Introduction
According to the 2016 Global Burden of Disease Study, migraine is filed
as the second most impairing disorder worldwide and the main cause of
disability in people under 50 years of age 1-3.
Although it is known to affect the function of individuals in multiple
aspects and settings of their lives (personal and family), the societal
burden is magnified by the fact that migraine prevalence is higher from
the second to the fifth decade of life, when work productivity is often
at its peak, imposing an onerous economic burden on patients in terms of
direct, indirect and intangible costs 4,5.
Moreover, stigma resulting from migraine is usually under-recognized and
can influence the patient’s willingness to seek treatment which only
serves to underscore the urging need of new preventive therapeutic
strategies that improve migraineurs quality of life5-7. Nevertheless, migraine has a wide, extremely
complex and still unclarified pathogenesis 8 that
results in patients being usually inefficiently treated9 with a wide range of nonspecific pharmacological
options (antidepressants, anticonvulsants, blood-pressure lowering drugs
and onabotulinumtoxinA) 8.
During the last decades, pharmacological modulation of the calcitonin
gene-related peptide (CGRP) has been seen as a promising approach for
migraine prevention due to the increasing body of work showing how this
peptide neurotransmitter, which acts as a vasodilator, plays a
substantial role in the onset of migraine through the trigeminovascular
system 9. In 2018, three CGRP monoclonal antibodies
(MoAbs) were approved for the preventive treatment of episodic and
chronic migraine due to their safety and efficacy10-14. Erenumab acts by blocking the CGRP receptor,
while galcanezumab and fremanezumab bind to the CGRP peptide15. The results derived from these studies and
posterior meta-analysis showed a reduction in monthly migraine days and
monthly acute migraine-specific medication days, while also diminishing
the score obtained in the Migraine Disability Assessment Questionnaire
(MIDAS) or Headache Impact Test (HIT-6) 12-14,16-18,
Patient Reported Outcome Measures (PROMs) that provide valuable
information to broadly improve disease management and patients’ quality
of life 19.
However, despite this uplifting data, clinical trials’ (CTs) strict
inclusion criteria needed to evaluate drug’s efficacy without the
interference of further treatments that could bias the results and can
be barely representative of real-world patients, leading, ultimately, to
an under- or overestimation of the therapeutic effects observed8,20. Therefore, post-market observational studies
involving data from patients using concomitant oral preventive therapies
are still mandatory to elucidate a more precise profile of effectiveness
and tolerability 20-22.
In this regard, the present study aims to evaluate effectiveness, safety
and tolerability of erenumab and galcanezumab in a real-world setting.