Data at MDS International Congress of Parkinson's Disease and Movement Disorders demonstrates comparable improvement over time in tardive dyskinesia severity and impact following treatment With Ingrezza.- Neurocrine Biosciences Inc.
Neurocrine Biosciences, Inc. presented findings from a data analysis of KINECT-4 demonstrating a comparable pattern of improvement over time of clinician-rated tardive dyskinesia (TD) severity and awareness/distress as measured by the Abnormal Involuntary Movement Scale (AIMS) and patient-reported TD impact as measured by the Trajectories of Tardive Dyskinesia Impact Scale (TDIS).
The data (Poster #657) was presented at the MDS International Congress of Parkinson's Disease and Movement Disorders in Copenhagen, Denmark.
The data analysis evaluated the use of Ingrezza for the treatment of TD among all 167 patients with either schizophrenia or mood disorders enrolled over the course of the Phase III, open-label, long-term study. On average, the analysis suggested that clinician-rated TD severity as measured by AIMS and patient-reported assessment of the physical, social and emotional impact of TD as measured by TDIS decreased with one-capsule, once-daily Ingrezza treatment over the course of the 48-week study. Researchers concluded that the use of AIMS and TDIS in evaluating symptom improvement during treatment may give a more complementary understanding regarding the patient's TD experience.
"The use of AIMS and TDIS provides a more complete perspective on the patient's TD experience," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. "While AIMS is helpful to assess TD severity as perceived by the healthcare provider and to follow the severity of TD over time, TDIS enables us to assess the physical, social and emotional impact of these involuntary movements from the patient perspective. The insight gained from these data also supports the efficacy of treatment with Ingrezza in reducing both HCP-perceived severity and patient-reported impact of TD."
The study showed that though AIMS and TDIS measure unique aspects of TD, TDIS demonstrated a comparable pattern of improvement to the AIMS total score, TD severity as measured by AIMS item 8 (AIMS8), incapacitation as measured by AIMS item 9 (AIMS9) and awareness/distress as measured by AIMS item 10 (AIMS10) over the 48-week treatment period.
Key results from the analysis demonstrated the following : i. Mean AIMS total score at baseline was 14.6 and decreased over 48 weeks, with a mean change from baseline of -10.2 (standard deviation [SD]=1.2) for the 40 mg cohort and -11.0 (SD=0.5) for the 80 mg cohort, as assessed by site raters. (n=163). ii. At baseline, TD severity was moderate (AIMS8 mean=3.2) and most patients were aware of TD with moderate distress (AIMS10 mean=2.7). TD severity and distress decreased, with most patients scored with minimal severity (AIMS8=1) and as aware/no distress at 48 weeks (AIMS10=1). (n=167). iii. Mean TDIS scores decreased from 16.5 at baseline to 6.0 at Week 48, indicating TD had a moderate impact on activity by the end of the Ingrezza treatment period. (n=167).
Additional presentation at the MDS International Congress of Parkinson's Disease and Movement Disorders includes: Crushing Valbenazine Capsule Contents for Potential Addition to Soft Foods or Administration via G Tube (poster #9).
About the KINECT-4 Phase III Study : KINECT -4 is a Phase III, open-label study, in which 163 participants with moderate to severe TD and underlying schizophrenia, schizoaffective disorder or mood disorder (including bipolar disorder or major depressive disorder) received 48 weeks of open-label treatment with once-daily Ingrezza (40 mg or 80 mg capsules) followed by a four-week washout. Dosing was initiated at 40 mg/day in all participants, with escalation to 80 mg/day at Week 4 based on effectiveness and tolerability. Dose reduction to 40 mg was allowed in participants who could not tolerate the 80 mg dose. Patients were discontinued if the new dose was not tolerated.
Participants experienced TD improvements during long-term treatment as demonstrated by mean change from baseline to Week 48 in AIMS total score (sum of items 1-7, evaluated by site raters) with Ingrezza 40 mg/day (-10.2) or 80 mg/day (-11.0). Consistent with previous studies, Ingrezza was generally well tolerated. After Week 4, treatment emergent adverse events (TEAEs) that occurred in greater than 5 percent of all participants (combined dose groups) were urinary tract infection (8.5 percent) and headache (5.2 percent). Changes from baseline in psychiatric stability, vital signs, electrocardiogram parameters and laboratory test values were generally small and not clinically significant.
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