Om du vill rapportera en biverkning gällande en av Lillys produkter, kontakta oss via e-post på DK_PHv@lilly.com eller på telefon 08-737 88 00. Har du ytterligare medicinska frågor gällande en av Lillys produkter, kontakta oss via länken ovan.
Emgality ® (galkanezumab)
Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska
Hur ska en patient byta från en annan CGRP -antikropp till Emgality® ▼ (galcanezumab)?
Vi har inga randomiserade data om säkerheten och effekten av att byta från en anti-CGRP-behandling till galcanezumab för migränprofylax. Retrospektiva uppgifter och fallrapporter från Real-World data beskrivs nedan.
Real World Data: Switching From Another CGRP mAb to Galcanezumab
Limited real-world data on switching from another CGRP mAb to galcanezumab are available and are summarized below.1-3
Retrospective Chart Review
A tertiary headache center evaluated the experiences of patients who switched from erenumab to galcanezumab in a retrospective chart review. This analysis included a review of 3789 prescriptions for erenumab or galcanezumab, of which there were 100 patients who switched from erenumab to galcanezumab (68 patients were still taking galcanezumab at the time of the chart review).2
On average, patients were on
- erenumab for 7 months prior to switching, and
- galcanezumab for 4.8 months after the switch.2
The most common reason for discontinuation in both groups was for lack of efficacy (53% erenumab vs 21% galcanezumab).2
The most common side effects reported were
- constipation in erenumab-treated patients (35% erenumab vs 8% galcanezumab), and
- injection site reactions in galcanezumab-treated patients (1% erenumab vs 10% galcanezumab).2
In patients who switched from erenumab to galcanezumab, a similar percentage of patients reported improvement with erenumab and galcanezumab (51% and 50%, respectively). Other responses to treatment reported were
- initial improvement then worsening back to baseline (11% of erenumab patients vs 2% of galcanezumab patients), and
- no improvement (35% of erenumab patients vs 29% of galcanezumab patients).2
A case series discussed 3 female patients suffering from chronic and episodic migraine and their experience with preventative medications prior to switching to galcanezumab.3
Each patient was switched from therapy with erenumab (70 mg or 140 mg per month for 3 or 6 months) to galcanezumab 120 mg (loading dose of 240 mg). Prior to erenumab, different preventative medications included topiramate, metoprolol, flunarizine, amitriptyline, propranolol, opipramol, valproate, or onabotulinum toxin A.3
A switch to galcanezumab 120 mg per month lead to a significant decrease in headache days in all 3 patients after 3 months of treatment. The number of headache days per month in the 3 patients ranged from
- 10 to 20 before galcanezumab, and
- 1 to 7 after galcanezumab.3
Patient-reported reasons for starting, switching, and stopping CGRP mAbs (erenumab, fremanezumab, and galcanezumab) were assessed from a web-based survey conducted in the United States. Of the 20,782 respondents, 950 patients reported ever using ≥1 CGRP mAb for the preventive treatment of migraine.1
Of the 950 CGRP mAb users, 11.8% (n=112) had switched between mAbs. Although there are no data explaining how patients were switched between CGRP mAbs, the reasons for switching are provided in .1
Patient Reasons for CGRP mAb Use Behavior
Dosing or deliveryc
Recommendation or requestd
Access or economicsf
Abbreviations: CGRP = calcitonin gene-related peptide; mAb = monoclonal antibody; NA = not applicable.
aSwitched = still taking a CGRP mAb but not the initial CGRP mAb.
bEfficacy: reasons pertaining to a medication working/not working (or believed to potentially work) by itself or compared with another medication, a specific outcome (eg, headache-free days, 50% to 100% response), or achieving a functional outcome.
cDosing or delivery: reasons pertaining to the delivery method (eg, autoinjector, prefilled syringe), dosing regimen/schedule, or ease of use.
dRecommendation or request: reasons pertaining to the recommendation of a healthcare provider or family/friend, or personal request by the patient.
eTolerability: reasons pertaining to side effects, drug-drug interaction, comorbid condition, or safety over time.
fAccess or economic: reasons pertaining to insurance coverage, out-of-pocket costs, being given free samples, or affordability.
gNovel: single-item “Is different from other migraine or severe headache treatments available."
hDisease resolution: single-item “My migraine/severe headaches got better."
iStigma: single-item “I did not want anyone to think I was just someone who complains.”
Considerations Regarding a Washout Phase between Another CGRP mAb Therapy and Galcanezumab
Patients were excluded from phase-3-study enrollment if they had prior or current exposure to
- galcanezumab, or
- another CGRP antibody.4-8
Considerations Regarding Loading Dose of Galcanezumab When Switching From Another CGRP mAb Therapy
Pharmacokinetic modeling of phase 3 data confirmed that
- with a 240-mg loading dose, the 120-mg monthly dose did achieve steady-state by month 1, and
- without a 240-mg loading dose, the 120-mg monthly dose did not achieve steady-state until 4 to 5 months.9
The REGAIN study had a double-blind treatment duration of 3 months, with an optional 9-month open-label extension phase.7
In this study, all patients who entered the open-label extension received a 240 mg loading dose at the first open-label dosing visit, regardless if they received placebo, 120 mg galcanezumab or 240 mg galcanezumab during the double-blind phase.4
CONQUER had a double-blind treatment duration of 3 months, with an optional 3-month open-label extension phase.8
In this study,
- patients randomized to placebo during double-blind treatment received a loading dose of galcanezumab 240 mg, and
- patients randomized to galcanezumab during double-blind treatment received 1 injection of galcanezumab 120 mg and 1 injection of placebo.10
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 in the REGAIN and CONQUER studies are not available.
1Buse DC, Schuh K, Nicholson RA, et al. Patients' reasons for starting, switching, and stopping CGRP targeted monoclonal antibodies: results of the OVERCOME study. Cephalalgia. 2020;40(1_suppl):20-21. Migraine Trust Virtual 2020 – Digital presentations abstract MTV20-DP-003. https://dx.doi.org/10.1177/0333102420962305
2Pham A, Burch R. A real-world comparison of erenumab and galcanezumab in a tertiary headache center. Headache. 2020;60(suppl):4. 62nd Annual Scientific Meeting American Headache Society abstract. https://doi.org/10.1111/head.13854
3Ziegeler C, May A. Non-responders to treatment with antibodies to the CGRP-receptor may profit from a switch of antibody class. Headache. 2020;60(2):469-470. http://dx.doi.org/10.1111/head.13729
4Data on file, Eli Lilly and Company and/or one of its subsidiaries.
5Stauffer 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
6Skljarevski 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
7Detke 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
8Mulleners WM, Kim BK, 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. http://dx.doi.org/10.1016/S1474-4422(20)30279-9
9Kielbasa W, Quinlan T. Population pharmacokinetics of galcanezumab, an anti-CGRP antibody, following subcutaneous dosing to healthy individuals and patients with migraine. J Clin Pharmacol. 2020;60(2):229-239. http://dx.doi.org/10.1002/jcph.1511
10Detke HC, Reuter U, Lucas C, et al. Galcanezumab in patients with treatment-resistant migraine: results from the open-label phase of the CONQUER phase 3 trial. Poster presented at: 14th European Headache Federation (EHF Virtual); June 29-July 2, 2020.
11Mrowietz 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
12Tsai YC, Tsai TF. Switching biologics in psoriasis - practical guidance and evidence to support. Expert Rev Clin Pharmacol. 2020;13(5):493-503. http://dx.doi.org/10.1080/17512433.2020.1767590
13Cohen 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
14Kappos 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
15Furst 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-i29. http://dx.doi.org/10.1136/ard.2009.123885
16Saag 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
17Smolen 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
18Kerschbaumer A, Sepriano A, Smolen JS, et al. Efficacy of pharmacological treatment in rheumatoid arthritis: a systematic literature research informing the 2019 update of the EULAR recommendations for management of rheumatoid arthritis. Ann Rheum Dis. 2020;79(6):744-759. http://dx.doi.org/10.1136/annrheumdis-2019-216656
19Smolen 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
20Schiff 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
21Bykerk 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
CGRP = calcitonin gene-related peptide
mAb = monoclonal antibody
Appendix: Efficacy and Safety of Switching From Biologics in Other Disease States
The following information while not specific to CGRP mAbs may be of assistance as a reference point to inform your independent clinical judgment.
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
Switching Biologics in Multiple Sclerosis
Studies involving transitioning between biologics for multiple sclerosis suggest that the washout out period between mAbs be
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 are well-established.15-18
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.19-21
▼ 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 2020 M11 18