Mean (s.d). supine systolic blood pressure at the end of treatment increased by 4.8±16.1 and 2.0±12.2 mm Hg in the lanicemine 150 and 100 mg groups, respectively, vs −0.6±12.1 with placebo.
Both doses of lanicemine were generally well tolerated, with the most common adverse event being dizziness around the time of infusion, with 12, 49, and 37%, in the placebo, lanicemine 100 and 150 mg groups, respectively, experiencing transient dizziness (Table 3).
Over the 12-week DBTP, incidence of ISR-AEs was 3.2%, 5.6%, and 4.5% in the placebo, erenumab 70 mg, and erenumab 140 mg groups, respectively (Table 1).
Over the EEP, which extended erenumab exposure to median 46 weeks (mean 47, range 0 159), incidence of ISR-AEs was 6.1% and 4.2% in the erenumab 70 mg and 140 mg groups, respectively (Table 2).
(A) During baseline, the mean number of AHM days/month in the overall population was 6.91, 6.58, and 6.60 in the placebo, erenumab 70 mg, and erenumab 140 mg groups, respectively.
Response (i.e., >50% reduction in migraine frequency) was 46% in the placebo group as compared with 41, 36 and 51% in the DVPX ER 250 mg, 500 or 1,000 mg groups, respectively.
Mean number of AMSM days/month in patients who used AMSM during baseline was 5.68, 5.67, and 5.67 in the placebo, erenumab 70 mg, and erenumab 140 mg groups, respectively.
Best overall tumour response summarised in Table 2 was PR for one and three patients in the 1000 and 2000 mg groups, respectively, and SD for three, two and one patients in the 500, 1000 and 2000 mg groups, respectively.
Serious infections occurred in 0%, 3.2% and 2.4% in the placebo, certolizumab pegol 200 mg and 400 mg groups, respectively.
The gain was 0.5 and 2.3 letters for the 0.3 mg and 0.5 mg groups, respectively, at 12 months.
Median absolute changes in LVEF, measured by cardiac magnetic resonance, were 1.9% (interquartile range -1.1 to 4.3), 0.3% (-1.4 to 2.7), and 2.2% (0.4 to 4.5), in the placebo, 10-mg, and 20-mg groups, respectively.
