The evolving understanding of risk with calcitonin gene‐related peptide monoclonal antibodies based on real‐world data: A focus on hypertension and Raynaud phenomenon

Breen, Ilana; Mangold, Aaron R.; VanderPluym, Juliana

doi:10.1111/head.14198

Cited by 5 publications

(4 citation statements)

References 7 publications

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“…22 Given the unpredictable natural course of RP, the authors comment that it is hard to say whether these individuals would have developed RP regardless of exposure to CGRP monoclonal antibodies. 23 The following cases suggest a possible relationship between RP and gepant treatment in two patients. One individual experienced RP with both ubrogepant and rimegepant for acute treatment.…”

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confidence: 85%

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Raynaud's phenomenon associated with calcitonin gene‐related peptide receptor antagonists case report

2022

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Background Calcitonin gene‐related peptide (CGRP) is a potent vasodilator that regulates the cerebrovascular and peripheral circulation. A new class of migraine therapies decreases CGRP through various mechanisms. One unknown off‐target effect is the impact decreasing CGRP will have on the peripheral circulation. The following cases report new onset Raynaud's phenomenon (RP) following the use of CGRP receptor antagonists (−gepants) for both the acute and preventive treatment of migraine. These cases describe the development of RP in two individuals after using each of the currently available gepant medications. To our knowledge these are the first cases reported of RP associated with the use of gepants. RP has previously been reported in association with monoclonal antibodies to the CGRP ligand and CGRP receptor indicated in the prevention of migraine. Case presentation One case involved oral CGRP receptor antagonists for acute treatment inducing RP. In this case, rimegepant and ubrogepant used separately for different migraine attacks each led to RP in the digits. The other case involved oral CGRP receptor antagonist, atogepant, used as a preventive treatment and induced RP in the digits. This patient had a prior history of areolar tissue RP while breastfeeding, but never in her fingers. In both cases, the offending medications were discontinued, and the patients reported no further episodes of RP. Conclusion Two cases are reported of people with migraine with new onset digital RP while taking CGRP receptor antagonists (rimegepant, ubrogepant, atogepant) for acute and preventive treatment.

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confidence: 85%

“…These complications ranged from worsening of underlying RP to necessitating distal digit amputation due to gangrene and autonecrosis 22 . Given the unpredictable natural course of RP, the authors comment that it is hard to say whether these individuals would have developed RP regardless of exposure to CGRP monoclonal antibodies 23 …”

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confidence: 99%

Raynaud's phenomenon associated with calcitonin gene‐related peptide receptor antagonists case report

2022

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“…Due to the vasodilatory action of CGRP particular attention has been paid to the potential effects on blood pressure [23]. Clinical trials did not show a significant risk of hypertension with erenumab but it has been reported in post-marketing surveillance [24,25] and is now included as a warning on the package insert in the US [26]. We found a statistically significant rise in systolic BP following 3 months of erenumab treatment but the magnitude of this was very small (2.4 mmHg) and therefore of questionable clinical significance.…”

Section: Tolerability Of Erenumabmentioning

confidence: 99%

Efficacy of erenumab and factors predicting response after 3 months in treatment resistant chronic migraine: a clinical service evaluation

Lowe

Murray²,

Tyagi³

et al. 2022

J Headache Pain

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Background Calcitonin gene-related peptide (CGRP) inhibitors have been developed as options for treatment of chronic and episodic migraine. We present our experience of the use of erenumab in a tertiary headache centre. Methods This was a prospective clinical audit of all patients commenced on erenumab following a locally agreed pathway and criteria over a consecutive period. Patients received monthly erenumab 140 mg for 3 months. Data were collected prospectively at baseline and 3 months follow up. Results One hundred three patients were commenced on erenumab during the study period. Patients had tried a median of 7 previous prophylactics, including onabotulinum toxin A in 94%. At 3 months there was a reduction in median total (28 to 20, 29% reduction, p < 0.0001) and severe (15 to 5, 67% reduction, p < 0.0001) headache days. 39.8% of patients achieved at least a 30% reduction in total headache days; 61.8% of patients achieved at least a 50% reduction in severe headache days. Meeting either of these thresholds was considered a positive response, 68% of patients achieved this. Presence of daily headache pattern was negatively associated with response, (56% response vs. 90% without daily headache, p = 0.0003). There was no association between age, gender, presence of medication overuse or number of previously tried prophylactic treatments and response to erenumab. 43% of patients reported at least one adverse effect, most commonly constipation (26%); treatment was discontinued in 3 patients due to adverse effects. Conclusions Erenumab was an effective treatment for chronic migraine in this treatment resistant population over 3 months of follow up. Presence of daily headache predicted poorer response but there was still a significant positive response rate in this group.

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“…Safety data for the use of monoclonal antibodies in these patient groups are not yet available. Therefore, in the following conditions, the use of monoclonal antibodies against CGRP or the CGRP-receptor should be considered only on a case-by-case basis after detailed consideration of potential risks and the potential benefits: Pregnancy and lactation, subarachnoid hemorrhage [57], familial aneurysms, inflammatory bowel disease [58], gastrointestinal ulcers, stroke [57], TIA, coronary artery disease, poorly controlled hypertension [59], Raynaud's disease [60][61][62], COPD, pulmonary hypertension, wound healing disorders [63], and psoriasis [64].…”

Section: Drug And/or Non-drug Prophylaxis For the Treatment Of Mohmentioning

confidence: 99%

Management of medication overuse (MO) and medication overuse headache (MOH) S1 guideline

Diener

Kropp

Dresler

et al. 2022

Neurol. Res. Pract.

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Introduction Chronic headache due to the overuse of medication for the treatment of migraine attacks has a prevalence of 0.5–2.0%. This guideline provides guidance for the management of medication overuse (MO) and medication overuse headache (MOH). Recommendations Treatment of headache due to overuse of analgesics or specific migraine medications involves several stages. Patients with medication overuse (MO) or medication overuse headache (MOH) should be educated about the relationship between frequent use of symptomatic headache medication and the transition from episodic to chronic migraine (chronification), with the aim of reducing and limiting the use of acute medication. In a second step, migraine prophylaxis should be initiated in patients with migraine and overuse of analgesics or specific migraine drugs. Topiramate, onabotulinumtoxinA and the monoclonal antibodies against CGRP or the CGRP-receptor are effective in patients with chronic migraine and medication overuse. In patients with tension-type headache, prophylaxis is performed with amitriptyline. Drug prophylaxis should be supplemented by non-drug interventions. For patients in whom education and prophylactic medication are not effective, pausing acute medication is recommended. This treatment can be performed in an outpatient, day hospital or inpatient setting. Patients with headache due to overuse of opioids should undergo inpatient withdrawal. The success rate of the stepped treatment approach is 50–70% after 6 to 12 months. A high relapse rate is observed in patients with opioid overuse. Tricyclic antidepressants, neuroleptics (antiemetics) and the administration of steroids are recommended for the treatment of withdrawal symptoms or headaches during the medication pause. Consistent patient education and further close monitoring reduce the risk of relapse.

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The evolving understanding of risk with calcitonin gene‐related peptide monoclonal antibodies based on real‐world data: A focus on hypertension and Raynaud phenomenon

Abstract: How to cite this article: Breen ID, Mangold AR, VanderPluym JH. The evolving understanding of risk with calcitonin gene-related peptide monoclonal antibodies based on real-world data: a focus on hypertension and Raynaud

Cited by 5 publications

References 7 publications

Raynaud's phenomenon associated with calcitonin gene‐related peptide receptor antagonists case report

Raynaud's phenomenon associated with calcitonin gene‐related peptide receptor antagonists case report

Efficacy of erenumab and factors predicting response after 3 months in treatment resistant chronic migraine: a clinical service evaluation

Management of medication overuse (MO) and medication overuse headache (MOH) S1 guideline

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