Comparison between prefilled syringe and autoinjector devices on patient-reported experiences and pharmacokinetics in galcanezumab studies

References

• HazardEMunakataJBigalMERupnowMFLiptonRBThe burden of migraine in the United States: current and emerging perspectives on disease management and economic analysisValue Health2009121556418671771
   PubMed Web of Science ®Google Scholar
• BurchRCLoderSLoderESmithermanTAThe prevalence and burden of migraine and severe headache in the United States: updated statistics from government health surveillance studiesHeadache2015551213425600719
   PubMed Web of Science ®Google Scholar
• DiamondSBigalMESilbersteinSLoderEReedMLiptonRBPatterns of diagnosis and acute and preventive treatment for migraine in the United States: results from the American Migraine Prevalence and Prevention studyHeadache200747335536317371352
   PubMed Web of Science ®Google Scholar
• LiptonRBBigalMEDiamondMAMPP Advisory Group Migraine prevalence, disease burden, and the need for preventive therapy. Neurology200768534334917261680
   PubMed Web of Science ®Google Scholar
• SilbersteinSDHollandSFreitagFQuality Standards Subcommittee of the American Academy of Neurology and the American Headache SocietyEvidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache SocietyNeurology201278171337134522529202
   PubMed Web of Science ®Google Scholar
• SilbersteinSDPractice parameter: evidence-based guidelines for migraine headache (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of NeurologyNeurology200055675476210993991
   PubMed Web of Science ®Google Scholar
• VanderpluymJEvansRWStarlingAJLong-term use and safety of migraine preventive medicationsHeadache20165681335134327477594
   PubMed Web of Science ®Google Scholar
• LiptonRBSilbersteinSDEpisodic and chronic migraine headache: breaking down barriers to optimal treatment and preventionHeadache201555suppl 210312225662743
   PubMed Web of Science ®Google Scholar
• HeppZDodickDWVaronSFGillardPHansenRNDevineEBAdherence to oral migraine-preventive medications among patients with chronic migraineCephalalgia201535647848825164920
   PubMed Web of Science ®Google Scholar
• KivitzACohenSDowdJEClinical assessment of pain, tolerability, and preference of an autoinjection pen versus a prefilled syringe for patient self-administration of the fully human, monoclonal antibody adalimumab: the TOUCH trialClin Ther200628101619162917157117
   PubMed Web of Science ®Google Scholar
• RothrockJFFreitagFGFarrSJSmithEFA review of needle-free sumatriptan injection for rapid control of migraineHeadache201353suppl 2213324024600
   PubMed Web of Science ®Google Scholar
• AndreADBrand-SchieberERamirezMMunjalSKumarRSubcutaneous sumatriptan delivery devices: comparative ease of use and preference among migraineursPatient Prefer Adherence20171112112928176899
   PubMed Web of Science ®Google Scholar
• VermeerschSBenschopRJvan HeckenATranslational pharmacodynamics of calcitonin gene-related peptide monoclonal antibody LY2951742 in a capsaicin-induced dermal blood flow modelJ Pharmacol Exp Ther2015354335035726116630
   PubMed Web of Science ®Google Scholar
• DodickDWGoadsbyPJSpieringsELSchererJCSweeneySPGrayzelDSSafety and efficacy of LY2951742, a monoclonal antibody to calcitonin gene-related peptide, for the prevention of migraine: a phase 2, randomised, double-blind, placebo-controlled studyLancet Neurol201413988589225127173
   PubMed Web of Science ®Google Scholar
• SkljarevskiVOakesTMZhangQEffect of different doses of galcanezumab vs placebo for episodic migraine prevention: a randomized clinical trialJAMA Neurol201875218719329255900
   PubMed Web of Science ®Google Scholar
• StaufferVLDodickDWZhangQCarterJAilaniJXConleyRREvaluation of galcanezumab for the prevention of episodic migraine: results from the EVOLVE-1 study, a randomized phase 3 placebo-controlled clinical trialJAMA Neurol Epub2018529
   Web of Science ®Google Scholar
• SkljarevskiVMatharuMMillenBAOssipovMHKimB-KYangJYEfficacy and safety of galcanezumab for the prevention of episodic migraine: results of the EVOLVE-2 phase 3 randomized controlled clinical trialCephalalgia201847033310241877954
   Google Scholar
• DetkeHWangSSkljarevskiA Phase 3 Placebo-Controlled Study of Galcanezumab in Patients with Chronic Migraine: Results from the 3-month Double-Blind Treatment Phase of the REGAIN study. 59th Annual Scientific Meeting American Headache Society® June 8–11, 2017 Westin Boston Waterfront Boston, MAHeadache: The Journal of Head and Face Pain20175713111337
   Web of Science ®Google Scholar
• Callis DuffinKBukhaloMBobonichMUsability of a novel disposable autoinjector devise for ixekizumab: results from a qualitative study and an open-label clinical trial, including patient-reported experienceMed Devices (Auckl)2016936136927785115
   PubMedGoogle Scholar
• StaufferVLSidesRCamporealeAA Phase 3, Long-Term, Open-Label Safety Study of Self-Administered Galcanezumab Injections in Patients with MigraineCephalalgia201737suppl 1330 Abstract PO-01-184
   Google Scholar
• OakesTMMSkljarevskiVZhangQSafety of galcanezumab in patients with episodic migraine: a randomized placebo-controlled dose-ranging phase 2b studyCephalalgia20183861015102529310444
   PubMed Web of Science ®Google Scholar
• FoodUSDrug Administration/Center for Drug Evaluation and ResearchGuidance for Industry: Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs – General Considerations2014 Available from: https://www.fda.gov/downloads/drugs/guidancecom-plianceregulatoryinformation/guidances/ucm389370.pdfAccessed March 26, 2018
   Google Scholar
• LiptonRBFanningKMSerranoDReedMLCadyRBuseDCIneffective acute treatment of episodic migraine is associated with new-onset chronic migraineNeurology201584768869525609757
   PubMed Web of Science ®Google Scholar