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Adult Cervical Dystonia Efficacy

What would more time between injections mean to your patients?

When stiffness returns too early, the struggle resumes... Use Dysport for symptom* relief that lasts between injections
*Symptoms of cervical dystonia can include abnormal head position and neck pain.

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When efficacy wears off, even something as simple as walking can When efficacy wears off, even something as simple as walking can become a challenge again. become a challenge again.

Patient’s experience

Patient’s experience

 

First symptoms or without treatment: “[By the time I was diagnosed,] the symptoms had progressed to a very obvious uncontrollable movement … back and neck pain … Then the pain got worse from the constant muscle spasms….”

With Dysport treatment “I feel sustained between injections up to the 12 weeks.… [Dysport] has lived up to my expectations … it has been a reliable, effective treatment—it’s comforting to know that I can count on [it] to work for me.”

A History of FDA Approval

Duration of FDA approval is not intended to imply superiority in efficacy or safety of Dysport

Commitment to spasticity

Dysport has been available for 10+ years in the US and it has been FDA approved for the treatment of AULS since 2015 and for ALLS since 2017.

2009

Dysport approved for cervical dystonia

2015

Dysport approved for adult upper limb spasticity

2016

Dysport approved for pediatric lower limb spasticity

2017

Dysport approved for expanded indication for adult spasticity to include lower limb

2019

Dysport approved for expanded indication for pediatric spasticity to include upper limb (aged 2 years and older)

Proven Efficacy

Dysport has an established efficacy in reducing abnormal head position and neck pain of patients with cervical dystonia at week 4* and improvement could last beyond the minimum retreatment period1,2

*Primary endpoint, total Toronto Western Spasmodic Torticollis Rating Scale [TWSTRS] change

In the treatment of adults with cervical dystonia, start Dysport for lasting symptom relief1

The median time for retreatment in the clinical studies was 14 weeks and 25% of patients had a time to retreatment of at least 18 weeks.
Dysport is FDA approved for the treatment of spasticity in patients aged 2 years and older, and cervical dystonia in adults.

Study Design for Studies 1 and 2

The efficacy of Dysport was evaluated in 2 randomized, double-blind, placebo-controlled, multicenter, parallel-group, single-dose studies with a 12-week follow-up in 252 patients with cervical dystonia (Dysport, n=121; placebo, n=131).

Patients could switch to open-label extension studies after week 4. Dysport 500 Units was given by intramuscular injection, divided among 2 to 4 affected muscles.

  • The primary efficacy endpoint was total TWSTRS change from baseline at week 4 for both studies.
  • TWSTRS total score (maximum: 85 points) is composed of 3 subscales (Severity, Disability, and Pain).
  • For Study 1, the mean TWSTRS total score at baseline was 46 for placebo and 44 for Dysport 500 Units.
  • For Study 2, the mean TWSTRS total score at baseline was 46 for placebo and 45 for Dysport 500 Units.

Established efficacy

  • Dysport significantly reduced abnormal head position at week 4 compared to placebo1,2

Improvement from baseline at week 4 in abnormal head position as measured by reduction in TWSTRS total score

Established efficacy

TWSTRS=Toronto Western Spasmodic Torticollis Rating Scale.

At week 4, adults receiving Dysport had a significant reduction in abnormal head positioning vs placebo in 2 studies, as measured by the TWSTRS total score1,2

Most commonly observed adverse reactions (≥5% of patients) were muscular weakness, dysphagia, dry mouth, injection site discomfort, fatigue, headache, musculoskeletal pain, dysphonia, injection site pain, and eye disorders

How Dysport works

*Primary endpoint, total Toronto Western Spasmodic Torticollis Rating Scale [TWSTRS] change

†Defined as not previously treated with a botulinum toxin for the treatment of cervical dystonia.

Pain Relief

Dysport significantly reduced neck pain at week 42,4

Reduction from baseline in pain severity following 1 treatment dose

Reduction from baseline in pain severity following 1 treatment dose

VAS=visual analog scale.

On a 100-point scale (0 [no symptoms] to 100 mm [worst possible symptoms]), baseline VAS score (patient self-rated) was 48.6 in the Dysport group and 52.9 in the placebo group.

Time to Retreatment

Time to retreatment

Use Dysport for symptoms relief that lasts between injections — because a long duration of response should matter

For most patients, Dysport provides improvement in range of motion that lasts beyond the minimum retreatment time of 12 weeks (N=108)1,2

time to treatment

Time to retreatment was not a primary endpoint. Repeat Dysport treatment should be administered no sooner than 12 weeks after the previous injection

Study 1 and Study 2 were followed by long-term, open-label extensions that allowed titration in 250-Unit steps to doses in a range of 250 to 1000 Units, after the initial dose of 500 Units. In the extension studies, retreatment was determined by clinical need after a minimum of 12 weeks

The median time to retreatment was 14 weeks and 18 weeks for the 75th percentile

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Learn more about Adult Cervical Dystonia

Support Dosing & Dilution Safety

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 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 products, cow’s milk protein, or to any of the components in the formulation, or infection at the proposed injection site(s). Serious hypersensitivity reactions including anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea have been reported. If such a serious reaction occurs, discontinue DYSPORT and institute appropriate medical therapy immediately. 

Warnings and Precautions

Lack of Interchangeability Between Botulinum Toxin Product

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 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. Treatment of cervical dystonia with botulinum toxins may weaken accessory muscles of ventilation, which may result in a critical loss of breathing capacity in patients with respiratory disorders who may have become dependent upon these muscles. 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 Disorder

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 Disease

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, vCJD, or CJD 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.

Adverse Reactions

  • The most common adverse reactions (≥4%) in adults with upper limb spasticity include muscular weakness; in adults with lower limb spasticity (≥5%) 
    include falls, muscular weakness, and pain in extremity
  • The most common adverse reactions (≥10%) in pediatric patients with upper limb spasticity include upper respiratory tract infection and pharyngitis; in
    pediatric patients with lower limb spasticity include nasopharyngitis, cough, and pyrexia
  • The most common adverse reactions (≥5%) in adults with cervical dystonia include muscular weakness, dysphagia, dry mouth, injection site discomfort,
    fatigue, headache, musculoskeletal pain, dysphonia, injection site pain, and eye disorders

Drug Interactions

Co-administration of DYSPORT and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like agents) should only be performed with caution because the effect of the 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 and after administration of DYSPORT.

INDICATIONS

DYSPORT (abobotulinumtoxinA) for injection is indicated for the treatment of:

  • spasticity in patients 2 years of age and older
  • cervical dystonia in adults

Please see full Prescribing Information, including BOXED WARNING.

 

REFERENCES
  1. Dysport® (abobotulinumtoxinA) [Prescribing Information]. Cambridge, MA: Ipsen Biopharmaceuticals, Inc; July 2020.
  2. Data on file. Cambridge, MA; Ipsen Biopharmaceuticals, Inc.
  3. Differential diagnosis for spasticity. NeuroRehabResource.org website. http://www.neurorehabresource.org/Files/NRR_Differential_Diagnosis.pdf. Accessed April 6, 2021.
  4. Esquenazi A, Alfaro A, Ayyoub Z, et al. OnabotulinumtoxinA for lower limb spasticity: Guidance from a Delphi Panel approach. PM R. 2017;9(10):960-968.
  5. Barnes M, Kocer S, Fernandez MM, et al. An international survey of patients living with spasticity. Disabil Rehabil. 2017;39(14):1428-1434.
  6. Delgado MR, Tilton A, Russman B, et al. AbobotulinumtoxinA for equinus foot deformity in cerebral palsy: a randomized controlled trial. Pediatrics. 2016;137(2): doi: 10.1542/peds.2015-2830.
  7. Blitzer E, Benson BE, Guss J. Botulinum Neurotoxin for Head and Neck Disorders. New York, NY. Thieme Medical Publishers, Inc. 2012.
  8. Delgado MR, Tilton A, Carranza-del Rio J, et al. Efficacy and safety of abobotulinumtoxinA for upper limb spasticity in children with cerebral palsy: a randomized repeat-treatment study. Dev Med Child Neurol. 2021;63(5):592-600.
  9. Gracies JM, Brashear A, Jech R, et al. Safety and efficacy of abobotulinumtoxinA for hemiparesis in adults with upper limb spasticity after stroke or traumatic brain injury: a double-blind randomised controlled trial. Lancet Neurol. 2015;14(10):992-1001.
  10. Gracies JM, Esquenazi A, Brashear A, et al. Efficacy and safety of abobotulinumtoxinA in spastic lower limb. Neurology. 2017;89(22):2245-2253
  11. Truong D, Brodsky M, Lew M, et al. Long-term efficacy and safety of botulinum toxin type A (Dysport) in cervical dystonia. Parkinsonism Relat Disord. 2010;16:316-323.
  12. Truong D, Duane D, Jankovic J, et al. Efficacy and safety of botulinum type A toxin (Dysport) in cervical dystonia: results of the first US randomized, double-blind, placebo-controlled study. Mov Disord. 2005;20:783-791.
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© Ipsen Group 2019

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© Ipsen Group 2019

Dysport® (abobotulinumtoxinA) for injection, for intramuscular use 300- and 500-Unit vials.
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