[Google Scholar] 10. 0.97, 95% confidence interval [CI]: 0.95, 0.98, are two\sided, with values below 0.05 considered significant. All analyses were conducted with SAS software (SAS Institute, Inc, Cary, NC) version 9.2 or higher. Open in a separate window FIGURE 1 Percentage of patients with 50% migraine response by weeks 1C12 and weeks 13C24 and treatment group in (A) PROMISE\1 (episodic migraine) and (B) PROMISE\2 (chronic migraine) RESULTS Second\dose responders A total of 416 patients (46.8% of treated participants) with EM PD166866 (PROMISE\1) and 479 patients (44.7% of treated participants) with CM (PROMISE\2) had a suboptimal 50% MMD response across weeks 1C12 and had PD166866 patient\reported outcome data available at weeks 12 and 24. In patients with EM, the proportion of suboptimal responders to the first eptinezumab infusion across weeks 1C12 who were responders to the second eptinezumab infusion across weeks 13C24 was 38.0% (38/100), 37.6% (38/101), and 36.3% (33/91) with eptinezumab 30, 100, and 300?mg, respectively, and was 37.0% (71/192) for the pooled eptinezumab 100 and 300?mg doses. The corresponding rate with placebo was 33.9% (42/124). In patients with CM, the proportion of suboptimal responders to the first eptinezumab infusion across weeks 1C12 who were responders to the second eptinezumab infusion across weeks 13C24 was 28.7% (41/143), and 29.0% (38/131) with eptinezumab 100 and 300?mg, respectively, and was 28.8% (79/274) for the pooled eptinezumab dose levels. The corresponding rate with placebo was 18.5% (38/205). The median additional decrease in patients treated with eptinezumab in MMDs post second infusion (weeks 13C24) was 13.9% (mean?=?13.3%) for patients with EM and 6.5% (mean?=?7.9%) for patients with CM; thus, 25% of those non\responders after the first dose saw an additional decrease of over 25% (38.2% and 26.7%, respectively) (Figure?2). The HIT\6 responder rate (6\point score decrease) at week 12 in patients with CM overall was 47.2% (168/356) and 56.0% (196/350) with eptinezumab 100 and 300?mg, respectively, and was 36.3% (133/366) with placebo. In suboptimal first\dose responders, the HIT\6 responder rate at week 12 Rabbit Polyclonal to CPZ was 22.5% (34/151) and PD166866 29.6% (40/135) with eptinezumab 100 and 300?mg, respectively, and was 23.4% (52/222) with placebo. Open in a separate window FIGURE 2 Difference in monthly migraine days between infusion 1 (weeks 1C12) and 2 (weeks 13C24) for infusion 1 non\responders by study (PROMISE\1, episodic migraine; PROMISE\2, chronic migraine). MMD, monthly migraine days First\dose predictors of second\dose response The full logistic regression analysis (model including all possible predictors) of pooled data from the eptinezumab 100 and 300?mg treatment groups demonstrated that percent change in MMDs across weeks 1C12 was a significant first\infusion predictor of second\infusion 50% MMD response in patients with EM and CM; change in HIT\6 total score, which was assessed only in patients with CM, was an additional significant first\dose predictor of second\infusion response (Table?1). Thus, the final stepwise logistic regression analysis included one predictor for patients with EM (percent change in MMDs, odds ratio [OR]: 0.97; 95% confidence interval [CI]: 0.95, 0.98; parameter estimate [PE]; ?0.03; em p /em ? ?0.0001) and two predictors for patients with CM (percent change in MMDs, OR: 0.94; CI: 0.92, 0.96; PE: ?0.07; em p /em ? ?0.001) and PD166866 change in HIT\6 total score (OR: 0.92; CI: 0.87, 0.98; PE: ?0.08; em p /em ?=?0.007). TABLE 1 Potential first\infusion predictors of second\infusion 50% MMD response in patients who had a? 50% MMD response across weeks 1C12, using full logistic regression analysis (eptinezumab 100 and 300?mg treatment groups, pooled data) thead valign=”bottom” th align=”left” rowspan=”2″ valign=”bottom” colspan=”1″ Infusion 1 predictor at week 12/over weeks 1C12 /th th align=”left” colspan=”3″ style=”border-bottom:solid 1px #000000″ valign=”bottom” rowspan=”1″ PROMISE\1 (EM) /th th align=”left” colspan=”3″ style=”border-bottom:solid 1px #000000″ valign=”bottom” rowspan=”1″ PROMISE\2 (CM) /th th align=”left” valign=”bottom” rowspan=”1″ colspan=”1″ Odds ratio (95% CI) /th th valign=”bottom” rowspan=”1″ colspan=”1″ Parameter estimate /th th align=”left” valign=”bottom” rowspan=”1″ colspan=”1″ em p /em \value /th th align=”left” valign=”bottom” rowspan=”1″ colspan=”1″ Odds ratio (95% CI) /th th valign=”bottom” rowspan=”1″ colspan=”1″ Parameter estimate /th th valign=”bottom” rowspan=”1″ colspan=”1″ em p /em \value /th /thead Percent change in MMDs0.97 (0.95, 0.98)?0.030.00010.94 (0.92, 0.96)?0.06 0.0001Change in HIT\6 total scoreN/AN/AN/A0.92 (0.86, 0.99)?0.080.027PGICN/AN/AN/A1.50.