MDedge Dermatology

Key clinical point: Apremilast significantly improved nail-specific quality of life, clinical signs, and ultrasound parameters, along with a consistent safety profile in patients with psoriasis and predominant nail disease.

Major finding: At 52 weeks, 52% of patients had Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA) Patient Benefit Index global weighted score of 2 or more. Median NAPPA Quality of Life and fingernail Nail Psoriasis Severity Index (NAPSI) improved by 57% and 53%, respectively. Ultrasound parameters improved from 16 weeks onward. Adverse events were mostly mild and transient.

Study details: This was a prospective cohort study that included 45 adult patients with plaque and nail psoriasis and a fingernail NAPSI score of 12 or more who were treated with apremilast 30 mg twice a day for 52 weeks.

Disclosures: This study was supported by Amgen. Dr. Muñoz-Santos, Dr. Vidal, and Dr. Guilabert declared receiving personal fees, presentation honoraria, or travel expenses from various sources including Amgen.

Source: Muñoz-Santos C et al. J Dermatol. 2021 Aug 12. doi: 10.1111/1346-8138.16074.

Key clinical point: Apremilast significantly improved nail-specific quality of life, clinical signs, and ultrasound parameters, along with a consistent safety profile in patients with psoriasis and predominant nail disease.

Major finding: At 52 weeks, 52% of patients had Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA) Patient Benefit Index global weighted score of 2 or more. Median NAPPA Quality of Life and fingernail Nail Psoriasis Severity Index (NAPSI) improved by 57% and 53%, respectively. Ultrasound parameters improved from 16 weeks onward. Adverse events were mostly mild and transient.

Study details: This was a prospective cohort study that included 45 adult patients with plaque and nail psoriasis and a fingernail NAPSI score of 12 or more who were treated with apremilast 30 mg twice a day for 52 weeks.

Disclosures: This study was supported by Amgen. Dr. Muñoz-Santos, Dr. Vidal, and Dr. Guilabert declared receiving personal fees, presentation honoraria, or travel expenses from various sources including Amgen.

Source: Muñoz-Santos C et al. J Dermatol. 2021 Aug 12. doi: 10.1111/1346-8138.16074.

Key clinical point: Apremilast significantly improved nail-specific quality of life, clinical signs, and ultrasound parameters, along with a consistent safety profile in patients with psoriasis and predominant nail disease.

Major finding: At 52 weeks, 52% of patients had Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA) Patient Benefit Index global weighted score of 2 or more. Median NAPPA Quality of Life and fingernail Nail Psoriasis Severity Index (NAPSI) improved by 57% and 53%, respectively. Ultrasound parameters improved from 16 weeks onward. Adverse events were mostly mild and transient.

Study details: This was a prospective cohort study that included 45 adult patients with plaque and nail psoriasis and a fingernail NAPSI score of 12 or more who were treated with apremilast 30 mg twice a day for 52 weeks.

Disclosures: This study was supported by Amgen. Dr. Muñoz-Santos, Dr. Vidal, and Dr. Guilabert declared receiving personal fees, presentation honoraria, or travel expenses from various sources including Amgen.

Source: Muñoz-Santos C et al. J Dermatol. 2021 Aug 12. doi: 10.1111/1346-8138.16074.

Key clinical point: Anxiety and depressive symptoms, individually or in concurrence, were prevalent among patients with plaque psoriasis. Depressive symptoms seemed to have more impact on psoriasis and patient health-related quality of life (QoL) than anxiety symptoms.

Major finding: Overall, 27% and 22% of patients had symptoms of anxiety and depression, respectively, whereas 14% of patients had both. Patients with vs. without depression had significantly higher itch (6.0 vs 3.0; P = .009) and skin pain (2.5 vs 1.0; P = .01) numeric rating scale (NRS) score. However, itch (P = .42) and skin pain (P = .06) NRS were not significantly different in patients with vs. without anxiety.

Study details: Findings are from an analysis of 73 Japanese patients aged 18 years or more with plaque psoriasis without peripheral arthritis symptoms from the ProLOGUE study.

Disclosures: The study was sponsored by Kyowa Kirin Co., Ltd. Dr. Ohata, Dr. Murotani, and Dr. Imafuku declared receiving grants, personal fees, meeting and travel expenses, or nonfinancial support from various sources, including Kyowa Kirin Co., Ltd. Dr. Kanai and Mr. Kitabayashi reported being employees of Kyowa Kirin Co. Ltd.

Source: Ohata C et al. J Eur Acad Dermatol Venereol. 2021 Aug 21. doi: 10.1111/jdv.17621.

Key clinical point: Anxiety and depressive symptoms, individually or in concurrence, were prevalent among patients with plaque psoriasis. Depressive symptoms seemed to have more impact on psoriasis and patient health-related quality of life (QoL) than anxiety symptoms.

Major finding: Overall, 27% and 22% of patients had symptoms of anxiety and depression, respectively, whereas 14% of patients had both. Patients with vs. without depression had significantly higher itch (6.0 vs 3.0; P = .009) and skin pain (2.5 vs 1.0; P = .01) numeric rating scale (NRS) score. However, itch (P = .42) and skin pain (P = .06) NRS were not significantly different in patients with vs. without anxiety.

Study details: Findings are from an analysis of 73 Japanese patients aged 18 years or more with plaque psoriasis without peripheral arthritis symptoms from the ProLOGUE study.

Disclosures: The study was sponsored by Kyowa Kirin Co., Ltd. Dr. Ohata, Dr. Murotani, and Dr. Imafuku declared receiving grants, personal fees, meeting and travel expenses, or nonfinancial support from various sources, including Kyowa Kirin Co., Ltd. Dr. Kanai and Mr. Kitabayashi reported being employees of Kyowa Kirin Co. Ltd.

Source: Ohata C et al. J Eur Acad Dermatol Venereol. 2021 Aug 21. doi: 10.1111/jdv.17621.

Key clinical point: Anxiety and depressive symptoms, individually or in concurrence, were prevalent among patients with plaque psoriasis. Depressive symptoms seemed to have more impact on psoriasis and patient health-related quality of life (QoL) than anxiety symptoms.

Major finding: Overall, 27% and 22% of patients had symptoms of anxiety and depression, respectively, whereas 14% of patients had both. Patients with vs. without depression had significantly higher itch (6.0 vs 3.0; P = .009) and skin pain (2.5 vs 1.0; P = .01) numeric rating scale (NRS) score. However, itch (P = .42) and skin pain (P = .06) NRS were not significantly different in patients with vs. without anxiety.

Study details: Findings are from an analysis of 73 Japanese patients aged 18 years or more with plaque psoriasis without peripheral arthritis symptoms from the ProLOGUE study.

Disclosures: The study was sponsored by Kyowa Kirin Co., Ltd. Dr. Ohata, Dr. Murotani, and Dr. Imafuku declared receiving grants, personal fees, meeting and travel expenses, or nonfinancial support from various sources, including Kyowa Kirin Co., Ltd. Dr. Kanai and Mr. Kitabayashi reported being employees of Kyowa Kirin Co. Ltd.

Source: Ohata C et al. J Eur Acad Dermatol Venereol. 2021 Aug 21. doi: 10.1111/jdv.17621.

Key clinical point: Findings from this network meta-analysis confirm efficacy and safety of topical Janus kinase (JAK) and phosphodiesterase-4 (PDE4) inhibitors for atopic dermatitis (AD).

Major finding: All included JAK and PDE4 inhibitors, specially tofacitinib 2% twice a day (BID; odds ratio [OR], 19.0; 95% confidence interval [CI], 5.6-77.0), delgocitinib 3% BID (OR, 19.2; 95% CI, 4.6-90.3), and ruxolitinib 1.5% once a day (QD; OR, 13.2; 95% CI, 7.5-25.0), showed higher Investigators Global Assessment response vs placebo. Tofacitinib 2% BID (OR, 0.4; 95% CI, 0.1-1.0) and ruxolitinib 1.5% QD (OR, 0.7; 95% CI, 0.5-1.0) had lower risk for adverse events vs placebo, whereas others showed a comparable safety profile.

Study details: Findings are from a network meta-analysis of 10 randomized controlled trials including 4,689 patients, mostly with mild-to-moderate AD treated with topical JAK and PDE4 inhibitors.

Disclosures: This study was supported by the National Natural Science Foundation of China and the Project for Disciplines of Excellence, West China Hospital. The authors declared no conflict of interests.

Source: Zhang L et al. J Dermatol. 2021 Sep 6. doi: 10.1111/1346-8138.16126.

Key clinical point: Findings from this network meta-analysis confirm efficacy and safety of topical Janus kinase (JAK) and phosphodiesterase-4 (PDE4) inhibitors for atopic dermatitis (AD).

Major finding: All included JAK and PDE4 inhibitors, specially tofacitinib 2% twice a day (BID; odds ratio [OR], 19.0; 95% confidence interval [CI], 5.6-77.0), delgocitinib 3% BID (OR, 19.2; 95% CI, 4.6-90.3), and ruxolitinib 1.5% once a day (QD; OR, 13.2; 95% CI, 7.5-25.0), showed higher Investigators Global Assessment response vs placebo. Tofacitinib 2% BID (OR, 0.4; 95% CI, 0.1-1.0) and ruxolitinib 1.5% QD (OR, 0.7; 95% CI, 0.5-1.0) had lower risk for adverse events vs placebo, whereas others showed a comparable safety profile.

Study details: Findings are from a network meta-analysis of 10 randomized controlled trials including 4,689 patients, mostly with mild-to-moderate AD treated with topical JAK and PDE4 inhibitors.

Disclosures: This study was supported by the National Natural Science Foundation of China and the Project for Disciplines of Excellence, West China Hospital. The authors declared no conflict of interests.

Source: Zhang L et al. J Dermatol. 2021 Sep 6. doi: 10.1111/1346-8138.16126.

Key clinical point: Findings from this network meta-analysis confirm efficacy and safety of topical Janus kinase (JAK) and phosphodiesterase-4 (PDE4) inhibitors for atopic dermatitis (AD).

Major finding: All included JAK and PDE4 inhibitors, specially tofacitinib 2% twice a day (BID; odds ratio [OR], 19.0; 95% confidence interval [CI], 5.6-77.0), delgocitinib 3% BID (OR, 19.2; 95% CI, 4.6-90.3), and ruxolitinib 1.5% once a day (QD; OR, 13.2; 95% CI, 7.5-25.0), showed higher Investigators Global Assessment response vs placebo. Tofacitinib 2% BID (OR, 0.4; 95% CI, 0.1-1.0) and ruxolitinib 1.5% QD (OR, 0.7; 95% CI, 0.5-1.0) had lower risk for adverse events vs placebo, whereas others showed a comparable safety profile.

Study details: Findings are from a network meta-analysis of 10 randomized controlled trials including 4,689 patients, mostly with mild-to-moderate AD treated with topical JAK and PDE4 inhibitors.

Disclosures: This study was supported by the National Natural Science Foundation of China and the Project for Disciplines of Excellence, West China Hospital. The authors declared no conflict of interests.

Source: Zhang L et al. J Dermatol. 2021 Sep 6. doi: 10.1111/1346-8138.16126.

Key clinical point: Patients with atopic dermatitis (AD) were at a higher risk of developing cardiovascular diseases (CVD) and major adverse cardiovascular events (MACEs), independent of metabolic disorders.

Major finding: The risk for CVD (odds ratio [OR], 1.38; 95% confidence interval [CI], 1.34-1.41) and MACEs (OR, 1.40; 95% CI, 1.34-1.45) was significantly higher in patients with vs without AD. The risk for MACEs and CVD was higher in patients without (CVD: OR, 1.25; 95% CI, 1.13-1.39; MACE: OR, 1.22; 95% CI, 1.01-1.47) vs those with (CVD: OR, 1.09; 95% CI, 1.07-1.12; MACE: OR, 1.14; 95% CI, 1.09-1.18) metabolic disorders.

Study details: Findings are from a retrospective analysis of 1,32,460 adult patients with AD matched with 3,97,380 adults without AD.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc. The authors declared being investigator, consultant, speaker, current and/or former employees, and stockholders for various sources including Sanofi and/or Regeneron Pharmaceuticals, Inc.

Source: Wu JJ et al. Dermatol Ther (Heidelb). 2021 Aug 27. doi: 10.1007/s13555-021-00587-9.

Key clinical point: Patients with atopic dermatitis (AD) were at a higher risk of developing cardiovascular diseases (CVD) and major adverse cardiovascular events (MACEs), independent of metabolic disorders.

Major finding: The risk for CVD (odds ratio [OR], 1.38; 95% confidence interval [CI], 1.34-1.41) and MACEs (OR, 1.40; 95% CI, 1.34-1.45) was significantly higher in patients with vs without AD. The risk for MACEs and CVD was higher in patients without (CVD: OR, 1.25; 95% CI, 1.13-1.39; MACE: OR, 1.22; 95% CI, 1.01-1.47) vs those with (CVD: OR, 1.09; 95% CI, 1.07-1.12; MACE: OR, 1.14; 95% CI, 1.09-1.18) metabolic disorders.

Study details: Findings are from a retrospective analysis of 1,32,460 adult patients with AD matched with 3,97,380 adults without AD.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc. The authors declared being investigator, consultant, speaker, current and/or former employees, and stockholders for various sources including Sanofi and/or Regeneron Pharmaceuticals, Inc.

Source: Wu JJ et al. Dermatol Ther (Heidelb). 2021 Aug 27. doi: 10.1007/s13555-021-00587-9.

Key clinical point: Patients with atopic dermatitis (AD) were at a higher risk of developing cardiovascular diseases (CVD) and major adverse cardiovascular events (MACEs), independent of metabolic disorders.

Major finding: The risk for CVD (odds ratio [OR], 1.38; 95% confidence interval [CI], 1.34-1.41) and MACEs (OR, 1.40; 95% CI, 1.34-1.45) was significantly higher in patients with vs without AD. The risk for MACEs and CVD was higher in patients without (CVD: OR, 1.25; 95% CI, 1.13-1.39; MACE: OR, 1.22; 95% CI, 1.01-1.47) vs those with (CVD: OR, 1.09; 95% CI, 1.07-1.12; MACE: OR, 1.14; 95% CI, 1.09-1.18) metabolic disorders.

Study details: Findings are from a retrospective analysis of 1,32,460 adult patients with AD matched with 3,97,380 adults without AD.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc. The authors declared being investigator, consultant, speaker, current and/or former employees, and stockholders for various sources including Sanofi and/or Regeneron Pharmaceuticals, Inc.

Source: Wu JJ et al. Dermatol Ther (Heidelb). 2021 Aug 27. doi: 10.1007/s13555-021-00587-9.

Key clinical point: Patients with atopic dermatitis (AD) were at a significantly higher risk of developing rheumatoid arthritis (RA).

Major finding: Patients with AD had a significantly higher risk for incident RA than patients without AD (pooled odds ratio, 1.30; 95% confidence interval, 1.17-1.44).

Study details: Findings are from a meta-analysis of 4 cohorts and 9 case-control studies.

Disclosures: The study did not report any source of funding. No conflict of interests was reported.

Source: Rittiphairoj T et al. Dermatitis. 2021 Aug 16. doi: 10.1097/DER.0000000000000781.

Key clinical point: Patients with atopic dermatitis (AD) were at a significantly higher risk of developing rheumatoid arthritis (RA).

Major finding: Patients with AD had a significantly higher risk for incident RA than patients without AD (pooled odds ratio, 1.30; 95% confidence interval, 1.17-1.44).

Study details: Findings are from a meta-analysis of 4 cohorts and 9 case-control studies.

Disclosures: The study did not report any source of funding. No conflict of interests was reported.

Source: Rittiphairoj T et al. Dermatitis. 2021 Aug 16. doi: 10.1097/DER.0000000000000781.

Key clinical point: Patients with atopic dermatitis (AD) were at a significantly higher risk of developing rheumatoid arthritis (RA).

Major finding: Patients with AD had a significantly higher risk for incident RA than patients without AD (pooled odds ratio, 1.30; 95% confidence interval, 1.17-1.44).

Study details: Findings are from a meta-analysis of 4 cohorts and 9 case-control studies.

Disclosures: The study did not report any source of funding. No conflict of interests was reported.

Source: Rittiphairoj T et al. Dermatitis. 2021 Aug 16. doi: 10.1097/DER.0000000000000781.

Key clinical point: Dupilumab improved signs of atopic dermatitis (AD) rapidly and consistently across all anatomical regions in pediatric patients.

Major finding: In children, dupilumab improved Eczema Area and Severity Index (EASI) score as early as week 1 in head and neck, trunk, and upper extremities and as early as week 2 in lower extremities. In adolescents, dupilumab improved the EASI score in all anatomical regions as early as week 2. All improvements were sustained through week 16 (all P less than .05).

Study details: Findings are a post hoc analysis of 2 phase 3 dupilumab therapy trials, LIBERTY AD ADOL and LIBERTY AD PEDS, including 167 adolescents with moderate-to-severe AD and 304 children with severe AD inadequately controlled by topical medication.

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

Source: Simpson EL et al. Dermatol Ther (Heidelb). 2021 Aug 24. doi: 10.1007/s13555-021-00568-y.

Key clinical point: Dupilumab improved signs of atopic dermatitis (AD) rapidly and consistently across all anatomical regions in pediatric patients.

Major finding: In children, dupilumab improved Eczema Area and Severity Index (EASI) score as early as week 1 in head and neck, trunk, and upper extremities and as early as week 2 in lower extremities. In adolescents, dupilumab improved the EASI score in all anatomical regions as early as week 2. All improvements were sustained through week 16 (all P less than .05).

Study details: Findings are a post hoc analysis of 2 phase 3 dupilumab therapy trials, LIBERTY AD ADOL and LIBERTY AD PEDS, including 167 adolescents with moderate-to-severe AD and 304 children with severe AD inadequately controlled by topical medication.

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

Source: Simpson EL et al. Dermatol Ther (Heidelb). 2021 Aug 24. doi: 10.1007/s13555-021-00568-y.

Key clinical point: Dupilumab improved signs of atopic dermatitis (AD) rapidly and consistently across all anatomical regions in pediatric patients.

Major finding: In children, dupilumab improved Eczema Area and Severity Index (EASI) score as early as week 1 in head and neck, trunk, and upper extremities and as early as week 2 in lower extremities. In adolescents, dupilumab improved the EASI score in all anatomical regions as early as week 2. All improvements were sustained through week 16 (all P less than .05).

Study details: Findings are a post hoc analysis of 2 phase 3 dupilumab therapy trials, LIBERTY AD ADOL and LIBERTY AD PEDS, including 167 adolescents with moderate-to-severe AD and 304 children with severe AD inadequately controlled by topical medication.

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

Source: Simpson EL et al. Dermatol Ther (Heidelb). 2021 Aug 24. doi: 10.1007/s13555-021-00568-y.

Key clinical point: Continuous and long-term use of crisaborole is safe and effective for managing mild-to-moderate atopic dermatitis (AD).

Major finding: Following 1-4 crisaborole treatment cycles (TC), 77.6%, 76.3%, 59.4%, and 43.1% of patients achieved Investigator’s Static Global Assessment (ISGA) score of 0/1, respectively. After a 28-day off-TC, ISGA 0/1 was maintained in 49.5%, 37.8%, 44.4%, and 45.2% of patients from TC 1-4, respectively. Treatment-related adverse events were reported by less than 5% of patients across cohorts.

Study details: Findings are from CORE 3, a 48-week extension study including 418 patients aged 2 years or more with mild-to-moderate AD who completed CrisADe CORE 1 or CrisADe CORE 2 phase 3 trials without any drug-related safety issues and received crisaborole for 1-4 consecutive initial on-TC during the extension study.

Disclosures: This study was funded by Pfizer Inc. The authors declared receiving honoraria, serving as speaker and consultant, and/or being an employee and/or shareholders of various sources including Pfizer.

Source: Geng B et al. Dermatol Ther (Heidelb). 2021 Aug 11. doi: 10.1007/s13555-021-00584-y.

Key clinical point: Continuous and long-term use of crisaborole is safe and effective for managing mild-to-moderate atopic dermatitis (AD).

Major finding: Following 1-4 crisaborole treatment cycles (TC), 77.6%, 76.3%, 59.4%, and 43.1% of patients achieved Investigator’s Static Global Assessment (ISGA) score of 0/1, respectively. After a 28-day off-TC, ISGA 0/1 was maintained in 49.5%, 37.8%, 44.4%, and 45.2% of patients from TC 1-4, respectively. Treatment-related adverse events were reported by less than 5% of patients across cohorts.

Study details: Findings are from CORE 3, a 48-week extension study including 418 patients aged 2 years or more with mild-to-moderate AD who completed CrisADe CORE 1 or CrisADe CORE 2 phase 3 trials without any drug-related safety issues and received crisaborole for 1-4 consecutive initial on-TC during the extension study.

Disclosures: This study was funded by Pfizer Inc. The authors declared receiving honoraria, serving as speaker and consultant, and/or being an employee and/or shareholders of various sources including Pfizer.

Source: Geng B et al. Dermatol Ther (Heidelb). 2021 Aug 11. doi: 10.1007/s13555-021-00584-y.

Key clinical point: Continuous and long-term use of crisaborole is safe and effective for managing mild-to-moderate atopic dermatitis (AD).

Major finding: Following 1-4 crisaborole treatment cycles (TC), 77.6%, 76.3%, 59.4%, and 43.1% of patients achieved Investigator’s Static Global Assessment (ISGA) score of 0/1, respectively. After a 28-day off-TC, ISGA 0/1 was maintained in 49.5%, 37.8%, 44.4%, and 45.2% of patients from TC 1-4, respectively. Treatment-related adverse events were reported by less than 5% of patients across cohorts.

Study details: Findings are from CORE 3, a 48-week extension study including 418 patients aged 2 years or more with mild-to-moderate AD who completed CrisADe CORE 1 or CrisADe CORE 2 phase 3 trials without any drug-related safety issues and received crisaborole for 1-4 consecutive initial on-TC during the extension study.

Disclosures: This study was funded by Pfizer Inc. The authors declared receiving honoraria, serving as speaker and consultant, and/or being an employee and/or shareholders of various sources including Pfizer.

Source: Geng B et al. Dermatol Ther (Heidelb). 2021 Aug 11. doi: 10.1007/s13555-021-00584-y.

Key clinical point: Abrocitinib showed manageable tolerability and a safety profile appropriate for long-term use in patients with moderate-to-severe atopic dermatitis (AD), provided patient and dose selection were carried out judiciously.

Major finding: In the placebo-controlled cohort, adverse events (AEs) occurred in 68.3%, 61.0%, and 55.0% of patients receiving abrocitinib 200 mg, abrocitinib 100 mg, and placebo, respectively, with the most common AEs being nausea, headache, and acne. In the all-abrocitinib cohort, AEs, serious AEs, and severe AEs were similar with abrocitinib 200 mg and 100 mg with incidence rates for serious infection being 2.33/100 patient-years (PY) and 2.65/100 PY, respectively.

Study details: Findings are from an integrated safety analysis using pooled data from 5 short- and 1 long-term extension study and included a placebo-controlled cohort (n=1,540) and an all-abrocitinib cohort (n=2,856).

Disclosures: This study was funded by Pfizer Inc. The authors declared receiving grants, research funding, honoraria, and personal fees and/or serving as a consultant, speaker, advisor, and/or investigator for various sources including Pfizer. Seven authors declared being employees and shareholders of Pfizer, Inc.

Source: Simpson EL et al. Am J Clin Dermatol. 2021 Aug 18. doi: 10.1007/s40257-021-00618-3.

Key clinical point: Abrocitinib showed manageable tolerability and a safety profile appropriate for long-term use in patients with moderate-to-severe atopic dermatitis (AD), provided patient and dose selection were carried out judiciously.

Major finding: In the placebo-controlled cohort, adverse events (AEs) occurred in 68.3%, 61.0%, and 55.0% of patients receiving abrocitinib 200 mg, abrocitinib 100 mg, and placebo, respectively, with the most common AEs being nausea, headache, and acne. In the all-abrocitinib cohort, AEs, serious AEs, and severe AEs were similar with abrocitinib 200 mg and 100 mg with incidence rates for serious infection being 2.33/100 patient-years (PY) and 2.65/100 PY, respectively.

Study details: Findings are from an integrated safety analysis using pooled data from 5 short- and 1 long-term extension study and included a placebo-controlled cohort (n=1,540) and an all-abrocitinib cohort (n=2,856).

Disclosures: This study was funded by Pfizer Inc. The authors declared receiving grants, research funding, honoraria, and personal fees and/or serving as a consultant, speaker, advisor, and/or investigator for various sources including Pfizer. Seven authors declared being employees and shareholders of Pfizer, Inc.

Source: Simpson EL et al. Am J Clin Dermatol. 2021 Aug 18. doi: 10.1007/s40257-021-00618-3.

Key clinical point: Abrocitinib showed manageable tolerability and a safety profile appropriate for long-term use in patients with moderate-to-severe atopic dermatitis (AD), provided patient and dose selection were carried out judiciously.

Major finding: In the placebo-controlled cohort, adverse events (AEs) occurred in 68.3%, 61.0%, and 55.0% of patients receiving abrocitinib 200 mg, abrocitinib 100 mg, and placebo, respectively, with the most common AEs being nausea, headache, and acne. In the all-abrocitinib cohort, AEs, serious AEs, and severe AEs were similar with abrocitinib 200 mg and 100 mg with incidence rates for serious infection being 2.33/100 patient-years (PY) and 2.65/100 PY, respectively.

Study details: Findings are from an integrated safety analysis using pooled data from 5 short- and 1 long-term extension study and included a placebo-controlled cohort (n=1,540) and an all-abrocitinib cohort (n=2,856).

Disclosures: This study was funded by Pfizer Inc. The authors declared receiving grants, research funding, honoraria, and personal fees and/or serving as a consultant, speaker, advisor, and/or investigator for various sources including Pfizer. Seven authors declared being employees and shareholders of Pfizer, Inc.

Source: Simpson EL et al. Am J Clin Dermatol. 2021 Aug 18. doi: 10.1007/s40257-021-00618-3.

Key clinical point: Most patients with moderate-to-severe atopic dermatitis (AD) who initially respond to abrocitinib maintained response with reduced dosing. Moreover, rescue treatment with abrocitinib and topical therapy recaptured response in patients who flared.

Major finding: At the end of the maintenance period, flare probability was 18.9%, 42.6%, and 80.9% with abrocitinib 200 mg, abrocitinib 100 mg, and placebo, respectively. Overall, 351 patients entered the rescue period, and Investigator’s Global Assessment of 0/1 response was recaptured in 36.6%, 58.8%, and 81.6% of patients in the abrocitinib 200 mg, abrocitinib 100 mg, and placebo maintenance arms, respectively.

Study details: JADE REGIMEN, a phase 3 trial included 1,233 patients with moderate-to-severe AD. Patients (n=798) who responded to 12 weeks of abrocitinib 200 mg were randomly assigned to abrocitinib 200 mg, abrocitinib 100 mg, or placebo for 40 weeks.

Disclosures: This study was funded by Pfizer Inc. Some of the authors declared serving as advisor, investigator, advisory board member, speaker, lecturer, and/or consultant and/or receiving grants and personal fees from various sources including Pfizer and being present/past employees and shareholders of Pfizer.

Source: Blauvelt A et al. J Am Acad Dermatol. 2021 Aug 16. doi: 10.1016/j.jaad.2021.05.075.

Key clinical point: Most patients with moderate-to-severe atopic dermatitis (AD) who initially respond to abrocitinib maintained response with reduced dosing. Moreover, rescue treatment with abrocitinib and topical therapy recaptured response in patients who flared.

Major finding: At the end of the maintenance period, flare probability was 18.9%, 42.6%, and 80.9% with abrocitinib 200 mg, abrocitinib 100 mg, and placebo, respectively. Overall, 351 patients entered the rescue period, and Investigator’s Global Assessment of 0/1 response was recaptured in 36.6%, 58.8%, and 81.6% of patients in the abrocitinib 200 mg, abrocitinib 100 mg, and placebo maintenance arms, respectively.

Study details: JADE REGIMEN, a phase 3 trial included 1,233 patients with moderate-to-severe AD. Patients (n=798) who responded to 12 weeks of abrocitinib 200 mg were randomly assigned to abrocitinib 200 mg, abrocitinib 100 mg, or placebo for 40 weeks.

Disclosures: This study was funded by Pfizer Inc. Some of the authors declared serving as advisor, investigator, advisory board member, speaker, lecturer, and/or consultant and/or receiving grants and personal fees from various sources including Pfizer and being present/past employees and shareholders of Pfizer.

Source: Blauvelt A et al. J Am Acad Dermatol. 2021 Aug 16. doi: 10.1016/j.jaad.2021.05.075.

Key clinical point: Most patients with moderate-to-severe atopic dermatitis (AD) who initially respond to abrocitinib maintained response with reduced dosing. Moreover, rescue treatment with abrocitinib and topical therapy recaptured response in patients who flared.

Major finding: At the end of the maintenance period, flare probability was 18.9%, 42.6%, and 80.9% with abrocitinib 200 mg, abrocitinib 100 mg, and placebo, respectively. Overall, 351 patients entered the rescue period, and Investigator’s Global Assessment of 0/1 response was recaptured in 36.6%, 58.8%, and 81.6% of patients in the abrocitinib 200 mg, abrocitinib 100 mg, and placebo maintenance arms, respectively.

Study details: JADE REGIMEN, a phase 3 trial included 1,233 patients with moderate-to-severe AD. Patients (n=798) who responded to 12 weeks of abrocitinib 200 mg were randomly assigned to abrocitinib 200 mg, abrocitinib 100 mg, or placebo for 40 weeks.

Disclosures: This study was funded by Pfizer Inc. Some of the authors declared serving as advisor, investigator, advisory board member, speaker, lecturer, and/or consultant and/or receiving grants and personal fees from various sources including Pfizer and being present/past employees and shareholders of Pfizer.

Source: Blauvelt A et al. J Am Acad Dermatol. 2021 Aug 16. doi: 10.1016/j.jaad.2021.05.075.

Key clinical point: The combination of upadacitinib and topical corticosteroids (TCS) showed long-term efficacy and a favorable safety profile in moderate-to-severe atopic dermatitis (AD).

Major finding: Among patients receiving upadacitinib 15 mg or 30 mg each in combination with TCS, 50.8% (95% confidence interval [CI], 45.1%-56.5%) and 69.0% (95% CI, 63.7%-74.3%) achieved 75% or more improvement in Eczema Area and Severity Index, whereas 33.5% (95% CI, 28.1%-38.9%) and 45.2% (95% CI, 39.5%-50.9%) achieved validated Investigator’s Global Assessment for AD 0/1, respectively, at week 52. Both doses of upadacitinib+TCS were well tolerated with no new safety risks or deaths.

Study details: Findings are 52-week results from AD Up, an ongoing phase 3 trial including 901 patients with chronic AD randomly assigned to upadacitinib 15 mg, upadacitinib 30 mg, or placebo, all in combination with TCS.

Disclosures: This study was funded by AbbVie. The authors declared serving as speaker, consultant, advisor, and investigator and/or receiving consulting fees, honoraria, and grants from various sources including AbbVie. Five authors declared being employees and/or shareholders of AbbVie.

Source: Silverberg JI et al. J Allergy Clin Immunol. 2021 Aug 14. doi: 10.1016/j.jaci.2021.07.036.

Key clinical point: The combination of upadacitinib and topical corticosteroids (TCS) showed long-term efficacy and a favorable safety profile in moderate-to-severe atopic dermatitis (AD).

Major finding: Among patients receiving upadacitinib 15 mg or 30 mg each in combination with TCS, 50.8% (95% confidence interval [CI], 45.1%-56.5%) and 69.0% (95% CI, 63.7%-74.3%) achieved 75% or more improvement in Eczema Area and Severity Index, whereas 33.5% (95% CI, 28.1%-38.9%) and 45.2% (95% CI, 39.5%-50.9%) achieved validated Investigator’s Global Assessment for AD 0/1, respectively, at week 52. Both doses of upadacitinib+TCS were well tolerated with no new safety risks or deaths.

Study details: Findings are 52-week results from AD Up, an ongoing phase 3 trial including 901 patients with chronic AD randomly assigned to upadacitinib 15 mg, upadacitinib 30 mg, or placebo, all in combination with TCS.

Disclosures: This study was funded by AbbVie. The authors declared serving as speaker, consultant, advisor, and investigator and/or receiving consulting fees, honoraria, and grants from various sources including AbbVie. Five authors declared being employees and/or shareholders of AbbVie.

Source: Silverberg JI et al. J Allergy Clin Immunol. 2021 Aug 14. doi: 10.1016/j.jaci.2021.07.036.

Key clinical point: The combination of upadacitinib and topical corticosteroids (TCS) showed long-term efficacy and a favorable safety profile in moderate-to-severe atopic dermatitis (AD).

Major finding: Among patients receiving upadacitinib 15 mg or 30 mg each in combination with TCS, 50.8% (95% confidence interval [CI], 45.1%-56.5%) and 69.0% (95% CI, 63.7%-74.3%) achieved 75% or more improvement in Eczema Area and Severity Index, whereas 33.5% (95% CI, 28.1%-38.9%) and 45.2% (95% CI, 39.5%-50.9%) achieved validated Investigator’s Global Assessment for AD 0/1, respectively, at week 52. Both doses of upadacitinib+TCS were well tolerated with no new safety risks or deaths.

Study details: Findings are 52-week results from AD Up, an ongoing phase 3 trial including 901 patients with chronic AD randomly assigned to upadacitinib 15 mg, upadacitinib 30 mg, or placebo, all in combination with TCS.

Disclosures: This study was funded by AbbVie. The authors declared serving as speaker, consultant, advisor, and investigator and/or receiving consulting fees, honoraria, and grants from various sources including AbbVie. Five authors declared being employees and/or shareholders of AbbVie.

Source: Silverberg JI et al. J Allergy Clin Immunol. 2021 Aug 14. doi: 10.1016/j.jaci.2021.07.036.