Uncover the efficacy demonstrated in the ICE study
THE ICE STUDY—THE LONGEST STUDY OF AN IVIG TREATMENT OPTION FOR CIDP2
The ICE study led to an FDA indication for GAMUNEX-C in CIDP and established IVIG as a level A recommendation in the EFNS/PNS* CIDP guidelines.2,3
ALL GAMUNEX-C RESPONDERS DOSED ACCORDING TO THE ICE STUDY ACHIEVED MAXIMAL RESPONSE AT 24 WEEKS
First-period responders on the INCAT† disability score with treatment every 3 weeks4
All the patients who responded at Week 3 showed maximal improvement in disability scores at Week 24 with steady GAMUNEX-C dosing as prescribed in the ICE study.4
STEADY DOSING OF GAMUNEX-C IN THE ICE STUDY SHOWED SIGNIFICANT
IMPROVEMENTS IN MULTIPLE PARAMETERS AT 24 WEEKS2,5
"…discontinuing IVIG treatment before maximal improvement in CIDP is achieved may deprive patients of the full therapeutic benefit." —Latov N, et al.4
MORE THAN 87% OF RESPONDERS WERE RELAPSE-FREE AT 48 WEEKS
Percentage of responders who were relapse-free in the extension period of the ICE study2
Phase 3, randomized, double-blind, placebo-controlled, multinational, multicenter study. A landmark 48-week study of 117 adult patients with CIDP that included an initial efficacy period (with a response-conditional crossover period) and an extension phase. Primary endpoint: Percentage of adjusted-INCAT responders who completed the first period without crossing over and maintained improvement ≥1 point through week 24. Modified intent-to-treat population.2
Get the ICE study from Lancet Neurology.
Monitor the patient's response using subjective and objective tests before tapering treatment.
It's vital to treat appropriately from the beginning and continue with the dosing protocol proven in the ICE study to diminish the demyelination taking place in the body. 2,6 This can allow time for remyelination of the damaged nerves.7
GAMUNEX-C is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. It is contraindicated in IgA-deficient patients with antibodies against IgA and history of hypersensitivity.
ADVERSE REACTIONS IN CIDP TRIAL
In CIDP, the most common adverse reactions with GAMUNEX-C were headache, pyrexia, hypertension, chills, rash, nausea, arthralgia, and asthenia. The most serious adverse reaction was pulmonary embolism (PE) in 1 subject with a history of PE.
GAMUNEX-C is a proven formulation for a wide range of patients.8,9
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*EFNS/PNS, European Federation of Neurological Societies/Peripheral Nerve Society.
†INCAT, Inflammatory Neuropathy Cause and Treatment.