Key clinical point: Bimekizumab improved the signs and symptoms of psoriatic arthritis (PsA) in patients with previous inadequate response to or intolerance of tumor necrosis factor-alpha (TNFα) inhibitors without causing any unprecedented adverse events (AE).

Major finding: At week 16, a significantly higher proportion of patients receiving bimekizumab vs placebo achieved ≥50% improvement in American College of Rheumatology response (43% vs 7%; odds ratio 11.1; P < .0001), with treatment-emergent AE being reported by 40% of patients receiving bimekizumab and 33% of patients receiving placebo.

Study details: Findings are from the multicenter, phase 3 BE COMPLETE study including 400 patients with active PsA and previous inadequate response to or intolerance of TNFα inhibitors who were randomly assigned to receive 160 mg subcutaneous bimekizumab every 4 weeks or placebo.

Disclosures: This study was funded by UCB Pharma. Five authors declared being employees and shareholders of UCB Pharma, and the other authors reported ties with several sources, including UCB Pharma.

Source: Merola JF et al. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: A randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE). Lancet. 2022 (Dec 6). Doi: 10.1016/S0140-6736(22)02303-0

Key clinical point: Bimekizumab improved the signs and symptoms of psoriatic arthritis (PsA) in patients with previous inadequate response to or intolerance of tumor necrosis factor-alpha (TNFα) inhibitors without causing any unprecedented adverse events (AE).

Major finding: At week 16, a significantly higher proportion of patients receiving bimekizumab vs placebo achieved ≥50% improvement in American College of Rheumatology response (43% vs 7%; odds ratio 11.1; P < .0001), with treatment-emergent AE being reported by 40% of patients receiving bimekizumab and 33% of patients receiving placebo.

Study details: Findings are from the multicenter, phase 3 BE COMPLETE study including 400 patients with active PsA and previous inadequate response to or intolerance of TNFα inhibitors who were randomly assigned to receive 160 mg subcutaneous bimekizumab every 4 weeks or placebo.

Disclosures: This study was funded by UCB Pharma. Five authors declared being employees and shareholders of UCB Pharma, and the other authors reported ties with several sources, including UCB Pharma.

Source: Merola JF et al. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: A randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE). Lancet. 2022 (Dec 6). Doi: 10.1016/S0140-6736(22)02303-0

Key clinical point: Bimekizumab improved the signs and symptoms of psoriatic arthritis (PsA) in patients with previous inadequate response to or intolerance of tumor necrosis factor-alpha (TNFα) inhibitors without causing any unprecedented adverse events (AE).

Major finding: At week 16, a significantly higher proportion of patients receiving bimekizumab vs placebo achieved ≥50% improvement in American College of Rheumatology response (43% vs 7%; odds ratio 11.1; P < .0001), with treatment-emergent AE being reported by 40% of patients receiving bimekizumab and 33% of patients receiving placebo.

Study details: Findings are from the multicenter, phase 3 BE COMPLETE study including 400 patients with active PsA and previous inadequate response to or intolerance of TNFα inhibitors who were randomly assigned to receive 160 mg subcutaneous bimekizumab every 4 weeks or placebo.

Disclosures: This study was funded by UCB Pharma. Five authors declared being employees and shareholders of UCB Pharma, and the other authors reported ties with several sources, including UCB Pharma.

Source: Merola JF et al. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: A randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE). Lancet. 2022 (Dec 6). Doi: 10.1016/S0140-6736(22)02303-0

Key clinical point: A booster dose of BNT162b2 messenger ribonucleic acid (mRNA) SARS-CoV-2 vaccine (BioNTech-Pfizer) restored the anti-SARS-CoV-2 immunoglobulin G (IgG) levels in patients with psoriatic arthritis (PsA) who were receiving tumor necrosis factor (TNF) inhibitors.

Major finding: Although the mean anti-SARS-CoV-2 IgG levels were significantly lower in patients with PsA vs matched control individuals (2009.22 vs 6206.59 AU/mL; P = .0006) 4 months after two doses of vaccination, the mean IgG levels were similar between both groups after the booster dose (P = .20).

Study details: Findings are from a prospective study including 40 patients with PsA on TNF inhibitors and 40 matched control individuals who received two shots of the BNT162b2 mRNA vaccine.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Venerito V et al. Anti-SARS-CoV-2 antibody decay after vaccination and immunogenicity of the booster dose of the BNT162b2 mRNA vaccine in patients with psoriatic arthritis on TNF inhibitors. Clin Exp Rheumatol. 2022 (Nov 24). Doi: 10.55563/clinexprheumatol/hptln9

Key clinical point: A booster dose of BNT162b2 messenger ribonucleic acid (mRNA) SARS-CoV-2 vaccine (BioNTech-Pfizer) restored the anti-SARS-CoV-2 immunoglobulin G (IgG) levels in patients with psoriatic arthritis (PsA) who were receiving tumor necrosis factor (TNF) inhibitors.

Major finding: Although the mean anti-SARS-CoV-2 IgG levels were significantly lower in patients with PsA vs matched control individuals (2009.22 vs 6206.59 AU/mL; P = .0006) 4 months after two doses of vaccination, the mean IgG levels were similar between both groups after the booster dose (P = .20).

Study details: Findings are from a prospective study including 40 patients with PsA on TNF inhibitors and 40 matched control individuals who received two shots of the BNT162b2 mRNA vaccine.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Venerito V et al. Anti-SARS-CoV-2 antibody decay after vaccination and immunogenicity of the booster dose of the BNT162b2 mRNA vaccine in patients with psoriatic arthritis on TNF inhibitors. Clin Exp Rheumatol. 2022 (Nov 24). Doi: 10.55563/clinexprheumatol/hptln9

Key clinical point: A booster dose of BNT162b2 messenger ribonucleic acid (mRNA) SARS-CoV-2 vaccine (BioNTech-Pfizer) restored the anti-SARS-CoV-2 immunoglobulin G (IgG) levels in patients with psoriatic arthritis (PsA) who were receiving tumor necrosis factor (TNF) inhibitors.

Major finding: Although the mean anti-SARS-CoV-2 IgG levels were significantly lower in patients with PsA vs matched control individuals (2009.22 vs 6206.59 AU/mL; P = .0006) 4 months after two doses of vaccination, the mean IgG levels were similar between both groups after the booster dose (P = .20).

Study details: Findings are from a prospective study including 40 patients with PsA on TNF inhibitors and 40 matched control individuals who received two shots of the BNT162b2 mRNA vaccine.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Venerito V et al. Anti-SARS-CoV-2 antibody decay after vaccination and immunogenicity of the booster dose of the BNT162b2 mRNA vaccine in patients with psoriatic arthritis on TNF inhibitors. Clin Exp Rheumatol. 2022 (Nov 24). Doi: 10.55563/clinexprheumatol/hptln9

Key clinical point: Bimekizumab demonstrated superior efficacy outcomes compared with placebo and was well-tolerated with a consistent safety profile in patients with active psoriatic arthritis (PsA) who were naive to biologic disease-modifying antirheumatic drugs (bDMARD).

Major finding: At week 16, a significantly higher proportion of patients receiving bimekizumab vs placebo achieved ≥50% improvement in American College of Rheumatology response (44% vs 10%; odds ratio 7.1; P < .0001). Treatment-emergent adverse events were reported by 60% vs 49% of patients in the bimekizumab vs placebo arm, respectively, and no deaths occurred.

Study details: Findings are from the phase 3 BE OPTIMAL study including 852 patients with active PsA who were naive to bDMARD and were randomly assigned to receive bimekizumab, placebo, or adalimumab.

Disclosures: This study was funded by UCB Pharma. Five authors declared being employees and shareholders of UCB Pharma, and the other authors declared receiving grants, fees, honoraria, or having other ties with several sources, including UCB Pharma.

Source: McInnes IB et al. Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: A randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL). Lancet. 2022 (Dec 5). Doi: 10.1016/S0140-6736(22)02302-9

Key clinical point: Bimekizumab demonstrated superior efficacy outcomes compared with placebo and was well-tolerated with a consistent safety profile in patients with active psoriatic arthritis (PsA) who were naive to biologic disease-modifying antirheumatic drugs (bDMARD).

Major finding: At week 16, a significantly higher proportion of patients receiving bimekizumab vs placebo achieved ≥50% improvement in American College of Rheumatology response (44% vs 10%; odds ratio 7.1; P < .0001). Treatment-emergent adverse events were reported by 60% vs 49% of patients in the bimekizumab vs placebo arm, respectively, and no deaths occurred.

Study details: Findings are from the phase 3 BE OPTIMAL study including 852 patients with active PsA who were naive to bDMARD and were randomly assigned to receive bimekizumab, placebo, or adalimumab.

Disclosures: This study was funded by UCB Pharma. Five authors declared being employees and shareholders of UCB Pharma, and the other authors declared receiving grants, fees, honoraria, or having other ties with several sources, including UCB Pharma.

Source: McInnes IB et al. Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: A randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL). Lancet. 2022 (Dec 5). Doi: 10.1016/S0140-6736(22)02302-9

Key clinical point: Bimekizumab demonstrated superior efficacy outcomes compared with placebo and was well-tolerated with a consistent safety profile in patients with active psoriatic arthritis (PsA) who were naive to biologic disease-modifying antirheumatic drugs (bDMARD).

Major finding: At week 16, a significantly higher proportion of patients receiving bimekizumab vs placebo achieved ≥50% improvement in American College of Rheumatology response (44% vs 10%; odds ratio 7.1; P < .0001). Treatment-emergent adverse events were reported by 60% vs 49% of patients in the bimekizumab vs placebo arm, respectively, and no deaths occurred.

Study details: Findings are from the phase 3 BE OPTIMAL study including 852 patients with active PsA who were naive to bDMARD and were randomly assigned to receive bimekizumab, placebo, or adalimumab.

Disclosures: This study was funded by UCB Pharma. Five authors declared being employees and shareholders of UCB Pharma, and the other authors declared receiving grants, fees, honoraria, or having other ties with several sources, including UCB Pharma.

Source: McInnes IB et al. Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: A randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL). Lancet. 2022 (Dec 5). Doi: 10.1016/S0140-6736(22)02302-9

NEW ORLEANS – Patients with chronic immune thrombocytopenia (ITP) fared better on intravenous efgartigimod (Vyvgart) than a placebo, a new study found. Still, only 21.8% of subjects who received the biologic reached the primary endpoint of sustained platelet count response, an indication that most patients won’t benefit.

Nevertheless, “efgartigimod demonstrated a strong clinical benefit,” said hematologist/oncologist and study lead author Catherine M. Broome, MD, of Georgetown University, Washington, in an interview about the findings presented at the annual meeting of the American Society of Hematology.

“The data showed statistically significant and clinically meaningful improvement in platelet counts over placebo, a fast and robust platelet count improvement over placebo, and the confirmed ability for every-other-week dosing, as well as a favorable safety and tolerability profile, consistent with previous clinical trials,” she said.

In ITP, according to the National Organization for Rare Disorders, “the patient’s immune system tags their own platelets as ‘foreign,’ leading their B lymphocytes and plasma cells to produce self-reactive antiplatelet antibodies that attach to platelet surface.”

The prevalence of ITP among adults in the United States is 9.5 per 100,000, NORD says. Children are also affected, but they usually recover. An estimated 60% of adults recover within 3 years.

Treatment options include corticosteroids and intravenous immunoglobulin.

“There are a relatively large number of current treatments, and they tend to work well for most patients. However, there are a minority of patients who do not respond to or tolerate current therapies and would benefit from new treatment options,” said hematologist Adam C. Cuker, MD, MS, of Penn Medicine, Philadelphia, in an interview. He is chair of ASH’s Committee on Quality.

For the new industry-funded ADVANCE study, researchers recruited patients with long-standing, persistent/chronic ITP (an average of two platelet counts of < 30×109/L).

Subjects were randomized 2:1 to receive 10 mg/kg of efgartigimod weekly – or response-dependent doses after the first 4 weeks – or placebo for 24 weeks. There were 86 patients in the intervention group and 45 in the placebo group. Overall, 60 were male and 71 were female; 107 were under 65; 121 were White and 8 were Asian. Details about the others were not provided.

Subjects were allowed to take several other drugs such as oral corticosteroids, and oral thrombopoietin receptor agonists other than romiplostim.

Per the primary endpoint, 17/78 (21.8%) reached a sustained response, defined as platelet counts ≥ 50×109/L in ≥ four of six visits between weeks 19 and 24 without intercurrent events, such as rescue therapy at week 12 or later. In the placebo group, 2/40 reached this response (5.0%; P = .0316).

“The primary endpoint was a high bar to achieve,” Dr. Broome said. “This was a difficult-to-treat patient population heavily pretreated and refractory to other treatments: 68.6% of patients in the efgartigimod arm had received three or more prior ITP treatments.”

She added that “subgroup analyses – including prior ITP therapy, time since diagnosis, baseline platelet count and age/region demographics – of patients who achieved the primary endpoint all favored efgartigimod over placebo.”

Side effects were extremely common among both the drug and placebo groups, and serious adverse events were common in the placebo group. No deaths were reported.

Efgartigimod, a neonatal Fc receptor blocker, is an extremely expensive drug that is Food and Drug Administration approved for some cases of generalized myasthenia gravis. According to a report in Neurology earlier this year, company statements listed its price as $855,400 a year; the report questioned its cost-effectiveness.

In response to a query about price, Luc Truyen, MD, PhD, chief medical officer of drug manufacturer Argenx, declined to talk about cost – a sensitive topic for pharmaceutical companies. “It is too early to discuss pricing and access as no regulatory submission or discussion has occurred,” Dr. Truyen said.

Penn Medicine’s Dr. Cuker, who is familiar with the study findings, said the primary endpoint results are not very impressive. “That said, it should be borne in mind that the patients enrolled in the trial tended to be heavily pretreated and refractory patients,” he said.

As for adverse effects, he said the drug “appears to be safe and well tolerated. The biggest theoretical concern with this class of drugs is an increased risk of infection due to lowering of IgG levels.”

It would be helpful to have trials that directly compare second-line therapies in ITP, he added. “Unfortunately, no such trials exist, and pharmaceutical companies would not be motivated to conduct them.”

For now, he said, off-label use of efgartigimod “may be reasonable, but only in rare situations where other approved and better established ITP treatments have been exhausted.”

What’s next? According to Dr. Broome, another trial is currently evaluating efgartigimod for the treatment of primary ITP, with top-line data expected in the second half of 2023.

The study was funded by Argenx. Dr. Broome discloses honoraria from Alexion, Argenx, Apellis, and Sano. Dr. Truyen’s disclosures weren’t available. Dr. Cuker has no disclosures.

NEW ORLEANS – Patients with chronic immune thrombocytopenia (ITP) fared better on intravenous efgartigimod (Vyvgart) than a placebo, a new study found. Still, only 21.8% of subjects who received the biologic reached the primary endpoint of sustained platelet count response, an indication that most patients won’t benefit.

Nevertheless, “efgartigimod demonstrated a strong clinical benefit,” said hematologist/oncologist and study lead author Catherine M. Broome, MD, of Georgetown University, Washington, in an interview about the findings presented at the annual meeting of the American Society of Hematology.

“The data showed statistically significant and clinically meaningful improvement in platelet counts over placebo, a fast and robust platelet count improvement over placebo, and the confirmed ability for every-other-week dosing, as well as a favorable safety and tolerability profile, consistent with previous clinical trials,” she said.

In ITP, according to the National Organization for Rare Disorders, “the patient’s immune system tags their own platelets as ‘foreign,’ leading their B lymphocytes and plasma cells to produce self-reactive antiplatelet antibodies that attach to platelet surface.”

The prevalence of ITP among adults in the United States is 9.5 per 100,000, NORD says. Children are also affected, but they usually recover. An estimated 60% of adults recover within 3 years.

Treatment options include corticosteroids and intravenous immunoglobulin.

“There are a relatively large number of current treatments, and they tend to work well for most patients. However, there are a minority of patients who do not respond to or tolerate current therapies and would benefit from new treatment options,” said hematologist Adam C. Cuker, MD, MS, of Penn Medicine, Philadelphia, in an interview. He is chair of ASH’s Committee on Quality.

For the new industry-funded ADVANCE study, researchers recruited patients with long-standing, persistent/chronic ITP (an average of two platelet counts of < 30×109/L).

Subjects were randomized 2:1 to receive 10 mg/kg of efgartigimod weekly – or response-dependent doses after the first 4 weeks – or placebo for 24 weeks. There were 86 patients in the intervention group and 45 in the placebo group. Overall, 60 were male and 71 were female; 107 were under 65; 121 were White and 8 were Asian. Details about the others were not provided.

Subjects were allowed to take several other drugs such as oral corticosteroids, and oral thrombopoietin receptor agonists other than romiplostim.

Per the primary endpoint, 17/78 (21.8%) reached a sustained response, defined as platelet counts ≥ 50×109/L in ≥ four of six visits between weeks 19 and 24 without intercurrent events, such as rescue therapy at week 12 or later. In the placebo group, 2/40 reached this response (5.0%; P = .0316).

“The primary endpoint was a high bar to achieve,” Dr. Broome said. “This was a difficult-to-treat patient population heavily pretreated and refractory to other treatments: 68.6% of patients in the efgartigimod arm had received three or more prior ITP treatments.”

She added that “subgroup analyses – including prior ITP therapy, time since diagnosis, baseline platelet count and age/region demographics – of patients who achieved the primary endpoint all favored efgartigimod over placebo.”

Side effects were extremely common among both the drug and placebo groups, and serious adverse events were common in the placebo group. No deaths were reported.

Efgartigimod, a neonatal Fc receptor blocker, is an extremely expensive drug that is Food and Drug Administration approved for some cases of generalized myasthenia gravis. According to a report in Neurology earlier this year, company statements listed its price as $855,400 a year; the report questioned its cost-effectiveness.

In response to a query about price, Luc Truyen, MD, PhD, chief medical officer of drug manufacturer Argenx, declined to talk about cost – a sensitive topic for pharmaceutical companies. “It is too early to discuss pricing and access as no regulatory submission or discussion has occurred,” Dr. Truyen said.

Penn Medicine’s Dr. Cuker, who is familiar with the study findings, said the primary endpoint results are not very impressive. “That said, it should be borne in mind that the patients enrolled in the trial tended to be heavily pretreated and refractory patients,” he said.

As for adverse effects, he said the drug “appears to be safe and well tolerated. The biggest theoretical concern with this class of drugs is an increased risk of infection due to lowering of IgG levels.”

It would be helpful to have trials that directly compare second-line therapies in ITP, he added. “Unfortunately, no such trials exist, and pharmaceutical companies would not be motivated to conduct them.”

For now, he said, off-label use of efgartigimod “may be reasonable, but only in rare situations where other approved and better established ITP treatments have been exhausted.”

What’s next? According to Dr. Broome, another trial is currently evaluating efgartigimod for the treatment of primary ITP, with top-line data expected in the second half of 2023.

The study was funded by Argenx. Dr. Broome discloses honoraria from Alexion, Argenx, Apellis, and Sano. Dr. Truyen’s disclosures weren’t available. Dr. Cuker has no disclosures.

NEW ORLEANS – Patients with chronic immune thrombocytopenia (ITP) fared better on intravenous efgartigimod (Vyvgart) than a placebo, a new study found. Still, only 21.8% of subjects who received the biologic reached the primary endpoint of sustained platelet count response, an indication that most patients won’t benefit.

Nevertheless, “efgartigimod demonstrated a strong clinical benefit,” said hematologist/oncologist and study lead author Catherine M. Broome, MD, of Georgetown University, Washington, in an interview about the findings presented at the annual meeting of the American Society of Hematology.

“The data showed statistically significant and clinically meaningful improvement in platelet counts over placebo, a fast and robust platelet count improvement over placebo, and the confirmed ability for every-other-week dosing, as well as a favorable safety and tolerability profile, consistent with previous clinical trials,” she said.

In ITP, according to the National Organization for Rare Disorders, “the patient’s immune system tags their own platelets as ‘foreign,’ leading their B lymphocytes and plasma cells to produce self-reactive antiplatelet antibodies that attach to platelet surface.”

The prevalence of ITP among adults in the United States is 9.5 per 100,000, NORD says. Children are also affected, but they usually recover. An estimated 60% of adults recover within 3 years.

Treatment options include corticosteroids and intravenous immunoglobulin.

“There are a relatively large number of current treatments, and they tend to work well for most patients. However, there are a minority of patients who do not respond to or tolerate current therapies and would benefit from new treatment options,” said hematologist Adam C. Cuker, MD, MS, of Penn Medicine, Philadelphia, in an interview. He is chair of ASH’s Committee on Quality.

For the new industry-funded ADVANCE study, researchers recruited patients with long-standing, persistent/chronic ITP (an average of two platelet counts of < 30×109/L).

Subjects were randomized 2:1 to receive 10 mg/kg of efgartigimod weekly – or response-dependent doses after the first 4 weeks – or placebo for 24 weeks. There were 86 patients in the intervention group and 45 in the placebo group. Overall, 60 were male and 71 were female; 107 were under 65; 121 were White and 8 were Asian. Details about the others were not provided.

Subjects were allowed to take several other drugs such as oral corticosteroids, and oral thrombopoietin receptor agonists other than romiplostim.

Per the primary endpoint, 17/78 (21.8%) reached a sustained response, defined as platelet counts ≥ 50×109/L in ≥ four of six visits between weeks 19 and 24 without intercurrent events, such as rescue therapy at week 12 or later. In the placebo group, 2/40 reached this response (5.0%; P = .0316).

“The primary endpoint was a high bar to achieve,” Dr. Broome said. “This was a difficult-to-treat patient population heavily pretreated and refractory to other treatments: 68.6% of patients in the efgartigimod arm had received three or more prior ITP treatments.”

She added that “subgroup analyses – including prior ITP therapy, time since diagnosis, baseline platelet count and age/region demographics – of patients who achieved the primary endpoint all favored efgartigimod over placebo.”

Side effects were extremely common among both the drug and placebo groups, and serious adverse events were common in the placebo group. No deaths were reported.

Efgartigimod, a neonatal Fc receptor blocker, is an extremely expensive drug that is Food and Drug Administration approved for some cases of generalized myasthenia gravis. According to a report in Neurology earlier this year, company statements listed its price as $855,400 a year; the report questioned its cost-effectiveness.

In response to a query about price, Luc Truyen, MD, PhD, chief medical officer of drug manufacturer Argenx, declined to talk about cost – a sensitive topic for pharmaceutical companies. “It is too early to discuss pricing and access as no regulatory submission or discussion has occurred,” Dr. Truyen said.

Penn Medicine’s Dr. Cuker, who is familiar with the study findings, said the primary endpoint results are not very impressive. “That said, it should be borne in mind that the patients enrolled in the trial tended to be heavily pretreated and refractory patients,” he said.

As for adverse effects, he said the drug “appears to be safe and well tolerated. The biggest theoretical concern with this class of drugs is an increased risk of infection due to lowering of IgG levels.”

It would be helpful to have trials that directly compare second-line therapies in ITP, he added. “Unfortunately, no such trials exist, and pharmaceutical companies would not be motivated to conduct them.”

For now, he said, off-label use of efgartigimod “may be reasonable, but only in rare situations where other approved and better established ITP treatments have been exhausted.”

What’s next? According to Dr. Broome, another trial is currently evaluating efgartigimod for the treatment of primary ITP, with top-line data expected in the second half of 2023.

The study was funded by Argenx. Dr. Broome discloses honoraria from Alexion, Argenx, Apellis, and Sano. Dr. Truyen’s disclosures weren’t available. Dr. Cuker has no disclosures.

Key clinical point: Migraine or severe headache is a significant risk factor for cardiovascular diseases and significantly increases the risk for angina and stroke.

Major finding: Migraine or severe headache increased the overall risk for cardiovascular diseases (adjusted odds ratio [aOR] 2.77; P = .001), angina (aOR 2.27; P = .046), and stroke (aOR 3.80; P = .006), with the increased risk for cardiovascular diseases being the most prominent among participants with migraine who were women (aOR 6.02; P < .001), aged >60 years (aOR 2.69; P = .049), or had hypertension (aOR 3.57; P < .001) or hyperlipidemia (aOR 2.74; P = .003).

Study details: This cross-sectional study evaluated 5692 participants from the US National Health and Nutrition Examination Survey (NHANES), of which 1090 had migraine or severe headache.

Disclosures: This study was supported by grants from the National Natural Science Foundation of China and the Natural Science Foundation of Jiangsu Province. The authors declared no conflicts of interest.

Source: Wang K et al. Association between migraine and cardiovascular disease: A cross-sectional study. Front Cardiovasc Med. 2022;9:1044465 (Nov 24). Doi: 10.3389/fcvm.2022.1044465

Key clinical point: Migraine or severe headache is a significant risk factor for cardiovascular diseases and significantly increases the risk for angina and stroke.

Major finding: Migraine or severe headache increased the overall risk for cardiovascular diseases (adjusted odds ratio [aOR] 2.77; P = .001), angina (aOR 2.27; P = .046), and stroke (aOR 3.80; P = .006), with the increased risk for cardiovascular diseases being the most prominent among participants with migraine who were women (aOR 6.02; P < .001), aged >60 years (aOR 2.69; P = .049), or had hypertension (aOR 3.57; P < .001) or hyperlipidemia (aOR 2.74; P = .003).

Study details: This cross-sectional study evaluated 5692 participants from the US National Health and Nutrition Examination Survey (NHANES), of which 1090 had migraine or severe headache.

Disclosures: This study was supported by grants from the National Natural Science Foundation of China and the Natural Science Foundation of Jiangsu Province. The authors declared no conflicts of interest.

Source: Wang K et al. Association between migraine and cardiovascular disease: A cross-sectional study. Front Cardiovasc Med. 2022;9:1044465 (Nov 24). Doi: 10.3389/fcvm.2022.1044465

Key clinical point: Migraine or severe headache is a significant risk factor for cardiovascular diseases and significantly increases the risk for angina and stroke.

Major finding: Migraine or severe headache increased the overall risk for cardiovascular diseases (adjusted odds ratio [aOR] 2.77; P = .001), angina (aOR 2.27; P = .046), and stroke (aOR 3.80; P = .006), with the increased risk for cardiovascular diseases being the most prominent among participants with migraine who were women (aOR 6.02; P < .001), aged >60 years (aOR 2.69; P = .049), or had hypertension (aOR 3.57; P < .001) or hyperlipidemia (aOR 2.74; P = .003).

Study details: This cross-sectional study evaluated 5692 participants from the US National Health and Nutrition Examination Survey (NHANES), of which 1090 had migraine or severe headache.

Disclosures: This study was supported by grants from the National Natural Science Foundation of China and the Natural Science Foundation of Jiangsu Province. The authors declared no conflicts of interest.

Source: Wang K et al. Association between migraine and cardiovascular disease: A cross-sectional study. Front Cardiovasc Med. 2022;9:1044465 (Nov 24). Doi: 10.3389/fcvm.2022.1044465

Key clinical point: The COVID-19 pandemic adversely affected psychological functioning in young US college students with migraine and increased depression and anxiety, attenuating potential improvements achieved in headache-related disability during the pandemic.

Major finding: Levels of depression, anxiety, and stress were significantly higher during vs before the COVID-19 pandemic (all P ≤ .01), whereas headache-related disability was lower (direct effect [c′] −1.6; 95% CI −3.1 to −0.1). However, anxiety (indirect effect [b] 0.3; 95% CI 0.01-0.9) and depression (b 0.7; 95% CI 0.07-1.4) mediated an increase in headache-related disability during vs before the pandemic, thereby canceling improvements achieved during the pandemic.

Study details: This cross-sectional study included 365 undergraduate students aged ≥18 years with episodic migraine with or without aura or chronic migraine who were surveyed before (n = 223) or during (n = 142) the COVID-19 pandemic.

Disclosures: This study did not receive any specific funding. TA Smitherman reported previously serving on the advisory board for Teva Pharmaceuticals (unrelated to this study).

Source: Thaxter LY and Smitherman TA. The effect of the COVID-19 pandemic on headache-related disability among young adults with migraine. Headache. 2022;62(10):1293-1301 (Nov 23). Doi: 10.1111/head.14411

Key clinical point: The COVID-19 pandemic adversely affected psychological functioning in young US college students with migraine and increased depression and anxiety, attenuating potential improvements achieved in headache-related disability during the pandemic.

Major finding: Levels of depression, anxiety, and stress were significantly higher during vs before the COVID-19 pandemic (all P ≤ .01), whereas headache-related disability was lower (direct effect [c′] −1.6; 95% CI −3.1 to −0.1). However, anxiety (indirect effect [b] 0.3; 95% CI 0.01-0.9) and depression (b 0.7; 95% CI 0.07-1.4) mediated an increase in headache-related disability during vs before the pandemic, thereby canceling improvements achieved during the pandemic.

Study details: This cross-sectional study included 365 undergraduate students aged ≥18 years with episodic migraine with or without aura or chronic migraine who were surveyed before (n = 223) or during (n = 142) the COVID-19 pandemic.

Disclosures: This study did not receive any specific funding. TA Smitherman reported previously serving on the advisory board for Teva Pharmaceuticals (unrelated to this study).

Source: Thaxter LY and Smitherman TA. The effect of the COVID-19 pandemic on headache-related disability among young adults with migraine. Headache. 2022;62(10):1293-1301 (Nov 23). Doi: 10.1111/head.14411

Key clinical point: The COVID-19 pandemic adversely affected psychological functioning in young US college students with migraine and increased depression and anxiety, attenuating potential improvements achieved in headache-related disability during the pandemic.

Major finding: Levels of depression, anxiety, and stress were significantly higher during vs before the COVID-19 pandemic (all P ≤ .01), whereas headache-related disability was lower (direct effect [c′] −1.6; 95% CI −3.1 to −0.1). However, anxiety (indirect effect [b] 0.3; 95% CI 0.01-0.9) and depression (b 0.7; 95% CI 0.07-1.4) mediated an increase in headache-related disability during vs before the pandemic, thereby canceling improvements achieved during the pandemic.

Study details: This cross-sectional study included 365 undergraduate students aged ≥18 years with episodic migraine with or without aura or chronic migraine who were surveyed before (n = 223) or during (n = 142) the COVID-19 pandemic.

Disclosures: This study did not receive any specific funding. TA Smitherman reported previously serving on the advisory board for Teva Pharmaceuticals (unrelated to this study).

Source: Thaxter LY and Smitherman TA. The effect of the COVID-19 pandemic on headache-related disability among young adults with migraine. Headache. 2022;62(10):1293-1301 (Nov 23). Doi: 10.1111/head.14411

Key clinical point: Erenumab may serve as an effective and well-tolerated therapeutic agent for migraine prophylaxis.

Major finding: Compared with placebo, 28 mg (mean difference [MD] −1.1; P = .02), 70 mg (MD −1.4; P < .001), and 140 mg (MD −1.8; P < .001) erenumab led to significant reductions in monthly migraine days at 12 weeks, with each erenumab dose being associated with a significantly higher proportion of patients achieving ≥50% reduction in migraine days (all P < .001) and similar risk for adverse events.

Study details: This was a systematic review and meta-analysis of eight randomized controlled trials including 4860 patients with migraine who received erenumab (7, 21, 28, 70, or 140 mg) or placebo.

Disclosures: This study was funded by the Jiangsu Province Key Research and Development Program, National Natural Science Foundation of China, and Natural Science Foundation of Jiangsu Province. The authors declared no conflicts of interest.

Source: Gui T, Li H et al. Different dosage regimens of erenumab for the treatment of migraine: A systematic review and meta-analysis of the efficacy and safety of randomized controlled trials. Headache. 2022;62(10):1281-1292 (Nov 14). Doi: 10.1111/head.14423

Key clinical point: Erenumab may serve as an effective and well-tolerated therapeutic agent for migraine prophylaxis.

Major finding: Compared with placebo, 28 mg (mean difference [MD] −1.1; P = .02), 70 mg (MD −1.4; P < .001), and 140 mg (MD −1.8; P < .001) erenumab led to significant reductions in monthly migraine days at 12 weeks, with each erenumab dose being associated with a significantly higher proportion of patients achieving ≥50% reduction in migraine days (all P < .001) and similar risk for adverse events.

Study details: This was a systematic review and meta-analysis of eight randomized controlled trials including 4860 patients with migraine who received erenumab (7, 21, 28, 70, or 140 mg) or placebo.

Disclosures: This study was funded by the Jiangsu Province Key Research and Development Program, National Natural Science Foundation of China, and Natural Science Foundation of Jiangsu Province. The authors declared no conflicts of interest.

Source: Gui T, Li H et al. Different dosage regimens of erenumab for the treatment of migraine: A systematic review and meta-analysis of the efficacy and safety of randomized controlled trials. Headache. 2022;62(10):1281-1292 (Nov 14). Doi: 10.1111/head.14423

Key clinical point: Erenumab may serve as an effective and well-tolerated therapeutic agent for migraine prophylaxis.

Major finding: Compared with placebo, 28 mg (mean difference [MD] −1.1; P = .02), 70 mg (MD −1.4; P < .001), and 140 mg (MD −1.8; P < .001) erenumab led to significant reductions in monthly migraine days at 12 weeks, with each erenumab dose being associated with a significantly higher proportion of patients achieving ≥50% reduction in migraine days (all P < .001) and similar risk for adverse events.

Study details: This was a systematic review and meta-analysis of eight randomized controlled trials including 4860 patients with migraine who received erenumab (7, 21, 28, 70, or 140 mg) or placebo.

Disclosures: This study was funded by the Jiangsu Province Key Research and Development Program, National Natural Science Foundation of China, and Natural Science Foundation of Jiangsu Province. The authors declared no conflicts of interest.

Source: Gui T, Li H et al. Different dosage regimens of erenumab for the treatment of migraine: A systematic review and meta-analysis of the efficacy and safety of randomized controlled trials. Headache. 2022;62(10):1281-1292 (Nov 14). Doi: 10.1111/head.14423

Key clinical point: High quality diet and higher total intake of phytochemicals and polyphenols are significantly associated with lower migraine severity in patients with episodic migraine.

Major finding: Migraine severity was negatively correlated with the intake of good quality diet (correlation coefficient [r] −0.37; P = .0003) and higher intake of phytochemicals (r −0.37; P = .0003) and phenolic components, such as flavanones (r −0.27; P = .01) and lignans (r −0.27; P = .01). The total intake of phenols and flavonoids from olive oil, oil, and fruits was also significantly negatively correlated with migraine severity (each P ≤ .04).

Study details: This questionnaire-based study included 90 patients with episodic migraine who were assessed for their migraine characteristics and dietary phytochemical and polyphenol intake.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Bakırhan H et al. Migraine severity, disability, and duration: Is a good diet quality, high intake of phytochemicals and polyphenols important? Front Nutr. 2022;9:1041907 (Nov 21). Doi: 10.3389/fnut.2022.1041907

Key clinical point: High quality diet and higher total intake of phytochemicals and polyphenols are significantly associated with lower migraine severity in patients with episodic migraine.

Major finding: Migraine severity was negatively correlated with the intake of good quality diet (correlation coefficient [r] −0.37; P = .0003) and higher intake of phytochemicals (r −0.37; P = .0003) and phenolic components, such as flavanones (r −0.27; P = .01) and lignans (r −0.27; P = .01). The total intake of phenols and flavonoids from olive oil, oil, and fruits was also significantly negatively correlated with migraine severity (each P ≤ .04).

Study details: This questionnaire-based study included 90 patients with episodic migraine who were assessed for their migraine characteristics and dietary phytochemical and polyphenol intake.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Bakırhan H et al. Migraine severity, disability, and duration: Is a good diet quality, high intake of phytochemicals and polyphenols important? Front Nutr. 2022;9:1041907 (Nov 21). Doi: 10.3389/fnut.2022.1041907

Key clinical point: High quality diet and higher total intake of phytochemicals and polyphenols are significantly associated with lower migraine severity in patients with episodic migraine.

Major finding: Migraine severity was negatively correlated with the intake of good quality diet (correlation coefficient [r] −0.37; P = .0003) and higher intake of phytochemicals (r −0.37; P = .0003) and phenolic components, such as flavanones (r −0.27; P = .01) and lignans (r −0.27; P = .01). The total intake of phenols and flavonoids from olive oil, oil, and fruits was also significantly negatively correlated with migraine severity (each P ≤ .04).

Study details: This questionnaire-based study included 90 patients with episodic migraine who were assessed for their migraine characteristics and dietary phytochemical and polyphenol intake.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Bakırhan H et al. Migraine severity, disability, and duration: Is a good diet quality, high intake of phytochemicals and polyphenols important? Front Nutr. 2022;9:1041907 (Nov 21). Doi: 10.3389/fnut.2022.1041907

Key clinical point: The first two administrations of onabotulinum toxin A (onabotA) were well-tolerated in patients with chronic migraine, with adverse events (AE) being mostly mild and tolerability to onabotA not being correlated with AE or clinical response.

Major finding: The mean tolerability scores were 7.8/10 and 7.2/10 in the first and second onabotA administration sessions, respectively, with no association being observed between tolerability and AE occurrence or clinical response. The AE were mostly mild and were reported by 71.4% and 68.6% of patients after the first and second onabotA administration sessions, respectively; 49.5% of patients showed a 50% response rate between weeks 20 and 24.

Study details: This was an observational prospective cohort study including 105 patients with chronic migraine who had received onabotA for the first time.

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

Source: García-Azorín D et al. Real-world evaluation of the tolerability to onabotulinum toxin A: The RETO study. Toxins (Basel). 2022;14(12),850 (Dec 3). Doi: 10.3390/toxins14120850.

Key clinical point: The first two administrations of onabotulinum toxin A (onabotA) were well-tolerated in patients with chronic migraine, with adverse events (AE) being mostly mild and tolerability to onabotA not being correlated with AE or clinical response.

Major finding: The mean tolerability scores were 7.8/10 and 7.2/10 in the first and second onabotA administration sessions, respectively, with no association being observed between tolerability and AE occurrence or clinical response. The AE were mostly mild and were reported by 71.4% and 68.6% of patients after the first and second onabotA administration sessions, respectively; 49.5% of patients showed a 50% response rate between weeks 20 and 24.

Study details: This was an observational prospective cohort study including 105 patients with chronic migraine who had received onabotA for the first time.

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

Source: García-Azorín D et al. Real-world evaluation of the tolerability to onabotulinum toxin A: The RETO study. Toxins (Basel). 2022;14(12),850 (Dec 3). Doi: 10.3390/toxins14120850.

Key clinical point: The first two administrations of onabotulinum toxin A (onabotA) were well-tolerated in patients with chronic migraine, with adverse events (AE) being mostly mild and tolerability to onabotA not being correlated with AE or clinical response.

Major finding: The mean tolerability scores were 7.8/10 and 7.2/10 in the first and second onabotA administration sessions, respectively, with no association being observed between tolerability and AE occurrence or clinical response. The AE were mostly mild and were reported by 71.4% and 68.6% of patients after the first and second onabotA administration sessions, respectively; 49.5% of patients showed a 50% response rate between weeks 20 and 24.

Study details: This was an observational prospective cohort study including 105 patients with chronic migraine who had received onabotA for the first time.

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

Source: García-Azorín D et al. Real-world evaluation of the tolerability to onabotulinum toxin A: The RETO study. Toxins (Basel). 2022;14(12),850 (Dec 3). Doi: 10.3390/toxins14120850.

Key clinical point: Erenumab demonstrated an early onset of and superior efficacy in achieving ≥50% reduction in monthly migraine days (MMD) than topiramate in patients with migraine.

Major finding: A significantly higher proportion of patients receiving erenumab vs topiramate reported ≥50% reduction in MMD at 1 month (39.2% vs 24.0%) and during the last 3 months (60.3% vs 43.3%) of treatment (both P < .001). Reductions in MMD over last 3 months were significantly higher with erenumab vs topiramate (mean difference −1.24 days; P < .001).

Study details: This post hoc analysis of the phase 4 HER-MES trial included 776 patients with migraine who were naive to migraine prophylactics or had failed or were ill-suited for metoprolol/propranolol, amitriptyline, or flunarizine and were randomized to receive erenumab (70 or 140 mg/month) or topiramate (50-100 mg/day).

Disclosures: This study was funded by Novartis Pharma GmbH, Germany. Four authors, including the first author, declared being employees of and holding stocks in Novartis. U Reuter reported receiving grants, personal fees, and other supports from Novartis and various other sources.

Source: Ehrlich M et al. Erenumab versus topiramate: Post hoc efficacy analysis from the HER‑MES study. J Headache Pain. 2022;23:141 (Nov 15). Doi: 10.1186/s10194-022-01511-y

Key clinical point: Erenumab demonstrated an early onset of and superior efficacy in achieving ≥50% reduction in monthly migraine days (MMD) than topiramate in patients with migraine.

Major finding: A significantly higher proportion of patients receiving erenumab vs topiramate reported ≥50% reduction in MMD at 1 month (39.2% vs 24.0%) and during the last 3 months (60.3% vs 43.3%) of treatment (both P < .001). Reductions in MMD over last 3 months were significantly higher with erenumab vs topiramate (mean difference −1.24 days; P < .001).

Study details: This post hoc analysis of the phase 4 HER-MES trial included 776 patients with migraine who were naive to migraine prophylactics or had failed or were ill-suited for metoprolol/propranolol, amitriptyline, or flunarizine and were randomized to receive erenumab (70 or 140 mg/month) or topiramate (50-100 mg/day).

Disclosures: This study was funded by Novartis Pharma GmbH, Germany. Four authors, including the first author, declared being employees of and holding stocks in Novartis. U Reuter reported receiving grants, personal fees, and other supports from Novartis and various other sources.

Source: Ehrlich M et al. Erenumab versus topiramate: Post hoc efficacy analysis from the HER‑MES study. J Headache Pain. 2022;23:141 (Nov 15). Doi: 10.1186/s10194-022-01511-y

Key clinical point: Erenumab demonstrated an early onset of and superior efficacy in achieving ≥50% reduction in monthly migraine days (MMD) than topiramate in patients with migraine.

Major finding: A significantly higher proportion of patients receiving erenumab vs topiramate reported ≥50% reduction in MMD at 1 month (39.2% vs 24.0%) and during the last 3 months (60.3% vs 43.3%) of treatment (both P < .001). Reductions in MMD over last 3 months were significantly higher with erenumab vs topiramate (mean difference −1.24 days; P < .001).

Study details: This post hoc analysis of the phase 4 HER-MES trial included 776 patients with migraine who were naive to migraine prophylactics or had failed or were ill-suited for metoprolol/propranolol, amitriptyline, or flunarizine and were randomized to receive erenumab (70 or 140 mg/month) or topiramate (50-100 mg/day).

Disclosures: This study was funded by Novartis Pharma GmbH, Germany. Four authors, including the first author, declared being employees of and holding stocks in Novartis. U Reuter reported receiving grants, personal fees, and other supports from Novartis and various other sources.

Source: Ehrlich M et al. Erenumab versus topiramate: Post hoc efficacy analysis from the HER‑MES study. J Headache Pain. 2022;23:141 (Nov 15). Doi: 10.1186/s10194-022-01511-y