Patients receiving onabotulinumtoxinA treatment for chronic migraine (CM) may have coexisting diseases warranting multi-indication use of onabotulinumtoxinA. However, data on safety and treatment patterns for concomitant treatment of CM and other diseases are limited. SYNCHRONIZE was a phase 4, multicenter, retrospective study that explored the safety of onabotulinumtoxinA treatment for ≥ 2 therapeutic (non-aesthetic) indications within 3 months. The observation period of interest was approximately 6 months before and 24 months after receiving treatment for the second indication. The primary outcome was treatment-emergent adverse events (TEAEs) occurring within 6 months. Results are reported descriptively and stratified by treatment indications. This analysis focuses on patients treated for CM and ≥ 1 other onabotulinumtoxinA indication. A total of 183 patients had CM and ≥ 1 other onabotulinumtoxinA indication (CM + cervical dystonia [CD], n = 121; CM + oromandibular dystonia [OD] ± blepharospasm [BS], n = 17; CM + BS or hemifacial spasm [HS], n = 13; CM + CD + other movement disorders [MD], n = 11; CM + spasticity [SP] or focal dystonia [FD], n = 10; CM + hyperhidrosis [HH] ± other MD, n = 5; CM + overactive bladder [OAB] or neurogenic detrusor overactivity [NDO], n = 4; CM + other MD, n = 2). The 3-month mean cumulative onabotulinumtoxinA dose ranged from 163.4 U (CM + OD ± BS) to 396.2 U (CM + SP or FD), and most patients received treatment for their first and subsequent indications within 24 h. The proportion of patients with ≥ 1 TEAE in the 6 months post-index was 23.5
OnabotulinumtoxinA (onabotA) is approved in the US for 12 therapeutic indications. Real-world data on onabotA multi-indication use are limited, often leading to delayed or reduced treatment. This study provides real-world evidence on the safety of onabotA when treating multiple indications concomitantly. SYNCHRONIZE was a multicenter, retrospective, chart-review study evaluating onabotA’s safety for adults treated for ≥2 therapeutic indications within a 3-month period. The primary outcome was treatment-emergent adverse events (TEAEs) within 6 months post-treatment. A total of 279 patients were included. The most common concomitant indications treated were cervical dystonia and chronic migraine (43.4%). The average 3-month cumulative dose for multiple indications was 282.2 U. The treatment interval for multiple indications was ≤24 h for most patients (62.4%). Overall, 28.7% of patients reported ≥1 TEAE with no apparent trends in TEAEs and dose interval or cumulative dose. Reported TEAEs included UTI (5.7%), neck pain (5.0%), and headache (4.3%). No patient had a lack of effect according to clinical objective measurements. SYNCHRONIZE described the real-world safety of onabotA for patients treated concomitantly for ≥2 indications within a 3-month period. TEAEs were generally consistent with the known safety profiles of individual indications. No new safety signals were identified).
OBJECTIVE:To assess changes in real-world use of acute and preventive medications for migraine over a 12-month follow-up period in the United States following initiation of the anti-calcitonin gene-related peptide (CGRP) pathway monoclonal antibody (mAb) erenumab. BACKGROUND:Early assessments of real-world use of acute and preventive medications for migraine after initiation of erenumab have been limited to 6 months of follow-up. METHODS:This retrospective cohort study used data from the IQVIA open-source longitudinal prescription (LRx) and medical (Dx) claims databases. Adult patients with an initial claim (index date) for erenumab between May 2018 and April 2020 were identified. RESULTS:Among 201,176 patients who met inclusion criteria, the mean (standard deviation [SD]) age was 47.5 (13.8) years and 85.6% (n = 172,153) were female. Most patients used one or more acute (88.4%; n = 177,795) and one or more traditional preventive (86.1%; n = 173,225) medications during the 12-month pre-index period. Adherence to erenumab (proportion of days covered [PDC] ≥0.80) was 40.2% (n = 80,927) with an overall mean (SD) PDC of 0.60 (0.34). Among all patients, 70.0% (n = 140,809) discontinued erenumab. After accounting for 24.7% (n = 49,720) of patients who restarted erenumab, discontinuation without reinitiation was observed in 45.3% (n = 91,089) of total patients. Switching to a different anti-CGRP pathway mAb was observed in 13.1% (n = 26,446) of total patients. Among 177,795 patients with pre-index use of one or more acute migraine medication class, 86.5% (n = 153,788) had post-index use of the same class, and 56.7% (87,134/153,788) of them discontinued one or more class of acute medication in the 12-month follow-up period. Similarly, among 173,225 patients with pre-index use of one or more traditional migraine preventive medication class, 67.7% (n = 117,274) had post-index use of the same class, and 46.7% (54,790/117,274) of them discontinued one or more class of traditional preventive medication in the 12-month follow-up period. CONCLUSIONS:In this long-term study, we observed the discontinuation of both acute and preventive medications for migraine post-erenumab initiation.
Longer periods between headache episodes (interictal periods) may provide greater time for the nervous system to reset from a previous episode, potentially improving disease status and health-related quality of life. This post hoc analysis evaluated this hypothesis by associating patients’ longest interictal periods with improvements in patient-reported outcomes. PROMISE-2 (NCT02974153) was a double-blind, placebo-controlled study evaluating eptinezumab for preventive treatment of chronic migraine (N = 1072). Daily electronic diary data from Weeks 1–12 and Weeks 1–24 were used to identify interictal periods, defined as days between headache episodes. For each patient, the longest interictal period within these intervals was identified and categorized (1–4, 5–9, 10–14, > 14, and > 21 days). For each category, the following patient-reported outcomes were assessed: 6-item Headache Impact Test (HIT-6), Patient Global Impression of Change (PGIC), and patient-identified most bothersome symptom (PI-MBS). Excluding interictal periods with > 10
Combination use of atogepant and onabotulinumtoxinA has the potential to be more effective than either alone for the preventive treatment of chronic migraine (CM) due to their complementary mechanisms of action. This analysis collected real-world data to evaluate the safety, tolerability, and effectiveness of adding atogepant to onabotulinumtoxinA as a combination preventive treatment for CM. This retrospective, longitudinal, multicenter chart review included adults with CM who received ≥ 2 consecutive cycles of onabotulinumtoxinA before ≥ 1 month of onabotulinumtoxinA and atogepant combination treatment. Charts at atogepant prescription (index date) and two subsequent onabotulinumtoxinA treatment visits ( 3 and 6 months post-index) were reviewed for change from baseline in monthly headache days (MHDs), ≥ 50
