GAMMAGARD LIQUID is indicated as a therapy to improve neuromuscular disability and impairment in adult patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

LIMITATIONS OF USE:  GAMMAGARD LIQUID has not been studied in immunoglobulin-naive patients with CIDP. GAMMAGARD LIQUID maintenance therapy in CIDP has not been studied for periods longer than 6 months. After responding during an initial treatment period, not all patients require indefinite maintenance therapy with GAMMAGARD LIQUID in order to remain free of CIDP symptoms. Individualize the duration of any treatment beyond 6 months based upon the patient’s response and demonstrated need for continued therapy.

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    GAMMAGARD LIQUID

    CIDP Clinical Trial Results

    CIDP = chronic inflammatory demyelinating polyneuropathy.

    Demonstrated improvement of functional disability1

    Study Design

    In a prospective, open-label, single-arm, multicenter clinical study, a total of 18 patients with CIDP who developed a relapse in Epoch 1 and received GAMMAGARD LIQUID in Epoch 2 were included in efficacy analyses; safety was evaluated in 20 patients. GAMMAGARD LIQUID was administered at an induction dose of 2 g/kg body weight, followed by maintenance infusions at every 3 weeks for a period of 6 months. The dose of GAMMAGARD LIQUID treatment could be adjusted at the investigator's discretion. Adjustments to the dosing interval of every 3 weeks were not allowed. All patients completed the study. All dosed patients were analyzed for efficacy and safety.  

    Efficacy in Epoch 2 was based on responder rate, where a responder was defined as a patient who demonstrated an improvement of functional disability, indicated by at least a 1 point decrease in the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score at the completion of the IV treatment period (6 months) or the last study visit of the IV treatment period, relative to pre-IV treatment baseline. The responder rate was 94.4% (N=18, 95% CI: 74.2% to 99.0%). The adjusted INCAT score returned to baseline values prior to joining the study in 17 of the 18 patients (94.4%) at 6 months. All subjects (N=18) had improvement in functional ability. Functional ability was a composite measure based on meeting any of the following criteria: decrease of ≥1 point in the adjusted INCAT disability score, increase of ≥8 kPa in hand grip strength in the more affected hand, or increase of ≥4 points in raw summed RODs score.

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    Primary endpoint based on 1-point decrease in adjusted INCAT disability score

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    Improvement of functional disability

    94% of patients (N=18) with CIDP saw an improvement of functional disability. The mean adjusted INCAT score showed an improvement by 2.1 points. 

    Other endpoints* include:

    *Study was not designed to control for multiplicity, therefore no definitive conclusions may be drawn from this information.

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    MRC

    Medical Research Council (MRC) sum score improved by a mean of 5.4 points. 

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    RODS

    The mean change in centile Rasch-built Overall Disability Scale (RODS) score was 15.0 points. 

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    Grip strength

    Grip strength improved by a mean of 13.8 kPa in the more affected hand and 9.8 kPa in the less affected hand. 

    INCAT = Inflammatory Neuropathy Cause and Treatment.

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    Reference:

    1. GAMMAGARD LIQUID. Prescribing Information. Takeda Pharmaceuticals U.S.A., Inc.; 2024.