Acthar has been proven in multiple clinical trials to stop spasms and resolve hypsarrhythmia, thereby satisfying the AAN and CNS guidelines.1-3,5,11-16

In fact, in the pivotal clinical study, 86.7% of children had no spasms and no hypsarrhythmia by week 2 after injections of Acthar 75 U/m2 twice a day compared to 28.6% of patients who received prednisone.2,3

Acthar was shown to be efficacious in symptomatic and cryptogenic cases of IS2,3

  • In the pivotal prospective, randomized, single-blind, crossover efficacy study for Acthar:
    • A 2-week course of high-dose Acthar (75 U/m2 BID) was superior to prednisone 1 mg/kg BID for both cessation of spasms and resolution of hypsarrhythmia
    • Acthar stopped spasms and eliminated hypsarrhythmia in both cryptogenic and symptomatic (including tuberous sclerosis [TS]) cases of IS (n=15)

    aP=0.0015 vs prednisone 1 mg/kg BID.

    Of the 10 infants who did not respond to prednisone, 8 received Acthar and 7 (87.5%) responded.1

    Of the 2 infants who did not respond to Acthar, 2 received prednisone and 1 (50.0%) responded.1

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 occur 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.

Acthar treatment resulted in early (2 weeks) and sustained (3 months) responses17

A US, multicenter, prospective, real-world study of 230 patients evaluated clinical remission and resolution of hypsarrhythmia.

at 2 weeks (P=0.027)

68% for Acthar
(66 of 97 patients)
49% for vigabatrin
(23 of 47 patients)

at 3 months (P=0.038)

55% for Acthar
(53 of 97 patients)
36% for vigabatrin
(17 of 47 patients)

Common adverse reactions for Acthar are similar to those of corticosteroids and include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite, and weight gain.

To ensure increased efficacy, Acthar should be dosed as recommended by the FDA1-3,11-16

In an independent analysis of previously published data from randomized controlled trials, greater overall efficacy of Acthar was seen with BID administration than QD administration.3,11-16

Cessation of Spasms and Resolution of Hypsarrhythmia

Acthar should never be administered intravenously. Acthar is contraindicated where congenital infections are suspected in infants. Acthar can cause GI bleeding and gastric ulcer. There is also an increased risk for perforation in patients with certain gastrointestinal disorders. Monitor for signs of bleeding.

Previously published data from nonrandomized controlled trials were consistent with this analysis

  • 80% (4 of 5 patients) overall response rate when dosed 100 to 150 U/m2/d (40-80 U/d)3,11
  • 93% (14 of 15 patients) and 97% (29 of 30 patients) overall response rate when dosed 75 U/m2 BID3,12,13

Helpful Resources

Step-by-Step Injection Training Guide

Download this convenient and easy-to-follow Injection Training Guide for caregivers of children with IS.

Physician Referral/Prescription Form

Download for your practice to complete.

Take the guesswork out of dosing Acthar for IS

From per-injection volume to number of vials, our calculator does it all.