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Observational Study
. 2022 Jun 2;23(1):61.
doi: 10.1186/s10194-022-01433-9.

Real-world long-term efficacy and safety of erenumab in adults with chronic migraine: a 52-week, single-center, prospective, observational study

Christopher Kjaer Cullum #  1 , Thien Phu Do #  1 , Messoud Ashina  1 , Lars Bendtsen  1 , Sarah Sonja Hugger  1 , Afrim Iljazi  1 , Julia Gusatovic  1 , Josefin Snellman  2 , Cristina Lopez-Lopez  3 , Håkan Ashina  1   4 , Faisal Mohammad Amin  5   6
Affiliations
Observational Study

Real-world long-term efficacy and safety of erenumab in adults with chronic migraine: a 52-week, single-center, prospective, observational study

Christopher Kjaer Cullum et al. J Headache Pain. .

Abstract

Background: Clinical trials have shown that erenumab is effective and well-tolerated for the preventive treatment of chronic migraine. To extend the results from clinical trials, we assessed the real-world efficacy and safety of erenumab in patients with chronic migraine from the outpatient clinic at the Danish Headache Center.

Methods: A 52-week, single-center, prospective, observation study of erenumab in adults with chronic migraine who are eligible for treatment with monoclonal antibodies against CGRP or its receptor in Denmark. The primary outcome was defined as proportion of patients who achieved ≥ 30% reduction in monthly migraine days (MMDs) from baseline to weeks 9-12.

Results: A total of 300 adult patients with chronic migraine were enrolled and received at least one dose of erenumab. At baseline, the mean (SD) number of monthly headache days was 23 ± 4.9 and mean number of MMDs was 16.8 ± 6.4. Of 300 enrolled patients, 273 (91.0%) patients completed 12 weeks of treatment, and 119 (39.7%) completed 52 weeks of treatment. The number of patients who achieved ≥ 30% reduction in MMDs from baseline to weeks 9-12 was 195 (71.4%) of 273 patients. Sustained ≥ 30% reduction in MMDs at all assessment periods throughout the 52-week treatment period was achieved by 102 (34%) of 300 patients. Adverse events occurred in 220 (73.3%) out of 300 patients. The most common adverse event was constipation. Treatment discontinuation due to lack of tolerability occurred in 41 (13.7%) patients.

Conclusions: Among adult patients with chronic migraine and previous failure of medications for migraine prevention, erenumab was found to be effective and well-tolerated.

Keywords: Adverse events; Calcitonin gene-related peptide; Chronic migraine; Erenumab; Headache; Preventive treatment; mAb.

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Conflict of interest statement

Christopher Kjaer Cullum reports no conflicts of interest. Thien Phu Do reports no conflicts of interest. Messoud Ashina is a consultant, speaker, or scientific advisor for AbbVie, Allergan, Amgen, Eli Lilly, Lundbeck, Novartis, and Teva and a primary investigator for ongoing AbbVie/Allergan, Amgen, Eli Lilly, Lundbeck, Novartis, and Teva trials. Messoud Ashina has no ownership interest and does not own stocks of any pharmaceutical company. Messoud Ashina serves as associate editor of Cephalalgia, associate editor of the Journal of Headache and Pain, and associate editor of Brain. Lars Bendtsen has given lectures and served on the scientific advisory board for Novartis, Allergan, Teva, Lundbeck and Eli Lilly. LB has received a research grant from Novartis. Sarah Sonja Hugger reports no conflicts of interest. Afrim Iljazi reports no conflicts of interest. Julia Gusatovic reports no conflicts of interest. Josefin Snellman is an employee of Novartis Pharma AG and have Novartis shares. Christina Lopez-Lopez is an employee of Novartis Pharma AG and have Novartis shares. Håkan Ashina reports no conflicts of interest. Faisal Mohammad Amin reported receiving a grant from the American Brain Foundation and personal fees from Novartis, Eli Lilly, Teva Pharmaceuticals, and Lundbeck outside of the submitted work.

Figures

Fig. 1
Fig. 1
Patient Flowchart and Disposition. All patients were started on 140-mg erenumab and received this dose from week 1 through week 12. After the initial 12 weeks of treatment, all patients had a dose reduction and received 70 mg erenumab from week 13 through week 24. From week 24 through week 52, patients continued with the dose with the highest efficacy (140-mg or 70-mg). Final evaluation was conducted at week 52
Fig. 2
Fig. 2
Proportion of patients with ≥ 30%, ≥ 50%, and ≥ 75% reduction in number of monthly migraine days. Green represents patients treated with 140-mg erenumab, light: ≥ 30%, medium: ≥ 50%, and dark: ≥ 75%. Orange represents patients treated with 70-mg erenumab, light: ≥ 30%, medium: ≥ 50%, and dark: ≥ 75%. Participants with data available for analysis; Weeks 9–12, n = 273; Weeks 13–24, n = 162; Weeks 25–36; 140-mg, n = 121; 70-mg, n = 27; Weeks 41–52; 140-mg, n = 95; 70-mg, n = 24
Fig. 3
Fig. 3
Proportion of patients With ≥ 30%, ≥ 50%, and ≥ 75% reduction in number of monthly headache days of any severity. Green represents patients treated with 140-mg erenumab, light: ≥ 30%, medium: ≥ 50%, and dark: ≥ 75%. Orange represents patients treated with 70-mg erenumab, light: ≥ 30%, medium: ≥ 50%, and dark: ≥ 75%. Participants with data available for analysis; Weeks 9–12, n = 273; Weeks 13–24, n = 162; Weeks 25–36; 140-mg, n = 121; 70-mg, n = 27; Weeks 41–52; 140-mg, n = 95; 70-mg, n = 24
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References

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