Clinical Edge Journal Scan

Key clinical point: Patients with chronic migraine (CM) or episodic migraine (EM) show a clinically significant improvement in headache characteristics after prophylactic transcutaneous nerve stimulation.

Major finding: Transcutaneous nerve stimulation reduced the headache frequency (mean monthly headache days) by 2.81 (95% CI 2.18-3.43) days in EM and by 2.97 (95% CI 1.66-4.28) days in CM and the pain severity by 2.23 (95% CI 1.64-2.81) pain scale points in EM.

Study details: The data come from a meta-analysis of 14 studies that included 995 patients with EM or CM treated with transcutaneous stimulation of a single nerve.

Disclosures: The study received no financial support. The authors declared no conflicts of interest.

Source: Evans AG et al. Outcomes of transcutaneous nerve stimulation for migraine headaches: a systematic review and meta-analysis. J Neurol. 2022 (Mar 16). Doi: 10.1007/s00415-022-11059-1

Key clinical point: Patients with chronic migraine (CM) or episodic migraine (EM) show a clinically significant improvement in headache characteristics after prophylactic transcutaneous nerve stimulation.

Major finding: Transcutaneous nerve stimulation reduced the headache frequency (mean monthly headache days) by 2.81 (95% CI 2.18-3.43) days in EM and by 2.97 (95% CI 1.66-4.28) days in CM and the pain severity by 2.23 (95% CI 1.64-2.81) pain scale points in EM.

Study details: The data come from a meta-analysis of 14 studies that included 995 patients with EM or CM treated with transcutaneous stimulation of a single nerve.

Disclosures: The study received no financial support. The authors declared no conflicts of interest.

Source: Evans AG et al. Outcomes of transcutaneous nerve stimulation for migraine headaches: a systematic review and meta-analysis. J Neurol. 2022 (Mar 16). Doi: 10.1007/s00415-022-11059-1

Key clinical point: Patients with chronic migraine (CM) or episodic migraine (EM) show a clinically significant improvement in headache characteristics after prophylactic transcutaneous nerve stimulation.

Major finding: Transcutaneous nerve stimulation reduced the headache frequency (mean monthly headache days) by 2.81 (95% CI 2.18-3.43) days in EM and by 2.97 (95% CI 1.66-4.28) days in CM and the pain severity by 2.23 (95% CI 1.64-2.81) pain scale points in EM.

Study details: The data come from a meta-analysis of 14 studies that included 995 patients with EM or CM treated with transcutaneous stimulation of a single nerve.

Disclosures: The study received no financial support. The authors declared no conflicts of interest.

Source: Evans AG et al. Outcomes of transcutaneous nerve stimulation for migraine headaches: a systematic review and meta-analysis. J Neurol. 2022 (Mar 16). Doi: 10.1007/s00415-022-11059-1

Key clinical point: Fremanezumab is effective and well-tolerated in real-life patients with difficult-to-treat high-frequency episodic migraine (HFEM) or chronic migraine (CM).

Major finding: At week 12, fremanezumab significantly decreased monthly migraine days (−4.6 days; P < .05) in patients with HFEM and monthly headache days (−9.4 days; P < .001) in patients with CM. The rate of treatment-emergent adverse events, graded mild and transient, was only 5.7%.

Study details: This was a multicenter, prospective, real-life study including 53 patients with HFEM (8-14 days/month) or CM who had multiple therapeutic failures and received subcutaneous fremanezumab (225 mg monthly or 675 mg quarterly) for 12 weeks.

Disclosures: The study was partially sponsored by the Italian Ministry of Health (Ricerca Corrente). Some authors declared receiving travel grants or honoraria for advisory boards, speaker panels, consultation, or clinical investigation studies from various sources. M Filippi is the Editor-in-Chief of the Journal of Neurology.

Source: Barbanti P et al. Fremanezumab in the prevention of high-frequency episodic and chronic migraine: a 12-week, multicenter, real-life, cohort study (the FRIEND study). J Headache Pain. 2022;23:46 (Apr 9). Doi: 10.1186/s10194-022-01396-x

Key clinical point: Fremanezumab is effective and well-tolerated in real-life patients with difficult-to-treat high-frequency episodic migraine (HFEM) or chronic migraine (CM).

Major finding: At week 12, fremanezumab significantly decreased monthly migraine days (−4.6 days; P < .05) in patients with HFEM and monthly headache days (−9.4 days; P < .001) in patients with CM. The rate of treatment-emergent adverse events, graded mild and transient, was only 5.7%.

Study details: This was a multicenter, prospective, real-life study including 53 patients with HFEM (8-14 days/month) or CM who had multiple therapeutic failures and received subcutaneous fremanezumab (225 mg monthly or 675 mg quarterly) for 12 weeks.

Disclosures: The study was partially sponsored by the Italian Ministry of Health (Ricerca Corrente). Some authors declared receiving travel grants or honoraria for advisory boards, speaker panels, consultation, or clinical investigation studies from various sources. M Filippi is the Editor-in-Chief of the Journal of Neurology.

Source: Barbanti P et al. Fremanezumab in the prevention of high-frequency episodic and chronic migraine: a 12-week, multicenter, real-life, cohort study (the FRIEND study). J Headache Pain. 2022;23:46 (Apr 9). Doi: 10.1186/s10194-022-01396-x

Key clinical point: Fremanezumab is effective and well-tolerated in real-life patients with difficult-to-treat high-frequency episodic migraine (HFEM) or chronic migraine (CM).

Major finding: At week 12, fremanezumab significantly decreased monthly migraine days (−4.6 days; P < .05) in patients with HFEM and monthly headache days (−9.4 days; P < .001) in patients with CM. The rate of treatment-emergent adverse events, graded mild and transient, was only 5.7%.

Study details: This was a multicenter, prospective, real-life study including 53 patients with HFEM (8-14 days/month) or CM who had multiple therapeutic failures and received subcutaneous fremanezumab (225 mg monthly or 675 mg quarterly) for 12 weeks.

Disclosures: The study was partially sponsored by the Italian Ministry of Health (Ricerca Corrente). Some authors declared receiving travel grants or honoraria for advisory boards, speaker panels, consultation, or clinical investigation studies from various sources. M Filippi is the Editor-in-Chief of the Journal of Neurology.

Source: Barbanti P et al. Fremanezumab in the prevention of high-frequency episodic and chronic migraine: a 12-week, multicenter, real-life, cohort study (the FRIEND study). J Headache Pain. 2022;23:46 (Apr 9). Doi: 10.1186/s10194-022-01396-x

Key clinical point: Patients with migraine show higher treatment adherence and persistence to calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb), specifically to galcanezumab, over standard-of-care (SOC) migraine preventive treatments.

Major finding: At 12 months of follow-up, CGRP mAb vs. SOC initiators had significantly higher mean adherence (proportion of days covered: 55.1% vs. 35.2%; P < .001) and persistence (212.5 vs. 131.9 days; P < .001). Similarly, galcanezumab vs. SOC initiators showed significantly higher adherence (63.7% vs. 33.7%; P < .001) and persistence (252.3 vs. 127.3 days; P < .001).

Study details: This retrospective, observational, claims database study created two separate 1:1 propensity-score-matched cohorts of adult patients with migraine initiating SOC or a CGRP mAb (n = 3082 pairs) and SOC or galcanezumab (n = 421 pairs).

Disclosures: The study was funded by Eli Lilly and Company. All authors declared being current/former employees or minor shareholders of Eli Lilly or a company contracted by Eli Lilly.

Source: Varnado OJ et al. Treatment patterns for calcitonin gene-related peptide monoclonal antibodies including galcanezumab versus conventional preventive treatments for migraine: A retrospective us claims study, Patient Prefer Adherence. 2022;16:821-839 (Mar 29). Doi: 10.2147/PPA.S346660

Key clinical point: Patients with migraine show higher treatment adherence and persistence to calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb), specifically to galcanezumab, over standard-of-care (SOC) migraine preventive treatments.

Major finding: At 12 months of follow-up, CGRP mAb vs. SOC initiators had significantly higher mean adherence (proportion of days covered: 55.1% vs. 35.2%; P < .001) and persistence (212.5 vs. 131.9 days; P < .001). Similarly, galcanezumab vs. SOC initiators showed significantly higher adherence (63.7% vs. 33.7%; P < .001) and persistence (252.3 vs. 127.3 days; P < .001).

Study details: This retrospective, observational, claims database study created two separate 1:1 propensity-score-matched cohorts of adult patients with migraine initiating SOC or a CGRP mAb (n = 3082 pairs) and SOC or galcanezumab (n = 421 pairs).

Disclosures: The study was funded by Eli Lilly and Company. All authors declared being current/former employees or minor shareholders of Eli Lilly or a company contracted by Eli Lilly.

Source: Varnado OJ et al. Treatment patterns for calcitonin gene-related peptide monoclonal antibodies including galcanezumab versus conventional preventive treatments for migraine: A retrospective us claims study, Patient Prefer Adherence. 2022;16:821-839 (Mar 29). Doi: 10.2147/PPA.S346660

Key clinical point: Patients with migraine show higher treatment adherence and persistence to calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb), specifically to galcanezumab, over standard-of-care (SOC) migraine preventive treatments.

Major finding: At 12 months of follow-up, CGRP mAb vs. SOC initiators had significantly higher mean adherence (proportion of days covered: 55.1% vs. 35.2%; P < .001) and persistence (212.5 vs. 131.9 days; P < .001). Similarly, galcanezumab vs. SOC initiators showed significantly higher adherence (63.7% vs. 33.7%; P < .001) and persistence (252.3 vs. 127.3 days; P < .001).

Study details: This retrospective, observational, claims database study created two separate 1:1 propensity-score-matched cohorts of adult patients with migraine initiating SOC or a CGRP mAb (n = 3082 pairs) and SOC or galcanezumab (n = 421 pairs).

Disclosures: The study was funded by Eli Lilly and Company. All authors declared being current/former employees or minor shareholders of Eli Lilly or a company contracted by Eli Lilly.

Source: Varnado OJ et al. Treatment patterns for calcitonin gene-related peptide monoclonal antibodies including galcanezumab versus conventional preventive treatments for migraine: A retrospective us claims study, Patient Prefer Adherence. 2022;16:821-839 (Mar 29). Doi: 10.2147/PPA.S346660

Key clinical point: Real-time ultrasound-guided stellate ganglion block (SGB) can effectively ameliorate migraine pain and disability without causing any serious complications, thus improving the quality of life of patients.

Major finding: After 3 months of SGB administration, the numerical rating scale score decreased from 7.0 to 2.0 (P < .01), Migraine Disability Assessment Scale total score from 14.0 to 7.0 (P < .001), and analgesic use frequency from 6.2 ± 2.8 to 1.9 ± 1.8. No serious complications were observed.

Study details: The study enrolled 81 patients aged >18 years with migraine who received SGB on the affected side with 0.15% ropivacaine weekly 4 times.

Disclosures: The study was sponsored by a grant from the Shanghai Municipal Health Commission. The authors reported no conflicts of interest.

Source: Hou J et al. Real-time ultrasound-guided stellate ganglion block for migraine: an observational study. BMC Anesthesiol. 2022;22:78 (Mar 24). Doi: 10.1186/s12871-022-01622-8

Key clinical point: Real-time ultrasound-guided stellate ganglion block (SGB) can effectively ameliorate migraine pain and disability without causing any serious complications, thus improving the quality of life of patients.

Major finding: After 3 months of SGB administration, the numerical rating scale score decreased from 7.0 to 2.0 (P < .01), Migraine Disability Assessment Scale total score from 14.0 to 7.0 (P < .001), and analgesic use frequency from 6.2 ± 2.8 to 1.9 ± 1.8. No serious complications were observed.

Study details: The study enrolled 81 patients aged >18 years with migraine who received SGB on the affected side with 0.15% ropivacaine weekly 4 times.

Disclosures: The study was sponsored by a grant from the Shanghai Municipal Health Commission. The authors reported no conflicts of interest.

Source: Hou J et al. Real-time ultrasound-guided stellate ganglion block for migraine: an observational study. BMC Anesthesiol. 2022;22:78 (Mar 24). Doi: 10.1186/s12871-022-01622-8

Key clinical point: Real-time ultrasound-guided stellate ganglion block (SGB) can effectively ameliorate migraine pain and disability without causing any serious complications, thus improving the quality of life of patients.

Major finding: After 3 months of SGB administration, the numerical rating scale score decreased from 7.0 to 2.0 (P < .01), Migraine Disability Assessment Scale total score from 14.0 to 7.0 (P < .001), and analgesic use frequency from 6.2 ± 2.8 to 1.9 ± 1.8. No serious complications were observed.

Study details: The study enrolled 81 patients aged >18 years with migraine who received SGB on the affected side with 0.15% ropivacaine weekly 4 times.

Disclosures: The study was sponsored by a grant from the Shanghai Municipal Health Commission. The authors reported no conflicts of interest.

Source: Hou J et al. Real-time ultrasound-guided stellate ganglion block for migraine: an observational study. BMC Anesthesiol. 2022;22:78 (Mar 24). Doi: 10.1186/s12871-022-01622-8

Key clinical point: Migraine frequency decreases significantly in most patients with migraine on resuming preventive treatment with the same calcitonin gene-related peptide-receptor (CGRP-[R]) monoclonal antibody (mAb) after a 3-month drug holiday.

Major finding: After 9-12 weeks of therapy resumption, monthly migraine days reduced significantly (−4.5 days, P < .001) and attained a level comparable with that in the 4-week period before therapy discontinuation (P > .999).

Study details: Findings are from a longitudinal cohort study including 39 patients with episodic or chronic migraine who restarted treatment with erenumab (n = 16) or galcanezumab/fremanezumab (n = 23) after a 3-month drug holiday following the first treatment cycle with the same CGRP(-R) mAb.

Disclosures: This study did not receive any financial support. Some authors declared serving on the advisory board of or receiving consulting, speaker, or personal fees from various sources.

Source: Raffaelli B et al. Resumption of migraine preventive treatment with CGRP(-receptor) antibodies after a 3-month drug holiday: A real-world experience. J Headache Pain. 2022;23:40 (Mar 30). Doi:  10.1186/s10194-022-01417-9

Key clinical point: Migraine frequency decreases significantly in most patients with migraine on resuming preventive treatment with the same calcitonin gene-related peptide-receptor (CGRP-[R]) monoclonal antibody (mAb) after a 3-month drug holiday.

Major finding: After 9-12 weeks of therapy resumption, monthly migraine days reduced significantly (−4.5 days, P < .001) and attained a level comparable with that in the 4-week period before therapy discontinuation (P > .999).

Study details: Findings are from a longitudinal cohort study including 39 patients with episodic or chronic migraine who restarted treatment with erenumab (n = 16) or galcanezumab/fremanezumab (n = 23) after a 3-month drug holiday following the first treatment cycle with the same CGRP(-R) mAb.

Disclosures: This study did not receive any financial support. Some authors declared serving on the advisory board of or receiving consulting, speaker, or personal fees from various sources.

Source: Raffaelli B et al. Resumption of migraine preventive treatment with CGRP(-receptor) antibodies after a 3-month drug holiday: A real-world experience. J Headache Pain. 2022;23:40 (Mar 30). Doi:  10.1186/s10194-022-01417-9

Key clinical point: Migraine frequency decreases significantly in most patients with migraine on resuming preventive treatment with the same calcitonin gene-related peptide-receptor (CGRP-[R]) monoclonal antibody (mAb) after a 3-month drug holiday.

Major finding: After 9-12 weeks of therapy resumption, monthly migraine days reduced significantly (−4.5 days, P < .001) and attained a level comparable with that in the 4-week period before therapy discontinuation (P > .999).

Study details: Findings are from a longitudinal cohort study including 39 patients with episodic or chronic migraine who restarted treatment with erenumab (n = 16) or galcanezumab/fremanezumab (n = 23) after a 3-month drug holiday following the first treatment cycle with the same CGRP(-R) mAb.

Disclosures: This study did not receive any financial support. Some authors declared serving on the advisory board of or receiving consulting, speaker, or personal fees from various sources.

Source: Raffaelli B et al. Resumption of migraine preventive treatment with CGRP(-receptor) antibodies after a 3-month drug holiday: A real-world experience. J Headache Pain. 2022;23:40 (Mar 30). Doi:  10.1186/s10194-022-01417-9

Key clinical point: Topiramate in combination with monthly injections of greater occipital nerve block (GONB) is better at decreasing monthly migraine days (MMD) in chronic migraine (CM) than topiramate monotherapy at month 3 and is equally well tolerated.

Major finding: At month 3, greater reductions in MMD were observed in patients receiving topiramate and GONB with lidocaine+methylprednisolone (−9.6 vs. −7.3 days; P = .003) and topiramate and GONB with only lidocaine (−10.1 vs. −7.3 days; P < .001) compared with patients receiving topiramate monotherapy. Tolerability between the groups was comparable.

Study details: Findings are from a parallel group, three-arm study including 125 adult patients with CM who were randomly assigned to receive topiramate alone (n = 41), topiramate and GONB with lidocaine+methylprednisolone in month 1 followed by monthly lidocaine injections (n = 44), or topiramate and GONB with monthly lidocaine injections (n = 40) for 3 months.

Disclosures: The study received no financial support. The authors declared no conflicts of interest.

Source: Chowdhury D et al. Efficacy and tolerability of combination treatment of topiramate and greater occipital nerve block versus topiramate monotherapy for the preventive treatment of chronic migraine: A randomized controlled trial. Cephalalgia. 2022 (Mar 8). Doi: 10.1177/03331024221082077

Key clinical point: Topiramate in combination with monthly injections of greater occipital nerve block (GONB) is better at decreasing monthly migraine days (MMD) in chronic migraine (CM) than topiramate monotherapy at month 3 and is equally well tolerated.

Major finding: At month 3, greater reductions in MMD were observed in patients receiving topiramate and GONB with lidocaine+methylprednisolone (−9.6 vs. −7.3 days; P = .003) and topiramate and GONB with only lidocaine (−10.1 vs. −7.3 days; P < .001) compared with patients receiving topiramate monotherapy. Tolerability between the groups was comparable.

Study details: Findings are from a parallel group, three-arm study including 125 adult patients with CM who were randomly assigned to receive topiramate alone (n = 41), topiramate and GONB with lidocaine+methylprednisolone in month 1 followed by monthly lidocaine injections (n = 44), or topiramate and GONB with monthly lidocaine injections (n = 40) for 3 months.

Disclosures: The study received no financial support. The authors declared no conflicts of interest.

Source: Chowdhury D et al. Efficacy and tolerability of combination treatment of topiramate and greater occipital nerve block versus topiramate monotherapy for the preventive treatment of chronic migraine: A randomized controlled trial. Cephalalgia. 2022 (Mar 8). Doi: 10.1177/03331024221082077

Key clinical point: Topiramate in combination with monthly injections of greater occipital nerve block (GONB) is better at decreasing monthly migraine days (MMD) in chronic migraine (CM) than topiramate monotherapy at month 3 and is equally well tolerated.

Major finding: At month 3, greater reductions in MMD were observed in patients receiving topiramate and GONB with lidocaine+methylprednisolone (−9.6 vs. −7.3 days; P = .003) and topiramate and GONB with only lidocaine (−10.1 vs. −7.3 days; P < .001) compared with patients receiving topiramate monotherapy. Tolerability between the groups was comparable.

Study details: Findings are from a parallel group, three-arm study including 125 adult patients with CM who were randomly assigned to receive topiramate alone (n = 41), topiramate and GONB with lidocaine+methylprednisolone in month 1 followed by monthly lidocaine injections (n = 44), or topiramate and GONB with monthly lidocaine injections (n = 40) for 3 months.

Disclosures: The study received no financial support. The authors declared no conflicts of interest.

Source: Chowdhury D et al. Efficacy and tolerability of combination treatment of topiramate and greater occipital nerve block versus topiramate monotherapy for the preventive treatment of chronic migraine: A randomized controlled trial. Cephalalgia. 2022 (Mar 8). Doi: 10.1177/03331024221082077

Key clinical point: External trigeminal nerve stimulation (e-TNS) for 2 consecutive hours is an effective, safe, nonpharmacological, and noninvasive acute treatment option for a migraine attack with or without aura.

Major finding: A significantly higher percentage of patients experienced pain freedom (25.5% vs. 18.3%; P < .05) and showed resolution of the most bothersome migraine symptoms (56.4% vs. 42.3%; P < .01) with e-TNS vs. sham treatment, effectuating a therapeutic gain of 7.2% and 14.1%, respectively.

Study details: The intention-to-treat population in this multicenter, prospective, phase 3 study, TEAM, consisted of 538 adult patients with episodic migraine with or without aura who were randomly assigned to receive active (n = 259) or sham (n = 279) stimulation for 2 hours.

Disclosures: The study was sponsored by Cefaly Technology, Belgium. Some authors reported receiving consulting fees, advisory board honoraria, or research grants from various sources. MAL Johnson is the Global Director of Medical Affairs for Cefaly.

Source: Kuruvilla DE et al. Phase 3 randomized, double-blind, sham-controlled Trial of e-TNS for the Acute treatment of Migraine (TEAM). Sci Rep. 2022;12:5110 (Mar 24). Doi: 10.1038/s41598-022-09071-6

Key clinical point: External trigeminal nerve stimulation (e-TNS) for 2 consecutive hours is an effective, safe, nonpharmacological, and noninvasive acute treatment option for a migraine attack with or without aura.

Major finding: A significantly higher percentage of patients experienced pain freedom (25.5% vs. 18.3%; P < .05) and showed resolution of the most bothersome migraine symptoms (56.4% vs. 42.3%; P < .01) with e-TNS vs. sham treatment, effectuating a therapeutic gain of 7.2% and 14.1%, respectively.

Study details: The intention-to-treat population in this multicenter, prospective, phase 3 study, TEAM, consisted of 538 adult patients with episodic migraine with or without aura who were randomly assigned to receive active (n = 259) or sham (n = 279) stimulation for 2 hours.

Disclosures: The study was sponsored by Cefaly Technology, Belgium. Some authors reported receiving consulting fees, advisory board honoraria, or research grants from various sources. MAL Johnson is the Global Director of Medical Affairs for Cefaly.

Source: Kuruvilla DE et al. Phase 3 randomized, double-blind, sham-controlled Trial of e-TNS for the Acute treatment of Migraine (TEAM). Sci Rep. 2022;12:5110 (Mar 24). Doi: 10.1038/s41598-022-09071-6

Key clinical point: External trigeminal nerve stimulation (e-TNS) for 2 consecutive hours is an effective, safe, nonpharmacological, and noninvasive acute treatment option for a migraine attack with or without aura.

Major finding: A significantly higher percentage of patients experienced pain freedom (25.5% vs. 18.3%; P < .05) and showed resolution of the most bothersome migraine symptoms (56.4% vs. 42.3%; P < .01) with e-TNS vs. sham treatment, effectuating a therapeutic gain of 7.2% and 14.1%, respectively.

Study details: The intention-to-treat population in this multicenter, prospective, phase 3 study, TEAM, consisted of 538 adult patients with episodic migraine with or without aura who were randomly assigned to receive active (n = 259) or sham (n = 279) stimulation for 2 hours.

Disclosures: The study was sponsored by Cefaly Technology, Belgium. Some authors reported receiving consulting fees, advisory board honoraria, or research grants from various sources. MAL Johnson is the Global Director of Medical Affairs for Cefaly.

Source: Kuruvilla DE et al. Phase 3 randomized, double-blind, sham-controlled Trial of e-TNS for the Acute treatment of Migraine (TEAM). Sci Rep. 2022;12:5110 (Mar 24). Doi: 10.1038/s41598-022-09071-6

Key clinical point: Fremanezumab lowers the pain and neurological symptom days in patients with episodic migraine (EM) or chronic migraine (CM) with associated neurological dysfunction and inadequate response to 2-4 prior classes of prophylactic medications.

Major finding: Quarterly and monthly fremanezumab vs. placebo significantly reduced monthly mean days with neurological symptoms (least square mean difference −1.7 days and −1.8 days vs. −0.5 days; both P ≤ .01) and monthly migraine days (P < .0001) over 12 weeks.

Study details: This post hoc analysis included 837 patients with difficult-to-treat EM or CM from the phase 3b FOCUS study who received quarterly fremanezumab, monthly fremanezumab, or placebo over 12 weeks and were categorized into patients with (n = 493) and without (n = 344) associated neurological dysfunction.

Disclosures: This study was funded by Teva Branded Pharmaceutical Products R&D, Inc., USA. Some authors declared serving as consultants, speakers, or principal clinical trial investigators for or receiving personal fees from various sources, including Teva, and other authors are employees or stockholders of Teva.

Source: Lampl C et al. Efficacy and quality-of-life improvements with fremanezumab treatment in patients with difficult-to-treat migraine with associated neurological dysfunction. Eur J Neurol. 2022 (Mar 18). Doi: 10.1111/ene.15328

Key clinical point: Fremanezumab lowers the pain and neurological symptom days in patients with episodic migraine (EM) or chronic migraine (CM) with associated neurological dysfunction and inadequate response to 2-4 prior classes of prophylactic medications.

Major finding: Quarterly and monthly fremanezumab vs. placebo significantly reduced monthly mean days with neurological symptoms (least square mean difference −1.7 days and −1.8 days vs. −0.5 days; both P ≤ .01) and monthly migraine days (P < .0001) over 12 weeks.

Study details: This post hoc analysis included 837 patients with difficult-to-treat EM or CM from the phase 3b FOCUS study who received quarterly fremanezumab, monthly fremanezumab, or placebo over 12 weeks and were categorized into patients with (n = 493) and without (n = 344) associated neurological dysfunction.

Disclosures: This study was funded by Teva Branded Pharmaceutical Products R&D, Inc., USA. Some authors declared serving as consultants, speakers, or principal clinical trial investigators for or receiving personal fees from various sources, including Teva, and other authors are employees or stockholders of Teva.

Source: Lampl C et al. Efficacy and quality-of-life improvements with fremanezumab treatment in patients with difficult-to-treat migraine with associated neurological dysfunction. Eur J Neurol. 2022 (Mar 18). Doi: 10.1111/ene.15328

Key clinical point: Fremanezumab lowers the pain and neurological symptom days in patients with episodic migraine (EM) or chronic migraine (CM) with associated neurological dysfunction and inadequate response to 2-4 prior classes of prophylactic medications.

Major finding: Quarterly and monthly fremanezumab vs. placebo significantly reduced monthly mean days with neurological symptoms (least square mean difference −1.7 days and −1.8 days vs. −0.5 days; both P ≤ .01) and monthly migraine days (P < .0001) over 12 weeks.

Study details: This post hoc analysis included 837 patients with difficult-to-treat EM or CM from the phase 3b FOCUS study who received quarterly fremanezumab, monthly fremanezumab, or placebo over 12 weeks and were categorized into patients with (n = 493) and without (n = 344) associated neurological dysfunction.

Disclosures: This study was funded by Teva Branded Pharmaceutical Products R&D, Inc., USA. Some authors declared serving as consultants, speakers, or principal clinical trial investigators for or receiving personal fees from various sources, including Teva, and other authors are employees or stockholders of Teva.

Source: Lampl C et al. Efficacy and quality-of-life improvements with fremanezumab treatment in patients with difficult-to-treat migraine with associated neurological dysfunction. Eur J Neurol. 2022 (Mar 18). Doi: 10.1111/ene.15328

Key clinical point: Consistent with the overall study population results, eptinezumab therapy demonstrated favorable efficacy and safety in patients with episodic migraine (EM) or chronic migraine (CM) and self-reported aura from the PROMISE studies.

Major finding: Over weeks 1-12, monthly migraine days decreased with 100 mg and 300 mg eptinezumab vs. placebo in patients with EM (100 mg, −3.9 days; 300 mg, −4.2 days vs. −3.3 days) and CM (100 mg, −7.1 days; 300 mg, −7.6 days vs. −5.9 days) with aura. Treatment-emergent adverse event rates were similar across treatment groups.

Study details: Of 1741 patients with EM/CM from the PROMISE-1 and PROMISE-2 trials, this post hoc analysis included 877 patients who self-reported migraine with aura at screening and received eptinezumab (n = 583) or placebo (n = 294).

Disclosures: Lundbeck Seattle BioPharmaceuticals, Inc., USA, funded the study. Some authors declared serving as consultants, speakers, advisors, or as a primary trial investigator for and receiving personal fees and research support from various sources, including Lundbeck. Some authors are current or former employees of Lundbeck or its subsidiary company.

Source: Ashina M et al. Efficacy and safety of eptinezumab in patients with migraine and self-reported aura: Post hoc analysis of PROMISE-1 and PROMISE-2. Cephalalgia. 2022 (Mar 18). Doi: 10.1177/03331024221077646

Key clinical point: Consistent with the overall study population results, eptinezumab therapy demonstrated favorable efficacy and safety in patients with episodic migraine (EM) or chronic migraine (CM) and self-reported aura from the PROMISE studies.

Major finding: Over weeks 1-12, monthly migraine days decreased with 100 mg and 300 mg eptinezumab vs. placebo in patients with EM (100 mg, −3.9 days; 300 mg, −4.2 days vs. −3.3 days) and CM (100 mg, −7.1 days; 300 mg, −7.6 days vs. −5.9 days) with aura. Treatment-emergent adverse event rates were similar across treatment groups.

Study details: Of 1741 patients with EM/CM from the PROMISE-1 and PROMISE-2 trials, this post hoc analysis included 877 patients who self-reported migraine with aura at screening and received eptinezumab (n = 583) or placebo (n = 294).

Disclosures: Lundbeck Seattle BioPharmaceuticals, Inc., USA, funded the study. Some authors declared serving as consultants, speakers, advisors, or as a primary trial investigator for and receiving personal fees and research support from various sources, including Lundbeck. Some authors are current or former employees of Lundbeck or its subsidiary company.

Source: Ashina M et al. Efficacy and safety of eptinezumab in patients with migraine and self-reported aura: Post hoc analysis of PROMISE-1 and PROMISE-2. Cephalalgia. 2022 (Mar 18). Doi: 10.1177/03331024221077646

Key clinical point: Consistent with the overall study population results, eptinezumab therapy demonstrated favorable efficacy and safety in patients with episodic migraine (EM) or chronic migraine (CM) and self-reported aura from the PROMISE studies.

Major finding: Over weeks 1-12, monthly migraine days decreased with 100 mg and 300 mg eptinezumab vs. placebo in patients with EM (100 mg, −3.9 days; 300 mg, −4.2 days vs. −3.3 days) and CM (100 mg, −7.1 days; 300 mg, −7.6 days vs. −5.9 days) with aura. Treatment-emergent adverse event rates were similar across treatment groups.

Study details: Of 1741 patients with EM/CM from the PROMISE-1 and PROMISE-2 trials, this post hoc analysis included 877 patients who self-reported migraine with aura at screening and received eptinezumab (n = 583) or placebo (n = 294).

Disclosures: Lundbeck Seattle BioPharmaceuticals, Inc., USA, funded the study. Some authors declared serving as consultants, speakers, advisors, or as a primary trial investigator for and receiving personal fees and research support from various sources, including Lundbeck. Some authors are current or former employees of Lundbeck or its subsidiary company.

Source: Ashina M et al. Efficacy and safety of eptinezumab in patients with migraine and self-reported aura: Post hoc analysis of PROMISE-1 and PROMISE-2. Cephalalgia. 2022 (Mar 18). Doi: 10.1177/03331024221077646

Key clinical point: Galcanezumab is an effective and safe long-term treatment option for chronic migraine.

Major finding: At month 12, patients in the placebo, 120 mg galcanezumab, and 240 mg galcanezumab groups showed a mean change of −8.5, −9.0, and −8.0 days in monthly migraine days from the beginning of the double-blind period, respectively (all within-group P < .001). No new safety concerns emerged with extended treatment.

Study details: Findings are from the 9-month open-label extension of the REGAIN trial including 1022 patients with chronic migraine who completed the preceding 3-month double-blind treatment (501, 259, and 262 patients assigned to the placebo, 120 mg galcanezumab, and 240 mg galcanezumab groups, respectively) and received a 240-mg galcanezumab loading dose, followed by 120 mg in the next month and flexible dosing thereafter.

Disclosures: This study was sponsored by Eli Lilly and Company. Some authors declared receiving speaker, consultant, or advisory board member honoraria from various sources, including Eli Lilly. Two authors reported being full-time employees and minor stockholders of Eli Lilly.

Source: Pozo-Rosich P et al. Long-term treatment with galcanezumab in patients with chronic migraine: results from the open-label extension of the REGAIN study. Curr Med Res Opin. 2022 (Apr 8). Doi:   10.1080/03007995.2022.2059975

Key clinical point: Galcanezumab is an effective and safe long-term treatment option for chronic migraine.

Major finding: At month 12, patients in the placebo, 120 mg galcanezumab, and 240 mg galcanezumab groups showed a mean change of −8.5, −9.0, and −8.0 days in monthly migraine days from the beginning of the double-blind period, respectively (all within-group P < .001). No new safety concerns emerged with extended treatment.

Study details: Findings are from the 9-month open-label extension of the REGAIN trial including 1022 patients with chronic migraine who completed the preceding 3-month double-blind treatment (501, 259, and 262 patients assigned to the placebo, 120 mg galcanezumab, and 240 mg galcanezumab groups, respectively) and received a 240-mg galcanezumab loading dose, followed by 120 mg in the next month and flexible dosing thereafter.

Disclosures: This study was sponsored by Eli Lilly and Company. Some authors declared receiving speaker, consultant, or advisory board member honoraria from various sources, including Eli Lilly. Two authors reported being full-time employees and minor stockholders of Eli Lilly.

Source: Pozo-Rosich P et al. Long-term treatment with galcanezumab in patients with chronic migraine: results from the open-label extension of the REGAIN study. Curr Med Res Opin. 2022 (Apr 8). Doi:   10.1080/03007995.2022.2059975

Key clinical point: Galcanezumab is an effective and safe long-term treatment option for chronic migraine.

Major finding: At month 12, patients in the placebo, 120 mg galcanezumab, and 240 mg galcanezumab groups showed a mean change of −8.5, −9.0, and −8.0 days in monthly migraine days from the beginning of the double-blind period, respectively (all within-group P < .001). No new safety concerns emerged with extended treatment.

Study details: Findings are from the 9-month open-label extension of the REGAIN trial including 1022 patients with chronic migraine who completed the preceding 3-month double-blind treatment (501, 259, and 262 patients assigned to the placebo, 120 mg galcanezumab, and 240 mg galcanezumab groups, respectively) and received a 240-mg galcanezumab loading dose, followed by 120 mg in the next month and flexible dosing thereafter.

Disclosures: This study was sponsored by Eli Lilly and Company. Some authors declared receiving speaker, consultant, or advisory board member honoraria from various sources, including Eli Lilly. Two authors reported being full-time employees and minor stockholders of Eli Lilly.

Source: Pozo-Rosich P et al. Long-term treatment with galcanezumab in patients with chronic migraine: results from the open-label extension of the REGAIN study. Curr Med Res Opin. 2022 (Apr 8). Doi:   10.1080/03007995.2022.2059975