Erenumab Outperforms Topiramate in PROs, Atogepant Dose-Dependent With Weight Changes, Vutrisiran FDA-Approved for ATTR Amyloidosis


Neurology News Network for the week ending June 18, 2022. [WATCH TIME: 3 minutes]

WATCH TIME: 3 minutes

Welcome to this special edition of Neurology News Network. I’m Marco Meglio.

Data from the HER-MES study (NCT03828539), a comparator trial between erenumab (Aimovig; Amgen) and topiramate (Topamax; Janssen), showed that patients with migraine on erenumab performed better on patient reported outcomes, including Headache Impact Test (HIT-6) and Short Form 36 Health Survey Questionnaire, version 2 (SF-36 v2). The study compared adult patients with migraine who were randomized 1:1 to subcutaneous monthly erenumab 70 mg or 140 mg (n = 389), the first FDA approved calcitonin gene-related peptide (CGRP) inhibitor, or topiramate oral daily 50 to 100 mg (n = 388). In total, 72.2% of those on erenumab achieved relevant improvement on HIT-6, as shown by reductions of at least 5 points (<.001). On SF-36 v2 scores, 47.7% and 25.3% of those in the erenumab group demonstrated at least 5-point improvements on PCS and MCS, respectively, compared with 37.4% and 16.8% of those on topiramate.

Atogepant (Qulipta; AbbVie), an oral, calcitonin gene-related peptide (CGRP) receptor antagonist FDA-approved for the prevention of migraine, was found to be associated with dose-dependent decreases in body weight, according to new post-hoc data from the phase 3 ADVANCE study. Presented at the 2022 American Headache Society (AHS) Annual Meeting, June 9-12, in Denver, Colorado, the results showed a least square (LS) mean percentage change in body weight of +0.37 in the placebo group after 12 weeks compared with +0.14 (= 0.4138), –0.61 (= .0005), and –1.27 (<.0001), in the atogepant 10-, 30-, and 60-mg groups, respectively. Atogepant is a relatively young drug within the field, gaining the FDA greenlight in September 2021 and becoming the second overall member of the gepant class to receive approval.In ADVANCE, 3.2% of those on placebo demonstrated at least 7% weight loss compared with 4.1%, 2.7%, and 5.7% for the atogepant 10-, 30-, and 60-mg groups, respectively. In contrast, weight gains of at least 7% were found in 2.3%, 1.8%, and 0.0% of those in the respective atogepant groups and 2.7% of those on placebo.

After the FDA first extended its review by an additional 3 months, the agency approved Alnylam’s investigational subcutaneous RNA interface therapy vutrisiran, marketed as Amvuttra, for the treatment of ATTR amyloidosis.The RNAi therapeutic administered once every 3 months was approved based on positive 9-month results from the phase 3 HELIOS-A study (NCT03759379). Results from the study showed that the treatment met the primary end point of change from baseline in the modified Neuropathy Impairment Score (mNIS+7) at 9 months (<.001). Additionally, vutrisiran achieved statistically significant results (<.001) on secondary measures such as the Norfolk Quality of Life Questionnaire–Diabetic Neuropathy (Norfolk QoL-DN) and timed 10-meter walk test (10-MWT) as compared with historical placebo results. HELIOS-A was a global, open-label, multicenter study that evaluated 164 patients with hATTR amyloidosis who were randomized 3:1 to either 25 mg of vutrisiran (n = 122) or 0.3 mg/kg of patrisiran (Onpratto; Alnylam) (n = 42) via intravenous infusion once every 3 weeks for 18 months.

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