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Knupp KG, Coryell J, Nickels KC, Ryan N, Leister E, Loddenkemper T, Grinspan Z, Hartman AL, Kossoff EH, Gaillard WD, Mytinger JR, Joshi S, Shellhaas RA, Sullivan J, Dlugos D, Hamikawa L, Berg AT, Millichap J, Nordli DR, Wirrell E; the Pediatric Epilepsy Research Consortium—Annals of Neurology, 2016
Assess early and sustained response to Acthar Gel and other treatments for IS of varied etiologies, based on clinical remission and resolution of hypsarrhythmia
A multicenter, prospective study of 230 infants diagnosed with IS from the National Infantile Spasms Consortium (NISC)
Dosing recommendations were provided to all 22 NISC centers1
IM=intramuscular; NISC=National Infantile Spasms Consortium; PERC=Pediatric Epilepsy Research Consortium.
*If no clinical response by Day 14, consider alternative treatment.
†Side effects (eg, sedation, hypotonia) may necessitate slower titration.
‡If there is no clinical response after day 7 (ie, no 24 hour period free of IS), the dose can be increased to 20 mg 3 times daily. If done, the taper schedule from Days 15 to 19 would be 10 mg 4 times daily, then proceed as in the table beginning on Day 20.
Response was categorized according to study criteria1
Primary analyses classified patients as "Responders" or "Nonresponders."
§When hypsarrhythmia was present at IS onset.
Acthar Gel: initial and sustained response rates1
Acthar Gel was most often the first treatment choice:
A 68% response rate occurred with Acthar Gel at 2 weeks
*Response did not reach statistical significance vs glucocorticoids.
Standard therapeutic agents generated significantly higher overall response rates than nonstandard therapy1
The response rate in the Acthar Gel group was significantly higher than the nonstandard therapy group (P<.01).
High-dose Acthar Gel showed a trend for higher response rates
†High-dose was defined as >140 units/m2/day at initiation of medication.
Sustained efficacy: Acthar Gel showed significant response at 3 months vs vigabatrin1
The sustained response rate (3 months) in the Acthar Gel group was significantly higher than the vigabatrin group (P=.038) and marginally higher than the glucocorticoid group (P=.06).1
Insights and considerations1
Start the referral process for your appropriate patients
Acthar® Gel is indicated for:
Contraindications
Acthar is contraindicated:
Warnings and Precautions
Adverse Reactions
Pregnancy
Please see full Prescribing Information for additional Important Safety Information.
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