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CGRP in the Journals

Are you looking for a specific study of anti-CGRP therapy or just want a quick update of recently published research? Take a look at our summary of some of the most important CGRP publications of recent months.

August 2021 Update

Phase 3 data of atogepant in episodic migraine. Ailani J, Lipton RB, Goadsby PJ et al. Atogepant for the Preventive Treatment of Migraine. N Engl J Med. 2021 Aug 19;385(8):695-706.

Expert review of eptinezumab data. Spuntarelli V, Negro A, Luciani M et al. Eptinezumab for the treatment of migraine. Expert Opin Biol Ther. 2021 Aug; 21 (8): 999-1011

Latest fremanezumab data from FOCUS trial. Ashina M, Cohen JM, Galic M et al. Efficacy and safety of fremanezumab in patients with episodic and chronic migraine with documented inadequate response to 2 to 4 classes of migraine preventive medications over 6 months of treatment in the phase 3b FOCUS study. The Journal of Headache and Pain 2021; 22:68

Spanish real world data on anti-CGRP mAb/botulinum toxin A combinations. Alpuente A, Gallardo VJ, Caronna E et al. Partial and nonresponders to onabotulinumtoxinA can benefit from anti-CGRP monoclonal antibodies preventive treatment: A real-world evidence study. Eur J Neurol. 2021 Jul;28(7):2378-2382.

Galcanezumab impact on cluster headache pain burden. Scott Andrews J, Rettiganti M, Oaked T et al. Impact of Galcanezumab on Total Pain Burden: A Post Hoc Analysis of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study in Patients with Episodic Cluster Headache. J Pain Res. 2021 Jul 8;14:2059-2070.

Erenumab reduces acute migraine medication use. Tepper SJ, Ashina M, Reuter U et al. Reduction in acute migraine-specific and non-specific medication use in patients treated with erenumab: post-hoc analyses of episodic and chronic migraine clinical trials.  J Headache Pain. 2021 Jul 23;22(1):81.

Expert overview of clinical trial and real world anti-CGRP mAb use. Mavridis T, Deligianni CI, Karagiorgis G et al.  Monoclonal Antibodies Targeting CGRP: From Clinical Studies to Real-World Evidence—What Do We Know So Far? Pharmaceuticals 2021 July 20, 14(7): 700.

Benefits of anti-CGRP mAbs vs topiramate. Overeem LH, Raffaelli B, Mecklenburg J et al. Indirect Comparison of Topiramate and Monoclonal Antibodies Against CGRP or Its Receptor for the Prophylaxis of Episodic Migraine: A Systematic Review with Meta-Analysis. CNS Drugs. 2021 Jul 16. Online ahead of print.

Latest AHS migraine guideline including eptinezumab and gepants. Ailani J, Burch RC, Robbins MS et al. The American Headache Society Consensus Statement: Update on integrating new migraine treatments into clinical practice. Headache 2021 Jul;61(7):1021-1039.

Review of rimegepant use in migraine. De Vries T, Al-Hassany L, MaassenVanDenBrink A. Evaluating rimegepant for the treatment of migraine. Expert Opin Pharmacother. 2021 Jun; 22(8):973-979.

Benefits of anti-CGRP mAb and botulinum toxin combination. Blumenfeld AM, Frishberg BM, Schim JD et al. Real-world evidence for control of chronic migraine patients receiving CGRP monoclonal antibody therapy added to onabotulinumtoxinA: A retrospective chart review. Pain Therapy 2021 Apr 21. Online ahead of print.

Anti-CGRP mAbs do not worsen COVID-19 infection prognosis. Caronna E, Gallardo VJ, Alpuente A et al. Safety of anti-CGRP monoclonal antibodies in patients with migraine during the COVID-19 pandemic: present and future implications. Neurología 2021. Online ahead of publication.

PREVAIL study reports eptinezumab 2-year safety and efficacy. Kudrow D, Cady RK, Allan B et al. Long-term safety and tolerability of eptinezumab in patients with chronic migraine: a 2-year, open-label, phase 3 trial. BMC Neurology 2021; 21:126

February 2021 Update

First publication of real world use of ubrogepant. Chiang  CC, Arca KN, Dunn RB et al. Real-world efficacy, tolerability, and safety of ubrogepant. Headache 2021 Feb 5. Online ahead of print.

New update of novel treatment targets for migraine. Edvinsson L, Haanes KA. Identifying New Antimigraine Targets: Lessons from Molecular Biology Trends Pharmacol Sci. 2021 Jan 23; Online ahead of print.

Safety of anti-CGRP therapies in pregnancy. Noseda R, Bedussi F, Gobbi C et al. Safety profile of erenumab, galcanezumab and fremanezumab in pregnancy and lactation: Analysis of the WHO pharmacovigilance database. Cephalalgia  2021 Jan 12; Online ahead of print.

Longest follow-up to date of anti-CGRP treatment. Ashina M, Goadsby P, Reuter U et al. Long-term efficacy and safety of erenumab in migraine prevention: Results from a 5-year, open-label treatment phase of a randomized clinical trial. Eur J Neurol 2021 Jan 5.

Impact of treatment discontinuation in a real world setting. De Matteis, Affaitati G, Frattale I et al. Early outcomes of migraine after erenumab discontinuation: data from a real-life setting. Neurological Sciences 2021 Jan 2. Online ahead of print.

Major rimegepant publication in migraine prevention. Croop R, Lipton RB, Kudrow D et al. Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. Lancet 2021; 397: 51-60

Potential biomarkers linking medication overuse with progression from episodic to chronic migraine.  Greco R, De Icco R, Demartini C et al. Plasma levels of CGRP and expression of specific microRNAs in blood cells of episodic and chronic migraine subjects: towards the identification of a panel of peripheral biomarkers of migraine? J Headache Pain 2020 Oct 16;21(1):122.

Sustained efficacy and safety of fremanezumab. Goadsby PJ, Silberstein SD, Yeung PP et al. Long-term safety, tolerability, and efficacy of fremanezumab in migraine: a randomized study. Neurology. 2020 Sep 10:10.1212 Online ahead of print.

Pivotal atogepant data in migraine prevention. Goadsby P. Dodick DW, Ailani J et al. Safety, tolerability, and efficacy of orally administered atogepant for the prevention of episodic migraine in adults: a double-blind, randomised phase 2b/3 trial. Lancet Neurol. 2020 Sep;19(9):727-737.

October 2020 Update

Sub-group analysis shows that rimegepant is well tolerated with CGRP mAbs. Berman G, Croop R, Kudrow D et al. Safety of Rimegepant, an Oral CGRP Receptor Antagonist, Plus CGRP Monoclonal Antibodies for Migraine. Headache 2020 Sep; 60(8): 1734–1742.

Rimegepant acts as antagonist at both CGRP and AMY1 receptors. Pan KS, Siow A, Hay DL, Walker CS. Antagonism of CGRP Signaling by Rimegepant at Two Receptors. Front Pharmacol. 2020; 11: 1240.

Expert review of cluster headache data. Pellesi L, De Icco R, Al-Mahdi Al-Karagholi M, Ashina M. Reducing Episodic Cluster Headaches: Focus on Galcanezumab. J Pain Res. 2020; 13: 1591–1599.

Open label data show erenumab efficacy in post-traumatic headache. Ashina H, Iljazi A, Al-Khazali HM, Eigenbrodt AK et al. Efficacy, tolerability, and safety of erenumab for the preventive treatment of persistent post-traumatic headache attributed to mild traumatic brain injury: an open-label study. J Headache Pain 2020; 21(1): 62.

Real world data support erenumab efficacy in hard to treat migraine. Scheffler A, Messel O, Wurthmann S et al. Erenumab in highly therapy-refractory migraine patients: First German real-world evidence. J Headache Pain 2020; 21(1): 84.

Promising ubrogepant results in preclinical model of medication overuse headache. Navratilova E, Behravesh S, Oyarzo J et al. Ubrogepant does not induce latent sensitization in a preclinical model of medication overuse headache. Cephalalgia 2020 Aug; 40(9): 892–902.

70% responder rate with erenumab 70 mg in Italian real world study. Russo A, Silvestro M, di Clemente FS et al. Multidimensional assessment of the effects of erenumab in chronic migraine patients with previous unsuccessful preventive treatments: a comprehensive real-world experience. J Headache Pain 2020; 21(1): 69.

Coadministration of ubrogepant and sumatriptan well tolerated. Jakate A, Boinpally R, Butler M et al. Evaluation of the Pharmacokinetic Interaction of Ubrogepant Coadministered With Sumatriptan and of the Safety of Ubrogepant With Triptans. Headache 2020 Jul-Aug; 60(7): 1340–1350.

Patients prefer quarterly to monthly fremanezumab treatment. Buse DC, Gandhi SK, Cohen JM et al. Improvements across a range of patient-reported domains with fremanezumab treatment: results from a patient survey study. J Headache Pain 2020; 21(1): 109.

Two thirds of patients convert from chronic to episodic migraine in real world study. Ornello R, Casalena A, Frattale I et al. Conversion from chronic to episodic migraine in patients treated with erenumab: real-life data from an Italian region. J Headache Pain. 2020; 21(1): 102.

Sustained erenumab efficacy over 52 weeks. Goadsby PJ, Reuter U, Hallström Y et al. One-year sustained efficacy of erenumab in episodic migraine: Results of the STRIVE study. Neurology 2020 Aug 4; 95(5): e469–e479.

COVID-19 limits anti-CGRP therapy initiation in Spain. López-Bravo A, García-Azorín D, Belvís R et al. Impact of the COVID-19 pandemic on headache management in Spain: an analysis of the current situation and future perspectives. Neurología (English Edition) 2020 July-August; 35(6): 372–380.

Erenumab effective and well tolerated in refractory chronic migraine. Lambru G, Hill B, Murphy M et al. A prospective real-world analysis of erenumab in refractory chronic migraine. J Headache Pain. 2020; 21(1): 61.

STRIVE sub group analysis shown erenumab efficacy in menstrual migraine consistent with overall data. Pavlovic JM, Paemeleire K, Göbel H et al.  Efficacy and safety of erenumab in women with a history of menstrual migraine. J Headache Pain. 2020; 21(1): 95.

UK real world experience with erenumab. Lambru G, Hill B, Murphy M et al. A prospective real-world analysis of erenumab in refractory chronic migraine. J Headache Pain. 2020 Jun 1;21(1):61.

May 2020 Update

Targeting CGRP and PACAP pathways in cluster headache. Chan C, Goadsby PJ. CGRP pathway monoclonal antibodies for cluster headache. Expert Opin Biol Ther. 2020 Apr 28:1-7.

Appeal for easier access to anti-CGRP therapies during COVID-19. Szperka CL, Ailani J, Barmherzig R et al. Migraine care in the era of COVID-19: Clinical Pearls and Plea to Insurers. Headache 2020; 60: 833-842.

Second publication of Phase 3 eptinezumab data. Lipton RB, Goadsby PJ, Smith J et al. Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2. Neurology. 2020 Mar 31;94(13):e1365-e1377.

Galcanezumab benefit following botulinum toxin treatment failure. Ailani J, Pearlman E, Zhang Q et al. Positive response to galcanezumab following treatment failure to onabotulinumtoxinA in patients with migraine: post hoc analyses of three randomized double-blind studies. Eur J Neurol. 2020 Mar;27(3):542-549.

First publication of Phase 3 eptinezumab data. Ashina M, Saper J, Cady R et al. Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1). Cephalalgia. 2020 Mar;40(3):241-254.

Sustained efficacy of erenumab in chronic migraine at 12 months. Tepper SJ, Ashina M, Reuter U et al. Long-term safety and efficacy of erenumab in patients with chronic migraine: Results from a 52-week, open-label extension study. Cephalalgia. 2020 Mar 26:333102420912726. doi: 10.1177/0333102420912726. [Epub ahead of print]

Potential of GLP-1 agonists in constipation related to anti-CGRP therapy. Haanes KA, Edvinsson L, Sams A. Understanding side-effects of anti-CGRP and anti-CGRP receptor antibodies. The Journal of Headache and Pain 2020; 21: 26.

Efficacy failure of galcanezumab in chronic cluster headache. Dodick DW, Goadsby PJ, Lucas C et al. Phase 3 randomized, placebo-controlled study of galcanezumab in patients with chronic cluster headache: Results from 3-month double-blind treatment. 2020 Feb 12:333102420905321. doi: 10.1177/0333102420905321. [Epub ahead of print]

January 2020 update

No evidence of liver toxicity with supratherapeutic ubrogepant dosing. Ankrom W, Bondiskey P, Li CC et al. Ubrogepant Is Not Associated With Clinically Meaningful Elevations of Alanine Aminotransferase in Healthy Adult Males. Clin Transl Sci. 2020 Jan 3. doi: 10.1111/cts.12728. [Epub ahead of print]

Report of switching to galcanezumab in erenumab non-responders. Ziegeler C, May A. Non-Responders to Treatment With Antibodies to the CGRP-Receptor May Profit From a Switch of Antibody Class. Headache. 2019 Dec 24. doi: 10.1111/head.13729. [Epub ahead of print]

Full results from the ACHIEVE I trial of ubrogepant in the acute treatment of migraine
Dodick DW, Lipton RB, Ailani J et al. Ubrogepant for the Treatment of Migraine. N Engl J Med. 2019 Dec 5;381(23):2230-2241.

Secondary endpoint data from Phase 3 HALO study of fremanezumab: Brandes JL, Kudrow D, Yeung PP et al. Effects of fremanezumab on the use of acute headache medication and associated symptoms of migraine in patients with episodic migraine. Cephalalgia. 2019 Nov 21:333102419885905. doi: 10.1177/0333102419885905. [Epub ahead of print]

ACHIEVE II publication of ubrogepant for acute migraine: Lipton RB, Dodick DW, Ailani J et al. Effect of ubrogepant vs placebo on pain and the most bothersome associated symptom in the acute treatment of migraine: The ACHIEVE II randomized clinical trial. JAMA. 2019 Nov 19;322(19):1887-1898.

Novel potential site of action for CGRP therapy: Edvinsson JCA, Warfvinge K, Krause DN et al. C-fibers may modulate adjacent Aδ-fibers through axon-axon CGRP signaling at nodes of Ranvier in the trigeminal system. J Headache Pain. 2019 Nov 12;20(1):105. doi: 10.1186/s10194-019-1055-3.

Phase 2 data supporting erenumab use in Japanese patients: Sakai F, Takeshima T, Tatsuoka Y et al. A randomized Phase 2 study of erenumab for the prevention of episodic migraine in Japanese adults. Headache. 2019 Nov;59(10):1731-1742.

Differential effects of ubrogepant and atogepant on intracranial and coronary arteries: Rubio-Beltran E, Chan KY, Danser AJ et al. Characterisation of the calcitonin gene-related peptide receptor antagonists ubrogepant and atogepant in human isolated coronary, cerebral and middle meningeal arteries. Cephalalgia. 2019 Nov 1:333102419884943. doi: 10.1177/0333102419884943. [Epub ahead of print]

Phase 3 post hoc data on galcanezumab following treatment failure with onabotulinumtoxinA: Ailani J, Pearlman E, Zhang Q et al. Positive response to galcanezumab following treatment failure to onabotulinumtoxinA in patients with migraine: post hoc analyses of 3 randomized double-blind studies. Eur J Neurol. 2019 Oct 8. doi: 10.1111/ene.14102. [Epub ahead of print]

September 2019

First major publication of clinical trial data on ubrogepant: Goadsby PJ, Tepper SJ, Watkins PB et al. Safety and tolerability of ubrogepant following intermittent, high-frequency dosing: Randomized, placebo-controlled trial in healthy adults. Cephalalgia. 2019 Sep 19:333102419869918. doi: 10.1177/0333102419869918. [Epub ahead of print]

Publication of the Phase 3 FOCUS study of fremanezumab: Ferrari MD, Diener HC, Ning X et al. Fremanezumab versus placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS): a randomised, double-blind, placebo-controlled, phase 3b trial. Lancet. 2019 Sep 21;394(10203):1030-1040. 

First major publication of clinical trial data for eptinezumab: Dodick DW, Lipton RB, Silberstein S et al. Eptinezumab for prevention of chronic migraine: A randomized phase 2b clinical trial. Cephalalgia. 2019 Aug;39(9):1075-1085.

A comprehensive review of the scientific research behind CGRP: Ashina M, Hansen JM, Do TP et al.  Migraine and the trigeminovascular system-40 years and counting. Lancet Neurol. 2019 Aug;18(8):795-804.

A Lancet editorial focused on newly published rimegepant ODT data: Edvinsson L. Rimegepant oral disintegrating tablet for migraine. Lancet. 2019 Jul 12. pii: S0140-6736(19)31611-3.

First publication of clinical data on rimegepant ODT (study 303): Croop R, Goadsby PJ, Stock DA et al. Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial. Lancet. 2019 Jul 12. pii: S0140-6736(19)31606-X.

Publication of a Phase 3 trial (study 302) of rimegepant in its original formulation: Lipton RB, Croop R, Stock EG et al. Rimegepant, an Oral Calcitonin Gene-Related Peptide Receptor Antagonist, for Migraine. N Engl J Med. 2019 Jul 11;381(2):142-149.

A CGRP research review initiated by the Spanish Society of Neurology's Headache Study Group: Santos-Lasaosa S, Belvís R, Cuadrado ML et al. Calcitonin gene-related peptide in migraine: from pathophysiology to treatment. Neurologia. 2019 Jul 17. pii: S0213-4853(19)30075-1.

Publication of pivotal data supporting approval of galcanezumab in the prevention of episodic cluster headache: Goadsby PJ, Dodick DW, Leone M et al. Trial of Galcanezumab in Prevention of Episodic Cluster Headache. N Engl J Med. 2019 Jul 11;381(2):132-141.

Illuminating research demonstrating continuing effects of CGRP therapies after treatment is stopped:  Raffaelli B, Mussetto V, Israel H et al. Erenumab and galcanezumab in chronic migraine prevention: effects after treatment termination. J Headache Pain. 2019 Jun 3;20(1):66.

Long term data from a Phase 2 erenumab study in episodic migraine: Ashina M, Goadsby PJ, Reuter U et al. Long-term safety and tolerability of erenumab: Three-plus year results from a five-year open-label extension study in episodic migraine. Cephalalgia. 2019 May 30:333102419854082.

Promising erenumab findings in chronic migraine with medication overuse:  Tepper SJ, Diener HC, Ashina M et al.  Erenumab in chronic migraine with medication overuse: Subgroup analysis of a randomized trial. Neurology. 2019 May 14;92(20):e2309-e2320.

Phase 2 data showing rapid response to fremanezumab in high frequency episodic migraine: Silberstein SD, Rapoport AM, Loupe PS, Aycardi E, McDonald M, Yang R, Bigal ME. The Effect of Beginning Treatment With Fremanezumab on Headache and Associated Symptoms in the Randomized Phase 2 Study of High Frequency Episodic Migraine: Post-Hoc Analyses on the First 3 Weeks of Treatment. Headache 2019 Mar;59(3):383-393.

Review of current CGRP knowledge in migraine by one of the pioneers of CGRP research. Edvinsson L. Role of CGRP in Migraine.  Handb Exp Pharmacol. 2019 Feb 7. doi: 10.1007/164_2018_201. [Epub ahead of print]

European Headache Federation guidelines on anti-CGRP therapies for migraine prevention: Sacco S, Bendtsen L, Ashina M et al. European headache federation guideline on the use of monoclonal antibodies acting on the calcitonin gene related peptide or its receptor for migraine prevention. J Headache Pain. 2019 Jan 16;20(1):6.

Publication of the Phase 3 REGAIN study of galcanezumab in chronic migraine:  Detke HC, Goadsby PJ, Wang S, Friedman DI et al. Galcanezumab in chronic migraine: The randomized, double-blind, placebo-controlled REGAIN study. Neurology. 2018 Dec 11;91(24):e2211-e222.

Data from EVOLVE 1 and 2 on the effects of galcanezumab on patient function and disability: Ford JH, Ayer DW, Zhang Q et al. Two randomized migraine studies of galcanezumab: Effects on patient functioning and disability. Neurology. 2019 Jul 30;93(5):e508-e517.

American Headache Society recommendations on the use of anti-CGRP therapy in children and adolescents: Szperka CL, VanderPluym J, Orr SL et al. Recommendations on the use of anti-CGRP monoclonal antibodies in children and adolescents. Headache 2018 Nov;58(10):1658-1669. 

Publication of the LIBERTY trial of erenumab following 2-4 preventive treatment failures: Reuter U, Goadsby PJ, Lanteri-Minet M et al. Efficacy and tolerability of erenumab in patients with episodic migraine in whom two-to-four previous preventive treatments were unsuccessful: a randomised, double-blind, placebo-controlled, phase 3b study. Lancet. 2018 Nov 24;392(10161):2280-2287.

A review focusing on the similar mechanisms of migraine and cluster headache: Vollesen AL, Benemei S, Cortese F et al. Migraine and cluster headache - the common link. J Headache Pain. 2018 Sep 21;19(1):89.

Phase 3 STRIVE data on erenumab effects on migraine disability and quality of life: Buse DC, Lipton RB, Hallström Y et al. Migraine-related disability, impact, and health-related quality of life among patients with episodic migraine receiving preventive treatment with erenumab. Cephalalgia 2018 Sep;38(10):1622-1631.

Publication of the EVOLVE-1 study of galcanezumab in episodic migraine. Stauffer VL, Dodick DW, Zhang Q et al.  Evaluation of Galcanezumab for the Prevention of Episodic Migraine: The EVOLVE-1 Randomized Clinical Trial. JAMA Neurol. 2018 Sep 1;75(9):1080-1088.