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dc.contributorVall d'Hebron Barcelona Hospital Campus
dc.contributor.authorPozo Rosich, Patricia
dc.contributor.authorDetke, Holland
dc.contributor.authorWang, Shufang
dc.contributor.authorDoležil, David
dc.contributor.authorLi, Lily Q.
dc.contributor.authorAurora, Sheena K.
dc.contributor.authorReuter, Uwe
dc.date.accessioned2022-08-19T06:42:20Z
dc.date.available2022-08-19T06:42:20Z
dc.date.issued2022-04-15
dc.identifier.citationPozo-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.issn1473-4877
dc.identifier.urihttp://hdl.handle.net/11351/8019
dc.descriptionGalcanezumab; Chronic migraine; Preventive treatment
dc.description.abstractBackground 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.isoeng
dc.publisherTaylor & Francis
dc.relation.ispartofseriesCurrent Medical Research and Opinion;38(5)
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.sourceScientia
dc.subjectMigranya - Tractament
dc.subjectAvaluació de resultats (Assistència sanitària)
dc.subject.meshMigraine Disorders
dc.subject.mesh/drug therapy
dc.subject.meshTreatment Outcome
dc.titleLong-term treatment with galcanezumab in patients with chronic migraine: results from the open-label extension of the REGAIN study
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1080/03007995.2022.2059975
dc.subject.decstrastornos migrañosos
dc.subject.decs/farmacoterapia
dc.subject.decsresultado del tratamiento
dc.relation.publishversionhttps://doi.org/10.1080/03007995.2022.2059975
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dc.audienceProfessionals
dc.contributor.organismesInstitut 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.pmid35392739
dc.identifier.wos000782893800001
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess


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