ipsen to improving the lives of patients with spasticity.” said Alexandre Lebeaut, MD, Executive Vice-President R&D and Chief Scientific Officer, Ipsen.
Since its inception, the Upper Limb International Spasticity (ULIS) programme has involved more than 2,400 patients living with upper limb spasticity in 31 countries. The objective of the ULIS program is to develop a comprehensive and patient-centred approach to spasticity management to be implemented internationally.
“Since the start of the program ten years ago, we have participated in significant training and standardisation efforts, developed and refined methods of outcomes assessment and learned a lot about how we use botulinum toxins in routine clinical practice.” said Professor Lynne Turner-Stokes, DM FRCP MBE, Northwick Park Professor of Rehabilitation Medicine, King’s College London, and Director, Regional Hyper-acute Rehabilitation Unit, Northwick Park Hospital and Cordinating investigator of the ULIS program.
“Ipsen’s long-lasting partnership with the WFNR confirms Ipsen’s commitment to both neurorehabilitation research and the daily care of patients with spasticity. WFNR, in collaboration with Ipsen, conducted the first International survey related to “Patients living with Spasticity”, which was published in Disability and Rehabilitation in 2016[1]. This survey gave our patients the opportunity to let clinicians hear their voice.” said Professor Mike Barnes, Founding President of the WFNR, Honorary Professor of Neurological rehabilitation at Newcastle University.
At WCNR 2018 in Mumbai, abstracts on the following topics will be presented from Thursday 8th February 2018 to Saturday 10th February:
The Upper Limb International Spasticity (ULIS) programme:
- Title: Time to retreatment with botulinum toxin A in upper limb spasticity management: initial data from the Upper Limb International Spasticity (ULIS)-III study
Presenter: Lynne Turner-Stokes, UK
Thursday 8th February, 14:00 – 14:08; Hall D
- Title: Relief of spasticity-related pain with Botulinum neurotoxin-A (BoNT-A) in real life practice. Post-hoc analysis from a large international cohort series
Presenter: Lynne Turner-Stokes, UK
Thursday 8th February, 15:12 – 15:20; Hall F
- Title: Botulinum Toxin A in Upper Limb Spasticity Management: Baseline Data from the Upper Limb International Spasticity (ULIS)-III Study
Presenter: Lynne Turner-Stokes, UK
Friday 9th February, 14:36 – 14:44; Hall A
The ONTIME Pilot study:
- Title: Effect of early use of abobotulinumtoxinA (Dysport®) on time to post-stroke spasticity progression: Results of the ONTIME pilot study
Presenter: Raymond L Rosales, Philippines
Thursday 8th February, 15:03 – 15:11; Hall A
The ENGAGE study:
- Title: Effect on voluntary movements of simultaneous upper and lower limb abobotulinumtoxinA injections in conjunction with Guided Self-rehabilitation Contracts in adults with spastic hemiparesis: methodology of the ENGAGE study
Presenter: Jean-Michel Gracies, France
Saturday 10th February, 14:09 – 14:17; Hall A
The Adult Upper Limb Spasticity, Adult Lower Limb Spasticity, and ULIS-2 studies:
- Title: AbobotulinumtoxinA injections in shoulder muscles: results from a real world and phase 3 studies
Presenter: Thierry Lejeune, Belgium
Thursday 8th February, 15:12 – 15:20; Hall D
- Title: AbobotulinumtoxinA injections in the upper and lower limb in patients with spastic paresis and impaired function following stroke or traumatic brain injury
Presenter: Jean-Michel Gracies, France
Friday 9th February, 14:18 – 14:26; Hall A
- Title: Continuous Improvement in Composite Active Range of Motion Across Repeated Injections with AbobotulinumtoxinA (Dysport®) for Upper and Lower Limb Spasticity
Presenter: Jean-Michel Gracies, France
Saturday 10th February, 14:00 – 14:08; Hall A
About Dysport®
Dysport® is an injectable form of a botulinum neurotoxin type A product, which is a substance derived from Clostridium bacteria producing BoNT-A that inhibits the effective transmission of nerve impulses and thereby reduces muscular contractions. It is supplied as a lyophilized powder. As of 31 December 2017, Dysport® had marketing authorization in more than 85 countries.
About Spasticity
Spasticity is a condition in which there is an abnormal increase in muscle tone or stiffness in one or more muscles, which might interfere with movement. Spasticity is usually caused by damage to nerve pathways in the brain or spinal cord that control muscle movement, and may occur in association with cerebral palsy, spinal cord injury, multiple sclerosis, stroke, and brain or head trauma.3 In adults, approximately one in three stroke patients, one in three patients with spinal cord injury, one in six patients with traumatic brain injury, and two in three patients with MS will develop lower limb spasticity.1,2
INDICATIONS AND IMPORTANT SAFETY INFORMATION for the United States
INDICATIONS
Dysport® (abobotulinumtoxinA) for injection is indicated for the treatment of:
- Adults with cervical dystonia
- Spasticity in adult patients
- Lower limb spasticity in pediatric patients 2 years of age and older
IMPORTANT SAFETY INFORMATION
Warning: Distant Spread of Toxin Effect
Postmarketing reports indicate that the effects of Dysport® and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including upper limb spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to or lower than the maximum recommended total dose.
Contraindications
Dysport® is contraindicated in patients with known hypersensitivity to any botulinum toxin preparation or to any of the components; or in the presence of infection at the proposed injection site(s); or in patients known to be allergic to cow’s milk protein. Hypersensitivity reactions including anaphylaxis have been reported.
Warnings and Precautions
Lack of Interchangeability Between Botulinum Toxin Products
The potency Units of Dysport® are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products, and, therefore, units of biological activity of Dysport® cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method.
Dysphagia and Breathing Difficulties
Treatment with Dysport® and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or swallowing. When distant side effects occur, additional respiratory muscles may be involved. Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist for several weeks, and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised. Patients treated with botulinum toxin may require immediate medical attention should they develop problems with swallowing, speech, or respiratory disorders. These reactions can occur within hours to weeks after injection with botulinum toxin.
Pre-existing Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of Dysport®.
Human Albumin and Transmission of Viral Diseases
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.
Intradermal Immune Reaction
The possibility of an immune reaction when injected intradermally is unknown. The safety of Dysport® for the treatment of hyperhidrosis has not been established. Dysport® is approved only for intramuscular injection.
Most Common Adverse Reactions
Adults with upper limb spasticity (≥2% and greater than placebo): nasopharyngitis, urinary tract infection, muscular weakness, musculoskeletal pain, dizziness, fall, and depression.
Adults with lower limb spasticity (≥ 5% and greater than placebo): falls, muscular weakness, and pain in extremity.
Adults with cervical dystonia (≥5% and greater than placebo): muscular weakness, dysphagia, dry mouth, injection site discomfort, fatigue, headache, musculoskeletal pain, dysphonia, injection site pain, and eye disorders.
Pediatric patients with lower limb spasticity (≥10% and greater than placebo): upper respiratory tract infection, nasopharyngitis, influenza, pharyngitis, cough, and pyrexia.
Drug Interactions
Co-administration of Dysport® and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like agents), or muscle relaxants, should be observed closely because the effect of botulinum toxin may be potentiated. Use of anticholinergic drugs after administration of Dysport® may potentiate systemic anticholinergic effects, such as blurred vision. The effect of administering different botulinum neurotoxins at the same time or within several months of each other is unknown. Excessive weakness may be exacerbated by another administration of botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin. Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of Dysport®.
Use in Pregnancy
Based on animal data, Dysport® may cause fetal harm. There are no adequate and well-controlled studies in pregnant women. Dysport® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pediatric Use
Based on animal data Dysport® may cause atrophy of injected and adjacent muscles; decreased bone growth, length, and mineral content; delayed sexual maturation; and decreased fertility.
Geriatric Use
In general, elderly patients should be observed to evaluate their tolerability of Dysport®, due to the greater frequency of concomitant disease and other drug therapy. Subjects aged 65 years and over who were treated with Dysport® for lower limb spasticity reported a greater percentage of fall and asthenia as compared to those younger (10% vs. 6% and 4% vs. 2%, respectively).
To report SUSPECTED ADVERSE REACTIONS or product complaints in the United States, contact Ipsen at 1-855-463-5127. You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see Full Prescribing Information, including Boxed Warning and Medication Guide.
[1] Barnes M. et al, An international survey of patients living with spasticity. Disability and Rehabilitation. 2016; Volume 39, 2017 -issue 14
