154
Views
0
CrossRef citations to date
0
Altmetric
Review

Developments in targeting calcitonin gene-related peptide

, , & ORCID Icon
Pages 477-485 | Received 10 Oct 2023, Accepted 15 Mar 2024, Published online: 01 Apr 2024

References

  • Edvinsson L. CGRP and migraine: from bench to bedside. Rev Neurol. 2021;177(7):785–790. doi: 10.1016/j.neurol.2021.06.003
  • Pietrobon D, Moskowitz MA. Pathophysiology of migraine. Annu Rev Physiol. 2013;75(1):365–391. doi: 10.1146/annurev-physiol-030212-183717
  • Ashina M, Hansen JM, Do TP, et al. Migraine and the trigeminovascular system-40 years and counting. Lancet Neurol. 2019;18(8):795–804.
  • Yuan H, Lauritsen CG, Kaiser EA, et al. CGRP monoclonal antibodies for migraine: rationale and progress. Bio Drugs. 2017;31(6):487–501. doi: 10.1007/s40259-017-0250-5
  • de Vries T, Villalón CM, MaassenVandenbrink A. Pharmacological treatment of migraine: CGRP and 5-HT beyond the triptans. Pharmacol Ther. 2020;211:107528. doi: 10.1016/j.pharmthera.2020.107528
  • Goadsby PJ, Reuter U, Hallström Y, et al. A controlled trial of erenumab for episodic migraine. N Engl J Med. 2017;377(22):2123–2132. doi: 10.1056/NEJMoa1705848
  • Dodick DW, Ashina M, Brandes JL, et al. ARISE: a phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia. 2018;38(6):1026–1037. doi: 10.1177/0333102418759786
  • 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;392(10161):2280–2287. doi: 10.1016/S0140-6736(18)32534-0
  • Tepper S, Ashina M, Reuter U, et al. Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2017;16(6):425–434. doi: 10.1016/S1474-4422(17)30083-2
  • Ashina M, Goadsby PJ, 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;28(5):1716–1725. doi: 10.1111/ene.14715
  • Barbanti P, Aurilia C, Cevoli S, et al. Long-term (48 weeks) effectiveness, safety, and tolerability of erenumab in the prevention of high-frequency episodic and chronic migraine in a real world: results of the EARLY 2 study. Headache. 2021;61(9):1351–1363. doi: 10.1111/head.14194
  • Barbanti P, Aurilia C, Egeo G, et al. Erenumab in the prevention of high-frequency episodic and chronic migraine: erenumab in real life in Italy (EARLY), the first Italian multicenter, prospective real-life study. Headache. 2021;61(2):363–372. doi: 10.1111/head.14032
  • Skljarevski V, Matharu M, Millen BA, et al. Efficacy and safety of galcanezumab for the prevention of episodic migraine: results of the EVOLVE-2 phase 3 randomized controlled clinical trial. Cephalalgia. 2018;38(8):1442–1454. doi: 10.1177/0333102418779543
  • Detke HC, Goadsby PJ, Wang S, et al. Galcanezumab in chronic migraine: The randomized, double-blind, placebo-controlled REGAIN study. Neurology. 2018;91(24):e2211–e2221. doi: 10.1212/WNL.0000000000006640
  • 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;75(9):1080–1088. doi: 10.1001/jamaneurol.2018.1212
  • Mulleners WM, Kim B-K, Láinez MJA, et al. Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2020;19(10):814–825. doi: 10.1016/S1474-4422(20)30279-9
  • Vernieri F, Altamura C, Brunelli N, et al. Galcanezumab for the prevention of high frequency episodic and chronic migraine in real life in Italy: a multicenter prospective cohort study (the GARLIT study). J Headache Pain. 2021;22(1):35. doi: 10.1186/s10194-021-01247-1
  • Silberstein SD, Dodick DW, Bigal ME, et al. Fremanezumab for the preventive treatment of chronic migraine. N Engl J Med. 2017;377(22):2113–2122. doi: 10.1056/NEJMoa1709038
  • Dodick DW, Silberstein SD, Bigal ME, et al. Effect of fremanezumab compared with placebo for prevention of episodic migraine: a randomized clinical trial. JAMA. 2018;319(19):1999–2008. doi: 10.1001/jama.2018.4853
  • 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;394(10203):1030–1040. doi: 10.1016/S0140-6736(19)31946-4
  • Silberstein SD, Cohen JM, Seminerio MJ, et al. The impact of fremanezumab on medication overuse in patients with chronic migraine: subgroup analysis of the HALO CM study. J Headache Pain. 2020;21(1):114. doi: 10.1186/s10194-020-01173-8
  • Ashina M, Saper J, Cady R, et al. Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1). Cephalalgia. 2020;40(3):241–254. doi: 10.1177/0333102420905132
  • Lipton RB, Goadsby PJ, Smith J, et al. Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2. Neurology. 2020;94(13):e1365–e1377. doi: 10.1212/WNL.0000000000009169
  • Ashina M, Lanteri-Minet M, Pozo-Rosich P, et al. Safety and efficacy of eptinezumab for migraine prevention in patients with two-to-four previous preventive treatment failures (DELIVER): a multi-arm, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2022;21(7):597–607. doi: 10.1016/S1474-4422(22)00185-5
  • 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 neurol. 2021;21(1):126. doi: 10.1186/s12883-021-02123-w
  • Winner PK, McAllister P, Chakhava G, et al. Effects of intravenous eptinezumab vs placebo on headache pain and most bothersome symptom when initiated during a migraine attack: a randomized clinical trial. JAMA. 2021;325(23):2348–2356. doi: 10.1001/jama.2021.7665
  • Dodick DW, Lipton RB, Ailani J, et al. Ubrogepant for the treatment of migraine. N Engl J Med. 2019;381(23):2230–2241. doi: 10.1056/NEJMoa1813049
  • 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;322(19):1887–1898. doi: 10.1001/jama.2019.16711
  • Dodick DW, Goadsby PJ, Schwedt TJ, et al. Ubrogepant for the treatment of migraine attacks during the prodrome: a phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in the USA. Lancet. 2023;402(10419):2307–2316. doi: 10.1016/S0140-6736(23)01683-5
  • Hutchinson S, Silberstein SD, Blumenfeld AM, et al. Safety and efficacy of ubrogepant in participants with major cardiovascular risk factors in two single-attack phase 3 randomized trials: ACHIEVE I and II. Cephalalgia. 2021;41(9):979–990. doi: 10.1177/03331024211000311
  • Tong G, Savant I, Jariwala N, et al. Phase I single and multiple dose study to evaluate the safety, tolerability, and pharmacokinetics of BMS-927711 in healthy subjects. J Headache Pain. 2013;14(S1):118.
  • Lipton RB, Croop R, Stock EG, et al. Rimegepant, an oral calcitonin gene-related peptide receptor antagonist, for migraine. N Engl J Med. 2019;381(2):142–149.
  • 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;394(10200):737–745. doi: 10.1016/S0140-6736(19)31606-X
  • 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(10268):51–60. doi: 10.1016/S0140-6736(20)32544-7
  • Schwedt TJ, Myers Oakes TM, Martinez JM, et al. Comparing the efficacy and safety of galcanezumab versus rimegepant for prevention of episodic migraine: results from a randomized, controlled clinical trial. Neurol Ther. 2024;13(1):85–105. doi: 10.1007/s40120-023-00562-w
  • Boinpally R, Jakate A, Butler M, et al. Single-dose pharmacokinetics and safety of atogepant in adults with hepatic impairment: results from an open-label, phase 1 trial. Clin Pharmacol Drug Dev. 2021;10(7):726–733. doi: 10.1002/cpdd.916
  • Goadsby PJ, 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;19(9):727–737. doi: 10.1016/S1474-4422(20)30234-9
  • Ailani J, Lipton RB, Goadsby PJ, et al. Atogepant for the preventive treatment of migraine. N Engl J Med. 2021;385(8):695–706. doi: 10.1056/NEJMoa2035908
  • Pozo-Rosich P, Ailani J, Ashina M, et al. Atogepant for the preventive treatment of chronic migraine (PROGRESS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023;402(10404):775–785. doi: 10.1016/S0140-6736(23)01049-8
  • Croop R, Madonia J, Stock DA, et al. Zavegepant nasal spray for the acute treatment of migraine: A Phase 2/3 double-blind, randomized, placebo-controlled, dose-ranging trial. Headache. 2022;62(9):1153–1163. doi: 10.1111/head.14389
  • Lipton RB, Croop R, Stock DA, et al. Safety, tolerability, and efficacy of zavegepant 10 mg nasal spray for the acute treatment of migraine in the USA: a phase 3, double-blind, randomised, placebo-controlled multicentre trial. Lancet Neurol. 2023;22(3):209–217. doi: 10.1016/S1474-4422(22)00517-8
  • Alpuente A, Torres-Ferrus M, Terwindt GM. Preventive CGRP-targeted therapies for chronic migraine with and without medication-overuse headache. Cephalalgia. 2023;43(3):033310242211502. doi: 10.1177/03331024221150235
  • Barbanti P, Egeo G, Aurilia C, et al. Predictors of response to anti-CGRP monoclonal antibodies: a 24-week, multicenter, prospective study on 864 migraine patients. J Headache Pain. 2022;23(1):138. doi: 10.1186/s10194-022-01498-6
  • Pijpers JA, Kies DA, van Zwet EW, et al. Cutaneous allodynia as predictor for treatment response in chronic migraine: a cohort study. J Headache Pain. 2023;24(1):118. doi: 10.1186/s10194-023-01651-9
  • Bigal ME, Lipton RB, Holland PR, et al. Obesity, migraine, and chronic migraine: possible mechanisms of interaction. Neurology. 2007;68(21):1851–1861. doi: 10.1212/01.wnl.0000262045.11646.b1
  • Hong JB, Lange KS, Overeem LH, et al. A scoping review and meta-analysis of anti-CGRP monoclonal antibodies: predicting response. Pharmaceuticals. 2023;16(7):934. doi: 10.3390/ph16070934
  • Raffaelli B, Fitzek M, Overeem LH, et al. Clinical evaluation of super-responders vs. non-responders to CGRP(-receptor) monoclonal antibodies: a real-world experience. J Headache Pain. 2023;24(1):16. doi: 10.1186/s10194-023-01552-x
  • Maasumi K, Tepper SJ, Kriegler JS. Menstrual migraine and treatment options: review. Headache. 2017;57(2):194–208. doi: 10.1111/head.12978
  • Ibrahimi K, Danser AH, Villalón CM, et al. Influence of varying estrogen levels on trigeminal CGRP release in healthy women. J Headache Pain. 2013;14(S1):123.
  • 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. doi: 10.1186/s10194-020-01167-6
  • Ornello R, Frattale I, Caponnetto V, et al. Menstrual headache in women with chronic migraine treated with erenumab: an observational case series. Brain Sci. 2021;11(3):370.
  • Silvestro M, Orologio I, Bonavita S, et al. Effectiveness and safety of CGRP-mAbs in menstrual-related migraine: a real-world experience. Pain Ther. 2021;10(2):1203–1214. doi: 10.1007/s40122-021-00273-w
  • Russo CV, Saccà F, Braca S, et al. Anti-calcitonin gene-related peptide monoclonal antibodies for the treatment of vestibular migraine: a prospective observational cohort study. Cephalalgia. 2023;43(4):033310242311618. doi: 10.1177/03331024231161809
  • Hoskin JL, Fife TD. New anti-CGRP medications in the treatment of vestibular migraine. Front Neurol. 2021;12:799002. doi: 10.3389/fneur.2021.799002
  • Carmine Belin A, Ran C, Edvinsson L. Calcitonin gene-related peptide (CGRP) and cluster headache. Brain Sci. 2020;10(1):30. doi: 10.3390/brainsci10010030
  • Goadsby PJ, Dodick DW, Leone M, et al. Trial of galcanezumab in prevention of episodic cluster headache. N Engl J Med. 2019;381(2):132–141. doi: 10.1056/NEJMoa1813440
  • Ruscheweyh R, Broessner G, Goßrau G, et al. Effect of calcitonin gene-related peptide (-receptor) antibodies in chronic cluster headache: results from a retrospective case series support individual treatment attempts. Cephalalgia. 2020;40(14):1574–1584. doi: 10.1177/0333102420949866
  • 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. Cephalalgia. 2020;40(9):935–948. doi: 10.1177/0333102420905321
  • Teva Branded Pharmaceutical Products R&D, Inc. A study to evaluate the efficacy and safety of TEV-48125 (fremanezumab) for the prevention of episodic cluster headache (ECH). ClinicalTrials.Gov [Internet]. Bethesda (MD): National Library of Medicine (US); 2000 [cited 2024 Mar 15]. Available from: http://clinicaltrials.gov/show/NCT02945046 NLM Identifier: NCT02945046
  • Teva Branded Pharmaceutical Products R&D, Inc. A study comparing the efficacy and safety of fremanezumab (TEV-48125) for the prevention of chronic cluster headache (CCH). ClinicalTrials.Gov [Internet]. Bethesda (MD): National Library of Medicine (US); 2000 [cited 2024 Mar 15]. Available from: http://clinicaltrials.gov/show/NCT02964338 NLM Identifier: NCT02964338
  • Lundbeck A/S H. Eptinezumab in participants with episodic cluster headache (ALLEVIATE) In: ClinicalTrials.Gov [Internet]. Bethesda (MD): National Library of Medicine (US);2000 [cited 2024 Mar 15]. Available from: http://clinicaltrials.gov/show/NCT04688775 NLM Identifier: NCT04688775
  • Lundbeck A/S H. A 1-year trial to inform about long-term exposure to eptinezumab in participants with chronic cluster headache (CCH) ClinicalTrials.Gov [Internet]. Bethesda (MD): National Library of Medicine (US); 2000 [cited 2024 Mar 15]. Available from: http://clinicaltrials.gov/show/NCT05064397 NLM Identifier: NCT05064397
  • de Simone R, Ranieri A, Sansone M, et al. Dural sinus collapsibility, idiopathic intracranial hypertension, and the pathogenesis of chronic migraine. Neurol Sci. 2019;40(S1):59–70.
  • Wall M, Kupersmith MJ, Kieburtz KD, et al. The idiopathic intracranial hypertension treatment trial: clinical profile at baseline. JAMA Neurol. 2014;71(6):693–701. doi: 10.1001/jamaneurol.2014.133
  • de Simone R, Sansone M, Bonavita V. Headache in idiopathic intracranial hypertension. A CGRP-dependent head pain? Neurol Sci. 2020;41(S2):417–421. doi: 10.1007/s10072-020-04641-w
  • Yiangou A, Mitchell JL, Vijay V, et al. Calcitonin gene related peptide monoclonal antibody treats headache in patients with active idiopathic intracranial hypertension. J Headache Pain. 2020;21(1):116. doi: 10.1186/s10194-020-01182-7
  • Yiangou A, Mitchell JL, Fisher C, et al. Erenumab for headaches in idiopathic intracranial hypertension: a prospective open-label evaluation. Headache. 2021;61(1):157–169. doi: 10.1111/head.14026
  • Ashina H, Iljazi A, Al-Khazali HM, et al. CGRP-induced migraine-like headache in persistent post-traumatic headache attributed to mild traumatic brain injury. J Headache Pain. 2022;23(1):135. doi: 10.1186/s10194-022-01499-5
  • Ashina H, Iljazi A, Al-Khazali HM, et al. Hypersensitivity to calcitonin gene-related peptide in post-traumatic headache. Ann Neurol. 2020;88(6):1220–1228.
  • Kureshi S, Mendizabal M, Francis J, et al. Conservative management of acute sports-related concussions: a narrative review. Healthcare. 2024;12(3):289. doi: 10.3390/healthcare12030289
  • Ashina H, Dodick DW. Post-traumatic headache: pharmacologic management and targeting CGRP signaling. Curr Neurol Neurosci Rep. 2022;22(2):105–111. doi: 10.1007/s11910-022-01175-w
  • Navratilova E, Rau J, Oyarzo J, et al. CGRP-dependent and independent mechanisms of acute and persistent post-traumatic headache following mild traumatic brain injury in mice. Cephalalgia. 2019;39(14):1762–1775. doi: 10.1177/0333102419877662
  • Mullin K, Kudrow D, Croop R, et al. Potential for treatment benefit of small molecule CGRP receptor antagonist plus monoclonal antibody in migraine therapy. Neurology. 2020;94(20):e2121–e2125. doi: 10.1212/WNL.0000000000008944
  • Berman G, Croop R, Kudrow D, et al. Safety of rimegepant, an oral cgrp receptor antagonist, plus cgrp monoclonal antibodies for migraine. Headache. 2020;60(8):1734–1742. doi: 10.1111/head.13930
  • Lipton RB, Contreras-De Lama J, Serrano D, et al. Real-world use of ubrogepant as acute treatment for migraine with an anti-calcitonin gene-related peptide monoclonal antibody: results from courage. Neurol Ther. 2024;13(1):69–83. doi: 10.1007/s40120-023-00556-8
  • Blumenfeld AM, Stevanovic DM, Ortega M, et al. No “wearing-off effect” seen in quarterly or monthly dosing of fremanezumab: subanalysis of a randomized long-term study. Headache. 2020;60(10):2431–2443. doi: 10.1111/head.13994
  • Robblee J, Devick KL, Mendez N, et al. Real-world patient experience with erenumab for the preventive treatment of migraine. Headache. 2020;60(9):2014–2025. doi: 10.1111/head.13951
  • Ailani J, Kuruppu DK, Rettiganti M, et al. Does “wearing off” of efficacy occur in galcanezumab-treated patients at the end of the monthly treatment cycle? Post hoc analyses of four phase III randomized trials. Headache. 2022;62(2):198–207. doi: 10.1111/head.14257
  • Ailani J, Xie H, Driessen M, et al. No ‘wearing-off effect’ seen with fremanezumab in the real-world: retrospective, claims-based analysis of migraine-related healthcare resource and acute medication use (p12-12.005). Neurology. 2023;100(17_supplement_2):3715. doi: 10.1212/WNL.0000000000203473
  • Vernieri F, Brunelli N, Messina R, et al. Discontinuing monoclonal antibodies targeting CGRP pathway after one-year treatment: an observational longitudinal cohort study. J Headache Pain. 2021;22(1):154. doi: 10.1186/s10194-021-01363-y
  • Kuruppu DK, North JM, Kovacik AJ, et al. Onset, maintenance, and cessation of effect of galcanezumab for prevention of migraine: a narrative review of three randomized placebo-controlled trials. Adv Ther. 2021;38(3):1614–1626. doi: 10.1007/s12325-021-01632-x
  • Raffaelli B, Mussetto V, Israel H, et al. Erenumab and galcanezumab in chronic migraine prevention: effects after treatment termination. J Headache Pain. 2019;20(1):66. doi: 10.1186/s10194-019-1018-8
  • Schiano di Cola F, Caratozzolo S, Venturelli E, et al. Erenumab discontinuation after 12-month treatment: a multicentric, observational real-life study. Neur Clin Pract. 2021;11(6):e834–e839.
  • de Matteis E, Affaitati G, Frattale I, et al. Early outcomes of migraine after erenumab discontinuation: data from a real-life setting. Neurol Sci. 2021;42(8):3297–3303.
  • Gantenbein AR, Agosti R, Gobbi C, et al. Impact on monthly migraine days of discontinuing anti-CGRP antibodies after one year of treatment – a real-life cohort study. Cephalalgia. 2021;41(11–12):1181–1186.
  • Tringali G, Vollono C, Calabresi P, et al. A proof-of-concept study on CGRP plasma levels of migraineurs during a 6-month treatment with ERENUMAB. J Headache Pain. 2020;21(1):124. doi: 10.1186/s10194-020-01193-4
  • Theoharides TC, Tsilioni I, Bawazeer M. Mast cells, neuroinflammation and pain in fibromyalgia syndrome. Front Cell Neurosci. 2019;13:353. doi: 10.3389/fncel.2019.00353
  • Walsh DA, McWilliams DF. CGRP and painful pathologies other than headache. In: Brain S Geppetti P editors Calcitonin gene-related peptide (CGRP) mechanisms: focus on migraine. Cham: Springer International Publishing. 2019. p. 141–167. doi: 10.1007/164_2019_242
  • Korucu RU, Karadağ A, Taş A, et al. Serum calcitonin gene-related peptide and receptor protein levels in patients with fibromyalgia syndrome: a cross-sectional study. Arch Rheumatol. 2020;35(4):463–467. doi: 10.46497/ArchRheumatol.2020.7783
  • Neugebauer V, Mazzitelli M, Cragg B, et al. Amygdala, neuropeptides, and chronic pain-related affective behaviors. Neuropharmacology. 2020;170:108052. doi: 10.1016/j.neuropharm.2020.108052
  • Smitherman TA, Tietjen GE, Schuh K, et al. Efficacy of galcanezumab for migraine prevention in patients with a medical history of anxiety and/or depression: a post hoc analysis of the phase 3, randomized, double-blind, placebo-controlled regain, and pooled EVOLVE-1 and EVOLVE-2 studies. Headache. 2020;60(10):2202–2219. doi: 10.1111/head.13970
  • Cuciureanu DI, Bistriceanu CE, Vulpoi G-A, et al. Migraine comorbidities. Life. 2024;14(1):74. doi: 10.3390/life14010074

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.