ICE Study Results
Patients receiving GAMMAKED in
the ICE study experienced:
1. Lower probability of relapse1,2:
> The probability of relapse for patients receiving
GAMMAKED was 13% vs 45% for those receiving
> Patients receiving GAMMAKED had a longer time to
relapse vs patients receiving placebo
> Withdrawal of therapy (re-randomization to placebo)
increased the risk of CIDP relapse
2. Improved physical functioning3:
Long-term therapy with GAMMAKED improved physical functioning in patients with CIDP.
ICE study participants were assessed using the Short Form-36 (SF-36) health survey. SF-36 physical component domain scores were recorded at screening and again at the end of each period.
> Significant improvements from baseline were
observed in SF-36 domain scores for:
– Physical functioning (such as the ability to
walk or climb stairs)4
– Role-physical (activities of daily living,
3. Continued improvement over the full 24 weeks of therapy5:
> Among CIDP patients who responded* to GAMMAKED:
– 47% initially responded by week 3
– 53% initially responded by week 6
Cumulative number of responders reaching maximum improvement† in INCAT scores
> The number of patients reaching their maximal improvement continued to increase for the full duration of
GAMMAKED therapy (24 weeks)
> Discontinuing GAMMAKED treatment before maximal improvement is achieved may deprive patients the
full therapeutic benefit, such as the abilities to walk or dress unaided6
*Responders were defined as patients who maintained an improvement of ≥ 1 point in adjusted INCAT
score through week 24
† An individual patient’s maximal INCAT score over the course of the ICE study
Adverse reactions in CIDP2
In clinical studies, the most common adverse reactions with GAMMAKED (≥5% of subjects) were, headache, fever, chills, hypertension, rash, nausea, and asthenia (for CIDP).
References: 1. Hughes RAC, Donofrio P, Bril V, et al, on behalf of the ICE Study Group. Intravenous immune globulin (10% caprylate-chromatography purified) for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (ICE study); a randomized placebo-controlled trial. Lancet Neurol. 2008;7:136-44. 2. GAMMAKED [prescribing information]. Fort Lee, NJ: Kedrion Biopharma Inc.; 2016. 3. Merkies ISJ, Bril V, Dalakas MC, et al. Health-related quality-of-life improvements in CIDP with immune globulin IV 10%: The ICE study. Neurology. 2009;72:1337-44. 4. McHorney CA, Ware JE, Lu JFR, Sherbourne CD. The MOS 36-item short-form health survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care. 1994;1:40-66. 5. Latov N, Deng C, Dalakas MC, et al, on behalf of the ICE Study Group. Timing and course of clinical response to intravenous immunoglobulin in chronic inflammatory demyelinating polyradiculoneuropathy. Arch Neurol. 2010;67(7):802-807. 6. Merkies ISJ, Schmitz PIM, van der Meche FGA, et al, for the INCAT group. Clinimetric evaluation of a new overall disability scale in immune mediated polyneuropathies. J Neurol Neurosurg Psychiatry. 2002;72:596-601.