Background We compared the tolerability and efficacy of erenumab, a monoclonal antibody binding to the calcitonin gene-related peptide receptor, to topiramate for migraine prophylaxis in adults. Methods HER-MES was a 24-week, randomised, double-blind, double-dummy, controlled trial conducted in 82 sites in Germany. Patients with ≥4 migraine days per month and naïve to study drugs were randomly assigned (1:1) to either subcutaneous erenumab (70 or 140 mg/month) plus topiramate placebo (erenumab group) or oral topiramate at the individual dose with optimal efficacy (50–100 mg/day) plus erenumab placebo (topiramate group). The primary endpoint was medication discontinuation due to an adverse event during the double-blind phase. The proportion of patients that achieved ≥50% reduction from baseline in monthly migraine days during the last 3 months of the double-blind phase was a secondary endpoint. Results Seven hundred and seventy-seven patients were randomised (from 22 February 2019 to 29 July, 2020) and 95.1% completed the study. In the erenumab group, 10.6% discontinued medication due to adverse events compared to 38.9% in the topiramate group (odds ratio, 0.19; 95% confidence interval 0.13–0.27; p < 0.001). Significantly more patients achieved a ≥50% reduction in monthly migraine days from baseline with erenumab (55.4% vs. 31.2%; odds ratio 2.76; 95% confidence interval 2.06–3.71; p < 0.001). No new safety signals occurred. Conclusions Erenumab demonstrated a favourable tolerability and efficacy profile compared to topiramate. Trial registration: ClinicalTrials.gov NCT03828539, URL: https://clinicaltrials.gov/ct2/show/NCT03828539
Objective HER-MES was the first head-to-head, phase 4 trial to assess the tolerability and effectiveness of erenumab against standard of care treatment (topiramate). This post hoc analysis compared the efficacy of erenumab with topiramate in patients who completed the trial on study medication. Methods Post hoc sensitivity analysis was performed using the full analysis set. Outcomes assessed included the proportion of patients with a ≥50% reduction in monthly migraine days (MMD) from baseline (50% responder rate), over the last 3 months (months 4, 5, and 6) of the double-blind treatment phase (DBTP), the 50% responder rate during the first month of the DBTP, and change from baseline in MMD during the DBTP. Multiple imputation was done for efficacy values of patients who discontinued study treatment. Results Patients (N = 777) were randomly assigned (1:1) to either 70 or 140 mg/month erenumab (N = 389) or 50–100 mg/day topiramate (N = 388). Of these, 334 patients (85.9%) receiving erenumab, and 231 patients (59.5%) receiving topiramate completed the DBTP on study medication. Patients on study medication until the end of the DBTP received a mean dose of 119 mg/month for erenumab and 92 mg/day for topiramate. At month 1, a significantly greater proportion of patients receiving erenumab (39.2%) reported ≥50% reduction in MMD from baseline compared with those receiving topiramate (24.0%; p < 0.001). In the last 3 months, a significantly larger proportion of patients receiving erenumab (60.3%) achieved ≥50% reduction in MMD from baseline compared with those receiving topiramate (43.3%; p < 0.001). Patients receiving erenumab demonstrated significantly greater reductions in MMD during the last 3 months from baseline versus those receiving topiramate (− 6.13 vs − 4.90; 95% CI: − 1.87 to − 0.61; p < 0.001). Conclusions This post hoc analysis demonstrated significantly superior efficacy of erenumab versus topiramate in achieving a ≥50% reduction in MMD with an early onset of efficacy. Trial registration ClinicalTrials.gov NCT03828539.
Migraine affects about 12% of the worldwide population causing substantial personal and societal burden. Yet, migraine remains underdiagnosed and untreated. EPISCOPE was a web-based survey among a German migraine patient cohort to characterize the medical care and prophylactic treatment status aiming to identify unmet needs. Potential migraine patients were identified via an ID Migraine screener. Their socioeconomic background, medical care experience, acute medication use, as well as use and experience of migraine prophylaxis was assessed by a questionnaire. Data of 29,011 participants was collected. 21,504 participants were identified as migraine patients. Patients with a higher number of monthly migraine days experienced better medical care. However, even among chronic migraine patients, 54% were not consulting a physician, 30% did not feel well-informed about medication overuse and 48% had never tried prophylactic migraine treatment. Among patients receiving prophylactic migraine treatment, up to 33% were not satisfied with their prophylaxis due to insufficient efficacy. Taken together, EPISCOPE describes the largest German migraine patient cohort so far. The survey provides detailed and valuable insight into the current medical care and prophylactic treatment situation in a highly developed European country and identifies reasons why the medical care of migraine patients is still insufficient.
Background: Prior studies have established that botulinum toxin type A (BTX-A) is a safe and effective treatment of coarse dynamic rhytids. However, BTX-A has little known effect on the mottled hyperpigmentation, tactile roughness, skin thinning, and fine wrinkles that develop on periorbital skin as a result of cumulative photodamage. In contrast, topical retinoids have demonstrated the capacity to reverse clinical signs of cumulative photodamage in a number of studies. We hypothesize that the combination of BTX-A plus a topical retinoid (tazarotene 0.1% cream) for the treatment of lateral canthal rhytids (crow's feet) may be synergistic. Objective: To evaluate the effect of tazarotene 0.1% cream on crow's feet and mottled hyperpigmentation after a single treatment with BTX-A. Methods: This is a 16-week, single-center, double-blind, randomized, placebo-controlled study comparing the safety and efficacy of a single 12-U bilateral injection of BTX-A (Botox, Allergan Inc, Irvine, Calif) into the lateral third of the orbicularis oculi muscle at day 0 followed by nightly application of tazarotene 0.1% cream (Avage, Allergan) to one side and placebo cream to the contralateral side. Lateral canthal rhytids and mottled hyperpigmentation were scored by blinded physician evaluators at baseline and monthly intervals based on physical examination of the subjects and high-quality digital photographs. Overall improvement and adverse side effects were rated by patients at each visit via a patient questionnaire. Results: Sixteen of 20 subjects (80%) completed the trial. The mean baseline wrinkle scores for the lateral canthal areas randomized to tazarotene or placebo cream were 3.53 and 3.41, respectively (3 = moderate wrinkling). There were no statistically significant differences in the wrinkle scores between the two groups at baseline (P = .54). According to the blinded physician evaluators, the decreases from baseline of the mean wrinkle scores at the end of the trial (day 112) were 1.37 and 0.75 for the tazarotene-treated and the placebo-treated groups, respectively. There was 1.8-fold greater improvement from baseline of the mean wrinkle score of the tazarotene-treated group compared with placebo at the completion of the trial (P < .001). Treatment satisfaction scores assigned by the subjects were consistent with the physicians' evaluations. At the end of the trial (day 112), the subjects saw 2-fold greater improvement from baseline on the sides treated with tazarotene 0.1% cream versus those treated with placebo cream (P < .001). The mean mottled hyperpigmentation score for the sides randomized to tazarotene treatment improved 40%, from 4.07 (severe) at baseline to 2.4 (2 = mild, 3 = moderate) at the end of the trial (P < .001). Adverse side effects were few and transient and did not cause any subject to discontinue the study. Conclusion: Our results suggest that the therapeutic combination of BTX-A plus topical tazarotene 0.1% cream is a safe and more efficacious treatment of crow's feet and mottled hyperpigment...
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