TRIUMPH: a first-of-its-kind, real-world study of Emgality® for migraine prevention
Eli Lilly and Company (IN, USA) has announced the launch of the first, long-term, real-world study investigating the use of Emgality® (galcanezumab-gnlm) for migraine prevention.
The first, long-term, real-world study, investigating the use of Emgality® (galcanezumab-gnlm) for migraine prevention, has been launched by Eli Lilly and Company (IN, USA). In the novel study, entitled the preventive TReatment of mIgraine: oUtcoMes for Patients in real-world Healthcare systems (TRIUMPH), all treatment decisions will be collaboratively made by physicians and patients, and the comparative effectiveness of Emgality will be evaluated against various other preventative treatments for migraine.
In the USA, migraine affects more than 30 million individuals, predominantly women, and accounts for approximately 1 million emergency department visits for headache each year. The Medical Expenditures Panel Survey estimates that migraine is associated with unadjusted healthcare costs in excess of US$55 billion each year in the USA. Despite this, migraine intervention options remain poor.
Further, as Gudarz Davar, Vice President of neurology development at Lilly Bio-Medicines (IN, USA), explained: “…more than 40% of people who use migraine preventive treatments have a history of failure or switching.”
The TRIUMPH study plans to enroll a total of 2850 individuals with migraine, across sites in Europe, Asia and the USA. All treatment initiation and switching decisions will be at the discretion of physicians and patients only; investigators will track the treatment options offered and ensuing prescribing patterns of preventative migraine treatments for study participants for 2 years.
Importantly, researchers will evaluate the treatment switching, adherence and discontinuation patterns of study subjects prescribed Emgality – an anti-CGRP biologic – other marketed anti-CGRP therapies, botulinum toxins A and B, as well as oral migraine prevention drugs.
Investigators will leverage patient-reported outcomes to assess participants’ migraine burden, quality of life and overall treatment satisfactions. These will be taken into account alongside measurements including the reduction in individuals’ monthly migraine headache days.
Patrik Jonsson, Senior Vice President and President of Lilly Bio-Medicines, stated: “It's important for us to examine the real-world impact of our therapies outside of a formal, clinical trial setting. By tracking physician and patient treatment decisions in the real-world, the results from TRIUMPH will contribute to a more comprehensive understanding of the real-world benefit of Emgality and its comparative effectiveness as a long-term treatment option.”