Clinical Edge Journal Scan

Key clinical point: Romyelocel-L plus granulocyte colony-stimulating factor (G-CSF) vs G-CSF monotherapy led to a significant reduction in the incidence of infections and length of hospitalization in patients with acute myeloid leukemia (AML) receiving induction chemotherapy.

Major finding: From days 15 to 28, romyelocel-L plus G-CSF vs G-CSF monotherapy significantly reduced the mean duration of febrile episodes (2.36 days vs 3.90 days; P = .02) and incidence of infections (6.8% vs 27.9%; P = .0013). Length of hospitalization was significantly shorter in the romyelocel-L plus G-CSF vs G-CSF monotherapy group (25.5 days vs 28.7 days; P = .002).

Study details: This phase 2 study included 163 patients with de novo AML receiving induction chemotherapy. Evaluable patients (n=120) were randomly assigned to receive either romyelocel-L plus G-CSF (n=59) or G-CSF monotherapy (n=61).

Disclosures: This study was supported by the Biomedical Advanced Research and Development Authority. Some investigators including the lead author reported ties with various pharmaceutical companies.

Source: Desai PM et al. J Clin Oncol. 2021 Jun 22. doi: 10.1200/JCO.20.01739.

Key clinical point: Romyelocel-L plus granulocyte colony-stimulating factor (G-CSF) vs G-CSF monotherapy led to a significant reduction in the incidence of infections and length of hospitalization in patients with acute myeloid leukemia (AML) receiving induction chemotherapy.

Major finding: From days 15 to 28, romyelocel-L plus G-CSF vs G-CSF monotherapy significantly reduced the mean duration of febrile episodes (2.36 days vs 3.90 days; P = .02) and incidence of infections (6.8% vs 27.9%; P = .0013). Length of hospitalization was significantly shorter in the romyelocel-L plus G-CSF vs G-CSF monotherapy group (25.5 days vs 28.7 days; P = .002).

Study details: This phase 2 study included 163 patients with de novo AML receiving induction chemotherapy. Evaluable patients (n=120) were randomly assigned to receive either romyelocel-L plus G-CSF (n=59) or G-CSF monotherapy (n=61).

Disclosures: This study was supported by the Biomedical Advanced Research and Development Authority. Some investigators including the lead author reported ties with various pharmaceutical companies.

Source: Desai PM et al. J Clin Oncol. 2021 Jun 22. doi: 10.1200/JCO.20.01739.

Key clinical point: Romyelocel-L plus granulocyte colony-stimulating factor (G-CSF) vs G-CSF monotherapy led to a significant reduction in the incidence of infections and length of hospitalization in patients with acute myeloid leukemia (AML) receiving induction chemotherapy.

Major finding: From days 15 to 28, romyelocel-L plus G-CSF vs G-CSF monotherapy significantly reduced the mean duration of febrile episodes (2.36 days vs 3.90 days; P = .02) and incidence of infections (6.8% vs 27.9%; P = .0013). Length of hospitalization was significantly shorter in the romyelocel-L plus G-CSF vs G-CSF monotherapy group (25.5 days vs 28.7 days; P = .002).

Study details: This phase 2 study included 163 patients with de novo AML receiving induction chemotherapy. Evaluable patients (n=120) were randomly assigned to receive either romyelocel-L plus G-CSF (n=59) or G-CSF monotherapy (n=61).

Disclosures: This study was supported by the Biomedical Advanced Research and Development Authority. Some investigators including the lead author reported ties with various pharmaceutical companies.

Source: Desai PM et al. J Clin Oncol. 2021 Jun 22. doi: 10.1200/JCO.20.01739.

Key clinical point: Clinical therapeutic decisions based on dynamic measurable residual disease (MRD) may improve therapy stratification and optimize post-remission treatment with either chemotherapy, autologous stem cell transplant (auto-SCT), or allogeneic SCT (allo-SCT) in patients with intermediate-risk acute myeloid leukemia (AML).

Major finding: In patients with persistent MRD-negative after 1, 2, or 3 chemotherapy cycles, chemotherapy (P = .03) and auto-SCT (P = .01) vs allo-SCT improved graft-vs-host-disease-free, relapse-free survival. Allo-SCT led to favorable outcomes among patients with persistent MRD-positive or MRD-negative after 3 chemotherapy courses and those with recurrent MRD-positive after MRD-negative. Patients who were MRD-negative after 2 chemotherapy cycles had better leukemia-free survival, overall survival, and relapse with auto-SCT vs allo-SCT and chemotherapy (all P less than .05).

Study details: Findings are from 549 patients with intermediate-risk AML treated with either chemotherapy, auto-SCT or allo-SCT after the first complete remission.

Disclosures: This study was funded by grants from the National Key Research and Development Projects, National Natural Science Foundation of China, and others. The authors declared no conflicts of interest.

Source: Yu S et al. JAMA Netw Open. 2021 Jul 7. doi: 10.1001/jamanetworkopen.2021.15991.

Key clinical point: Clinical therapeutic decisions based on dynamic measurable residual disease (MRD) may improve therapy stratification and optimize post-remission treatment with either chemotherapy, autologous stem cell transplant (auto-SCT), or allogeneic SCT (allo-SCT) in patients with intermediate-risk acute myeloid leukemia (AML).

Major finding: In patients with persistent MRD-negative after 1, 2, or 3 chemotherapy cycles, chemotherapy (P = .03) and auto-SCT (P = .01) vs allo-SCT improved graft-vs-host-disease-free, relapse-free survival. Allo-SCT led to favorable outcomes among patients with persistent MRD-positive or MRD-negative after 3 chemotherapy courses and those with recurrent MRD-positive after MRD-negative. Patients who were MRD-negative after 2 chemotherapy cycles had better leukemia-free survival, overall survival, and relapse with auto-SCT vs allo-SCT and chemotherapy (all P less than .05).

Study details: Findings are from 549 patients with intermediate-risk AML treated with either chemotherapy, auto-SCT or allo-SCT after the first complete remission.

Disclosures: This study was funded by grants from the National Key Research and Development Projects, National Natural Science Foundation of China, and others. The authors declared no conflicts of interest.

Source: Yu S et al. JAMA Netw Open. 2021 Jul 7. doi: 10.1001/jamanetworkopen.2021.15991.

Key clinical point: Clinical therapeutic decisions based on dynamic measurable residual disease (MRD) may improve therapy stratification and optimize post-remission treatment with either chemotherapy, autologous stem cell transplant (auto-SCT), or allogeneic SCT (allo-SCT) in patients with intermediate-risk acute myeloid leukemia (AML).

Major finding: In patients with persistent MRD-negative after 1, 2, or 3 chemotherapy cycles, chemotherapy (P = .03) and auto-SCT (P = .01) vs allo-SCT improved graft-vs-host-disease-free, relapse-free survival. Allo-SCT led to favorable outcomes among patients with persistent MRD-positive or MRD-negative after 3 chemotherapy courses and those with recurrent MRD-positive after MRD-negative. Patients who were MRD-negative after 2 chemotherapy cycles had better leukemia-free survival, overall survival, and relapse with auto-SCT vs allo-SCT and chemotherapy (all P less than .05).

Study details: Findings are from 549 patients with intermediate-risk AML treated with either chemotherapy, auto-SCT or allo-SCT after the first complete remission.

Disclosures: This study was funded by grants from the National Key Research and Development Projects, National Natural Science Foundation of China, and others. The authors declared no conflicts of interest.

Source: Yu S et al. JAMA Netw Open. 2021 Jul 7. doi: 10.1001/jamanetworkopen.2021.15991.

Key clinical point: At 5 years of follow-up, a fixed combination of daunorubicin and cytarabine (CPX-351) vs standard chemotherapy with cytarabine for 7 days and daunorubicin for 3 days (7+3) improved overall survival (OS) in older patients with newly diagnosed high-risk or secondary acute myeloid leukemia (AML).

Major finding: Favorable difference in median OS in favor of CPX-351 vs 7+3 group was maintained (hazard ratio, 0.70; 95% confidence interval [CI], 0.55-0.91). At 5 years, survival estimates were higher for CPX-351 vs 7+3 (18% [95% CI, 12%-25%] vs 8% [95% CI, 4%-13%]). Overall, 5% of deaths in both groups were considered related to the study treatment.

Study details: Findings are the final 5-year follow-up results of a phase 3 trial including 309 patients aged 60-75 years with newly diagnosed high-risk or secondary AML. Patients were randomly assigned to either CPX-351 (n=153) or 7+3 chemotherapy (n=156).

Disclosures: This study was supported by Jazz Pharmaceuticals. The lead author reported consulting for various sources. Other authors reported ties with various pharmaceutical companies including Jazz Pharmaceuticals.

Source: Lancet JE et al. Lancet Haematol. 2021 Jul. doi: 10.1016/S2352-3026(21)00134-4.

Key clinical point: At 5 years of follow-up, a fixed combination of daunorubicin and cytarabine (CPX-351) vs standard chemotherapy with cytarabine for 7 days and daunorubicin for 3 days (7+3) improved overall survival (OS) in older patients with newly diagnosed high-risk or secondary acute myeloid leukemia (AML).

Major finding: Favorable difference in median OS in favor of CPX-351 vs 7+3 group was maintained (hazard ratio, 0.70; 95% confidence interval [CI], 0.55-0.91). At 5 years, survival estimates were higher for CPX-351 vs 7+3 (18% [95% CI, 12%-25%] vs 8% [95% CI, 4%-13%]). Overall, 5% of deaths in both groups were considered related to the study treatment.

Study details: Findings are the final 5-year follow-up results of a phase 3 trial including 309 patients aged 60-75 years with newly diagnosed high-risk or secondary AML. Patients were randomly assigned to either CPX-351 (n=153) or 7+3 chemotherapy (n=156).

Disclosures: This study was supported by Jazz Pharmaceuticals. The lead author reported consulting for various sources. Other authors reported ties with various pharmaceutical companies including Jazz Pharmaceuticals.

Source: Lancet JE et al. Lancet Haematol. 2021 Jul. doi: 10.1016/S2352-3026(21)00134-4.

Key clinical point: At 5 years of follow-up, a fixed combination of daunorubicin and cytarabine (CPX-351) vs standard chemotherapy with cytarabine for 7 days and daunorubicin for 3 days (7+3) improved overall survival (OS) in older patients with newly diagnosed high-risk or secondary acute myeloid leukemia (AML).

Major finding: Favorable difference in median OS in favor of CPX-351 vs 7+3 group was maintained (hazard ratio, 0.70; 95% confidence interval [CI], 0.55-0.91). At 5 years, survival estimates were higher for CPX-351 vs 7+3 (18% [95% CI, 12%-25%] vs 8% [95% CI, 4%-13%]). Overall, 5% of deaths in both groups were considered related to the study treatment.

Study details: Findings are the final 5-year follow-up results of a phase 3 trial including 309 patients aged 60-75 years with newly diagnosed high-risk or secondary AML. Patients were randomly assigned to either CPX-351 (n=153) or 7+3 chemotherapy (n=156).

Disclosures: This study was supported by Jazz Pharmaceuticals. The lead author reported consulting for various sources. Other authors reported ties with various pharmaceutical companies including Jazz Pharmaceuticals.

Source: Lancet JE et al. Lancet Haematol. 2021 Jul. doi: 10.1016/S2352-3026(21)00134-4.

Atopic Dermatitis (AD) is complex with heterogeneous symptoms (e.g. skin-pain, sleep disturbance), signs (e.g. lichenification, prurigo nodules, follicular accentuation), and longitudinal course (intermittent, persistent). These disparate signs and symptoms should be addressed in optimize disease control.

Multiple extracellular cytokines are upregulated in skin of AD patients, including interleukins 4, 5, 13, 22, 31 and thymic stromal lymphopoietin, all of which signal intracellularly through Janus Kinase (JAK)-Signal Transducer and Activator of Transcription (STAT) pathways. Differential cytokine expression is proposed to underlie clinical variability. It may be necessary to inhibit signaling of multiple cytokines to achieve adequate control of AD.

Dupilumab is currently the only biologic treatment approved in the United States for moderate-severe AD. Dupilumab revolutionized AD management. However, there remain unmet needs, including the need for faster and more potent efficacy, and oral treatment options. Recently, oral JAK-inhibitors were investigated as treatments for moderate-severe AD. Multiple JAK-inhibitors demonstrated strong and rapid efficacy across multiple clinician-reported and patient-reported outcomes.

• Miao et al. recently conducted a meta-analysis of 10 randomized controlled trials and found that patients receiving JAK inhibitors showed significantly higher efficacy for eczema area and severity index (EASI) and Numeric Rating Scale (NRS)-itch scores and similar rates of adverse-events.
• Kim et al. pooled data from 3 randomized controlled trials of abrocitinib and found significantly higher proportions of clinically meaningful responses for itch in patients receiving abrocitinib 200 mg and 100 mg vs placebo as early as week 2 which continued through week 12.
• Lio et al. performed a post-hoc analysis of a phase 3 study of conducted in North America and found significant improvements for itch severity and sleep disturbance in patients treated with baricitinib 1 mg and 2 mg vs placebo. In particular, patients who achieved improvement of itch or sleep disturbance compared to those who did not were more likely to report having no impact on quality of life impact and improved work productivity.

This new therapeutic class will be an important addition to our therapeutic armamentarium and has potential to transform the AD treatment landscape.

• Many patients prefer taking pills over injections.
• Rapid-onset of efficacy for JAK-inhibitors will certainly be appreciated by patients, especially when trying to control tough flares. It may even guide clinical decision-making. Patients who have a good clinical response to JAK-inhibitors tend to do so within 4-8 weeks. By 8 weeks, if patients have no clinical response, they are likely not going to respond and may benefit from switching to alternative therapies.
• JAK-inhibitors can have robust efficacy, with higher doses of upadacitinib and abrocritinib showing greater efficacy than dupilumab at 12-16 weeks. This makes them attractive options to consider in patients who previously failed dupilumab.
• On the other hand, JAK-inhibitors have laboratory monitoring requirements, including complete blood count, comprehensive metabolic panel, lipid panel, etc.
• JAK-inhibitors warrant adverse-event monitoring for headache, nausea, acne, herpesvirus infections, risk of venous thromboembolism, etc.

Future research is needed to identify patient subsets who will benefit most from JAK-inhibitor therapy and where to position these agents in treatment guidelines.

Atopic Dermatitis (AD) is complex with heterogeneous symptoms (e.g. skin-pain, sleep disturbance), signs (e.g. lichenification, prurigo nodules, follicular accentuation), and longitudinal course (intermittent, persistent). These disparate signs and symptoms should be addressed in optimize disease control.

Multiple extracellular cytokines are upregulated in skin of AD patients, including interleukins 4, 5, 13, 22, 31 and thymic stromal lymphopoietin, all of which signal intracellularly through Janus Kinase (JAK)-Signal Transducer and Activator of Transcription (STAT) pathways. Differential cytokine expression is proposed to underlie clinical variability. It may be necessary to inhibit signaling of multiple cytokines to achieve adequate control of AD.

Dupilumab is currently the only biologic treatment approved in the United States for moderate-severe AD. Dupilumab revolutionized AD management. However, there remain unmet needs, including the need for faster and more potent efficacy, and oral treatment options. Recently, oral JAK-inhibitors were investigated as treatments for moderate-severe AD. Multiple JAK-inhibitors demonstrated strong and rapid efficacy across multiple clinician-reported and patient-reported outcomes.

• Miao et al. recently conducted a meta-analysis of 10 randomized controlled trials and found that patients receiving JAK inhibitors showed significantly higher efficacy for eczema area and severity index (EASI) and Numeric Rating Scale (NRS)-itch scores and similar rates of adverse-events.
• Kim et al. pooled data from 3 randomized controlled trials of abrocitinib and found significantly higher proportions of clinically meaningful responses for itch in patients receiving abrocitinib 200 mg and 100 mg vs placebo as early as week 2 which continued through week 12.
• Lio et al. performed a post-hoc analysis of a phase 3 study of conducted in North America and found significant improvements for itch severity and sleep disturbance in patients treated with baricitinib 1 mg and 2 mg vs placebo. In particular, patients who achieved improvement of itch or sleep disturbance compared to those who did not were more likely to report having no impact on quality of life impact and improved work productivity.

This new therapeutic class will be an important addition to our therapeutic armamentarium and has potential to transform the AD treatment landscape.

• Many patients prefer taking pills over injections.
• Rapid-onset of efficacy for JAK-inhibitors will certainly be appreciated by patients, especially when trying to control tough flares. It may even guide clinical decision-making. Patients who have a good clinical response to JAK-inhibitors tend to do so within 4-8 weeks. By 8 weeks, if patients have no clinical response, they are likely not going to respond and may benefit from switching to alternative therapies.
• JAK-inhibitors can have robust efficacy, with higher doses of upadacitinib and abrocritinib showing greater efficacy than dupilumab at 12-16 weeks. This makes them attractive options to consider in patients who previously failed dupilumab.
• On the other hand, JAK-inhibitors have laboratory monitoring requirements, including complete blood count, comprehensive metabolic panel, lipid panel, etc.
• JAK-inhibitors warrant adverse-event monitoring for headache, nausea, acne, herpesvirus infections, risk of venous thromboembolism, etc.

Future research is needed to identify patient subsets who will benefit most from JAK-inhibitor therapy and where to position these agents in treatment guidelines.

Atopic Dermatitis (AD) is complex with heterogeneous symptoms (e.g. skin-pain, sleep disturbance), signs (e.g. lichenification, prurigo nodules, follicular accentuation), and longitudinal course (intermittent, persistent). These disparate signs and symptoms should be addressed in optimize disease control.

Multiple extracellular cytokines are upregulated in skin of AD patients, including interleukins 4, 5, 13, 22, 31 and thymic stromal lymphopoietin, all of which signal intracellularly through Janus Kinase (JAK)-Signal Transducer and Activator of Transcription (STAT) pathways. Differential cytokine expression is proposed to underlie clinical variability. It may be necessary to inhibit signaling of multiple cytokines to achieve adequate control of AD.

Dupilumab is currently the only biologic treatment approved in the United States for moderate-severe AD. Dupilumab revolutionized AD management. However, there remain unmet needs, including the need for faster and more potent efficacy, and oral treatment options. Recently, oral JAK-inhibitors were investigated as treatments for moderate-severe AD. Multiple JAK-inhibitors demonstrated strong and rapid efficacy across multiple clinician-reported and patient-reported outcomes.

• Miao et al. recently conducted a meta-analysis of 10 randomized controlled trials and found that patients receiving JAK inhibitors showed significantly higher efficacy for eczema area and severity index (EASI) and Numeric Rating Scale (NRS)-itch scores and similar rates of adverse-events.
• Kim et al. pooled data from 3 randomized controlled trials of abrocitinib and found significantly higher proportions of clinically meaningful responses for itch in patients receiving abrocitinib 200 mg and 100 mg vs placebo as early as week 2 which continued through week 12.
• Lio et al. performed a post-hoc analysis of a phase 3 study of conducted in North America and found significant improvements for itch severity and sleep disturbance in patients treated with baricitinib 1 mg and 2 mg vs placebo. In particular, patients who achieved improvement of itch or sleep disturbance compared to those who did not were more likely to report having no impact on quality of life impact and improved work productivity.

This new therapeutic class will be an important addition to our therapeutic armamentarium and has potential to transform the AD treatment landscape.

• Many patients prefer taking pills over injections.
• Rapid-onset of efficacy for JAK-inhibitors will certainly be appreciated by patients, especially when trying to control tough flares. It may even guide clinical decision-making. Patients who have a good clinical response to JAK-inhibitors tend to do so within 4-8 weeks. By 8 weeks, if patients have no clinical response, they are likely not going to respond and may benefit from switching to alternative therapies.
• JAK-inhibitors can have robust efficacy, with higher doses of upadacitinib and abrocritinib showing greater efficacy than dupilumab at 12-16 weeks. This makes them attractive options to consider in patients who previously failed dupilumab.
• On the other hand, JAK-inhibitors have laboratory monitoring requirements, including complete blood count, comprehensive metabolic panel, lipid panel, etc.
• JAK-inhibitors warrant adverse-event monitoring for headache, nausea, acne, herpesvirus infections, risk of venous thromboembolism, etc.

Future research is needed to identify patient subsets who will benefit most from JAK-inhibitor therapy and where to position these agents in treatment guidelines.

Rana et al published a cost-effectiveness analysis in the British Journal of Obstetrics and Gynecology that evaluated the cost-effectiveness of uterine artery embolization (UAE) and myomectomy for women with symptomatic uterine fibroids wishing to avoid hysterectomy. The analysis was conducted along the FEMME randomized control trial, that examined the quality of life of menstruating women with symptomatic fibroids experience after treatment with UAE or myomectomy. Over a 2-year time period, UAE was associated with higher mean costs and lower quality-adjusted life years compared with myomectomy. Similar results were observed over the 4-year time period. The authors concluded that myomectomy is a cost-effective option for the treatment of uterine fibroids.

A third study by Moor et al evaluated the impact of herpes simplex type 2 (HSV-2) infection on incidence and growth of ultrasound-diagnosed uterine fibroids in a large group of African American women. As reproductive tract infections have long been suspected as risk factors for fibroid development, this is a key study. In this prospective study analyzing data from the Study of Environment, Lifestyle and a large cohort of 25-35 year-old African American women with uterine fibroids were monitored by ultrasound over a 5-year period. A key finding was that fibroid HSV-2 positive status was not associated with fibroid incidence.

Rana et al published a cost-effectiveness analysis in the British Journal of Obstetrics and Gynecology that evaluated the cost-effectiveness of uterine artery embolization (UAE) and myomectomy for women with symptomatic uterine fibroids wishing to avoid hysterectomy. The analysis was conducted along the FEMME randomized control trial, that examined the quality of life of menstruating women with symptomatic fibroids experience after treatment with UAE or myomectomy. Over a 2-year time period, UAE was associated with higher mean costs and lower quality-adjusted life years compared with myomectomy. Similar results were observed over the 4-year time period. The authors concluded that myomectomy is a cost-effective option for the treatment of uterine fibroids.

A third study by Moor et al evaluated the impact of herpes simplex type 2 (HSV-2) infection on incidence and growth of ultrasound-diagnosed uterine fibroids in a large group of African American women. As reproductive tract infections have long been suspected as risk factors for fibroid development, this is a key study. In this prospective study analyzing data from the Study of Environment, Lifestyle and a large cohort of 25-35 year-old African American women with uterine fibroids were monitored by ultrasound over a 5-year period. A key finding was that fibroid HSV-2 positive status was not associated with fibroid incidence.

Rana et al published a cost-effectiveness analysis in the British Journal of Obstetrics and Gynecology that evaluated the cost-effectiveness of uterine artery embolization (UAE) and myomectomy for women with symptomatic uterine fibroids wishing to avoid hysterectomy. The analysis was conducted along the FEMME randomized control trial, that examined the quality of life of menstruating women with symptomatic fibroids experience after treatment with UAE or myomectomy. Over a 2-year time period, UAE was associated with higher mean costs and lower quality-adjusted life years compared with myomectomy. Similar results were observed over the 4-year time period. The authors concluded that myomectomy is a cost-effective option for the treatment of uterine fibroids.

A third study by Moor et al evaluated the impact of herpes simplex type 2 (HSV-2) infection on incidence and growth of ultrasound-diagnosed uterine fibroids in a large group of African American women. As reproductive tract infections have long been suspected as risk factors for fibroid development, this is a key study. In this prospective study analyzing data from the Study of Environment, Lifestyle and a large cohort of 25-35 year-old African American women with uterine fibroids were monitored by ultrasound over a 5-year period. A key finding was that fibroid HSV-2 positive status was not associated with fibroid incidence.

Key clinical point: Janus kinase (JAK) inhibitors were safe and effective in reducing the intensity of signs and symptoms of atopic dermatitis (AD) with significant improvements observed for Eczema Area and Severity Index (EASI) and pruritus numerical rating scale (NRS) scores.

Major finding: Patients receiving JAK inhibitors showed significant improvements in both total EASI score (mean difference [MD], −0.31; 95% confidence interval [CI], −0.46 to −0.17) and pruritus NRS score (MD, −1.15; 95% CI, −1.48 to −0.83). The risk of total adverse events was not significantly different between JAK inhibitor and control groups (risk ratio, 1.02; P = .745).

Study details: Findings are from a meta-analysis of 10 randomized controlled trials including 2583 patients with AD, of which 1,761 were in JAK inhibitor and 822 in control groups.

Disclosures: The study did not report any source of funding. No conflicts of interest were reported.

Source: Miao M et al. J Dermatolog Treat. 2021 Jun 16. doi: 10.1080/09546634.2021.1942422.

Key clinical point: Janus kinase (JAK) inhibitors were safe and effective in reducing the intensity of signs and symptoms of atopic dermatitis (AD) with significant improvements observed for Eczema Area and Severity Index (EASI) and pruritus numerical rating scale (NRS) scores.

Major finding: Patients receiving JAK inhibitors showed significant improvements in both total EASI score (mean difference [MD], −0.31; 95% confidence interval [CI], −0.46 to −0.17) and pruritus NRS score (MD, −1.15; 95% CI, −1.48 to −0.83). The risk of total adverse events was not significantly different between JAK inhibitor and control groups (risk ratio, 1.02; P = .745).

Study details: Findings are from a meta-analysis of 10 randomized controlled trials including 2583 patients with AD, of which 1,761 were in JAK inhibitor and 822 in control groups.

Disclosures: The study did not report any source of funding. No conflicts of interest were reported.

Source: Miao M et al. J Dermatolog Treat. 2021 Jun 16. doi: 10.1080/09546634.2021.1942422.

Key clinical point: Janus kinase (JAK) inhibitors were safe and effective in reducing the intensity of signs and symptoms of atopic dermatitis (AD) with significant improvements observed for Eczema Area and Severity Index (EASI) and pruritus numerical rating scale (NRS) scores.

Major finding: Patients receiving JAK inhibitors showed significant improvements in both total EASI score (mean difference [MD], −0.31; 95% confidence interval [CI], −0.46 to −0.17) and pruritus NRS score (MD, −1.15; 95% CI, −1.48 to −0.83). The risk of total adverse events was not significantly different between JAK inhibitor and control groups (risk ratio, 1.02; P = .745).

Study details: Findings are from a meta-analysis of 10 randomized controlled trials including 2583 patients with AD, of which 1,761 were in JAK inhibitor and 822 in control groups.

Disclosures: The study did not report any source of funding. No conflicts of interest were reported.

Source: Miao M et al. J Dermatolog Treat. 2021 Jun 16. doi: 10.1080/09546634.2021.1942422.

Key clinical point: Analysis of serum biomarker profiles in pediatric patients with atopic dermatitis (AD) indicates the existence of unique endotypes that could predict patients at risk of persistent disease and guide personalized, endotype-driven therapeutic approaches.

Major finding: Distinct biomarker profiles identified Th2/retinol dominant (mean Eczema Area Severity Index [EASI] score: 9.2), skin-homing dominant (mean EASI score: 27.8), Th1/Th2/Th17/IL-1 dominant (mean EASI score: 10.5), and Th1/IL-1/eosinophil inferior (mean EASI score: 12.3) as the 4 distinct pediatric clusters. The clusters were influenced by disease severity and not age, with the skin-homing dominant cluster having more severe AD than other clusters (P less than .001).

Study details: Findings are from an analysis of biomarker profiles of 240 pediatric patients with AD aged 0-17 years compared with previously found profiles in adult patients with AD.

Disclosures: This study was funded by Regeneron and Sanofi-Genzyme pharmaceuticals, Inc. Dr. M de Graaf, Dr. MS de Bruin-Weller, Dr. DS Bakker, Dr. E Knol, and Dr. JL Thijs declared being speaker, principal investigator, consultant, and/or advisory board member for various sources including Sanofi-Genzyme and Regeneron.

Source: Bakker DS et al. J Allergy Clin Immun. 2021 Jul 6. doi: 10.1016/j.jaci.2021.06.029.

Key clinical point: Analysis of serum biomarker profiles in pediatric patients with atopic dermatitis (AD) indicates the existence of unique endotypes that could predict patients at risk of persistent disease and guide personalized, endotype-driven therapeutic approaches.

Major finding: Distinct biomarker profiles identified Th2/retinol dominant (mean Eczema Area Severity Index [EASI] score: 9.2), skin-homing dominant (mean EASI score: 27.8), Th1/Th2/Th17/IL-1 dominant (mean EASI score: 10.5), and Th1/IL-1/eosinophil inferior (mean EASI score: 12.3) as the 4 distinct pediatric clusters. The clusters were influenced by disease severity and not age, with the skin-homing dominant cluster having more severe AD than other clusters (P less than .001).

Study details: Findings are from an analysis of biomarker profiles of 240 pediatric patients with AD aged 0-17 years compared with previously found profiles in adult patients with AD.

Disclosures: This study was funded by Regeneron and Sanofi-Genzyme pharmaceuticals, Inc. Dr. M de Graaf, Dr. MS de Bruin-Weller, Dr. DS Bakker, Dr. E Knol, and Dr. JL Thijs declared being speaker, principal investigator, consultant, and/or advisory board member for various sources including Sanofi-Genzyme and Regeneron.

Source: Bakker DS et al. J Allergy Clin Immun. 2021 Jul 6. doi: 10.1016/j.jaci.2021.06.029.

Key clinical point: Analysis of serum biomarker profiles in pediatric patients with atopic dermatitis (AD) indicates the existence of unique endotypes that could predict patients at risk of persistent disease and guide personalized, endotype-driven therapeutic approaches.

Major finding: Distinct biomarker profiles identified Th2/retinol dominant (mean Eczema Area Severity Index [EASI] score: 9.2), skin-homing dominant (mean EASI score: 27.8), Th1/Th2/Th17/IL-1 dominant (mean EASI score: 10.5), and Th1/IL-1/eosinophil inferior (mean EASI score: 12.3) as the 4 distinct pediatric clusters. The clusters were influenced by disease severity and not age, with the skin-homing dominant cluster having more severe AD than other clusters (P less than .001).

Study details: Findings are from an analysis of biomarker profiles of 240 pediatric patients with AD aged 0-17 years compared with previously found profiles in adult patients with AD.

Disclosures: This study was funded by Regeneron and Sanofi-Genzyme pharmaceuticals, Inc. Dr. M de Graaf, Dr. MS de Bruin-Weller, Dr. DS Bakker, Dr. E Knol, and Dr. JL Thijs declared being speaker, principal investigator, consultant, and/or advisory board member for various sources including Sanofi-Genzyme and Regeneron.

Source: Bakker DS et al. J Allergy Clin Immun. 2021 Jul 6. doi: 10.1016/j.jaci.2021.06.029.

Key clinical point: Higher maternal serum 25-hydroxyvitamin D (25[OH]D) levels during pregnancy may be associated with increased risk for early-onset infant atopic dermatitis (AD).

Major finding: Overall, 26.5% of infants developed AD before 1 year of age. Higher maternal serum 25(OH)D levels during pregnancy were associated with increased risks for AD in infants before 1 year of age with borderline statistical significance, particularly in the first trimester (per ln unit increase, adjusted odds ratio [aOR], 1.93; 95% confidence interval [CI], 0.96-3.88) and the second trimester (per ln unit increase, aOR, 1.72; 95% CI, 0.93-3.19).

Study details: Findings are from the analysis of pregnant women from the MKFOAD birth cohort and their infants (n=456) who received routine child care visits at birth, day 42, and 6 and 12 months after birth.

Disclosures: This study was funded by Shanghai Public Health Three-Year Action Plan, National Key Research and Development Program, Canada-China Clinical Research Program, Collaboration Grant of Children’s Hospital of Fudan University, and Pigeon Maternal and Infant Skin Care Research Institute. The authors declared no conflicts of interest.

Source: Tian Y et al. Pediatr Allergy Immunol. 2021 Jun 23. doi: 10.1111/pai.13582. 

Key clinical point: Higher maternal serum 25-hydroxyvitamin D (25[OH]D) levels during pregnancy may be associated with increased risk for early-onset infant atopic dermatitis (AD).

Major finding: Overall, 26.5% of infants developed AD before 1 year of age. Higher maternal serum 25(OH)D levels during pregnancy were associated with increased risks for AD in infants before 1 year of age with borderline statistical significance, particularly in the first trimester (per ln unit increase, adjusted odds ratio [aOR], 1.93; 95% confidence interval [CI], 0.96-3.88) and the second trimester (per ln unit increase, aOR, 1.72; 95% CI, 0.93-3.19).

Study details: Findings are from the analysis of pregnant women from the MKFOAD birth cohort and their infants (n=456) who received routine child care visits at birth, day 42, and 6 and 12 months after birth.

Disclosures: This study was funded by Shanghai Public Health Three-Year Action Plan, National Key Research and Development Program, Canada-China Clinical Research Program, Collaboration Grant of Children’s Hospital of Fudan University, and Pigeon Maternal and Infant Skin Care Research Institute. The authors declared no conflicts of interest.

Source: Tian Y et al. Pediatr Allergy Immunol. 2021 Jun 23. doi: 10.1111/pai.13582. 

Key clinical point: Higher maternal serum 25-hydroxyvitamin D (25[OH]D) levels during pregnancy may be associated with increased risk for early-onset infant atopic dermatitis (AD).

Major finding: Overall, 26.5% of infants developed AD before 1 year of age. Higher maternal serum 25(OH)D levels during pregnancy were associated with increased risks for AD in infants before 1 year of age with borderline statistical significance, particularly in the first trimester (per ln unit increase, adjusted odds ratio [aOR], 1.93; 95% confidence interval [CI], 0.96-3.88) and the second trimester (per ln unit increase, aOR, 1.72; 95% CI, 0.93-3.19).

Study details: Findings are from the analysis of pregnant women from the MKFOAD birth cohort and their infants (n=456) who received routine child care visits at birth, day 42, and 6 and 12 months after birth.

Disclosures: This study was funded by Shanghai Public Health Three-Year Action Plan, National Key Research and Development Program, Canada-China Clinical Research Program, Collaboration Grant of Children’s Hospital of Fudan University, and Pigeon Maternal and Infant Skin Care Research Institute. The authors declared no conflicts of interest.

Source: Tian Y et al. Pediatr Allergy Immunol. 2021 Jun 23. doi: 10.1111/pai.13582. 

Key clinical point: Dupilumab with or without topical corticosteroids (TCS) was beneficial in adults with moderate-to-severe atopic dermatitis (AD) regardless of any prior use of systemic nonsteroidal immunosuppressants (NSISS).

Major finding: Compared with placebo with/without TCS, dupilumab with/without TCS showed significant improvement in Eczema Area and Severity Index, SCORing AD, Peak Pruritus Numerical Rating Scale, and quality of life in patients with/without prior use of NSISS (P less than .001) by week 16 which continued through week 52 of treatment.

Study details: Findings are from a post hoc analysis of 4 phase 3 clinical trials including 1553 patients with moderate-to-severe AD randomly assigned to placebo or dupilumab as monotherapy for 16 weeks or with concomitant TCS for 16/52 weeks.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc. Some of the authors declared receiving grants, honoraria and serving as consultant or speaker or on advisory board for various sources. Some of the authors declared being employees and/or holding stocks/stock options at Sanofi, Regeneron Pharmaceuticals, Inc or Sanofi Genzyme.

Source: Griffiths C et al. Dermatol Ther (Heidelb). 2021 Jun 18. doi: 10.1007/s13555-021-00558-0.

Key clinical point: Dupilumab with or without topical corticosteroids (TCS) was beneficial in adults with moderate-to-severe atopic dermatitis (AD) regardless of any prior use of systemic nonsteroidal immunosuppressants (NSISS).

Major finding: Compared with placebo with/without TCS, dupilumab with/without TCS showed significant improvement in Eczema Area and Severity Index, SCORing AD, Peak Pruritus Numerical Rating Scale, and quality of life in patients with/without prior use of NSISS (P less than .001) by week 16 which continued through week 52 of treatment.

Study details: Findings are from a post hoc analysis of 4 phase 3 clinical trials including 1553 patients with moderate-to-severe AD randomly assigned to placebo or dupilumab as monotherapy for 16 weeks or with concomitant TCS for 16/52 weeks.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc. Some of the authors declared receiving grants, honoraria and serving as consultant or speaker or on advisory board for various sources. Some of the authors declared being employees and/or holding stocks/stock options at Sanofi, Regeneron Pharmaceuticals, Inc or Sanofi Genzyme.

Source: Griffiths C et al. Dermatol Ther (Heidelb). 2021 Jun 18. doi: 10.1007/s13555-021-00558-0.

Key clinical point: Dupilumab with or without topical corticosteroids (TCS) was beneficial in adults with moderate-to-severe atopic dermatitis (AD) regardless of any prior use of systemic nonsteroidal immunosuppressants (NSISS).

Major finding: Compared with placebo with/without TCS, dupilumab with/without TCS showed significant improvement in Eczema Area and Severity Index, SCORing AD, Peak Pruritus Numerical Rating Scale, and quality of life in patients with/without prior use of NSISS (P less than .001) by week 16 which continued through week 52 of treatment.

Study details: Findings are from a post hoc analysis of 4 phase 3 clinical trials including 1553 patients with moderate-to-severe AD randomly assigned to placebo or dupilumab as monotherapy for 16 weeks or with concomitant TCS for 16/52 weeks.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc. Some of the authors declared receiving grants, honoraria and serving as consultant or speaker or on advisory board for various sources. Some of the authors declared being employees and/or holding stocks/stock options at Sanofi, Regeneron Pharmaceuticals, Inc or Sanofi Genzyme.

Source: Griffiths C et al. Dermatol Ther (Heidelb). 2021 Jun 18. doi: 10.1007/s13555-021-00558-0.

Key clinical point: In real world clinical practice, combination of tacrolimus ointment and dupilumab was an effective and safe treatment option for facial atopic dermatitis (AD).

Major finding: On 16 weeks of treatment, a significant decrease was observed in average scores including Investigator’s Global Assessment, overall Eczema Area and Severity Index (EASI), and head/neck EASI (P less than .0001). Moreover, the rate of improvement in head/neck EASI scores significantly correlated with the rate of improvement in the overall EASI scores (Pearson’s r, 0.61; P less than .01). None of the patients developed herpes simplex, whereas 2 patients developed conjunctivitis.

Study details: Findings are from a retrospective chart review of 109 patients with moderate-to-severe AD who initiated dupilumab, of which 60 patients also used tacrolimus ointment. Of these, 20 patients used tacrolimus ointment without any topical steroids.

Disclosures: This work was supported by grants from Japan Society for the Promotion of Science. The authors did not declare any conflicts of interest.

Source: Matsutani M et al. J Dermatol. 2021 Jun 22. doi: 10.1111/1346-8138.16039.

Key clinical point: In real world clinical practice, combination of tacrolimus ointment and dupilumab was an effective and safe treatment option for facial atopic dermatitis (AD).

Major finding: On 16 weeks of treatment, a significant decrease was observed in average scores including Investigator’s Global Assessment, overall Eczema Area and Severity Index (EASI), and head/neck EASI (P less than .0001). Moreover, the rate of improvement in head/neck EASI scores significantly correlated with the rate of improvement in the overall EASI scores (Pearson’s r, 0.61; P less than .01). None of the patients developed herpes simplex, whereas 2 patients developed conjunctivitis.

Study details: Findings are from a retrospective chart review of 109 patients with moderate-to-severe AD who initiated dupilumab, of which 60 patients also used tacrolimus ointment. Of these, 20 patients used tacrolimus ointment without any topical steroids.

Disclosures: This work was supported by grants from Japan Society for the Promotion of Science. The authors did not declare any conflicts of interest.

Source: Matsutani M et al. J Dermatol. 2021 Jun 22. doi: 10.1111/1346-8138.16039.

Key clinical point: In real world clinical practice, combination of tacrolimus ointment and dupilumab was an effective and safe treatment option for facial atopic dermatitis (AD).

Major finding: On 16 weeks of treatment, a significant decrease was observed in average scores including Investigator’s Global Assessment, overall Eczema Area and Severity Index (EASI), and head/neck EASI (P less than .0001). Moreover, the rate of improvement in head/neck EASI scores significantly correlated with the rate of improvement in the overall EASI scores (Pearson’s r, 0.61; P less than .01). None of the patients developed herpes simplex, whereas 2 patients developed conjunctivitis.

Study details: Findings are from a retrospective chart review of 109 patients with moderate-to-severe AD who initiated dupilumab, of which 60 patients also used tacrolimus ointment. Of these, 20 patients used tacrolimus ointment without any topical steroids.

Disclosures: This work was supported by grants from Japan Society for the Promotion of Science. The authors did not declare any conflicts of interest.

Source: Matsutani M et al. J Dermatol. 2021 Jun 22. doi: 10.1111/1346-8138.16039.