Article

Key clinical point: Treatment with toripalimab + nab-paclitaxel vs placebo + nab-paclitaxel significantly improved progression-free survival (PFS) and showed an acceptable safety profile in patients with programmed death ligand-1 (PD-L1)-positive metastatic or recurrent triple-negative breast cancer (TNBC).

Major finding: Toripalimab + nab-paclitaxel vs placebo + nab-paclitaxel led to a significantly longer PFS (median 8.4 vs 5.6 months) in patients with PD-L1-positive TNBC (hazard ratio 0.65; P = .0102) and similar incidences of grade ≥3 treatment-emergent adverse events (56.4% vs 54.3%) and fatal adverse events (0.6% vs 3.4%).

Study details: Findings are from the phase 3 TORCHLIGHT trial which included 531 patients with metastatic or recurrent locally advanced TNBC who were previously untreated or treated with up to one systemic chemotherapy and were randomly assigned to receive toripalimab + nab-paclitaxel or placebo + nab-paclitaxel. Of these, 300 patients had PD-L1-positive TNBC.

Disclosures: This study was sponsored by Shanghai Junshi Biosciences and supported by other sources. Five authors declared being employees of Shanghai Junshi Biosciences or TopAlliance Biosciences. The other authors declared no competing interests.

Source: Jiang Z, Ouyang Q, Sun T, et al. Toripalimab plus nab-paclitaxel in metastatic or recurrent triple-negative breast cancer: A randomized phase 3 trial. Nat Med. 2024;30:249-256. doi: 10.1038/s41591-023-02677-x Source

Key clinical point: Treatment with toripalimab + nab-paclitaxel vs placebo + nab-paclitaxel significantly improved progression-free survival (PFS) and showed an acceptable safety profile in patients with programmed death ligand-1 (PD-L1)-positive metastatic or recurrent triple-negative breast cancer (TNBC).

Major finding: Toripalimab + nab-paclitaxel vs placebo + nab-paclitaxel led to a significantly longer PFS (median 8.4 vs 5.6 months) in patients with PD-L1-positive TNBC (hazard ratio 0.65; P = .0102) and similar incidences of grade ≥3 treatment-emergent adverse events (56.4% vs 54.3%) and fatal adverse events (0.6% vs 3.4%).

Study details: Findings are from the phase 3 TORCHLIGHT trial which included 531 patients with metastatic or recurrent locally advanced TNBC who were previously untreated or treated with up to one systemic chemotherapy and were randomly assigned to receive toripalimab + nab-paclitaxel or placebo + nab-paclitaxel. Of these, 300 patients had PD-L1-positive TNBC.

Disclosures: This study was sponsored by Shanghai Junshi Biosciences and supported by other sources. Five authors declared being employees of Shanghai Junshi Biosciences or TopAlliance Biosciences. The other authors declared no competing interests.

Source: Jiang Z, Ouyang Q, Sun T, et al. Toripalimab plus nab-paclitaxel in metastatic or recurrent triple-negative breast cancer: A randomized phase 3 trial. Nat Med. 2024;30:249-256. doi: 10.1038/s41591-023-02677-x Source

Key clinical point: Treatment with toripalimab + nab-paclitaxel vs placebo + nab-paclitaxel significantly improved progression-free survival (PFS) and showed an acceptable safety profile in patients with programmed death ligand-1 (PD-L1)-positive metastatic or recurrent triple-negative breast cancer (TNBC).

Major finding: Toripalimab + nab-paclitaxel vs placebo + nab-paclitaxel led to a significantly longer PFS (median 8.4 vs 5.6 months) in patients with PD-L1-positive TNBC (hazard ratio 0.65; P = .0102) and similar incidences of grade ≥3 treatment-emergent adverse events (56.4% vs 54.3%) and fatal adverse events (0.6% vs 3.4%).

Study details: Findings are from the phase 3 TORCHLIGHT trial which included 531 patients with metastatic or recurrent locally advanced TNBC who were previously untreated or treated with up to one systemic chemotherapy and were randomly assigned to receive toripalimab + nab-paclitaxel or placebo + nab-paclitaxel. Of these, 300 patients had PD-L1-positive TNBC.

Disclosures: This study was sponsored by Shanghai Junshi Biosciences and supported by other sources. Five authors declared being employees of Shanghai Junshi Biosciences or TopAlliance Biosciences. The other authors declared no competing interests.

Source: Jiang Z, Ouyang Q, Sun T, et al. Toripalimab plus nab-paclitaxel in metastatic or recurrent triple-negative breast cancer: A randomized phase 3 trial. Nat Med. 2024;30:249-256. doi: 10.1038/s41591-023-02677-x Source

Key clinical point: In patients with platinum-pretreated advanced triple-negative breast cancer (TNBC), a chemotherapy-free maintenance regimen containing olaparib with or without durvalumab vs continued platinum-based chemotherapy led to a greater improvement in progression-free survival (PFS) with no new safety signals.

Major finding: The median PFS was 4.0 months with olaparib and 6.1 months with olaparib + durvalumab, with both treatments providing greater PFS benefit than the historical control of continued platinum-based therapy (P = .0023 and P < .0001, respectively). No treatment-related deaths or new safety signals were reported.

Study details: Findings are from the phase 2 DORA trial which included 45 patients with advanced TNBC who had stable disease or complete or partial response after receiving platinum-based chemotherapy and were randomly assigned to receive olaparib or olaparib + durvalumab.

Disclosures: This study was supported by AstraZeneca Pharmaceuticals LP. Some authors declared receiving honoraria, research funding, or fees; owning stocks; or having other ties with AstraZeneca and various other sources.

Source: Tan TJ, Sammons S, Im YH, et al. Phase II DORA study of olaparib with or without durvalumab as a chemotherapy-free maintenance strategy in platinum-pretreated advanced triple-negative breast cancer. Clin Cancer Res. 2024 (Jan 18). doi: 10.1158/1078-0432.CCR-23-2513 Source

Key clinical point: In patients with platinum-pretreated advanced triple-negative breast cancer (TNBC), a chemotherapy-free maintenance regimen containing olaparib with or without durvalumab vs continued platinum-based chemotherapy led to a greater improvement in progression-free survival (PFS) with no new safety signals.

Major finding: The median PFS was 4.0 months with olaparib and 6.1 months with olaparib + durvalumab, with both treatments providing greater PFS benefit than the historical control of continued platinum-based therapy (P = .0023 and P < .0001, respectively). No treatment-related deaths or new safety signals were reported.

Study details: Findings are from the phase 2 DORA trial which included 45 patients with advanced TNBC who had stable disease or complete or partial response after receiving platinum-based chemotherapy and were randomly assigned to receive olaparib or olaparib + durvalumab.

Disclosures: This study was supported by AstraZeneca Pharmaceuticals LP. Some authors declared receiving honoraria, research funding, or fees; owning stocks; or having other ties with AstraZeneca and various other sources.

Source: Tan TJ, Sammons S, Im YH, et al. Phase II DORA study of olaparib with or without durvalumab as a chemotherapy-free maintenance strategy in platinum-pretreated advanced triple-negative breast cancer. Clin Cancer Res. 2024 (Jan 18). doi: 10.1158/1078-0432.CCR-23-2513 Source

Key clinical point: In patients with platinum-pretreated advanced triple-negative breast cancer (TNBC), a chemotherapy-free maintenance regimen containing olaparib with or without durvalumab vs continued platinum-based chemotherapy led to a greater improvement in progression-free survival (PFS) with no new safety signals.

Major finding: The median PFS was 4.0 months with olaparib and 6.1 months with olaparib + durvalumab, with both treatments providing greater PFS benefit than the historical control of continued platinum-based therapy (P = .0023 and P < .0001, respectively). No treatment-related deaths or new safety signals were reported.

Study details: Findings are from the phase 2 DORA trial which included 45 patients with advanced TNBC who had stable disease or complete or partial response after receiving platinum-based chemotherapy and were randomly assigned to receive olaparib or olaparib + durvalumab.

Disclosures: This study was supported by AstraZeneca Pharmaceuticals LP. Some authors declared receiving honoraria, research funding, or fees; owning stocks; or having other ties with AstraZeneca and various other sources.

Source: Tan TJ, Sammons S, Im YH, et al. Phase II DORA study of olaparib with or without durvalumab as a chemotherapy-free maintenance strategy in platinum-pretreated advanced triple-negative breast cancer. Clin Cancer Res. 2024 (Jan 18). doi: 10.1158/1078-0432.CCR-23-2513 Source

Key clinical point: Neoadjuvant endocrine therapy with fulvestrant or anastrozole + fulvestrant led to an endocrine-sensitive disease rate (ESDR) comparable to anastrozole alone in postmenopausal women with estrogen receptor (ER)-rich, human epidermal growth factor receptor 2-negative (ERBB2−) breast cancer (BC).

Major finding: Both fulvestrant and anastrozole + fulvestrant vs anastrozole alone demonstrated no significant improvement in the ESDR at 6 months (22.8% and 20.5% vs 18.7%, respectively; Wald test, P ≥ .98) and median percentage change in Ki67 at 4 weeks (−79.1% and −83.5% vs −80.6%, respectively; P ≥ .15).

Study details: Findings are from the phase 3 ALTERNATE trial, which included 1298 treatment-naive postmenopausal women with ER-rich/ERBB2− BC who were randomly assigned to receive anastrozole, fulvestrant, or anastrozole + fulvestrant for 6 months in a neoadjuvant setting.

Disclosures: This study was supported by the US National Institutes of Health (NIH)/National Cancer Institute (NCI) and other sources. Several authors declared receiving grants, personal fees, or research support or having other ties with various sources, including NIH/NCI.

Source: Ma CX, Suman VJ, Sanati S, et al. Endocrine-sensitive disease rate in postmenopausal patients with estrogen receptor-rich/ERBB2-negative breast cancer receiving neoadjuvant anastrozole, fulvestrant, or their combination: A phase 3 randomized clinical trial. JAMA Oncol. 2024 (Jan 18). doi: 10.1001/jamaoncol.2023.6038  Source

Key clinical point: Neoadjuvant endocrine therapy with fulvestrant or anastrozole + fulvestrant led to an endocrine-sensitive disease rate (ESDR) comparable to anastrozole alone in postmenopausal women with estrogen receptor (ER)-rich, human epidermal growth factor receptor 2-negative (ERBB2−) breast cancer (BC).

Major finding: Both fulvestrant and anastrozole + fulvestrant vs anastrozole alone demonstrated no significant improvement in the ESDR at 6 months (22.8% and 20.5% vs 18.7%, respectively; Wald test, P ≥ .98) and median percentage change in Ki67 at 4 weeks (−79.1% and −83.5% vs −80.6%, respectively; P ≥ .15).

Study details: Findings are from the phase 3 ALTERNATE trial, which included 1298 treatment-naive postmenopausal women with ER-rich/ERBB2− BC who were randomly assigned to receive anastrozole, fulvestrant, or anastrozole + fulvestrant for 6 months in a neoadjuvant setting.

Disclosures: This study was supported by the US National Institutes of Health (NIH)/National Cancer Institute (NCI) and other sources. Several authors declared receiving grants, personal fees, or research support or having other ties with various sources, including NIH/NCI.

Source: Ma CX, Suman VJ, Sanati S, et al. Endocrine-sensitive disease rate in postmenopausal patients with estrogen receptor-rich/ERBB2-negative breast cancer receiving neoadjuvant anastrozole, fulvestrant, or their combination: A phase 3 randomized clinical trial. JAMA Oncol. 2024 (Jan 18). doi: 10.1001/jamaoncol.2023.6038  Source

Key clinical point: Neoadjuvant endocrine therapy with fulvestrant or anastrozole + fulvestrant led to an endocrine-sensitive disease rate (ESDR) comparable to anastrozole alone in postmenopausal women with estrogen receptor (ER)-rich, human epidermal growth factor receptor 2-negative (ERBB2−) breast cancer (BC).

Major finding: Both fulvestrant and anastrozole + fulvestrant vs anastrozole alone demonstrated no significant improvement in the ESDR at 6 months (22.8% and 20.5% vs 18.7%, respectively; Wald test, P ≥ .98) and median percentage change in Ki67 at 4 weeks (−79.1% and −83.5% vs −80.6%, respectively; P ≥ .15).

Study details: Findings are from the phase 3 ALTERNATE trial, which included 1298 treatment-naive postmenopausal women with ER-rich/ERBB2− BC who were randomly assigned to receive anastrozole, fulvestrant, or anastrozole + fulvestrant for 6 months in a neoadjuvant setting.

Disclosures: This study was supported by the US National Institutes of Health (NIH)/National Cancer Institute (NCI) and other sources. Several authors declared receiving grants, personal fees, or research support or having other ties with various sources, including NIH/NCI.

Source: Ma CX, Suman VJ, Sanati S, et al. Endocrine-sensitive disease rate in postmenopausal patients with estrogen receptor-rich/ERBB2-negative breast cancer receiving neoadjuvant anastrozole, fulvestrant, or their combination: A phase 3 randomized clinical trial. JAMA Oncol. 2024 (Jan 18). doi: 10.1001/jamaoncol.2023.6038  Source

Key clinical point: High initial fat body mass was associated with a risk for vertebral fracture (VF) progression in postmenopausal women with hormone receptor-positive (HR+) early breast cancer (BC) who received aromatase inhibitors (AI) plus denosumab.

Major finding: After 18 months of adjuvant therapy with AI and denosumab, 4.4% of patients had VF progression, with percentage of fat body mass (odds ratio [OR] 5.41; P = .01) and Fracture Risk Assessment Tool score (OR 3.95; P = .04) being independently associated with VF progression risk.

Study details: Findings are from a prospective cohort study including 237 postmenopausal women with HR+ early BC who received adjuvant therapy with AI and denosumab.

Disclosures: This study did not declare any specific funding. Three authors declared receiving personal fees or grants or having other ties with various sources.

Source: Cosentini D, Pedersini R, Mauro PD, et al. Fat body mass and vertebral fracture progression in women with breast cancer. JAMA Netw Open. 2024;7:e2350950. doi:10.1001/jamanetworkopen.2023.50950 Source

Key clinical point: High initial fat body mass was associated with a risk for vertebral fracture (VF) progression in postmenopausal women with hormone receptor-positive (HR+) early breast cancer (BC) who received aromatase inhibitors (AI) plus denosumab.

Major finding: After 18 months of adjuvant therapy with AI and denosumab, 4.4% of patients had VF progression, with percentage of fat body mass (odds ratio [OR] 5.41; P = .01) and Fracture Risk Assessment Tool score (OR 3.95; P = .04) being independently associated with VF progression risk.

Study details: Findings are from a prospective cohort study including 237 postmenopausal women with HR+ early BC who received adjuvant therapy with AI and denosumab.

Disclosures: This study did not declare any specific funding. Three authors declared receiving personal fees or grants or having other ties with various sources.

Source: Cosentini D, Pedersini R, Mauro PD, et al. Fat body mass and vertebral fracture progression in women with breast cancer. JAMA Netw Open. 2024;7:e2350950. doi:10.1001/jamanetworkopen.2023.50950 Source

Key clinical point: High initial fat body mass was associated with a risk for vertebral fracture (VF) progression in postmenopausal women with hormone receptor-positive (HR+) early breast cancer (BC) who received aromatase inhibitors (AI) plus denosumab.

Major finding: After 18 months of adjuvant therapy with AI and denosumab, 4.4% of patients had VF progression, with percentage of fat body mass (odds ratio [OR] 5.41; P = .01) and Fracture Risk Assessment Tool score (OR 3.95; P = .04) being independently associated with VF progression risk.

Study details: Findings are from a prospective cohort study including 237 postmenopausal women with HR+ early BC who received adjuvant therapy with AI and denosumab.

Disclosures: This study did not declare any specific funding. Three authors declared receiving personal fees or grants or having other ties with various sources.

Source: Cosentini D, Pedersini R, Mauro PD, et al. Fat body mass and vertebral fracture progression in women with breast cancer. JAMA Netw Open. 2024;7:e2350950. doi:10.1001/jamanetworkopen.2023.50950 Source

Key clinical point: Risk factors affecting oral Janus kinase inhibitor (JAKi) treatment were prevalent among adult patients with atopic dermatitis (AD), especially older individuals, thus necessitating careful risk assessment among patients before JAKi therapy initiation.

Major finding: Nearly half (49.5%) of the patients with AD at some point had at least one risk factor that could affect JAKi treatment and most (60.3%) patients age ≥ 65 years had at least three risk factors. The recorded non-modifiable risk factors included cancer (5.6%), smoking history (15.6%), age ≥ 65 years (12.4%), and major adverse cardiovascular events (2.6%).

Study details: This cross-sectional study included adult patients with AD from the Danish national registers (n = 18,618) and Danish Skin Cohort (n = 3573).

Disclosures: This study did not disclose the source of funding. Several authors declared receiving research support, lecture honoraria, or consulting honoraria from or serving as speakers or advisory board members for various organizations.

Source: Vittrup I, Thein D, Thomsen SF, Egeberg A, Thyssen JP. Risk factors that impact treatment with oral Janus kinase inhibitors among adult patients with atopic dermatitis: A nationwide registry study. Acta Derm Venereol. 2024 (Jan 22). doi: 10.2340/actadv.v104.18638 Source

Key clinical point: Risk factors affecting oral Janus kinase inhibitor (JAKi) treatment were prevalent among adult patients with atopic dermatitis (AD), especially older individuals, thus necessitating careful risk assessment among patients before JAKi therapy initiation.

Major finding: Nearly half (49.5%) of the patients with AD at some point had at least one risk factor that could affect JAKi treatment and most (60.3%) patients age ≥ 65 years had at least three risk factors. The recorded non-modifiable risk factors included cancer (5.6%), smoking history (15.6%), age ≥ 65 years (12.4%), and major adverse cardiovascular events (2.6%).

Study details: This cross-sectional study included adult patients with AD from the Danish national registers (n = 18,618) and Danish Skin Cohort (n = 3573).

Disclosures: This study did not disclose the source of funding. Several authors declared receiving research support, lecture honoraria, or consulting honoraria from or serving as speakers or advisory board members for various organizations.

Source: Vittrup I, Thein D, Thomsen SF, Egeberg A, Thyssen JP. Risk factors that impact treatment with oral Janus kinase inhibitors among adult patients with atopic dermatitis: A nationwide registry study. Acta Derm Venereol. 2024 (Jan 22). doi: 10.2340/actadv.v104.18638 Source

Key clinical point: Risk factors affecting oral Janus kinase inhibitor (JAKi) treatment were prevalent among adult patients with atopic dermatitis (AD), especially older individuals, thus necessitating careful risk assessment among patients before JAKi therapy initiation.

Major finding: Nearly half (49.5%) of the patients with AD at some point had at least one risk factor that could affect JAKi treatment and most (60.3%) patients age ≥ 65 years had at least three risk factors. The recorded non-modifiable risk factors included cancer (5.6%), smoking history (15.6%), age ≥ 65 years (12.4%), and major adverse cardiovascular events (2.6%).

Study details: This cross-sectional study included adult patients with AD from the Danish national registers (n = 18,618) and Danish Skin Cohort (n = 3573).

Disclosures: This study did not disclose the source of funding. Several authors declared receiving research support, lecture honoraria, or consulting honoraria from or serving as speakers or advisory board members for various organizations.

Source: Vittrup I, Thein D, Thomsen SF, Egeberg A, Thyssen JP. Risk factors that impact treatment with oral Janus kinase inhibitors among adult patients with atopic dermatitis: A nationwide registry study. Acta Derm Venereol. 2024 (Jan 22). doi: 10.2340/actadv.v104.18638 Source

Key clinical point: Pathogenic filaggrin (FLG) variants do not affect the effectiveness of dupilumab treatment in patients with atopic dermatitis (AD).

Major finding: No clinically relevant differences were observed in the Eczema Area and Severity Index, Investigator Global Assessment, Numeric Rating Scale for pruritus, and total Patient Oriented Eczema Measure (POEM) scores between patients with and without pathogenic FLG variants at week 16 or 52. However, patients with bi-allelic pathogenic variants vs wild-type alleles had significantly higher POEM dryness scores at week 16 (P = .002) and week 52 (P = .016).

Study details: This prospective observational study included 285 adult patients with AD from the Dutch BioDay Registry who had received dupilumab for 16 weeks or more and underwent genomic variant analysis for FLG.

Disclosures: This study did not receive any funding. Some authors declared being consultants, advisory board members, or speakers for or having other ties with various organizations.

Source: Clabbers J, Boesjes C, Spekhorst L, et al. Influence of pathogenic filaggrin variants on dupilumab treatment in atopic dermatitis. J Allergy Clin Immunol. 2024 (Jan 22). doi: 10.1016/j.jaci.2023.12.027 Source

Key clinical point: Pathogenic filaggrin (FLG) variants do not affect the effectiveness of dupilumab treatment in patients with atopic dermatitis (AD).

Major finding: No clinically relevant differences were observed in the Eczema Area and Severity Index, Investigator Global Assessment, Numeric Rating Scale for pruritus, and total Patient Oriented Eczema Measure (POEM) scores between patients with and without pathogenic FLG variants at week 16 or 52. However, patients with bi-allelic pathogenic variants vs wild-type alleles had significantly higher POEM dryness scores at week 16 (P = .002) and week 52 (P = .016).

Study details: This prospective observational study included 285 adult patients with AD from the Dutch BioDay Registry who had received dupilumab for 16 weeks or more and underwent genomic variant analysis for FLG.

Disclosures: This study did not receive any funding. Some authors declared being consultants, advisory board members, or speakers for or having other ties with various organizations.

Source: Clabbers J, Boesjes C, Spekhorst L, et al. Influence of pathogenic filaggrin variants on dupilumab treatment in atopic dermatitis. J Allergy Clin Immunol. 2024 (Jan 22). doi: 10.1016/j.jaci.2023.12.027 Source

Key clinical point: Pathogenic filaggrin (FLG) variants do not affect the effectiveness of dupilumab treatment in patients with atopic dermatitis (AD).

Major finding: No clinically relevant differences were observed in the Eczema Area and Severity Index, Investigator Global Assessment, Numeric Rating Scale for pruritus, and total Patient Oriented Eczema Measure (POEM) scores between patients with and without pathogenic FLG variants at week 16 or 52. However, patients with bi-allelic pathogenic variants vs wild-type alleles had significantly higher POEM dryness scores at week 16 (P = .002) and week 52 (P = .016).

Study details: This prospective observational study included 285 adult patients with AD from the Dutch BioDay Registry who had received dupilumab for 16 weeks or more and underwent genomic variant analysis for FLG.

Disclosures: This study did not receive any funding. Some authors declared being consultants, advisory board members, or speakers for or having other ties with various organizations.

Source: Clabbers J, Boesjes C, Spekhorst L, et al. Influence of pathogenic filaggrin variants on dupilumab treatment in atopic dermatitis. J Allergy Clin Immunol. 2024 (Jan 22). doi: 10.1016/j.jaci.2023.12.027 Source

Key clinical point: Upadacitinib resulted in a good survival rate and was effective in patients with moderate to severe atopic dermatitis (AD) after over a year of continuous treatment, with no single characteristic of the study population being significantly associated with drug discontinuation.

Major finding: The drug survival rates at 1 and 1.5 years were 91.5% and 80.2%, respectively. The main reasons for discontinuation, occurring in 7.7% of patients, were adverse effects and ineffectiveness. However, no specific patient characteristics, such as sex or age at AD onset, showed a significant association with drug discontinuation.

Study details: This real-world retrospective study included 325 adult patients with moderate to severe AD who were treated with upadacitinib for at least 4 weeks and up to 72 weeks.

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

Source: Pezzolo E, Ortoncelli M, Ferrucci SM, et al. Drug survival of upadacitinib and predicting factors of discontinuation in adult patients affected by moderate-to-severe atopic dermatitis: An Italian multicenter analysis. J Clin Med. 2024;13:553 (Jan 18). doi: 10.3390/jcm13020553 Source

Key clinical point: Upadacitinib resulted in a good survival rate and was effective in patients with moderate to severe atopic dermatitis (AD) after over a year of continuous treatment, with no single characteristic of the study population being significantly associated with drug discontinuation.

Major finding: The drug survival rates at 1 and 1.5 years were 91.5% and 80.2%, respectively. The main reasons for discontinuation, occurring in 7.7% of patients, were adverse effects and ineffectiveness. However, no specific patient characteristics, such as sex or age at AD onset, showed a significant association with drug discontinuation.

Study details: This real-world retrospective study included 325 adult patients with moderate to severe AD who were treated with upadacitinib for at least 4 weeks and up to 72 weeks.

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

Source: Pezzolo E, Ortoncelli M, Ferrucci SM, et al. Drug survival of upadacitinib and predicting factors of discontinuation in adult patients affected by moderate-to-severe atopic dermatitis: An Italian multicenter analysis. J Clin Med. 2024;13:553 (Jan 18). doi: 10.3390/jcm13020553 Source

Key clinical point: Upadacitinib resulted in a good survival rate and was effective in patients with moderate to severe atopic dermatitis (AD) after over a year of continuous treatment, with no single characteristic of the study population being significantly associated with drug discontinuation.

Major finding: The drug survival rates at 1 and 1.5 years were 91.5% and 80.2%, respectively. The main reasons for discontinuation, occurring in 7.7% of patients, were adverse effects and ineffectiveness. However, no specific patient characteristics, such as sex or age at AD onset, showed a significant association with drug discontinuation.

Study details: This real-world retrospective study included 325 adult patients with moderate to severe AD who were treated with upadacitinib for at least 4 weeks and up to 72 weeks.

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

Source: Pezzolo E, Ortoncelli M, Ferrucci SM, et al. Drug survival of upadacitinib and predicting factors of discontinuation in adult patients affected by moderate-to-severe atopic dermatitis: An Italian multicenter analysis. J Clin Med. 2024;13:553 (Jan 18). doi: 10.3390/jcm13020553 Source

Key clinical point: In infants and young children with atopic dermatitis (AD), dupilumab treatment with concomitant low-potency topical corticosteroids (TCS) does not increase infection rates and is associated with a reduced risk for bacterial and non-herpetic skin infections.

Major finding: Patients receiving dupilumab vs placebo had similar total infection rates week 16 (rate ratio [RR] 0.75; P = .223) and a significantly lower frequency of non-herpetic skin infections (RR 0.46; P = .047) and bacterial infections (RR 0.09; P = .019).

Study details: This post hoc analysis of the phase 3 LIBERTY AD PRESCHOOL trial included 162 patients (age 6 months to 5 years) with moderate to severe AD who were randomly assigned to receive 200 or 300 mg dupilumab (n = 83) or placebo (n = 79) every 4 weeks with concomitant low-potency TCS.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Four authors declared being employees or shareholders of Sanofi or Regeneron. The remaining authors declared having ties with Sanofi, Regeneron, or others.

Source: Paller AS, Siegfried EC, Cork MJ, et al. Infections in children aged 6 months to 5 years treated with dupilumab in a placebo-controlled clinical trial of moderate-to-severe atopic dermatitis. Paediatr Drugs. 2024 (Jan 24). doi: 10.1007/s40272-023-00611-9 Source

Key clinical point: In infants and young children with atopic dermatitis (AD), dupilumab treatment with concomitant low-potency topical corticosteroids (TCS) does not increase infection rates and is associated with a reduced risk for bacterial and non-herpetic skin infections.

Major finding: Patients receiving dupilumab vs placebo had similar total infection rates week 16 (rate ratio [RR] 0.75; P = .223) and a significantly lower frequency of non-herpetic skin infections (RR 0.46; P = .047) and bacterial infections (RR 0.09; P = .019).

Study details: This post hoc analysis of the phase 3 LIBERTY AD PRESCHOOL trial included 162 patients (age 6 months to 5 years) with moderate to severe AD who were randomly assigned to receive 200 or 300 mg dupilumab (n = 83) or placebo (n = 79) every 4 weeks with concomitant low-potency TCS.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Four authors declared being employees or shareholders of Sanofi or Regeneron. The remaining authors declared having ties with Sanofi, Regeneron, or others.

Source: Paller AS, Siegfried EC, Cork MJ, et al. Infections in children aged 6 months to 5 years treated with dupilumab in a placebo-controlled clinical trial of moderate-to-severe atopic dermatitis. Paediatr Drugs. 2024 (Jan 24). doi: 10.1007/s40272-023-00611-9 Source

Key clinical point: In infants and young children with atopic dermatitis (AD), dupilumab treatment with concomitant low-potency topical corticosteroids (TCS) does not increase infection rates and is associated with a reduced risk for bacterial and non-herpetic skin infections.

Major finding: Patients receiving dupilumab vs placebo had similar total infection rates week 16 (rate ratio [RR] 0.75; P = .223) and a significantly lower frequency of non-herpetic skin infections (RR 0.46; P = .047) and bacterial infections (RR 0.09; P = .019).

Study details: This post hoc analysis of the phase 3 LIBERTY AD PRESCHOOL trial included 162 patients (age 6 months to 5 years) with moderate to severe AD who were randomly assigned to receive 200 or 300 mg dupilumab (n = 83) or placebo (n = 79) every 4 weeks with concomitant low-potency TCS.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Four authors declared being employees or shareholders of Sanofi or Regeneron. The remaining authors declared having ties with Sanofi, Regeneron, or others.

Source: Paller AS, Siegfried EC, Cork MJ, et al. Infections in children aged 6 months to 5 years treated with dupilumab in a placebo-controlled clinical trial of moderate-to-severe atopic dermatitis. Paediatr Drugs. 2024 (Jan 24). doi: 10.1007/s40272-023-00611-9 Source

Key clinical point: Dose reduction of 300 mg dupilumab was successfully achieved by dose spacing to >2 weeks without loss of efficacy in most patients with persistently controlled atopic dermatitis (AD), regardless of previous exposure to biologics and Janus kinase inhibitors (JAKi).

Major finding: At a median follow-up of 10 months, dose spacing of 300 mg dupilumab without loss in efficacy was achieved in 35 of 37 patients with controlled AD receiving dupilumab treatment for a median duration of 20.1 months. Similar findings were observed in patients with vs without previous exposure to biologics or JAKi (P > .05).

Study details: Findings are from a retrospective cohort study including 37 patients with controlled AD for more than a year, who were treated with 300 mg dupilumab at intervals > 2 weeks, and of whom 7 patients were classified as non-naive to biologics and JAKi.

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

Source: Lasheras-Pérez MA, Palacios-Diaz RD, González-Delgado VA, et al. Dose tapering of dupilumab in patients with persistently controlled atopic dermatitis: A Spanish multicenter cohort study. Int J Dermatol. 2024 (Jan 16). doi: 10.1111/ijd.17030  Source

Key clinical point: Dose reduction of 300 mg dupilumab was successfully achieved by dose spacing to >2 weeks without loss of efficacy in most patients with persistently controlled atopic dermatitis (AD), regardless of previous exposure to biologics and Janus kinase inhibitors (JAKi).

Major finding: At a median follow-up of 10 months, dose spacing of 300 mg dupilumab without loss in efficacy was achieved in 35 of 37 patients with controlled AD receiving dupilumab treatment for a median duration of 20.1 months. Similar findings were observed in patients with vs without previous exposure to biologics or JAKi (P > .05).

Study details: Findings are from a retrospective cohort study including 37 patients with controlled AD for more than a year, who were treated with 300 mg dupilumab at intervals > 2 weeks, and of whom 7 patients were classified as non-naive to biologics and JAKi.

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

Source: Lasheras-Pérez MA, Palacios-Diaz RD, González-Delgado VA, et al. Dose tapering of dupilumab in patients with persistently controlled atopic dermatitis: A Spanish multicenter cohort study. Int J Dermatol. 2024 (Jan 16). doi: 10.1111/ijd.17030  Source

Key clinical point: Dose reduction of 300 mg dupilumab was successfully achieved by dose spacing to >2 weeks without loss of efficacy in most patients with persistently controlled atopic dermatitis (AD), regardless of previous exposure to biologics and Janus kinase inhibitors (JAKi).

Major finding: At a median follow-up of 10 months, dose spacing of 300 mg dupilumab without loss in efficacy was achieved in 35 of 37 patients with controlled AD receiving dupilumab treatment for a median duration of 20.1 months. Similar findings were observed in patients with vs without previous exposure to biologics or JAKi (P > .05).

Study details: Findings are from a retrospective cohort study including 37 patients with controlled AD for more than a year, who were treated with 300 mg dupilumab at intervals > 2 weeks, and of whom 7 patients were classified as non-naive to biologics and JAKi.

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

Source: Lasheras-Pérez MA, Palacios-Diaz RD, González-Delgado VA, et al. Dose tapering of dupilumab in patients with persistently controlled atopic dermatitis: A Spanish multicenter cohort study. Int J Dermatol. 2024 (Jan 16). doi: 10.1111/ijd.17030  Source

Key clinical point: In real-world settings, dupilumab is safe and leads to significant and sustained improvements in the severity of atopic dermatitis (AD) in patients with moderate-to-severe AD, including those with malignancies and other comorbidities.

Major finding: At week 52, 64% of patients showed a decrease in disease severity, achieving a Physician Global Assessment score of 0 or 1 compared with a score of 3 or 4 at baseline. No adverse effect on current malignancy or recurrence of prior malignancy was reported with dupilumab use.

Study details: This real-world retrospective study analyzed the data of 155 adult patients with moderate-to-severe AD, including those with other significant comorbidities like malignancies, who were treated with dupilumab.

Disclosures: This study did not receive any funding. Mohannad Abu-Hilal declared serving as an advisor, consultant, or speaker for or receiving grants or honoraria from various sources.

Source: Metko D, Alkofide M, Abu-Hilal M. A real-world study of dupilumab in patients with atopic dermatitis including patients with malignancy and other medical comorbidities. JAAD Int. 2024;15:5-11 (Jan 15). doi: 10.1016/j.jdin.2024.01.002  Source

Key clinical point: In real-world settings, dupilumab is safe and leads to significant and sustained improvements in the severity of atopic dermatitis (AD) in patients with moderate-to-severe AD, including those with malignancies and other comorbidities.

Major finding: At week 52, 64% of patients showed a decrease in disease severity, achieving a Physician Global Assessment score of 0 or 1 compared with a score of 3 or 4 at baseline. No adverse effect on current malignancy or recurrence of prior malignancy was reported with dupilumab use.

Study details: This real-world retrospective study analyzed the data of 155 adult patients with moderate-to-severe AD, including those with other significant comorbidities like malignancies, who were treated with dupilumab.

Disclosures: This study did not receive any funding. Mohannad Abu-Hilal declared serving as an advisor, consultant, or speaker for or receiving grants or honoraria from various sources.

Source: Metko D, Alkofide M, Abu-Hilal M. A real-world study of dupilumab in patients with atopic dermatitis including patients with malignancy and other medical comorbidities. JAAD Int. 2024;15:5-11 (Jan 15). doi: 10.1016/j.jdin.2024.01.002  Source

Key clinical point: In real-world settings, dupilumab is safe and leads to significant and sustained improvements in the severity of atopic dermatitis (AD) in patients with moderate-to-severe AD, including those with malignancies and other comorbidities.

Major finding: At week 52, 64% of patients showed a decrease in disease severity, achieving a Physician Global Assessment score of 0 or 1 compared with a score of 3 or 4 at baseline. No adverse effect on current malignancy or recurrence of prior malignancy was reported with dupilumab use.

Study details: This real-world retrospective study analyzed the data of 155 adult patients with moderate-to-severe AD, including those with other significant comorbidities like malignancies, who were treated with dupilumab.

Disclosures: This study did not receive any funding. Mohannad Abu-Hilal declared serving as an advisor, consultant, or speaker for or receiving grants or honoraria from various sources.

Source: Metko D, Alkofide M, Abu-Hilal M. A real-world study of dupilumab in patients with atopic dermatitis including patients with malignancy and other medical comorbidities. JAAD Int. 2024;15:5-11 (Jan 15). doi: 10.1016/j.jdin.2024.01.002  Source