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Letter to the editor: European headache federation guidelines on the use of monoclonal antibodies acting on the calcitonin gene-related peptide or its receptor for migraine prevention

The Correction to this article has been published in The Journal of Headache and Pain 2019 20:58

To the Editor,

We thank you for publishing the guidelines on the use of monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (CGRP) pathway for migraine prevention [1]. We believe that these guidelines will be of great importance for clinicians in guiding treatment decisions and ultimately benefiting patients with migraine, which is a significant contribution to the field.

While reviewing the guidelines, we observed a few inconsistencies in the data presented for erenumab. On Page 20, Fig. 1 mentions “Treatment with Erenumab 140 mg results in a small unimportant increase of serious adverse events occurrence compared to placebo” [1]. However, as reflected in Fig. 1, the risk with placebo was 25 per 1000 and 11 per 1000 with erenumab. Hence, there is a “decrease” in serious adverse event occurrence observed with erenumab versus placebo, which we have highlighted in Fig. 1.

Fig. 1
figure1

Proposed amends for Table 14

We also observed an inconsistency within Fig. 2 (Page 30) that provides information on binding or neutralising antibodies for all pivotal trials included in this guideline [1]. In this table, the data from the ARISE study [2] have been erroneously shown for the STRIVE study [3]. Similarly, the data from the STRIVE study [3] have been shown for the ARISE study [2]. Also, the percentage of neutralising antibodies in the ARISE study is reported as 0.3%, whereas the correct value is 0.4% (n = 1/283). The proposed correction for this swapping of data between the ARISE and STRIVE studies and for correcting the value for the neutralising antibodies is presented in Fig. 2. In addition, Fig. 2 includes frequencies of neutralising antibodies for the 7 mg and 21 mg doses, which were used in a relatively small Phase 2 proof-of-concept study [4]. These doses were ineffective, not studied further, and are not commercially available. Hence, for proper guidance to clinicians, we suggest omitting the data for 7 mg and 21 mg.

Fig. 2
figure2

Proposed amends for Table 20

We would like to acknowledge the efforts and contributions of the consensus panel for drafting these guidelines. The data inconsistencies highlighted in this letter could have affected the final results and recommendations made in the guidelines. Moreover, the erroneous data may be cited by authors in upcoming publications, which may potentially affect the recommendations for the mAbs targeting the CGRP pathway. Hence, we request that you consider the proposed amendments to address these inconsistencies for the benefit of the readers.

Abbreviations

CGRP:

Calcitonin gene-related peptide

mAb:

Monoclonal antibody

References

  1. 1.

    Sacco S, Bendtsen L, Ashina M, Reuter U, Terwindt G, Mitsikostas DD et al (2019) 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 20:6

  2. 2.

    Dodick DW, Ashina M, Brandes JL, Kudrow D, Lanteri-Minet M, Osipova V et al (2018) ARISE: a phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia 38(6):1026–1037

  3. 3.

    Goadsby PJ, Reuter U, Hallström Y, Broessner G, Bonner JH, Zhang F et al (2017) A controlled trial of Erenumab for episodic migraine. N Engl J Med 377(22):2123–2132

  4. 4.

    Sun H, Dodick DW, Silberstein S, Goadsby PJ, Reuter U, Ashina M et al (2016) Safety and efficacy of AMG 334 for prevention of episodic migraine: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol 15(4):382–390

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Acknowledgements

Authors acknowledge the editorial support received from Dinesh Makhija, Novartis HealthCare Pvt. Ltd. India for drafting this letter.

Funding

Not applicable.

Availability of data and materials

ARISE study data publication is available online at: https://journals.sagepub.com/doi/full/10.1177/0333102418759786?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dpubmed

STRIVE study data publication is available online at:

https://www.nejm.org/doi/10.1056/NEJMoa1705848?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dwww.ncbi.nlm.nih.gov

Author information

Both authors participated in the conception of the letter, read and approved the final letter.

Correspondence to Josefin Snellman.

Ethics declarations

Ethics approval and consent to participate

The study protocols were reviewed and approved by the appropriate institutional review board for each of the study sites. The studies were conducted according to Good Clinical Practice and the Declaration of Helsinki guidelines. Patients provided written informed consent before undergoing study procedures.

Consent for publication

Not applicable.

Competing interests

Daniel D. Mikol is a full-time employee of Amgen Inc. Thousand Oaks, California. Josefin Snellman is a full-time employee of Novartis Pharma A.G. Basel, Switzerland.

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