Emgality ® (galkanezumab)

För fullständig produktresumé för Emgality® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Emgality® ▼ (galcanezumab): Byte från annan CGRP monoklonal antikropp

Information om byte från en annan CGRP-mAb till galcanezumab vid migränförebyggande är inte tillgänglig. Information om byte till mAb från annan indikation tillhandahålls.

Switching From Another CGRP mAb

Galcanezumab has been studied in phase 3 randomized, double-blind, placebo-controlled studies in adult patients for the prevention of

  • episodic migraine (EVOLVE-1 and EVOLVE-2),1,2 and

  • chronic migraine (REGAIN).3

Patients were excluded from study enrollment in the phase 3 double-blind, placebo-controlled migraine prevention clinical trials, EVOLVE-1, EVOLVE-2, and REGAIN, if they had prior or current exposure to

  • galcanezumab, or 

  • another CGRP antibody.1-4

Currently, there are no data regarding the safety and efficacy of switching from one CGRP mAb to another for migraine prevention. Most CGRP mAb therapeutic regimens, including galcanezumab, are commonly dosed monthly.4-6

Clinicians are encouraged to use their independent clinical judgment to determine whether an individual patient is a candidate for switching from one CGRP mAb to another for migraine prevention. Decisions regarding the optimal time between taking one CGRP mAb and switching to another is best determined based on clinician and patient agreement that takes into account the patient’s situation, needs, and preference.

Recommended Dose of Galcanezumab

The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.7

A 240 mg loading dose for the galcanezumab 120 mg monthly maintenance dose allows for concentrations to reach steady-state by month 1.4

In the phase 2 dose-ranging study, a loading dose was not implemented.8 In that study, the galcanezumab 120 mg dose did not achieve statistically significant separation from placebo in mean change from baseline migraine headache days until month 3.

In the phase 3 migraine prevention studies, all patients randomized to galcanezumab treatment received a 240 mg dose at the first dosing visit.1-3 

The REGAIN study had a double-blind treatment duration of 3 months, with an optional 9-month open-label extension after completion of the double-blind phase.3 At the start of the double-blind treatment phase, patients were randomized in a 2:1:1 ratio to receive monthly subcutaneous injections of placebo, galcanezumab 120 mg with a 240 mg loading dose, or 240 mg.

In this study, all patients who entered the open-label extension received a galcanezumab 240 mg loading dose at the first open-label dosing visit to maintain the blind to treatment assignment during the double-blind phase.4 Subgroup analyses between patients who were randomized to placebo during the double-blind period compared with those who were randomized to active treatment during the double-blind period are not available.

Please note that a maintenance dose of 240 mg galcanezumab once monthly is not approved and therefore not recommended.

Efficacy and Safety of Switching From Biologics in Other Disease States

While there are not data regarding the safety and efficacy of switching among CGRP mAbs, the following information while not specific to CGRP mAbs may be of assistance as a reference point to inform your independent clinical judgment. 

The safety and efficacy of switching from biologics has been explored in other disease states and are discussed below.

Switching Biologics in Psoriasis

Consensus regarding treatment optimization and transitioning for moderate to severe plaque psoriasis suggests that switching from one biologic therapy to another 

  • includes the use of a washout period if the switch is made due to an adverse event, and

  • does not include a washout period if the switch is made due to a lack of efficacy.9

Switching From Biologics in Multiple Sclerosis

Studies involving transitioning between biologics for multiple sclerosis suggest that the washout out period between mAbs be

  • no longer than necessary, and

  • less than three months.10,11

This is to balance concerns over multiple antibodies being present with concerns over elevated disease activity and subsequent patient impairment resulting from an extended washout period.10,11 

Switching Biologics in Rheumatoid Arthritis

For those diseases such as rheumatoid arthritis where mAbs have been available for an extended period of time, the safety and efficacy of switching due to tolerability or efficacy among biologics in the same class is well-established.12-14 

A series of trials in patients with rheumatoid arthritis ranging from 6 months to 2 years in length suggests a similar safety profile when switching occurs with or without a washout period.15-17

Therapeutic Indication

Galcanezumab is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.7

The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.7

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

5. Aimovig [package insert]. Thousand Oaks, CA: Novartis; 2019.

6. Ajovy [package insert]. North Wales, PA: Teva; 2018.

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

8. 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

9. Mrowietz U, de Jong EMGJ, Kragballe K, et al. A consensus report on appropriate treatment optimization and transitioning in the management of moderate-to-severe plaque psoriasis. J Eur Acad Dermatol Venereol. 2014;28(4):438-453. http://dx.doi.org/10.1111/jdv.12118

10. Cohen M, Maillart E, Tourbah A, et al. Switching from natalizumab to fingolimod in multiple sclerosis: a French prospective study. JAMA Neurol. 2014;71(4):436-441. http://dx.doi.org/10.1001/jamaneurol.2013.6240

11. Kappos L, Radue EW, Comi G, et al. Switching from natalizumab to fingolimod: a randomized, placebo-controlled study in RRMS. Neurology. 2015;85(1):29-39. http://dx.doi.org/10.1212/wnl.0000000000001706

12. Furst DE, Keystone EC, Fleischmann R, et al. Updated consensus statement on biological agents for the treatment of rheumatic diseases, 2009. Ann Rheum Dis. 2010;69 Suppl 1:i2-29. http://dx.doi.org/10.1136/ard.2009.123885

13. Saag KG, Teng GG, Patkar NM, et al. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum. 2008;59(6):762-784. http://dx.doi.org/10.1002/art.23721

14. Smolen JS, Landewe R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017;76(6):960-977. http://dx.doi.org/10.1136/annrheumdis-2016-210715

15. Smolen JS, Burmester GR, Combe B, et al. Head-to-head comparison of certolizumab pegol versus adalimumab in rheumatoid arthritis: 2-year efficacy and safety results from the randomised EXXELERATE study. Lancet. 2016;388(10061):2763-2774. http://dx.doi.org/10.1016/s0140-6736(16)31651-8

16. Schiff M, Pritchard C, Huffstutter JE, et al. The 6-month safety and efficacy of abatacept in patients with rheumatoid arthritis who underwent a washout after anti-tumour necrosis factor therapy or were directly switched to abatacept: the ARRIVE trial. Ann Rheum Dis. 2009;68(11):1708-1714. http://dx.doi.org/10.1136/ard.2008.099218

17. Bykerk VP, Ostor AJ, Alvaro-Gracia J, et al. Tocilizumab in patients with active rheumatoid arthritis and inadequate responses to DMARDs and/or TNF inhibitors: a large, open-label study close to clinical practice. Ann Rheum Dis. 2012;71(12):1950-1954. http://dx.doi.org/10.1136/annrheumdis-2011-201087

Glossary

CGRP = calcitonin gene-related peptide

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 2018 M10 18


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