Clinical Edge Journal Scan

Key clinical point: Ribociclib plus a nonsteroidal aromatase inhibitor (NSAI) vs NSAI alone for 3 years significantly improved invasive disease-free survival in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) early breast cancer (BC).

Major finding: At 3 years, ribociclib + NSAI vs NSAI alone led to a 25.2% lower risk for invasive disease, recurrence, or death (hazard ratio 0.75; two-sided P = .003), with an absolute invasive disease-free survival benefit of 3.3% (90.4% vs 87.1%). No new safety signals were reported.

Study details: This prespecified interim analysis of the phase 3 NATALEE trial included 5101 patients with HR+/HER2− stage II or III early BC who were randomly assigned to receive ribociclib (dosage 400 mg/day for 21 consecutive days followed by 7 days off; duration 36 months) in combination with an NSAI or NSAI alone.

Disclosures: The trial was funded by Novartis. Six authors declared being employees of or holding stocks in Novartis. Several authors declared ties with various sources, including Novartis.

Source: Slamon D, Lipatov O, Nowecki Z, et al. Ribociclib plus endocrine therapy in early breast cancer. N Engl J Med. 2024;390:1080-1091 (Mar 20). doi: 10.1056/NEJMoa2305488 Source

Key clinical point: Ribociclib plus a nonsteroidal aromatase inhibitor (NSAI) vs NSAI alone for 3 years significantly improved invasive disease-free survival in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) early breast cancer (BC).

Major finding: At 3 years, ribociclib + NSAI vs NSAI alone led to a 25.2% lower risk for invasive disease, recurrence, or death (hazard ratio 0.75; two-sided P = .003), with an absolute invasive disease-free survival benefit of 3.3% (90.4% vs 87.1%). No new safety signals were reported.

Study details: This prespecified interim analysis of the phase 3 NATALEE trial included 5101 patients with HR+/HER2− stage II or III early BC who were randomly assigned to receive ribociclib (dosage 400 mg/day for 21 consecutive days followed by 7 days off; duration 36 months) in combination with an NSAI or NSAI alone.

Disclosures: The trial was funded by Novartis. Six authors declared being employees of or holding stocks in Novartis. Several authors declared ties with various sources, including Novartis.

Source: Slamon D, Lipatov O, Nowecki Z, et al. Ribociclib plus endocrine therapy in early breast cancer. N Engl J Med. 2024;390:1080-1091 (Mar 20). doi: 10.1056/NEJMoa2305488 Source

Key clinical point: Ribociclib plus a nonsteroidal aromatase inhibitor (NSAI) vs NSAI alone for 3 years significantly improved invasive disease-free survival in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) early breast cancer (BC).

Major finding: At 3 years, ribociclib + NSAI vs NSAI alone led to a 25.2% lower risk for invasive disease, recurrence, or death (hazard ratio 0.75; two-sided P = .003), with an absolute invasive disease-free survival benefit of 3.3% (90.4% vs 87.1%). No new safety signals were reported.

Study details: This prespecified interim analysis of the phase 3 NATALEE trial included 5101 patients with HR+/HER2− stage II or III early BC who were randomly assigned to receive ribociclib (dosage 400 mg/day for 21 consecutive days followed by 7 days off; duration 36 months) in combination with an NSAI or NSAI alone.

Disclosures: The trial was funded by Novartis. Six authors declared being employees of or holding stocks in Novartis. Several authors declared ties with various sources, including Novartis.

Source: Slamon D, Lipatov O, Nowecki Z, et al. Ribociclib plus endocrine therapy in early breast cancer. N Engl J Med. 2024;390:1080-1091 (Mar 20). doi: 10.1056/NEJMoa2305488 Source

Key clinical point: Recurrence-free survival after sentinel lymph node biopsy (SLNB) yielded noninferior outcomes compared to complete axillary lymph node dissection (ALND) in patients with clinically node-negative breast cancer (BC) and one or two sentinel-node macrometastases.

Major finding: The estimated 5-year recurrence-free survival was comparable in the SLNB alone vs completion ALND group (89.7% [95% CI 87.5%-91.9%] vs 88.7% [95% CI 86.3%-91.1%]), with the hazard ratio for recurrence or death being significantly below the noninferiority margin (0.89; P < .001 for non-inferiority).

Study details: Findings are from the noninferiority trial, SENOMAC, which included 2540 patients with clinically node-negative primary T1 to T3 BC with one or two sentinel lymph-node macrometastases who were randomly assigned to undergo SLNB alone (n = 1335) or completion ALND (n = 1205).

Disclosures: This study was supported by the Swedish Research Council and others. Oreste D. Gentilini declared serving as a consultant for various sources. The other authors declared no conflicts of interest.

Source: de Boniface J, Tvedskov TF, Rydén L, et al, for the SENOMAC Trialists’ Group. Omitting axillary dissection in breast cancer with sentinel-node metastases. N Engl J Med. 2024;390:1163-1175 (Apr 3). doi: 10.1056/NEJMoa2313487 Source

Key clinical point: Recurrence-free survival after sentinel lymph node biopsy (SLNB) yielded noninferior outcomes compared to complete axillary lymph node dissection (ALND) in patients with clinically node-negative breast cancer (BC) and one or two sentinel-node macrometastases.

Major finding: The estimated 5-year recurrence-free survival was comparable in the SLNB alone vs completion ALND group (89.7% [95% CI 87.5%-91.9%] vs 88.7% [95% CI 86.3%-91.1%]), with the hazard ratio for recurrence or death being significantly below the noninferiority margin (0.89; P < .001 for non-inferiority).

Study details: Findings are from the noninferiority trial, SENOMAC, which included 2540 patients with clinically node-negative primary T1 to T3 BC with one or two sentinel lymph-node macrometastases who were randomly assigned to undergo SLNB alone (n = 1335) or completion ALND (n = 1205).

Disclosures: This study was supported by the Swedish Research Council and others. Oreste D. Gentilini declared serving as a consultant for various sources. The other authors declared no conflicts of interest.

Source: de Boniface J, Tvedskov TF, Rydén L, et al, for the SENOMAC Trialists’ Group. Omitting axillary dissection in breast cancer with sentinel-node metastases. N Engl J Med. 2024;390:1163-1175 (Apr 3). doi: 10.1056/NEJMoa2313487 Source

Key clinical point: Recurrence-free survival after sentinel lymph node biopsy (SLNB) yielded noninferior outcomes compared to complete axillary lymph node dissection (ALND) in patients with clinically node-negative breast cancer (BC) and one or two sentinel-node macrometastases.

Major finding: The estimated 5-year recurrence-free survival was comparable in the SLNB alone vs completion ALND group (89.7% [95% CI 87.5%-91.9%] vs 88.7% [95% CI 86.3%-91.1%]), with the hazard ratio for recurrence or death being significantly below the noninferiority margin (0.89; P < .001 for non-inferiority).

Study details: Findings are from the noninferiority trial, SENOMAC, which included 2540 patients with clinically node-negative primary T1 to T3 BC with one or two sentinel lymph-node macrometastases who were randomly assigned to undergo SLNB alone (n = 1335) or completion ALND (n = 1205).

Disclosures: This study was supported by the Swedish Research Council and others. Oreste D. Gentilini declared serving as a consultant for various sources. The other authors declared no conflicts of interest.

Source: de Boniface J, Tvedskov TF, Rydén L, et al, for the SENOMAC Trialists’ Group. Omitting axillary dissection in breast cancer with sentinel-node metastases. N Engl J Med. 2024;390:1163-1175 (Apr 3). doi: 10.1056/NEJMoa2313487 Source

A recent study, published in the March 2024 issue of Sleep Medicine, identified shift work as one of the risk factors for headache and migraine. The researchers conducted a meta-analysis, including seven studies and involving 422,869 participants. The authors defined shift work as characterized by individuals or teams working consecutively to exceed the standard 8-hour day. They reported that the pooled analysis revealed a significant association between shift work and an increased risk for headache. Specifically, they determined that "individuals working night shifts had a 44% higher risk of developing headaches and a higher incidence of migraines." The authors stated that this association did not establish any causal relationship, and they suggested that future research should investigate the impact of genetics or health behaviors, which could be considered shared risk factors.

An article that had been published in 2019 in Headache included two case reports detailing the effects of shift work on patients with migraine. The authors of the case reports stated that "in the two cases presented, shift work appeared to be associated with chronification of migraine and higher headache-related disability, despite optimal headache management and good patient adherence."^[1] They observed that "a switch to only day shifts promoted transition to an episodic, less disabling pattern of migraine."^[1] These publications both support the idea that, while patients may have an underlying predisposition to migraine, certain lifestyle factors can play a role in exacerbating symptoms.

Erenumab, one of the relatively new therapies for migraine, was found to have a potential link to worsening hypertension. According to an article published in February in Headache: The Journal of Head and Face Pain, there has not been evidence of hypertension in preclinical models or clinical trials, yet postmarketing data suggest that erenumab may be associated with hypertension. The authors conducted an observational retrospective cohort study that included 335 patients who had been seen at a tertiary headache or neurology department. At baseline, 20.9% (70/335) of patients had a prior diagnosis of hypertension. The researchers observed that 23.3% (78/335) of the patients were found to have worsening hypertension, and 13 patients of the 225 who continued on erenumab experienced an improvement in their blood pressure. The authors noted that there was no association between worsening hypertension and preexisting hypertension, sex, body mass index, or age, but patients with atrial fibrillation were more likely to develop worsening hypertension (odds ratio 4.9; 95% CI 1.12-21.4; P = .035).

Consideration of a relationship between hypertension and anti-calcitonin gene–related peptide migraine (CGRP) therapies has been found in other studies as well. Results of a retrospective study conducted at the University Hospital of Modena, to explore the rate of hypertension among patients treated with anti-CGRP monoclonal antibodies, were published in April 2024 in Neurological Sciences (published online November 6, 2023). Those authors reported that no significant increase in blood pressure was detected overall, yet 5.7% of the patients developed a significant increase in their blood pressure.^[2] Specifically, the researchers reported that patients with preexisting hypertension were more likely to have a significant increase in blood pressure.^[2] The study authors of the Neurological Sciences publication suggested that patients with preexisting hypertension should be cautiously monitored for signs of hypertension. A more recent publication noted that "CGRP is involved in the regulation of vasomotor tone under physiologic and pathologic conditions, including hypertension," which could explain these findings. As the two studies noted different underlying risk factors for hypertension for patients taking anti-CGRP migraine therapies, it is important to monitor patients for signs of hypertension regardless of their underlying cardiovascular status.

Migraine was also noted to potentially be associated with an increased risk for cerebrovascular disease and stroke among women who have underlying cardiovascular disease risk factors. According to a cross-sectional analysis whose results were published in Mayo Clinic Proceedings in May 2023, women with migraine were significantly more likely to have severe hot flashes compared with women without migraine.^[3] Additionally, the authors stated that migraine was associated with a diagnosis of hypertension.^[3]

Results of a secondary data analysis of a subset of 1954 women in the Coronary Artery Risk Development in Young Adults (CARDIA) study were published in the April 2024 issue of Menopause. After adjustment for age, race, estrogen use, oophorectomy, and hysterectomy, women with histories of migraine and persistent vasomotor symptoms were found to have a greater risk for cerebrovascular disease (hazard ratio [HR] 2.25; 95% CI 1.15-4.38), and stroke (HR 3.15; 95% CI 1.35-7.34), compared with women without migraine histories and with minimal vasomotor symptoms. After adjustment for cerebrovascular disease risk factors, the associations between migraine/vasomotor symptoms and cerebrovascular disease were attenuated (HR 1.51; 95% CI 0.73-3.10), and associations between migraine/vasomotor symptoms and stroke were similarly attenuated (HR 1.70; 95% CI 0.66-4.38). The authors of this research article concluded that migraine and persistent vasomotor symptoms are jointly associated with greater risk for cerebrovascular disease and stroke, particularly for women who already have traditional risk factors for cerebrovascular disease.

This new research brings the importance of managing migraine risk factors and symptoms to the forefront. Patients who experience migraine may have a higher risk for cerebrovascular disease. Minimizing migraine risk factors could potentially help reduce this risk for cerebrovascular disease for some patients, and effectively treating migraines may also play a role in reducing the risk for cerebrovascular disease. Some migraine therapies could worsen cardiovascular disease for some patients, however — particularly patients who already have underlying risk factors. Therefore, it is crucial for physicians to approach migraine care with a comprehensive strategy to reduce risk factors, assess underlying disease, and monitor for comorbidities.

Additional References

1. Sandoe CH, Sasikumar S, Lay C, Lawler V. The impact of shift work on migraine: A case series and narrative review. Headache. 2019;59:1631-1640. doi: 10.1111/head.13622  Source

2. Guerzoni S, Castro FL, Brovia D, Baraldi C, Pani L. Evaluation of the risk of hypertension in patients treated with anti-CGRP monoclonal antibodies in a real-life study. Neurol Sci. 2024;45:1661-1668. doi: 10.1007/s10072-023-07167-z Source

3. Faubion SS, Smith T, Thielen J, et al. Association of migraine and vasomotor symptoms. Mayo Clin Proc. 2023;98:701-712. doi: 10.1016/j.mayocp.2023.01.010 Source

A recent study, published in the March 2024 issue of Sleep Medicine, identified shift work as one of the risk factors for headache and migraine. The researchers conducted a meta-analysis, including seven studies and involving 422,869 participants. The authors defined shift work as characterized by individuals or teams working consecutively to exceed the standard 8-hour day. They reported that the pooled analysis revealed a significant association between shift work and an increased risk for headache. Specifically, they determined that "individuals working night shifts had a 44% higher risk of developing headaches and a higher incidence of migraines." The authors stated that this association did not establish any causal relationship, and they suggested that future research should investigate the impact of genetics or health behaviors, which could be considered shared risk factors.

An article that had been published in 2019 in Headache included two case reports detailing the effects of shift work on patients with migraine. The authors of the case reports stated that "in the two cases presented, shift work appeared to be associated with chronification of migraine and higher headache-related disability, despite optimal headache management and good patient adherence."^[1] They observed that "a switch to only day shifts promoted transition to an episodic, less disabling pattern of migraine."^[1] These publications both support the idea that, while patients may have an underlying predisposition to migraine, certain lifestyle factors can play a role in exacerbating symptoms.

Erenumab, one of the relatively new therapies for migraine, was found to have a potential link to worsening hypertension. According to an article published in February in Headache: The Journal of Head and Face Pain, there has not been evidence of hypertension in preclinical models or clinical trials, yet postmarketing data suggest that erenumab may be associated with hypertension. The authors conducted an observational retrospective cohort study that included 335 patients who had been seen at a tertiary headache or neurology department. At baseline, 20.9% (70/335) of patients had a prior diagnosis of hypertension. The researchers observed that 23.3% (78/335) of the patients were found to have worsening hypertension, and 13 patients of the 225 who continued on erenumab experienced an improvement in their blood pressure. The authors noted that there was no association between worsening hypertension and preexisting hypertension, sex, body mass index, or age, but patients with atrial fibrillation were more likely to develop worsening hypertension (odds ratio 4.9; 95% CI 1.12-21.4; P = .035).

Consideration of a relationship between hypertension and anti-calcitonin gene–related peptide migraine (CGRP) therapies has been found in other studies as well. Results of a retrospective study conducted at the University Hospital of Modena, to explore the rate of hypertension among patients treated with anti-CGRP monoclonal antibodies, were published in April 2024 in Neurological Sciences (published online November 6, 2023). Those authors reported that no significant increase in blood pressure was detected overall, yet 5.7% of the patients developed a significant increase in their blood pressure.^[2] Specifically, the researchers reported that patients with preexisting hypertension were more likely to have a significant increase in blood pressure.^[2] The study authors of the Neurological Sciences publication suggested that patients with preexisting hypertension should be cautiously monitored for signs of hypertension. A more recent publication noted that "CGRP is involved in the regulation of vasomotor tone under physiologic and pathologic conditions, including hypertension," which could explain these findings. As the two studies noted different underlying risk factors for hypertension for patients taking anti-CGRP migraine therapies, it is important to monitor patients for signs of hypertension regardless of their underlying cardiovascular status.

Migraine was also noted to potentially be associated with an increased risk for cerebrovascular disease and stroke among women who have underlying cardiovascular disease risk factors. According to a cross-sectional analysis whose results were published in Mayo Clinic Proceedings in May 2023, women with migraine were significantly more likely to have severe hot flashes compared with women without migraine.^[3] Additionally, the authors stated that migraine was associated with a diagnosis of hypertension.^[3]

Results of a secondary data analysis of a subset of 1954 women in the Coronary Artery Risk Development in Young Adults (CARDIA) study were published in the April 2024 issue of Menopause. After adjustment for age, race, estrogen use, oophorectomy, and hysterectomy, women with histories of migraine and persistent vasomotor symptoms were found to have a greater risk for cerebrovascular disease (hazard ratio [HR] 2.25; 95% CI 1.15-4.38), and stroke (HR 3.15; 95% CI 1.35-7.34), compared with women without migraine histories and with minimal vasomotor symptoms. After adjustment for cerebrovascular disease risk factors, the associations between migraine/vasomotor symptoms and cerebrovascular disease were attenuated (HR 1.51; 95% CI 0.73-3.10), and associations between migraine/vasomotor symptoms and stroke were similarly attenuated (HR 1.70; 95% CI 0.66-4.38). The authors of this research article concluded that migraine and persistent vasomotor symptoms are jointly associated with greater risk for cerebrovascular disease and stroke, particularly for women who already have traditional risk factors for cerebrovascular disease.

This new research brings the importance of managing migraine risk factors and symptoms to the forefront. Patients who experience migraine may have a higher risk for cerebrovascular disease. Minimizing migraine risk factors could potentially help reduce this risk for cerebrovascular disease for some patients, and effectively treating migraines may also play a role in reducing the risk for cerebrovascular disease. Some migraine therapies could worsen cardiovascular disease for some patients, however — particularly patients who already have underlying risk factors. Therefore, it is crucial for physicians to approach migraine care with a comprehensive strategy to reduce risk factors, assess underlying disease, and monitor for comorbidities.

Additional References

1. Sandoe CH, Sasikumar S, Lay C, Lawler V. The impact of shift work on migraine: A case series and narrative review. Headache. 2019;59:1631-1640. doi: 10.1111/head.13622  Source

2. Guerzoni S, Castro FL, Brovia D, Baraldi C, Pani L. Evaluation of the risk of hypertension in patients treated with anti-CGRP monoclonal antibodies in a real-life study. Neurol Sci. 2024;45:1661-1668. doi: 10.1007/s10072-023-07167-z Source

3. Faubion SS, Smith T, Thielen J, et al. Association of migraine and vasomotor symptoms. Mayo Clin Proc. 2023;98:701-712. doi: 10.1016/j.mayocp.2023.01.010 Source

A recent study, published in the March 2024 issue of Sleep Medicine, identified shift work as one of the risk factors for headache and migraine. The researchers conducted a meta-analysis, including seven studies and involving 422,869 participants. The authors defined shift work as characterized by individuals or teams working consecutively to exceed the standard 8-hour day. They reported that the pooled analysis revealed a significant association between shift work and an increased risk for headache. Specifically, they determined that "individuals working night shifts had a 44% higher risk of developing headaches and a higher incidence of migraines." The authors stated that this association did not establish any causal relationship, and they suggested that future research should investigate the impact of genetics or health behaviors, which could be considered shared risk factors.

An article that had been published in 2019 in Headache included two case reports detailing the effects of shift work on patients with migraine. The authors of the case reports stated that "in the two cases presented, shift work appeared to be associated with chronification of migraine and higher headache-related disability, despite optimal headache management and good patient adherence."^[1] They observed that "a switch to only day shifts promoted transition to an episodic, less disabling pattern of migraine."^[1] These publications both support the idea that, while patients may have an underlying predisposition to migraine, certain lifestyle factors can play a role in exacerbating symptoms.

Erenumab, one of the relatively new therapies for migraine, was found to have a potential link to worsening hypertension. According to an article published in February in Headache: The Journal of Head and Face Pain, there has not been evidence of hypertension in preclinical models or clinical trials, yet postmarketing data suggest that erenumab may be associated with hypertension. The authors conducted an observational retrospective cohort study that included 335 patients who had been seen at a tertiary headache or neurology department. At baseline, 20.9% (70/335) of patients had a prior diagnosis of hypertension. The researchers observed that 23.3% (78/335) of the patients were found to have worsening hypertension, and 13 patients of the 225 who continued on erenumab experienced an improvement in their blood pressure. The authors noted that there was no association between worsening hypertension and preexisting hypertension, sex, body mass index, or age, but patients with atrial fibrillation were more likely to develop worsening hypertension (odds ratio 4.9; 95% CI 1.12-21.4; P = .035).

Consideration of a relationship between hypertension and anti-calcitonin gene–related peptide migraine (CGRP) therapies has been found in other studies as well. Results of a retrospective study conducted at the University Hospital of Modena, to explore the rate of hypertension among patients treated with anti-CGRP monoclonal antibodies, were published in April 2024 in Neurological Sciences (published online November 6, 2023). Those authors reported that no significant increase in blood pressure was detected overall, yet 5.7% of the patients developed a significant increase in their blood pressure.^[2] Specifically, the researchers reported that patients with preexisting hypertension were more likely to have a significant increase in blood pressure.^[2] The study authors of the Neurological Sciences publication suggested that patients with preexisting hypertension should be cautiously monitored for signs of hypertension. A more recent publication noted that "CGRP is involved in the regulation of vasomotor tone under physiologic and pathologic conditions, including hypertension," which could explain these findings. As the two studies noted different underlying risk factors for hypertension for patients taking anti-CGRP migraine therapies, it is important to monitor patients for signs of hypertension regardless of their underlying cardiovascular status.

Migraine was also noted to potentially be associated with an increased risk for cerebrovascular disease and stroke among women who have underlying cardiovascular disease risk factors. According to a cross-sectional analysis whose results were published in Mayo Clinic Proceedings in May 2023, women with migraine were significantly more likely to have severe hot flashes compared with women without migraine.^[3] Additionally, the authors stated that migraine was associated with a diagnosis of hypertension.^[3]

Results of a secondary data analysis of a subset of 1954 women in the Coronary Artery Risk Development in Young Adults (CARDIA) study were published in the April 2024 issue of Menopause. After adjustment for age, race, estrogen use, oophorectomy, and hysterectomy, women with histories of migraine and persistent vasomotor symptoms were found to have a greater risk for cerebrovascular disease (hazard ratio [HR] 2.25; 95% CI 1.15-4.38), and stroke (HR 3.15; 95% CI 1.35-7.34), compared with women without migraine histories and with minimal vasomotor symptoms. After adjustment for cerebrovascular disease risk factors, the associations between migraine/vasomotor symptoms and cerebrovascular disease were attenuated (HR 1.51; 95% CI 0.73-3.10), and associations between migraine/vasomotor symptoms and stroke were similarly attenuated (HR 1.70; 95% CI 0.66-4.38). The authors of this research article concluded that migraine and persistent vasomotor symptoms are jointly associated with greater risk for cerebrovascular disease and stroke, particularly for women who already have traditional risk factors for cerebrovascular disease.

This new research brings the importance of managing migraine risk factors and symptoms to the forefront. Patients who experience migraine may have a higher risk for cerebrovascular disease. Minimizing migraine risk factors could potentially help reduce this risk for cerebrovascular disease for some patients, and effectively treating migraines may also play a role in reducing the risk for cerebrovascular disease. Some migraine therapies could worsen cardiovascular disease for some patients, however — particularly patients who already have underlying risk factors. Therefore, it is crucial for physicians to approach migraine care with a comprehensive strategy to reduce risk factors, assess underlying disease, and monitor for comorbidities.

Additional References

1. Sandoe CH, Sasikumar S, Lay C, Lawler V. The impact of shift work on migraine: A case series and narrative review. Headache. 2019;59:1631-1640. doi: 10.1111/head.13622  Source

2. Guerzoni S, Castro FL, Brovia D, Baraldi C, Pani L. Evaluation of the risk of hypertension in patients treated with anti-CGRP monoclonal antibodies in a real-life study. Neurol Sci. 2024;45:1661-1668. doi: 10.1007/s10072-023-07167-z Source

3. Faubion SS, Smith T, Thielen J, et al. Association of migraine and vasomotor symptoms. Mayo Clin Proc. 2023;98:701-712. doi: 10.1016/j.mayocp.2023.01.010 Source

After PsA onset, early diagnosis and management leads to better long-term outcomes. These prior observations were confirmed in a study by Snoeck Henkemans and colleagues that included 708 newly diagnosed patients with PsA naive to disease-modifying antirheumatic drugs (DMARD) who were followed up for 3 years or more. Patients with a short (<12 weeks) vs long delay (>1 year) in PsA diagnosis after symptom onset were more likely to achieve minimum disease activity (OR 2.55; 95% CI 1.37-4.76). Thus, longer delay in diagnosing PsA is associated with worse clinical outcomes.

Bimekizumab is a novel biologic therapy that inhibits interleukins (IL)-17A and -17F and is efficacious in the treatment of psoriasis, PsA, and axial spondyloarthritis. However, the effectiveness in PsA vis-à-vis other IL-17A inhibitors is not known. In the absence of a formal head-to-head study, matching-adjusted indirect comparisons is a method to evaluate comparative effectiveness. Such a study by Mease and colleagues included the data of patients with PsA who were biological DMARD–naive or who had an inadequate response to tumor necrosis factor inhibitors (TNFi-IR), and who received bimekizumab from the BE OPTIMAL (n = 236) and BE COMPLETE (n = 146) trials and secukinumab from the FUTURE 2 trial (n = 200). They demonstrated that, in the biological DMARD–naive subgroup, the probability of achieving at least 70% improvement in American College of Rheumatology (ACR) response was two times higher with bimekizumab (160 mg every 4 weeks) vs secukinumab (150 mg or 300 mg every 4 weeks) at week 52. In the TNFi-IR subgroup, bimekizumab had a greater likelihood of response compared with 150 mg secukinumab for ACR20, ACR70, and minimal disease activity outcomes and a greater likelihood of response compared with 300 mg secukinumab for ACR50 and minimal disease activity. Thus, bimekizumab is at least as effective as secukinumab in PsA. Formal head-to-head studies comparing bimekizumab with other IL-17A inhibitors are required.

Distal interphalangeal (DIP) joint involvement is an important manifestation of PsA and is closely related to nail dystrophy in the adjacent nail. Ixekizumab is another biologic that targets IL-17A. In a post hoc analysis of the SPIRIT-H2H study, McGonagle and colleagues confirmed that over 96% of patients with PsA and simultaneous DIP joint involvement reported adjacent nail psoriasis. When compared with adalimumab, ixekizumab led to greater improvements in DIP involvement and adjacent nail psoriasis as early as week 12 (38.8% vs 28.4%; P < .0001), with improvements sustained up to week 52 (64.9% vs 57.5%; P = .0055). This probably reflects a greater effectiveness of IL-17A inhibition in treating skin and nail psoriasis compared with TNFi.

Finally, in a population-based retrospective cohort study that included 13,905 patients with PsA (n = 1672) or rheumatoid arthritis (n = 12,233) who did not have any previous history of major adverse cardiovascular events (MACE), Meng and colleagues showed that the incidence rates of MACE were similar in patients with PsA and rheumatoid arthritis. Thus, cardiovascular risk management should be similarly aggressive in patients with PsA and rheumatoid arthritis.

After PsA onset, early diagnosis and management leads to better long-term outcomes. These prior observations were confirmed in a study by Snoeck Henkemans and colleagues that included 708 newly diagnosed patients with PsA naive to disease-modifying antirheumatic drugs (DMARD) who were followed up for 3 years or more. Patients with a short (<12 weeks) vs long delay (>1 year) in PsA diagnosis after symptom onset were more likely to achieve minimum disease activity (OR 2.55; 95% CI 1.37-4.76). Thus, longer delay in diagnosing PsA is associated with worse clinical outcomes.

Bimekizumab is a novel biologic therapy that inhibits interleukins (IL)-17A and -17F and is efficacious in the treatment of psoriasis, PsA, and axial spondyloarthritis. However, the effectiveness in PsA vis-à-vis other IL-17A inhibitors is not known. In the absence of a formal head-to-head study, matching-adjusted indirect comparisons is a method to evaluate comparative effectiveness. Such a study by Mease and colleagues included the data of patients with PsA who were biological DMARD–naive or who had an inadequate response to tumor necrosis factor inhibitors (TNFi-IR), and who received bimekizumab from the BE OPTIMAL (n = 236) and BE COMPLETE (n = 146) trials and secukinumab from the FUTURE 2 trial (n = 200). They demonstrated that, in the biological DMARD–naive subgroup, the probability of achieving at least 70% improvement in American College of Rheumatology (ACR) response was two times higher with bimekizumab (160 mg every 4 weeks) vs secukinumab (150 mg or 300 mg every 4 weeks) at week 52. In the TNFi-IR subgroup, bimekizumab had a greater likelihood of response compared with 150 mg secukinumab for ACR20, ACR70, and minimal disease activity outcomes and a greater likelihood of response compared with 300 mg secukinumab for ACR50 and minimal disease activity. Thus, bimekizumab is at least as effective as secukinumab in PsA. Formal head-to-head studies comparing bimekizumab with other IL-17A inhibitors are required.

Distal interphalangeal (DIP) joint involvement is an important manifestation of PsA and is closely related to nail dystrophy in the adjacent nail. Ixekizumab is another biologic that targets IL-17A. In a post hoc analysis of the SPIRIT-H2H study, McGonagle and colleagues confirmed that over 96% of patients with PsA and simultaneous DIP joint involvement reported adjacent nail psoriasis. When compared with adalimumab, ixekizumab led to greater improvements in DIP involvement and adjacent nail psoriasis as early as week 12 (38.8% vs 28.4%; P < .0001), with improvements sustained up to week 52 (64.9% vs 57.5%; P = .0055). This probably reflects a greater effectiveness of IL-17A inhibition in treating skin and nail psoriasis compared with TNFi.

Finally, in a population-based retrospective cohort study that included 13,905 patients with PsA (n = 1672) or rheumatoid arthritis (n = 12,233) who did not have any previous history of major adverse cardiovascular events (MACE), Meng and colleagues showed that the incidence rates of MACE were similar in patients with PsA and rheumatoid arthritis. Thus, cardiovascular risk management should be similarly aggressive in patients with PsA and rheumatoid arthritis.

After PsA onset, early diagnosis and management leads to better long-term outcomes. These prior observations were confirmed in a study by Snoeck Henkemans and colleagues that included 708 newly diagnosed patients with PsA naive to disease-modifying antirheumatic drugs (DMARD) who were followed up for 3 years or more. Patients with a short (<12 weeks) vs long delay (>1 year) in PsA diagnosis after symptom onset were more likely to achieve minimum disease activity (OR 2.55; 95% CI 1.37-4.76). Thus, longer delay in diagnosing PsA is associated with worse clinical outcomes.

Bimekizumab is a novel biologic therapy that inhibits interleukins (IL)-17A and -17F and is efficacious in the treatment of psoriasis, PsA, and axial spondyloarthritis. However, the effectiveness in PsA vis-à-vis other IL-17A inhibitors is not known. In the absence of a formal head-to-head study, matching-adjusted indirect comparisons is a method to evaluate comparative effectiveness. Such a study by Mease and colleagues included the data of patients with PsA who were biological DMARD–naive or who had an inadequate response to tumor necrosis factor inhibitors (TNFi-IR), and who received bimekizumab from the BE OPTIMAL (n = 236) and BE COMPLETE (n = 146) trials and secukinumab from the FUTURE 2 trial (n = 200). They demonstrated that, in the biological DMARD–naive subgroup, the probability of achieving at least 70% improvement in American College of Rheumatology (ACR) response was two times higher with bimekizumab (160 mg every 4 weeks) vs secukinumab (150 mg or 300 mg every 4 weeks) at week 52. In the TNFi-IR subgroup, bimekizumab had a greater likelihood of response compared with 150 mg secukinumab for ACR20, ACR70, and minimal disease activity outcomes and a greater likelihood of response compared with 300 mg secukinumab for ACR50 and minimal disease activity. Thus, bimekizumab is at least as effective as secukinumab in PsA. Formal head-to-head studies comparing bimekizumab with other IL-17A inhibitors are required.

Distal interphalangeal (DIP) joint involvement is an important manifestation of PsA and is closely related to nail dystrophy in the adjacent nail. Ixekizumab is another biologic that targets IL-17A. In a post hoc analysis of the SPIRIT-H2H study, McGonagle and colleagues confirmed that over 96% of patients with PsA and simultaneous DIP joint involvement reported adjacent nail psoriasis. When compared with adalimumab, ixekizumab led to greater improvements in DIP involvement and adjacent nail psoriasis as early as week 12 (38.8% vs 28.4%; P < .0001), with improvements sustained up to week 52 (64.9% vs 57.5%; P = .0055). This probably reflects a greater effectiveness of IL-17A inhibition in treating skin and nail psoriasis compared with TNFi.

Finally, in a population-based retrospective cohort study that included 13,905 patients with PsA (n = 1672) or rheumatoid arthritis (n = 12,233) who did not have any previous history of major adverse cardiovascular events (MACE), Meng and colleagues showed that the incidence rates of MACE were similar in patients with PsA and rheumatoid arthritis. Thus, cardiovascular risk management should be similarly aggressive in patients with PsA and rheumatoid arthritis.

A positive family history of cancer and obesity are established risk factors for development of breast cancer among women.^[4,5] A population-based cohort study that included 15,055 Chinese women evaluated the association and interaction between body mass index (BMI) and family history of cancer on the risk for breast cancer (Cao et al). The incidence risk for breast cancer was highest in the group with obesity vs the group with normal weight (adjusted HR 2.09; 95% CI 1.42-3.07), and those with a family history of cancer also had an increased risk vs those without a family history of cancer (adjusted HR 1.63; 95% CI 1.22-2.49). Furthermore, women with a BMI ≥ 24 and family history of cancer had a higher risk for breast cancer development compared with women with a BMI < 24 and no family history of cancer (adjusted HR 2.06; 95% CI 1.39-3.06). This study indicates a heightened breast cancer risk when cancer family history and obesity coexist, suggesting the importance of addressing modifiable risk factors and targeting lifestyle interventions in this population.

Triple-negative breast cancer (TNBC), although exhibiting its own heterogeneity, has various features that differentiate this subtype from luminal breast cancers. For example, TNBC generally has a more aggressive course, increased responsiveness to chemotherapy, and earlier pattern of recurrence compared with hormone receptor–positive disease. Prior studies have also shown that established breast cancer risk factors reflect those for the luminal A subtype, whereas those for TNBC are less consistent.^[6] A meta-analysis that included 33 studies evaluated the association between traditional breast cancer risk factors and TNBC incidence (Kumar et al). Family history (odds ratio [OR] 1.55; 95% CI 1.34-1.81; P < .001), longer duration of oral contraceptive use (OR 1.29; 95% CI 1.08-1.55; P < .001), and higher breast density (OR 2.19; 95% CI 1.67-2.88; P < .001) were significantly associated with an increased risk for TNBC. Factors including later age at menarche, later age at first birth, and breastfeeding were associated with reduced risk for TNBC. Furthermore, there was no significant association with parity, menopausal hormone therapy, alcohol, smoking, and BMI. This study highlights distinct risk factors that may contribute to a higher risk for TNBC, and future research will be valuable to better elucidate the mechanisms at play and to further understand the differences within this subtype itself.

Additional References

1. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. Genetic/familial high-risk assessment: breast, ovarian, and pancreatic. Version 3.2024. Source 
2. Saadatmand S, Geuzinge HA, Rutgers EJT, et al; on behalf of the FaMRIsc study group. MRI versus mammography for breast cancer screening in women with familial risk (FaMRIsc): A multicentre, randomised, controlled trial. Lancet Oncol. 2019;20:1136-1147. doi: 10.1016/S1470-2045(19)30275-X  Source
3. Warner E, Zhu S, Plewes DB, et al. Breast cancer mortality among women with a BRCA1 or BRCA2 mutation in a magnetic resonance imaging plus mammography screening program. Cancers (Basel). 2020;12:3479. doi: 10.3390/cancers12113479 Source
4. Picon-Ruiz M, Morata-Tarifa C, Valle-Goffin JJ, et al. Obesity and adverse breast cancer risk and outcome: Mechanistic insights and strategies for intervention. CA Cancer J Clin. 2017;67:378-397. doi: 10.3322/caac.21405 Source
5. Engmann NJ, Golmakani MK, Miglioretti DL, et al; for the Breast Cancer Surveillance Consortium. Population-attributable risk proportion of clinical risk factors for breast cancer. JAMA Oncol. 2017;3:1228-1236. doi: 10.1001/jamaoncol.2016.6326 Source
6. Barnard ME, Boeke CE, Tamimi RM. Established breast cancer risk factors and risk of intrinsic tumor subtypes. Biochim Biophys Acta Rev Cancer. 2015;1856:73-85. doi: 10.1016/j.bbcan.2015.0002 Source

A positive family history of cancer and obesity are established risk factors for development of breast cancer among women.^[4,5] A population-based cohort study that included 15,055 Chinese women evaluated the association and interaction between body mass index (BMI) and family history of cancer on the risk for breast cancer (Cao et al). The incidence risk for breast cancer was highest in the group with obesity vs the group with normal weight (adjusted HR 2.09; 95% CI 1.42-3.07), and those with a family history of cancer also had an increased risk vs those without a family history of cancer (adjusted HR 1.63; 95% CI 1.22-2.49). Furthermore, women with a BMI ≥ 24 and family history of cancer had a higher risk for breast cancer development compared with women with a BMI < 24 and no family history of cancer (adjusted HR 2.06; 95% CI 1.39-3.06). This study indicates a heightened breast cancer risk when cancer family history and obesity coexist, suggesting the importance of addressing modifiable risk factors and targeting lifestyle interventions in this population.

Triple-negative breast cancer (TNBC), although exhibiting its own heterogeneity, has various features that differentiate this subtype from luminal breast cancers. For example, TNBC generally has a more aggressive course, increased responsiveness to chemotherapy, and earlier pattern of recurrence compared with hormone receptor–positive disease. Prior studies have also shown that established breast cancer risk factors reflect those for the luminal A subtype, whereas those for TNBC are less consistent.^[6] A meta-analysis that included 33 studies evaluated the association between traditional breast cancer risk factors and TNBC incidence (Kumar et al). Family history (odds ratio [OR] 1.55; 95% CI 1.34-1.81; P < .001), longer duration of oral contraceptive use (OR 1.29; 95% CI 1.08-1.55; P < .001), and higher breast density (OR 2.19; 95% CI 1.67-2.88; P < .001) were significantly associated with an increased risk for TNBC. Factors including later age at menarche, later age at first birth, and breastfeeding were associated with reduced risk for TNBC. Furthermore, there was no significant association with parity, menopausal hormone therapy, alcohol, smoking, and BMI. This study highlights distinct risk factors that may contribute to a higher risk for TNBC, and future research will be valuable to better elucidate the mechanisms at play and to further understand the differences within this subtype itself.

Additional References

1. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. Genetic/familial high-risk assessment: breast, ovarian, and pancreatic. Version 3.2024. Source 
2. Saadatmand S, Geuzinge HA, Rutgers EJT, et al; on behalf of the FaMRIsc study group. MRI versus mammography for breast cancer screening in women with familial risk (FaMRIsc): A multicentre, randomised, controlled trial. Lancet Oncol. 2019;20:1136-1147. doi: 10.1016/S1470-2045(19)30275-X  Source
3. Warner E, Zhu S, Plewes DB, et al. Breast cancer mortality among women with a BRCA1 or BRCA2 mutation in a magnetic resonance imaging plus mammography screening program. Cancers (Basel). 2020;12:3479. doi: 10.3390/cancers12113479 Source
4. Picon-Ruiz M, Morata-Tarifa C, Valle-Goffin JJ, et al. Obesity and adverse breast cancer risk and outcome: Mechanistic insights and strategies for intervention. CA Cancer J Clin. 2017;67:378-397. doi: 10.3322/caac.21405 Source
5. Engmann NJ, Golmakani MK, Miglioretti DL, et al; for the Breast Cancer Surveillance Consortium. Population-attributable risk proportion of clinical risk factors for breast cancer. JAMA Oncol. 2017;3:1228-1236. doi: 10.1001/jamaoncol.2016.6326 Source
6. Barnard ME, Boeke CE, Tamimi RM. Established breast cancer risk factors and risk of intrinsic tumor subtypes. Biochim Biophys Acta Rev Cancer. 2015;1856:73-85. doi: 10.1016/j.bbcan.2015.0002 Source

A positive family history of cancer and obesity are established risk factors for development of breast cancer among women.^[4,5] A population-based cohort study that included 15,055 Chinese women evaluated the association and interaction between body mass index (BMI) and family history of cancer on the risk for breast cancer (Cao et al). The incidence risk for breast cancer was highest in the group with obesity vs the group with normal weight (adjusted HR 2.09; 95% CI 1.42-3.07), and those with a family history of cancer also had an increased risk vs those without a family history of cancer (adjusted HR 1.63; 95% CI 1.22-2.49). Furthermore, women with a BMI ≥ 24 and family history of cancer had a higher risk for breast cancer development compared with women with a BMI < 24 and no family history of cancer (adjusted HR 2.06; 95% CI 1.39-3.06). This study indicates a heightened breast cancer risk when cancer family history and obesity coexist, suggesting the importance of addressing modifiable risk factors and targeting lifestyle interventions in this population.

Triple-negative breast cancer (TNBC), although exhibiting its own heterogeneity, has various features that differentiate this subtype from luminal breast cancers. For example, TNBC generally has a more aggressive course, increased responsiveness to chemotherapy, and earlier pattern of recurrence compared with hormone receptor–positive disease. Prior studies have also shown that established breast cancer risk factors reflect those for the luminal A subtype, whereas those for TNBC are less consistent.^[6] A meta-analysis that included 33 studies evaluated the association between traditional breast cancer risk factors and TNBC incidence (Kumar et al). Family history (odds ratio [OR] 1.55; 95% CI 1.34-1.81; P < .001), longer duration of oral contraceptive use (OR 1.29; 95% CI 1.08-1.55; P < .001), and higher breast density (OR 2.19; 95% CI 1.67-2.88; P < .001) were significantly associated with an increased risk for TNBC. Factors including later age at menarche, later age at first birth, and breastfeeding were associated with reduced risk for TNBC. Furthermore, there was no significant association with parity, menopausal hormone therapy, alcohol, smoking, and BMI. This study highlights distinct risk factors that may contribute to a higher risk for TNBC, and future research will be valuable to better elucidate the mechanisms at play and to further understand the differences within this subtype itself.

Additional References

1. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. Genetic/familial high-risk assessment: breast, ovarian, and pancreatic. Version 3.2024. Source 
2. Saadatmand S, Geuzinge HA, Rutgers EJT, et al; on behalf of the FaMRIsc study group. MRI versus mammography for breast cancer screening in women with familial risk (FaMRIsc): A multicentre, randomised, controlled trial. Lancet Oncol. 2019;20:1136-1147. doi: 10.1016/S1470-2045(19)30275-X  Source
3. Warner E, Zhu S, Plewes DB, et al. Breast cancer mortality among women with a BRCA1 or BRCA2 mutation in a magnetic resonance imaging plus mammography screening program. Cancers (Basel). 2020;12:3479. doi: 10.3390/cancers12113479 Source
4. Picon-Ruiz M, Morata-Tarifa C, Valle-Goffin JJ, et al. Obesity and adverse breast cancer risk and outcome: Mechanistic insights and strategies for intervention. CA Cancer J Clin. 2017;67:378-397. doi: 10.3322/caac.21405 Source
5. Engmann NJ, Golmakani MK, Miglioretti DL, et al; for the Breast Cancer Surveillance Consortium. Population-attributable risk proportion of clinical risk factors for breast cancer. JAMA Oncol. 2017;3:1228-1236. doi: 10.1001/jamaoncol.2016.6326 Source
6. Barnard ME, Boeke CE, Tamimi RM. Established breast cancer risk factors and risk of intrinsic tumor subtypes. Biochim Biophys Acta Rev Cancer. 2015;1856:73-85. doi: 10.1016/j.bbcan.2015.0002 Source

Not everyone with AD treated with dupilumab gets clear or almost clear in clinical trials. The study by Cork and colleagues looked to see whether those patients who did not get to clear or almost clear were still having clinically meaningful improvement. To test this, the investigators looked at patients who still had mild or worse disease and then at the proportion of those patients at week 16 who achieved a composite endpoint encompassing clinically meaningful changes in AD signs, symptoms, and quality of life: ≥50% improvement in Eczema Area and Severity Index or ≥4-point reduction in worst scratch/itch numerical rating scale, or ≥6-point reduction in Children's Dermatology Life Quality Index/Infants' Dermatitis Quality of Life Index. Significantly more patients, both clinically and statistically significantly more, receiving dupilumab vs placebo achieved the composite endpoint (77.7% vs 24.6%; P < .0001). 

The "success rate" reported in clinical trials underestimates how often patients can be successfully treated with dupilumab. I don't need a complicated composite outcome to know this. I just use the standardized 2-point Patient Global Assessment measure. I ask patients, "How are you doing?" If they say "Great," that's success. If they say, "Not so good," that's failure. I think about 80% of patients with AD treated with dupilumab have success based on this standard.

Hand dermatitis can be quite resistant to treatment. Even making a diagnosis can be challenging, as psoriasis and dermatitis of the hands looks so similar to me (and when I used to send biopsies and ask the pathologist whether it's dermatitis or psoriasis, invariably the dermatopathologist responded "yes"). The study by Kamphuis and colleagues examined the efficacy of abrocitinib in just over 100 patients with hand eczema who were enrolled in the BioDay registry. Such registries are very helpful for assessing real-world results. The drug seemed reasonably successful, with only about 30% discontinuing treatment. About two thirds of the discontinuations were due to inefficacy and about one third to an adverse event.

I think there's real value in prescribing the treatments patients want. Studies like the one by Ameen and colleagues, using a discrete-choice methodology, allows one to determine patients' average preferences. In this study, the discrete-choice approach found that patients prefer safety over other attributes. Some years ago, my colleagues and I queried patients to get a sense of their quantitative preferences for different treatments. Our study also found that patients preferred safety over other attributes. However, when we asked them to choose among different treatment options, they didn't choose the safest one. I think they believe that they prefer safety, but I'm not sure they really do. In any case, the average preference of the entire population of people with AD isn't really all that important when we've got just one patient sitting in front of us. It's that particular patient's preference that should drive the treatment plan.

Not everyone with AD treated with dupilumab gets clear or almost clear in clinical trials. The study by Cork and colleagues looked to see whether those patients who did not get to clear or almost clear were still having clinically meaningful improvement. To test this, the investigators looked at patients who still had mild or worse disease and then at the proportion of those patients at week 16 who achieved a composite endpoint encompassing clinically meaningful changes in AD signs, symptoms, and quality of life: ≥50% improvement in Eczema Area and Severity Index or ≥4-point reduction in worst scratch/itch numerical rating scale, or ≥6-point reduction in Children's Dermatology Life Quality Index/Infants' Dermatitis Quality of Life Index. Significantly more patients, both clinically and statistically significantly more, receiving dupilumab vs placebo achieved the composite endpoint (77.7% vs 24.6%; P < .0001). 

The "success rate" reported in clinical trials underestimates how often patients can be successfully treated with dupilumab. I don't need a complicated composite outcome to know this. I just use the standardized 2-point Patient Global Assessment measure. I ask patients, "How are you doing?" If they say "Great," that's success. If they say, "Not so good," that's failure. I think about 80% of patients with AD treated with dupilumab have success based on this standard.

Hand dermatitis can be quite resistant to treatment. Even making a diagnosis can be challenging, as psoriasis and dermatitis of the hands looks so similar to me (and when I used to send biopsies and ask the pathologist whether it's dermatitis or psoriasis, invariably the dermatopathologist responded "yes"). The study by Kamphuis and colleagues examined the efficacy of abrocitinib in just over 100 patients with hand eczema who were enrolled in the BioDay registry. Such registries are very helpful for assessing real-world results. The drug seemed reasonably successful, with only about 30% discontinuing treatment. About two thirds of the discontinuations were due to inefficacy and about one third to an adverse event.

I think there's real value in prescribing the treatments patients want. Studies like the one by Ameen and colleagues, using a discrete-choice methodology, allows one to determine patients' average preferences. In this study, the discrete-choice approach found that patients prefer safety over other attributes. Some years ago, my colleagues and I queried patients to get a sense of their quantitative preferences for different treatments. Our study also found that patients preferred safety over other attributes. However, when we asked them to choose among different treatment options, they didn't choose the safest one. I think they believe that they prefer safety, but I'm not sure they really do. In any case, the average preference of the entire population of people with AD isn't really all that important when we've got just one patient sitting in front of us. It's that particular patient's preference that should drive the treatment plan.

Not everyone with AD treated with dupilumab gets clear or almost clear in clinical trials. The study by Cork and colleagues looked to see whether those patients who did not get to clear or almost clear were still having clinically meaningful improvement. To test this, the investigators looked at patients who still had mild or worse disease and then at the proportion of those patients at week 16 who achieved a composite endpoint encompassing clinically meaningful changes in AD signs, symptoms, and quality of life: ≥50% improvement in Eczema Area and Severity Index or ≥4-point reduction in worst scratch/itch numerical rating scale, or ≥6-point reduction in Children's Dermatology Life Quality Index/Infants' Dermatitis Quality of Life Index. Significantly more patients, both clinically and statistically significantly more, receiving dupilumab vs placebo achieved the composite endpoint (77.7% vs 24.6%; P < .0001). 

The "success rate" reported in clinical trials underestimates how often patients can be successfully treated with dupilumab. I don't need a complicated composite outcome to know this. I just use the standardized 2-point Patient Global Assessment measure. I ask patients, "How are you doing?" If they say "Great," that's success. If they say, "Not so good," that's failure. I think about 80% of patients with AD treated with dupilumab have success based on this standard.

Hand dermatitis can be quite resistant to treatment. Even making a diagnosis can be challenging, as psoriasis and dermatitis of the hands looks so similar to me (and when I used to send biopsies and ask the pathologist whether it's dermatitis or psoriasis, invariably the dermatopathologist responded "yes"). The study by Kamphuis and colleagues examined the efficacy of abrocitinib in just over 100 patients with hand eczema who were enrolled in the BioDay registry. Such registries are very helpful for assessing real-world results. The drug seemed reasonably successful, with only about 30% discontinuing treatment. About two thirds of the discontinuations were due to inefficacy and about one third to an adverse event.

I think there's real value in prescribing the treatments patients want. Studies like the one by Ameen and colleagues, using a discrete-choice methodology, allows one to determine patients' average preferences. In this study, the discrete-choice approach found that patients prefer safety over other attributes. Some years ago, my colleagues and I queried patients to get a sense of their quantitative preferences for different treatments. Our study also found that patients preferred safety over other attributes. However, when we asked them to choose among different treatment options, they didn't choose the safest one. I think they believe that they prefer safety, but I'm not sure they really do. In any case, the average preference of the entire population of people with AD isn't really all that important when we've got just one patient sitting in front of us. It's that particular patient's preference that should drive the treatment plan.

Key clinical point: Long-term fremanezumab treatment appears to be highly effective, safe, and well tolerated in patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) who have experienced multiple (more than three) treatment failures and have various comorbidities.

Major finding: At 48 weeks, fremanezumab led to significant reductions in the monthly migraine days in patients with HFEM (mean change −6.4 days) and monthly headache days in patients with CM (mean change −14.5 days; both P < .001). Overall, 7.8% of patients reported mild and transient treatment-emergent adverse events, and none of the patients discontinued the treatment for any reason.

Study details: This prospective, multicenter, cohort study included 130 patients with migraine (49 with HEFM; 81 with CM) and multiple treatment failures who received fremanezumab for at least 48 weeks (≥ 12 doses).

Disclosures: This study was partially supported by the Italian Ministry of Health (Institutional Funding Ricerca Corrente) San Raffaele and Fondazione Italiana Cefalee. Several authors declared receiving travel grants, research support, or honoraria from or having other ties with various sources. Twenty authors declared no conflicts of interest.

Source: Barbanti P, Egeo G, Proietti S, et al for the Italian Migraine Registry study group. Assessing the long-term (48-week) effectiveness, safety, and tolerability of fremanezumab in migraine in real life: Insights from the multicenter, prospective, FRIEND3 study. Neurol Ther. 2024 (Mar 7). doi: 10.1007/s40120-024-00591-z Source

Key clinical point: Long-term fremanezumab treatment appears to be highly effective, safe, and well tolerated in patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) who have experienced multiple (more than three) treatment failures and have various comorbidities.

Major finding: At 48 weeks, fremanezumab led to significant reductions in the monthly migraine days in patients with HFEM (mean change −6.4 days) and monthly headache days in patients with CM (mean change −14.5 days; both P < .001). Overall, 7.8% of patients reported mild and transient treatment-emergent adverse events, and none of the patients discontinued the treatment for any reason.

Study details: This prospective, multicenter, cohort study included 130 patients with migraine (49 with HEFM; 81 with CM) and multiple treatment failures who received fremanezumab for at least 48 weeks (≥ 12 doses).

Disclosures: This study was partially supported by the Italian Ministry of Health (Institutional Funding Ricerca Corrente) San Raffaele and Fondazione Italiana Cefalee. Several authors declared receiving travel grants, research support, or honoraria from or having other ties with various sources. Twenty authors declared no conflicts of interest.

Source: Barbanti P, Egeo G, Proietti S, et al for the Italian Migraine Registry study group. Assessing the long-term (48-week) effectiveness, safety, and tolerability of fremanezumab in migraine in real life: Insights from the multicenter, prospective, FRIEND3 study. Neurol Ther. 2024 (Mar 7). doi: 10.1007/s40120-024-00591-z Source

Key clinical point: Long-term fremanezumab treatment appears to be highly effective, safe, and well tolerated in patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) who have experienced multiple (more than three) treatment failures and have various comorbidities.

Major finding: At 48 weeks, fremanezumab led to significant reductions in the monthly migraine days in patients with HFEM (mean change −6.4 days) and monthly headache days in patients with CM (mean change −14.5 days; both P < .001). Overall, 7.8% of patients reported mild and transient treatment-emergent adverse events, and none of the patients discontinued the treatment for any reason.

Study details: This prospective, multicenter, cohort study included 130 patients with migraine (49 with HEFM; 81 with CM) and multiple treatment failures who received fremanezumab for at least 48 weeks (≥ 12 doses).

Disclosures: This study was partially supported by the Italian Ministry of Health (Institutional Funding Ricerca Corrente) San Raffaele and Fondazione Italiana Cefalee. Several authors declared receiving travel grants, research support, or honoraria from or having other ties with various sources. Twenty authors declared no conflicts of interest.

Source: Barbanti P, Egeo G, Proietti S, et al for the Italian Migraine Registry study group. Assessing the long-term (48-week) effectiveness, safety, and tolerability of fremanezumab in migraine in real life: Insights from the multicenter, prospective, FRIEND3 study. Neurol Ther. 2024 (Mar 7). doi: 10.1007/s40120-024-00591-z Source

Key clinical point: Untreated women with endometriosis and concomitant migraine (EM-MO) experienced more severe symptoms and frequent painful days than those with endometriosis alone (EM-O) or migraine alone (MG-O).

Major finding: The prevalence of severe adenomyosis (14% vs 4%; P = .027) and posterior (48% vs 30%; P = .031) and anterior (10% vs 2%; P = .029) deep infiltrating endometriosis was higher in women with EM-MO vs EM-O. Women with EM-MO vs MG-O had significantly higher pain intensity (visual analogue scale scores 8.44 vs 7.74; P = .004), monthly migraine days (6.68 vs 5.44 days; P = .042), and Headache Impact Test-6 scores (62.33 vs 57.38; P = .010).

Study details: This prospective case-control study included 50 women with EM-MO and matched control patients with EM-O (n = 100) and MG-O (n = 100) who underwent pelvic and neurologic examination.

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

Source: Selntigia A, Exacoustos C, Ortoleva C, et al. Correlation between endometriosis and migraine features: Results from a prospective case-control study. Cephalalgia. 2024 (Mar 4). doi: 10.1177/03331024241235 Source

Key clinical point: Untreated women with endometriosis and concomitant migraine (EM-MO) experienced more severe symptoms and frequent painful days than those with endometriosis alone (EM-O) or migraine alone (MG-O).

Major finding: The prevalence of severe adenomyosis (14% vs 4%; P = .027) and posterior (48% vs 30%; P = .031) and anterior (10% vs 2%; P = .029) deep infiltrating endometriosis was higher in women with EM-MO vs EM-O. Women with EM-MO vs MG-O had significantly higher pain intensity (visual analogue scale scores 8.44 vs 7.74; P = .004), monthly migraine days (6.68 vs 5.44 days; P = .042), and Headache Impact Test-6 scores (62.33 vs 57.38; P = .010).

Study details: This prospective case-control study included 50 women with EM-MO and matched control patients with EM-O (n = 100) and MG-O (n = 100) who underwent pelvic and neurologic examination.

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

Source: Selntigia A, Exacoustos C, Ortoleva C, et al. Correlation between endometriosis and migraine features: Results from a prospective case-control study. Cephalalgia. 2024 (Mar 4). doi: 10.1177/03331024241235 Source

Key clinical point: Untreated women with endometriosis and concomitant migraine (EM-MO) experienced more severe symptoms and frequent painful days than those with endometriosis alone (EM-O) or migraine alone (MG-O).

Major finding: The prevalence of severe adenomyosis (14% vs 4%; P = .027) and posterior (48% vs 30%; P = .031) and anterior (10% vs 2%; P = .029) deep infiltrating endometriosis was higher in women with EM-MO vs EM-O. Women with EM-MO vs MG-O had significantly higher pain intensity (visual analogue scale scores 8.44 vs 7.74; P = .004), monthly migraine days (6.68 vs 5.44 days; P = .042), and Headache Impact Test-6 scores (62.33 vs 57.38; P = .010).

Study details: This prospective case-control study included 50 women with EM-MO and matched control patients with EM-O (n = 100) and MG-O (n = 100) who underwent pelvic and neurologic examination.

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

Source: Selntigia A, Exacoustos C, Ortoleva C, et al. Correlation between endometriosis and migraine features: Results from a prospective case-control study. Cephalalgia. 2024 (Mar 4). doi: 10.1177/03331024241235 Source

Key clinical point: Migraine is more prevalent among patients with inflammatory bowel disease (IBD), especially women, suggesting an influence of sex-related factors.

Major finding: The prevalence of migraine was significantly higher in patients with IBD (20.8%; P < .0001) than in the general population (12.6%; P < .0001), and this association was statistically significant in women (29.8%; P < .0001) but not in men (9.6%; P = .30). However, there were no significant differences in migraine prevalence between patients with ulcerative colitis and those with Crohn’s disease (P = .88).

Study details: This cross-sectional study included 283 patients age 18-65 years with IBD, of whom 20.85% had definite (11.66%) or probable (9.18%) migraine based on their response to the ID-Migraine questionnaire.

Disclosures: This study was funded by the Instituto de Salud Carlos III, Spain, and  Fondos Europeos de Desarrollo Regional. The authors declared no conflicts of interest.

Source: Pascual-Mato M, Gárate G, de Prado-Tejerina C, et al. Increased prevalence of migraine in women with inflammatory bowel disease: A cross-sectional study. Cephalalgia. 2024 (Mar 1). doi: 10.1177/03331024241233979 Source

Key clinical point: Migraine is more prevalent among patients with inflammatory bowel disease (IBD), especially women, suggesting an influence of sex-related factors.

Major finding: The prevalence of migraine was significantly higher in patients with IBD (20.8%; P < .0001) than in the general population (12.6%; P < .0001), and this association was statistically significant in women (29.8%; P < .0001) but not in men (9.6%; P = .30). However, there were no significant differences in migraine prevalence between patients with ulcerative colitis and those with Crohn’s disease (P = .88).

Study details: This cross-sectional study included 283 patients age 18-65 years with IBD, of whom 20.85% had definite (11.66%) or probable (9.18%) migraine based on their response to the ID-Migraine questionnaire.

Disclosures: This study was funded by the Instituto de Salud Carlos III, Spain, and  Fondos Europeos de Desarrollo Regional. The authors declared no conflicts of interest.

Source: Pascual-Mato M, Gárate G, de Prado-Tejerina C, et al. Increased prevalence of migraine in women with inflammatory bowel disease: A cross-sectional study. Cephalalgia. 2024 (Mar 1). doi: 10.1177/03331024241233979 Source

Key clinical point: Migraine is more prevalent among patients with inflammatory bowel disease (IBD), especially women, suggesting an influence of sex-related factors.

Major finding: The prevalence of migraine was significantly higher in patients with IBD (20.8%; P < .0001) than in the general population (12.6%; P < .0001), and this association was statistically significant in women (29.8%; P < .0001) but not in men (9.6%; P = .30). However, there were no significant differences in migraine prevalence between patients with ulcerative colitis and those with Crohn’s disease (P = .88).

Study details: This cross-sectional study included 283 patients age 18-65 years with IBD, of whom 20.85% had definite (11.66%) or probable (9.18%) migraine based on their response to the ID-Migraine questionnaire.

Disclosures: This study was funded by the Instituto de Salud Carlos III, Spain, and  Fondos Europeos de Desarrollo Regional. The authors declared no conflicts of interest.

Source: Pascual-Mato M, Gárate G, de Prado-Tejerina C, et al. Increased prevalence of migraine in women with inflammatory bowel disease: A cross-sectional study. Cephalalgia. 2024 (Mar 1). doi: 10.1177/03331024241233979 Source

Key clinical point: Patients with migraine experiencing typically left-sided headache during attacks had a higher burden of headache frequency and severity than those experiencing typically right-sided headache.

Major finding: Patients with left-sided vs right-sided migraine had 3.5 (95% CI 0.6-6.4) fewer headache-free days and 3.3 (95% CI 1.3-5.4) more severe headache days per 4 weeks. There were no other significant differences in migraine characteristics or psychiatric comorbidities between patients with left- and right-sided migraine.

Study details: This cross-sectional study included 340 patients with migraine, of whom 166 (48.8%) and 174 (51.2%) had left- and right-sided migraines, respectively.

Disclosures: The study did not disclose any funding source. The authors declared no conflicts of interest.

Source: Sprouse Blum AS, DaSilva LA, Greenberg MD, et al. Comparison of migraine with left- versus right-sided headache: A cross-sectional study. Headache. 2024 (Mar 3). doi: 10.1111/head.14689 Source

Key clinical point: Patients with migraine experiencing typically left-sided headache during attacks had a higher burden of headache frequency and severity than those experiencing typically right-sided headache.

Major finding: Patients with left-sided vs right-sided migraine had 3.5 (95% CI 0.6-6.4) fewer headache-free days and 3.3 (95% CI 1.3-5.4) more severe headache days per 4 weeks. There were no other significant differences in migraine characteristics or psychiatric comorbidities between patients with left- and right-sided migraine.

Study details: This cross-sectional study included 340 patients with migraine, of whom 166 (48.8%) and 174 (51.2%) had left- and right-sided migraines, respectively.

Disclosures: The study did not disclose any funding source. The authors declared no conflicts of interest.

Source: Sprouse Blum AS, DaSilva LA, Greenberg MD, et al. Comparison of migraine with left- versus right-sided headache: A cross-sectional study. Headache. 2024 (Mar 3). doi: 10.1111/head.14689 Source

Key clinical point: Patients with migraine experiencing typically left-sided headache during attacks had a higher burden of headache frequency and severity than those experiencing typically right-sided headache.

Major finding: Patients with left-sided vs right-sided migraine had 3.5 (95% CI 0.6-6.4) fewer headache-free days and 3.3 (95% CI 1.3-5.4) more severe headache days per 4 weeks. There were no other significant differences in migraine characteristics or psychiatric comorbidities between patients with left- and right-sided migraine.

Study details: This cross-sectional study included 340 patients with migraine, of whom 166 (48.8%) and 174 (51.2%) had left- and right-sided migraines, respectively.

Disclosures: The study did not disclose any funding source. The authors declared no conflicts of interest.

Source: Sprouse Blum AS, DaSilva LA, Greenberg MD, et al. Comparison of migraine with left- versus right-sided headache: A cross-sectional study. Headache. 2024 (Mar 3). doi: 10.1111/head.14689 Source