Post-marketing safety surveillance of erenumab: new insight from Eudravigilance

Liang, David; Sessa, Maurizio

doi:10.1080/14740338.2022.2049231

Cited by 6 publications

(2 citation statements)

References 31 publications

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“…However, it should be acknowledged that these randomized-controlled trials had strict inclusion criteria and thus findings cannot be generalized to the general population. We must continue to rely on post-marketing surveillance and realworld observations to provide new insights into the safety of erenumab in a wider patient population [27,29,30].…”

Section: Discussionmentioning

confidence: 99%

Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials

et al. 2022

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Background Erenumab, a fully human monoclonal antibody that targets the calcitonin gene-related peptide receptor, has demonstrated efficacy and safety in the prevention of episodic and chronic migraine. There exists an unmet need to establish the safety of erenumab in older individuals, in view of existing multiple comorbidities, polypharmacy, and age-related physiological changes. This pooled analysis of five large migraine-prevention studies examined the safety of erenumab stratified across age groups, particularly in older populations. Methods Pooled and age-stratified analysis of safety data from the 12-week double-blind treatment phase (DBTP) of five randomized, placebo-controlled Phase 2 and 3 studies of erenumab in participants with episodic or chronic migraine across the age groups < 40 years, 40–49 years, 50–59 years, and ≥ 60 years was completed. The safety of erenumab across age groups was determined by assessing safety endpoints including treatment-emergent adverse events (AEs), serious AEs, and events leading to study drug discontinuation. Results Overall, 3345 participants across five studies were randomized to receive either placebo (n = 1359), erenumab 70 mg (n = 1132) or erenumab 140 mg (n = 854); 3176 (94.9%) completed the DBTP, and 169 (5.1%) discontinued, mainly due to participant decision (110; 3.3%). Overall, 1349 (40.6%), 1122 (33.8%), and 850 (25.6%) participants received at least one dose of placebo, erenumab 70 mg, and erenumab 140 mg, respectively. Incidence of treatment-emergent AEs was similar across all age groups for both doses of erenumab (70 mg or 140 mg) and placebo (< 40 years, 44.0% vs 44.4%; 40–49 years, 42.5% vs 49.2%; 50–59 years, 46.5% vs 41.6%; ≥ 60 years, 43.8% vs 59.4%). Incidence of treatment-emergent serious AEs overall, and stratified by age groups for both doses and placebo was low (< 40 years, 0.9% vs 1.2%; 40–49 years, 1.7% vs 1.9%; and 50–59 years, 1.6% vs 1.1%), with no serious AEs reported in participants aged ≥ 60 years. No deaths were reported. Conclusions Erenumab (70 mg or 140 mg) exhibited a similar safety profile compared with placebo across age groups in individuals with episodic or chronic migraine, with no increased emergence of events due to age. Erenumab was well tolerated in older participants with multiple comorbidities, polypharmacy, and age-related physiological changes. Trial registration number ClinicalTrials.gov Identifiers: NCT02066415, NCT02456740, NCT02483585, NCT03096834, NCT03333109.

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Section: Discussionmentioning

confidence: 99%

Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials

et al. 2022

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“…Erenumab is the first monoclonal antibody targeting the receptor of CGRP approved for the prevention of migraine [13][14][15][16][17][18][19][20][21][22]. The substance is injected subcutaneously in 4-week intervals by patients using an autoinjector.…”

Section: Introductionmentioning

confidence: 99%

First Report of Symmetrical Drug-related Intertriginous and Flexural Exanthema (SDRIFE or Baboon Syndrome) After Erenumab Application for Migraine Prevention

et al. 2022

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Introduction: Symmetrical drug-related intertriginous and flexural exanthema (SDRIFE), formerly also called baboon syndrome, is characterized by symmetrical erythematous rash with typical localization in the gluteal and intertriginous areas. A type IV delayed hypersensitivity immune response is thought to be responsible for its development. CGRP monoclonal antibodies (CGRP mAbs) are a new class of drugs for the prevention of migraine. We present the first case of SDRIFE occurring in temporal relation to the use of erenumab for migraine prevention. Case: A 48-year-old female patient with migraine received erenumab 140 mg subcutaneously in the thigh area for the prevention of migraine in repetitive cycles, each 1 month apart. Initially, the patient experienced no side effects. After the third cycle, a masseuse incidentally noticed a reddish, circular rash in the buttock area during a back massage. There were no other symptoms. The skin changes resolved spontaneously. Two years later, approximately 40 h after reapplication of erenumab 140 mg, the patient experienced a severe pain in the buttock area centered over the anal crease. The area of pain extended in a circular pattern with approximately 20 cm in diameter. The pain started abruptly and reached a severe intensity within about 30 min. Sitting on the buttocks was no longer possible for the patient. There was marked allodynia and hyperpathia in the entire buttocks region. A flat, broad-based blister-like skin swelling developed in this region. The blisters began opening up on the fourth day after the onset of the skin reaction. In addition, there was a pronounced redness in the entire buttock area. Here, the patient felt a strong burning pain, similar to a scald. Results: The symptoms lasted for a period of 10 days. From this point on, they fully subsided under concomitant therapy with prednisolone. Conclusion: SDRIFE as a rare dermatological side effect should be considered in the monitoring of skin lesions during migraine prophylaxis. In view of the high migraine prevalence, knowledge of this uncommon syndrome is important. It is crucial to recognize the relationship between the medication and the circumscribed exanthema occurring distant from the injection site.

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Cardiovascular Adverse Drug Reactions of Anti-Calcitonin Gene-Related Peptide Monoclonal Antibodies for Migraine Prevention: An Analysis from the European Spontaneous Adverse Event Reporting System

Sorbara,

Barbieri,

Russo

et al. 2024

BioDrugs

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Post-marketing safety surveillance of erenumab: new insight from Eudravigilance

Cited by 6 publications

References 31 publications

Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials

Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials

First Report of Symmetrical Drug-related Intertriginous and Flexural Exanthema (SDRIFE or Baboon Syndrome) After Erenumab Application for Migraine Prevention

Cardiovascular Adverse Drug Reactions of Anti-Calcitonin Gene-Related Peptide Monoclonal Antibodies for Migraine Prevention: An Analysis from the European Spontaneous Adverse Event Reporting System

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