Improvement in mNIS 7 from patisiran treatment was also consistently observed across all defined patient subgroups, including age, sex, race, geographic region, baseline neuropathy impairment, genotype, prior TTR stabilizer use, baseline familial amyloid polyneuropathy (FAP) stage, and inclusion in the pre specified cardiac subpopulation.Patisiran treatment resulted in a negative 6.7 point mean change (improvement) in Norfolk Quality of Life Diabetic Neuropathy (Norfolk QOL DN) score from baseline at 18 months as compared to a 14.4 point mean increase (worsening) reported for the placebo group, resulting in a mean 21.1 point difference relative to placebo (p=1.10 x 10 10).Improvements in mNIS 7 and Norfolk QOL DN with patisiran were also seen at nine months, the earliest time point for these measurements in the study with a mean 16.0 and a mean 15.0 point difference observed, respectively, relative to placebo.In a pre specified binary analysis of neurological improvement, 56 percent (95 percent CI: 48.1, 64.1) of patisiran patients had an improvement in mNIS 7 (less than 0 point change compared to baseline at 18 months), while 4 percent (95 percent CI: 0.0, 8.2) of placebo patients had an improvement (p=1.82 x 10 15).Similarly, 51 percent (95 percent CI: 43.3, 59.4) of patisiran patients had an improvement in Norfolk QOL DN (less than 0 point change compared to baseline at 18 months), versus 10 percent (95 percent CI: 3.6, 17.2) for placebo (p=1.95 x 10 10).Patisiran also demonstrated statistically significant and clinically meaningful improvements over placebo in all other secondary endpoints at 18 months, including: NIS W (p=1.40 x 10 13), the subdomain of mNIS 7 assessing muscle strength; Rasch built Overall Disability Scale (R ODS) (p=4.07 x 10 16), a patient reported outcome measure of daily living and disability; timed ten meter walk test (10 MWT) (p=1.88 x 10 12), assessing ambulatory ability and gait speed; modified body mass index (mBMI) (p=8.83 x 10 11), assessing nutritional status; and, COMPASS 31 (p=0.0008), a patient questionnaire assessing autonomic disease symptoms.Patisiran treatment resulted in a median decrease (improvement) of 49.9 pg/ml in NT proBNP levels as compared to a median increase (worsening) of 320 pg/ml reported for the placebo arm at 18 months (nominal p=7.74 x 10 8, based on analysis of log transformed values).Regarding echocardiographic measures, patisiran treatment resulted in a mean 0.93 mm reduction (improvement) in left ventricular (LV) wall thickness (nominal p=0.0173) and a mean absolute 1.37 percent improvement in longitudinal strain (nominal p=0.0154) relative to placebo.Regarding functional measures in the cardiac subpopulation, patisiran treatment resulted in a 0.35 m/sec increase (improvement) in 10 MWT (nominal p=7.42 x 10 9) relative to placebo at 18 months.Changes relative to baseline were also measured for troponin I, LV mass, and LV ejection fraction but were not statistically significant. „The exciting APOLLO data that were released today demonstrate the potential of patisiran to alleviate the multiple neurological, cardiac, and autonomic manifestations of the disease. If approved, I believe that patisiran could have a tremendous impact for patients and physicians in the amyloidosis Replica Hermes community.

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