Discussion
migraine
MIGRAINE
In this 3-month OLE of the PERSIST study, galcanezumab 120 mg continued to be efficacious in patients from China, India and Russia with episodic migraine for up to 6 months, with a generally good safety profile.The findings in predominantly Asian patients are consistent with published results from the OLE of the phase 3 CONQUER episodic migraine populations [In the present study, the PBO/GMB group showed a rapid improvement in all efficacy endpoints following their transition to open-label galcanezumab. This result is in-line with the findings from the double-blind periods of the PERSIST and other phase 3 trials [Galcanezumab also had a maintained response during this OLE study, with two-thirds of patients (66.2%) who achieved a clinically meaningful ≥ 50% response during the double-blind phase of the trial maintaining this level of response during the OLE. This suggests patients achieving a good initial response to galcanezumab are likely to continue to show a good response for up to 6 months of treatment.Galcanezumab previously showed acceptable tolerability during the double-blind phase of the PERSIST trial and this continued throughout longer-term treatment in the OLE. No patients experienced a treatment-related SAE and only three patients (0.6%) discontinued treatment due to a TEAE during the OLE. Furthermore, treatment compliance was high (> 97%) during the OLE. Based on the high treatment adherence and acceptable tolerability observed in the PERSIST study it is likely that patient adherence would be high in a clinical setting, this has important clinical implications, as patients with migraine typically exhibit poor adherence to standard preventive treatments [Limitations of this study included that, as for all OLE studies, there was no comparator arm or blinding, thus limiting the interpretability of results from open-label period. Furthermore, the study was only six months in duration, and the longer-term safety and efficacy of galcanezumab in Asian patients remain unknown.