Emgality ® (galkanezumab)

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Emgality® ▼ (galcanezumab): Användning hos patienter med komorbid kronisk smärta

Upp till 22% av alla inskrivna patienter rapporterade mer än en kronisk smärta som inte var migrän vid baslinjen, men undergruppsanalyser har inte slutförts.

Detailed Information

Patients with chronic pain were not excluded from the galcanezumab phase 3 migraine prevention trials. In these trials (EVOLVE-1, EVOLVE-2, and REGAIN),

  • between 11% and 22% of all patients across the galcanezumab and placebo treatment groups reported ≥1 non-migraine chronic pain condition at baseline, however

  • subgroup analyses were not completed in patients with chronic pain.1

Baseline Characteristics - Phase 3 Migraine Prevention Trials

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),2,3 and

  • chronic migraine (REGAIN).4

Between 11% and 22% of all patients across the galcanezumab and placebo treatment groups in EVOLVE-1, EVOLVE-2, and REGAIN reported ≥1 non-migraine chronic pain condition at baseline.1

In these studies, non-migraine chronic pain conditions present at baseline in ≥1% across treatment groups included

  • arthralgia (1.2-2.0%)

  • arthritis (0.5-1.1%)

  • back pain (2.3-5.6%)

  • fibromyalgia (0.4-2.1%)

  • neck pain (1.2-2.1%), and

  • osteoarthritis (1.1-3.9%).1

Exclusion Criteria - Phase 3 Migraine Prevention Trials

Patients were excluded if they used opioids or barbituate containing analgesic 

  • >2X per month for the treatment of pain in >2 of the past 6 months in the episodic migraine prevention studies (EVOLVE-1; EVOLVE-2), and

  • >3X per month for the treatment of pain in >2 of the past 6 months in the chronic migraine prevention study (REGAIN).1

Opioid administration in an emergency setting may have been an exception.1

Therapeutic Indication

Galcanezumab is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.5

The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.5

References

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

2. 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

3. 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

4. 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

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

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 M04 20

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