Gammaked Background

Clinical CIDP Information

GAMMAKED SIGNIFICANTLY IMPROVED PATIENT OUTCOMES, AS MEASURED BY THE INCAT DISABILITY SCORE 

Disability scores (INCAT) maintained significant improvement through week 241

Responders were defined as patients who maintained an improvement of ≥ 1 point in adjusted INCAT (Inflammatory Neuropathy Cause and Treatment) score through week 24.1

From a 24-week multicenter, randomized, double-blind, placebo-controlled trial. The efficacy period and the crossover treatment started with a loading dose of 2 g/kg body weight of Gammaked or equal volume of placebo given over 2-4 consecutive days. All other infusions were given as maintenance doses of 1 g/kg bw (or equivalent volume of placebo) every three weeks.

Using the 10-point INCAT scale, a validated assessment tool in neuropathy clinical research, patients were scored on their ability to walk (0-5) and on their ability to perform arm functions (0-5).

Significantly more patients were relapse free when given Gammaked every 3 weeks during the 24-week randomized withdrawal period (= 0.011)1

  • The probability of relapse was 13% with Gammaked versus 45% with placebo (hazard ratio, 0.19; 95% confidence interval, 0.05, 0.70)

The 24-week randomized withdrawal period included a subset of previous Gammaked responders (n = 57). The responders (n = 57) were randomly assigned to continue to receive Gammaked (n = 31) or placebo (n = 26).

 

Reference: 1. GAMMAKED [package insert]. Fort Lee, NJ; Kedrion Biopharma Inc.; 2013.