PsA: Methotrexate+leflunomide more effective but less well tolerated than methotrexate monotherapy

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Key clinical point: Methotrexate+leflunomide therapy was superior to methotrexate monotherapy at improving disease activity in patients with psoriatic arthritis (PsA); however methotrexate+leflunomide therapy was less well tolerated than methotrexate monotherapy.

Major finding: At week 16, PsA disease activity score improved significantly in the methotrexate+leflunomide vs. methotrexate monotherapy group (3.1 vs. 3.7; P = .025). Incidence of mild adverse events, such as nausea/vomiting (44% vs. 28%) and altered bowel habits (26% vs. 8%), was higher with methotrexate+leflunomide vs. methotrexate+placebo.

Study details: Findings are from the phase 3 COMPLETE-PsA trial including 78 patients with active PsA who were randomly assigned to receive 2 tablets/day of 10 mg leflunomide or placebo once/day, both with 25 mg/week methotrexate.

Disclosures: This study was supported by the Regional Junior Researcher Grant from the Sint Maartenskliniek, Nijmegen, and the Radboudumc, Nijmegen, The Netherlands. The authors declared serving as speakers or consultants or receiving payments, honoraria, consulting and speaker fees, and support for attending meetings from several sources.

Source: Mulder MLM et al. Comparing methotrexate monotherapy with methotrexate plus leflunomide combination therapy in psoriatic arthritis (COMPLETE-PsA): a double-blind, placebo-controlled, randomised, trial. Lancet Rheumatol. 2022 (Feb 28). Doi: 10.1016/S2665-9913(22)00028-5

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Key clinical point: Methotrexate+leflunomide therapy was superior to methotrexate monotherapy at improving disease activity in patients with psoriatic arthritis (PsA); however methotrexate+leflunomide therapy was less well tolerated than methotrexate monotherapy.

Major finding: At week 16, PsA disease activity score improved significantly in the methotrexate+leflunomide vs. methotrexate monotherapy group (3.1 vs. 3.7; P = .025). Incidence of mild adverse events, such as nausea/vomiting (44% vs. 28%) and altered bowel habits (26% vs. 8%), was higher with methotrexate+leflunomide vs. methotrexate+placebo.

Study details: Findings are from the phase 3 COMPLETE-PsA trial including 78 patients with active PsA who were randomly assigned to receive 2 tablets/day of 10 mg leflunomide or placebo once/day, both with 25 mg/week methotrexate.

Disclosures: This study was supported by the Regional Junior Researcher Grant from the Sint Maartenskliniek, Nijmegen, and the Radboudumc, Nijmegen, The Netherlands. The authors declared serving as speakers or consultants or receiving payments, honoraria, consulting and speaker fees, and support for attending meetings from several sources.

Source: Mulder MLM et al. Comparing methotrexate monotherapy with methotrexate plus leflunomide combination therapy in psoriatic arthritis (COMPLETE-PsA): a double-blind, placebo-controlled, randomised, trial. Lancet Rheumatol. 2022 (Feb 28). Doi: 10.1016/S2665-9913(22)00028-5

Key clinical point: Methotrexate+leflunomide therapy was superior to methotrexate monotherapy at improving disease activity in patients with psoriatic arthritis (PsA); however methotrexate+leflunomide therapy was less well tolerated than methotrexate monotherapy.

Major finding: At week 16, PsA disease activity score improved significantly in the methotrexate+leflunomide vs. methotrexate monotherapy group (3.1 vs. 3.7; P = .025). Incidence of mild adverse events, such as nausea/vomiting (44% vs. 28%) and altered bowel habits (26% vs. 8%), was higher with methotrexate+leflunomide vs. methotrexate+placebo.

Study details: Findings are from the phase 3 COMPLETE-PsA trial including 78 patients with active PsA who were randomly assigned to receive 2 tablets/day of 10 mg leflunomide or placebo once/day, both with 25 mg/week methotrexate.

Disclosures: This study was supported by the Regional Junior Researcher Grant from the Sint Maartenskliniek, Nijmegen, and the Radboudumc, Nijmegen, The Netherlands. The authors declared serving as speakers or consultants or receiving payments, honoraria, consulting and speaker fees, and support for attending meetings from several sources.

Source: Mulder MLM et al. Comparing methotrexate monotherapy with methotrexate plus leflunomide combination therapy in psoriatic arthritis (COMPLETE-PsA): a double-blind, placebo-controlled, randomised, trial. Lancet Rheumatol. 2022 (Feb 28). Doi: 10.1016/S2665-9913(22)00028-5

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Introducing adalimumab vs. escalating methotrexate in patients with inadequately controlled PsA

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Key clinical point: Findings from the CONTROL trial support adding adalimumab over escalating methotrexate in patients with psoriatic arthritis (PsA) who respond inadequately to the initial methotrexate dose.

Major finding: At week 16, a significantly higher proportion of patients achieved minimal disease activity after adding adalimumab to methotrexate vs. escalating methotrexate dose (41% vs. 13%; P < .0001), with the efficacy being maintained through 32 weeks by 80% of adalimumab responders despite methotrexate withdrawal at 16 weeks. No new safety signals were identified.

Study details: Findings are from the phase 4 CONTROL trial including 245 patients with active PsA with an inadequate response to methotrexate. They were randomly assigned to receive 15 mg/week adalimumab+methotrexate or have a methotrexate dose escalated up to 25 mg/week for 16 weeks; responders either maintained or modified their current therapy and nonresponders had their therapy escalated until 32 weeks.

Disclosures: This study was funded by AbbVie. Four authors declared being employees or stockholders of AbbVie and other authors reported ties with various sources including AbbVie.

Source: Coates LC et al. Comparison between adalimumab introduction and methotrexate dose escalation in patients with inadequately controlled psoriatic arthritis (CONTROL): a randomised, open-label, two-part, phase 4 study. Lancet Rheumatol. 2022 (Feb 25). Doi: 10.1016/S2665-9913(22)00008-X

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Key clinical point: Findings from the CONTROL trial support adding adalimumab over escalating methotrexate in patients with psoriatic arthritis (PsA) who respond inadequately to the initial methotrexate dose.

Major finding: At week 16, a significantly higher proportion of patients achieved minimal disease activity after adding adalimumab to methotrexate vs. escalating methotrexate dose (41% vs. 13%; P < .0001), with the efficacy being maintained through 32 weeks by 80% of adalimumab responders despite methotrexate withdrawal at 16 weeks. No new safety signals were identified.

Study details: Findings are from the phase 4 CONTROL trial including 245 patients with active PsA with an inadequate response to methotrexate. They were randomly assigned to receive 15 mg/week adalimumab+methotrexate or have a methotrexate dose escalated up to 25 mg/week for 16 weeks; responders either maintained or modified their current therapy and nonresponders had their therapy escalated until 32 weeks.

Disclosures: This study was funded by AbbVie. Four authors declared being employees or stockholders of AbbVie and other authors reported ties with various sources including AbbVie.

Source: Coates LC et al. Comparison between adalimumab introduction and methotrexate dose escalation in patients with inadequately controlled psoriatic arthritis (CONTROL): a randomised, open-label, two-part, phase 4 study. Lancet Rheumatol. 2022 (Feb 25). Doi: 10.1016/S2665-9913(22)00008-X

Key clinical point: Findings from the CONTROL trial support adding adalimumab over escalating methotrexate in patients with psoriatic arthritis (PsA) who respond inadequately to the initial methotrexate dose.

Major finding: At week 16, a significantly higher proportion of patients achieved minimal disease activity after adding adalimumab to methotrexate vs. escalating methotrexate dose (41% vs. 13%; P < .0001), with the efficacy being maintained through 32 weeks by 80% of adalimumab responders despite methotrexate withdrawal at 16 weeks. No new safety signals were identified.

Study details: Findings are from the phase 4 CONTROL trial including 245 patients with active PsA with an inadequate response to methotrexate. They were randomly assigned to receive 15 mg/week adalimumab+methotrexate or have a methotrexate dose escalated up to 25 mg/week for 16 weeks; responders either maintained or modified their current therapy and nonresponders had their therapy escalated until 32 weeks.

Disclosures: This study was funded by AbbVie. Four authors declared being employees or stockholders of AbbVie and other authors reported ties with various sources including AbbVie.

Source: Coates LC et al. Comparison between adalimumab introduction and methotrexate dose escalation in patients with inadequately controlled psoriatic arthritis (CONTROL): a randomised, open-label, two-part, phase 4 study. Lancet Rheumatol. 2022 (Feb 25). Doi: 10.1016/S2665-9913(22)00008-X

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Psychiatric comorbidities highly prevalent in children hospitalized with migraine

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Key clinical point: Children hospitalized with migraine showed a high prevalence of psychiatric comorbidities, the presence of which was associated with increased medication use, a longer length of stay (LOS), and increased readmission.

 

Major finding: Psychiatric comorbidities were prevalent in 32% of children hospitalized for migraine headaches, with the prevalence of anxiety (11.2%), depression (6.7%), and attention-deficit/hyperactivity disorder (6.5%) being the highest. Children with vs. without psychiatric comorbidity were significantly more likely to receive dihydroergotamine, topiramate, and valproate, and had a longer mean LOS and higher 30-day readmission (all P < .001).

 

Study details: This multicenter, retrospective, cohort study included 21,436 children aged 6-18 years who were hospitalized for migraine headache.

 

Disclosures: No funding was received for this study. The authors declared no conflict of interests.

 

Source: Kafle M et al. Association of psychiatric comorbidities with treatment and outcomes in pediatric migraines. Hosp Pediatr. 2022;12(3):e101-e105 (Feb 14). Doi: 10.1542/hpeds.2021-006085

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Key clinical point: Children hospitalized with migraine showed a high prevalence of psychiatric comorbidities, the presence of which was associated with increased medication use, a longer length of stay (LOS), and increased readmission.

 

Major finding: Psychiatric comorbidities were prevalent in 32% of children hospitalized for migraine headaches, with the prevalence of anxiety (11.2%), depression (6.7%), and attention-deficit/hyperactivity disorder (6.5%) being the highest. Children with vs. without psychiatric comorbidity were significantly more likely to receive dihydroergotamine, topiramate, and valproate, and had a longer mean LOS and higher 30-day readmission (all P < .001).

 

Study details: This multicenter, retrospective, cohort study included 21,436 children aged 6-18 years who were hospitalized for migraine headache.

 

Disclosures: No funding was received for this study. The authors declared no conflict of interests.

 

Source: Kafle M et al. Association of psychiatric comorbidities with treatment and outcomes in pediatric migraines. Hosp Pediatr. 2022;12(3):e101-e105 (Feb 14). Doi: 10.1542/hpeds.2021-006085

Key clinical point: Children hospitalized with migraine showed a high prevalence of psychiatric comorbidities, the presence of which was associated with increased medication use, a longer length of stay (LOS), and increased readmission.

 

Major finding: Psychiatric comorbidities were prevalent in 32% of children hospitalized for migraine headaches, with the prevalence of anxiety (11.2%), depression (6.7%), and attention-deficit/hyperactivity disorder (6.5%) being the highest. Children with vs. without psychiatric comorbidity were significantly more likely to receive dihydroergotamine, topiramate, and valproate, and had a longer mean LOS and higher 30-day readmission (all P < .001).

 

Study details: This multicenter, retrospective, cohort study included 21,436 children aged 6-18 years who were hospitalized for migraine headache.

 

Disclosures: No funding was received for this study. The authors declared no conflict of interests.

 

Source: Kafle M et al. Association of psychiatric comorbidities with treatment and outcomes in pediatric migraines. Hosp Pediatr. 2022;12(3):e101-e105 (Feb 14). Doi: 10.1542/hpeds.2021-006085

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Neck pain highly prevalent in migraine

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Key clinical point: Neck pain is frequent in migraine, with the likelihood of neck pain being 12 times higher in patients with migraine than in nonheadache control individuals.

 

Major finding: Patients with migraine (77.0%; 95% CI 69.0%-86.4%) displayed a higher relative frequency of neck pain vs. nonheadache control individuals (23.2%; 95% CI 18.6%-28.5%) and a 12 times higher likelihood of experiencing neck pain (odds ratio 11.5; 95% CI 5.8-22.4).

 

Study details: Findings are from a meta-analysis of 24 clinic-based studies including 4,352 patients with migraine.

 

Disclosures: No funding was received for this study. Some of the authors declared receiving speaking fees, honoraria, consultant fees, personal fees, or research grants from or serving as a principal investigator of clinical trials for various organizations.

 

Source: Al-Khazali HM et al. Prevalence of neck pain in migraine: A systematic review and meta-analysis. Cephalalgia. 2022 (Feb 15). Doi: 10.1177/03331024211068073

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Key clinical point: Neck pain is frequent in migraine, with the likelihood of neck pain being 12 times higher in patients with migraine than in nonheadache control individuals.

 

Major finding: Patients with migraine (77.0%; 95% CI 69.0%-86.4%) displayed a higher relative frequency of neck pain vs. nonheadache control individuals (23.2%; 95% CI 18.6%-28.5%) and a 12 times higher likelihood of experiencing neck pain (odds ratio 11.5; 95% CI 5.8-22.4).

 

Study details: Findings are from a meta-analysis of 24 clinic-based studies including 4,352 patients with migraine.

 

Disclosures: No funding was received for this study. Some of the authors declared receiving speaking fees, honoraria, consultant fees, personal fees, or research grants from or serving as a principal investigator of clinical trials for various organizations.

 

Source: Al-Khazali HM et al. Prevalence of neck pain in migraine: A systematic review and meta-analysis. Cephalalgia. 2022 (Feb 15). Doi: 10.1177/03331024211068073

Key clinical point: Neck pain is frequent in migraine, with the likelihood of neck pain being 12 times higher in patients with migraine than in nonheadache control individuals.

 

Major finding: Patients with migraine (77.0%; 95% CI 69.0%-86.4%) displayed a higher relative frequency of neck pain vs. nonheadache control individuals (23.2%; 95% CI 18.6%-28.5%) and a 12 times higher likelihood of experiencing neck pain (odds ratio 11.5; 95% CI 5.8-22.4).

 

Study details: Findings are from a meta-analysis of 24 clinic-based studies including 4,352 patients with migraine.

 

Disclosures: No funding was received for this study. Some of the authors declared receiving speaking fees, honoraria, consultant fees, personal fees, or research grants from or serving as a principal investigator of clinical trials for various organizations.

 

Source: Al-Khazali HM et al. Prevalence of neck pain in migraine: A systematic review and meta-analysis. Cephalalgia. 2022 (Feb 15). Doi: 10.1177/03331024211068073

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Meta-analysis strengthens evidence of increased inflammation in migraine

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Key clinical point: Patients with migraine had significantly higher serum levels of interleukin (IL)-6, IL-1β, C-reactive protein (CRP), and tumor necrosis factor alpha (TNF-α) than healthy controls, with no significant difference being observed in the serum levels of IL-2 or IL-10.

 

Major finding: Patients with migraine vs. healthy controls had significantly higher serum levels of CRP (standardized mean difference [SMD] 1.48; P < .001), IL-1β (SMD 0.75; P < .001), IL-6 (SMD 1.18; P < .001), and TNF-α (SMD 0.69; P = .003); however, no significant difference was noted in serum IL-2 (P = .25) or IL-10 (P = .88) levels.

 

Study details: The data come from a meta-analysis of 10 studies that compared the peripheral cytokine levels between patients with migraine and healthy controls.

 

Disclosures: This study was supported by the Key Project of Henan Provincial Science and Technology Department. The authors declared no conflict of interests.

 

Source: Geng C et al. Aberrations in peripheral inflammatory cytokine levels in migraine: A systematic review and meta-analysis. J Clin Neurosci. 2022;98:213-218 (Feb 21). Doi: 10.1016/j.jocn.2022.02.026

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Key clinical point: Patients with migraine had significantly higher serum levels of interleukin (IL)-6, IL-1β, C-reactive protein (CRP), and tumor necrosis factor alpha (TNF-α) than healthy controls, with no significant difference being observed in the serum levels of IL-2 or IL-10.

 

Major finding: Patients with migraine vs. healthy controls had significantly higher serum levels of CRP (standardized mean difference [SMD] 1.48; P < .001), IL-1β (SMD 0.75; P < .001), IL-6 (SMD 1.18; P < .001), and TNF-α (SMD 0.69; P = .003); however, no significant difference was noted in serum IL-2 (P = .25) or IL-10 (P = .88) levels.

 

Study details: The data come from a meta-analysis of 10 studies that compared the peripheral cytokine levels between patients with migraine and healthy controls.

 

Disclosures: This study was supported by the Key Project of Henan Provincial Science and Technology Department. The authors declared no conflict of interests.

 

Source: Geng C et al. Aberrations in peripheral inflammatory cytokine levels in migraine: A systematic review and meta-analysis. J Clin Neurosci. 2022;98:213-218 (Feb 21). Doi: 10.1016/j.jocn.2022.02.026

Key clinical point: Patients with migraine had significantly higher serum levels of interleukin (IL)-6, IL-1β, C-reactive protein (CRP), and tumor necrosis factor alpha (TNF-α) than healthy controls, with no significant difference being observed in the serum levels of IL-2 or IL-10.

 

Major finding: Patients with migraine vs. healthy controls had significantly higher serum levels of CRP (standardized mean difference [SMD] 1.48; P < .001), IL-1β (SMD 0.75; P < .001), IL-6 (SMD 1.18; P < .001), and TNF-α (SMD 0.69; P = .003); however, no significant difference was noted in serum IL-2 (P = .25) or IL-10 (P = .88) levels.

 

Study details: The data come from a meta-analysis of 10 studies that compared the peripheral cytokine levels between patients with migraine and healthy controls.

 

Disclosures: This study was supported by the Key Project of Henan Provincial Science and Technology Department. The authors declared no conflict of interests.

 

Source: Geng C et al. Aberrations in peripheral inflammatory cytokine levels in migraine: A systematic review and meta-analysis. J Clin Neurosci. 2022;98:213-218 (Feb 21). Doi: 10.1016/j.jocn.2022.02.026

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Inflammatory potential of diets alters the frequency and severity of migraine attacks

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Key clinical point: Diets with higher proinflammatory effects as indicated by higher Dietary Inflammatory Index (DII) values are significantly associated with an increased frequency and severity of migraine headaches.

 

Major finding: After adjusting for potential confounders, an increase in the DII score from −4.04 to −1.83 increased the headache frequency by 3.48 (β 3.48; P = .001) and was associated with a higher risk for severe headaches (odds ratio 2.25; P = .015).

 

Study details: Findings are from a population-based cross-sectional study including 262 patients with migraine having a body mass index of 18.5-30.0 kg/m2 and daily energy consumption of 800-4,200 kcal/day.

 

Disclosures: The study was funded by Isfahan University of Medical Sciences, Iran. The authors declared no conflict of interests.

Source: Ghoreishy SM et al. Associations between potential inflammatory properties of the diet and frequency, duration, and severity of migraine headaches: a cross-sectional study. Sci Rep. 2022;12:2878 (Feb 21). Doi: 10.1038/s41598-022-06819-y

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Key clinical point: Diets with higher proinflammatory effects as indicated by higher Dietary Inflammatory Index (DII) values are significantly associated with an increased frequency and severity of migraine headaches.

 

Major finding: After adjusting for potential confounders, an increase in the DII score from −4.04 to −1.83 increased the headache frequency by 3.48 (β 3.48; P = .001) and was associated with a higher risk for severe headaches (odds ratio 2.25; P = .015).

 

Study details: Findings are from a population-based cross-sectional study including 262 patients with migraine having a body mass index of 18.5-30.0 kg/m2 and daily energy consumption of 800-4,200 kcal/day.

 

Disclosures: The study was funded by Isfahan University of Medical Sciences, Iran. The authors declared no conflict of interests.

Source: Ghoreishy SM et al. Associations between potential inflammatory properties of the diet and frequency, duration, and severity of migraine headaches: a cross-sectional study. Sci Rep. 2022;12:2878 (Feb 21). Doi: 10.1038/s41598-022-06819-y

Key clinical point: Diets with higher proinflammatory effects as indicated by higher Dietary Inflammatory Index (DII) values are significantly associated with an increased frequency and severity of migraine headaches.

 

Major finding: After adjusting for potential confounders, an increase in the DII score from −4.04 to −1.83 increased the headache frequency by 3.48 (β 3.48; P = .001) and was associated with a higher risk for severe headaches (odds ratio 2.25; P = .015).

 

Study details: Findings are from a population-based cross-sectional study including 262 patients with migraine having a body mass index of 18.5-30.0 kg/m2 and daily energy consumption of 800-4,200 kcal/day.

 

Disclosures: The study was funded by Isfahan University of Medical Sciences, Iran. The authors declared no conflict of interests.

Source: Ghoreishy SM et al. Associations between potential inflammatory properties of the diet and frequency, duration, and severity of migraine headaches: a cross-sectional study. Sci Rep. 2022;12:2878 (Feb 21). Doi: 10.1038/s41598-022-06819-y

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Chronic migraine with medication overuse: Optimizing consumption of the overused medication

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Key clinical point: Moderate-to-severe headache days in chronic migraine with medication overuse (CMMO) could be lowered with preventive medication irrespective of whether the overused symptomatic medication is continued or switched to a limited-use alternative.

 

Major finding: The number of monthly moderate-to-severe headache days achieved with the no switching strategy was not significantly different from that with the switching strategy both during weeks 1-2 (6.4 vs. 6.6 days; P = .57) and 9-12 (9.1 vs. 9.3 days; P = .75) after randomization.

 

Study details: The data come from MOTS trial including 720 patients aged ≥21 years with CMMO who were randomly assigned to receive migraine prophylactic medication and concurrently either switch from the overused medication to an alternative (≤2 days/week) or continue the overused medication with no maximum limit.

 

Disclosures: The study was sponsored by a Patient-Centered Outcomes Research Institute Award. Some authors reported receiving personal compensation, research grants, stock options, or royalties from various pharmaceutical companies.

Source: Schwedt T et al. Patient-centered treatment of chronic migraine with medication overuse: A prospective, randomized, pragmatic clinical trial. Neurology. 2022 (Feb 15). Doi: 10.1212/WNL.0000000000200117

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Key clinical point: Moderate-to-severe headache days in chronic migraine with medication overuse (CMMO) could be lowered with preventive medication irrespective of whether the overused symptomatic medication is continued or switched to a limited-use alternative.

 

Major finding: The number of monthly moderate-to-severe headache days achieved with the no switching strategy was not significantly different from that with the switching strategy both during weeks 1-2 (6.4 vs. 6.6 days; P = .57) and 9-12 (9.1 vs. 9.3 days; P = .75) after randomization.

 

Study details: The data come from MOTS trial including 720 patients aged ≥21 years with CMMO who were randomly assigned to receive migraine prophylactic medication and concurrently either switch from the overused medication to an alternative (≤2 days/week) or continue the overused medication with no maximum limit.

 

Disclosures: The study was sponsored by a Patient-Centered Outcomes Research Institute Award. Some authors reported receiving personal compensation, research grants, stock options, or royalties from various pharmaceutical companies.

Source: Schwedt T et al. Patient-centered treatment of chronic migraine with medication overuse: A prospective, randomized, pragmatic clinical trial. Neurology. 2022 (Feb 15). Doi: 10.1212/WNL.0000000000200117

Key clinical point: Moderate-to-severe headache days in chronic migraine with medication overuse (CMMO) could be lowered with preventive medication irrespective of whether the overused symptomatic medication is continued or switched to a limited-use alternative.

 

Major finding: The number of monthly moderate-to-severe headache days achieved with the no switching strategy was not significantly different from that with the switching strategy both during weeks 1-2 (6.4 vs. 6.6 days; P = .57) and 9-12 (9.1 vs. 9.3 days; P = .75) after randomization.

 

Study details: The data come from MOTS trial including 720 patients aged ≥21 years with CMMO who were randomly assigned to receive migraine prophylactic medication and concurrently either switch from the overused medication to an alternative (≤2 days/week) or continue the overused medication with no maximum limit.

 

Disclosures: The study was sponsored by a Patient-Centered Outcomes Research Institute Award. Some authors reported receiving personal compensation, research grants, stock options, or royalties from various pharmaceutical companies.

Source: Schwedt T et al. Patient-centered treatment of chronic migraine with medication overuse: A prospective, randomized, pragmatic clinical trial. Neurology. 2022 (Feb 15). Doi: 10.1212/WNL.0000000000200117

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Early response to eptinezumab connotes a long-term response in chronic migraine

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Key clinical point: A higher proportion of patients with chronic migraine treated with eptinezumab vs. placebo showed an early treatment response, with most early responders maintaining the response for at least half of the entire 24-week treatment period.

 

Major finding: At 1 month, a ≥75% reduction in monthly migraine days was achieved by 30.9%, 36.9%, and 15.6% of patients receiving 100 mg eptinezumab, 300 mg eptinezumab, and placebo, respectively. Among patients who achieved a ≥75% migraine response at 1 month, more than one-third and two-thirds maintained the same for the next 5 months and ≥3 months, respectively.

 

Study details: This was a post hoc analysis of the PROMISE 2 trial, including 1,072 patients with chronic migraine who were randomly assigned to receive 100 mg eptinezumab, 300 mg eptinezumab, or placebo.

 

Disclosures: The study was funded by H. Lundbeck A/S, Copenhagen. R Cady and T Brevig declared being employees of Lundbeck or a subsidiary company or having equity in Lundbeck, and others declared serving on advisory panels for or receiving grant support, consulting support, or personal compensation from various sources, including Lundbeck.

 

Source: Buse DC et al. Early response to eptinezumab indicates high likelihood of continued response in patients with chronic migraine. J Headache Pain. 2022;23:29 (Feb 21). Doi: 10.1186/s10194-022-01387-y

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Key clinical point: A higher proportion of patients with chronic migraine treated with eptinezumab vs. placebo showed an early treatment response, with most early responders maintaining the response for at least half of the entire 24-week treatment period.

 

Major finding: At 1 month, a ≥75% reduction in monthly migraine days was achieved by 30.9%, 36.9%, and 15.6% of patients receiving 100 mg eptinezumab, 300 mg eptinezumab, and placebo, respectively. Among patients who achieved a ≥75% migraine response at 1 month, more than one-third and two-thirds maintained the same for the next 5 months and ≥3 months, respectively.

 

Study details: This was a post hoc analysis of the PROMISE 2 trial, including 1,072 patients with chronic migraine who were randomly assigned to receive 100 mg eptinezumab, 300 mg eptinezumab, or placebo.

 

Disclosures: The study was funded by H. Lundbeck A/S, Copenhagen. R Cady and T Brevig declared being employees of Lundbeck or a subsidiary company or having equity in Lundbeck, and others declared serving on advisory panels for or receiving grant support, consulting support, or personal compensation from various sources, including Lundbeck.

 

Source: Buse DC et al. Early response to eptinezumab indicates high likelihood of continued response in patients with chronic migraine. J Headache Pain. 2022;23:29 (Feb 21). Doi: 10.1186/s10194-022-01387-y

Key clinical point: A higher proportion of patients with chronic migraine treated with eptinezumab vs. placebo showed an early treatment response, with most early responders maintaining the response for at least half of the entire 24-week treatment period.

 

Major finding: At 1 month, a ≥75% reduction in monthly migraine days was achieved by 30.9%, 36.9%, and 15.6% of patients receiving 100 mg eptinezumab, 300 mg eptinezumab, and placebo, respectively. Among patients who achieved a ≥75% migraine response at 1 month, more than one-third and two-thirds maintained the same for the next 5 months and ≥3 months, respectively.

 

Study details: This was a post hoc analysis of the PROMISE 2 trial, including 1,072 patients with chronic migraine who were randomly assigned to receive 100 mg eptinezumab, 300 mg eptinezumab, or placebo.

 

Disclosures: The study was funded by H. Lundbeck A/S, Copenhagen. R Cady and T Brevig declared being employees of Lundbeck or a subsidiary company or having equity in Lundbeck, and others declared serving on advisory panels for or receiving grant support, consulting support, or personal compensation from various sources, including Lundbeck.

 

Source: Buse DC et al. Early response to eptinezumab indicates high likelihood of continued response in patients with chronic migraine. J Headache Pain. 2022;23:29 (Feb 21). Doi: 10.1186/s10194-022-01387-y

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Eptinezumab can prevent migraine in patients aged 50 years or older

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Key clinical point: With its efficacy and safety in patients aged ≥50 years with migraine being similar to those in the overall study population in the PROMISE-1 and PROMISE-2 trials, eptinezumab could be an effective treatment option in this subpopulation.

 

Major finding: Compared with those in the total study population, similar changes in mean monthly migraine days were observed in patients with episodic (least squares mean [LSM] changes in days: 100 mg eptinezumab: −3.6; 300 mg eptinezumab: −4.4; placebo: −2.8) and chronic (LSM changes in days: 100 mg eptinezumab: −7.6; 300 mg `eptinezumab: −8.4; placebo: −6.0) migraine. The incidence of treatment-emergent adverse events was similar among treatment groups.

 

Study details: Of 1,960 patients with episodic or chronic migraine from the PROMISE-1 and PROMISE-2 trials, this post hoc analysis evaluated 385 patients aged ≥50 years who received eptinezumab or placebo.

 

Disclosures: H. Lundbeck A/S, Copenhagen, sponsored the study. V Martin and C Tassorelli declared being consultants, speakers, clinical trial investigators, or advisory board members for various companies, including Lundbeck; the rest are current/former employees of Lundbeck or a subsidiary/contracted company.

Source: Martin V et al. Eptinezumab for migraine prevention in patients 50 years or older. Acta Neurol Scand. 2022 (Feb 26). Doi: 10.1111/ane.13603

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Key clinical point: With its efficacy and safety in patients aged ≥50 years with migraine being similar to those in the overall study population in the PROMISE-1 and PROMISE-2 trials, eptinezumab could be an effective treatment option in this subpopulation.

 

Major finding: Compared with those in the total study population, similar changes in mean monthly migraine days were observed in patients with episodic (least squares mean [LSM] changes in days: 100 mg eptinezumab: −3.6; 300 mg eptinezumab: −4.4; placebo: −2.8) and chronic (LSM changes in days: 100 mg eptinezumab: −7.6; 300 mg `eptinezumab: −8.4; placebo: −6.0) migraine. The incidence of treatment-emergent adverse events was similar among treatment groups.

 

Study details: Of 1,960 patients with episodic or chronic migraine from the PROMISE-1 and PROMISE-2 trials, this post hoc analysis evaluated 385 patients aged ≥50 years who received eptinezumab or placebo.

 

Disclosures: H. Lundbeck A/S, Copenhagen, sponsored the study. V Martin and C Tassorelli declared being consultants, speakers, clinical trial investigators, or advisory board members for various companies, including Lundbeck; the rest are current/former employees of Lundbeck or a subsidiary/contracted company.

Source: Martin V et al. Eptinezumab for migraine prevention in patients 50 years or older. Acta Neurol Scand. 2022 (Feb 26). Doi: 10.1111/ane.13603

Key clinical point: With its efficacy and safety in patients aged ≥50 years with migraine being similar to those in the overall study population in the PROMISE-1 and PROMISE-2 trials, eptinezumab could be an effective treatment option in this subpopulation.

 

Major finding: Compared with those in the total study population, similar changes in mean monthly migraine days were observed in patients with episodic (least squares mean [LSM] changes in days: 100 mg eptinezumab: −3.6; 300 mg eptinezumab: −4.4; placebo: −2.8) and chronic (LSM changes in days: 100 mg eptinezumab: −7.6; 300 mg `eptinezumab: −8.4; placebo: −6.0) migraine. The incidence of treatment-emergent adverse events was similar among treatment groups.

 

Study details: Of 1,960 patients with episodic or chronic migraine from the PROMISE-1 and PROMISE-2 trials, this post hoc analysis evaluated 385 patients aged ≥50 years who received eptinezumab or placebo.

 

Disclosures: H. Lundbeck A/S, Copenhagen, sponsored the study. V Martin and C Tassorelli declared being consultants, speakers, clinical trial investigators, or advisory board members for various companies, including Lundbeck; the rest are current/former employees of Lundbeck or a subsidiary/contracted company.

Source: Martin V et al. Eptinezumab for migraine prevention in patients 50 years or older. Acta Neurol Scand. 2022 (Feb 26). Doi: 10.1111/ane.13603

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Intravenous sodium valproate outperforms ibuprofen in acute migraine

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Key clinical point: A single intravenous (IV) dose of sodium valproate exerts a better analgesic effect than that of ibuprofen in the treatment of acute migraine attacks.

 

Major finding: Mean differences in the delta Numerical Rating Scale scores between the sodium valproate and ibuprofen groups were 1.69, 3.61, 4.11, and 3.92 (all P < .001) after 30, 60, 90, and 120 minutes from the time of presentation, respectively, with more patients achieving pain relief with IV sodium valproate (P < .001).

 

Study details: Findings are from a prospective, double-blinded study including 99 adult patients with migraine without aura who presented to the emergency department with acute headache and were randomly assigned to receive sodium valproate (n = 49) or ibuprofen (n = 50) by IV infusion over 5 minutes.

 

Disclosures: The authors reported receiving no financial support for the study and declared no conflict of interests.

Source: Dogruyol S et al. Intravenous ibuprofen versus sodium valproate in acute migraine attacks in the emergency department: A randomized clinical trial. Am J Emerg Med. 2022 (Mar 4). Doi:  10.1016/j.ajem.2022.02.046

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Key clinical point: A single intravenous (IV) dose of sodium valproate exerts a better analgesic effect than that of ibuprofen in the treatment of acute migraine attacks.

 

Major finding: Mean differences in the delta Numerical Rating Scale scores between the sodium valproate and ibuprofen groups were 1.69, 3.61, 4.11, and 3.92 (all P < .001) after 30, 60, 90, and 120 minutes from the time of presentation, respectively, with more patients achieving pain relief with IV sodium valproate (P < .001).

 

Study details: Findings are from a prospective, double-blinded study including 99 adult patients with migraine without aura who presented to the emergency department with acute headache and were randomly assigned to receive sodium valproate (n = 49) or ibuprofen (n = 50) by IV infusion over 5 minutes.

 

Disclosures: The authors reported receiving no financial support for the study and declared no conflict of interests.

Source: Dogruyol S et al. Intravenous ibuprofen versus sodium valproate in acute migraine attacks in the emergency department: A randomized clinical trial. Am J Emerg Med. 2022 (Mar 4). Doi:  10.1016/j.ajem.2022.02.046

Key clinical point: A single intravenous (IV) dose of sodium valproate exerts a better analgesic effect than that of ibuprofen in the treatment of acute migraine attacks.

 

Major finding: Mean differences in the delta Numerical Rating Scale scores between the sodium valproate and ibuprofen groups were 1.69, 3.61, 4.11, and 3.92 (all P < .001) after 30, 60, 90, and 120 minutes from the time of presentation, respectively, with more patients achieving pain relief with IV sodium valproate (P < .001).

 

Study details: Findings are from a prospective, double-blinded study including 99 adult patients with migraine without aura who presented to the emergency department with acute headache and were randomly assigned to receive sodium valproate (n = 49) or ibuprofen (n = 50) by IV infusion over 5 minutes.

 

Disclosures: The authors reported receiving no financial support for the study and declared no conflict of interests.

Source: Dogruyol S et al. Intravenous ibuprofen versus sodium valproate in acute migraine attacks in the emergency department: A randomized clinical trial. Am J Emerg Med. 2022 (Mar 4). Doi:  10.1016/j.ajem.2022.02.046

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