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Migraine affects approximately 15% of the global population. Its prevalence doubles or even triples in individuals with chronic inflammatory conditions, such as chronic inflammatory rheumatic diseases (34%), multiple sclerosis (MS) (46%), or endometriosis (35%). The prevalence of chronic migraine - defined as at least 15 headache days per month (on average over the past 3 months), of which at least 8 days have migrainous features - is also higher in certain conditions such as MS (4%) compared to the general population (1%). The mechanisms underlying migraine and its chronification remain uncertain, but inflammation appears to play an important role in its pathophysiology: it is present from the onset of a migraine attack, represented by the release of pro-inflammatory cytokines that sensitize the trigeminal system and promote the occurrence of new attacks. The investigators' recent bibliographic work has demonstrated elevated levels of interleukin-6 (IL-6), a pro-inflammatory cytokine, in the blood of episodic migraine patients between attacks (migrainous status) compared to non-migrainous subjects, and in chronic migraine patients compared to episodic migraine patients (chronic migraine status). IL-6 appears to play a role in the pathophysiology of migraine, and elevated levels may represent a marker of poorer response to prophylactic treatments. IL-6 levels are also elevated in inflammatory rheumatic diseases and are associated with disease severity. The efficacy of IL-6 pathway-blocking treatments in inflammatory rheumatic diseases is now well established, and these agents are commonly used for this indication. IL-6 could therefore represent a shared pathophysiological link between migraine and inflammatory rheumatic diseases. However, no study to date has measured the effect of IL-6-blocking treatments on migraine. This study therefore aims to assess the effect of anti-IL-6 treatments on migraine in migrainous patients followed in the rheumatology department of the Clermont-Ferrand University Hospital and treated with anti-IL-6 therapy for their rheumatological condition (rheumatoid arthritis, polymyalgia rheumatica, etc.). It will provide preliminary results regarding the effect of anti-IL-6 agents on migraine and could justify future therapeutic studies.
In this study, the investigators aim to measure the proportion of patients experiencing a reduction in migraine among those treated with anti-IL-6 therapy for their rheumatological condition, in terms of migraine frequency or intensity (primary objective). The secondary objectives are to :
From a pre-established list compiled by the investigators of patients on anti-IL-6 therapy (anti-IL-6 group) and patients on anti-TNF therapy (control group), all patients will be contacted by phone to identify those with migraine, using the International Classification of Headache Disorders, version 3 (ICHD-3) criteria from the International Headache Society (IHS). In cases where migraine is present, the effect of anti-IL-6 (anti-IL-6 group) or anti-TNF (control group) treatment in terms of the proportion of patients experiencing a reduction in migraine will be assessed using the Patient Global Impression of Change (PGI-C) score: a validated tool, widely used, translated into French and made available by eProvide - Mapi Research Trust [https://eprovide.mapi-trust.org/instruments/patient-global-impressions-scale-change-improvement-severity#need\_this\_questionnaire\]) (comparison: before vs. during treatment). The episodic or chronic nature of migraine will be determined during the telephone interview according to the following criteria: fewer than 15 monthly headache days for episodic migraine, and at least 15 monthly headache days - of which at least 8 days have migrainous features - for chronic migraine (IHS definition). All patients on this list who meet the inclusion and non-inclusion criteria and agree to participate in the study will be enrolled. The inclusion of a control group - comprising patients treated with a biotherapy other than anti-IL-6, namely anti-TNF agents - will strengthen the level of attribution of the measured effect to anti-IL-6 treatment and help offset recall bias.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-IL-6 group | Patient on anti-IL-6 therapy |
| |
| Anti-TNF group | Patients on anti-TNF therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Migraine assessement | Other | Migraine frequency and intensity will be assessed in patients on anti-IL-6 (anti-IL-6 group) and anti-TNF (anti-TNF group). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Change (PGI-C) on migraine (frequency or intensity) | Measure change in migraine under anti-IL-6, in terms of frequency or intensity, according to the PGI-C score. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Change on migraine (frequency) | Measure change in migraine under anti-IL-6, in terms of migraine frequency, according to the PGI-C score. | Day 1 |
| Patient Global Impression of Change on migraine (intensity) |
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Inclusion Criteria (for screening) :
Inclusion Criteria (patients to be enrolled) : migrainous patients, identified using the International Classification of Headache Disorders, version 3 (ICHD-3) criteria from the International Headache Society (IHS) during the telephone call
Exclusion Criteria:
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Migrainous patients, identified using the International Classification of Headache Disorders, version 3 (ICHD-3) criteria from the International Headache Society (IHS) during the telephone call, will complete the Patient Global Impression of Change (PGI-C) score to determine whether the treatment (anti-IL-6 or anti-TNF) is associated with a reduction in migraines or not.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise Laclautre | Contact | 0473754963 | promo_interne_drci@chu-clermontferrand.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Clermont-Ferrand | Clermont-Ferrand | France |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Patient Global Impression of Change | Other | Migraine frequency and intensity will be assessed in patients taking anti-IL-6 (anti-IL-6 group) and anti-TNF therapy (anti-TNF group) using the Patient Global Impression of Change (PGI-C) score. |
|
Measure change in migraine under anti-IL-6, in terms of migraine intensity, according to the PGI-C score.
| Day 1 |
| Patient Global Impression of Change on migraine (frequency and intensity) | Measure change in migraine under anti-IL-6, in terms of both frequency and intensity, according to the PGI-C scores. | Day 1 |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |