Clinical Edge Journal Scan

Key clinical point: Patients with atopic dermatitis (AD) who received adjunctive allergen immunotherapy (AIT) reported improvements in disease severity and quality of life despite an increase in the rate of adverse events (AE).

Major finding: AIT vs no AIT improved disease severity (risk ratio [RR] 1.53; 95% CI 1.31-1.78) and the Dermatology Life Quality Index by at least 4 points (RR 1.44; 95% CI 1.03-2.01). The rates of local (RR 1.65; 95% CI 1.48-1.64) and systemic (RR 1.37; 95% CI 1.15-1.64) AE were higher with AIT vs placebo.

Study details: Findings are from a meta-analysis of 23 randomized controlled trials including 1957 adult and pediatric patients with moderate-to-severe AD who were randomly assigned to adjunctive AIT (subcutaneous or sublingual immunotherapy) or no AIT (placebo or standard care).

Disclosures: This study was supported by the American Academy of Allergy, Asthma, & Immunology and other sources. The authors declared no conflicts of interest.

Source: Yepes-Nuñez JJ et al. Allergen immunotherapy for atopic dermatitis: A systematic review and meta-analysis of benefits and harms. J Allergy Clin Immunol. 2022 (Sep 30). Doi: 10.1016/j.jaci.2022.09.020

Key clinical point: Patients with atopic dermatitis (AD) who received adjunctive allergen immunotherapy (AIT) reported improvements in disease severity and quality of life despite an increase in the rate of adverse events (AE).

Major finding: AIT vs no AIT improved disease severity (risk ratio [RR] 1.53; 95% CI 1.31-1.78) and the Dermatology Life Quality Index by at least 4 points (RR 1.44; 95% CI 1.03-2.01). The rates of local (RR 1.65; 95% CI 1.48-1.64) and systemic (RR 1.37; 95% CI 1.15-1.64) AE were higher with AIT vs placebo.

Study details: Findings are from a meta-analysis of 23 randomized controlled trials including 1957 adult and pediatric patients with moderate-to-severe AD who were randomly assigned to adjunctive AIT (subcutaneous or sublingual immunotherapy) or no AIT (placebo or standard care).

Disclosures: This study was supported by the American Academy of Allergy, Asthma, & Immunology and other sources. The authors declared no conflicts of interest.

Source: Yepes-Nuñez JJ et al. Allergen immunotherapy for atopic dermatitis: A systematic review and meta-analysis of benefits and harms. J Allergy Clin Immunol. 2022 (Sep 30). Doi: 10.1016/j.jaci.2022.09.020

Key clinical point: Patients with atopic dermatitis (AD) who received adjunctive allergen immunotherapy (AIT) reported improvements in disease severity and quality of life despite an increase in the rate of adverse events (AE).

Major finding: AIT vs no AIT improved disease severity (risk ratio [RR] 1.53; 95% CI 1.31-1.78) and the Dermatology Life Quality Index by at least 4 points (RR 1.44; 95% CI 1.03-2.01). The rates of local (RR 1.65; 95% CI 1.48-1.64) and systemic (RR 1.37; 95% CI 1.15-1.64) AE were higher with AIT vs placebo.

Study details: Findings are from a meta-analysis of 23 randomized controlled trials including 1957 adult and pediatric patients with moderate-to-severe AD who were randomly assigned to adjunctive AIT (subcutaneous or sublingual immunotherapy) or no AIT (placebo or standard care).

Disclosures: This study was supported by the American Academy of Allergy, Asthma, & Immunology and other sources. The authors declared no conflicts of interest.

Source: Yepes-Nuñez JJ et al. Allergen immunotherapy for atopic dermatitis: A systematic review and meta-analysis of benefits and harms. J Allergy Clin Immunol. 2022 (Sep 30). Doi: 10.1016/j.jaci.2022.09.020

Key clinical point: Rate of COVID-19 hospitalizations varied by treatment modalities in patients with atopic dermatitis (AD) who received immunomodulatory drugs.

Major finding: Rate of COVID-19 hospitalizations was higher among patients who received topical treatment vs dupilumab (adjusted odds ratio [aOR] 4.99; 95% CI 1.4-20.84) or combination therapy with systemic corticosteroids vs monotherapy with nonsteroidal immunosuppressants (aOR 45.75; 95% CI 4.54-616.22).

Study details: Findings are from the SECURE-AD registry including 442 patients with AD and a diagnosis of COVID-19 who received immunomodulatory treatments.

Disclosures: This study is funded by the University of Amsterdam and other sources. Some authors declared serving as employees or receiving grants, consulting fees, honoraria, or travel support from several sources.

Source: Musters AH et al. The effects of systemic immunomodulatory treatments on COVID-19 outcomes in patients with atopic dermatitis: Results from the global SECURE-AD registry. J Eur Acad Dermatol Venereol. 2022 (Sep 28). Doi: 10.1111/jdv.18613

Key clinical point: Rate of COVID-19 hospitalizations varied by treatment modalities in patients with atopic dermatitis (AD) who received immunomodulatory drugs.

Major finding: Rate of COVID-19 hospitalizations was higher among patients who received topical treatment vs dupilumab (adjusted odds ratio [aOR] 4.99; 95% CI 1.4-20.84) or combination therapy with systemic corticosteroids vs monotherapy with nonsteroidal immunosuppressants (aOR 45.75; 95% CI 4.54-616.22).

Study details: Findings are from the SECURE-AD registry including 442 patients with AD and a diagnosis of COVID-19 who received immunomodulatory treatments.

Disclosures: This study is funded by the University of Amsterdam and other sources. Some authors declared serving as employees or receiving grants, consulting fees, honoraria, or travel support from several sources.

Source: Musters AH et al. The effects of systemic immunomodulatory treatments on COVID-19 outcomes in patients with atopic dermatitis: Results from the global SECURE-AD registry. J Eur Acad Dermatol Venereol. 2022 (Sep 28). Doi: 10.1111/jdv.18613

Key clinical point: Rate of COVID-19 hospitalizations varied by treatment modalities in patients with atopic dermatitis (AD) who received immunomodulatory drugs.

Major finding: Rate of COVID-19 hospitalizations was higher among patients who received topical treatment vs dupilumab (adjusted odds ratio [aOR] 4.99; 95% CI 1.4-20.84) or combination therapy with systemic corticosteroids vs monotherapy with nonsteroidal immunosuppressants (aOR 45.75; 95% CI 4.54-616.22).

Study details: Findings are from the SECURE-AD registry including 442 patients with AD and a diagnosis of COVID-19 who received immunomodulatory treatments.

Disclosures: This study is funded by the University of Amsterdam and other sources. Some authors declared serving as employees or receiving grants, consulting fees, honoraria, or travel support from several sources.

Source: Musters AH et al. The effects of systemic immunomodulatory treatments on COVID-19 outcomes in patients with atopic dermatitis: Results from the global SECURE-AD registry. J Eur Acad Dermatol Venereol. 2022 (Sep 28). Doi: 10.1111/jdv.18613

Key clinical point: Tralokinumab, with or without topical corticosteroids (TCS), demonstrated significant efficacy in reducing disease severity and was well-tolerated in North American patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 16, a significantly higher proportion of patients receiving tralokinumab vs placebo achieved ≥75% improvement in the Eczema Area and Severity Index in ECZTRA 1/2 (40.1% vs 19.4%; P < .001) and ECZTRA 3 (58.1% vs 37.0%; P  =  .012) studies. Tralokinumab with or without TCS was also well-tolerated in the North American population.

Study details: Findings are from a post hoc analysis of three tralokinumab trials including patients with moderate-to-severe AD who were randomly assigned to receive tralokinumab or placebo, both with TCS as needed (ECZTRA 3; n = 160) or without TCS (ECZTRA 1 and 2; n = 559).

Disclosures: The ECZTRA trials were sponsored by LEO Pharma A/S. Three authors declared being current or former employees of LEO Pharma. The other authors reported ties with several sources, including LEO Pharma.

Source: Blauvelt A et al. Tralokinumab efficacy and safety, with or without topical corticosteroids, in North American adults with moderate-to-severe atopic dermatitis: A subanalysis of phase 3 trials ECZTRA 1, 2, and 3. Dermatol Ther (Heidelb). 2022 (Sep 24). Doi: 10.1007/s13555-022-00805-y

Key clinical point: Tralokinumab, with or without topical corticosteroids (TCS), demonstrated significant efficacy in reducing disease severity and was well-tolerated in North American patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 16, a significantly higher proportion of patients receiving tralokinumab vs placebo achieved ≥75% improvement in the Eczema Area and Severity Index in ECZTRA 1/2 (40.1% vs 19.4%; P < .001) and ECZTRA 3 (58.1% vs 37.0%; P  =  .012) studies. Tralokinumab with or without TCS was also well-tolerated in the North American population.

Study details: Findings are from a post hoc analysis of three tralokinumab trials including patients with moderate-to-severe AD who were randomly assigned to receive tralokinumab or placebo, both with TCS as needed (ECZTRA 3; n = 160) or without TCS (ECZTRA 1 and 2; n = 559).

Disclosures: The ECZTRA trials were sponsored by LEO Pharma A/S. Three authors declared being current or former employees of LEO Pharma. The other authors reported ties with several sources, including LEO Pharma.

Source: Blauvelt A et al. Tralokinumab efficacy and safety, with or without topical corticosteroids, in North American adults with moderate-to-severe atopic dermatitis: A subanalysis of phase 3 trials ECZTRA 1, 2, and 3. Dermatol Ther (Heidelb). 2022 (Sep 24). Doi: 10.1007/s13555-022-00805-y

Key clinical point: Tralokinumab, with or without topical corticosteroids (TCS), demonstrated significant efficacy in reducing disease severity and was well-tolerated in North American patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 16, a significantly higher proportion of patients receiving tralokinumab vs placebo achieved ≥75% improvement in the Eczema Area and Severity Index in ECZTRA 1/2 (40.1% vs 19.4%; P < .001) and ECZTRA 3 (58.1% vs 37.0%; P  =  .012) studies. Tralokinumab with or without TCS was also well-tolerated in the North American population.

Study details: Findings are from a post hoc analysis of three tralokinumab trials including patients with moderate-to-severe AD who were randomly assigned to receive tralokinumab or placebo, both with TCS as needed (ECZTRA 3; n = 160) or without TCS (ECZTRA 1 and 2; n = 559).

Disclosures: The ECZTRA trials were sponsored by LEO Pharma A/S. Three authors declared being current or former employees of LEO Pharma. The other authors reported ties with several sources, including LEO Pharma.

Source: Blauvelt A et al. Tralokinumab efficacy and safety, with or without topical corticosteroids, in North American adults with moderate-to-severe atopic dermatitis: A subanalysis of phase 3 trials ECZTRA 1, 2, and 3. Dermatol Ther (Heidelb). 2022 (Sep 24). Doi: 10.1007/s13555-022-00805-y

Key clinical point: Certain cutaneous biomarkers isolated from the clinically healthy skin of 2-month-old infants were able to predict the onset of atopic dermatitis (AD) in the first year of life.

Major finding: Skin thymus- and activation-regulated chemokine levels were slightly but significantly higher (0.02 vs 0.01 pg/μg, P  =  .01), phytosphingosine levels were significantly lower (238 vs 535 pmol/mg, P < .001), and sphingoid bases of chain lengths 17 (P  =  .02) and 18 (P  =  .000001) were different in children who developed vs did not develop AD.

Study details: Findings are from a prospective birth cohort study that analyzed tape strips collected at 2 months of age before AD onset in 44 children who developed AD in the first year of life and 44 matched controls who did not develop AD.

Disclosures: This study was supported by the LEO Foundation and other sources. Four authors declared serving as advisors, speakers, or consultants, or receiving research grants or support from several sources, including LEO Pharma. The other authors reported no conflicts of interest.

Source: Rinnov MR et al. Skin biomarkers predict development of atopic dermatitis in infancy. Allergy. 2022 (Sep 16). Doi: 10.1111/all.15518

Key clinical point: Certain cutaneous biomarkers isolated from the clinically healthy skin of 2-month-old infants were able to predict the onset of atopic dermatitis (AD) in the first year of life.

Major finding: Skin thymus- and activation-regulated chemokine levels were slightly but significantly higher (0.02 vs 0.01 pg/μg, P  =  .01), phytosphingosine levels were significantly lower (238 vs 535 pmol/mg, P < .001), and sphingoid bases of chain lengths 17 (P  =  .02) and 18 (P  =  .000001) were different in children who developed vs did not develop AD.

Study details: Findings are from a prospective birth cohort study that analyzed tape strips collected at 2 months of age before AD onset in 44 children who developed AD in the first year of life and 44 matched controls who did not develop AD.

Disclosures: This study was supported by the LEO Foundation and other sources. Four authors declared serving as advisors, speakers, or consultants, or receiving research grants or support from several sources, including LEO Pharma. The other authors reported no conflicts of interest.

Source: Rinnov MR et al. Skin biomarkers predict development of atopic dermatitis in infancy. Allergy. 2022 (Sep 16). Doi: 10.1111/all.15518

Key clinical point: Certain cutaneous biomarkers isolated from the clinically healthy skin of 2-month-old infants were able to predict the onset of atopic dermatitis (AD) in the first year of life.

Major finding: Skin thymus- and activation-regulated chemokine levels were slightly but significantly higher (0.02 vs 0.01 pg/μg, P  =  .01), phytosphingosine levels were significantly lower (238 vs 535 pmol/mg, P < .001), and sphingoid bases of chain lengths 17 (P  =  .02) and 18 (P  =  .000001) were different in children who developed vs did not develop AD.

Study details: Findings are from a prospective birth cohort study that analyzed tape strips collected at 2 months of age before AD onset in 44 children who developed AD in the first year of life and 44 matched controls who did not develop AD.

Disclosures: This study was supported by the LEO Foundation and other sources. Four authors declared serving as advisors, speakers, or consultants, or receiving research grants or support from several sources, including LEO Pharma. The other authors reported no conflicts of interest.

Source: Rinnov MR et al. Skin biomarkers predict development of atopic dermatitis in infancy. Allergy. 2022 (Sep 16). Doi: 10.1111/all.15518

Key clinical point: Abrocitinib demonstrated a rapid improvement in the signs and symptoms of atopic dermatitis (AD) in patients with moderate-to-severe AD.

Major finding: At week 12, a higher proportion of patients receiving 200/100 mg abrocitinib (70.3%/58.7%) vs placebo (27.1%) achieved ≥75% improvement in the Eczema Area and Severity Index (EASI-75). The time to achieve EASI-75 was significantly lower in the 200/100 mg abrocitinib vs placebo group (29/57 days vs 114 days; 2-sided P < .0001).

Study details: Findings are from the phase 3 JADE COMPARE study including adults with moderate-to-severe AD who were randomly assigned to receive 200/100 mg oral abrocitinib once daily+placebo, dupilumab+placebo, or placebo for 16 weeks.

Disclosures: This study was funded by Pfizer, Inc. Five authors declared being current or former employees and stockholders of Pfizer. The other authors reported ties with several sources.

Source: Reich K et al. Magnitude and time course of response to abrocitinib for moderate-to-severe atopic dermatitis. J Allergy Clin Immunol Pract. 2022 (Sep 12). Doi: 10.1016/j.jaip.2022.08.042

Key clinical point: Abrocitinib demonstrated a rapid improvement in the signs and symptoms of atopic dermatitis (AD) in patients with moderate-to-severe AD.

Major finding: At week 12, a higher proportion of patients receiving 200/100 mg abrocitinib (70.3%/58.7%) vs placebo (27.1%) achieved ≥75% improvement in the Eczema Area and Severity Index (EASI-75). The time to achieve EASI-75 was significantly lower in the 200/100 mg abrocitinib vs placebo group (29/57 days vs 114 days; 2-sided P < .0001).

Study details: Findings are from the phase 3 JADE COMPARE study including adults with moderate-to-severe AD who were randomly assigned to receive 200/100 mg oral abrocitinib once daily+placebo, dupilumab+placebo, or placebo for 16 weeks.

Disclosures: This study was funded by Pfizer, Inc. Five authors declared being current or former employees and stockholders of Pfizer. The other authors reported ties with several sources.

Source: Reich K et al. Magnitude and time course of response to abrocitinib for moderate-to-severe atopic dermatitis. J Allergy Clin Immunol Pract. 2022 (Sep 12). Doi: 10.1016/j.jaip.2022.08.042

Key clinical point: Abrocitinib demonstrated a rapid improvement in the signs and symptoms of atopic dermatitis (AD) in patients with moderate-to-severe AD.

Major finding: At week 12, a higher proportion of patients receiving 200/100 mg abrocitinib (70.3%/58.7%) vs placebo (27.1%) achieved ≥75% improvement in the Eczema Area and Severity Index (EASI-75). The time to achieve EASI-75 was significantly lower in the 200/100 mg abrocitinib vs placebo group (29/57 days vs 114 days; 2-sided P < .0001).

Study details: Findings are from the phase 3 JADE COMPARE study including adults with moderate-to-severe AD who were randomly assigned to receive 200/100 mg oral abrocitinib once daily+placebo, dupilumab+placebo, or placebo for 16 weeks.

Disclosures: This study was funded by Pfizer, Inc. Five authors declared being current or former employees and stockholders of Pfizer. The other authors reported ties with several sources.

Source: Reich K et al. Magnitude and time course of response to abrocitinib for moderate-to-severe atopic dermatitis. J Allergy Clin Immunol Pract. 2022 (Sep 12). Doi: 10.1016/j.jaip.2022.08.042

Key clinical point: Patients with atopic dermatitis (AD) who received ruxolitinib achieved an itch-free state within 2 days, which was maintained throughout the 8-week treatment period.

Major finding: A significantly higher proportion of patients receiving ruxolitinib (1.5%/0.75%) vs vehicle achieved itch numerical rating scale (NRS) score of 0/1 as early as within 2 days (19.0%/15.4% vs 4.6%), with improvements sustained till week 8 (49.5%/43.9% vs 18.3%; all P < .05). The median time to achieve itch NRS 0/1 was <15 days with ruxolitinib cream and not estimable with the vehicle.

Study details: Findings are from a pooled analysis of two phase 3 studies, TRuE-AD1 and TruE-AD2, including 1208 patients with AD and itch NRS score of >1 who were randomly assigned to receive ruxolitinib cream or vehicle.

Disclosures: This study was funded by Incyte Corporation. Three authors declared being employees and shareholders of Incyte Corporation. The other authors declared serving as scientific advisors, investigators, or consultants, or receiving research grants or honoraria from several sources, including Incyte.

Source: Blauvelt A et al. Itch-free state in patients with atopic dermatitis treated with ruxolitinib cream: Pooled analysis from two randomized phase 3 studies. J Am Acad Dermatol. 2022 (Sep 13). Doi: 10.1016/j.jaad.2022.09.010

Key clinical point: Patients with atopic dermatitis (AD) who received ruxolitinib achieved an itch-free state within 2 days, which was maintained throughout the 8-week treatment period.

Major finding: A significantly higher proportion of patients receiving ruxolitinib (1.5%/0.75%) vs vehicle achieved itch numerical rating scale (NRS) score of 0/1 as early as within 2 days (19.0%/15.4% vs 4.6%), with improvements sustained till week 8 (49.5%/43.9% vs 18.3%; all P < .05). The median time to achieve itch NRS 0/1 was <15 days with ruxolitinib cream and not estimable with the vehicle.

Study details: Findings are from a pooled analysis of two phase 3 studies, TRuE-AD1 and TruE-AD2, including 1208 patients with AD and itch NRS score of >1 who were randomly assigned to receive ruxolitinib cream or vehicle.

Disclosures: This study was funded by Incyte Corporation. Three authors declared being employees and shareholders of Incyte Corporation. The other authors declared serving as scientific advisors, investigators, or consultants, or receiving research grants or honoraria from several sources, including Incyte.

Source: Blauvelt A et al. Itch-free state in patients with atopic dermatitis treated with ruxolitinib cream: Pooled analysis from two randomized phase 3 studies. J Am Acad Dermatol. 2022 (Sep 13). Doi: 10.1016/j.jaad.2022.09.010

Key clinical point: Patients with atopic dermatitis (AD) who received ruxolitinib achieved an itch-free state within 2 days, which was maintained throughout the 8-week treatment period.

Major finding: A significantly higher proportion of patients receiving ruxolitinib (1.5%/0.75%) vs vehicle achieved itch numerical rating scale (NRS) score of 0/1 as early as within 2 days (19.0%/15.4% vs 4.6%), with improvements sustained till week 8 (49.5%/43.9% vs 18.3%; all P < .05). The median time to achieve itch NRS 0/1 was <15 days with ruxolitinib cream and not estimable with the vehicle.

Study details: Findings are from a pooled analysis of two phase 3 studies, TRuE-AD1 and TruE-AD2, including 1208 patients with AD and itch NRS score of >1 who were randomly assigned to receive ruxolitinib cream or vehicle.

Disclosures: This study was funded by Incyte Corporation. Three authors declared being employees and shareholders of Incyte Corporation. The other authors declared serving as scientific advisors, investigators, or consultants, or receiving research grants or honoraria from several sources, including Incyte.

Source: Blauvelt A et al. Itch-free state in patients with atopic dermatitis treated with ruxolitinib cream: Pooled analysis from two randomized phase 3 studies. J Am Acad Dermatol. 2022 (Sep 13). Doi: 10.1016/j.jaad.2022.09.010

Key clinical point: Dupilumab reduced disease severity and showed a tolerable safety profile in children with moderate-to-severe atopic dermatitis (AD) as young as 6 months.

Major finding: At week 16, a significantly higher proportion of children receiving dupilumab vs placebo achieved the Investigator’s Global Assessment score of 0/1 (28% vs 4%; P < .0001). Both groups had a similar prevalence of adverse events (AE; 64% vs 74%), and no dupilumab-related serious AE were reported.

Study details: Findings are from the phase 3 LIBERTY AD PRESCHOOL study including 162 children between the ages of 6 months and 6 years with moderate-to-severe AD who were randomly assigned to receive subcutaneous dupilumab or placebo, both with low-potency topical corticosteroids.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals. Ten authors declared being current or former employees and shareholders of Regeneron Pharmaceuticals, and 5 authors declared being employees or shareholders of Sanofi. The other authors reported ties with several sources.

Source: Paller AS et al. Dupilumab in children aged 6 months to younger than 6 years with uncontrolled atopic dermatitis: A randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2022;400(10356):908-919 (Sep 17). Doi: 10.1016/S0140-6736(22)01539-2

Key clinical point: Dupilumab reduced disease severity and showed a tolerable safety profile in children with moderate-to-severe atopic dermatitis (AD) as young as 6 months.

Major finding: At week 16, a significantly higher proportion of children receiving dupilumab vs placebo achieved the Investigator’s Global Assessment score of 0/1 (28% vs 4%; P < .0001). Both groups had a similar prevalence of adverse events (AE; 64% vs 74%), and no dupilumab-related serious AE were reported.

Study details: Findings are from the phase 3 LIBERTY AD PRESCHOOL study including 162 children between the ages of 6 months and 6 years with moderate-to-severe AD who were randomly assigned to receive subcutaneous dupilumab or placebo, both with low-potency topical corticosteroids.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals. Ten authors declared being current or former employees and shareholders of Regeneron Pharmaceuticals, and 5 authors declared being employees or shareholders of Sanofi. The other authors reported ties with several sources.

Source: Paller AS et al. Dupilumab in children aged 6 months to younger than 6 years with uncontrolled atopic dermatitis: A randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2022;400(10356):908-919 (Sep 17). Doi: 10.1016/S0140-6736(22)01539-2

Key clinical point: Dupilumab reduced disease severity and showed a tolerable safety profile in children with moderate-to-severe atopic dermatitis (AD) as young as 6 months.

Major finding: At week 16, a significantly higher proportion of children receiving dupilumab vs placebo achieved the Investigator’s Global Assessment score of 0/1 (28% vs 4%; P < .0001). Both groups had a similar prevalence of adverse events (AE; 64% vs 74%), and no dupilumab-related serious AE were reported.

Study details: Findings are from the phase 3 LIBERTY AD PRESCHOOL study including 162 children between the ages of 6 months and 6 years with moderate-to-severe AD who were randomly assigned to receive subcutaneous dupilumab or placebo, both with low-potency topical corticosteroids.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals. Ten authors declared being current or former employees and shareholders of Regeneron Pharmaceuticals, and 5 authors declared being employees or shareholders of Sanofi. The other authors reported ties with several sources.

Source: Paller AS et al. Dupilumab in children aged 6 months to younger than 6 years with uncontrolled atopic dermatitis: A randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2022;400(10356):908-919 (Sep 17). Doi: 10.1016/S0140-6736(22)01539-2

Key clinical point: Lower serum bile acid levels (≤2.8 mmol/L) were an independent predictor of progression of diabetic kidney disease (DKD) to end-stage renal disease (ESRD) in patients with type 2 diabetes mellitus (T2DM) and biopsy-proven DKD.

Major finding: Overall, 34.78% of patients progressed to ESRD during a median follow-up of 19.02 months, with lower levels of serum bile acids being independently associated with a higher risk for progression to ESRD (adjusted hazard ratio, 5.319; P = .027).

Study details: This was a retrospective cohort study including 184 patients with T2DM and biopsy-proven DKD.

Disclosures: This study was supported by the Health Commission of Sichuan Province Program. The authors declared no conflict of interests.

Source: Xiao X et al. Lower bile acids as an independent risk factor for renal outcomes in patients with type 2 diabetes mellitus and biopsy-proven diabetic kidney disease. Front Endocrinol (Lausanne). 2022;13:1026995  (Oct 7). Doi: 10.3389/fendo.2022.1026995.

Key clinical point: Lower serum bile acid levels (≤2.8 mmol/L) were an independent predictor of progression of diabetic kidney disease (DKD) to end-stage renal disease (ESRD) in patients with type 2 diabetes mellitus (T2DM) and biopsy-proven DKD.

Major finding: Overall, 34.78% of patients progressed to ESRD during a median follow-up of 19.02 months, with lower levels of serum bile acids being independently associated with a higher risk for progression to ESRD (adjusted hazard ratio, 5.319; P = .027).

Study details: This was a retrospective cohort study including 184 patients with T2DM and biopsy-proven DKD.

Disclosures: This study was supported by the Health Commission of Sichuan Province Program. The authors declared no conflict of interests.

Source: Xiao X et al. Lower bile acids as an independent risk factor for renal outcomes in patients with type 2 diabetes mellitus and biopsy-proven diabetic kidney disease. Front Endocrinol (Lausanne). 2022;13:1026995  (Oct 7). Doi: 10.3389/fendo.2022.1026995.

Key clinical point: Lower serum bile acid levels (≤2.8 mmol/L) were an independent predictor of progression of diabetic kidney disease (DKD) to end-stage renal disease (ESRD) in patients with type 2 diabetes mellitus (T2DM) and biopsy-proven DKD.

Major finding: Overall, 34.78% of patients progressed to ESRD during a median follow-up of 19.02 months, with lower levels of serum bile acids being independently associated with a higher risk for progression to ESRD (adjusted hazard ratio, 5.319; P = .027).

Study details: This was a retrospective cohort study including 184 patients with T2DM and biopsy-proven DKD.

Disclosures: This study was supported by the Health Commission of Sichuan Province Program. The authors declared no conflict of interests.

Source: Xiao X et al. Lower bile acids as an independent risk factor for renal outcomes in patients with type 2 diabetes mellitus and biopsy-proven diabetic kidney disease. Front Endocrinol (Lausanne). 2022;13:1026995  (Oct 7). Doi: 10.3389/fendo.2022.1026995.

Key clinical point: Sodium glucose cotransporter 2 inhibitors (SGLT2i) did not increase the risk for hospitalization for critical limb ischemia (CLI) and lower extremity amputation (LEA) in patients with type 2 diabetes (T2D) compared with glucagon-like peptide-1 receptor agonists (GLP-1RA) or dipeptidyl peptidase-4 inhibitors (DPP4i).

Major finding: SGLT2i was not associated with a higher risk for hospitalization for CLI and LEA compared with either GLP-1RA (hazard ratio [HR] 1.13; 95% CI 0.77-1.65 and HR 1.27; 95% CI 0.63-2.55, respectively) or DPP4i (HR 1.06; 95% CI 0.75-1.50 and HR 0.80; 95% CI 0.42-1.53, respectively).

Study details: Findings are from a population-based retrospective cohort study that propensity score-matched patients with T2D who initiated SGLT2i (n = 13,378) and those who initiated GLP-1RA (n = 13,378).

Disclosures: This study was partly supported by the research grant from National Taiwan University Hospital Yunlin Branch and Ministry of Science and Technology, Taiwan. The authors declared no conflicts of interest.

Source: Lee YC et al. Risk of major adverse limb events in patients with type 2 diabetes mellitus receiving sodium glucose cotransporter 2 inhibitors and glucagon-like peptide-1 receptor agonists: A population-based retrospective cohort study. Front Pharmacol. 2022;13:869804  (Sep 13). Doi: 10.3389/fphar.2022.869804

Key clinical point: Sodium glucose cotransporter 2 inhibitors (SGLT2i) did not increase the risk for hospitalization for critical limb ischemia (CLI) and lower extremity amputation (LEA) in patients with type 2 diabetes (T2D) compared with glucagon-like peptide-1 receptor agonists (GLP-1RA) or dipeptidyl peptidase-4 inhibitors (DPP4i).

Major finding: SGLT2i was not associated with a higher risk for hospitalization for CLI and LEA compared with either GLP-1RA (hazard ratio [HR] 1.13; 95% CI 0.77-1.65 and HR 1.27; 95% CI 0.63-2.55, respectively) or DPP4i (HR 1.06; 95% CI 0.75-1.50 and HR 0.80; 95% CI 0.42-1.53, respectively).

Study details: Findings are from a population-based retrospective cohort study that propensity score-matched patients with T2D who initiated SGLT2i (n = 13,378) and those who initiated GLP-1RA (n = 13,378).

Disclosures: This study was partly supported by the research grant from National Taiwan University Hospital Yunlin Branch and Ministry of Science and Technology, Taiwan. The authors declared no conflicts of interest.

Source: Lee YC et al. Risk of major adverse limb events in patients with type 2 diabetes mellitus receiving sodium glucose cotransporter 2 inhibitors and glucagon-like peptide-1 receptor agonists: A population-based retrospective cohort study. Front Pharmacol. 2022;13:869804  (Sep 13). Doi: 10.3389/fphar.2022.869804

Key clinical point: Sodium glucose cotransporter 2 inhibitors (SGLT2i) did not increase the risk for hospitalization for critical limb ischemia (CLI) and lower extremity amputation (LEA) in patients with type 2 diabetes (T2D) compared with glucagon-like peptide-1 receptor agonists (GLP-1RA) or dipeptidyl peptidase-4 inhibitors (DPP4i).

Major finding: SGLT2i was not associated with a higher risk for hospitalization for CLI and LEA compared with either GLP-1RA (hazard ratio [HR] 1.13; 95% CI 0.77-1.65 and HR 1.27; 95% CI 0.63-2.55, respectively) or DPP4i (HR 1.06; 95% CI 0.75-1.50 and HR 0.80; 95% CI 0.42-1.53, respectively).

Study details: Findings are from a population-based retrospective cohort study that propensity score-matched patients with T2D who initiated SGLT2i (n = 13,378) and those who initiated GLP-1RA (n = 13,378).

Disclosures: This study was partly supported by the research grant from National Taiwan University Hospital Yunlin Branch and Ministry of Science and Technology, Taiwan. The authors declared no conflicts of interest.

Source: Lee YC et al. Risk of major adverse limb events in patients with type 2 diabetes mellitus receiving sodium glucose cotransporter 2 inhibitors and glucagon-like peptide-1 receptor agonists: A population-based retrospective cohort study. Front Pharmacol. 2022;13:869804  (Sep 13). Doi: 10.3389/fphar.2022.869804

Key clinical point: Stringent management of blood pressure (BP) with amlodipine in addition to standard diabetes therapy significantly improved glycemic control in patients with type 2 diabetes  (T2D) compared with standard diabetes therapy alone.

Major finding: After 24 weeks, amlodipine plus standard diabetes therapy vs. standard diabetes therapy alone led to a significant reduction in the mean glycated hemoglobin level (6.62% vs 7.01%; P = .01), fasting plasma glucose level (122 vs 129 mg/dL; P < .001), systolic blood pressure (132 vs 143 mm Hg; P < .001), and diastolic blood pressure (78.9 vs 86.0 mm Hg; P < .001), with neural effects on the lipid profile and urinary albumin excretion.

Study details: Findings are from a prospective cohort study including 168 patients with newly diagnosed T2D who received amlodipine plus standard diabetes therapy (n = 87) or standard diabetes therapy alone (n = 81).

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

Source: Li JC et al. Antihypertensive treatment improves glycemic control in patients with newly diagnosed type 2 diabetes mellitus: A prospective cohort study. Front Endocrinol (Lausanne). 2022;13:935561  (Sep 9). Doi: 10.3389/fendo.2022.935561.

Key clinical point: Stringent management of blood pressure (BP) with amlodipine in addition to standard diabetes therapy significantly improved glycemic control in patients with type 2 diabetes  (T2D) compared with standard diabetes therapy alone.

Major finding: After 24 weeks, amlodipine plus standard diabetes therapy vs. standard diabetes therapy alone led to a significant reduction in the mean glycated hemoglobin level (6.62% vs 7.01%; P = .01), fasting plasma glucose level (122 vs 129 mg/dL; P < .001), systolic blood pressure (132 vs 143 mm Hg; P < .001), and diastolic blood pressure (78.9 vs 86.0 mm Hg; P < .001), with neural effects on the lipid profile and urinary albumin excretion.

Study details: Findings are from a prospective cohort study including 168 patients with newly diagnosed T2D who received amlodipine plus standard diabetes therapy (n = 87) or standard diabetes therapy alone (n = 81).

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

Source: Li JC et al. Antihypertensive treatment improves glycemic control in patients with newly diagnosed type 2 diabetes mellitus: A prospective cohort study. Front Endocrinol (Lausanne). 2022;13:935561  (Sep 9). Doi: 10.3389/fendo.2022.935561.

Key clinical point: Stringent management of blood pressure (BP) with amlodipine in addition to standard diabetes therapy significantly improved glycemic control in patients with type 2 diabetes  (T2D) compared with standard diabetes therapy alone.

Major finding: After 24 weeks, amlodipine plus standard diabetes therapy vs. standard diabetes therapy alone led to a significant reduction in the mean glycated hemoglobin level (6.62% vs 7.01%; P = .01), fasting plasma glucose level (122 vs 129 mg/dL; P < .001), systolic blood pressure (132 vs 143 mm Hg; P < .001), and diastolic blood pressure (78.9 vs 86.0 mm Hg; P < .001), with neural effects on the lipid profile and urinary albumin excretion.

Study details: Findings are from a prospective cohort study including 168 patients with newly diagnosed T2D who received amlodipine plus standard diabetes therapy (n = 87) or standard diabetes therapy alone (n = 81).

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

Source: Li JC et al. Antihypertensive treatment improves glycemic control in patients with newly diagnosed type 2 diabetes mellitus: A prospective cohort study. Front Endocrinol (Lausanne). 2022;13:935561  (Sep 9). Doi: 10.3389/fendo.2022.935561.