dc.contributor | Vall d'Hebron Barcelona Hospital Campus |
dc.contributor.author | Pozo Rosich, Patricia |
dc.contributor.author | Detke, Holland |
dc.contributor.author | Wang, Shufang |
dc.contributor.author | Doležil, David |
dc.contributor.author | Li, Lily Q. |
dc.contributor.author | Aurora, Sheena K. |
dc.contributor.author | Reuter, Uwe |
dc.date.accessioned | 2022-08-19T06:42:20Z |
dc.date.available | 2022-08-19T06:42:20Z |
dc.date.issued | 2022-04-15 |
dc.identifier.citation | Pozo-Rosich P, Detke HC, Wang S, Doležil D, Li LQ, Aurora SK, et al. Long-term treatment with galcanezumab in patients with chronic migraine: results from the open-label extension of the REGAIN study. Curr Med Res Opin. 2022 Apr 15;38(5):731–42. |
dc.identifier.issn | 1473-4877 |
dc.identifier.uri | https://hdl.handle.net/11351/8019 |
dc.description | Galcanezumab; Chronic migraine; Preventive treatment |
dc.description.abstract | Background
Galcanezumab, a monoclonal antibody to calcitonin gene-related peptide, was found to be safe and efficacious for the preventive treatment of chronic migraine based on the randomized, placebo-controlled double-blind period of the REGAIN study. Long-term safety and efficacy were assessed in an open-label extension.
Methods
Patients 18–65 years old with chronic migraine completing the 3-month double-blind period of REGAIN could enter a 9-month open-label extension (OLE; months 4–12). Upon entering the OLE, patients received a 240-mg galcanezumab loading dose, then 120 mg at the next month, with flexible dosing thereafter (120 or 240 mg/month). The primary efficacy measure was the mean change in the number of monthly migraine headache days from double-blind baseline to month 12. Other endpoints included response rates (based on percent reduction in monthly migraine headache days from double-blind baseline to month 12), safety and tolerability.
Results
Of patients who completed double-blind treatment, 1022 (99%) entered the OLE, with 81% completing month 12. From a baseline of 19.4 monthly migraine headache days at the beginning of the double-blind period, patients at month 12 in the previous placebo, 120-mg, and 240-mg galcanezumab groups had a mean change of −8.5, −9.0, and −8.0, respectively (SE = 0.43 to 0.55, within-group p’s < .001). At month 12, the percentage of patients with ≥50% response was 57%, 57%, and 53%, respectively. Percentage with ≥75% response was 32%, 31%, and 30%, respectively. Percentage with 100% response was 8%, 6%, and 6%, respectively. There were no significant new safety findings during the open-label period. The incidence of discontinuation from the OLE due to adverse events was 5%.
Conclusion
Galcanezumab was effective, safe, and well-tolerated, with high adherence, for up to 12 months of treatment in patients with chronic migraine. |
dc.language.iso | eng |
dc.publisher | Taylor & Francis |
dc.relation.ispartofseries | Current Medical Research and Opinion;38(5) |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 International |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ |
dc.source | Scientia |
dc.subject | Migranya - Tractament |
dc.subject | Avaluació de resultats (Assistència sanitària) |
dc.subject.mesh | Migraine Disorders |
dc.subject.mesh | /drug therapy |
dc.subject.mesh | Treatment Outcome |
dc.title | Long-term treatment with galcanezumab in patients with chronic migraine: results from the open-label extension of the REGAIN study |
dc.type | info:eu-repo/semantics/article |
dc.identifier.doi | 10.1080/03007995.2022.2059975 |
dc.subject.decs | trastornos migrañosos |
dc.subject.decs | /farmacoterapia |
dc.subject.decs | resultado del tratamiento |
dc.relation.publishversion | https://doi.org/10.1080/03007995.2022.2059975 |
dc.type.version | info:eu-repo/semantics/publishedVersion |
dc.audience | Professionals |
dc.contributor.organismes | Institut Català de la Salut |
dc.contributor.authoraffiliation | [Pozo-Rosich P] Unitat de Cefalea, Servei de Neurologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Grup de recerca en Cefalea i Dolor Neurològic, Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. [Detke HC] Eli Lilly and Company, Indianapolis, IN, USA. [Wang S] Eli Lilly and Company, Indianapolis, IN, USA. Now at Sarepta Therapeutics, Cambridge, MA, USA. [Doležil D] Prague Headache Center, DADO MEDICAL s.r.o, Prague, Czech Republic. [Li LQ] Eli Lilly and Company, Indianapolis, IN, USA. [Aurora SK] Eli Lilly and Company, Indianapolis, IN, USA. Now at Impel NeuroPharma, Seattle, WA, USA . [Reuter U] Department of Neurology, Charité-Universitätsmedizin Berlin, Berlin, Germany |
dc.identifier.pmid | 35392739 |
dc.identifier.wos | 000782893800001 |
dc.rights.accessrights | info:eu-repo/semantics/openAccess |