Peter L. Salgo, MD: We’ve got these 2 studies: STRIVE and ARISE. What are they? How were they done? What were they designed to find? What did they find?
Peter Goadsby, MD, PhD: STRIVE and ARISE are randomized, placebo-controlled trials. They are parallel group studies of the canonical CGRP [calcitonin gene‐related peptide] receptor antibody called erenumab. Both studies looked at treatment of episodic migraine. ARISE was a 3-month study. Patients were screened, there was a baseline, and were treated for 3 months. The primary endpoint was reduction in migraine days. STRIVE, again, was a 3-month baseline and a 6-month placebo-controlled trial in episodic migraine. Both of them, more or less, came to the same result.
About 25% to 30% of patients had a 50% response rate on placebo. About 40% of patients, 43% of patients, had a 50% response on 70 mg, and about 50% of patients will have a 50% response on 140 mg. When you look at the more detailed endpoints, about a third of patients had a 75% response, and about 15% will have 100% response on the 140-mg dose.
This was paralleled by a reduction in acute migraine treatment use. Triptan use was reduced because they were having less attacks and an improvement in function. What was developed were migraine-specific assessments of disability and function, and they all improved. An important part of the results of both studies, and it’s true across the development program, is they’re very well tolerated. The most common side effect in both studies was some irritation at the injection site. A small percentage of patients, 3% in the active group and 1% in the placebo group, had some constipation. About 2% of patients have this sort of nasal symptomatology. So, we saw 2 large, phase III, well-powered, positive, effective, and well-tolerated studies on this medicine.
Peter L. Salgo, MD: Is there another trial out there? I hesitate to say a “chronic trial?”
Peter Goadsby, MD, PhD: STRIVE and ARISE were studied in episodic migraine—4 to 14 days per month. There’s a chronic migraine trial, published in Lancet Neurology, that was studied. Again, there was a 1-month baseline and 3 months of treatment. We saw a reduction in migraine days, again, at around the 40%. As with STRIVE and ARISE, there were no other adverse events. The treatment was well tolerated. We saw a reduction in migraine-specific treatments and improvement in disability. So, the trial program, altogether, demonstrates that erenumab, specifically, is effective in episodic and chronic migraine.