AE = adverse event
AE = adverse event. in weekly headache days of at least moderate intensity, both doses were superior to placebo at week 2 (= 0.031 and = 0.005). Conclusions: TEV-48125 demonstrated a significant improvement within 1 week of therapy initiation in patients with CM. Classification of evidence: This study provides Class II evidence that for patients with CM, TEV-48125 significantly decreases the number of headache SGK2 hours within 3 to 7 days of injection. Chronic migraine (CM) is characterized by headaches occurring on at least 15 days per month, with at least 8 days of migraine per month.1 It affects approximately 1% of mTOR inhibitor-2 the adult population2,3 and is the most frequently seen headache syndrome at major headache clinics and neurology specialty centers.4,5 On the basis of ictal disability alone, migraine was ranked sixth highest among specific causes of disability globally.6,7 Migraine-related disability is classified by the World Health Organization as more burdensome than paraplegia, deafness, or angina, and at the same level as psychosis and quadriplegia.8 Furthermore, relative to individuals with episodic migraine or without headaches, those with CM are significantly more likely to be unemployed or employable but not actively working for pay. 9 Individuals with CM are also significantly more likely to be divorced and to have psychological comorbidities.9 Despite its enormous burden, CM is undertreated. Effective treatment, at a minimum, requires consultation with a physician, an accurate diagnosis, and receiving appropriate treatment. In the United States, less than 5% of persons with CM are able to traverse mTOR inhibitor-2 all 3 of these hurdles, and only a third of those with CM receive preventive medications.10 Furthermore, 1-year adherence to labeled or off-label migraine preventive medication among individuals with mTOR inhibitor-2 CM occurs in less than 20% of patients. The most important reasons for discontinuation of preventive medications among individuals with CM appear to be incomplete efficacy, as well as slow time to reach meaningful efficacy, and poor tolerability.10,11 It has been suggested that fast onset of efficacy of migraine drugs may have significant implications for patients, since it would favor compliance and improve long-term outcomes.12 TEV-48125 is a fully humanized monoclonal antibody that potently and selectively binds to calcitonin gene-related peptide (CGRP).13 Its efficacy in the preventive treatment of CM was demonstrated in a large phase 2b study, where both tested doses separated from placebo after 1 month of therapy for primary, secondary, and exploratory endpoints.14 Since statistically significant effects were seen very early in that trial, herein we conducted post hoc analyses to evaluate the efficacy of 2 doses of subcutaneous TEV-48125 within the first few weeks of therapy in patients with CM. METHODS Study design and patients. The current study represents post hoc analyses conducted as part of a phase 2b trial assessing the efficacy of TEV-48125 in the preventive treatment of CM in adults.14 The randomized, double-blind, placebo-controlled, phase 2b study was conducted at 62 sites in the United States (headache centers, neurology clinics, and primary care facilities) and an independent clinical research organization, NCGS, monitored the study, assessing for appropriate patient eligibility, protocol adherence, and completeness and accuracy of case report entries. Eligible study participants were men or women aged 18 to 65 years with a history of CM as per the values presented are nominal without multiplicity adjustment. Analyses were conducted with SAS version 9.2 (SAS Institute, Cary, NC). mTOR inhibitor-2 RESULTS Eligibility mTOR inhibitor-2 screening for the phase 2 study began in.