Clinical Edge Journal Scan

Key clinical point: Adult patients with atopic dermatitis (AD) are at an increased risk of developing subsequent gastroesophageal reflux disease (GERD).

Major finding: Patients with AD vs matched control individuals had a 15% higher risk for subsequent GERD (adjusted hazard ratio [aHR] 1.15; P = .0013), with the risk being higher in women (aHR 1.17; P = .0120) vs men (aHR 1.15; P = .0343) with AD.

Study details: The data come from a retrospective population-based cohort study including 9164 patients aged ≥20 years with AD and 9164 matched control individuals without AD.

Disclosures: This study was supported by a grant of the National Research Foundation of Korea funded by the Ministry of Education, Science, and Technology. The authors declared no conflicts of interest.

Source: Lee SW et al. Atopic dermatitis and risk of gastroesophageal reflux disease: A nationwide population-based study. PLoS One. 2023;18(2):e0281883 (Feb 17). Doi: 10.1371/journal.pone.0281883

Key clinical point: Adult patients with atopic dermatitis (AD) are at an increased risk of developing subsequent gastroesophageal reflux disease (GERD).

Major finding: Patients with AD vs matched control individuals had a 15% higher risk for subsequent GERD (adjusted hazard ratio [aHR] 1.15; P = .0013), with the risk being higher in women (aHR 1.17; P = .0120) vs men (aHR 1.15; P = .0343) with AD.

Study details: The data come from a retrospective population-based cohort study including 9164 patients aged ≥20 years with AD and 9164 matched control individuals without AD.

Disclosures: This study was supported by a grant of the National Research Foundation of Korea funded by the Ministry of Education, Science, and Technology. The authors declared no conflicts of interest.

Source: Lee SW et al. Atopic dermatitis and risk of gastroesophageal reflux disease: A nationwide population-based study. PLoS One. 2023;18(2):e0281883 (Feb 17). Doi: 10.1371/journal.pone.0281883

Key clinical point: Adult patients with atopic dermatitis (AD) are at an increased risk of developing subsequent gastroesophageal reflux disease (GERD).

Major finding: Patients with AD vs matched control individuals had a 15% higher risk for subsequent GERD (adjusted hazard ratio [aHR] 1.15; P = .0013), with the risk being higher in women (aHR 1.17; P = .0120) vs men (aHR 1.15; P = .0343) with AD.

Study details: The data come from a retrospective population-based cohort study including 9164 patients aged ≥20 years with AD and 9164 matched control individuals without AD.

Disclosures: This study was supported by a grant of the National Research Foundation of Korea funded by the Ministry of Education, Science, and Technology. The authors declared no conflicts of interest.

Source: Lee SW et al. Atopic dermatitis and risk of gastroesophageal reflux disease: A nationwide population-based study. PLoS One. 2023;18(2):e0281883 (Feb 17). Doi: 10.1371/journal.pone.0281883

Key clinical point: Environmental conditions characterized by the month of birth affect the risk of developing eczema and atopic dermatitis (AD) in infants until 1 year of age.

Major finding: With infants born in spring as a reference, those born in autumn had the highest risk for eczema at 6 months (adjusted odds ratio [aOR] 2.19; 95% CI 2.10-2.30) and 1 year (aOR 1.08; 95% CI 1.02-1.14) of age and for physician-diagnosed AD up to 1 year of age (aOR 1.33; 95% CI 1.20-1.47), whereas those born in summer had the highest risk for eczema at the age of 1 month (aOR 1.19; 95% CI 1.14-1.24).

Study details: This study analyzed the data of 81,615 infants from a prospective birth cohort study, the Japan Environment and Children’s Study (JECS).

Disclosures: The JECS is supported by the Ministry of the Environment, Japan. The authors declared no conflicts of interest.

Source: Tsuchida A et al. Season of birth and atopic dermatitis in early infancy: Results from the Japan Environment and Children’s Study. BMC Pediatr. 2023;23(1):78 (Feb 15). Doi: 10.1186/s12887-023-03878-6

Key clinical point: Environmental conditions characterized by the month of birth affect the risk of developing eczema and atopic dermatitis (AD) in infants until 1 year of age.

Major finding: With infants born in spring as a reference, those born in autumn had the highest risk for eczema at 6 months (adjusted odds ratio [aOR] 2.19; 95% CI 2.10-2.30) and 1 year (aOR 1.08; 95% CI 1.02-1.14) of age and for physician-diagnosed AD up to 1 year of age (aOR 1.33; 95% CI 1.20-1.47), whereas those born in summer had the highest risk for eczema at the age of 1 month (aOR 1.19; 95% CI 1.14-1.24).

Study details: This study analyzed the data of 81,615 infants from a prospective birth cohort study, the Japan Environment and Children’s Study (JECS).

Disclosures: The JECS is supported by the Ministry of the Environment, Japan. The authors declared no conflicts of interest.

Source: Tsuchida A et al. Season of birth and atopic dermatitis in early infancy: Results from the Japan Environment and Children’s Study. BMC Pediatr. 2023;23(1):78 (Feb 15). Doi: 10.1186/s12887-023-03878-6

Key clinical point: Environmental conditions characterized by the month of birth affect the risk of developing eczema and atopic dermatitis (AD) in infants until 1 year of age.

Major finding: With infants born in spring as a reference, those born in autumn had the highest risk for eczema at 6 months (adjusted odds ratio [aOR] 2.19; 95% CI 2.10-2.30) and 1 year (aOR 1.08; 95% CI 1.02-1.14) of age and for physician-diagnosed AD up to 1 year of age (aOR 1.33; 95% CI 1.20-1.47), whereas those born in summer had the highest risk for eczema at the age of 1 month (aOR 1.19; 95% CI 1.14-1.24).

Study details: This study analyzed the data of 81,615 infants from a prospective birth cohort study, the Japan Environment and Children’s Study (JECS).

Disclosures: The JECS is supported by the Ministry of the Environment, Japan. The authors declared no conflicts of interest.

Source: Tsuchida A et al. Season of birth and atopic dermatitis in early infancy: Results from the Japan Environment and Children’s Study. BMC Pediatr. 2023;23(1):78 (Feb 15). Doi: 10.1186/s12887-023-03878-6

Key clinical point: Patients with atopic dermatitis (AD) who experienced greater pruritus reductions after nemolizumab treatment also showed clinically meaningful improvements in other pruritus and cutaneous symptoms.

Major finding: At week 16, a greater proportion of pruritus Visual Analogy Scale (VAS) responders (≥50% improvement) vs nonresponders achieved a pruritus VAS score of <30 mm (81.6% vs 0%), ≥50% improvement in the Eczema Area and Severity Index score (65.3% vs 44.7%), ≥4-point improvement in pruritus numerical rating scale score (89.6% vs 2.1%), and 5-level itch score of ≤1 (42.9% vs 3.2%).

Study details: This post hoc analysis of the Nemolizumab-JP01 study Part A included 215 patients with inadequately controlled AD who had been randomly assigned to receive subcutaneous 60 mg nemolizumab (n = 143) or placebo (n = 72) every 4 weeks for 16 weeks.

Disclosures: This study was funded by Maruho. Some authors declared receiving grants or personal fees from various organizations, including Maruho. Two authors declared being employees of Maruho.

Source: Kabashima K et al for the Nemolizumab-JP01 Study Group. Clinically meaningful improvements in cutaneous lesions and quality of life measures in patients with atopic dermatitis with greater pruritus reductions after treatment with 60 mg nemolizumab subcutaneously every 4 weeks: Subgroup analysis from a phase 3, randomized, controlled trial. J Dermatolog Treat. 2023;1-13 (Feb 13). Doi: 10.1080/09546634.2023.2177096

Key clinical point: Patients with atopic dermatitis (AD) who experienced greater pruritus reductions after nemolizumab treatment also showed clinically meaningful improvements in other pruritus and cutaneous symptoms.

Major finding: At week 16, a greater proportion of pruritus Visual Analogy Scale (VAS) responders (≥50% improvement) vs nonresponders achieved a pruritus VAS score of <30 mm (81.6% vs 0%), ≥50% improvement in the Eczema Area and Severity Index score (65.3% vs 44.7%), ≥4-point improvement in pruritus numerical rating scale score (89.6% vs 2.1%), and 5-level itch score of ≤1 (42.9% vs 3.2%).

Study details: This post hoc analysis of the Nemolizumab-JP01 study Part A included 215 patients with inadequately controlled AD who had been randomly assigned to receive subcutaneous 60 mg nemolizumab (n = 143) or placebo (n = 72) every 4 weeks for 16 weeks.

Disclosures: This study was funded by Maruho. Some authors declared receiving grants or personal fees from various organizations, including Maruho. Two authors declared being employees of Maruho.

Source: Kabashima K et al for the Nemolizumab-JP01 Study Group. Clinically meaningful improvements in cutaneous lesions and quality of life measures in patients with atopic dermatitis with greater pruritus reductions after treatment with 60 mg nemolizumab subcutaneously every 4 weeks: Subgroup analysis from a phase 3, randomized, controlled trial. J Dermatolog Treat. 2023;1-13 (Feb 13). Doi: 10.1080/09546634.2023.2177096

Key clinical point: Patients with atopic dermatitis (AD) who experienced greater pruritus reductions after nemolizumab treatment also showed clinically meaningful improvements in other pruritus and cutaneous symptoms.

Major finding: At week 16, a greater proportion of pruritus Visual Analogy Scale (VAS) responders (≥50% improvement) vs nonresponders achieved a pruritus VAS score of <30 mm (81.6% vs 0%), ≥50% improvement in the Eczema Area and Severity Index score (65.3% vs 44.7%), ≥4-point improvement in pruritus numerical rating scale score (89.6% vs 2.1%), and 5-level itch score of ≤1 (42.9% vs 3.2%).

Study details: This post hoc analysis of the Nemolizumab-JP01 study Part A included 215 patients with inadequately controlled AD who had been randomly assigned to receive subcutaneous 60 mg nemolizumab (n = 143) or placebo (n = 72) every 4 weeks for 16 weeks.

Disclosures: This study was funded by Maruho. Some authors declared receiving grants or personal fees from various organizations, including Maruho. Two authors declared being employees of Maruho.

Source: Kabashima K et al for the Nemolizumab-JP01 Study Group. Clinically meaningful improvements in cutaneous lesions and quality of life measures in patients with atopic dermatitis with greater pruritus reductions after treatment with 60 mg nemolizumab subcutaneously every 4 weeks: Subgroup analysis from a phase 3, randomized, controlled trial. J Dermatolog Treat. 2023;1-13 (Feb 13). Doi: 10.1080/09546634.2023.2177096

Key clinical point: Use of e-cigarettes is significantly associated with the development of atopic dermatitis (AD) in the US adult population.

Major finding: E-cigarette use was significantly associated with AD (adjusted odds ratio 1.35; P < .001). The association was significant in women (P < .001) but not in men (P = .5).

Study details: This population-based study analyzed the data of 28,563 adults from the US National Health Interview Survey 2021.

Disclosures: This study did not receive any funding. Some authors declared serving as consultants, speakers, investigators, or advisors for or receiving speaking fees from various organizations.

Source: Smith B et al. Association between electronic cigarette use and atopic dermatitis among United States adults. J Am Acad Dermatol. 2023 (Feb 24). Doi: 10.1016/j.jaad.2023.02.027.

Key clinical point: Use of e-cigarettes is significantly associated with the development of atopic dermatitis (AD) in the US adult population.

Major finding: E-cigarette use was significantly associated with AD (adjusted odds ratio 1.35; P < .001). The association was significant in women (P < .001) but not in men (P = .5).

Study details: This population-based study analyzed the data of 28,563 adults from the US National Health Interview Survey 2021.

Disclosures: This study did not receive any funding. Some authors declared serving as consultants, speakers, investigators, or advisors for or receiving speaking fees from various organizations.

Source: Smith B et al. Association between electronic cigarette use and atopic dermatitis among United States adults. J Am Acad Dermatol. 2023 (Feb 24). Doi: 10.1016/j.jaad.2023.02.027.

Key clinical point: Use of e-cigarettes is significantly associated with the development of atopic dermatitis (AD) in the US adult population.

Major finding: E-cigarette use was significantly associated with AD (adjusted odds ratio 1.35; P < .001). The association was significant in women (P < .001) but not in men (P = .5).

Study details: This population-based study analyzed the data of 28,563 adults from the US National Health Interview Survey 2021.

Disclosures: This study did not receive any funding. Some authors declared serving as consultants, speakers, investigators, or advisors for or receiving speaking fees from various organizations.

Source: Smith B et al. Association between electronic cigarette use and atopic dermatitis among United States adults. J Am Acad Dermatol. 2023 (Feb 24). Doi: 10.1016/j.jaad.2023.02.027.

Key clinical point: After patch testing, the frequency of allergic contact dermatitis (ACD) diagnosis was higher among patients with atopic dermatitis (AD) than among individuals without AD.

Major finding: Among patients with AD vs individuals without AD, the diagnosis rate of ACD (54.8% vs 47.3%; P < .0001), particularly ACD to cosmetics (7.0% vs 5.7%; P = .0007), medicaments (2.3% vs 1.7%; P = .02), dyes (1.9% vs 1.4%; P = .036), and foods contacting the skin (0.4% vs 0.1%; P = .003), was significantly higher.

Study details: This retrospective study included 15,737 individuals who underwent patch testing, of which 5641 were diagnosed with AD.

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

Source: Qian MF et al. Prevalence of allergic contact dermatitis following patch testing in patients with atopic dermatitis: A retrospective United States claims-based study. J Am Acad Dermatol. 2023 (Feb 10). Doi: 10.1016/j.jaad.2022.12.051

Key clinical point: After patch testing, the frequency of allergic contact dermatitis (ACD) diagnosis was higher among patients with atopic dermatitis (AD) than among individuals without AD.

Major finding: Among patients with AD vs individuals without AD, the diagnosis rate of ACD (54.8% vs 47.3%; P < .0001), particularly ACD to cosmetics (7.0% vs 5.7%; P = .0007), medicaments (2.3% vs 1.7%; P = .02), dyes (1.9% vs 1.4%; P = .036), and foods contacting the skin (0.4% vs 0.1%; P = .003), was significantly higher.

Study details: This retrospective study included 15,737 individuals who underwent patch testing, of which 5641 were diagnosed with AD.

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

Source: Qian MF et al. Prevalence of allergic contact dermatitis following patch testing in patients with atopic dermatitis: A retrospective United States claims-based study. J Am Acad Dermatol. 2023 (Feb 10). Doi: 10.1016/j.jaad.2022.12.051

Key clinical point: After patch testing, the frequency of allergic contact dermatitis (ACD) diagnosis was higher among patients with atopic dermatitis (AD) than among individuals without AD.

Major finding: Among patients with AD vs individuals without AD, the diagnosis rate of ACD (54.8% vs 47.3%; P < .0001), particularly ACD to cosmetics (7.0% vs 5.7%; P = .0007), medicaments (2.3% vs 1.7%; P = .02), dyes (1.9% vs 1.4%; P = .036), and foods contacting the skin (0.4% vs 0.1%; P = .003), was significantly higher.

Study details: This retrospective study included 15,737 individuals who underwent patch testing, of which 5641 were diagnosed with AD.

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

Source: Qian MF et al. Prevalence of allergic contact dermatitis following patch testing in patients with atopic dermatitis: A retrospective United States claims-based study. J Am Acad Dermatol. 2023 (Feb 10). Doi: 10.1016/j.jaad.2022.12.051

Key clinical point: In real-life settings, upadacitinib was effective and safe in patients with moderate-to-severe atopic dermatitis (AD), including those with prior inadequate response to dupilumab or baricitinib.

Major finding: At week 16, the mean Eczema Area and Severity Index and Numerical Rating Scale pruritus scores decreased significantly from 16.6 to 5.7 and 7.0 to 3.7, respectively (both P < .001), with rapid improvement being observed in the first 4 weeks. Adverse events were mostly mild in severity.

Study details: This prospective multicenter observational study included 47 adult patients with moderate-to-severe AD from the Dutch BioDay registry who received upadacitinib (15 or 30 mg once daily), of which 23 and 14 had not or inadequately responded to previous dupilumab and baricitinib therapies, respectively.

Disclosures: The BioDay registry is sponsored by Eli Lilly and others. Some authors reported ties with various sources, including the BioDay registry sponsors.

Source: Boesjes CM et al. Effectiveness of upadacitinib in patients with atopic dermatitis including those with inadequate response to dupilumab and/or baricitinib: Results from the BioDay Registry. Acta Derm Venereol. 2023;103:adv00872 (Feb 16). Doi: 10.2340/actadv.v103.5243

Key clinical point: In real-life settings, upadacitinib was effective and safe in patients with moderate-to-severe atopic dermatitis (AD), including those with prior inadequate response to dupilumab or baricitinib.

Major finding: At week 16, the mean Eczema Area and Severity Index and Numerical Rating Scale pruritus scores decreased significantly from 16.6 to 5.7 and 7.0 to 3.7, respectively (both P < .001), with rapid improvement being observed in the first 4 weeks. Adverse events were mostly mild in severity.

Study details: This prospective multicenter observational study included 47 adult patients with moderate-to-severe AD from the Dutch BioDay registry who received upadacitinib (15 or 30 mg once daily), of which 23 and 14 had not or inadequately responded to previous dupilumab and baricitinib therapies, respectively.

Disclosures: The BioDay registry is sponsored by Eli Lilly and others. Some authors reported ties with various sources, including the BioDay registry sponsors.

Source: Boesjes CM et al. Effectiveness of upadacitinib in patients with atopic dermatitis including those with inadequate response to dupilumab and/or baricitinib: Results from the BioDay Registry. Acta Derm Venereol. 2023;103:adv00872 (Feb 16). Doi: 10.2340/actadv.v103.5243

Key clinical point: In real-life settings, upadacitinib was effective and safe in patients with moderate-to-severe atopic dermatitis (AD), including those with prior inadequate response to dupilumab or baricitinib.

Major finding: At week 16, the mean Eczema Area and Severity Index and Numerical Rating Scale pruritus scores decreased significantly from 16.6 to 5.7 and 7.0 to 3.7, respectively (both P < .001), with rapid improvement being observed in the first 4 weeks. Adverse events were mostly mild in severity.

Study details: This prospective multicenter observational study included 47 adult patients with moderate-to-severe AD from the Dutch BioDay registry who received upadacitinib (15 or 30 mg once daily), of which 23 and 14 had not or inadequately responded to previous dupilumab and baricitinib therapies, respectively.

Disclosures: The BioDay registry is sponsored by Eli Lilly and others. Some authors reported ties with various sources, including the BioDay registry sponsors.

Source: Boesjes CM et al. Effectiveness of upadacitinib in patients with atopic dermatitis including those with inadequate response to dupilumab and/or baricitinib: Results from the BioDay Registry. Acta Derm Venereol. 2023;103:adv00872 (Feb 16). Doi: 10.2340/actadv.v103.5243

Key clinical point: Dupilumab is safe and improves atopic dermatitis (AD) signs and symptoms in patients aged ≥60 years with moderate-to-severe AD.

Major finding: At week 16, similar to the <60-year group, a significantly higher proportion of patients receiving dupilumab (every 2 weeks or every week) vs placebo in the ≥60-year group achieved an Investigator’s Global Assessment score of 0 or 1 (44.4% or 39.7% vs 7.1%, respectively; both P < .0001) and a 75% improvement in the Eczema Area and Severity Index (63.0% or 61.6% vs 14.3%, respectively; both P < .0001). Most treatment-emergent adverse events were of mild-to-moderate severity.

Study details: This post hoc pooled analysis of four phase 3 trials included 2444 patients (≥60 years, n = 183; <60 years, n = 2261) with moderate-to-severe AD who were randomly assigned to receive dupilumab or placebo.

Disclosures: This study was funded by Sanofi-Regeneron Pharmaceuticals Inc. Some authors reported various ties, including employment, with Sanofi, Regeneron, or others.

Source: Silverberg JI et al. Efficacy and safety of dupilumab maintained in adults ≥ 60 years of age with moderate-to-severe atopic dermatitis: Analysis of pooled data from four randomized clinical trials. Am J Clin Dermatol. 2023 (Feb 20). Doi: 10.1007/s40257-022-00754-4

Key clinical point: Dupilumab is safe and improves atopic dermatitis (AD) signs and symptoms in patients aged ≥60 years with moderate-to-severe AD.

Major finding: At week 16, similar to the <60-year group, a significantly higher proportion of patients receiving dupilumab (every 2 weeks or every week) vs placebo in the ≥60-year group achieved an Investigator’s Global Assessment score of 0 or 1 (44.4% or 39.7% vs 7.1%, respectively; both P < .0001) and a 75% improvement in the Eczema Area and Severity Index (63.0% or 61.6% vs 14.3%, respectively; both P < .0001). Most treatment-emergent adverse events were of mild-to-moderate severity.

Study details: This post hoc pooled analysis of four phase 3 trials included 2444 patients (≥60 years, n = 183; <60 years, n = 2261) with moderate-to-severe AD who were randomly assigned to receive dupilumab or placebo.

Disclosures: This study was funded by Sanofi-Regeneron Pharmaceuticals Inc. Some authors reported various ties, including employment, with Sanofi, Regeneron, or others.

Source: Silverberg JI et al. Efficacy and safety of dupilumab maintained in adults ≥ 60 years of age with moderate-to-severe atopic dermatitis: Analysis of pooled data from four randomized clinical trials. Am J Clin Dermatol. 2023 (Feb 20). Doi: 10.1007/s40257-022-00754-4

Key clinical point: Dupilumab is safe and improves atopic dermatitis (AD) signs and symptoms in patients aged ≥60 years with moderate-to-severe AD.

Major finding: At week 16, similar to the <60-year group, a significantly higher proportion of patients receiving dupilumab (every 2 weeks or every week) vs placebo in the ≥60-year group achieved an Investigator’s Global Assessment score of 0 or 1 (44.4% or 39.7% vs 7.1%, respectively; both P < .0001) and a 75% improvement in the Eczema Area and Severity Index (63.0% or 61.6% vs 14.3%, respectively; both P < .0001). Most treatment-emergent adverse events were of mild-to-moderate severity.

Study details: This post hoc pooled analysis of four phase 3 trials included 2444 patients (≥60 years, n = 183; <60 years, n = 2261) with moderate-to-severe AD who were randomly assigned to receive dupilumab or placebo.

Disclosures: This study was funded by Sanofi-Regeneron Pharmaceuticals Inc. Some authors reported various ties, including employment, with Sanofi, Regeneron, or others.

Source: Silverberg JI et al. Efficacy and safety of dupilumab maintained in adults ≥ 60 years of age with moderate-to-severe atopic dermatitis: Analysis of pooled data from four randomized clinical trials. Am J Clin Dermatol. 2023 (Feb 20). Doi: 10.1007/s40257-022-00754-4

With regard to advanced targeted therapies, there is concern about the side effects of Janus kinase (JAK) inhibitors, especially in patients with comorbidities. To address safety concerns with upadacitinib, a selective JAK1 inhibitor, Burmester and colleagues conducted an integrated safety analysis of 12 phase 3 trials that included 6991 patients (PsA n = 907; rheumatoid arthritis [RA] n = 3209; ankylosing spondylitis n = 182; and atopic dermatitis n = 2693) who received upadacitinib (15 or 30 mg once daily). Some trials included active comparators; therefore, safety among 1008 patients (RA n = 579; PsA n = 429) who received 40-mg adalimumab every other week and 314 patients with RA who received methotrexate were compared with those treated with upadacitinib. Overall, patients with PsA receiving 15-mg upadacitinib once daily had acceptable rates of treatment-emergent adverse events (TEAE; 244.8/100 patient-years [PY]), serious TEAE (11.1/100 PY), TEAE leading to discontinuation (5.4/100 PY), and death (0.8/100 PY). Patients with PsA treated with upadacitinib had higher rates of herpes zoster, nonmelanoma skin cancer, and elevations in creatine phosphokinase when compared with patients treated with adalimumab. Although these results are reassuring to clinicians treating PsA, continued surveillance regarding the risks for venous thrombosis, cardiovascular events, and cancer are required.

In a post hoc analysis of 10 clinical trials that included patients with PsA (n = 783) and psoriasis (n = 3663) who received tofacitinib, Kristensen and colleagues reported that the risk for major adverse cardiac events was higher among patients with PsA and a high 10-year atherosclerotic cardiovascular disease (ASCVD) risk vs patients with a low ASCVD risk. The incidence of cancer was highest in patients with PsA and an intermediate 10-year ASCVD risk. Although these studies are reassuring, the assessment and risk stratification of adverse events with JAK inhibitors and therapies in PsA will require longer-term comparative clinical trials as well as an evaluation of observational data from disease registries.

Comorbidities also have an impact on treatment persistence in PsA. Tillett and colleagues conducted a retrospective study including 9057 patients with plaque psoriasis alone or with concomitant PsA who received either ustekinumab or conventional systemic disease-modifying antirheumatic drugs. They demonstrated that among patients receiving ustekinumab, those with concomitant PsA had a higher comorbidity burden, including diabetes, hypertension, and obesity, and a shorter time to ustekinumab discontinuation when compared with those with psoriasis alone. Secondary failure of advanced therapies is increasingly noted in the management of psoriatic disease. Female sex, depression, previous exposure to biologics, and the presence of comorbidities are important risk factors. Comprehensive management of psoriatic disease should include appropriate management of comorbidities for better long-term treatment persistence and outcomes.

With regard to advanced targeted therapies, there is concern about the side effects of Janus kinase (JAK) inhibitors, especially in patients with comorbidities. To address safety concerns with upadacitinib, a selective JAK1 inhibitor, Burmester and colleagues conducted an integrated safety analysis of 12 phase 3 trials that included 6991 patients (PsA n = 907; rheumatoid arthritis [RA] n = 3209; ankylosing spondylitis n = 182; and atopic dermatitis n = 2693) who received upadacitinib (15 or 30 mg once daily). Some trials included active comparators; therefore, safety among 1008 patients (RA n = 579; PsA n = 429) who received 40-mg adalimumab every other week and 314 patients with RA who received methotrexate were compared with those treated with upadacitinib. Overall, patients with PsA receiving 15-mg upadacitinib once daily had acceptable rates of treatment-emergent adverse events (TEAE; 244.8/100 patient-years [PY]), serious TEAE (11.1/100 PY), TEAE leading to discontinuation (5.4/100 PY), and death (0.8/100 PY). Patients with PsA treated with upadacitinib had higher rates of herpes zoster, nonmelanoma skin cancer, and elevations in creatine phosphokinase when compared with patients treated with adalimumab. Although these results are reassuring to clinicians treating PsA, continued surveillance regarding the risks for venous thrombosis, cardiovascular events, and cancer are required.

In a post hoc analysis of 10 clinical trials that included patients with PsA (n = 783) and psoriasis (n = 3663) who received tofacitinib, Kristensen and colleagues reported that the risk for major adverse cardiac events was higher among patients with PsA and a high 10-year atherosclerotic cardiovascular disease (ASCVD) risk vs patients with a low ASCVD risk. The incidence of cancer was highest in patients with PsA and an intermediate 10-year ASCVD risk. Although these studies are reassuring, the assessment and risk stratification of adverse events with JAK inhibitors and therapies in PsA will require longer-term comparative clinical trials as well as an evaluation of observational data from disease registries.

Comorbidities also have an impact on treatment persistence in PsA. Tillett and colleagues conducted a retrospective study including 9057 patients with plaque psoriasis alone or with concomitant PsA who received either ustekinumab or conventional systemic disease-modifying antirheumatic drugs. They demonstrated that among patients receiving ustekinumab, those with concomitant PsA had a higher comorbidity burden, including diabetes, hypertension, and obesity, and a shorter time to ustekinumab discontinuation when compared with those with psoriasis alone. Secondary failure of advanced therapies is increasingly noted in the management of psoriatic disease. Female sex, depression, previous exposure to biologics, and the presence of comorbidities are important risk factors. Comprehensive management of psoriatic disease should include appropriate management of comorbidities for better long-term treatment persistence and outcomes.

With regard to advanced targeted therapies, there is concern about the side effects of Janus kinase (JAK) inhibitors, especially in patients with comorbidities. To address safety concerns with upadacitinib, a selective JAK1 inhibitor, Burmester and colleagues conducted an integrated safety analysis of 12 phase 3 trials that included 6991 patients (PsA n = 907; rheumatoid arthritis [RA] n = 3209; ankylosing spondylitis n = 182; and atopic dermatitis n = 2693) who received upadacitinib (15 or 30 mg once daily). Some trials included active comparators; therefore, safety among 1008 patients (RA n = 579; PsA n = 429) who received 40-mg adalimumab every other week and 314 patients with RA who received methotrexate were compared with those treated with upadacitinib. Overall, patients with PsA receiving 15-mg upadacitinib once daily had acceptable rates of treatment-emergent adverse events (TEAE; 244.8/100 patient-years [PY]), serious TEAE (11.1/100 PY), TEAE leading to discontinuation (5.4/100 PY), and death (0.8/100 PY). Patients with PsA treated with upadacitinib had higher rates of herpes zoster, nonmelanoma skin cancer, and elevations in creatine phosphokinase when compared with patients treated with adalimumab. Although these results are reassuring to clinicians treating PsA, continued surveillance regarding the risks for venous thrombosis, cardiovascular events, and cancer are required.

In a post hoc analysis of 10 clinical trials that included patients with PsA (n = 783) and psoriasis (n = 3663) who received tofacitinib, Kristensen and colleagues reported that the risk for major adverse cardiac events was higher among patients with PsA and a high 10-year atherosclerotic cardiovascular disease (ASCVD) risk vs patients with a low ASCVD risk. The incidence of cancer was highest in patients with PsA and an intermediate 10-year ASCVD risk. Although these studies are reassuring, the assessment and risk stratification of adverse events with JAK inhibitors and therapies in PsA will require longer-term comparative clinical trials as well as an evaluation of observational data from disease registries.

Comorbidities also have an impact on treatment persistence in PsA. Tillett and colleagues conducted a retrospective study including 9057 patients with plaque psoriasis alone or with concomitant PsA who received either ustekinumab or conventional systemic disease-modifying antirheumatic drugs. They demonstrated that among patients receiving ustekinumab, those with concomitant PsA had a higher comorbidity burden, including diabetes, hypertension, and obesity, and a shorter time to ustekinumab discontinuation when compared with those with psoriasis alone. Secondary failure of advanced therapies is increasingly noted in the management of psoriatic disease. Female sex, depression, previous exposure to biologics, and the presence of comorbidities are important risk factors. Comprehensive management of psoriatic disease should include appropriate management of comorbidities for better long-term treatment persistence and outcomes.

Key clinical point: Nearly half of the patients with psoriatic arthritis (PsA) treated with apremilast achieved disease activity index for psoriatic arthritis (DAPSA) low disease activity/remission at 6 or 12 months, with lower baseline disease activity being the only factor associated with the achievement of low disease activity or remission.

Major finding: Overall, 42.7% and 54.9% of patients achieved DAPSA low disease activity or remission at 6 and 12 months, respectively. Baseline DAPSA was inversely associated with the odds of achieving low disease activity or remission at 6 months (odds ratio [OR] 0.84) and 12 months (OR 0.91; both P < .01).

Study details: Findings are from a retrospective study including 293 patients with PsA who were treated with apremilast.

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

Source: Becciolini A et al. Predictors of DAPSA response in psoriatic arthritis patients treated with apremilast in a retrospective observational multi-centric study. Biomedicines. 2023;11(2):433 (Feb 2). Doi: 10.3390/biomedicines11020433

Key clinical point: Nearly half of the patients with psoriatic arthritis (PsA) treated with apremilast achieved disease activity index for psoriatic arthritis (DAPSA) low disease activity/remission at 6 or 12 months, with lower baseline disease activity being the only factor associated with the achievement of low disease activity or remission.

Major finding: Overall, 42.7% and 54.9% of patients achieved DAPSA low disease activity or remission at 6 and 12 months, respectively. Baseline DAPSA was inversely associated with the odds of achieving low disease activity or remission at 6 months (odds ratio [OR] 0.84) and 12 months (OR 0.91; both P < .01).

Study details: Findings are from a retrospective study including 293 patients with PsA who were treated with apremilast.

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

Source: Becciolini A et al. Predictors of DAPSA response in psoriatic arthritis patients treated with apremilast in a retrospective observational multi-centric study. Biomedicines. 2023;11(2):433 (Feb 2). Doi: 10.3390/biomedicines11020433

Key clinical point: Nearly half of the patients with psoriatic arthritis (PsA) treated with apremilast achieved disease activity index for psoriatic arthritis (DAPSA) low disease activity/remission at 6 or 12 months, with lower baseline disease activity being the only factor associated with the achievement of low disease activity or remission.

Major finding: Overall, 42.7% and 54.9% of patients achieved DAPSA low disease activity or remission at 6 and 12 months, respectively. Baseline DAPSA was inversely associated with the odds of achieving low disease activity or remission at 6 months (odds ratio [OR] 0.84) and 12 months (OR 0.91; both P < .01).

Study details: Findings are from a retrospective study including 293 patients with PsA who were treated with apremilast.

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

Source: Becciolini A et al. Predictors of DAPSA response in psoriatic arthritis patients treated with apremilast in a retrospective observational multi-centric study. Biomedicines. 2023;11(2):433 (Feb 2). Doi: 10.3390/biomedicines11020433

Key clinical point: Upadacitinib demonstrated an acceptable long-term safety profile and was generally well tolerated with no new safety signals in patients with psoriatic arthritis (PsA).

Major finding: Overall, patients with PsA receiving 15 mg upadacitinib once daily had acceptable rates of treatment-emergent adverse events (TEAE; 244.8/100 patient-years [PY]), serious TEAE (11.1/100 PY), TEAE leading to discontinuation (5.4/100 PY), and deaths (0.8/100 PY).

Study details: This integrated safety analysis of 12 phase 3 trials included 6991 patients with PsA (n = 907), rheumatoid arthritis (n = 3,209), ankylosing spondylitis (n = 182), and atopic dermatitis (n = 2693) who received upadacitinib (15 or 30 mg once daily); 1008 patients with RA (n = 579) and PsA (n = 429) who received 40 mg adalimumab every other week; and 314 patients with RA who received methotrexate.

Disclosures: This study was funded by AbbVie. Five authors declared being full-time employees of AbbVie or Mount Sinai or holding stock or stock options in AbbVie. Several authors reported ties with various sources, including AbbVie.

Source: Burmester GR et al. Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis. RMD Open. 2023;9(1):e002735;15(Feb 8). Doi: 10.1136/rmdopen-2022-002735

Key clinical point: Upadacitinib demonstrated an acceptable long-term safety profile and was generally well tolerated with no new safety signals in patients with psoriatic arthritis (PsA).

Major finding: Overall, patients with PsA receiving 15 mg upadacitinib once daily had acceptable rates of treatment-emergent adverse events (TEAE; 244.8/100 patient-years [PY]), serious TEAE (11.1/100 PY), TEAE leading to discontinuation (5.4/100 PY), and deaths (0.8/100 PY).

Study details: This integrated safety analysis of 12 phase 3 trials included 6991 patients with PsA (n = 907), rheumatoid arthritis (n = 3,209), ankylosing spondylitis (n = 182), and atopic dermatitis (n = 2693) who received upadacitinib (15 or 30 mg once daily); 1008 patients with RA (n = 579) and PsA (n = 429) who received 40 mg adalimumab every other week; and 314 patients with RA who received methotrexate.

Disclosures: This study was funded by AbbVie. Five authors declared being full-time employees of AbbVie or Mount Sinai or holding stock or stock options in AbbVie. Several authors reported ties with various sources, including AbbVie.

Source: Burmester GR et al. Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis. RMD Open. 2023;9(1):e002735;15(Feb 8). Doi: 10.1136/rmdopen-2022-002735

Key clinical point: Upadacitinib demonstrated an acceptable long-term safety profile and was generally well tolerated with no new safety signals in patients with psoriatic arthritis (PsA).

Major finding: Overall, patients with PsA receiving 15 mg upadacitinib once daily had acceptable rates of treatment-emergent adverse events (TEAE; 244.8/100 patient-years [PY]), serious TEAE (11.1/100 PY), TEAE leading to discontinuation (5.4/100 PY), and deaths (0.8/100 PY).

Study details: This integrated safety analysis of 12 phase 3 trials included 6991 patients with PsA (n = 907), rheumatoid arthritis (n = 3,209), ankylosing spondylitis (n = 182), and atopic dermatitis (n = 2693) who received upadacitinib (15 or 30 mg once daily); 1008 patients with RA (n = 579) and PsA (n = 429) who received 40 mg adalimumab every other week; and 314 patients with RA who received methotrexate.

Disclosures: This study was funded by AbbVie. Five authors declared being full-time employees of AbbVie or Mount Sinai or holding stock or stock options in AbbVie. Several authors reported ties with various sources, including AbbVie.

Source: Burmester GR et al. Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis. RMD Open. 2023;9(1):e002735;15(Feb 8). Doi: 10.1136/rmdopen-2022-002735