Efficacy

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Dysport Efficacy

Based on trials with 252 patients, Dysport has been proven to significantly reduce the severity of abnormal head position and neck muscle pain associated with cervical dystonia for 3-4 months or longer. In clinical studies, symptom relief was observed regardless of disease severity at baseline, extent of underlying pain, or history of treatment with botulinum toxin.

Significant symptom relief with Dysport Time to retreatment with Dysport Significant reduction in neck pain Long-term responses after multiple treatments

Improved symptoms1,2

  • Benefits seen in patients with or without a history of botulinum toxin use1
*Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) evaluates the severity of dystonia, patient perceived disability from dystonia, and pain.

†Statistically significant.

Study design: Randomized, double-blind, placebo-controlled, single-dose, parallel group study to evaluate the safety and efficacy of Dysport in the treatment of cervical dystonia patients. Starting dose of 500 Units of Dysport was divided among affected muscles. TWSTRS-Total Score at Week 4 was the primary study endpoint. TWSTRS-Total Score at Week 8 was a secondary endpoint.

  • Symptom relief‡ with Dysport was observed regardless of:
    • Disease severity at baseline1
    • Extent of underlying pain1
    • History of treatment with botulinum toxin1
‡Based on change from baseline at Week 4 in TWSTRS-Total Score, evaluating severity of dystonia, patient perceived disability, and pain.

References:

1. Dysport Prescribing Information. Ipsen. April 2010. 2. 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.

Median time to retreatment was 14 weeks

*Retreatment determined by clinical need after a minimum of 12 weeks.

Study design: Two long-term, open-label extensions of placebo-controlled trials that allowed titration in 250 Unit steps to doses in a range of 250 to 1000 Units, after the initial dose of 500 Units. Of the 239 patients, 55 patients discontinued participation prior to study completion.

  • 25% of patients were not retreated for at least 18 weeks
  • Retreatment with Dysport should occur every 12 to 16 weeks or longer, as necessary, based on return of clinical symptoms1
  • Retreatment should not occur in intervals of less than 12 weeks1
Reference:

1. Dysport Prescribing Information. Ipsen. April 2010.

Dysport relieves neck pain1

*VAS=visual analogue scale.
†Statistically significant.
‡At Week 4, 37 patients receiving Dysport and 42 patients receiving placebo were evaluable. At Week 8, 22 patients receiving Dysport and 15 patients receiving placebo were evaluable.

Study design: Randomized, double-blind, placebo-controlled, single-dose, parallel group study to evaluate the safety and efficacy of Dysport in the treatment of cervical dystonia patients. Starting dose of 500 Units of Dysport was divided among affected muscles. On a 100-point scale, baseline VAS score (patient self-rated) was 48.6 in the Dysport group and 52.9 in the placebo group. TWSTRS-Total Score at Week 4 was the primary study endpoint. Secondary endpoints were change in Pain VAS and patient assessment of signs and symptoms at Week 4 compared with baseline. Change in VAS at Week 8 was a tertiary endpoint.

Reference:

1. Truong D, Duane DD, 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.

Results with repeated treatments in open-label extension study1

Study design: Long-term, open-label extension of placebo-controlled trial that allowed titration in 250 Unit steps to doses in a range of 250 to 1000 Units, after the initial dose of 500 Units. Baseline and 4-week follow-up scores were recorded for each treatment.

  • In a long-term, open-label extension study, TWSTRS-Total Scores at 4-week follow-up were reduced from baseline after each treatment

Rates of neutralizing antibodies

  • Approximately 3% of patients developed antibodies (binding or neutralizing) over time with Dysport treatment2
    • The significance of these antibodies is unknown, since in the presence of binding and neutralizing antibodies, some patients may continue to experience clinical benefit2
References:

1. 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. 2. Dysport Prescribing Information. Ipsen. April 2010.

Indication

Dysport is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain in both toxin-naïve and previously treated patients.

Important Safety Information

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 spasticity in children and adults, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses.

Dysport is contraindicated in patients with hypersensitivity to any botulinum toxin product or its excipients, including human albumin, lactose, and cow's milk protein, or who have an infection at the proposed injection site.

The potency Units of Dysport 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. Recommended dose and frequency of administration should not be exceeded.

Immediate medical attention may be required in cases of respiratory, speech, or swallowing difficulties. 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. Concomitant neuromuscular disorder may exacerbate clinical effects of treatment.

Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders 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.

Dysport contains human albumin. Based on effective donor screening and product manufacturing processes, Dysport carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.

The possibility of an immune reaction when injected intradermally is unknown. The safety of Dysport for the treatment of hyperhidrosis has not been established.

Patients receiving concomitant treatment 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 may potentiate systemic anticholinergic effects. The effect of administering different botulinum neurotoxins during the course of treatment with Dysport is unknown.

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.

The most commonly observed adverse reactions (>5% of patients) with Dysport for the treatment of cervical dystonia are muscular weakness, dysphagia, dry mouth, injection site discomfort, fatigue, headache, neck pain, musculoskeletal pain, dysphonia, injection site pain, and eye disorders.

To report SUSPECTED ADVERSE REACTIONS or product complaints, contact Ipsen at 1-877-397-7671 (877- DYSPOR1). 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.

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