Advanced search
1 file | 558.00 KB Add to list

Efficacy and safety of erenumab (AMG334) in episodic migraine patients with prior preventive treatment failure : a subgroup analysis of a randomized, double-blind, placebo-controlled study

(2019) CEPHALALGIA. 39(7). p.817-826
Author
Organization
Abstract
Background: Erenumab was effective and well tolerated in a pivotal clinical trial of episodic migraine that included subjects both naive to, and those who had failed, previous preventives. Here we evaluated the efficacy and safety of erenumab (70mg or 140mg) versus placebo in the subgroup of patients who had previously failed preventive treatment(s): 1 or 2 prior failed migraine preventive categories, and in patients who had never failed. Methods: Prespecified subgroup analyses evaluated change from baseline to months 4-6 (the primary endpoint of the blinded study phase) in monthly migraine days, achievement of 50% and 75% reduction in monthly migraine days, and change from baseline in acute migraine-specific medication days. Adverse events were also evaluated. Results: Treatment with both doses of erenumab resulted in greater reductions in monthly migraine days at months 4-6 (treatment difference versus placebo [95% CI], never failed subgroup: -0.9 [-1.5, -0.3] for 70mg and -1.3 [-1.9, -0.7] for 140mg; 1 prior failed medication categories subgroup: -2.0 [-2.8, -1.2] for 70mg and -2.5 [-3.4, -1.7] for 140mg; 2 prior failed medication categories subgroup: -1.3 [-2.6, 0.0] for 70mg and -2.7 [-4.0, -1.4] for 140mg). Similar results were observed in the monthly acute migraine-specific medication days endpoint, and in the achievement of 50% and 75% reduction in monthly migraine days. For the 50% reduction in monthly migraine day endpoint, placebo response in the no prior treatment failed group was 32.6%, in the 1 failed treatment 17.5%, and in the 2 failed treatments 11.1%. Conclusion: Erenumab showed consistent efficacy in episodic migraine patients who had failed prior preventive treatments and was well tolerated across subgroups. The data suggest prior patients with prior treatment failures have lower placebo response rates.
Keywords
Episodic migraine, preventive treatment failure, erenumab, CGRP, PREVALENCE, GUIDELINE, CGRP

Downloads

  • (...).pdf
    • full text
    • |
    • UGent only
    • |
    • PDF
    • |
    • 558.00 KB

Citation

Please use this url to cite or link to this publication:

MLA
Goadsby, Peter J et al. “Efficacy and Safety of Erenumab (AMG334) in Episodic Migraine Patients with Prior Preventive Treatment Failure : a Subgroup Analysis of a Randomized, Double-blind, Placebo-controlled Study.” CEPHALALGIA 39.7 (2019): 817–826. Print.
APA
Goadsby, P. J., Paemeleire, K., Broessner, G., Brandes, J., Klatt, J., Zhang, F., Picard, H., et al. (2019). Efficacy and safety of erenumab (AMG334) in episodic migraine patients with prior preventive treatment failure : a subgroup analysis of a randomized, double-blind, placebo-controlled study. CEPHALALGIA, 39(7), 817–826.
Chicago author-date
Goadsby, Peter J, Koen Paemeleire, Gregor Broessner, Jan Brandes, Jan Klatt, Feng Zhang, Hernan Picard, Robert Lenz, and Daniel D Mikol. 2019. “Efficacy and Safety of Erenumab (AMG334) in Episodic Migraine Patients with Prior Preventive Treatment Failure : a Subgroup Analysis of a Randomized, Double-blind, Placebo-controlled Study.” Cephalalgia 39 (7): 817–826.
Chicago author-date (all authors)
Goadsby, Peter J, Koen Paemeleire, Gregor Broessner, Jan Brandes, Jan Klatt, Feng Zhang, Hernan Picard, Robert Lenz, and Daniel D Mikol. 2019. “Efficacy and Safety of Erenumab (AMG334) in Episodic Migraine Patients with Prior Preventive Treatment Failure : a Subgroup Analysis of a Randomized, Double-blind, Placebo-controlled Study.” Cephalalgia 39 (7): 817–826.
Vancouver
1.
Goadsby PJ, Paemeleire K, Broessner G, Brandes J, Klatt J, Zhang F, et al. Efficacy and safety of erenumab (AMG334) in episodic migraine patients with prior preventive treatment failure : a subgroup analysis of a randomized, double-blind, placebo-controlled study. CEPHALALGIA. 2019;39(7):817–26.
IEEE
[1]
P. J. Goadsby et al., “Efficacy and safety of erenumab (AMG334) in episodic migraine patients with prior preventive treatment failure : a subgroup analysis of a randomized, double-blind, placebo-controlled study,” CEPHALALGIA, vol. 39, no. 7, pp. 817–826, 2019.
@article{8613832,
  abstract     = {Background: Erenumab was effective and well tolerated in a pivotal clinical trial of episodic migraine that included subjects both naive to, and those who had failed, previous preventives. Here we evaluated the efficacy and safety of erenumab (70mg or 140mg) versus placebo in the subgroup of patients who had previously failed preventive treatment(s): 1 or 2 prior failed migraine preventive categories, and in patients who had never failed. 
Methods: Prespecified subgroup analyses evaluated change from baseline to months 4-6 (the primary endpoint of the blinded study phase) in monthly migraine days, achievement of 50% and 75% reduction in monthly migraine days, and change from baseline in acute migraine-specific medication days. Adverse events were also evaluated. 
Results: Treatment with both doses of erenumab resulted in greater reductions in monthly migraine days at months 4-6 (treatment difference versus placebo [95% CI], never failed subgroup: -0.9 [-1.5, -0.3] for 70mg and -1.3 [-1.9, -0.7] for 140mg; 1 prior failed medication categories subgroup: -2.0 [-2.8, -1.2] for 70mg and -2.5 [-3.4, -1.7] for 140mg; 2 prior failed medication categories subgroup: -1.3 [-2.6, 0.0] for 70mg and -2.7 [-4.0, -1.4] for 140mg). Similar results were observed in the monthly acute migraine-specific medication days endpoint, and in the achievement of 50% and 75% reduction in monthly migraine days. For the 50% reduction in monthly migraine day endpoint, placebo response in the no prior treatment failed group was 32.6%, in the 1 failed treatment 17.5%, and in the 2 failed treatments 11.1%. 
Conclusion: Erenumab showed consistent efficacy in episodic migraine patients who had failed prior preventive treatments and was well tolerated across subgroups. The data suggest prior patients with prior treatment failures have lower placebo response rates.},
  author       = {Goadsby, Peter J and Paemeleire, Koen and Broessner, Gregor and Brandes, Jan and Klatt, Jan and Zhang, Feng and Picard, Hernan and Lenz, Robert and Mikol, Daniel D},
  issn         = {0333-1024},
  journal      = {CEPHALALGIA},
  keywords     = {Episodic migraine,preventive treatment failure,erenumab,CGRP,PREVALENCE,GUIDELINE,CGRP},
  language     = {eng},
  number       = {7},
  pages        = {817--826},
  title        = {Efficacy and safety of erenumab (AMG334) in episodic migraine patients with prior preventive treatment failure : a subgroup analysis of a randomized, double-blind, placebo-controlled study},
  url          = {http://dx.doi.org/10.1177/0333102419835459},
  volume       = {39},
  year         = {2019},
}

Altmetric
View in Altmetric
Web of Science
Times cited: