Mallinckrodt Data from New Company-Sponsored Studies Presented at American Academy of Neurology 69th Annual Meeting
H.P. Acthar Gel has been approved by the
Medical Resource Utilization in Patients with Infantile Spasms after Receipt of Repository Corticotropin Injection (H.P. Acthar Gel): Results of a
Key highlights include:
- A total of 101 physicians (68 neurologists; 33 internal medicine physicians) and 159 patients were reflected in the survey. The top underlying causes of IS in patients included tuberous sclerosis (21 patients), other genetic abnormalities (17 patients), and central nervous system infections (14 patients).
- There was a statistically significant decrease in the number of ER visits (-0.35; 21 percent reduction) and hospitalizations (-0.33; 20 percent reduction) in the three months after completing treatment with H.P. Acthar Gel (all p ≤ 0.02). Among those hospitalized, there was a decrease in the number of direct admissions (-0.11; 12 percent reduction), admissions through the ER (-0.22; 28 percent reduction), and days hospitalized (-1.32; 54 percent reduction).
- A non-significant decrease (-0.28; 10 percent reduction) in outpatient visits was also reported.
- The average age of patients with IS in the survey was eight months. Approximately one-third were female and about half were Caucasian.
Exclusive use of H.P. Acthar Gel was not mandated, and simultaneous use of other agents was not examined. Therefore, observed MRU reductions may not be attributable solely to H.P. Acthar Gel.
The poster is available on the Mallinckrodt website.
The Economic Burden of Moderate-to-Severe Multiple Sclerosis Relapse in
Key highlights include:
- The majority of studies do not address nor differentiate severity. The few studies that do, indicate the cost and impact of relapse increases with relapse severity.
- Two notable studies are those from O'Brien et al., 20033, and Parisé et al., 20134:
- O'Brien et al. reported 90-day direct costs per relapse of high- and moderate-intensity management of
$12,870and $1,847, respectively [2016 amount: $21,544and $3,092]3;
- Parisé et al. reported one-year mean MS-related direct costs per patient of high- and low-to-moderate severity relapse of
$29,355and $18,981, respectively [2016 amount: $33,961and $21,959]4;
- Parisé et al. reported spouse caregiver burden by relapse frequency, not severity.4
- Notably, effects of MS-relapse severity on patient functioning and disability, caregiver burden, and relapse duration are difficult to measure, incorporate, and translate into overall burden, and are not well addressed in the literature.
- The burden of moderate-to-severe relapse remains underappreciated and an unmet need in understanding MS relapse still exists. Implications for relapse awareness, characterization and management should be considered.
The few studies which met the criteria in the literature search used varying designs, relapse definitions, durations and metrics, complicating synthesis and interpretation of results.
The poster is available on the
ABOUT INFANTILE SPASMS
IS is a rare seizure disorder that affects approximately 2,500 children in the U.S. every year.5 It most commonly occurs between four and eight months of age.6 Sometimes called West syndrome, IS demands early identification, diagnosis, and treatment to help limit lasting effects.5 Children with IS generally have one or more of the following symptoms: a certain type of seizure (called "spasms"), a disorganized and chaotic brain-wave pattern called hypsarrhythmia as recorded on an EEG (electroencephalogram).6
ABOUT MULTIPLE SCLEROSIS (MS)
MS is a neurologic disorder that affects the central nervous system (i.e., the brain and spinal cord).7 Symptoms can include fatigue, balance/coordination issues, numbness or tingling, vision problems, muscle spasms, tremors and emotional changes.7 More than eight in 10 people with MS will experience a relapse, or flare-up, that brings new or worsening symptoms.8
About H.P. Acthar® Gel (repository corticotropin injection)
H.P. Acthar Gel is an injectable drug approved by the
- As an orphan monotherapy medication for the treatment of IS in infants and children under 2 years of age.
- Treatment of acute exacerbations of multiple sclerosis in adults.
For more information about Acthar, please visit www.acthar.com. The Full Prescribing Information may be accessed here. The Medication Guide that provides information about the use of H.P. Acthar Gel for the treatment of Infantile Spasms may be accessed here.
Important Safety Information
- Acthar should never be administered intravenously.
- Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of Acthar.
- Acthar is contraindicated where congenital infections are suspected in infants.
- Acthar is contraindicated in patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction or sensitivity to proteins of porcine origins.
- The adverse effects of Acthar are related primarily to its steroidogenic effects.
- Acthar may increase susceptibility to new infection or reactivation of latent infections.
- Suppression of the hypothalamic pituitary adrenal (HPA) axis may occur following prolonged therapy with the potential for adrenal insufficiency after withdrawal of the medication. Adrenal insufficiency may be minimized by tapering of the dose when discontinuing treatment. During recovery of the adrenal gland, patients should be protected from the stress (e.g., trauma or surgery) by the use of corticosteroids. Monitor patients for effects of HPA suppression after stopping treatment.
- Cushing's Syndrome may occur during therapy but generally resolves after therapy is stopped. Monitor patients for signs and symptoms.
- Monitor patients for elevation of blood pressure, salt and water retention, and hypokalemia.
- Acthar often acts by masking symptoms of other diseases/disorders. Monitor patients carefully during and following discontinuation.
- Acthar can cause gastrointestinal (GI) bleeding and gastric ulcer with an increased risk for perforation with certain GI disorders. Monitor for signs of bleeding.
- Acthar may be associated with central nervous system (CNS) effects ranging from euphoria, insomnia, irritability, mood swings, personality changes, depression, and psychosis. Existing conditions may be aggravated.
- Patients with comorbid disease may have that disease worsened. Caution should be used in patients with diabetes and myasthenia gravis.
- Prolonged use of Acthar may produce cataracts, glaucoma and secondary ocular infections.
- Acthar is immunogenic and prolonged use may increase the risk of hypersensitivity reactions.
- There is an enhanced effect in patients with hypothyroidism and those with cirrhosis of liver.
- Long-term use may have negative effects on growth and physical development in children. Monitor pediatric patients.
- Decrease in bone density may occur. Monitor during long-term therapy.
- Pregnancy Class C: Acthar has been shown to have an embryocidal effect and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- Common adverse reactions include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain.
- Specific adverse reactions reported in IS clinical trials in infants and children under 2 years of age included: infection, hypertension, irritability, Cushingoid symptoms, constipation, diarrhea, vomiting, pyrexia, weight gain, increased appetite, decreased appetite, nasal congestion, acne, rash, and cardiac hypertrophy. Convulsions were also reported, but these may actually be occurring because some IS patients progress to other forms of seizures and IS sometimes mask other seizures, which become visible once the clinical spasms from IS resolve.
Please see full Prescribing Information here for additional Important Safety Information. The Medication Guide that provides information about the use of H.P. Acthar Gel for the treatment of Infantile Spasms may be accessed here.
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1 Acthar Prescribing Information. 8.4 Pediatric Use. Available at: http://www.acthar.com/pdf/Acthar-PI.pdf. Accessed
2 Why Acthar for MS Relapse. ActharMSRelapse Website. Available at: https://msfocus.org/Get-Educated/Common-Questions#What is Multiple Sclerosis. Accessed
3 O'Brien JA et al. Cost of managing an episode of relapse in multiple sclerosis in
4 Parisé H et al. Direct and indirect cost burden associated with multiple sclerosis relapses: excess costs of persons with MS and their spouse caregivers.
5 Understanding Infantile Spasms. ActharIS Website. Available at: https://www.actharis.com/what-are-infantile-spasms. Accessed
6 Parent and Caregiver Brochure - Acthar for Infantile Spasms: Commonly asked questions about treatment, Mallinckrodt Website, p. 2. Available at: https://www.actharis.com/docs/acthar-infantile-spasms-brochure.pdf. Accessed
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