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Efficacy of galcanezumab in patients with chronic migraine and a history of preventive treatment failure.
Cephalalgia 2019; 39(8):931-944C

Abstract

BACKGROUND

Efficacy of galcanezumab in chronic migraine has been demonstrated in a pivotal Phase 3 study. Here, we assess efficacy in patients who have failed ≥2 and ≥1 prior migraine preventives for efficacy and/or safety reasons, and in those who never failed.

STUDY DESIGN/METHODS

REGAIN (NCT02614261) was a Phase 3, randomized, double-blind, placebo-controlled study in patients with chronic migraine. Patients were randomized 2:1:1 to receive placebo, galcanezumab 120 mg/240 mg once monthly during a double-blind treatment period lasting three months. Subgroup analyses were conducted among patients who failed ≥2 and ≥1 prior preventives and who never failed previously. Outcomes assessed were change from baseline in number of monthly migraine headache days, proportion of patients with ≥50% and ≥75% response (reduction in monthly migraine headache days), change in number of monthly migraine headache days with acute medication use and change in patient functioning per Migraine-Specific Quality of Life Questionnaire Role Function Restrictive (MSQ RF-R) domain score.

RESULTS

Treatment with galcanezumab versus placebo resulted in significant improvements (p < 0.01) in overall reduction (Months 1-3) from baseline in the number of monthly migraine headache days in patients with prior failures (LS mean change [SE]: ≥2 prior failures: galcanezumab 120 mg: -5.35 (0.71); galcanezumab 240 mg: -2.77 (0.66); placebo: -1.01 (0.54); ≥1 prior failures: galcanezumab 120 mg: -5.53 (0.60), galcanezumab 240 mg: -3.53 (0.59); placebo: -2.02 (0.49). Similarly, significant results were seen with galcanezumab versus placebo for ≥50% and ≥75% response rates, reductions in acute medication use and improvements in MSQ RF-R domain score. In the subgroup with no prior preventive failures, results were statistically significant for the 240 mg galcanezumab group versus placebo on all outcome measures, and for the 120 mg group on the reduction in migraine headache days with acute medication use. There was also a higher placebo response observed in the patients with no prior preventive failures.

CONCLUSION

Galcanezumab is consistently efficacious versus placebo in reducing monthly migraine headache days and several other key outcomes in patients with chronic migraine who have failed ≥2 or ≥1 preventives previously. In the subgroup with no prior failures, greater numerical differences were seen with galcanezumab, but statistical separation from placebo varied by dose and outcome.

CLINICALTRIALS.GOV IDENTIFIER NUMBER

NCT02614261.

Authors+Show Affiliations

1 Eli Lilly and Company, Indianapolis, IN, USA.1 Eli Lilly and Company, Indianapolis, IN, USA.2 Eli Lilly and Company, Erl Wood Manor, Windlesham, UK.1 Eli Lilly and Company, Indianapolis, IN, USA.3 Eli Lilly Services India Private Limited, Bengaluru, Karnataka, India.4 Lilly USA, LLC, Indianapolis, IN, USA.5 Brain Research Center, National Yang-Ming University, Taipei. 6 Department of Neurology, Neurological Institute, Taipei Veterans General Hospital, Taipei.7 Northwest Clinical Research Center, Bellevue, WA, USA. 8 Duke University School of Medicine, Durham, NC, USA.1 Eli Lilly and Company, Indianapolis, IN, USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31104507

Citation

Ruff, Dustin D., et al. "Efficacy of Galcanezumab in Patients With Chronic Migraine and a History of Preventive Treatment Failure." Cephalalgia : an International Journal of Headache, vol. 39, no. 8, 2019, pp. 931-944.
Ruff DD, Ford JH, Tockhorn-Heidenreich A, et al. Efficacy of galcanezumab in patients with chronic migraine and a history of preventive treatment failure. Cephalalgia. 2019;39(8):931-944.
Ruff, D. D., Ford, J. H., Tockhorn-Heidenreich, A., Sexson, M., Govindan, S., Pearlman, E. M., ... Aurora, S. K. (2019). Efficacy of galcanezumab in patients with chronic migraine and a history of preventive treatment failure. Cephalalgia : an International Journal of Headache, 39(8), pp. 931-944. doi:10.1177/0333102419847957.
Ruff DD, et al. Efficacy of Galcanezumab in Patients With Chronic Migraine and a History of Preventive Treatment Failure. Cephalalgia. 2019;39(8):931-944. PubMed PMID: 31104507.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of galcanezumab in patients with chronic migraine and a history of preventive treatment failure. AU - Ruff,Dustin D, AU - Ford,Janet H, AU - Tockhorn-Heidenreich,Antje, AU - Sexson,Matthew, AU - Govindan,Sriram, AU - Pearlman,Eric M, AU - Wang,Shuu-Jiun, AU - Khan,Arif, AU - Aurora,Sheena K, Y1 - 2019/05/19/ PY - 2019/5/21/pubmed PY - 2019/5/21/medline PY - 2019/5/21/entrez KW - Galcanezumab KW - LY2951742 KW - Phase 3 study KW - chronic migraine KW - preventive failure SP - 931 EP - 944 JF - Cephalalgia : an international journal of headache JO - Cephalalgia VL - 39 IS - 8 N2 - BACKGROUND: Efficacy of galcanezumab in chronic migraine has been demonstrated in a pivotal Phase 3 study. Here, we assess efficacy in patients who have failed ≥2 and ≥1 prior migraine preventives for efficacy and/or safety reasons, and in those who never failed. STUDY DESIGN/METHODS: REGAIN (NCT02614261) was a Phase 3, randomized, double-blind, placebo-controlled study in patients with chronic migraine. Patients were randomized 2:1:1 to receive placebo, galcanezumab 120 mg/240 mg once monthly during a double-blind treatment period lasting three months. Subgroup analyses were conducted among patients who failed ≥2 and ≥1 prior preventives and who never failed previously. Outcomes assessed were change from baseline in number of monthly migraine headache days, proportion of patients with ≥50% and ≥75% response (reduction in monthly migraine headache days), change in number of monthly migraine headache days with acute medication use and change in patient functioning per Migraine-Specific Quality of Life Questionnaire Role Function Restrictive (MSQ RF-R) domain score. RESULTS: Treatment with galcanezumab versus placebo resulted in significant improvements (p < 0.01) in overall reduction (Months 1-3) from baseline in the number of monthly migraine headache days in patients with prior failures (LS mean change [SE]: ≥2 prior failures: galcanezumab 120 mg: -5.35 (0.71); galcanezumab 240 mg: -2.77 (0.66); placebo: -1.01 (0.54); ≥1 prior failures: galcanezumab 120 mg: -5.53 (0.60), galcanezumab 240 mg: -3.53 (0.59); placebo: -2.02 (0.49). Similarly, significant results were seen with galcanezumab versus placebo for ≥50% and ≥75% response rates, reductions in acute medication use and improvements in MSQ RF-R domain score. In the subgroup with no prior preventive failures, results were statistically significant for the 240 mg galcanezumab group versus placebo on all outcome measures, and for the 120 mg group on the reduction in migraine headache days with acute medication use. There was also a higher placebo response observed in the patients with no prior preventive failures. CONCLUSION: Galcanezumab is consistently efficacious versus placebo in reducing monthly migraine headache days and several other key outcomes in patients with chronic migraine who have failed ≥2 or ≥1 preventives previously. In the subgroup with no prior failures, greater numerical differences were seen with galcanezumab, but statistical separation from placebo varied by dose and outcome. CLINICALTRIALS.GOV IDENTIFIER NUMBER: NCT02614261. SN - 1468-2982 UR - https://www.unboundmedicine.com/medline/citation/31104507/Efficacy_of_galcanezumab_in_patients_with_chronic_migraine_and_a_history_of_preventive_treatment_failure L2 - http://journals.sagepub.com/doi/full/10.1177/0333102419847957?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -