Starling, Amaal J.

Objective This post hoc study investigated the relationship between patient response in terms of migraine headache day reduction and patient‐reported outcomes of health‐related quality of life (HRQoL) and disability categories. Background Migraine causes considerable disease‐related disability and negatively impacts HRQoL of patients. Calcitonin gene‐related peptide inhibitors improve these outcomes and may eliminate disability due to migraine in some patients. Methods Analyses used data from 3 double‐blind, placebo (PBO)‐controlled, phase 3 studies in adults with episodic migraine (EM) (EVOLVE‐1: N = 858 and EVOLVE‐2: N = 915) or chronic migraine (CM) (REGAIN: N = 1113). Patients were randomized 2:1:1 to subcutaneous injection of PBO, galcanezumab (GMB) 120 mg, or GMB 240 mg once monthly for 6 months in EVOLVE‐1 and ‐2 and for 3 months in REGAIN. Primary endpoint was overall mean change from baseline in monthly migraine headache days. Patients were divided into 4 response‐level groups based on percent change from baseline (<30%, ≥30% to <50%, ≥50% to <75%, ≥75%). Patient‐reported outcomes included the 14‐item Migraine‐Specific Quality of Life Questionnaire version 2.1 (MSQ) and Migraine Disability Assessment (MIDAS) questionnaire. Results Among patients with migraine, mean improvements from baseline in MSQ domain scores increased with each successive level of migraine headache day response. On a 100‐pt scale, increases in Role Function‐Restrictive score in EM were 16.8 and 36.0 at the <30% and ≥75% response levels, respectively, and for CM were 10.7 and 46.5. Similar patterns in scores were observed for the Role Function‐Preventive and Emotional Function domains. Examination of improvement in MSQ item score by treatment group showed that, in patients with EM, approximately 10 to 20% more GMB‐treated patients (N = 796 for GMB 120 mg and GMB 240 mg) had improvements in all 14 MSQ items compared with PBO‐treated patients (N = 773) (all P < .001). In patients with CM, 3 to 16% more GMB‐treated patients (N = 507) had improvements in the 14 MSQ items compared with PBO (N = 494), though differences were statistically significant in only 19 of 28 comparisons. At baseline, mean MIDAS scores (EM, 33.1; CM, 67.2) indicated severe mean disability for patients with EM and very severe disability for patients with CM. Among patients with EM, 215 of 425 (50.6%) of those treated with GMB 120 mg and 212 of 413 (51.3%) treated with 240 mg had little/no disability due to migraine after 6 months (PBO: 277 of 832 (33.3%), P < .001 for both). Among patients with CM, 50 of 254 (19.7%) of those treated with GMB 120 mg and 54 of 258 (20.9%) treated with 240 mg reached the level of little/no disability after 3 months of treatment (PBO: 70 of 504 (13.9%), P = .045 for 120 mg, P = .017 for 240 mg). Conclusions Because migraine greatly impairs an individual’s ability to participate in activities of daily living, measurements of HRQoL are essential in clinical research. This study showed that function in daily life, as measured by MSQ score, improved as migraine headache days were reduced and that GMB‐treated patients were more likely to see improvement in MSQ item scores compared with PBO‐treated patients. Elimination of migraine‐related disability was also more frequent in GMB‐treated patients compared with placebo‐treated patients.

Introduction Access to headache consultations by a headache specialist is limited. E‐consultations are an efficient approach shown to reduce costs and improve continuity of care with the primary care provider. Indications, suitability, and uptake in the headache population are not well studied. Methods This quality improvement pilot aims to explore the appropriateness of e‐consultations for patients referred to a headache specialist. E‐consultation feasibility was explored through (1) retrospective review of completed face‐to‐face consultations; (2) prospective survey of providers to identify face‐to‐face consultations appropriate for e‐consultation; (3) cross‐sectional review of the current waiting list to assess theoretical triaging to face‐to‐face vs e‐consultation; and (4) prospective review of all e‐consultations requested from an academic headache clinic to improve the understanding of e‐consultation feasibility and referral triage. Results The retrospective review included 75 face‐to‐face consultations with a mean (SD) wait time of 33 (39.4) days for consultations, of which 28/75 (37.3%) were deemed to be feasible e‐consultations. The prospective survey of providers identified 10 face‐to‐face consultations that were felt to be theoretically appropriate for e‐consultation. The cross‐sectional review identified 20 patients on the clinic waiting list, of whom 5/20 (25%) were theoretically triaged to e‐consultation. Finally, the prospective review found 12 requested e‐consultations, of which 6/12 (50%) were for migraine prophylaxis recommendations. Chart data often lacked details for complete assessments, with 5/12 (41.7%) converted to face‐to‐face consultations and only 4/12 (33.3%) deemed appropriate for e‐consultation. Conclusion E‐consultation in headache medicine could be considered if appropriately triaged. Pathways are needed to reach patients earlier in their disease course to ensure headache care meets guideline recommendations, and e‐consultation is 1 option. However, better communication with primary care is required for system optimization.

Background Erenumab, a calcitonin gene‐related peptide (CGRP) receptor monoclonal antibody, has been well tolerated with good efficacy for the preventive treatment of episodic and chronic migraine in phase 2 and phase 3 clinical trials. Limited post‐market observations are available to validate these findings in a real‐world tertiary headache clinic population with complex comorbidities and refractory migraine. Objective The goal of this study is to demonstrate the real‐world performance of erenumab among patients in a tertiary care headache clinic by describing patient selection, experience, and clinical characteristics after 6 months of erenumab therapy. Methods A retrospective, exploratory, observational study was conducted on patients receiving at least 1 erenumab injection (70 or 140 mg). Baseline data obtained by chart review and telephone calls were compared to 6‐month follow‐up telephone calls. The primary outcome was the reduction in self‐reported headache days per month at baseline compared to 6 months for those with complete 6‐month data. The significance level was set at P < .05. Secondary analyses explored the distribution of headache severity, responder rates, Migraine Disability Assessment scores, adverse effects, ineffective preventives, comorbidities, wearing‐off, and discontinuation. Results Of the 101 patients who consented to participate, 89.1% (90/101) were women, and the mean age of all patients was 49 years (range, 19‐80 years). At baseline, 94.1% (95/101) of patients had chronic migraine, 5.0% (5/101) had episodic migraine, and 18.8% (19/101) had medication overuse headache. The mean (SD) number of baseline headache and migraine days per month for the entire cohort were 24.3 (8.2) and 18.2 (9.3) days, respectively. Participants had numerous comorbidities and had tried a mean of 11.2 unique oral medications and 4.8 unique medication categories before receiving erenumab, including 83.2% (84/101) who had also received onabotulinumtoxinA. Six‐month post‐erenumab follow‐up data were available for 42.6% (43/101) of participants. For these 43 participants, the number of headache days per month decreased significantly by 6.5 days from a baseline mean (SD) of 24.8 (6.47) days to 18.3 (12) days at 6‐month follow‐up ( P < .001); similarly, the monthly migraine days decreased significantly by 8.4 days from a baseline mean of 19.1 (9.3) days to 10.7 days at 6‐month follow‐up ( P < .001). The 50% responder rate was 34.9% (15/43) for monthly headache days and 54.8% (23/43) for monthly migraine days. Of all 101 participants, 28 (27.7%) discontinued erenumab, primarily because it was ineffective (39.3%, 11/28) or because of adverse effects (42.9%, 12/28). Conclusion This post‐market observational study of patient experience describes response to erenumab in a real‐world tertiary headache clinic with a complex patient population. Overall, these complex patients had a significant positive clinical response to erenumab, but with high rates of discontinuation. This study also noted a 1‐week wearing‐off response and high rates of constipation. Further post‐market studies are needed to better characterize patient selection and real‐world response to erenumab.

Objective To summarize the current literature on non‐steroidal anti‐inflammatory drug and corticosteroid use during the coronavirus disease 2019 (COVID‐19) pandemic, recognizing that these are commonly used treatments in the field of headache medicine. Background The use of non‐steroidal anti‐inflammatory drugs and corticosteroids in patients during the COVID‐19 pandemic has been a controversial topic within the medical community and international and national health organizations. Lay press and social media outlets have circulated opinions on this topic despite the fact that the evidence for or against the use of these medications is sparse. In the field of headache medicine, these medications are used commonly and both patients and clinicians may have questions or hesitations pertaining to their use during the COVID‐19 pandemic. Methods A detailed search of the scientific and popular literature was performed. Results There is limited literature pertaining to the safety of non‐steroidal anti‐inflammatory drugs and corticosteroids during the COVID‐19 pandemic. To date, there are no clear scientific data that preclude the use of non‐steroidal anti‐inflammatory drugs in the general population who may acquire COVID‐19 or in those acutely infected with the virus. Several health organizations have concluded that treatment with corticosteroids during active infection should be avoided due to concerns of prolonged viral shedding in the respiratory tract and the lack of survival benefit based on the data from past coronaviruses and influenza virus; specific exceptions exist including treatment for underlying asthma or chronic obstructive pulmonary disease, septic shock, and acute respiratory distress syndrome. Conclusion Scientific information regarding the COVID‐19 pandemic is constantly evolving, and limited or contradictory information can lead to confusion for both patients and clinicians. It is recommended that prior to prescribing non‐steroidal anti‐inflammatory drugs and steroids for the treatment of headache, clinicians have open discussions with their patients about the potential risks and benefits of using these medications during the COVID‐19 pandemic. This manuscript summarizes the currently available evidence and understanding about these risks and benefits to help clinicians navigate such discussions.

Background: Noninvasive neuromodulation devices have been used for a variety of headache disorders, including cluster and migraine, since recently being cleared by the Federal Drug Administration. Although these devices have been touted as low-risk options for improved headache control, the data behind actual efficacy endpoints remain unclear. Objective: To critically assess current evidence regarding the efficacy of the noninvasive vagus nerve stimulator (nVNS) device for acute migraine management. Methods: The objective was addressed through the development of a structured critically appraised topic. This included a clinical scenario with a clinical question, literature search strategy, critical appraisal, results, evidence summary, commentary, and bottom line conclusions. Participants included consultant and resident neurologists, a medical librarian, clinical epidemiologists, and a content expert in the field of headache. Results: A randomized, double-blind, sham-controlled clinical trial was selected for critical appraisal. In this trial, the primary endpoint (pain freedom at 120 min after use of nVNS for first acute migraine attack) was not met when compared with sham device (30.4% for nVNS vs. 19.7% for sham; P=0.067). However, there were statistically significant differences found for various secondary endpoints favoring nVNS, such as pain freedom rates at 30 and 60 minutes, pain relief at 120 minutes, and mean percentage pain score reduction rates at 60 and 120 minutes. Conclusions: When comparing nVNS with sham, no statistically significant differences were found with regards to the primary endpoint of pain freedom at 120 minutes, although differences were found with various secondary endpoints and post hoc analysis. nVNS is likely a safe alternative to medications.

Objective We surveyed the American Headache Society (AHS) New Investigators and Trainees Section (NITS), and International Headache Academy (IHA) attendees to better understand what they perceive as the most pressing issues for themselves as new investigators and trainees in the field of headache medicine. Background The NITS and IHA are intended as platforms for mentorship, leadership training, and professional development in the field of headache medicine. Identifying and addressing pressing issues among new investigators and trainees based on their perceived needs is critical to encouraging their development and success as headache medicine clinicians and researchers. Methods Paper surveys were administered at the NITS meeting at the November 2018 Scottsdale Headache Symposium and the January 2019 IHA. Additionally an online version was sent to the NIT listserv in November of 2018. The survey queried demographic information (gender, race, age, profession, training status, and years in practice) and asked participants to identify their top 3 most pressing issues/questions among a list of options. Results Fifty‐three responses were submitted (53/255; total response rate 20.7%). Among the surveys, 18 in‐person responses were from the NITS meeting (18/20; response rate 90.0%), 23 in‐person responses were from the IHA (23/45; response rate 51.1%), and 12 responses were from the online survey (12/190; response rate 6.3%). No duplicate responses were submitted based on comparison of demographics. One respondent identified as a researcher exclusively and was excluded from further analyses; the rest identified as clinicians at various levels of medical training. Fifteen respondents were not members of the NITS (28.8%); the most common reason for nonmembership was lack of awareness of the section (92.8%). Overall the most pressing issues/questions included (% of respondents who ranked issue/question among top 3): Career planning (51.9%), Logistics of running a headache clinic (40.4%), and Opportunities for involvement (38.5%). Most pressing issues/questions differed depending on level of training. Working with industry was the most pressing issue/question identified by early career physicians (55.0%). Career planning was the most pressing issue/question among fellows (72.2%) and residents (64.3%). Conclusion Many of the most pressing issues identified by respondents are topics that are not formally addressed in medical and research training.

Background The King-Devick test is a timed rapid number naming task that involves complex cerebral functions. The objective of this pilot exploratory study is to determine whether there is a difference in the King-Devick test during a migraine attack compared to the interictal phase. Methods We evaluated 29 adult subjects with migraine with aura or migraine without aura. For each participant, we performed King-Devick tests during migraine attacks and interictal phases. Subjects served as their own controls. Results The King-Devick test was slower during the migraine attack compared to the interictal baseline (median 4.6 sec slower, p < 0.001). The slowing of the King-Devick test during migraine attack was more prominent in those with migraine with aura compared to subjects with migraine without aura (median 7.5 vs. 2.8 sec, p = 0.028). Conclusions This exploratory, observational study shows changes in the King-Devick test during migraine compared to the interictal phase. Future studies are required to determine if the King-Devick test may be used as a rapid and simple tool to objectively characterize migraine-associated disability.