Article

Key clinical point: Amlitelimab is well-tolerated and improves disease signs and symptoms in patients with moderate-to-severe atopic dermatitis (AD) that is inadequately controlled by topical therapies.

Major finding: At week 16, the least-squares mean percentage change in Eczema Area and Severity Index score was significantly higher in low-dose (−80.12%; P = .009) and high-dose (−69.97%; P = .072) amlitelimab groups vs the placebo group (−49.37%). Overall, 62%, 47%, and 69% of patients reported ≥1 treatment-emergent adverse events with low- and high-dose amlitelimab and placebo groups, respectively.

Study details: This phase 2a study included 88 adult patients with moderate-to-severe AD and inadequate response to or inadvisability of topical treatments who were randomly assigned to receive low-dose (200 mg) or high-dose (500 mg) amlitelimab or placebo, followed by maintenance doses every 4 weeks.

Disclosures: This study was funded by Kymab Ltd., a Sanofi company. Some authors declared receiving research grants or consultancy fees or other ties with various sources, including Kymab and Sanofi. Six authors declared being employees or stockholders of Kymab or Sanofi.

Source: Weidinger S et al. Safety and efficacy of amlitelimab, a fully human, non-depleting, non-cytotoxic anti-OX40Ligand monoclonal antibody, in atopic dermatitis: Results of a phase IIa randomised placebo-controlled trial. Br J Dermatol. 2023 (Jul 18). doi: 10.1093/bjd/ljad240

Key clinical point: Amlitelimab is well-tolerated and improves disease signs and symptoms in patients with moderate-to-severe atopic dermatitis (AD) that is inadequately controlled by topical therapies.

Major finding: At week 16, the least-squares mean percentage change in Eczema Area and Severity Index score was significantly higher in low-dose (−80.12%; P = .009) and high-dose (−69.97%; P = .072) amlitelimab groups vs the placebo group (−49.37%). Overall, 62%, 47%, and 69% of patients reported ≥1 treatment-emergent adverse events with low- and high-dose amlitelimab and placebo groups, respectively.

Study details: This phase 2a study included 88 adult patients with moderate-to-severe AD and inadequate response to or inadvisability of topical treatments who were randomly assigned to receive low-dose (200 mg) or high-dose (500 mg) amlitelimab or placebo, followed by maintenance doses every 4 weeks.

Disclosures: This study was funded by Kymab Ltd., a Sanofi company. Some authors declared receiving research grants or consultancy fees or other ties with various sources, including Kymab and Sanofi. Six authors declared being employees or stockholders of Kymab or Sanofi.

Source: Weidinger S et al. Safety and efficacy of amlitelimab, a fully human, non-depleting, non-cytotoxic anti-OX40Ligand monoclonal antibody, in atopic dermatitis: Results of a phase IIa randomised placebo-controlled trial. Br J Dermatol. 2023 (Jul 18). doi: 10.1093/bjd/ljad240

Key clinical point: Amlitelimab is well-tolerated and improves disease signs and symptoms in patients with moderate-to-severe atopic dermatitis (AD) that is inadequately controlled by topical therapies.

Major finding: At week 16, the least-squares mean percentage change in Eczema Area and Severity Index score was significantly higher in low-dose (−80.12%; P = .009) and high-dose (−69.97%; P = .072) amlitelimab groups vs the placebo group (−49.37%). Overall, 62%, 47%, and 69% of patients reported ≥1 treatment-emergent adverse events with low- and high-dose amlitelimab and placebo groups, respectively.

Study details: This phase 2a study included 88 adult patients with moderate-to-severe AD and inadequate response to or inadvisability of topical treatments who were randomly assigned to receive low-dose (200 mg) or high-dose (500 mg) amlitelimab or placebo, followed by maintenance doses every 4 weeks.

Disclosures: This study was funded by Kymab Ltd., a Sanofi company. Some authors declared receiving research grants or consultancy fees or other ties with various sources, including Kymab and Sanofi. Six authors declared being employees or stockholders of Kymab or Sanofi.

Source: Weidinger S et al. Safety and efficacy of amlitelimab, a fully human, non-depleting, non-cytotoxic anti-OX40Ligand monoclonal antibody, in atopic dermatitis: Results of a phase IIa randomised placebo-controlled trial. Br J Dermatol. 2023 (Jul 18). doi: 10.1093/bjd/ljad240

Key clinical point: Nemolizumab is safe and effectively reduces pruritus in pediatric patients with atopic dermatitis (AD) whose pruritus has not been sufficiently improved with topical corticosteroids/calcineurin inhibitors or antihistamines.

Major finding: At week 16, the nemolizumab vs placebo group had a significantly greater improvement in the weekly mean 5-level itch score (−1.3 vs −0.5; P < .0001), with a significantly higher proportion of patients achieving a weekly mean 5-level itch score ≤ 1 (24.4% vs 2.3%; P = .0035). Most adverse events were mild in severity and none led to treatment discontinuation or death.

Study details: Findings are a from multicenter phase 3 study including patients age 6-12 years with AD and inadequately controlled moderate-to-severe pruritus who were randomly assigned to receive nemolizumab (n = 45) or placebo (n = 44) with concomitant topical agents.

Disclosures: This study was sponsored by Maruho Co. Ltd., Osaka, Japan. Two authors declared receiving grants and honoraria from various sources, including Maruho, and other two authors declared being employees of Maruho.

Source: Igarashi A et al. Efficacy and safety of nemolizumab in paediatric patients aged 6-12 years with atopic dermatitis with moderate-to-severe pruritus: Results from a phase III, randomised, double-blind, placebo-controlled, multicentre study. Br J Dermatol. 2023 (Jul 31). doi: 10.1093/bjd/ljad268

Key clinical point: Nemolizumab is safe and effectively reduces pruritus in pediatric patients with atopic dermatitis (AD) whose pruritus has not been sufficiently improved with topical corticosteroids/calcineurin inhibitors or antihistamines.

Major finding: At week 16, the nemolizumab vs placebo group had a significantly greater improvement in the weekly mean 5-level itch score (−1.3 vs −0.5; P < .0001), with a significantly higher proportion of patients achieving a weekly mean 5-level itch score ≤ 1 (24.4% vs 2.3%; P = .0035). Most adverse events were mild in severity and none led to treatment discontinuation or death.

Study details: Findings are a from multicenter phase 3 study including patients age 6-12 years with AD and inadequately controlled moderate-to-severe pruritus who were randomly assigned to receive nemolizumab (n = 45) or placebo (n = 44) with concomitant topical agents.

Disclosures: This study was sponsored by Maruho Co. Ltd., Osaka, Japan. Two authors declared receiving grants and honoraria from various sources, including Maruho, and other two authors declared being employees of Maruho.

Source: Igarashi A et al. Efficacy and safety of nemolizumab in paediatric patients aged 6-12 years with atopic dermatitis with moderate-to-severe pruritus: Results from a phase III, randomised, double-blind, placebo-controlled, multicentre study. Br J Dermatol. 2023 (Jul 31). doi: 10.1093/bjd/ljad268

Key clinical point: Nemolizumab is safe and effectively reduces pruritus in pediatric patients with atopic dermatitis (AD) whose pruritus has not been sufficiently improved with topical corticosteroids/calcineurin inhibitors or antihistamines.

Major finding: At week 16, the nemolizumab vs placebo group had a significantly greater improvement in the weekly mean 5-level itch score (−1.3 vs −0.5; P < .0001), with a significantly higher proportion of patients achieving a weekly mean 5-level itch score ≤ 1 (24.4% vs 2.3%; P = .0035). Most adverse events were mild in severity and none led to treatment discontinuation or death.

Study details: Findings are a from multicenter phase 3 study including patients age 6-12 years with AD and inadequately controlled moderate-to-severe pruritus who were randomly assigned to receive nemolizumab (n = 45) or placebo (n = 44) with concomitant topical agents.

Disclosures: This study was sponsored by Maruho Co. Ltd., Osaka, Japan. Two authors declared receiving grants and honoraria from various sources, including Maruho, and other two authors declared being employees of Maruho.

Source: Igarashi A et al. Efficacy and safety of nemolizumab in paediatric patients aged 6-12 years with atopic dermatitis with moderate-to-severe pruritus: Results from a phase III, randomised, double-blind, placebo-controlled, multicentre study. Br J Dermatol. 2023 (Jul 31). doi: 10.1093/bjd/ljad268

Nonradiographic axial spondyloarthritis (nr-axSpA) is a chronic, immune-mediated, inflammatory disease characterized by active inflammation of the spine and the sacroiliac joints. There is no cure for nr-axSpA, although tumor necrosis factor inhibitors (TNFi) have been established as the recommended standard treatment. Nevertheless, a considerable portion of patients either have an inadequate response to TNFi or are intolerant of the side effects of these agents. 

Dr Eric Ruderman, of Northwestern University Feinberg School of Medicine, Chicago, Illinois, discusses treatment goals for patients with active nr-axSpA, which include symptom control, preservation of function, and suppression of symptoms that interfere with daily activities. He also highlights treatment options for patients who have an inadequate response to or are intolerant of TNFi therapy. These therapies include interleukin-17 inhibitors (IL-17i), ixekizumab and secukinumab, and the Janus kinase inhibitor (JAKi) upadacitinib. 

IL-17i therapy carries a lower risk for infection compared with TNFi but is contraindicated in patients with irritable bowel disease. Dr Ruderman also notes that IL-17i are administered by subcutaneous injection while JAKi are taken orally, and these factors may influence patient preference.

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Eric M. Ruderman, MD, Professor, Department of Medicine, Division of Rheumatology, Northwestern University Feinberg School of Medicine; Associate Chief, Clinical Affairs, Department of Rheumatology, Northwestern Medical Group, Chicago, Illinois 

Eric M. Ruderman, MD, has disclosed the following relevant financial relationships: 

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; Amgen; Aurinia; Bristol Myers Squibb; Exagen; Janssen; Lilly; Novartis; Selecta 

Nonradiographic axial spondyloarthritis (nr-axSpA) is a chronic, immune-mediated, inflammatory disease characterized by active inflammation of the spine and the sacroiliac joints. There is no cure for nr-axSpA, although tumor necrosis factor inhibitors (TNFi) have been established as the recommended standard treatment. Nevertheless, a considerable portion of patients either have an inadequate response to TNFi or are intolerant of the side effects of these agents. 

Dr Eric Ruderman, of Northwestern University Feinberg School of Medicine, Chicago, Illinois, discusses treatment goals for patients with active nr-axSpA, which include symptom control, preservation of function, and suppression of symptoms that interfere with daily activities. He also highlights treatment options for patients who have an inadequate response to or are intolerant of TNFi therapy. These therapies include interleukin-17 inhibitors (IL-17i), ixekizumab and secukinumab, and the Janus kinase inhibitor (JAKi) upadacitinib. 

IL-17i therapy carries a lower risk for infection compared with TNFi but is contraindicated in patients with irritable bowel disease. Dr Ruderman also notes that IL-17i are administered by subcutaneous injection while JAKi are taken orally, and these factors may influence patient preference.

--

Eric M. Ruderman, MD, Professor, Department of Medicine, Division of Rheumatology, Northwestern University Feinberg School of Medicine; Associate Chief, Clinical Affairs, Department of Rheumatology, Northwestern Medical Group, Chicago, Illinois 

Eric M. Ruderman, MD, has disclosed the following relevant financial relationships: 

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; Amgen; Aurinia; Bristol Myers Squibb; Exagen; Janssen; Lilly; Novartis; Selecta 

Nonradiographic axial spondyloarthritis (nr-axSpA) is a chronic, immune-mediated, inflammatory disease characterized by active inflammation of the spine and the sacroiliac joints. There is no cure for nr-axSpA, although tumor necrosis factor inhibitors (TNFi) have been established as the recommended standard treatment. Nevertheless, a considerable portion of patients either have an inadequate response to TNFi or are intolerant of the side effects of these agents. 

Dr Eric Ruderman, of Northwestern University Feinberg School of Medicine, Chicago, Illinois, discusses treatment goals for patients with active nr-axSpA, which include symptom control, preservation of function, and suppression of symptoms that interfere with daily activities. He also highlights treatment options for patients who have an inadequate response to or are intolerant of TNFi therapy. These therapies include interleukin-17 inhibitors (IL-17i), ixekizumab and secukinumab, and the Janus kinase inhibitor (JAKi) upadacitinib. 

IL-17i therapy carries a lower risk for infection compared with TNFi but is contraindicated in patients with irritable bowel disease. Dr Ruderman also notes that IL-17i are administered by subcutaneous injection while JAKi are taken orally, and these factors may influence patient preference.

--

Eric M. Ruderman, MD, Professor, Department of Medicine, Division of Rheumatology, Northwestern University Feinberg School of Medicine; Associate Chief, Clinical Affairs, Department of Rheumatology, Northwestern Medical Group, Chicago, Illinois 

Eric M. Ruderman, MD, has disclosed the following relevant financial relationships: 

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; Amgen; Aurinia; Bristol Myers Squibb; Exagen; Janssen; Lilly; Novartis; Selecta 

Key clinical point: Severe obesity (body mass index [BMI] > 40 kg/m²) and postmenopausal status were associated with a significantly higher migraine frequency, with severe obesity also being associated with higher migraine severity.

Major finding: Migraine headache index scores (165.5 vs 105.5; P  =  .01) and the number of migraine headaches per month (P  =  .007) were significantly higher in patients with severe obesity vs those with healthy weight (BMI 18.5-24.9 kg/m²), with the number of migraine headaches per month being significantly higher among postmenopausal vs premenopausal women (mean 23 vs 19 days; P  =  .02).

Study details: Findings are from a retrospective cohort study including 223 patients with refractory migraine.

Disclosures: This study did not receive any specific funding. The authors declared no competing interests.

Source: Saffari TM et al. Severe obesity is associated with increased migraine severity and frequency: A retrospective cohort study. J Clin Neurosci. 2023;115:8-13 (Jul 14). doi: 10.1016/j.jocn.2023.07.007

Key clinical point: Severe obesity (body mass index [BMI] > 40 kg/m²) and postmenopausal status were associated with a significantly higher migraine frequency, with severe obesity also being associated with higher migraine severity.

Major finding: Migraine headache index scores (165.5 vs 105.5; P  =  .01) and the number of migraine headaches per month (P  =  .007) were significantly higher in patients with severe obesity vs those with healthy weight (BMI 18.5-24.9 kg/m²), with the number of migraine headaches per month being significantly higher among postmenopausal vs premenopausal women (mean 23 vs 19 days; P  =  .02).

Study details: Findings are from a retrospective cohort study including 223 patients with refractory migraine.

Disclosures: This study did not receive any specific funding. The authors declared no competing interests.

Source: Saffari TM et al. Severe obesity is associated with increased migraine severity and frequency: A retrospective cohort study. J Clin Neurosci. 2023;115:8-13 (Jul 14). doi: 10.1016/j.jocn.2023.07.007

Key clinical point: Severe obesity (body mass index [BMI] > 40 kg/m²) and postmenopausal status were associated with a significantly higher migraine frequency, with severe obesity also being associated with higher migraine severity.

Major finding: Migraine headache index scores (165.5 vs 105.5; P  =  .01) and the number of migraine headaches per month (P  =  .007) were significantly higher in patients with severe obesity vs those with healthy weight (BMI 18.5-24.9 kg/m²), with the number of migraine headaches per month being significantly higher among postmenopausal vs premenopausal women (mean 23 vs 19 days; P  =  .02).

Study details: Findings are from a retrospective cohort study including 223 patients with refractory migraine.

Disclosures: This study did not receive any specific funding. The authors declared no competing interests.

Source: Saffari TM et al. Severe obesity is associated with increased migraine severity and frequency: A retrospective cohort study. J Clin Neurosci. 2023;115:8-13 (Jul 14). doi: 10.1016/j.jocn.2023.07.007

Key clinical point: Higher dietary intake of zinc was negatively associated with the risk for migraine in adults, with the association being more prominent among those age 20-50 years.

Major finding: Compared with participants in the lowest quintile of dietary zinc consumption (≤ 5.93 mg/day), the risk for migraine was lower among those in the higher quintiles of dietary zinc consumption (5.94-8.38 mg/day: adjusted odds ratio [aOR] 0.73; P  =  .004; 8.39-11.26 mg/day: aOR 0.72; P  =  .02; and 11.27-15.75 mg/day: aOR 0.76; P  =  .04), with a non-linear association observed between zinc intake and migraine in the age 20-50 years group (P < .001).

Study details: This cross-sectional study included 9849 adult participants (age ≥ 20 years), of whom 1963 (19.93%) had migraine.

Disclosures: This study was supported by the National Natural Science Foundation of China, Natural Science Foundation of Jiangxi Province, and Jiangxi Provincial Department of Education Science and Technology Program Project. No potential conflicts of interest were declared.

Source: Zheng H et al. Dietary zinc intake in relation to migraine among adults: A cross sectional study of NHANES 1999-2004. Nutr Neurosci. 2023 (Aug 4). doi: 10.1080/1028415X.2023.2243678

Key clinical point: Higher dietary intake of zinc was negatively associated with the risk for migraine in adults, with the association being more prominent among those age 20-50 years.

Major finding: Compared with participants in the lowest quintile of dietary zinc consumption (≤ 5.93 mg/day), the risk for migraine was lower among those in the higher quintiles of dietary zinc consumption (5.94-8.38 mg/day: adjusted odds ratio [aOR] 0.73; P  =  .004; 8.39-11.26 mg/day: aOR 0.72; P  =  .02; and 11.27-15.75 mg/day: aOR 0.76; P  =  .04), with a non-linear association observed between zinc intake and migraine in the age 20-50 years group (P < .001).

Study details: This cross-sectional study included 9849 adult participants (age ≥ 20 years), of whom 1963 (19.93%) had migraine.

Disclosures: This study was supported by the National Natural Science Foundation of China, Natural Science Foundation of Jiangxi Province, and Jiangxi Provincial Department of Education Science and Technology Program Project. No potential conflicts of interest were declared.

Source: Zheng H et al. Dietary zinc intake in relation to migraine among adults: A cross sectional study of NHANES 1999-2004. Nutr Neurosci. 2023 (Aug 4). doi: 10.1080/1028415X.2023.2243678

Key clinical point: Higher dietary intake of zinc was negatively associated with the risk for migraine in adults, with the association being more prominent among those age 20-50 years.

Major finding: Compared with participants in the lowest quintile of dietary zinc consumption (≤ 5.93 mg/day), the risk for migraine was lower among those in the higher quintiles of dietary zinc consumption (5.94-8.38 mg/day: adjusted odds ratio [aOR] 0.73; P  =  .004; 8.39-11.26 mg/day: aOR 0.72; P  =  .02; and 11.27-15.75 mg/day: aOR 0.76; P  =  .04), with a non-linear association observed between zinc intake and migraine in the age 20-50 years group (P < .001).

Study details: This cross-sectional study included 9849 adult participants (age ≥ 20 years), of whom 1963 (19.93%) had migraine.

Disclosures: This study was supported by the National Natural Science Foundation of China, Natural Science Foundation of Jiangxi Province, and Jiangxi Provincial Department of Education Science and Technology Program Project. No potential conflicts of interest were declared.

Source: Zheng H et al. Dietary zinc intake in relation to migraine among adults: A cross sectional study of NHANES 1999-2004. Nutr Neurosci. 2023 (Aug 4). doi: 10.1080/1028415X.2023.2243678

Key clinical point: Patients with migraine are at a greater risk of experiencing rheumatoid arthritis (RA) attacks, with the risk being prominently higher among those having migraine without aura.

Major finding: The risk for RA was 1.94 times higher in patients with migraine vs control individuals (adjusted odds ratio [aOR] 1.94; 95% CI 1.74-2.17), with the risk being prominent in those with migraine without aura (aOR 1.49; 95% CI 1.35-1.64).

Study details: The data come from a meta-analysis of five studies including 321,877 participants.

Disclosures: This study did not disclose the funding source. The authors declared no competing interests.

Source: Tian D et al. Migraine and risk of rheumatoid arthritis: A systematic review and meta-analysis of observational studies. Heliyon. 2023;9(8):e18430 (Jul 18). doi: 10.1016/j.heliyon.2023.e18430

Key clinical point: Patients with migraine are at a greater risk of experiencing rheumatoid arthritis (RA) attacks, with the risk being prominently higher among those having migraine without aura.

Major finding: The risk for RA was 1.94 times higher in patients with migraine vs control individuals (adjusted odds ratio [aOR] 1.94; 95% CI 1.74-2.17), with the risk being prominent in those with migraine without aura (aOR 1.49; 95% CI 1.35-1.64).

Study details: The data come from a meta-analysis of five studies including 321,877 participants.

Disclosures: This study did not disclose the funding source. The authors declared no competing interests.

Source: Tian D et al. Migraine and risk of rheumatoid arthritis: A systematic review and meta-analysis of observational studies. Heliyon. 2023;9(8):e18430 (Jul 18). doi: 10.1016/j.heliyon.2023.e18430

Key clinical point: Patients with migraine are at a greater risk of experiencing rheumatoid arthritis (RA) attacks, with the risk being prominently higher among those having migraine without aura.

Major finding: The risk for RA was 1.94 times higher in patients with migraine vs control individuals (adjusted odds ratio [aOR] 1.94; 95% CI 1.74-2.17), with the risk being prominent in those with migraine without aura (aOR 1.49; 95% CI 1.35-1.64).

Study details: The data come from a meta-analysis of five studies including 321,877 participants.

Disclosures: This study did not disclose the funding source. The authors declared no competing interests.

Source: Tian D et al. Migraine and risk of rheumatoid arthritis: A systematic review and meta-analysis of observational studies. Heliyon. 2023;9(8):e18430 (Jul 18). doi: 10.1016/j.heliyon.2023.e18430

Key clinical point: Ubrogepant in combination with onabotulinumtoxinA led to meaningful pain relief and return to normal function at 2 and 4 hours post-dose in patients with self-identified migraine.

Major finding: Overall, 53.3% and 76.2% of patients achieved meaningful pain relief and 25.4% and 45.9% of patients achieved returned to normal function at 2 and 4 hours post-dose after the first treated attack, respectively.

Study details: The data come from a prospective real-world study including 122 patients with migraine (age ≥ 18 years) who received ubrogepant in combination with onabotulinumtoxinA.

Disclosures: This study was funded by Allergan (prior to its acquisition by AbbVie). Some authors declared receiving research support, royalties, or honoraria from, and serving as consultants and advisory board members for various sources, including AbbVie. Three authors declared being employees of or holding stocks in AbbVie.

Source: Manack Adams A et al. Real-world effectiveness, satisfaction, and optimization of ubrogepant for the acute treatment of migraine in combination with onabotulinumtoxinA: Results from the COURAGE Study. J Headache Pain. 2023;24:102 (Aug 3). doi: 10.1186/s10194-023-01622-0

Key clinical point: Ubrogepant in combination with onabotulinumtoxinA led to meaningful pain relief and return to normal function at 2 and 4 hours post-dose in patients with self-identified migraine.

Major finding: Overall, 53.3% and 76.2% of patients achieved meaningful pain relief and 25.4% and 45.9% of patients achieved returned to normal function at 2 and 4 hours post-dose after the first treated attack, respectively.

Study details: The data come from a prospective real-world study including 122 patients with migraine (age ≥ 18 years) who received ubrogepant in combination with onabotulinumtoxinA.

Disclosures: This study was funded by Allergan (prior to its acquisition by AbbVie). Some authors declared receiving research support, royalties, or honoraria from, and serving as consultants and advisory board members for various sources, including AbbVie. Three authors declared being employees of or holding stocks in AbbVie.

Source: Manack Adams A et al. Real-world effectiveness, satisfaction, and optimization of ubrogepant for the acute treatment of migraine in combination with onabotulinumtoxinA: Results from the COURAGE Study. J Headache Pain. 2023;24:102 (Aug 3). doi: 10.1186/s10194-023-01622-0

Key clinical point: Ubrogepant in combination with onabotulinumtoxinA led to meaningful pain relief and return to normal function at 2 and 4 hours post-dose in patients with self-identified migraine.

Major finding: Overall, 53.3% and 76.2% of patients achieved meaningful pain relief and 25.4% and 45.9% of patients achieved returned to normal function at 2 and 4 hours post-dose after the first treated attack, respectively.

Study details: The data come from a prospective real-world study including 122 patients with migraine (age ≥ 18 years) who received ubrogepant in combination with onabotulinumtoxinA.

Disclosures: This study was funded by Allergan (prior to its acquisition by AbbVie). Some authors declared receiving research support, royalties, or honoraria from, and serving as consultants and advisory board members for various sources, including AbbVie. Three authors declared being employees of or holding stocks in AbbVie.

Source: Manack Adams A et al. Real-world effectiveness, satisfaction, and optimization of ubrogepant for the acute treatment of migraine in combination with onabotulinumtoxinA: Results from the COURAGE Study. J Headache Pain. 2023;24:102 (Aug 3). doi: 10.1186/s10194-023-01622-0

Key clinical point: Addition of mindfulness-based intervention (MIND) comprising 6 weekly sessions and 7-10 minutes daily self-practice to treatment as usual (TaU) led to greater improvements in clinical outcomes compared with TaU alone in patients with chronic migraine (CM) and medication-overuse headache (MOH).

Major finding: TaU-plus-MIND outperformed TaU in the achievement of ≥ 50% reduction in headache frequency at 12 months (P < .0001), percentage reduction in headache days (P  =  .0001), and reduction in intake of total medication and non-steroidal anti-inflammatory drugs (P  =  .0001).

Study details: Finding are from MIND-CM, a phase 3 trial including 177 patients with CM and MOH who were randomly assigned to receive either TaU (including withdrawal from overused drugs, education on proper medication use and lifestyle issues, and tailored prophylaxis; n = 89) or MIND added to TaU (n = 88).

Disclosures: This study was funded by the Italian Ministry of Health. The authors declared no conflicts of interest.

Source: Grazzi L at al. Efficacy of mindfulness added to treatment as usual in patients with chronic migraine and medication overuse headache: A phase-III single-blind randomized-controlled trial (the MIND-CM study). J Headache Pain. 2023;24 (Jul 14). doi:  10.1186/s10194-023-01630-0

Key clinical point: Addition of mindfulness-based intervention (MIND) comprising 6 weekly sessions and 7-10 minutes daily self-practice to treatment as usual (TaU) led to greater improvements in clinical outcomes compared with TaU alone in patients with chronic migraine (CM) and medication-overuse headache (MOH).

Major finding: TaU-plus-MIND outperformed TaU in the achievement of ≥ 50% reduction in headache frequency at 12 months (P < .0001), percentage reduction in headache days (P  =  .0001), and reduction in intake of total medication and non-steroidal anti-inflammatory drugs (P  =  .0001).

Study details: Finding are from MIND-CM, a phase 3 trial including 177 patients with CM and MOH who were randomly assigned to receive either TaU (including withdrawal from overused drugs, education on proper medication use and lifestyle issues, and tailored prophylaxis; n = 89) or MIND added to TaU (n = 88).

Disclosures: This study was funded by the Italian Ministry of Health. The authors declared no conflicts of interest.

Source: Grazzi L at al. Efficacy of mindfulness added to treatment as usual in patients with chronic migraine and medication overuse headache: A phase-III single-blind randomized-controlled trial (the MIND-CM study). J Headache Pain. 2023;24 (Jul 14). doi:  10.1186/s10194-023-01630-0

Key clinical point: Addition of mindfulness-based intervention (MIND) comprising 6 weekly sessions and 7-10 minutes daily self-practice to treatment as usual (TaU) led to greater improvements in clinical outcomes compared with TaU alone in patients with chronic migraine (CM) and medication-overuse headache (MOH).

Major finding: TaU-plus-MIND outperformed TaU in the achievement of ≥ 50% reduction in headache frequency at 12 months (P < .0001), percentage reduction in headache days (P  =  .0001), and reduction in intake of total medication and non-steroidal anti-inflammatory drugs (P  =  .0001).

Study details: Finding are from MIND-CM, a phase 3 trial including 177 patients with CM and MOH who were randomly assigned to receive either TaU (including withdrawal from overused drugs, education on proper medication use and lifestyle issues, and tailored prophylaxis; n = 89) or MIND added to TaU (n = 88).

Disclosures: This study was funded by the Italian Ministry of Health. The authors declared no conflicts of interest.

Source: Grazzi L at al. Efficacy of mindfulness added to treatment as usual in patients with chronic migraine and medication overuse headache: A phase-III single-blind randomized-controlled trial (the MIND-CM study). J Headache Pain. 2023;24 (Jul 14). doi:  10.1186/s10194-023-01630-0

Key clinical point: Migraine increased the risk for ischemic cardio-cerebrovascular diseases (CCVD), but the risk was lower in those treated with triptans or ergotamine (TE).

Major finding: Compared with patients having non-migraine headaches (NMH), the risk for ischemic CCVD was higher in patients with migraine receiving TE (men: adjusted hazard ratio [aHR] 1.18; 95% CI 1.01-1.39; women: aHR 1.22; 95% CI 1.09-1.37) and in those receiving neither triptans nor ergotamine (NTNE; men: aHR 1.39; 95% CI 1.28-1.50; women: aHR 1.53; 95% CI 1.42-1.65). The risk for ischemic CCVD was lower in the TE vs NTNE group (men: aHR 0.86; 95% CI 0.73-0.999; women: aHR 0.80; 95% CI 0.72-0.88).

Study details: This study included 62,272 patients with migraine or NMH. Patients with migraine were categorized into those who received ≥ 1 prescriptions for TE (n = 4959) and those who received NTNE (n = 37,624).

Disclosures: This study received no specific funding. The authors declared no conflicts of interest.

Source: Kim Y et al. Association between migraine and ischemic cardio-cerebrovascular disease (CCVD) and effects of triptans and ergotamine on the risk of ischemic CCVD in patients with migraine in the Korean NHIS-HEALS cohort. Clin Drug Investig. 2023;43(7):541-550 (Jul 17). doi:  10.1007/s40261-023-01290-7

Key clinical point: Migraine increased the risk for ischemic cardio-cerebrovascular diseases (CCVD), but the risk was lower in those treated with triptans or ergotamine (TE).

Major finding: Compared with patients having non-migraine headaches (NMH), the risk for ischemic CCVD was higher in patients with migraine receiving TE (men: adjusted hazard ratio [aHR] 1.18; 95% CI 1.01-1.39; women: aHR 1.22; 95% CI 1.09-1.37) and in those receiving neither triptans nor ergotamine (NTNE; men: aHR 1.39; 95% CI 1.28-1.50; women: aHR 1.53; 95% CI 1.42-1.65). The risk for ischemic CCVD was lower in the TE vs NTNE group (men: aHR 0.86; 95% CI 0.73-0.999; women: aHR 0.80; 95% CI 0.72-0.88).

Study details: This study included 62,272 patients with migraine or NMH. Patients with migraine were categorized into those who received ≥ 1 prescriptions for TE (n = 4959) and those who received NTNE (n = 37,624).

Disclosures: This study received no specific funding. The authors declared no conflicts of interest.

Source: Kim Y et al. Association between migraine and ischemic cardio-cerebrovascular disease (CCVD) and effects of triptans and ergotamine on the risk of ischemic CCVD in patients with migraine in the Korean NHIS-HEALS cohort. Clin Drug Investig. 2023;43(7):541-550 (Jul 17). doi:  10.1007/s40261-023-01290-7

Key clinical point: Migraine increased the risk for ischemic cardio-cerebrovascular diseases (CCVD), but the risk was lower in those treated with triptans or ergotamine (TE).

Major finding: Compared with patients having non-migraine headaches (NMH), the risk for ischemic CCVD was higher in patients with migraine receiving TE (men: adjusted hazard ratio [aHR] 1.18; 95% CI 1.01-1.39; women: aHR 1.22; 95% CI 1.09-1.37) and in those receiving neither triptans nor ergotamine (NTNE; men: aHR 1.39; 95% CI 1.28-1.50; women: aHR 1.53; 95% CI 1.42-1.65). The risk for ischemic CCVD was lower in the TE vs NTNE group (men: aHR 0.86; 95% CI 0.73-0.999; women: aHR 0.80; 95% CI 0.72-0.88).

Study details: This study included 62,272 patients with migraine or NMH. Patients with migraine were categorized into those who received ≥ 1 prescriptions for TE (n = 4959) and those who received NTNE (n = 37,624).

Disclosures: This study received no specific funding. The authors declared no conflicts of interest.

Source: Kim Y et al. Association between migraine and ischemic cardio-cerebrovascular disease (CCVD) and effects of triptans and ergotamine on the risk of ischemic CCVD in patients with migraine in the Korean NHIS-HEALS cohort. Clin Drug Investig. 2023;43(7):541-550 (Jul 17). doi:  10.1007/s40261-023-01290-7

Key clinical point: Retreatment with monoclonal antibodies (mAb) targeting the calcitonin gene-related peptide (CGRP) or its receptor was highly effective with persistent benefits in patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) who completed the first treatment year followed by 1-3 months of discontinuation.

Major finding: In the second treatment year, monthly migraine days (MMD) were lower than pre-treatment baseline levels (P < .0001), with only 23.5% presenting with same or higher MMD at the baseline of the second vs first treatment year (P  =  .207). MMD at 90-112 days after treatment initiation were also lower in the second vs first treatment year (7.2 vs 8.8; P < .001).

Study details: Findings are from a prospective observational cohort study including 226 patients with HFEM and CM who received erenumab (n = 125) and either galcanezumab or fremanezumab (n = 101).

Disclosures: This study was funded by Fondazione Policlinico Campus Bio-Medico, Italy. Some authors declared receiving travel grants, personal fees, research support, or honoraria for participation in advisory boards, speaker panels, or clinical investigation studies from various sources.

Source: Vernieri F et al. Retreating migraine patients in the second year with monoclonal antibodies anti-CGRP pathway: The multicenter prospective cohort RE-DO study. J Neurol. 2023 (Jul 19). doi: 10.1007/s00415-023-11872-2

Key clinical point: Retreatment with monoclonal antibodies (mAb) targeting the calcitonin gene-related peptide (CGRP) or its receptor was highly effective with persistent benefits in patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) who completed the first treatment year followed by 1-3 months of discontinuation.

Major finding: In the second treatment year, monthly migraine days (MMD) were lower than pre-treatment baseline levels (P < .0001), with only 23.5% presenting with same or higher MMD at the baseline of the second vs first treatment year (P  =  .207). MMD at 90-112 days after treatment initiation were also lower in the second vs first treatment year (7.2 vs 8.8; P < .001).

Study details: Findings are from a prospective observational cohort study including 226 patients with HFEM and CM who received erenumab (n = 125) and either galcanezumab or fremanezumab (n = 101).

Disclosures: This study was funded by Fondazione Policlinico Campus Bio-Medico, Italy. Some authors declared receiving travel grants, personal fees, research support, or honoraria for participation in advisory boards, speaker panels, or clinical investigation studies from various sources.

Source: Vernieri F et al. Retreating migraine patients in the second year with monoclonal antibodies anti-CGRP pathway: The multicenter prospective cohort RE-DO study. J Neurol. 2023 (Jul 19). doi: 10.1007/s00415-023-11872-2

Key clinical point: Retreatment with monoclonal antibodies (mAb) targeting the calcitonin gene-related peptide (CGRP) or its receptor was highly effective with persistent benefits in patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) who completed the first treatment year followed by 1-3 months of discontinuation.

Major finding: In the second treatment year, monthly migraine days (MMD) were lower than pre-treatment baseline levels (P < .0001), with only 23.5% presenting with same or higher MMD at the baseline of the second vs first treatment year (P  =  .207). MMD at 90-112 days after treatment initiation were also lower in the second vs first treatment year (7.2 vs 8.8; P < .001).

Study details: Findings are from a prospective observational cohort study including 226 patients with HFEM and CM who received erenumab (n = 125) and either galcanezumab or fremanezumab (n = 101).

Disclosures: This study was funded by Fondazione Policlinico Campus Bio-Medico, Italy. Some authors declared receiving travel grants, personal fees, research support, or honoraria for participation in advisory boards, speaker panels, or clinical investigation studies from various sources.

Source: Vernieri F et al. Retreating migraine patients in the second year with monoclonal antibodies anti-CGRP pathway: The multicenter prospective cohort RE-DO study. J Neurol. 2023 (Jul 19). doi: 10.1007/s00415-023-11872-2