Key clinical point: Patients with migraine are at a higher risk of developing subsequent primary open angle glaucoma (POAG), with the risk being even higher among patients with chronic and severe migraine.

Major finding: Over 9 years of follow-up, the incidence rates of POAG were 3.249 and 2.408 per 1000 person-years in patients with and without migraine, respectively. Compared with individuals without migraine, patients with migraine and severe migraine had 1.19 (adjusted HR [aHR] 1.188; 95% CI 1.140-1.239) and 1.29 (aHR 1.285; 95% CI 1.166-1.415) times higher risk for POAG, respectively.

Study details: Findings are from a retrospective cohort study including 2,716,562 individuals aged ≥40 years, of which 87,809 had migraine.

Disclosures: The study was funded by Catholic Medical Center Research Foundation, New Hampshire. The authors declared no competing interests.

Source: Ohn K et al. Presence and severity of migraine is associated with development of primary open angle glaucoma: A population-based longitudinal cohort study. PLoS One. 2023;18(3):e0283495 (Mar 24). Doi: 10.1371/journal.pone.0283495

Key clinical point: Patients with migraine are at a higher risk of developing subsequent primary open angle glaucoma (POAG), with the risk being even higher among patients with chronic and severe migraine.

Major finding: Over 9 years of follow-up, the incidence rates of POAG were 3.249 and 2.408 per 1000 person-years in patients with and without migraine, respectively. Compared with individuals without migraine, patients with migraine and severe migraine had 1.19 (adjusted HR [aHR] 1.188; 95% CI 1.140-1.239) and 1.29 (aHR 1.285; 95% CI 1.166-1.415) times higher risk for POAG, respectively.

Study details: Findings are from a retrospective cohort study including 2,716,562 individuals aged ≥40 years, of which 87,809 had migraine.

Disclosures: The study was funded by Catholic Medical Center Research Foundation, New Hampshire. The authors declared no competing interests.

Source: Ohn K et al. Presence and severity of migraine is associated with development of primary open angle glaucoma: A population-based longitudinal cohort study. PLoS One. 2023;18(3):e0283495 (Mar 24). Doi: 10.1371/journal.pone.0283495

Key clinical point: Patients with migraine are at a higher risk of developing subsequent primary open angle glaucoma (POAG), with the risk being even higher among patients with chronic and severe migraine.

Major finding: Over 9 years of follow-up, the incidence rates of POAG were 3.249 and 2.408 per 1000 person-years in patients with and without migraine, respectively. Compared with individuals without migraine, patients with migraine and severe migraine had 1.19 (adjusted HR [aHR] 1.188; 95% CI 1.140-1.239) and 1.29 (aHR 1.285; 95% CI 1.166-1.415) times higher risk for POAG, respectively.

Study details: Findings are from a retrospective cohort study including 2,716,562 individuals aged ≥40 years, of which 87,809 had migraine.

Disclosures: The study was funded by Catholic Medical Center Research Foundation, New Hampshire. The authors declared no competing interests.

Source: Ohn K et al. Presence and severity of migraine is associated with development of primary open angle glaucoma: A population-based longitudinal cohort study. PLoS One. 2023;18(3):e0283495 (Mar 24). Doi: 10.1371/journal.pone.0283495

Key clinical point: Ultrasound-guided stellate ganglion blockade (SGB) is a safe and effective treatment option for patients with chronic migraine (CM); however, comorbid anxiety, or depression negatively predict SGB efficacy.

Major finding: The effective rates of ultrasound-guided SGB treatment were 90.7%, 82.5%, and 71.1% at 1-, 2-, and 3-month follow-ups, respectively, with the number of SGB being significantly greater in patients who did vs did not respond to SGB at the 3-month follow-up (P  =  .02) and comorbid anxiety or depression being a negative predictor of poor response to SGB (B −0.25; P  =  .01). Overall, the SGB-associated adverse event rate was 9.3%, with all adverse events being transient.

Study details: The data come from a retrospective, single-center study including 97 patients with CM who received ≥1 ultrasound-guided SGB treatment with a time interval of 1-7 days.

Disclosures: The study funded by The Capital’s Funds for Health Improvement and Research, China. The authors declared no conflicts of interest.

Source: Yu B et al. Effectiveness, safety, and predictors of response to ultrasound-guided stellate ganglion blockades for the treatment of patients with chronic migraine: A retrospective and observational study. Pain Pract. 2023 (Mar 16). Doi: 10.1111/papr.13224

Key clinical point: Ultrasound-guided stellate ganglion blockade (SGB) is a safe and effective treatment option for patients with chronic migraine (CM); however, comorbid anxiety, or depression negatively predict SGB efficacy.

Major finding: The effective rates of ultrasound-guided SGB treatment were 90.7%, 82.5%, and 71.1% at 1-, 2-, and 3-month follow-ups, respectively, with the number of SGB being significantly greater in patients who did vs did not respond to SGB at the 3-month follow-up (P  =  .02) and comorbid anxiety or depression being a negative predictor of poor response to SGB (B −0.25; P  =  .01). Overall, the SGB-associated adverse event rate was 9.3%, with all adverse events being transient.

Study details: The data come from a retrospective, single-center study including 97 patients with CM who received ≥1 ultrasound-guided SGB treatment with a time interval of 1-7 days.

Disclosures: The study funded by The Capital’s Funds for Health Improvement and Research, China. The authors declared no conflicts of interest.

Source: Yu B et al. Effectiveness, safety, and predictors of response to ultrasound-guided stellate ganglion blockades for the treatment of patients with chronic migraine: A retrospective and observational study. Pain Pract. 2023 (Mar 16). Doi: 10.1111/papr.13224

Key clinical point: Ultrasound-guided stellate ganglion blockade (SGB) is a safe and effective treatment option for patients with chronic migraine (CM); however, comorbid anxiety, or depression negatively predict SGB efficacy.

Major finding: The effective rates of ultrasound-guided SGB treatment were 90.7%, 82.5%, and 71.1% at 1-, 2-, and 3-month follow-ups, respectively, with the number of SGB being significantly greater in patients who did vs did not respond to SGB at the 3-month follow-up (P  =  .02) and comorbid anxiety or depression being a negative predictor of poor response to SGB (B −0.25; P  =  .01). Overall, the SGB-associated adverse event rate was 9.3%, with all adverse events being transient.

Study details: The data come from a retrospective, single-center study including 97 patients with CM who received ≥1 ultrasound-guided SGB treatment with a time interval of 1-7 days.

Disclosures: The study funded by The Capital’s Funds for Health Improvement and Research, China. The authors declared no conflicts of interest.

Source: Yu B et al. Effectiveness, safety, and predictors of response to ultrasound-guided stellate ganglion blockades for the treatment of patients with chronic migraine: A retrospective and observational study. Pain Pract. 2023 (Mar 16). Doi: 10.1111/papr.13224

Key clinical point: Anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb) are an effective treatment option for vestibular migraine (VM), with a large proportion of patients showing simultaneous reduction in migraine days, vertigo days, and Migraine Disability Assessment (MIDAS) score.

Major finding: At 12 months after CGRP mAb treatment, the mean monthly dizziness/vestibular symptom days (mean difference [MD] 9.5 days), headache frequency (MD 13.8 days), and MIDAS score (MD 36.1) were significantly reduced in the overall cohort (P < .001) and 78% of patients showed ≥50% reduction in all 3 parameters.

Study details: Findings are from a prospective observational cohort study including 50 patients with chronic migraine who met the criteria for VM and were treated with fremanezumab (n = 25), galcanezumab (n = 18), or erenumab (n = 7).

Disclosures: This study did not receive any funding. CV Russo, F Sacca, and R De Simone declared receiving personal compensation, public speaking honoraria, or consulting fees from various sources.

Source: Russo CV et al. Anti-calcitonin gene-related peptide monoclonal antibodies for the treatment of vestibular migraine: A prospective observational cohort study. Cephalalgia. 2023;43(4):3331024231161809 (Mar 22). Doi: 10.1177/03331024231161809

Key clinical point: Anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb) are an effective treatment option for vestibular migraine (VM), with a large proportion of patients showing simultaneous reduction in migraine days, vertigo days, and Migraine Disability Assessment (MIDAS) score.

Major finding: At 12 months after CGRP mAb treatment, the mean monthly dizziness/vestibular symptom days (mean difference [MD] 9.5 days), headache frequency (MD 13.8 days), and MIDAS score (MD 36.1) were significantly reduced in the overall cohort (P < .001) and 78% of patients showed ≥50% reduction in all 3 parameters.

Study details: Findings are from a prospective observational cohort study including 50 patients with chronic migraine who met the criteria for VM and were treated with fremanezumab (n = 25), galcanezumab (n = 18), or erenumab (n = 7).

Disclosures: This study did not receive any funding. CV Russo, F Sacca, and R De Simone declared receiving personal compensation, public speaking honoraria, or consulting fees from various sources.

Source: Russo CV et al. Anti-calcitonin gene-related peptide monoclonal antibodies for the treatment of vestibular migraine: A prospective observational cohort study. Cephalalgia. 2023;43(4):3331024231161809 (Mar 22). Doi: 10.1177/03331024231161809

Key clinical point: Anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb) are an effective treatment option for vestibular migraine (VM), with a large proportion of patients showing simultaneous reduction in migraine days, vertigo days, and Migraine Disability Assessment (MIDAS) score.

Major finding: At 12 months after CGRP mAb treatment, the mean monthly dizziness/vestibular symptom days (mean difference [MD] 9.5 days), headache frequency (MD 13.8 days), and MIDAS score (MD 36.1) were significantly reduced in the overall cohort (P < .001) and 78% of patients showed ≥50% reduction in all 3 parameters.

Study details: Findings are from a prospective observational cohort study including 50 patients with chronic migraine who met the criteria for VM and were treated with fremanezumab (n = 25), galcanezumab (n = 18), or erenumab (n = 7).

Disclosures: This study did not receive any funding. CV Russo, F Sacca, and R De Simone declared receiving personal compensation, public speaking honoraria, or consulting fees from various sources.

Source: Russo CV et al. Anti-calcitonin gene-related peptide monoclonal antibodies for the treatment of vestibular migraine: A prospective observational cohort study. Cephalalgia. 2023;43(4):3331024231161809 (Mar 22). Doi: 10.1177/03331024231161809

Key clinical point: Real-life study confirms the efficacy, safety, and high retention rate of secukinumab in patients with moderate-to-severe psoriatic arthritis (PsA), with male sex being an independent predictor of treatment response.

Major finding: The mean 28-Joint Disease Activity Score using C-reactive protein was significantly lower at week 52 vs  baseline (2.2 vs  5.8; P  =  .0001), suggesting remission, with men vs  women being more likely to achieve inactive disease or remission (odds ratio 5.16; 95% CI 1.35-26.63). The treatment retention rate at 1-year follow-up was 75%, with none of the patients discontinuing due to adverse events.

Study details: The data come from a retrospective study including 85 patients with moderate-to-severe PsA (n = 56) or ankylosing spondylitis (n = 29) treated with secukinumab and followed for 52 weeks.

Disclosures: This study did not receive any funding, except open access funding through Projekt DEAL, Germany. The authors declared no conflicts of interest.

Source: Molica Colella F et al. Effectiveness and safety of secukinumab in ankylosing spondylitis and psoriatic arthritis: A 52-week real-life study in an Italian cohort. Adv Rheumatol. 2023;63(1):15 (Mar 27). Doi: 10.1186/s42358-023-00295-2

Key clinical point: Real-life study confirms the efficacy, safety, and high retention rate of secukinumab in patients with moderate-to-severe psoriatic arthritis (PsA), with male sex being an independent predictor of treatment response.

Major finding: The mean 28-Joint Disease Activity Score using C-reactive protein was significantly lower at week 52 vs  baseline (2.2 vs  5.8; P  =  .0001), suggesting remission, with men vs  women being more likely to achieve inactive disease or remission (odds ratio 5.16; 95% CI 1.35-26.63). The treatment retention rate at 1-year follow-up was 75%, with none of the patients discontinuing due to adverse events.

Study details: The data come from a retrospective study including 85 patients with moderate-to-severe PsA (n = 56) or ankylosing spondylitis (n = 29) treated with secukinumab and followed for 52 weeks.

Disclosures: This study did not receive any funding, except open access funding through Projekt DEAL, Germany. The authors declared no conflicts of interest.

Source: Molica Colella F et al. Effectiveness and safety of secukinumab in ankylosing spondylitis and psoriatic arthritis: A 52-week real-life study in an Italian cohort. Adv Rheumatol. 2023;63(1):15 (Mar 27). Doi: 10.1186/s42358-023-00295-2

Key clinical point: Real-life study confirms the efficacy, safety, and high retention rate of secukinumab in patients with moderate-to-severe psoriatic arthritis (PsA), with male sex being an independent predictor of treatment response.

Major finding: The mean 28-Joint Disease Activity Score using C-reactive protein was significantly lower at week 52 vs  baseline (2.2 vs  5.8; P  =  .0001), suggesting remission, with men vs  women being more likely to achieve inactive disease or remission (odds ratio 5.16; 95% CI 1.35-26.63). The treatment retention rate at 1-year follow-up was 75%, with none of the patients discontinuing due to adverse events.

Study details: The data come from a retrospective study including 85 patients with moderate-to-severe PsA (n = 56) or ankylosing spondylitis (n = 29) treated with secukinumab and followed for 52 weeks.

Disclosures: This study did not receive any funding, except open access funding through Projekt DEAL, Germany. The authors declared no conflicts of interest.

Source: Molica Colella F et al. Effectiveness and safety of secukinumab in ankylosing spondylitis and psoriatic arthritis: A 52-week real-life study in an Italian cohort. Adv Rheumatol. 2023;63(1):15 (Mar 27). Doi: 10.1186/s42358-023-00295-2

Key clinical point: Anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb) led to consistent reduction in migraine days throughout the menstrual cycle (perimenstrual and non-perimenstrual days), thereby supporting their prophylactic use in women with menstrual migraine.

Major finding: No significant association was observed between menstrual window and CGRP mAb treatment effect (P =  .726), indicating similar reductions in migraine days during the menstrual window and the remainder of the menstrual cycle (odds ratio 0.44; 95% CI 0.38-0.51).

Study details: This post hoc analysis of a single-arm study included 174 patients with migraine treated with either erenumab or fremanezumab for 6 months, and evaluated the effects of anti-CGRP mAb on perimenstrual and non-perimenstrual migraine days in 45 of 174 women with available data on migraine days during ≥3 menstrual cycles.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Verhagen IE et al. Both perimenstrual and non-perimenstrual migraine days respond to anti-calcitonin gene-related peptide (receptor) antibodies. Eur J Neurol. 2023 (Mar 20). Doi: 10.1111/ene.15794

Key clinical point: Anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb) led to consistent reduction in migraine days throughout the menstrual cycle (perimenstrual and non-perimenstrual days), thereby supporting their prophylactic use in women with menstrual migraine.

Major finding: No significant association was observed between menstrual window and CGRP mAb treatment effect (P =  .726), indicating similar reductions in migraine days during the menstrual window and the remainder of the menstrual cycle (odds ratio 0.44; 95% CI 0.38-0.51).

Study details: This post hoc analysis of a single-arm study included 174 patients with migraine treated with either erenumab or fremanezumab for 6 months, and evaluated the effects of anti-CGRP mAb on perimenstrual and non-perimenstrual migraine days in 45 of 174 women with available data on migraine days during ≥3 menstrual cycles.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Verhagen IE et al. Both perimenstrual and non-perimenstrual migraine days respond to anti-calcitonin gene-related peptide (receptor) antibodies. Eur J Neurol. 2023 (Mar 20). Doi: 10.1111/ene.15794

Key clinical point: Anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb) led to consistent reduction in migraine days throughout the menstrual cycle (perimenstrual and non-perimenstrual days), thereby supporting their prophylactic use in women with menstrual migraine.

Major finding: No significant association was observed between menstrual window and CGRP mAb treatment effect (P =  .726), indicating similar reductions in migraine days during the menstrual window and the remainder of the menstrual cycle (odds ratio 0.44; 95% CI 0.38-0.51).

Study details: This post hoc analysis of a single-arm study included 174 patients with migraine treated with either erenumab or fremanezumab for 6 months, and evaluated the effects of anti-CGRP mAb on perimenstrual and non-perimenstrual migraine days in 45 of 174 women with available data on migraine days during ≥3 menstrual cycles.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Verhagen IE et al. Both perimenstrual and non-perimenstrual migraine days respond to anti-calcitonin gene-related peptide (receptor) antibodies. Eur J Neurol. 2023 (Mar 20). Doi: 10.1111/ene.15794

Key clinical point: The risk for hypertensive disorders of pregnancy (HDOP) was significantly higher in women who experienced migraine before 20 weeks of pregnancy, with the risk being most prominent among women with migraine during the first trimester and those who used migraine medications.

Major finding: The risk for HDOP was significantly higher in women with vs without pre-pregnancy migraine (adjusted risk ratio [aRR] 1.17; 95% CI 1.09-1.26), with the risk being the highest in those with migraine that persisted during the first trimester (aRR 1.84; 95% CI 1.35-2.50) and in those who received migraine-specific medication (aRR 1.50; 95% CI 1.15-1.97).

Study details: Findings are from a population-based prospective cohort study including 1,049,839 women without a history of cardiovascular diseases or hypertension who had liveborn or stillborn singleton deliveries, of which 127,295 women had pre-pregnancy migraine.

Disclosures: This study was supported by the National Institute of Child Health and Human Development, US National Institutes of Health. The authors declared no conflicts of interest.

Source: Crowe HM et al. Migraine and risk of hypertensive disorders of pregnancy: A population-based cohort study. Cephalalgia. 2023;43(4):3331024231161746 (Mar 19). Doi: 10.1177/03331024231161746

Key clinical point: The risk for hypertensive disorders of pregnancy (HDOP) was significantly higher in women who experienced migraine before 20 weeks of pregnancy, with the risk being most prominent among women with migraine during the first trimester and those who used migraine medications.

Major finding: The risk for HDOP was significantly higher in women with vs without pre-pregnancy migraine (adjusted risk ratio [aRR] 1.17; 95% CI 1.09-1.26), with the risk being the highest in those with migraine that persisted during the first trimester (aRR 1.84; 95% CI 1.35-2.50) and in those who received migraine-specific medication (aRR 1.50; 95% CI 1.15-1.97).

Study details: Findings are from a population-based prospective cohort study including 1,049,839 women without a history of cardiovascular diseases or hypertension who had liveborn or stillborn singleton deliveries, of which 127,295 women had pre-pregnancy migraine.

Disclosures: This study was supported by the National Institute of Child Health and Human Development, US National Institutes of Health. The authors declared no conflicts of interest.

Source: Crowe HM et al. Migraine and risk of hypertensive disorders of pregnancy: A population-based cohort study. Cephalalgia. 2023;43(4):3331024231161746 (Mar 19). Doi: 10.1177/03331024231161746

Key clinical point: The risk for hypertensive disorders of pregnancy (HDOP) was significantly higher in women who experienced migraine before 20 weeks of pregnancy, with the risk being most prominent among women with migraine during the first trimester and those who used migraine medications.

Major finding: The risk for HDOP was significantly higher in women with vs without pre-pregnancy migraine (adjusted risk ratio [aRR] 1.17; 95% CI 1.09-1.26), with the risk being the highest in those with migraine that persisted during the first trimester (aRR 1.84; 95% CI 1.35-2.50) and in those who received migraine-specific medication (aRR 1.50; 95% CI 1.15-1.97).

Study details: Findings are from a population-based prospective cohort study including 1,049,839 women without a history of cardiovascular diseases or hypertension who had liveborn or stillborn singleton deliveries, of which 127,295 women had pre-pregnancy migraine.

Disclosures: This study was supported by the National Institute of Child Health and Human Development, US National Institutes of Health. The authors declared no conflicts of interest.

Source: Crowe HM et al. Migraine and risk of hypertensive disorders of pregnancy: A population-based cohort study. Cephalalgia. 2023;43(4):3331024231161746 (Mar 19). Doi: 10.1177/03331024231161746

Key clinical point: Tofacitinib was more effective and as safe as placebo in men and women with psoriatic arthritis (PsA); however, men were more likely to achieve minimal disease activity (MDA) with tofacitinib due to differences in baseline disease activity.

Major finding: At 3 months, tofacitinib was more efficacious than placebo irrespective of sex (P < .001); however, MDA was achieved by a higher proportion of men vs  women receiving tofacitinib (P < .05), although the American College of Rheumatology 20/50/70 response was comparable. The incidence of treatment-emergent adverse events was similar in men and women receiving tofacitinib at doses of 5 mg (67.5% and 70.2%, respectively) or 10 mg (70.0% and 72.8%, respectively) twice daily.

Study details: This post hoc analysis of data pooled from phase 3 randomized controlled trials included 816 patients with PsA who received tofacitinib, adalimumab, or placebo.

Disclosures: This study was sponsored by Pfizer. Some authors declared being employees, holding shares, or having other ties with various sources, including Pfizer.

Source: Eder L et al. Sex differences in the efficacy, safety and persistence of patients with psoriatic arthritis treated with tofacitinib: A post-hoc analysis of phase 3 trials and long-term extension. RMD Open. 2023;9:e002718 (Mar 23). Doi: 10.1136/rmdopen-2022-002718

Key clinical point: Tofacitinib was more effective and as safe as placebo in men and women with psoriatic arthritis (PsA); however, men were more likely to achieve minimal disease activity (MDA) with tofacitinib due to differences in baseline disease activity.

Major finding: At 3 months, tofacitinib was more efficacious than placebo irrespective of sex (P < .001); however, MDA was achieved by a higher proportion of men vs  women receiving tofacitinib (P < .05), although the American College of Rheumatology 20/50/70 response was comparable. The incidence of treatment-emergent adverse events was similar in men and women receiving tofacitinib at doses of 5 mg (67.5% and 70.2%, respectively) or 10 mg (70.0% and 72.8%, respectively) twice daily.

Study details: This post hoc analysis of data pooled from phase 3 randomized controlled trials included 816 patients with PsA who received tofacitinib, adalimumab, or placebo.

Disclosures: This study was sponsored by Pfizer. Some authors declared being employees, holding shares, or having other ties with various sources, including Pfizer.

Source: Eder L et al. Sex differences in the efficacy, safety and persistence of patients with psoriatic arthritis treated with tofacitinib: A post-hoc analysis of phase 3 trials and long-term extension. RMD Open. 2023;9:e002718 (Mar 23). Doi: 10.1136/rmdopen-2022-002718

Key clinical point: Tofacitinib was more effective and as safe as placebo in men and women with psoriatic arthritis (PsA); however, men were more likely to achieve minimal disease activity (MDA) with tofacitinib due to differences in baseline disease activity.

Major finding: At 3 months, tofacitinib was more efficacious than placebo irrespective of sex (P < .001); however, MDA was achieved by a higher proportion of men vs  women receiving tofacitinib (P < .05), although the American College of Rheumatology 20/50/70 response was comparable. The incidence of treatment-emergent adverse events was similar in men and women receiving tofacitinib at doses of 5 mg (67.5% and 70.2%, respectively) or 10 mg (70.0% and 72.8%, respectively) twice daily.

Study details: This post hoc analysis of data pooled from phase 3 randomized controlled trials included 816 patients with PsA who received tofacitinib, adalimumab, or placebo.

Disclosures: This study was sponsored by Pfizer. Some authors declared being employees, holding shares, or having other ties with various sources, including Pfizer.

Source: Eder L et al. Sex differences in the efficacy, safety and persistence of patients with psoriatic arthritis treated with tofacitinib: A post-hoc analysis of phase 3 trials and long-term extension. RMD Open. 2023;9:e002718 (Mar 23). Doi: 10.1136/rmdopen-2022-002718

The U.S. Food and Drug Administration has granted breakthrough device designation to the Avantis spinal cord stimulation system (Reach Neuro), which has been shown in early testing to restore arm and hand movement in patients with post-stroke upper limb paresis.

“We are excited about the FDA’s recognition of our technology’s potential to change the lives of millions of people living with disability,” Marc Powell, PhD, CEO, and co-founder of Reach Neuro, said in a company news release.

“The breakthrough device designation is an incredible opportunity to work closely with FDA experts to expedite the clinical translation of the Avantis system,” Dr. Powell added.

Results of the first-in-human study of the system were published in Nature Medicine.

Investigators percutaneously implanted two linear leads in the dorsolateral epidural space targeting neural circuits that control arm and hand muscles in two chronic post-stroke patients.

In both patients, continuous stimulation of the targeted neural circuits led to significant and immediate improvement in arm and hand strength and dexterity. This enabled the patients to perform movements that they couldn’t perform without spinal cord stimulation.

The process also enabled fine motor skills, such as opening a lock and using utensils to eat independently – tasks that one patient had not been able to do for 9 years.

“Having the stimulation working and being able to move my arm/hand again after 9 years was one of the most surreal experiences of my life – it was as if my brain was in control of my arm again. This technology gave me such immense hope that one day I will regain a sense of independence again,” study participant Heather Rendulic said in the news release.

Surprisingly, some improvements were retained up to 1 month after the study, even without stimulation. No serious adverse events were reported.

Nearly three-quarters of patients with stroke experience lasting deficits in motor control of their arm and hand as a result of permanent damage to the brain’s ability to send signals to muscles.

The early results with the Avantis system provide “promising, albeit preliminary, evidence that spinal cord stimulation could be an assistive as well as a restorative approach for upper-limb recovery after stroke,” the study team said in Nature Medicine.

Reach Neuro was founded in 2021 as a spinout company of the University of Pittsburgh and Carnegie Mellon University, also in Pittsburgh, where the technology is currently being tested in a clinical trial funded by the National Institutes of Health.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has granted breakthrough device designation to the Avantis spinal cord stimulation system (Reach Neuro), which has been shown in early testing to restore arm and hand movement in patients with post-stroke upper limb paresis.

“We are excited about the FDA’s recognition of our technology’s potential to change the lives of millions of people living with disability,” Marc Powell, PhD, CEO, and co-founder of Reach Neuro, said in a company news release.

“The breakthrough device designation is an incredible opportunity to work closely with FDA experts to expedite the clinical translation of the Avantis system,” Dr. Powell added.

Results of the first-in-human study of the system were published in Nature Medicine.

Investigators percutaneously implanted two linear leads in the dorsolateral epidural space targeting neural circuits that control arm and hand muscles in two chronic post-stroke patients.

In both patients, continuous stimulation of the targeted neural circuits led to significant and immediate improvement in arm and hand strength and dexterity. This enabled the patients to perform movements that they couldn’t perform without spinal cord stimulation.

The process also enabled fine motor skills, such as opening a lock and using utensils to eat independently – tasks that one patient had not been able to do for 9 years.

“Having the stimulation working and being able to move my arm/hand again after 9 years was one of the most surreal experiences of my life – it was as if my brain was in control of my arm again. This technology gave me such immense hope that one day I will regain a sense of independence again,” study participant Heather Rendulic said in the news release.

Surprisingly, some improvements were retained up to 1 month after the study, even without stimulation. No serious adverse events were reported.

Nearly three-quarters of patients with stroke experience lasting deficits in motor control of their arm and hand as a result of permanent damage to the brain’s ability to send signals to muscles.

The early results with the Avantis system provide “promising, albeit preliminary, evidence that spinal cord stimulation could be an assistive as well as a restorative approach for upper-limb recovery after stroke,” the study team said in Nature Medicine.

Reach Neuro was founded in 2021 as a spinout company of the University of Pittsburgh and Carnegie Mellon University, also in Pittsburgh, where the technology is currently being tested in a clinical trial funded by the National Institutes of Health.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has granted breakthrough device designation to the Avantis spinal cord stimulation system (Reach Neuro), which has been shown in early testing to restore arm and hand movement in patients with post-stroke upper limb paresis.

“We are excited about the FDA’s recognition of our technology’s potential to change the lives of millions of people living with disability,” Marc Powell, PhD, CEO, and co-founder of Reach Neuro, said in a company news release.

“The breakthrough device designation is an incredible opportunity to work closely with FDA experts to expedite the clinical translation of the Avantis system,” Dr. Powell added.

Results of the first-in-human study of the system were published in Nature Medicine.

Investigators percutaneously implanted two linear leads in the dorsolateral epidural space targeting neural circuits that control arm and hand muscles in two chronic post-stroke patients.

In both patients, continuous stimulation of the targeted neural circuits led to significant and immediate improvement in arm and hand strength and dexterity. This enabled the patients to perform movements that they couldn’t perform without spinal cord stimulation.

The process also enabled fine motor skills, such as opening a lock and using utensils to eat independently – tasks that one patient had not been able to do for 9 years.

“Having the stimulation working and being able to move my arm/hand again after 9 years was one of the most surreal experiences of my life – it was as if my brain was in control of my arm again. This technology gave me such immense hope that one day I will regain a sense of independence again,” study participant Heather Rendulic said in the news release.

Surprisingly, some improvements were retained up to 1 month after the study, even without stimulation. No serious adverse events were reported.

Nearly three-quarters of patients with stroke experience lasting deficits in motor control of their arm and hand as a result of permanent damage to the brain’s ability to send signals to muscles.

The early results with the Avantis system provide “promising, albeit preliminary, evidence that spinal cord stimulation could be an assistive as well as a restorative approach for upper-limb recovery after stroke,” the study team said in Nature Medicine.

Reach Neuro was founded in 2021 as a spinout company of the University of Pittsburgh and Carnegie Mellon University, also in Pittsburgh, where the technology is currently being tested in a clinical trial funded by the National Institutes of Health.

A version of this article first appeared on Medscape.com.

Key clinical point: The efficacy of calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) galcanezumab “wore off” before the next injection but only in a small sub-population of patients with chronic migraine (CM).

Major finding: The efficacy of galcanezumab vs placebo wore off at a significantly higher rate in patients with CM (risk ratio [RR] 1.91; 95% CI 1.11-3.28); however, the wearing-off effects of galcanezumab and placebo were not significantly different in the overall cohort (RR 1.29; 95% CI 0.73-2.28).

Study details: The data come from a meta-analysis of four randomized controlled trials including 2409 patients with migraine.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Asawavichienjinda T et al. "Wearing-off" efficacy of CGRP monoclonal antibodies for migraine prevention: A meta-analysis of randomized controlled trials. Cephalalgia. 2023;43(4):3331024231161261 (Mar 16). Doi: 10.1177/03331024231161261

Key clinical point: The efficacy of calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) galcanezumab “wore off” before the next injection but only in a small sub-population of patients with chronic migraine (CM).

Major finding: The efficacy of galcanezumab vs placebo wore off at a significantly higher rate in patients with CM (risk ratio [RR] 1.91; 95% CI 1.11-3.28); however, the wearing-off effects of galcanezumab and placebo were not significantly different in the overall cohort (RR 1.29; 95% CI 0.73-2.28).

Study details: The data come from a meta-analysis of four randomized controlled trials including 2409 patients with migraine.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Asawavichienjinda T et al. "Wearing-off" efficacy of CGRP monoclonal antibodies for migraine prevention: A meta-analysis of randomized controlled trials. Cephalalgia. 2023;43(4):3331024231161261 (Mar 16). Doi: 10.1177/03331024231161261

Key clinical point: The efficacy of calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) galcanezumab “wore off” before the next injection but only in a small sub-population of patients with chronic migraine (CM).

Major finding: The efficacy of galcanezumab vs placebo wore off at a significantly higher rate in patients with CM (risk ratio [RR] 1.91; 95% CI 1.11-3.28); however, the wearing-off effects of galcanezumab and placebo were not significantly different in the overall cohort (RR 1.29; 95% CI 0.73-2.28).

Study details: The data come from a meta-analysis of four randomized controlled trials including 2409 patients with migraine.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Asawavichienjinda T et al. "Wearing-off" efficacy of CGRP monoclonal antibodies for migraine prevention: A meta-analysis of randomized controlled trials. Cephalalgia. 2023;43(4):3331024231161261 (Mar 16). Doi: 10.1177/03331024231161261

Key clinical point: COVID-19 vaccination was not associated with the worsening of disease activity in patients with psoriatic arthritis (PsA) who were treated with targeted therapies; however, COVID-19 vaccination may worsen disease activity in patients treated with interleukin-12/23 inhibitors (IL-12/23-i).

Major finding: The flare rate was not significantly different in the 6 months post-vaccination vs  the pre-vaccination period (P  =  .797), with no significant change in disease activity score in 28 joints before or after vaccination in the overall population. However, COVID-19 vaccination significantly worsened disease activity in patients treated with IL-12/23-i vs  tumor necrosis factor inhibitor (P  =  .019).

Study details: The data come from a prospective observational study including 1765 patients total with PsA (n = 587) or rheumatoid arthritis (n = 1178) treated with targeted therapies who were vaccinated for COVID-19 with any of the available vaccines.

Disclosures: This study was funded by Bristol-Myers Squibb, Galapagos Biopharma Spain SLU, and Roche Farma. Two authors reported ties with various sources, including Galapagos or Roche.

Source: Álvaro-Gracia JM et al. Effects of COVID-19 vaccination on disease activity in patients with rheumatoid arthritis and psoriatic arthritis on targeted therapy in the COVIDSER study. RMD Open. 2023;9(1):e002936 (Mar 16). Doi: 10.1136/rmdopen-2022-002936

Key clinical point: COVID-19 vaccination was not associated with the worsening of disease activity in patients with psoriatic arthritis (PsA) who were treated with targeted therapies; however, COVID-19 vaccination may worsen disease activity in patients treated with interleukin-12/23 inhibitors (IL-12/23-i).

Major finding: The flare rate was not significantly different in the 6 months post-vaccination vs  the pre-vaccination period (P  =  .797), with no significant change in disease activity score in 28 joints before or after vaccination in the overall population. However, COVID-19 vaccination significantly worsened disease activity in patients treated with IL-12/23-i vs  tumor necrosis factor inhibitor (P  =  .019).

Study details: The data come from a prospective observational study including 1765 patients total with PsA (n = 587) or rheumatoid arthritis (n = 1178) treated with targeted therapies who were vaccinated for COVID-19 with any of the available vaccines.

Disclosures: This study was funded by Bristol-Myers Squibb, Galapagos Biopharma Spain SLU, and Roche Farma. Two authors reported ties with various sources, including Galapagos or Roche.

Source: Álvaro-Gracia JM et al. Effects of COVID-19 vaccination on disease activity in patients with rheumatoid arthritis and psoriatic arthritis on targeted therapy in the COVIDSER study. RMD Open. 2023;9(1):e002936 (Mar 16). Doi: 10.1136/rmdopen-2022-002936

Key clinical point: COVID-19 vaccination was not associated with the worsening of disease activity in patients with psoriatic arthritis (PsA) who were treated with targeted therapies; however, COVID-19 vaccination may worsen disease activity in patients treated with interleukin-12/23 inhibitors (IL-12/23-i).

Major finding: The flare rate was not significantly different in the 6 months post-vaccination vs  the pre-vaccination period (P  =  .797), with no significant change in disease activity score in 28 joints before or after vaccination in the overall population. However, COVID-19 vaccination significantly worsened disease activity in patients treated with IL-12/23-i vs  tumor necrosis factor inhibitor (P  =  .019).

Study details: The data come from a prospective observational study including 1765 patients total with PsA (n = 587) or rheumatoid arthritis (n = 1178) treated with targeted therapies who were vaccinated for COVID-19 with any of the available vaccines.

Disclosures: This study was funded by Bristol-Myers Squibb, Galapagos Biopharma Spain SLU, and Roche Farma. Two authors reported ties with various sources, including Galapagos or Roche.

Source: Álvaro-Gracia JM et al. Effects of COVID-19 vaccination on disease activity in patients with rheumatoid arthritis and psoriatic arthritis on targeted therapy in the COVIDSER study. RMD Open. 2023;9(1):e002936 (Mar 16). Doi: 10.1136/rmdopen-2022-002936