Predictors of response to erenumab after 12 months of treatment

Carlo Baraldi, Flavia Lo Castro, Maria Michela Cainazzo, Luca Pani, Simona Guerzoni, Carlo Baraldi, Flavia Lo Castro, Maria Michela Cainazzo, Luca Pani, Simona Guerzoni

Abstract

Objective: Erenumab is a monoclonal antibody acting against calcitonin gene-related peptide receptor and approved for the preventive treatment of chronic migraine. The aim of the present study is to identify clinical predictors of good response in patients with chronic migraine and medication overuse-headache.

Material and methods: This was a retrospective single-center not funded study. Enrolled patients were affected by chronic migraine and medication overuse-headache treated with erenumab monthly, up to 1 year. At 1 year, patients were classified as good responders if they displayed a ≥50% reduction in the number of headache days per months compared to the baseline.

Results: After 1 year, a significant improvement in the number of headache days per months, analgesic consumption, 6-items headache impact test, and migraine disability assessment questionnaire scores were obtained compared to the baseline. Patients who obtained a ≥50% reduction in the number of headache days per month compared to the baseline displayed a longer history of medication overuse-headache, a higher number of painkillers taken per month at the baseline and a higher number of failed preventive treatments in the past.

Conclusions: Patients with longer medication overuse-headache duration, higher analgesic intake, and a higher number of previous preventive treatment failures may receive less benefit with erenumab.

Keywords: chronic migraine; erenumab; medication overuse-headache; predictors of response; real-life setting.

Conflict of interest statement

Carlo Baraldi received travel grants from Allergan, Teva, Novartis, and Ely Lilly. Simona Guerzoni received travel grants and honoraria from Allergan, Teva, Novartis, and Eli Lilly. Luca Pani is the Chief Scientific Officer of EDRA‐LSWR Publishing Company and of Inpeco SA Total Lab Automation Company. In the previous years, he served as a scientific consultant to AbbVie, USA; BCG, Switzerland; Boehringer‐Ingelheim, Germany; Compass Pathways, UK; Johnson & Johnson, USA; Takeda, USA; VeraSci, USA; and Vifor, Switzerland. Flavia Lo Castro and Maria Michela Cainazzo have no conflict of interest to declare.

© 2021 The Authors. Brain and Behavior published by Wiley Periodicals LLC.

Figures

FIGURE 1
FIGURE 1
Number of headache days (NHD), analgesic consumption (AC), number of days on medication (NDM), 6‐items headache impact test (HIT‐6)‐score, and migraine disability assessment (MIDAS)‐score at every time‐point

References

    1. Alpuente, A., Gallardo, V. J., Torres‐Ferrus, M., Alvarez‐Sabin, J., & Pozo‐Rosich, P. (2020). Short and mid‐term predictors of response to onabotulinumtoxina: Real‐life experience observational study. Headache, 60, 677–685.
    1. Barbanti, P., Aurilia, C., Egeo, G., Fofi, L., Cevoli, S., Colombo, B., Filippi, M., Frediani, F., Bono, F., Grazzi, L., Salerno, A., Mercuri, B., Carnevale, A., Altamura, C., & Vernieri, F. (2020). 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, 61(2), 363–372.
    1. Buonvicino, D., Urru, M., Muzzi, M., Ranieri, G., Luceri, C., Oterei, C., Lapucci, A., & Chiarugi, A. (2018). Trigeminal ganglion transcriptome analysis in 2 rat models of medication‐overuse headache reveals coherent and widespread induction of pronociceptive gene expression patterns. Pain, 159, 1980–1988.
    1. Cainazzo, M. M., Baraldi, C., Ferrari, A., Lo Castro, F., Pani, L., & Guerzoni, S. (2021). Erenumab for the preventive treatment of chronic migraine complicated with medicaiton overuse headache: An observational, retrospective, 12‐month real‐life study. Neurological Sciences. 10.1007/s10072-021-05105-5.
    1. Carlsen, L. N., Munksgaard, S. B., Jensen, R. H., & Bendtsen, L. (2018). Complete detoxification is the most effective treatment of medication‐ overuse headache: A randomized controlled open‐label trial. Cephalalgia, 38, 225–236.
    1. De Matteis, E., Affaiati, G., Frattale, I., Caponnetto, V., Pistoia, F., Giamberardino, M. A., Sacco, S., & Ornello, R. (2021). Early outcomes of migraine after erenumab discontinuation: Data from a real‐life setting. Neurological Sciences. 10.1007/s10072-020-05022-z
    1. Diener, H. C., Holle, D., Solbach, K., & Gaul, C. (2016). Medication‐overuse headache: Risk factors, pathophysiology and management. Nature reviews Neurology, 12, 575–583.
    1. Dominguez, C., Pozo‐Rosich, P., Leira, Y., & Leira, R. (2018). Unilateral pain and shorter duration of chronic migraine are significant predictors of response to onabotulinumtoxinA. European Journal of Neurology, 25, e48.
    1. Dominguez, C., Pozo‐Rosich, P., Torres‐Ferrus, H.‐.B. N., Jurado‐Cobo, C., Gonzalez‐Oria, C., Santos, S., Monzon, M. J., Latorre, G., Alvaro, L. C., Gago, A., Gallego, M., Medrano, V., Huerta, M., Garcoia‐Alhama, J., Belvis, R., Leira, Y., & Leira, R. (2018). OnabotulinumtoxinA in chronic migraine: Predictors of response. A prospective multicenter descriptive study. European Journal of Neurology, 25, 411–416.
    1. Greco, R., De Icco, R., Demartini, C., Zanaboni, A. M., Tumelero, E., Sances, G., Allena, M., & Tassorelli, C. (2020). Plasma levels of CGRP and expression of specific microRNAs in blood cells of episodi and chronic migraine subjects: Towards the identification of a panel of peripheral biomarkers of migraine? The Journal of Headache and Pain, 21, 122.
    1. Headache Classification Committee of the International Headache Society (IHS). (2018). The international classification of headache disorders, 3rd edition. Cephalalgia, 33(9), 629–808.
    1. Heneghan, C., Goldacre, B., & Mathani, K. R. (2017). Why clinical trial outcomes fail to translate into benefits for patients. Trials, 18, 122.
    1. Kanaan, S., Hettie, G., Loder, E., & Burch, R. (2020). Real‐world effectiveness and tolerability of Erenumab: A retrospective cohort study. Cephalalgia, 40, 1511–1522.
    1. Lanteri‐Minet, M., Duru, G., Mudge, M., & Cottrell, S. (2011). Quality of life impairment, disability and economic burden associated with chronic daily headache, focusing on chronic migraine with or without medication overuse: A systematic review. Cephalalgia, 31, 837–850.
    1. Ornello, R., Casalena, A., Frattale, I., Cponnetto, V., Gabriele, A., Affaiati, G., Giamberardino, M. A., Assetta, M., Maddestra, M., Marzoli, F., Violi, S., Cerone, D., Marini, C., Pistoia, F., & Sacco, S. (2020). Conversion from chronic to episodic migraine in pateints treated with erenumab: Real‐life data from an Italian region. The Journal of Headache and Pain, 21, 102.
    1. Ornello, R., Casalena, A., Frattale, I., Gabriele, A., Affaitati, G., Giamberardino, M. A., Assetta, M., Maddestra, M., Marzoli, F., Viola, S., Cerone, D., Marini, C., Pistoia, F., & Sacco, S. (2020). Real‐life data on the efficacy and safety of erenumab in the Abruzzo region, central Italy. The Journal of Headache and Pain, 21, 32.
    1. Perrotta, A., Serrao, M., Sandrini, G., Burstein, R., Sances, G., Rossi, P., Bartolo, M., Pierelli, F., & Nappi, G. (2010). Sensitisation of spinal cord pain processing in medication overuse headache involves supraspinal pain control. Cephalalgia, 30, 272–284.
    1. Raffaelli, B., Kalantzis, R., Mecklenburg, J., Hendrik Overeem, L., Neeb, L., Gendolla, A., & Reuter, U. (2020). Erenumab in chronic migraine patients who previously failed five first‐line oral prophylactics and onabotulinumtoxinA: A dual‐center retrospective observational study. Frontiers in Neurology, 11, 417.
    1. Reuter, U., Goadsby, P. J., Lanteri‐Minet, M., Wen, S., Hours‐Zesiger, P., Ferrari, M. D., & Klatt, J. (2018). Efficacy and tolerability of erenumab in patients with episodic migraine in whom two‐to‐four previous preventive treatments were unsuccessful: A randomized, double‐blind, placebo‐controlled, phase 3b study. The Lancet, 392, 2280–2287.
    1. Rothrock, J. F., Parada, V. A., Drinkard, R., Zweifler, R. M., & Key, K. F. (2005). Predictors of a negative response to topiramate therapy in patients with chronic migraine. Headache, 45, 932–935.
    1. Russell, F. A., King, R., Smillie, S. J., Kodji, X., & Brain, S. D. (2014). Calcitonin gene‐related peptide: Physiology and pathophysiology. Physiological Reviews, 94, 1099–1142.
    1. Russo, A., Silvestro, M., Scotto di Clemente, F., Trojsi, F., Bisecco, A., Bonavita, S., Tessitore, A., & Tedeschi, G. (2020). Multidimensional assessment of the effects of erenumab in chronic migraine patients with previous unsuccessful preventive treatments: A comprehensive real‐world experience. The Journal of Headache and Pain, 21, 69.
    1. Sacco, S., Bendtsen, L., Ashina, M., Reuter, U., Terwindt, G., Mitsikostas, D. D., & Martelletti, P. (2019). European headache federation guideline on the use of monoclonal antibodies acting on the calcitonin gene related peptide or its receptor for migraine prevention. The Journal of Headache and Pain, 20, 6.
    1. Schiano di Cola, F., Caratozzolo, S., Liberini, P., Rao, R., & Padovani, A. (2019). Response predictors in chronic migraine: Medication overuse and depressive symptoms negatively impact onabotulinumtoxinA‐ treatment. Frontiers in Neurology, 10, 678.
    1. Serrano, D., Lipton, R. B., Cher, A., Reed, M. L., Steward, W. B. F., Manack Adams, A., & Buse, D. C. (2017). Fluctuations in episodic and chronic migraine status over the course of 1 year: Implications for diagnosis, treatment and clinical trial design. The Journal of Headache and Pain, 18, 101.
    1. Silberstein, S., Tfelt‐Hansen, P., Dodick, D. W., Limmroth, V., Lipton, R. B., Pascual, J., & Wang, S. J. (2008). Task Force of the International Headache Society Clinical Trials Subcommittee. Guidelines for controlled trials of prophylactic treatment of chronic migraine in adults. Cephalalgia, 28, 484–495.
    1. Srikiatkhachorn, A., Maneesri le Grand, S., Supornsilpchai, W., & Storer, R. J. (2014). Pathophysiology of medication overuse headache—An update. Headache, 54, 204–210.
    1. Steiner, T. J., Jensen, R., Katsarava, Z., Linde, M., MacGregor, E. A., Osipova, V., Paemeleire, K., Olesen, J., Peters, M., & Martelletti, P. (2019). Aids to management of headache disorders in primary care (2nd edition): On behalf of the European Headache Federation and Lifting The Burden: The Global Campaign Against Headache. The Journal of Headache and Pain, 20, 57.
    1. Tepper, S. J., Ashina, M., Reuter, U., Brandes, J. L., Dolezil, D., Silberstein, S. D., Winner, P., Zhnag, F., Cheng, S., & Mikol, D. D. (2020). Long‐term safety and efficacy of erenumab in patients with chronic migraine: Results from a 52‐week, open‐label extension study. Cephalalgia, 40, 543–553.
    1. Tepper, S. J., Diener, H. C., Ashina, M., Brandes, J. L., Friedman, D. I., Reuter, U., Cheng, S., Nilsen, J., Leonardi, D. K., Lenz, R. A., & Mikol, D. D. (2019). Erenumab in chronic migraine with medication overuse: Subgroup analysis of a randomized trial. Neurology, 92, e2309–e2320.

Source: PubMed

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