The objective of this study is to evaluate the effect of erenumab on medication-specific treatment satisfaction in patients newly started on erenumab over 12 weeks

Start Date05 Jun 2024

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

NCT05684692

/ RecruitingPhase 2IIT

Screening Trial for Pain Relief in Schwannomatosis (STARFISH)

This is a placebo-controlled, multi-arm phase II platform screening trial designed to test the safety, pain responses, and pharmacodynamic activity of multiple experimental therapies simultaneously in participants with moderate-to-severe pain due to schwannomatosis (SWN).
This Master Study is being conducted as a platform that may allow participants with pain associated with schwannomatosis to receive a novel intervention throughout this study. Embedded within the Master Study are individual drug sub-studies:
Investigational Drug Sub-Study A: Siltuximab
Investigation Drug Sub-Study B: Erenumab-Aooe

Start Date31 Aug 2023

Sponsor / Collaborator

The Schwartz Center for Compassionate Healthcare

[+2]

NCT05281770

/ RecruitingNot ApplicableIIT

Non-interventional Study of the Austrian Headache Society: Monoclonal CGRP Antibodies for Migraine Prevention a Nationwide Real Life Study

The present non-interventional study on migraine prevention with monoclonal CGRP antibodies adresses questions concering safety, swichting from one CGRP mab to another, efficacy on auras in the real world setting.

Start Date01 Oct 2022

Sponsor / Collaborator

Medical University of Vienna

[+1]

100 Clinical Results associated with Erenumab (Genetical Recombination)

100 Translational Medicine associated with Erenumab (Genetical Recombination)

100 Patents (Medical) associated with Erenumab (Genetical Recombination)

569

Literatures (Medical) associated with Erenumab (Genetical Recombination)

01 Feb 2025·Neurology Clinical Practice

Efficacy and Tolerability of Anti-CGRP Monoclonal Antibodies in Patients Aged ≥ 65 Years With Daily or Nondaily Migraine

Article

Author: Biswas, Sudipa ; Hogue, Olivia ; Ahmed, Zubair ; Salim, Amira ; Mata, Ignacio F. ; Sonneborn, Claire ; Suneja, Aarushi ; Mays, Maryann ; Hennessy, Elise

Background and ObjectivesDespite decreasing prevalence of migraine with advancing age, there remains a significant proportion of individuals aged ≥65 years with migraine. Treatment of this population is difficult and they are often excluded from clinical trials, limiting evidence regarding migraine treatment outcomes. Our objective is to assess the efficacy and tolerability of anti-calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) therapies (erenumab, fremanezumab, and galcanezumab) in patients ≥65 years (O65) compared with patients <65 (U65) with daily or nondaily migraine.MethodsThis observational study uses retrospective data from the electronic medical records of patients who were treated with an anti-CGRP mAb between June 2018 and November 2021. Efficacy was determined through a reduction in monthly migraine days (MMDs) and Headache Impact Test (HIT-6) scores from baseline to posttreatment. Tolerability was examined through the number of adverse events reported per group. Mann-Whitney tests were used to compare the efficacy and tolerability of U65 and O65 patients overall and separated into daily and nondaily migraine groups.ResultsThe dataset consisted of U65 (n = 2,707; median [interquartile range]; 45.4 [35.8-53.8] years) or O65 (n = 304; 69.5 [67.3-73.3] years) and further separated into daily (n = 1,303) and nondaily (n = 1,708) migraine. There was no difference (p = 0.57) in the median MMD reduction between U65 (10 days [0.0-17.0]) and O65 (10 days [0.0-16.5]). Similarly, no difference was found among patients with nondaily migraine (p = 0.82) and patients with daily migraine (p = 0.59). HIT-6 scores decreased from severe to moderate/substantial impact for all groups. The daily and nondaily groups showed differences in meeting the 50% improvement threshold (nondaily U65, 67% vs daily U65, 54%, p < 0.0001; nondaily O65, 65% vs daily O65, 49%, p = 0.008). Side effects were reported (829/3,011), with a higher incidence in the U65 (22% O65, 28% U65). The most common side effects for both groups were injection site reaction/rash (40%) and constipation (25%).DiscussionThis retrospective analysis provides real-world evidence that there is no difference in the efficacy and tolerability of treatment with erenumab, fremanezumab, and galcanezumab in patients O65 when compared with patients U65 both with daily or nondaily migraine. These data may help guide the choice of migraine treatment in older populations.

01 Jan 2025·Headache: The Journal of Head and Face Pain

Effect of erenumab on the reversion from chronic migraine to episodic migraine in an Asian population: A post hoc analysis of the DRAGON study

Article

Author: Li, Zheng ; Yu, Shengyuan ; Kim, Byung‐Kun ; Wan, Qi ; Su, Wendy ; Yin, Fangfang ; Lian, Yajun ; Wang, Hebo ; Zhou, Jiying ; Yu, Tingmin ; Arkuszewski, Michal ; Wang, Shuu‐Jiun ; Snellman, Josefin ; Ecochard, Laurent ; Wen, Shihua

AbstractBackgroundErenumab is a fully human monoclonal antibody that selectively targets the calcitonin gene–related peptide receptor. It has been proven to be safe and efficacious in patients with episodic migraine (EM) and chronic migraine (CM) as demonstrated in phase 2 and 3 clinical trials including patients from Europe, Japan, and the United States. Reversion from CM to EM, as indicated by a reduction in the frequency of headache days, is an important indicator for efficacy outcome, though it has not been analyzed widely in patients with CM to date.ObjectivePrimary results of the DRAGON study demonstrated the efficacy and safety of erenumab in patients with CM from China and other Asian countries. This post hoc analysis evaluated the rate of reversion from CM to EM in the overall population and in subgroups of patients defined by baseline demographic and clinical characteristics (age, body mass index, gender, prior preventive treatment failure, medication overuse status, and disease duration).MethodsReversion from CM to EM was defined as a reduction in headache frequency to < 45 headache days over the 12 weeks of the double‐blind treatment period. In addition, migraine‐related disability and disease impact on functional impairment were assessed within each treatment group in reverters and non‐reverters using the Headache Impact Test‐6 (HIT‐6), Migraine Physical Function Impact Diary (MPFID), and modified Migraine Disability Assessment (mMIDAS).ResultsOverall, 557 patients with CM were randomized to monthly erenumab 70 mg (n = 279) or placebo (n = 278), of whom 52.3% (146 of 279) treated with erenumab reverted from CM to EM compared to 41.0% (114 of 278) in the placebo group (odds ratio [OR] 1.59, 95% confidence interval: 1.1–2.2; p = 0.007). Treatment with erenumab resulted in a greater mean change (standard error) from baseline in the HIT‐6 total score for reverters versus non‐reverters compared to placebo (erenumab: −9.5 [0.6] vs. −5.1 [0.5]; placebo: −8.9 [0.7] vs. −4.9 [0.5]). A similar pattern was observed for mMIDAS score in erenumab treatment groups versus placebo (erenumab: −22.1 [1.2] vs. −6.3 [1.8]; placebo: −19.9 [1.3] vs. −7.9 [1.6]). Substantial improvements were reported in MPFID‐Physical Impairment (PI) and Everyday Activities (EA) scores in reverters versus non‐reverters in erenumab treatment groups (MPFID‐PI: −5.9 [0.3] vs. −1.9 [0.6]; MPFID‐EA: −7.9 [0.4] vs. −3.4 [0.6]) and in placebo (MPFID‐PI: −5.4 [0.4] vs. −1.0 [0.5]; MPFID‐EA: −7.1 [0.5] vs. −3.2 [0.5]).ConclusionsThis analysis demonstrated that a greater proportion of patients treated with erenumab reverted from CM to EM compared to patients treated with placebo. The reversion from CM to EM was reflected by the greater improvements in patient‐reported outcomes in the erenumab group.

01 Jan 2025·European Journal of Neurology

Switching from ligand to receptor anti‐calcitonin gene‐related peptide (CGRP) antibodies or vice versa in non‐responders: A controlled cohort study

Article

Author: van Zwet, E. W. ; Hiele, E. ; van der Arend, Britt W. H. ; Terwindt, Gisela M. ; van Veelen, Nancy

AbstractBackground and purposeLimited options exist for migraine prevention after stopping anti‐calcitonin gene‐related peptide monoclonal antibodies. A systematic review examining the benefits of switching between different classes (ligand vs. receptor monoclonal antibody) is essential, alongside well‐designed real‐world studies.MethodsIn this cohort study 67 patients were included, who discontinued their first treatment with erenumab or fremanezumab. Patients (n = 31) switched to another monoclonal antibody class within 3 months, whilst those in the control group (n = 36) received standard care. Allocation to either group relied largely on the availability of alternative monoclonal antibody treatments, introducing pseudo‐random allocation. Changes in monthly migraine days were compared between groups 3 months post‐discontinuation of the first monoclonal antibody or initiation of a different monoclonal antibody class. A multivariate regression model was conducted that accounted for potential confounding factors.ResultsThe groups were comparable at baseline and poor treatment response was the main reason for treatment discontinuation of the first monoclonal antibody. The switching cohort experienced a reduction of 3.9 monthly migraine days (95% confidence interval −6.4, −1.3, p = 0.004) compared with the control group.ConclusionTransitioning to a different anti‐calcitonin gene‐related peptide monoclonal class yields reduction in monthly migraine days compared to returning to standard care for patients with inadequate initial treatment response.

News (Medical) associated with Erenumab (Genetical Recombination)

18 Sep 2024

·www.drugs.com

Erenumab Effective for Nonopioid Medication Overuse Headache in Chronic Migraine

WEDNESDAY, Sept. 18, 2024 -- Monthly use of erenumab injections (140 mg) is safe and effective in achieving medication overuse headache (MOH) remission in patients with nonopioid chronic migraine (CM) and MOH, according to a study published online Sept. 16 in JAMA Neurology . Stewart J. Tepper, M.D., from the New England Institute for Neurology and Headache in Stamford, Connecticut, and colleagues assessed the safety and efficacy of erenumab in patients with nonopioid CM-MOH. The analysis included 584 participants randomly assigned to erenumab (70 mg or 140 mg) or placebo, once monthly for 24 weeks. The researchers found that at month 6, 69.1 percent of participants in the erenumab 140-mg group (odds ratio, 2.01; 95 percent confidence interval, 1.33 to 3.05; P < 0.001 versus placebo) and 60.3 percent in the erenumab 70-mg group (odds ratio, 1.37; 95 percent confidence interval, 0.92 to 2.05; P = 0.13 versus placebo) achieved MOH remission versus 52.6 percent of participants in the placebo group. From baseline, least squares mean change in average monthly acute headache medication days was –9.4 days in the erenumab 140-mg group (difference from placebo, –2.7) and –7.8 days in the erenumab 70-mg group (difference from placebo, –1.2). Throughout the treatment period, MOH remission was sustained in 61.3 percent of participants in the erenumab 140-mg group, 49.5 percent of participants in the 70-mg group, and 37.6 percent in the placebo group. The safety profile was similar to that seen in previous trials, with treatment-emergent adverse event incidence in the combined erenumab group of 66.8 percent, including most commonly constipation (15.2 percent) and COVID-19 (13.9 percent). "This study is the first controlled trial to provide American Academy of Neurology class I evidence of beneficial effects of a migraine preventive treatment in patients with CM-MOH (nonopioid)," the authors write. Several authors disclosed ties to pharmaceutical companies, including Amgen, which manufactures erenumab and funded the study. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical Result

18 Jul 2024

·firstwordpharma.com

Teva touts first CGRP success in Phase III paediatric migraine prevention study

Teva is looking to expand its migraine prevention portfolio into the paediatric market, announcing positive results Thursday from the Phase III SPACE study evaluating Ajovy (fremanezumab) in children and adolescents. According to Teva, this is the first time an anti-CGRP monoclonal antibody has shown efficacy in this population.Teva estimates that migraines affect about 7.7% of children, with prevalence rising from 5% in kids aged 5 to 10 to around 15% in teenagers. "The SPACE data supports our ambitions to bring the proven benefits of Ajovy to children and adolescent patients who have fewer treatment options available to them," said Chief Medical Officer Eric Hughes.The trial randomised 235 subjects between the ages of 6 and 17 years to receive subcutaneously administered Ajovy or placebo over a 12-week period to prevent episodic migraines. Teva said the study met its primary endpoint, with Ajovy patients experiencing significantly fewer monthly migraine days compared to placebo."The results have particular significance given the lack of preventive migraine treatments approved for use in children and adolescent populations," the company said.So far, all other CGRP antibodies in the US — Amgen's Aimovig (erenumab), Lundbeck's Vyepti (eptinezumab) and Eli Lilly's Emgality (galcanezumab) — are only approved for adults. Ajovy was greenlit in the US as a preventative migraine treatment for adults in 2018 and was later also cleared in Europe.Amgen and Lundbeck are also testing their respective products in paediatric patients with chronic or episodic migraine. Aimovig is being evaluated in Amgen's OASIS(EM) and OASIS(CM) studies, both due to complete in 2027, while Vyepti is being investigated in the Phase III PROSPECT-1 and PROSPECT-2 trials, which are expected to wrap up towards the end of this year.Teva noted that the efficacy seen in the SPACE study was "consistent" with pivotal Phase III and real-world evidence in adults. No new emergent safety signals emerged. Full data will be presented at a medical meeting later this year.

Phase 3Clinical ResultDrug Approval

11 Mar 2024

·www.prnewswire.com

American Headache Society Publishes Updated Guidance on Migraine Preventive Therapy

Recommends therapies targeting calcitonin gene-related peptide (CGRP) as a first-line option for migraine prevention MOUNT ROYAL, N.J., March 11, 2024 /PRNewswire/ -- The American Headache Society (AHS) published a consensus position statement today in Headache: The Journal of Head and Face Pain about the first-line role CGRP-targeting therapies should play in the prevention of migraine. Specifically, the AHS calls for CGRP-targeting therapies to be considered as a first-line approach for migraine prevention, along with previous first-line treatments, without a requirement for prior failure of other classes of migraine preventive treatment. The goal of preventive treatment is to reduce the frequency, intensity, duration, and disability associated with migraine attacks. AHS, the leading medical and scientific organization for healthcare professionals in migraine and other headache disorders, estimates that preventive therapy is indicated for approximately 40% of people with migraine, and many are unable to use existing first-line preventive migraine medicines due to limited effectiveness and tolerability. After a comprehensive review of clinical trial and real-world experience, the AHS found the evidence supporting the efficacy, tolerability, and safety of CGRP-targeting therapies—such as monoclonal antibodies (erenumab, fremanezumab, galcanezumab, and eptinezumab) and small-molecule CGRP receptor antagonists (rimegepant and atogepant)—for migraine prevention to be substantial in its volume, scope, and quality. "Moving CGRP-targeting therapies to the first line of treatment could have a transformational impact on the prevention of migraine attacks and their associated burdens," said Andrew Charles, MD, FAHS, position statement co-author and president of the American Headache Society. "Elevating CGRP-targeting therapies to the first line should reduce barriers for patients to receive these effective treatments and bring hope to countless people who experience this invisible, yet debilitating disease." The new position statement from the AHS, "Calcitonin gene-related peptide (CGRP)-targeting therapies are a first-line option for the prevention of migraine," provides guidance on how to integrate these treatments into clinical practice. ABOUT MIGRAINE Migraine is the third most common disease in the world. In the United States, an estimated 40 million Americans live with migraine. While migraine symptoms vary from person to person, common symptoms include severe headache; nausea and/or vomiting; increased sensitivity to light, sound, or smells; depressed mood or changes in mood; and yawning, fatigue, and difficulty sleeping. ABOUT THE AMERICAN HEADACHE SOCIETY The American Headache Society strives to improve the lives of people impacted by migraine and other headache disorders. The AHS is a professional society of health care providers dedicated to the study and treatment of headache and face pain. The Society's objective is to promote the exchange of information and ideas concerning the causes and treatments of headache and related painful disorders. Educating physicians, health professionals, and the public while encouraging scientific research are the primary functions of our Society. Learn more at AmericanHeadacheSociety.org. This consensus statement published by the American Headache Society (AHS) is an assessment of current scientific and clinical information that is provided as an educational service. The information should not be considered inclusive of all appropriate treatments. New evidence may develop between the time this statement is submitted and when it is published or read. This statement addresses only the question that is specifically identified. It does not mandate any particular course of medical care and is not intended to substitute for the independent professional judgment of the treating provider. CONTACT Tanya Kiniry [email protected] SOURCE American Headache Society

100 Deals associated with Erenumab (Genetical Recombination)

External Link

KEGG	Wiki	ATC	Drug Bank
-	Erenumab (Genetical Recombination)	N02CD01	DB14039

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Migraine Disorders	US	Amgen, Inc.	17 May 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Migraine Disorders	Phase 3	PL	Amgen, Inc.	17 Jul 2015
Migraine Disorders	Phase 3	FI	Amgen, Inc.	17 Jul 2015
Migraine Disorders	Phase 3	DE	Amgen, Inc.	17 Jul 2015
Migraine Disorders	Phase 3	BE	Amgen, Inc.	17 Jul 2015
Migraine Disorders	Discovery	NL	Amgen, Inc.	17 Jul 2015
Migraine Disorders	Discovery	SE	Amgen, Inc.	17 Jul 2015
Migraine Disorders	Discovery	SK	Amgen, Inc.	17 Jul 2015
Migraine Disorders	Discovery	CZ	Amgen, Inc.	17 Jul 2015
Migraine Disorders	Discovery	AT	Amgen, Inc.	17 Jul 2015
Migraine Disorders	Discovery	TR	Amgen, Inc.	17 Jul 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04084314 (APOLLON, Pubmed \| J Headache Pain) Manual	Phase 4	Migraine Disorders	701	Erenumab 70 mg	(naillbdbbm) = 4.1% of total cohort discontinued erenumab treatment during open-label treatment phase. Out of these, 65.5% (N = 19) were considered treatment-related. kleodmowgn (xlbpchmmmf )	Positive	25 Sep 2024
				Erenumab 140 mg
NCT04825678 (CTgov)	Phase 4	Migraine Disorders	240	Erenumab (Erenumab QM: Continued SoC)	mbvkmzquen(jidhhjljwy) = qrddjsnwhz yrnxjqpwgb (jxiageyymm, rlfsgbvavn - wjdhoyojjp) View more	-	19 Sep 2024
				Erenumab (Erenumab QM: Discontinued SoC)	mbvkmzquen(jidhhjljwy) = qcuiheoryo yrnxjqpwgb (jxiageyymm, ttbeuwnepm - yvdepqtrrl) View more
NCT03971071 (Pubmed \| JAMA Neurol) Manual	Phase 4	Migraine Disorders	620	Erenumab 70 mg	twodihytwj(ewwpswykpi) = ucqhtsezjx nfmxirooqu (dkgnkdkpdj ) View more	Positive	16 Sep 2024
				Erenumab 140 mg	twodihytwj(ewwpswykpi) = ycprjvebvk nfmxirooqu (dkgnkdkpdj ) View more
NCT04252742 (CTgov)	Phase 4	Migraine Disorders	512	Placebo	rvsgerbegj(fjhnphbjhi) = vvbkiigqld ixlvercjog (cybouzozoc, tgvjvildaz - egqepcawnw) View more	-	30 Aug 2024
NCT04265755 (INTERROGATE, CTgov)	Phase 4	Migraine Disorders	1,406	Erenumab (Erenumab 70 mg/140 mg)	lsjffcbewz(xodslhstqp) = hxintcbobj fupwzmmxus (zcchhyvakd, gjzxofoseo - cqxhrtwjzl)	-	07 Jun 2024
				Erenumab (Erenumab 70 mg)	cqbpvqmjhd(xrqpkqgfdp) = edgcoxkoeq tkthuyfgsb (lnexgblorh, vnwgdxorta - zgvqtlbcoy) View more
NCT03096834 (LIBERTY, Pubmed \| Neurology) Manual	Phase 3	Migraine Disorders Third line	151	Erenumab 140 mg	(kcusndugam) = The most common treatment-emergent AEs (per 100 person-years) were nasopharyngitis (28.8), influenza (7.5), and back pain (5.8). rvqolchrcf (mytmpchuje )	Positive	01 May 2024
NCT05162027 (TMD CARE, CTgov)	Phase 2	Temporomandibular Joint Disorders	5	Erenumab-Aooe 70 MG in 1 mL Prefilled Syringe (Erenumab-aooe)	otndlpwadz(huzrmjfhpn) = vyhemyulmq uradowlvow (ozgdyfmxwb, ibchcyszlj - jfjcifucvx) View more	-	02 Apr 2024
				Placebo (Placebo)	otndlpwadz(huzrmjfhpn) = nkhcmnmwob uradowlvow (ozgdyfmxwb, fgcwtusraa - vmftajxttx) View more
NCT05142228 (CTgov)	Phase 2	Trigeminal Nerve Diseases \| Neuralgia	5	Erenumab-Aooe (Erenumab-aooe)	voegxouysw(dyokbzuijj) = uzhuwugglb suoxcnutwe (fwdyixjshm, trtqdtaiii - plvgqsogfx) View more	-	22 Mar 2024
				Placebo (Placebo)	voegxouysw(dyokbzuijj) = rbcvsfhsqp suoxcnutwe (fwdyixjshm, cckvrapmfx - juvpqevkme) View more
NCT04084314 (APOLLON, CTgov)	Phase 4	Migraine Disorders	701	Erenumab	ybxkwczmqu(qkcemimrpd) = iosrxwvego eembqbgkhp (sngcduxxjo, pjonyrfawc - jviykbgtdq) View more	-	06 Feb 2024

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