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  • 1
    Online Resource
    Online Resource
    Erenumab treatment for migraine prevention in Japanese patients: Efficacy and safety results from a Phase 3, randomized, double‐blind, placebo‐controlled study
    Wiley ; 2021
    In:  Headache: The Journal of Head and Face Pain Vol. 61, No. 6 ( 2021-06), p. 927-935
    Details
    In: Headache: The Journal of Head and Face Pain, Wiley, Vol. 61, No. 6 ( 2021-06), p. 927-935
    Abstract: Erenumab is a human anti‐calcitonin gene‐related peptide receptor monoclonal antibody approved for migraine prevention. Global studies have demonstrated its efficacy in chronic and episodic migraine (EM). Here we report the outcomes from a Phase 3 study of erenumab in Japanese patients with chronic migraine (CM) or EM. Methods Japanese patients with EM ( 〈 15 headache days/month, including ≥4 migraine days/month) or CM (≥15 headache days/month, including ≥8 migraine days/month) were randomized 1:1 to placebo or erenumab 70 mg once monthly for a 24‐week double‐blind treatment phase (DBTP). The primary endpoint of change from baseline in mean monthly migraine days (MMD) over months 4, 5, and 6 of the DBTP was compared between erenumab and placebo groups. Secondary efficacy and safety endpoints were also assessed. Results A total of 261 patients were randomized to placebo ( n  = 131) or erenumab 70 mg ( n  = 130); all patients were included in the efficacy and safety analyses. The mean (standard deviation) MMD at baseline was 11.84 (5.70) for the placebo group and 12.40 (5.99) for erenumab 70 mg. The mean (standard error) change in MMD was –1.98 (0.38) for the placebo group ( n  = 131) and –3.60 (0.38) for erenumab 70 mg ( n  = 130). The difference in MMD reduction between groups was −1.67 (95% CI: –2.56, –0.78, p   〈  0.001) for EM and –1.57 (95% CI: –3.39, 0.24, p  = 0.089) for CM. Adverse events (AEs) were consistent with earlier studies. The most frequent AEs (placebo, erenumab) were nasopharyngitis (28.2% and 26.9%, respectively), back pain (4.6% and 5.4%), and constipation (0.8% and 4.6%). Conclusion Treatment with erenumab 70 mg once monthly demonstrated favorable efficacy and safety findings in Japanese patients with EM or CM.
    Type of Medium: Online Resource
    ISSN: 0017-8748 , 1526-4610
    URL: Issue
    URL: Article
    DOI: 10.1111/head.v61.6
    DOI: 10.1111/head.14138
    Language: English
    Publisher: Wiley
    Publication Date: 2021
    detail.hit.zdb_id: 2020316-0
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  • 2
    Online Resource
    Online Resource
    A Randomized Phase 2 Study of Erenumab for the Prevention of Episodic Migraine in Japanese Adults
    Wiley ; 2019
    In:  Headache: The Journal of Head and Face Pain Vol. 59, No. 10 ( 2019-11), p. 1731-1742
    Details
    In: Headache: The Journal of Head and Face Pain, Wiley, Vol. 59, No. 10 ( 2019-11), p. 1731-1742
    Abstract: A phase 2, double‐blind, placebo‐controlled study to evaluate the efficacy and safety of erenumab for the prevention of episodic migraine in Japanese patients was conducted. Background Previous global clinical studies have demonstrated the efficacy of erenumab in the prevention of migraine. Methods Patients were randomized to placebo or erenumab 28, 70, or 140 mg administered subcutaneously once per month for 6 months. The primary endpoint was change from baseline in mean monthly migraine days over months 4‐6 of the double‐blind treatment phase. Secondary endpoints included the proportion of patients achieving ≥50% reduction from baseline in mean monthly migraine days (≥50% response) and change from baseline in mean monthly acute migraine‐specific medication treatment days (MSMD) and mean Headache Impact Test (HIT‐6™) scores. Efficacy outcomes were also determined at months 1, 2, and 3. Results Four hundred and seventy five patients were randomized 2:1:2:2 to placebo and erenumab 28, 70, and 140 mg, respectively. Greater reductions in monthly migraine days were observed for erenumab vs placebo with differences of –1.25 (95% CI: –2.10 to –0.41; P  = .004), –2.31 (95% CI: –3.00 to –1.62; P   〈  .001), and –1.89 (95% CI: –2.58 to –1.20; P   〈  .001) days for erenumab 28, 70, and 140 mg. The odds of having a ≥50% response were 3.2, 5.6, and 4.7 times greater for erenumab 28 mg (95% CI: 1.30‐7.88; P  = .009), 70 mg (95% CI: 2.60‐12.06; P   〈  .001), and 140 mg (95% CI: 2.24‐9.99; P   〈  .001) than for placebo. Greater reductions from baseline in mean acute monthly MSMD were observed for erenumab vs placebo with differences of –1.07 (95% CI: –1.80 to –0.35; P  = .004), –2.07 (95% CI: –2.66 to –1.49; P   〈  .001), and –2.04 (95% CI: –2.63 to –1.45; P   〈  .001) days for erenumab 28, 70, and 140 mg. Erenumab 70 and 140 mg also resulted in greater improvements in HIT‐6™ scores. The safety profile was similar across treatment groups. The most common adverse event was nasopharyngitis, which occurred in 29.4% of patients in the placebo group and 28.9%‐33.3% of patients in the erenumab groups. Conclusion Monthly subcutaneous injections of erenumab 70 mg demonstrated statistically significant and numerically maximal efficacy with a favorable safety profile, suggesting that erenumab is a potential new therapy for migraine prevention in Japan.
    Type of Medium: Online Resource
    ISSN: 0017-8748 , 1526-4610
    URL: Issue
    URL: Article
    DOI: 10.1111/head.v59.10
    DOI: 10.1111/head.13652
    Language: English
    Publisher: Wiley
    Publication Date: 2019
    detail.hit.zdb_id: 2020316-0
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  • 3
    Online Resource
    Online Resource
    Early onset of efficacy with erenumab for migraine prevention in Japanese patients: Analysis of two randomized, double‐blind, placebo‐controlled studies
    Wiley ; 2022
    In:  Brain and Behavior Vol. 12, No. 3 ( 2022-03)
    Details
    In: Brain and Behavior, Wiley, Vol. 12, No. 3 ( 2022-03)
    Abstract: In two 24‐week migraine prevention studies in Japan, erenumab was associated with significantly greater reductions in migraine frequency versus placebo over Weeks 13–24 (primary endpoint). This post hoc analysis evaluated the onset of efficacy within the first 4 weeks after the initiation of erenumab from the 24‐week double‐blind periods of these studies. Methods Placebo‐adjusted differences in least squares mean (LSM) change from baseline in weekly migraine days (WMD) were assessed weekly in each study and by migraine type (episodic (EM]/chronic [CM] ) (Study 20170609). Results A total of 407 patients from Study 20120309 (70 mg: N = 135; 140 mg: N = 136; placebo: N = 136) and 261 patients from Study 20170609 ([EM] 70 mg: N = 78; placebo: N = 81; [CM] 70 mg: N = 52; placebo: N = 50) were included. For Study 20120309, onset of efficacy was observed as early as Week 1 in favor of erenumab versus placebo. Placebo‐adjusted differences in LSM (95% confidence interval [CI]) change from baseline in WMD at Week 1 were −0.38 (−0.71 to −0.05; p  = .022) and −0.49 (−0.82 to −0.16; p  = .004) in favor of erenumab 70 and 140 mg, respectively. For Study 20170609, significant placebo‐adjusted differences were observed with erenumab 70 mg at Week 1 in patients with EM (LSM [95% CI]: −0.55 [−0.97 to −0.12; p  = .012]), and at Week 2 in patients with CM (LSM [95% CI] : −0.81 [−1.53 to −0.09; p  = .028]) and for the overall population (LSM [95% CI] : −0.71 [−1.09 to −0.33; p   〈  .001]). Conclusions Erenumab treatment significantly reduced WMD compared with placebo. Onset of erenumab efficacy occurred as early as Week 1 in patients with migraine.
    Type of Medium: Online Resource
    ISSN: 2162-3279 , 2162-3279
    URL: Issue
    URL: Article
    DOI: 10.1002/brb3.v12.3
    DOI: 10.1002/brb3.2526
    Language: English
    Publisher: Wiley
    Publication Date: 2022
    detail.hit.zdb_id: 2623587-0
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  • 4
    Online Resource
    Online Resource
    Efficacy and safety of erenumab in Japanese migraine patients with prior preventive treatment failure or concomitant preventive treatment: subgroup analyses of a phase 3, randomized trial
    Springer Science and Business Media LLC ; 2021
    In:  The Journal of Headache and Pain Vol. 22, No. 1 ( 2021-12)
    Details
    In: The Journal of Headache and Pain, Springer Science and Business Media LLC, Vol. 22, No. 1 ( 2021-12)
    Abstract: These subgroup analyses of a Phase 3, randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of erenumab 70 mg in Japanese migraine patients with/without prior preventive treatment failure(s) (“failed-yes” and “failed-no” subgroups) and with/without concomitant preventive treatment (“concomitant preventive-yes” and “concomitant preventive-no” subgroups). Methods Overall, 261 patients were randomized; 130 and 131 patients to erenumab 70 mg and placebo, respectively. Subgroup analyses evaluated the change from baseline to Months 4–6 in mean monthly migraine days (MMD) (primary endpoint), achievement of a ≥50% reduction in mean MMD, and change from baseline in mean monthly acute migraine-specific medication (MSM) treatment days. Treatment-emergent adverse events were also evaluated. Results Of the 261 patients randomized, 117 (44.8%) and 92 (35.3%) patients were in the failed-yes and concomitant preventive-yes subgroups, respectively. Erenumab 70 mg demonstrated consistent efficacy across all subgroups, with greater reductions from baseline in mean MMD versus placebo at Months 4–6 (treatment difference versus placebo [95% CI], failed-yes: − 1.9 [− 3.3, − 0.4] ; failed-no: − 1.4 [− 2.6, − 0.3]; concomitant preventive-yes: − 1.7 [− 3.3, 0.0] ; concomitant preventive-no: − 1.6 [− 2.6, − 0.5]). Similar results were seen for achievement of ≥50% reduction in mean MMD and change from baseline in mean monthly acute MSM treatment days. The safety profile of erenumab 70 mg was similar across subgroups, and similar to placebo in each subgroup. Conclusion Erenumab was associated with clinically relevant improvements in all efficacy endpoints and was well tolerated across all subgroups of Japanese migraine patients with/without prior preventive treatment failure(s) and with/without concomitant preventive treatment. Trial registration Clinicaltrials.gov . NCT03812224. Registered January 23, 2019.
    Type of Medium: Online Resource
    ISSN: 1129-2369 , 1129-2377
    URL: Article
    DOI: 10.1186/s10194-021-01313-8
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
    detail.hit.zdb_id: 2020168-0
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  • 5
    Online Resource
    Online Resource
    Long‐term efficacy and safety during open‐label erenumab treatment in Japanese patients with episodic migraine
    Wiley ; 2021
    In:  Headache: The Journal of Head and Face Pain Vol. 61, No. 4 ( 2021-04), p. 653-661
    Details
    In: Headache: The Journal of Head and Face Pain, Wiley, Vol. 61, No. 4 ( 2021-04), p. 653-661
    Abstract: To assess long‐term (up to 2 years) efficacy, tolerability, and safety of erenumab for the prevention of episodic migraine (EM) in Japanese patients. Background Previously published results from the double‐blind treatment phase (DBTP) of a phase 2 clinical study have demonstrated the efficacy and safety of erenumab in Japanese patients with EM. Methods Patients completing the 24‐week placebo‐controlled DBTP could continue into the 76‐week open‐label treatment phase (OLTP), receiving erenumab 70 mg or 140 mg subcutaneously once monthly. The initial dose in the OLTP was erenumab 70 mg monthly, which was later changed to 140 mg. After study completion, the following were assessed: change from baseline in monthly migraine days (MMD), change from baseline in monthly acute migraine‐specific medication days (MSMD), percentage of patients achieving ≥50% and ≥75% reduction in MMD, change from baseline in the 6‐item Headache Impact Test (HIT‐6™) score, and safety (exposure‐adjusted patient‐incidence of adverse events [AEs] , calculated as number of patients per 100 patient‐years). Results Of 475 patients enrolled in the DBTP, 459 (96.6%) continued in the OLTP. The mean (SD) MMD was 7.9 (2.3) at baseline with the overall change from baseline at week 100 of –2.9 (4.1) days. The monthly acute MSMD was 5.7 (2.8) at baseline with change from baseline at week 100 of −1.7 (3.7) days. The proportion of patients who achieved ≥50% and ≥75% reduction in MMD from baseline at week 100 was 177/398 (44.5%) and 94/398 (23.6%), respectively. The HIT‐6™ score was 58.4 (5.4) at baseline with a change of −6.4 (8.2) at week 100. The exposure‐adjusted patient‐incidence of AEs during the OLTP was 207.1/100 patient‐years for the combined erenumab group, similar to that observed for either erenumab (271.0/100 patient‐years) or placebo (257.3/100 patient‐years) during the DBTP, and no new safety signals were detected during the OLTP. Conclusion Long‐term erenumab treatment in Japanese patients with EM demonstrated sustained efficacy for up to 2 years, with a safety profile similar to previous studies, supporting erenumab as a potential new therapy for EM prevention in Japan.
    Type of Medium: Online Resource
    ISSN: 0017-8748 , 1526-4610
    URL: Issue
    URL: Article
    DOI: 10.1111/head.v61.4
    DOI: 10.1111/head.14096
    Language: English
    Publisher: Wiley
    Publication Date: 2021
    detail.hit.zdb_id: 2020316-0
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  • 6
    Online Resource
    Online Resource
    Long-term efficacy and safety of erenumab in Japanese patients with episodic and chronic migraine: results from a 28-week open-label treatment period of a randomised trial
    BMJ ; 2023
    In:  BMJ Open Vol. 13, No. 8 ( 2023-08), p. e068616-
    Details
    In: BMJ Open, BMJ, Vol. 13, No. 8 ( 2023-08), p. e068616-
    Abstract: To evaluate the 1-year efficacy and safety of once-monthly erenumab 70 mg following a 24-week double-blind treatment period (DBTP) of a phase III randomised study of Japanese patients with episodic migraine (EM) or chronic migraine (CM). Design Multicentre open-label study. Setting A total of 41 centres in Japan. Participants Patients completing the DBTP continued into the 28-week open-label treatment period (OLTP). 254 of 261 (97.3%) randomised patients continued into the OLTP; 244 (93.5%) completed treatment. Interventions Once-monthly subcutaneous erenumab 70 mg. Main outcome measures Changes from baseline in monthly migraine days (MMD) and monthly acute migraine-specific medication treatment days (MSMD) reported via patient eDiary; proportion of ≥50% and ≥75% responders in MMD reduction from baseline; incidence and exposure-adjusted incidence of treatment-emergent adverse events (TEAEs). Results At week 24 of the DBTP, the mean (SE) change from baseline in MMD for the erenumab group was –3.8 (0.4) days (EM, –3.0 (0.4); CM, –5.2 (0.8)); in MSMD, –2.6 (0.4) days (EM, –2.1 (0.4); CM, –3.4 (0.7)). At the end of the OLTP (52 weeks postbaseline), the mean (SE) change from baseline in MMD was –4.7 (0.3) days (EM, –3.4 (0.3); CM, –6.9 (0.6)); in MSMD, –3.3 (0.3) days (EM, –2.4 (0.3); CM, –4.6 (0.5)). The proportion of ≥50% responders for MMD reduction in the erenumab group was 34.1% at week 24; 44.4% at week 52. The exposure-adjusted incidence of TEAEs was 219.7 per 100 patient-years during the OLTP (DBTP, 251.0 for the erenumab group). The most common TEAEs during the OLTP were nasopharyngitis, constipation and influenza. No new safety concerns were identified. Conclusions Erenumab treatment was associated with reduced migraine frequency in Japanese patients with EM or CM for up to 1 year. Overall safety results from the OLTP were consistent with DBTP results. Trial registration number NCT03812224 .
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    URL: Article
    DOI: 10.1136/bmjopen-2022-068616
    DOI: 10.1136/bmjopen-2022-068616.supp1
    Language: English
    Publisher: BMJ
    Publication Date: 2023
    detail.hit.zdb_id: 2599832-8
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