A new drug to prevent migraine was associated with fewer headache hours for people with chronic migraine within three to seven days after the first injection, found a US study.
"Chronic migraine affects about 1% of all adults, yet less than 5 percent of those people receive a correct diagnosis and appropriate treatment," said study author Dr Marcelo Bigal, of Teva Pharmaceuticals in Frazer, Pennsynvalia, which developed the new drug, called TEV-48125. "Most people who receive preventive medication for chronic migraine stop using them, and one reason for that is the drugs can take a long time to become effective. If these results can be confirmed with larger studies, this could be exciting for people with migraine."
TEV-48125 is an antibody that blocks the calcitonin gene-related peptide that plays a role in migraine pain. The study involved 261 people who had migraine for an average of 18 years. They had an average of 162 hours of headaches a month and an average of 22 days with headache per month.
Of the participants, 87 people received a monthly shot for three months with a low dose of the drug, 85 people received a high dose and 89 people received a placebo shot. The participants used an electronic diary to record their headaches. The phase 2b study was conducted to look for the results after three months, and the positive results were published. For this study, the researchers re-analysed the results to look at the results on headache hours and days in the first days and weeks of the study.
After one week, the average number of headache hours went down by 2.9 hours for people taking the placebo, 9.1 hours for people taking the low dose of TEV-48125 and 11.4 hours for those taking the high dose. The higher dose first showed a difference from the placebo after three days, with 3.1 fewer headache hours, compared to an additional 0.4 hours for the placebo. The lower dose showed a difference from the placebo after seven days, with 7.3 fewer headache hours, compared to 1.6 fewer hours for the placebo.
For the number of days with moderate or severe headaches, both doses showed a difference from placebo after two weeks of treatment, with headaches reduced by 0.8 days for placebo, 1.3 days for the low dose and 1.5 days for the high dose.
Bigal noted that study limitations include that the analyses for the early results were not defined before the study was conducted and that study participants were not asked whether the results in the first days of the study were large enough to be meaningful for them.
Objective: To evaluate the onset of efficacy of TEV-48125, a monoclonal antibody against calcitonin gene-related peptide, recently shown to be effective for the preventive treatment of chronic migraine (CM) and high-frequency episodic migraine.
Methods: A randomized placebo-controlled study tested once-monthly injections of TEV-48125 675/225 mg or 900 mg vs placebo. Headache information was captured daily using an electronic headache diary. The primary endpoint was change from baseline in the number of headache hours in month 3. Herein, we assess the efficacy of each dose at earlier time points.
Results: The sample consisted of 261 patients. For headache hours, the 675/225-mg dose separated from placebo on day 7 and the 900-mg dose separated from placebo after 3 days of therapy (p = 0.048 and p = 0.033, respectively). For both the 675/225-mg and 900-mg doses, the improvement was sustained through the second (p = 0.004 and p < 0.001) and third (p = 0.025 and p < 0.001) weeks of therapy and throughout the study (month 3, p = 0.0386 and p = 0.0057). For change in weekly headache days of at least moderate intensity, both doses were superior to placebo at week 2 (p = 0.031 and p = 0.005).
Conclusions: TEV-48125 demonstrated a significant improvement within 1 week of therapy initiation in patients with CM.
Marcelo E Bigal, David W Dodick, Abouch V Krymchantowski, Juliana H VanderPluym, Stewart J Tepper, Ernesto Aycardi, Pippa S Loupe, Yuju Ma and Peter J Goadsby