Acute Migraine-specific Medication Days Research Articles

Swiss QUality of life and healthcare impact Assessment in a Real-world Erenumab treated migraine population (SQUARE study): interim results

BackgroundThe fully human monoclonal antibody erenumab, which targets the calcitonin gene-related peptide (CGRP) receptor, was licensed in Switzerland in July 2018 for the prophylactic treatment of migraine.To complement findings from the pivotal program, this observational study was designed to collect and evaluate clinical data on the impact of erenumab on several endpoints, such as quality of life, migraine-related impairment and treatment satisfaction in a real-world setting.MethodsAn interim analysis was conducted after all patients completed 6 months of erenumab treatment. Patients kept a headache diary and completed questionnaires at follow up visits. The overall study duration comprises 24 months.ResultsIn total, 172 adults with chronic or episodic migraine from 19 different sites across Switzerland were enrolled to receive erenumab every 4 weeks. At baseline, patients had 16.6 ± 7.2 monthly migraine days (MMD) and 11.6 ± 7.0 acute migraine-specific medication days per month. After 6 months, erenumab treatment reduced Headache Impact Test (HIT-6™) scores by 7.7 ± 8.4 (p < 0.001), the modified Migraine Disability Assessment (mMIDAS) by 14.1 ± 17.8 (p < 0.001), MMD by 7.6 ± 7.0 (p < 0.001) and acute migraine-specific medication days per month by 6.6 ± 5.4 (p < 0.001). Erenumab also reduced the impact of migraine on social and family life, as evidenced by a reduction of Impact of Migraine on Partners and Adolescent Children (IMPAC) scores by 6.1 ± 6.7 (p < 0.001). Patients reported a mean effectiveness of 67.1, convenience of 82.4 and global satisfaction of 72.4 in the Treatment Satisfaction Questionnaire for Medication (TSQM-9). In total, 99 adverse events (AE) and 12 serious adverse events (SAE) were observed in 62 and 11 patients, respectively. All SAE were regarded as not related to the study medication.ConclusionsOverall quality of life improved and treatment satisfaction was rated high with erenumab treatment in real-world clinical practice. In addition, the reported impact of migraine on spouses and children of patients was reduced.Trial registrationBASEC ID 2018–02,375 in the Register of All Projects in Switzerland (RAPS).Graphical

Different dosage regimens of erenumab for the treatment of migraine: A systematic review and meta-analysis of the efficacy and safety of randomized controlled trials.

Migraine is a worldwide epidemic neurological disorder that has a significant influence on the quality of life. Migraine attacks are considered to be related to a calcitonin gene-related peptide (CGRP) signaling molecule, and anti-CGRP medications are used to abort and prevent migraine attacks. Erenumab, a monoclonal antibody that targets the CGRP receptor, is the first migraine preventive medication approved by the US Food and Drug Administration. In the present study, we evaluate the efficacy and safety of erenumab. This study aims to systematically assess the efficacy and safety of erenumab as a migraine preventive treatment compared to a placebo. Randomized, placebo-controlled, single or double-blind trials were searched through MEDLINE, Embase, Cochrane Library, and ClinicalTrials.gov up to May 2022. The efficacy outcomes we collected include changes from baseline on monthly migraine days, monthly acute migraine-specific medication days, ≥50% responder rate, ≥75% responder rate, and 100% responder rate at week 12. Safety outcomes include treatment emergent adverse events, serious adverse events, and any adverse event that leads to discontinuation of treatment. The study was registered with PROSPERO (Registry number: CRD42022338861). In all eight included trials, we found that erenumab (28, 70, and 140 mg) is very effective and has a significantly greater reduction in baseline monthly migraine days (28 mg: mean difference [MD]=-1.1, 95% confidence interval [CI]: -2.0 to -0.2, p=0.020; 70 mg: MD=-1.4, 95% CI: -1.8 to -1.1, p < 0.001, I2 =26%; 140 mg: MD=-1.8, 95% CI: -2.1 to -1.4, p < 0.001, I2 =0%) than placebo at week 12, especially with 140 mg. Otherwise, we found that there were no statistical differences in the occurrence of adverse events (7mg: risk ratio [RR]=0.9, 95% CI: 0.7 to 1.2, p=0.570; 21 mg: RR=1.0, 95% CI: 0.8 to 1.2, p=0.730; 28 mg: RR=0.9, 95% CI: 0.7 to 1.1, p=0.340; 70 mg: RR=1.0, 95% CI: 0.9 to 1.0, p=0.230, I2 =0%; 140 mg: RR=1.0, 95% CI: 0.9 to 1.1, p=0.880, I2 =40%) between the erenumab and placebo groups. In our study, we found that erenumab, especially at the dose of 140 mg, is an effective and well-tolerated preventive treatment for migraine.

Real-world experience of erenumab in patients with chronic or episodic migraine in the UAE

BackgroundErenumab is a fully human monoclonal antibody and a highly potent, first-in-class calcitonin gene-related peptide receptor inhibitor approved for migraine prevention in adults. Randomised, placebo-controlled trials show that erenumab treatment results in clinically meaningful responses, including significant reductions in monthly migraine days. Real-world evidence of the effectiveness of erenumab in patients with migraine is accruing, but gaps remain, and findings may vary according to region. We evaluated the usage patterns and effectiveness of erenumab in real-world settings in patients with migraine in the United Arab Emirates (UAE).MethodsThis retrospective, observational real-world study enrolled patients ≥ 18 years with migraine who were prescribed erenumab in the UAE. Data were collected at baseline and Months 1, 3 and 6. The primary study objective was to characterise usage patterns of erenumab in patients with chronic migraine (CM) or episodic migraine (EM) in real-world settings in the UAE.ResultsOf the 166 patients, 124 (74.7%) were females. The mean (standard deviation) age at migraine onset was 29 (7.93) years. Seventy-one patients (42.8%) had CM and 95 (57.2%) had EM.In the overall population, the mean monthly headache/migraine days (MHD) at baseline was 15.7 (8.45) and mean change from baseline was − 8.2 (8.83) at Month 1, − 11.0 (9.15) at Month 3 and − 11.3 (8.90) at Month 6. The mean change from baseline in monthly acute migraine-specific medication days (MSMD) was − 9.0 (8.07) at Month 1, − 9.7 (8.73) at Month 3 and − 10.7 (8.95) at Month 6. At all time points, most patients achieved at least 50% reduction in MHD (80%–91%) and MSMD (84%–94%).Similar reductions in MHD and MSMD and clinical benefit in CM or EM were seen with erenumab monotherapy or erenumab add-on therapy, with or without dose escalation and for treatment naïve or ≥ 1 previous preventive treatment failures, with additional clinical benefit in the erenumab add-on therapy and dose escalation to 140 mg subgroups.ConclusionIn this real-world study on erenumab use in the UAE, patients prescribed erenumab achieved clinically meaningful reductions in MHD and MSMD at all assessed time points. Erenumab was well tolerated with no new safety events.

Long-term efficacy and safety of erenumab in patients with chronic migraine in whom prior preventive treatments had failed: A subgroup analysis.

ObjectiveTo assess the long‐term efficacy and safety of erenumab in the subgroup of patients with chronic migraine (CM) in whom prior preventive treatments had failed (TF) (≥1, ≥2, and ≥3 TF medication categories) and never failed (preventive naïve or prior preventive treatments had not failed), using the data from a 52‐week, open‐label treatment period (OLTP) of the parent study.BackgroundErenumab is a fully human monoclonal antibody that selectively binds to and inhibits the canonical calcitonin gene‐related peptide receptor. There are limited long‐term data evaluating the efficacy and safety of erenumab in patients with CM in whom prior preventive treatments had failed.MethodsPatients who had completed the 12‐week double‐blind treatment period (DBTP) in the parent study were eligible to participate in the 52‐week OLTP, during which they received erenumab every 4 weeks. The TF subgroups (≥1, ≥2, and ≥3 TF medication categories) were not mutually exclusive; patients in whom prior preventive treatments from ≥3 medication categories had failed were also counted in the ≥2 and ≥1 medication categories. Endpoints included monthly migraine days (MMD), monthly acute migraine‐specific medication days (MSMD), achievement of ≥50%, ≥75%, and 100% reduction from baseline in MMD, and exposure‐adjusted patient incidence rates of adverse events (AEs; per 100 patient‐years).ResultsErenumab treatment provided sustained mean reductions in MMD and MSMD relative to the parent study baseline throughout the 52 weeks of the OLTP across all TF subgroups. At Week 52, the mean MMD change was −8.6 (SD 6.6) (baseline: 18.4 [SD 4.5] days) in the ≥1 TF subgroup. A post hoc completer analysis (52 weeks [OLTP] erenumab) showed that compared with erenumab 70 mg, the 140 mg dose was associated with numerically greater reductions in the mean MMD (Week 40: −8.6 and −7.2 days; Week 52: −9.7 and −7.9 days [≥1 TF subgroup]) and a higher proportion of patients achieved ≥50%, ≥75%, and 100% response thresholds across all subgroups at Weeks 40 and 52. Overall the exposure‐adjusted patient incidence rates of AEs did not increase during the OLTP versus the DBTP (≥1 TF subgroup: 141.9/100 versus 317.9/100 patient‐years), and no new safety signals occurred.ConclusionThe long‐term treatment with erenumab was well tolerated and showed sustained efficacy in patients with CM in whom prior preventive treatments had failed, with numerically greater treatment effects for 140 mg versus 70 mg.

Effectiveness and safety of erenumab and galcanezumab in the prevention of chronic and episodic migraine: A retrospective cohort study.

WHAT IS KNOWN AND OBJECTIVE?: Erenumab and galcanezumab have shown great results for migraine prevention. However, strict inclusion criteria, absence of concomitant medication and selective outcome report of clinical trials may sometimes be barely representative of the real-world daily practice. Therefore, this study was designed to evaluate effectiveness and safety of these two monoclonal antibodies targeting calcitonin gene-related peptide in real-world patients. METHODS: This observational, retrospective study evaluated the effectiveness and safety of erenumab 140mg and galcanezumab 120mg in 142 real-world patients who had previously not responded to three well-established pharmacological alternatives for migraine prevention. To do so, a combination of objective parameters (monthly headache days and acute migraine-specific medication days) and subjective measurements (Migraine Disability Assessment questionnaire, Headache Impact Test and Visual Analogue Scale), validated for clinical research in migraine, were assessed during clinical interview. RESULTS AND DISCUSSION: Findings here reported show that erenumab and galcanezumab reduced monthly headache days, acute migraine specific medication days per month, Headache Impact Test score, Migraine Disability Assessment Test score and Visual Analogue Scale score after 3 and 6 doses (p<0.01). Additionally, more than 25% of the patients enrolled in the study experienced a reduction by a half in monthly headache days, and more than 50% of the patients also reported a reduction by a half in the number of migraine specific medication days. Both treatments exhibited a great safety profile, rarely leading to discontinuation because of poor tolerance. WHAT IS NEW AND CONCLUSIONS?: Altogether, these results support previous real-life studies regarding effectiveness and safety and provide an interesting insight in how these preventive therapies are also effective in patients diagnosed with difficult to treat migraine who have previously failed, at least, three different drug classes stablished by current neurology guidelines for migraine prevention. Moreover, these data may suggest that erenumab and galcanezumab are able to not only diminish frequency, but also migraine intensity, and that it should be also considered as an effectiveness measure in line with other authors suggestion.

Optimal Dose of Erenumab for Preventive Treatment of Episodic Migraine: A Systematic Review and Meta-Analysis.

Background:Erenumab is a novel monoclonal calcitonin gene-related peptide receptor antibody that is used for the preventive treatment of migraine.Objectives: This study aimed to evaluate the overall safety, efficacy, and dose-response relationship of erenumab in patients with episodic migraine and patients with prior migraine treatment failures.Methods:We searched randomized clinical trials on PUBMED, EMBASE database, and Cochrane Library database. A pair-wise meta-analysis and Bayesian network analysis were performed.Results:For efficacy outcomes, the network meta-analysis suggests that in comparison to erenumab 70 mg, participants who received erenumab 140 mg reported a significant decrease in monthly acute Migraine-Specific Medication Days (MSMD) and 50% increase in response rate, and erenumab was most likely to be ranked first for Monthly Migraine Days (MMD), MSMD, and 50% response rate. For safety outcomes, the network meta-analysis has found no significant difference between the 70 mg group and the 140 mg group measured by adverse events and serious adverse events. In the 140 mg erenumab group, a significant decreased in MMD and MSMD and 50% and 75% increased in response rate were reported in patients with ≥ 2 treatment failures compared to placebo. For safety outcomes, no significant difference was found between the 140 mg erenumab group and the placebo group.Conclusion:Erenumab was effective in patients with episodic migraine. A total of 140 mg erenumab was associated with better efficacy outcomes without any increased risk for developing adverse events compared to 70 mg erenumab. Furthermore, 140 mg erenumab was effective in patients with prior migraine treatment failures.

Assessment of Erenumab Safety and Efficacy in Patients With Migraine With and Without Aura

Migraine with aura may respond differently to therapies than migraine without aura. Individuals with migraine with aura have an elevated vascular risk, necessitating a safety assessment of migraine preventive treatments in this patient subgroup. To assess the efficacy and safety profiles of erenumab in patients with migraine with aura. This post hoc secondary analysis evaluated 4 double-blind, placebo-controlled randomized clinical trials that were conducted in treatment centers in North America, Europe, Russia, and Turkey between August 6, 2013, and November 12, 2019. Participants were adults aged 18 to 65 years with episodic migraine or chronic migraine and were randomized to receive either erenumab or placebo. One or more dose of erenumab (70 mg or 140 mg once per month) or placebo was administered by subcutaneous injection in the double-blind treatment phase and open-label or dose-blinded active treatment, and erenumab, 70 mg or 140 mg, was administered once per month by subcutaneous injection during extension phases. Efficacy assessments included change from baseline monthly migraine days (MMDs) and monthly acute migraine-specific medication (AMSM) days. Safety end points included patient incidences of adverse events. Subgroups of patients were categorized according to their history of aura. Of the 2682 patients who were randomized in the 4 trials, 1400 (52.2%) received 1 or more dose of erenumab, 70 mg or 140 mg, and 1043 (38.9%) received placebo. Patients had a mean (SD) age of 41.7 (11.2) years and were predominantly women (n = 2055 [84.1%]). Reductions from baseline MMDs and AMSM days were greater in the erenumab than placebo groups in patients with and without a history of aura during the double-blind treatment phase, and these reductions were maintained throughout the extension phases. In patients with episodic migraine and a history of aura, least-squares mean differences in change from baseline MMDs at week 12 were -1.1 (95% CI, -1.7 to -0.6) in those who received erenumab, 70 mg, and -0.9 (95% CI, -1.6 to -0.2) in those who received erenumab, 140 mg, compared with placebo. In patients with chronic migraine with a history of aura, the least-squares mean differences from placebo treatment were -2.1 (95% CI, -3.8 to -0.5) in those who received erenumab, 70 mg, and -3.1 (95% CI, -4.8 to -1.4) in those who received erenumab, 140 mg. Overall safety profiles were similar across treatment groups regardless of aura history and were comparable to that of placebo over 12 weeks, with no increased emergence of adverse events over time. Results of this secondary analysis of 4 randomized clinical trials showed reduced migraine frequency and AMSM days with erenumab treatment in patients with migraine with and without a history of aura. The findings support the efficacy and safety of using erenumab in this patient population. ClinicalTrials.gov Identifiers: NCT01952574, NCT02456740, NCT02483585, NTCT02066415, and NCT02174861.

Effects of Anti-CGRP monoclonal antibodies for episodic and chronic migraine on migraine characteristics, disability, impact and quality of life beyond 3 months of treatment: A Systematic review and Meta-analysis

Objective: At the time of this study, there were no systematic reviews to evaluate phase III RCT`s of CGRP monoclonal antibodies on migraine characteristics, migraine related disability, impact and quality of life after 3 months. This meta-analysis is aimed to systematically review available data on the effect of anti-CGRP monoclonal antibodies on migraine characteristics, migraine related disability, impact and quality of life after 3 months of treatment. Methods: A systematic literature search was performed to identify phase III randomized-controlled trials on anti-GCRP monoclonal antibodies on migraine prevention. The primary outcome was the change in migraine characteristics monthly migraine days, monthly acute migraine specific medication days and 50 % responder rate. Secondary outcome was change in patient functioning and quality of life assessed through Migraine- Specific Quality of Life Questionnaire (MSQ) Migraine Disability Assessment Questionnaire (MIDAS), Headache Impact test (HIT -6) and Migraine Physical Function Impact Diary (MPFID). We calculated the mean difference (MD), standard deviation (SD), and 95 % confidence intervals for the outcomes. Results: Four trials showed effect of anti-CGRP monoclonal antibodies on migraine characteristics and quality of life after 3 months, named EVOLVE 1, EVOLVE 2, STRIVE, HALO_LTS. These trials present data on galcanezumab (120mg, 240 mg, monthly), erenumab (70 mg, 140 mg, monthly) and fremanezumab (225 mg, 675 mg, quarterly, monthly), respectively. The trials included 4625 patients with migraine, 3515 with episodic migraine and 1110 with chronic migraine. Just three of them were included in the meta-analysis because HALO_LTS had no placebo-controlled group. In the included trials, anti-CGRP monoclonal antibodies (galcanezumab and erenumab) were superior to placebo for MMDs, 50% reduction rate, MSQ_RFR and MIDAS beyond a 3-month treatment period. Conclusion: Galcanezumab and erenumab demonstrated improvement in migraine characteristics and quality of life above and beyond those seen with placebo after 3-months of treatment in episodic migraine, providing placebo-controlled evidence. There is a need to perform good RCT`s to evaluate the efficacy of all anti-CGRP monoclonal antibodies on migraine characteristics, impact and quality of life on longer time frame (beyond 12 months) and on different migraine populations such as chronic migraine, medication overuse headache and refractory migraine. Keywords: CGRP, Antibodies, Migraine, Disability

Efficacy of erenumab in chronic migraine patients with and without ictal allodynia.

Ictal cutaneous allodynia, common in chronic migraine, is associated with reduced responses to acute treatment with triptans. Allodynia's impact on the efficacy of newer preventive treatments such as erenumab is unknown. Post-hoc subgroup analysis of a double-blind, randomized, placebo-controlled 12-week study of erenumab in chronic migraine, contrasting those with no allodynia with those with moderate-severe allodynia assessed with the Allodynia Symptom Checklist-12, was undertaken. Of 648 randomized individuals with baseline Allodynia Symptom Checklist-12 scores, 386 (59.6%) had no allodynia and 153 (23.6%) had moderate-to-severe allodynia. Mean (standard deviation) baseline monthly migraine days were 17.6 (4.8) and 18.9 (4.3), respectively. Compared to placebo, the erenumab group had greater reductions in monthly migraine days and monthly acute migraine-specific medication days in both no allodynia and allodynia subgroups. Mean (95% confidence interval) treatment differences in change from baseline for monthly migraine days at week 12 were -2.5 (-3.7, -1.4) in the no allodynia subgroup and -3.3 (-5.3, -1.3) in the moderate-severe allodynia subgroup. Change in acute migraine-specific medication days were -3.3 (-4.3, -2.3) and -2.5 (-4.3, -0.8), respectively. Erenumab's efficacy in reducing monthly migraine days and acute migraine-specific medication days in chronic migraine was not impacted by the presence of moderate-severe ictal allodynia.Trial registration: ClinicalTrials.gov NCT02066415.

Long-term efficacy and safety during open-label erenumab treatment in Japanese patients with episodic migraine.

ObjectiveTo assess long‐term (up to 2 years) efficacy, tolerability, and safety of erenumab for the prevention of episodic migraine (EM) in Japanese patients.BackgroundPreviously 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.MethodsPatients 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).ResultsOf 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.ConclusionLong‐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.

Long-term efficacy and safety of erenumab in migraine prevention: Results from a 5-year, open-label treatment phase of a randomized clinical trial.

Background and purposeAlthough erenumab has demonstrated significant reduction in migraine frequency and improved quality of life in studies lasting 3 to 12 months, little is known about long‐term therapy.MethodsThis study was an open‐label, 5‐year treatment phase following a 12‐week, double‐blind, placebo‐controlled trial in adults with episodic migraine. Patients initially received open‐label erenumab 70 mg, which increased to 140 mg following a protocol amendment. Efficacy analyses included change from baseline in monthly migraine days (MMDs), monthly acute migraine‐specific medication (AMSM) days, and health‐related quality of life.ResultsOf 383 patients enrolled, 250 switched to 140 mg; 215 (56.1%) completed open‐label treatment. Mean (standard error) change in MMDs from baseline of 8.7 (0.2) days was −5.3 (0.3) days; an average reduction of 62.3% at year 5. Among patients using AMSM at baseline (6.3 [2.8] treatment days), mean change in monthly AMSM days was −4.4 (0.3) days at the end of 5 years. Patient‐reported outcomes indicated stable improvements in disability, headache impact, and migraine‐specific quality of life. Exposure‐adjusted patient incidence rates of adverse events (AEs) were 123.0/100 patient‐years; AEs were most frequently nasopharyngitis, upper respiratory tract infection, and influenza. Serious AEs (SAEs) reported by 49 patients (3.8/100 patient‐years) were mostly single occurrence. Two fatal adverse events were reported. There were no increases in incidence of AEs, SAEs, or AEs leading to treatment discontinuation over 5 years of exposure.ConclusionsTreatment with erenumab was associated with reductions in migraine frequency and improvements in health‐related quality of life that were maintained for at least 5 years. No new safety signals were observed.

Efficacy and safety of erenumab in women with a history of menstrual migraine

BackgroundWe performed a post hoc, subgroup analysis of a phase 3, randomized, double-blind, placebo-controlled study of erenumab for prevention of episodic migraine (STRIVE) to determine the efficacy and safety of erenumab in women with self-reported menstrual migraine.MethodsPatients received placebo, erenumab 70 mg, or erenumab 140 mg subcutaneously once monthly during the 6-month double-blind treatment phase of STRIVE. Women who reported history of menstrual migraine and who were ≤ 50 years old were included in the analysis. Endpoints were change from baseline in monthly migraine days (MMD) and monthly acute migraine-specific medication days (MSMD; among patients who took acute migraine-specific medications at baseline), proportion of patients achieving ≥ 50% reduction from baseline in MMD, and incidence of adverse events.ResultsAmong 814 women enrolled in STRIVE, 232 (28.5%) reported a history of menstrual migraine and were ≤ 50 years old. Of the 232 patients, 214 (92%) had a baseline MMD > 5, suggesting a high proportion of women with attacks outside of the 5-day perimenstrual window (2 days before and 3 days after the start of menstruation). Information on “migraine days” includes (and does not discriminate between) perimenstrual and intermenstrual migraine attacks. Between-group differences from placebo over months 4–6 for erenumab 70 mg and 140 mg were − 1.8 (P = 0.001) and − 2.1 (P < 0.001) days for MMD and − 1.6 (P = 0.002) and − 2.4 (P < 0.001) days for acute MSMD, respectively. The odds of having a ≥ 50% reduction from baseline in MMD over months 4–6 were 2.2 (P = 0.024) and 2.8 (P = 0.002) times greater for erenumab 70 mg and 140 mg, respectively, than for placebo. Erenumab had an overall safety profile comparable to placebo.ConclusionData from this subgroup analysis of women with menstrual migraine are consistent with data from the overall STRIVE episodic migraine population, supporting the efficacy and safety of erenumab in women who experience menstrual migraine.Trial registration: ClinicalTrials.gov, NCT02456740. Registered 28 May 2015.

096 Assessment of the efficacy of erenumab during the open-label treatment (13–24 weeks) of subjects with episodic migraine who failed 2–4 prior preventive treatments: results of the LIBERTY study

IntroductionTo assess efficacy of erenumab in the first three months of the open-label extension phase (OLEP; 13–24 weeks) of the LIBERTY study.MethodsIn the double-blind treatment phase (DBTP), 246 patients were randomized to placebo and erenumab 140 mg for 12 weeks, following which, patients completing that phase (N=240) were enrolled in OLEP, to receive monthly erenumab 140 mg. Outcomes measured monthly throughout to week 24 were achievement of at least 50%/75%/100% reduction in monthly migraine days (MMD), change from DBTP baseline in MMD, monthly acute migraine-specific medication days (MSMD), Headache Impact Test (HIT-6TM) total score, everyday activities (EA) and physical impairment (PI) as measured by the Migraine Physical Function Impact Diary (MPFID).ResultsOverall, 228/240(95.0%) patients completed the 24 week visit of the OLEP. In the overall population at Week 24, 39.2%, 15.9% and 7.0% patients achieved ≥50%/≥75%/100% reduction in MMD. The mean (standard deviation) change from DBTP baseline in MMD was −2.7(4.4) and −1.4(3.0) in MSMD; and −7.6(8.0), −2.5(9.2) and −4.0(9.0) in HIT-6TM, MPFID-PI and MPFID-EA scores respectively. Patients with continuous use of erenumab showed sustained efficacy in all outcomes assessed. Patients who switched from placebo to erenumab in the OLEP showed improvement from the first measurement at Week 16 on all outcomes assessed.ConclusionsEfficacy of erenumab was sustained throughout 24 weeks in a hard to treat patient population with multiple prior preventive treatment failures. Overall, efficacy data over 24 weeks (assessed over weeks 13–16,17–20 and 21–24) was generally in line with prior erenumab trials.

Erenumab for Preventive Treatment of Migraine: A Systematic Review and Meta-Analysis of Efficacy and Safety

Novel therapeutic options with improved efficacy and safety profiles are needed for the prophylaxis of migraine. In recent years, the inhibition of calcitonin gene-related peptide (CGRP) signaling has attracted growing interest in the pharmacological research on migraine. Erenumab is the first fully human monoclonal antibody directed against the CGRP receptor to be approved for use in migraineurs. To evaluate the efficacy and safety of erenumab as preventive treatment in patients with migraine using meta-analytical techniques. Randomized, placebo-controlled, single- or double-blinded trials were identified through a systematic literature search (October week 4, 2018). Main outcomes included the changes from baseline in monthly migraine days (MMD) and monthly acute migraine-specific medication days (MSMD) at week 12, and the incidence of adverse events (AEs), severe AEs (SAEs) and treatment withdrawal due to AEs. Mean difference (MD) and risk ratio (RR) with 95% confidence intervals (95% CIs) were estimated. Across the five included trials, erenumab given as a subcutaneous injection at a monthly dosage of 70mg and 140mg was associated with a significantly greater reduction in baseline MMD (70mg: MD - 1.3, 95% CI - 1.7 to - 1.0, p < 0.001; 140mg: MD - 1.9, 95% CI - 2.3 to - 1.4, p < 0.001) and MSMD (70mg: MD - 1.0, 95% CI - 1.6 to - 0.4, p < 0.001; 140mg: MD - 1.8, 95% CI - 2.5 to - 1.1, p < 0.001) than placebo. There were no differences in the occurrence of AEs, SAEs, and drug withdrawal due to AEs between the erenumab and placebo groups. Erenumab is an efficacious and well tolerated preventive treatment in adult patients with episodic and chronic migraine.

Efficacy and safety of erenumab (AMG334) in chronic migraine patients with prior preventive treatment failure: A subgroup analysis of a randomized, double-blind, placebo-controlled study.

Background Erenumab was effective and well tolerated in a pivotal clinical trial of chronic migraine. Here, we evaluated efficacy and safety of monthly erenumab (70 mg or 140 mg) versus placebo in the subgroup of patients who had previously failed preventive treatment(s) (≥ 1, ≥ 2 prior failed medication categories) and in patients who had never failed. Methods Subgroup analyses evaluated change from baseline in monthly migraine days; achievement of ≥ 50% and ≥ 75% reduction in monthly migraine days; and change in monthly acute migraine-specific medication days. Adverse events were evaluated for each subgroup. Results Treatment with both doses of erenumab resulted in greater reductions in monthly migraine days (primary endpoint) at Month 3 (treatment difference [95% CI], never failed subgroup: -2.2 [-4.1, -0.3] for 70 mg and -0.5 [-2.4, 1.5] for 140 mg; ≥ 1 prior failed medication categories subgroup: -2.5 [-3.8, -1.2], for 70 mg and -3.3 [-4.6, -2.1] for 140 mg; ≥ 2 prior failed medication categories subgroup: -2.7 [-4.2, -1.2], for 70 mg and -4.3 [-5.8, -2.8] for 140 mg). Similar results were observed in the monthly acute migraine-specific medication days endpoint, and in the achievement of ≥ 50% and ≥ 75% reduction in monthly migraine days. There were no new or unexpected safety issues. Conclusion Erenumab showed consistent efficacy in chronic migraine patients who had failed prior preventive treatments and was well tolerated across subgroups.