Emgality ® (galkanezumab)

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Emgality® ▼ (galcanezumab): Samtidig medicinering för migränhuvudvärk i fas 3-studier

Mediciner för akut behandling av migränhuvudvärk tilläts under fas 3 med begränsningar för opiater, barbiturater och injicerbara steroider.

Concomitant Medications for Migraine Headache in Phase 3 Studies

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

In addition, CONQUER was a phase 3 randomized double-blind, placebo-controlled study that assessed galcanezumab efficacy and safety in adult patients with episodic migraine or chronic migraine who had not benefited from multiple previous migraine preventive treatments.4

Medications Allowed for the Acute Treatment of Migraine Headaches or Other Pain or Injury

Medications for the acute treatment of migraine headaches or other pain or injury were allowed during phase 3 migraine prevention studies.5 These included

  • acetaminophen (paracetamol)

  • NSAIDs

  • triptans

  • ergotamine and derivatives

  • isometheptene mucate

  • dichloralphenazone and acetaminophen combination (Midrin), or

  • combinations thereof.5

Medications allowed with restrictions included

  • opioid and barbiturates no more than 3 days/month in the EVOLVE-1, EVOLVE-2, and REGAIN studies1-3

  • opioid and barbiturates no more than 4 days/month in the CONQUER study, and

  • single dose of injectable steroids only once during the study, in an emergency setting.5

The following summarizes medications allowed specifically for migraine headaches in EVOLVE-1, EVOLVE-2, REGAIN, and CONQUER. The concomitant use of acute medications is summarized at the class level; a summary at the individual medication level is not readily available.

During each study, the patients recorded the name and dose of medications used for the acute treatment of migraine and the use of other pain medications using

  • an ePRO diary device in the EVOLVE-1, EVOLVE-2, and REGAIN studies, and

  • a paper headache medication log in the CONQUER study.5

Concomitant medications allowed for indications other than migraine are not discussed in this response.

Concomitant Usage of Acute Headache Medication in the Pivotal Migraine Prevention Studies (EVOLVE-1, EVOLVE-2, and REGAIN)

The majority of patients (≥93%) recorded concomitant use of ≥1 acute therapy in the

  • EVOLVE episodic migraine prevention studies (Table 1), and 

  • REGAIN chronic migraine prevention study (Table 2).5

The most frequently used concomitant medications (≥5%) included

  • ibuprofen, acetaminophen (paracetamol), Thomapyrin N, sumatriptan, and naproxen in EVOLVE-1

  • ibuprofen, acetaminophen (paracetamol), sumatriptan, Thomapyrin N, acetylsalicylic acid, naproxen, and ketorolac in EVOLVE-2, and

  • ibuprofen, acetaminophen (paracetamol), sumatriptan, Thomapyrin N, naproxen, and acetylsalicylic acid in REGAIN.5

Table 1. Summary of Concomitant Usage of Acute Therapya From ePRO Diary: EVOLVE-1 and EVOLVE-25

EVOLVE-1

Concomitant Therapy Classes from ePRO

PBO
N=433
n (%)

GMB 120mg
N=213
n (%)

GMB 240mg
N=212
n (%)

Subjects with ≥1 concomitant therapy from ePRO

413 (95.4)

199 (93.4)

205 (96.7)

NSAIDs/Aspirinb

346 (79.9)

157 (73.7)

172 (81.1)

Acetaminophen (paracetamol)b

255 (58.9)

103 (48.4)c

136 (64.2)d

Triptansb

198 (45.7)

95 (44.6)

70 (33.0)cd

Anti-nausea medicationb

20 (4.6)

8 (3.8)

4 (1.9)

Ergotsb

0 (0.0)

2 (0.9)

3 (0.7)

EVOLVE-2

Concomitant Therapy Classes from ePRO

PBO
N=461
n (%)

GMB 120mg
N=231
n (%)

GMB 240mg
N=223
n (%)

Subjects with ≥1 concomitant therapy from ePRO

446 (96.8)

215 (93.1)c

212 (95.1)

NSAIDs/Aspirinb

338 (73.2)

169 (73.2)

164 (73.5)

Acetaminophen (paracetamol)b

198 (43.0)

84 (36.4)

93 (41.7)

Triptansb

260 (56.4)

118 (51.1)

118 (52.9)

Anti-nausea medicationb

34 (7.4)

16 (6.9)

14 (6.3)

Ergotsb

14 (3.0)

3 (1.3)

3 (1.4)

Abbreviations: ePRO = electronic patient-reported outcomes; GMB = galcanezumab; NSAID = nonsteroidal anti-inflammatory drug; PBO = placebo.

a Summary by therapy class.

b As collected from ePRO diary.

c p<.05 vs PBO.

d p<.05 vs GMB 120 mg.

Table 2. Summary of Concomitant Usage of Acute Therapya From ePRO Diary: REGAIN5

Concomitant Therapy Classes from ePRO

PBO
N=558
n (%)

GMB 120mg
N=278
n (%)

GMB 240mg
N=277
n (%)

Subjects with ≥1 concomitant therapy from ePRO

536 (96.1)

268 (96.4)

266 (96.0)

NSAIDs/Aspirinb

426 (76.3)

200 (71.9)

192 (69.3)c

Triptansb

304 (54.5)

149 (53.6)

151 (54.5)

Acetaminophen (paracetamol) b

258 (46.2)

140 (50.4)

110 (39.7)d

Anti-nausea medicationb

56 (10.0)

21 (7.6)

29 (10.5)

Ergotsb

21 (3.8)

11 (4.0)

11 (4.0)

Abbreviations: ePRO = electronic patient-reported outcomes; GMB = galcanezumab; NSAID = nonsteroidal anti-inflammatory drug; PBO = placebo.

a Summary by therapy class.

b As collected from ePRO diary.

c p<.05 vs PBO.

d p<.05 vs GMB 120 mg.

Concomitant Usage of Acute Headache Medication in Patients With Previous Migraine Preventive Treatment Failures (CONQUER)

Similar to the pivotal phase 3 studies, in the CONQUER study more than 95% of patients used acute headache medication during the double-blind treatment phase. The incidence was slightly higher in the placebo group (99.6%) compared with galcanezumab (95.3%; p=.0057).5

The acute headache medication used by the greatest percentage of patients, sumatriptan, was also used in a significantly greater percentage of patients in the placebo group (42.6%) compared with galcanezumab (33.2%; p=.0439).5 The most frequently used acute medications (≥5%) in the galcanezumab group were sumatriptan, ibuprofen, acetaminophen (paracetamol), eletriptan, naproxen, rizatriptan, zolmitriptan, naratriptan, indomethacin, Thomapyrin N, metamizole, and nimesulide.

Therapeutic Indication

Galcanezumab is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.6

The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.6

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. Mulleners WM, Kim B, Láinez MJA, et al. A phase 3, placebo-controlled study of galcanezumab in patients with treatment-resistant migraine: results from the 3-month, double-blind treatment phase of the CONQUER study. J Neurol Sci. 2019;405(suppl):128. World Congress of Neurology abstract WCN19-2248. https://doi.org/10.1016/j.jns.2019.10.1817

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

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

Glossary

ePRO = electronic patient-reported outcomes

NSAID = nonsteroidal anti-inflammatory drug

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 M07 22


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