Emgality ® (galkanezumab)

För fullständig produktresumé för Emgality® se FASS.

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Emgality® ▼ (galcanezumab): Samtidig användning med botulinumtoxin A eller B

Samtidig användning av botulinumtoxin med galcanezumab har inte studerats.

Clinical Study and Use of Botulinum Toxin A or B

The use of Botox® with galcanezumab has not been systematically studied because treatment with botulinum toxin A or B administered to the head or neck area was required to be discontinued at least 4 months prior to entering the prospective baseline or baseline period in

  • all galcanezumab phase 3 chronic or episodic migraine prevention clinical trials,1-3 and

  • the phase 2 proof-of-concept and migraine prevention trials.4,5

While the use of galcanezumab is not contraindicated in patients treated with Botox,6 further studies in humans to assess the efficacy and safety of this combination are needed.

Limited data on the concomitant use of galcanezumab and Botox in patients with chronic migraine are available from retrospective chart reviews and these are summarized below.7-11

Evidence for Concomitant Use From Retrospective Chart Reviews

The use of a CGRP mAb as add-on therapy in patients with chronic migraine who are currently being treated with Botox and still need additional preventive therapy was evaluated in a retrospective chart review.7 This analysis included a review of 153 patient records, of which there were 51 patients (33%) using galcanezumab as add-on therapy. Other CGRP mAbs used as add-on therapy in this analysis included erenumab (n=89, 58%) and fremanezumab (n=13, 9%).

In the overall cohort, patients had

  • 25.7 monthly headache days at baseline

  • 14.8 monthly headache days remaining following Botox monotherapy, p<.0001 vs baseline, and

  • 9.1 monthly headache days remaining after add-on therapy with a CGRP mAb, p≤.0001 vs Botox monotherapy.7

In the subgroup of patients receiving galcanezumab as add-on therapy, patients had

  • 24.9 monthly headache days at baseline

  • 14.6 monthly headache days remaining following Botox monotherapy, and

  • 9.3 monthly headache days remaining after galcanezumab add-on therapy.7

Adverse events to the CGRP mAb medication

  • were reported in 13/153 patients (8.5%), and

  • included constipation, injection site reaction, and fatigue.7

There are additional chart reviews evaluating the addition of a CGRP mAb (erenumab, fremanezumab, or galcanezumab) to concurrent Botox for migraine prevention in patients with chronic migraine.8,9 The results were discussed collectively for the CGRP mAbs used at the centers, but authors generally concluded that the addition of a CGRP mAb

  • was generally beneficial regardless if it was added to Botox or other preventive therapy11

  • to concurrent Botox therapy further reduced migraine headache days compared to Botox monotherapy,10 and

  • could be beneficial in patients on Botox who need additional headache day reduction9 or experience wear off prior to the next Botox injection.8

Galcanezumab Mechanism of Action

Galcanezumab is a humanized IgG4 mAb that

  • binds CGRP, and

  • prevents its biological activity without blocking the CGRP receptor.6 

Galcanezumab is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.12

Botox Mechanism of Action

BOTOX blocks the release of neurotransmitters associated with the genesis of pain. The presumed mechanism for headache prophylaxis is by blocking peripheral signals to the central nervous system, which inhibits central sensitisation, as suggested by pre-clinical and clinical pharmacodynamic studies.13

Please refer to the manufacturer's prescribing information for additional information about Botox.

References

1. 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. http://dx.doi.org/10.1001/jamaneurol.2018.1212

2. 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. http://dx.doi.org/10.1177/0333102418779543

3. 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. http://dx.doi.org/10.1212/WNL.0000000000006640

4. Skljarevski V, Oakes TM, Zhang Q, et al. Effect of different doses of galcanezumab vs placebo for episodic migraine prevention: a randomized clinical trial. JAMA Neurol. 2018;75(2):187-193. http://dx.doi.org/10.1001/jamaneurol.2017.3859

5. Dodick DW, Goadsby PJ, Spierings ELH, et al. Safety and efficacy of LY2951742, a monoclonal antibody to calcitonin gene-related peptide, for the prevention of migraine: a phase 2, randomised, double-blind, placebo-controlled study. Lancet Neurol. 2014;13(9):885-892. http://dx.doi.org/10.1016/S1474-4422(14)70128-0

6. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

7. Cohen F, Armand CE, Vollbracht SE. Efficacy and tolerability of CGRP monoclonal antibody medications in patients with chronic migraine undergoing treatment with onabotulinumtoxinA. Headache. 2020;60(S1):13. 62nd Annual Scientific Meeting American Headache Society abstract. https://doi.org/10.1111/head.13854

8. Ozudogru SN, Bartell JW, Yuan H, et al. The effect of adding calcitonin gene-related peptide monoclonal antibodies to onabotulinum toxin A therapy on headache burden: a retrospective observational case series. Headache. 2020;60(7):1442-1443. https://doi.org/10.1111/head.13839

9. Toni T, Tamanaha R, Newman B, et al. Effectiveness of dual migraine therapy with CGRP antagonists and onabotulinumtoxinA injections: experience from a single migraine center in Hawaii. Cephalalgia. 2020;40(1_suppl):104. Migraine Trust Virtual 2020 – Digital presentations abstract MTV20-DP-094. https://doi.org/10.1177/0333102420962305

10. Blumenfeld AM, Frishberg BM, Schim JD, et al. Real-world evidence for control of patients with chronic migraine who received CGRP monoclonal antibody therapy added to onabotulinumtoxinA treatment. Cephalalgia. 2020;40(1_suppl):96-97. Migraine Trust Virtual 2020 – Digital presentations abstract MTV20-DP-087. https://dx.doi.org/10.1177/0333102420962305

11. Gottschalk C, Henn K, Robinson J, Schobel V. Anti-CGRP class reduces migraine burden regardless of concomitant therapies in US clinical practice. Poster presented at: American Academy of Neurology (AAN Virtual); April 25-May 1, 2020.

12. Emgality [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

13. Botox [summary of product characteristics]. Allergan Limited Marlow International The Parkway, Marlow, UK - accessed on 20/08/2020

Glossary

BOTOX® = onabotulinumtoxinA

CGRP = calcitonin gene-related peptide

Ig = immunoglobulin

mAb = monoclonal antibody

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Datum fӧr senaste ӧversyn November 12, 2020


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