16th European Headache Congress

Chair

A comparison between real-world studies and trials of anti-CGRP monoclonal antibodies

Invited speaker

Invited lecture

Start – stop – restart: real-world treatment patterns for CGRP(-receptor) monoclonal antibodies

Can we predict (side-)effects better with RCT or RWE?

Prof.

One-quarter of individuals with weekly headache have never consulted a medical doctor: A Danish nationwide cross-sectional survey

Epidemiology

Guidelines in headache

Abstract text (incl. figure legends and references) INTRODUCTION: Large numbers of people with headache who would benefit are not reached by headache services. Among the causes are poor or disorganized provision of headache services, but reluctance to seek healthcare has frequently been identified as a significant barrier. We conducted a national survey of people with headache to assess the extent of this problem in Denmark, a country with well organized, highly resourced, and readily accessible services. METHODS: We conducted a nationwide cross-sectional survey of adults ≥18 years old in Denmark reporting at least one headache day in the last year. The survey investigated five items: (1) disease burden, (2) social life, (3) presenteeism, (4) social support, and (5) healthcare utilization. RESULTS: We included 6,567 respondents from May 2021 to June 2021; 70.2% were female, 39.8% male, and mean age was 43.2±13.4 years. Of the respondents, 54.2% reported headache at least once a week, 33.4% reported headache a couple of times a month, and 12.4% reported headache a couple of times a year. Two-thirds of respondents (66.6%) reported that headache limited their social lives occasionally or frequently. Most respondents (86.8%) reported going to work or attending educational activities occasionally or more frequently even though they had headache. Half of the respondents (49.5%) experienced lack of understanding of their headaches from people occasionally or more frequently. Almost half of respondents (43.7%) had never consulted a medical doctor for their headache; even of those with weekly headache, more than a quarter (28.3%) had never done so in their lifetimes. CONCLUSIONS: Headache disorders continue to be a problem, even in a high-income country with free and easily accessible headache services.

Abstract lecture

Changes in Acute Headache Medication Use Among Patients With Chronic Migraine and Medication-Overuse Headache: An Exploratory Analysis of PROMISE-2

Migraine

Medication overuse headache

Abstract text (incl. figure legends and references) OBJECTIVE: This post hoc analysis evaluated changes in days of acute headache medication (AHM) use among patients with medication-overuse headache (MOH) from the PROMISE-2 trial. METHODS: PROMISE-2 (NCT02974153) was a double-blind, randomized, placebo-controlled phase 3 study evaluating safety and efficacy of eptinezumab (100 or 300 mg) in adults with chronic migraine (CM). In eDiaries, patients indicated daily whether they experienced a headache, used AHM, and type of AHM used. RESULTS: Of the 1072 patients with CM in PROMISE-2, 431 (40.2%) were formally diagnosed with MOH. The 28-day screening/baseline period comprised 18,504 (eptinezumab) and 9,560 (placebo) study days with medication data; Weeks 1-24 comprised 100,390 and 50,632 days, respectively. The proportion of headache days and AHM use decreased ‒29.1%-points (eptinezumab) vs ‒18.4%-points (placebo), and the proportion reporting no headache or AHM use increased 33.8%-points vs 23.6%-points, respectively. The proportion with headache and no AHM use decreased 6.1%-points and ‒7.1%-points for eptinezumab and placebo, respectively. Triptans were the most used AHMs at baseline (eptinezumab, 20.1%; placebo 19.3%), but triptan use decreased more with eptinezumab vs placebo (‒11.8 vs ‒7.2%-points). CONCLUSIONS: Eptinezumab was associated with greater declines in headache frequency and days of AHM use vs placebo in patients with a dual diagnosis of CM and MOH, especially the subgroup of patients experiencing ≥50% response.

Antibodies anti-CGRP in patients with fibromyalgia and resistant migraine, are they just as effective?

CGRP inhibitors in the clinic

Abstract text (incl. figure legends and references) QUESTION Fibromyalgia is a frequent chronic disease and appears frequently with chronic migraine in our patient. We design this sub-study to evaluate if patients with fibromyalgia and migraine responds to antibodies anti-CGRP (a-CGRP) as well as patients without fibromyalgia. METHODS We present a sub-analysis of a prospective study of patients with resistant migraine treated with a-CGRP analyzing days of migraine (MHD), headache (HHD) and symptomatic treatment (MusD) as well as scales (HIT-6, MIDAS, pain catastrophizing scale, quality of life (MsQol)). We compared the response to a-CGRP at 3 ant 6 months in patients with fibromyalgia (Fi) and without it (No-Fi) RESULTS We included 53 patients Fi and 283 No-Fi. 78% of women and mean age of 46 years in the group no-Fi and 98% of women and mean age of 53 in the group Fi, 5 treatment failures in both groups. In the group No-Fi before using the a-CGRP they have 22,6 HHD, 19,4 MHD and 19 MsuD. After 3 months, there is a reduction of 9,7 HHD, 7,8 MHD and 8 MsuD. After 6 months 10,7 HHD, 9,6 MHD, 8,6 MsuD. At 6 months, HIT-6 reduces 9,5 points, MIDAS 46,5 points and MsQol increases 20,5 points. In the group Fi before they have 23,9 HHD, 19,9 MHD and 18,9 MsuD. After 3 months, there is a reduction of 8,9 HHD, 6,4 MHD and 5,8 MsuD. After 6 months 10,7 HHD, 8,7 MHD, 8,1 MsuD. At 6 months, HIT-6 reduces 8,8 points, MIDAS 63,5 points and MsQol increases 22,3 points. 30% in group Fi reported adverse events and 36% in No-Fi. CONCLUSIONS Patients with fibromyalgia responds to a-CGRP too, although, according with our study, the improvement seems to be more delayed compared to patients without fibromyalgia. The quality of life and the disability improve slightly more in the group with fibromyalgia than in the group without it. There is no difference in the rate of adverse events. We consider that with these results, patients with fibromyalgia and migraine should be treated with a-CGRP as well as patients without it.

SciSe 7
RCTs vs. RWE: What is most useful in the clinic?

Appointment

Chair

Programme

SciSe 7RCTs vs. RWE: What is most useful in the clinic?

Appointment

Chair

Programme

SciSe 7
RCTs vs. RWE: What is most useful in the clinic?