<i>De Novo</i> Visual Aura Onset in a Migraineur on Galcanezumab‐Gnlm

Kearney, Elizabeth; Collins, Timothy A.; Sengupta, Sweta

doi:10.1111/head.13855

Cited by 8 publications

(6 citation statements)

References 11 publications

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“…These attacks were rare and did not need any supplementary treatment. De novo visual aura was also reported in a patient treated with galcanezumab (42).…”

Section: Discussionmentioning

confidence: 78%

Erenumab for Migraine Prevention in a 1-Year Compassionate Use Program: Efficacy, Tolerability, and Differences Between Clinical Phenotypes

et al. 2021

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During a 1-year compassionate use program, 156 patients with migraine self-administered a monthly dose of erenumab 140 mg with a subcutaneous autoinjector. Main inclusion criteria were: ≥ 4 migraine days/month and ≥two prior prophylactic treatment failures. The patients covered the migraine severity spectrum from episodic migraine (EM) (n = 80) to chronic migraine (CM) (n = 76). During the 3rd month of treatment, monthly headache days decreased by 45.7% in EM and 35.5% in CM. The 50% responder rate for reduction in monthly headache days was significantly higher in EM (55%) than in CM (43%) (p = 0.05). In both the migraine subgroups, the clinical improvement vs. baseline was already significant during the 1st month of treatment (p < 0.001). There were also significant reductions in mean headache severity, duration, and monthly days with acute drug intake. The 30% responder rate at 3 months was 60% in CM and 54.1% of patients reversed from CM to EM. The therapeutic effect was maintained at 12 months when 50% responder rates, considering discontinuation for lack of efficacy or adverse effects as 0% response, still were 51% in EM and 41% in CM. A total of 10 patients with EM (12.5%) and 23 patients with CM (30.3%) had discontinued treatment, considering the treatment as ineffective. At 3 months, 48% of patients reported non-serious adverse events among which the most frequent was constipation (20.5%); corresponding figures at 12 months were 30 and 15%. Discontinuation due to an adverse effect for the entire 12 month period was rare (3.8%). The lower efficacy in CM than in EM was mainly due to a very low 50% responder rate in patients with CM with continuous pain (13%) as compared to CM with pain-free periods (58%) (p < 0.001). Similarly, the 50% responder rate was lower in patients with ≥two prior prophylactic treatment failures (40.5%) compared to those with two failures (70%) (p < 0.05). There was no significant efficacy difference between low (4–7 migraine days/month, n = 22) and high frequency (8–14 days, n = 59) EM nor between patients with CM with (n = 50) or without (n = 26) acute medication overuse. Erenumab had no effect on the frequency of auras. Taken together, erenumab 140 mg monthly was highly effective for migraine prophylaxis over the whole severity spectrum of the disease, except in patients with continuous headaches. Its effect is significant after the first injection, quasi-maximal after the second injection, and does not wear off after 12 months. The most frequent adverse effect was constipation. These results are compared to those published for erenumab in the pivotal randomized placebo-controlled trials and to those reported in several recent real-world studies.

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“…These attacks were rare and did not need any supplementary treatment. De novo visual aura was also reported in a patient treated with galcanezumab (42).…”

Section: Discussionmentioning

confidence: 78%

Erenumab for Migraine Prevention in a 1-Year Compassionate Use Program: Efficacy, Tolerability, and Differences Between Clinical Phenotypes

et al. 2021

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“…Inquiring about elements such as change in migraine aura frequency is warranted. CGRP mAbs are thought to act primarily outside of the blood-brain barrier, and how they could impact the occurrence of cortical spreading depression is not well understood [33][34][35][36][37].…”

Section: Discussionmentioning

confidence: 99%

Real-Life Response to Erenumab in a Therapy-Resistant Case Series of Migraine Patients From the Province of Québec, Eastern Canada

Eghtesadi¹,

Leroux²,

Pagé

2021

Clin Drug Investig

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Background and ObjectiveErenumab is the first migraine-specific preventive therapy approved by Health Canada since the approval of onabotulinumtoxinA 10 years ago. It is one of four calcitonin gene-related peptide antagonist monoclonal antibodies that have been commercialized worldwide for use in the headache pipeline. The objective of our study was to determine real-life efficacy of monthly erenumab for the prevention of migraine in a small case series of difficult-to-treat patients followed at a tertiary headache clinic from the Canadian province of Québec. Methods We performed a retrospective chart audit of patients having failed four or more conventional migraine oral preventive therapies and who were treated with monthly self-administered subcutaneous erenumab (70 or 140 mg/mL dose) over a 1-year period. We assessed the patients' baseline characteristics, response to treatment, and tolerability. Results A total of 18 patients with a diagnosis of high-frequency episodic migraines or chronic migraine met criteria (83.3% female; mean age: 48.7 years; mean duration of migraine condition: 32.9 years). Patients self-administered erenumab using a prefilled disposable autoinjector on a monthly basis; 16 patients received a 140 mg/mL dosage, two patients received a 70 mg/mL dosage. At 1 year follow-up, 50% of patients reported ≥ 50% reduction in migraine frequency and were deemed responders. Patients attempted six doses of erenumab therapy prior to discontinuation for non-response, except for two patients with other concomitant chronic pain conditions, who required ten doses to reach a 50% response. For the overall cohort, there was a decrease of 5.2 monthly migraine days; 9 days for responders and 1.3 days for non-responders (t-test (df = 16) = -2.77, p = 0.014). There was an additional decrease of 7 monthly non-migraine days amongst patients with unremitting daily headaches; 8 days for responders and 5 days for non-responders (p > 0.05). There was a decrease of 5.4 monthly days using acute analgesics; 8.9 days for responders and 2 days for non-responders (T(16) = -2.33, p = 0.033). The overall mean reduction in disability using the Headache Impact Test (HIT-6) score was 5.6 points; only responders showed a reduction in HIT-6 severity category (p > 0.05). The most commonly reported adverse event was constipation (16.7%), which did not lead to treatment discontinuation and was successfully managed in all patients with early counselling and intervention. Conclusion This study supports the efficacy of erenumab in a case series of therapy-resistant migraine patients from the region of Québec. A high rate of previously failed preventive oral agents and medication overuse did not predict response in our patient cohort. In the presence of real-world complexity factors, such as psychological distress, regular opioid consumption and concomitant chronic pain conditions, a longer therapy trial may be warranted in obtaining optimal response.

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“…In our case series, the number of days each month with weakness decreased in four patients; however, this value increased in two patients. Whether galcanezumab affects the deterioration of weakness is unclear; de novo visual aura onset was reported after the initiation of galcanezumab, and it ceased after switching to fremanezumab 16 . These findings thus suggest that certain antibodies may be effective in some patients and not in others.…”

Section: Discussionmentioning

confidence: 99%

“…Whether galcanezumab affects the deterioration of weakness is unclear; de novo visual aura onset was reported after the initiation of galcanezumab, and it ceased after switching to fremanezumab. 16 These findings thus suggest that certain antibodies may be effective in some patients and not in others. A prospective clinical study will be needed to clarify the efficacy of anti-CGRP mAbs in HM in further detail.…”

Section: Patientmentioning

confidence: 98%

Treatment of hemiplegic migraine with anti‐calcitonin gene‐related peptide monoclonal antibodies: A case series in a tertiary‐care headache center

et al. 2023

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Hemiplegic migraine (HM) is a subtype of migraine with aura that includes motor weakness; such headaches can be excruciating. The presence of not only headache but also aura symptoms of HM increase the burden on patients, and the treatment of HM is sometimes challenging. Monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (CGRP) pathway are novel migraine preventive treatments that have shown promising efficacy in patients with migraine; however, there have been no reports regarding their efficacy in HM to date. Six patients with HM were treated with galcanezumab in a tertiary-care headache center. After 3 months of treatment, the number of monthly days with headache of at least moderate severity was reduced in three patients. The number of days each month with weakness was also reduced in four patients. Furthermore, the Patient's Global Impression of Change and change in Migraine Disability Assessment total score, were improved in five of the six patients after the treatment; however, the change from baseline in days with bothersome symptoms did not show any specific trends in our patients.Notably, no adverse events were reported during the treatments. The mechanism underlying the improvement in aura symptoms in our patients is not clear; however, we speculate that a small amount of CGRP mAbs have a direct mode of action in the central nervous system; alternatively, blocking the CGRP pathway in the periphery may secondarily inhibit cortical spreading depression. While prudence must be practiced, galcanezumab was still generally effective in HM and well tolerated. Further prospective clinical studies will more clearly elucidate the effects of CGRP mAbs in patients with HM.

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De Novo Visual Aura Onset in a Migraineur on Galcanezumab‐Gnlm

Cited by 8 publications

References 11 publications

Erenumab for Migraine Prevention in a 1-Year Compassionate Use Program: Efficacy, Tolerability, and Differences Between Clinical Phenotypes

Erenumab for Migraine Prevention in a 1-Year Compassionate Use Program: Efficacy, Tolerability, and Differences Between Clinical Phenotypes

Real-Life Response to Erenumab in a Therapy-Resistant Case Series of Migraine Patients From the Province of Québec, Eastern Canada

Treatment of hemiplegic migraine with anti‐calcitonin gene‐related peptide monoclonal antibodies: A case series in a tertiary‐care headache center

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