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Metastatic CRC: Repeated anti-EGFR therapy shows promise in phase 2
Key clinical point: Rechallenge therapy with cetuximab and avelumab was effective and well tolerated in patients with RAS wild-type metastatic colorectal cancer (mCRC) who experienced a response to first-line antiepidermal growth factor receptor (EGFR) therapy.
Major finding: The trial achieved its primary endpoint with a median overall survival of 11.6 (95% confidence interval [CI], 8.4-14.8) months. Overall, 65% of patients achieved disease control with a median progression-free survival of 3.6 (95% CI, 3.2-4.1) months. Cutaneous eruption (14%) and diarrhea (4%) were the most common grade 3 toxic effects.
Study details: Findings are from a single-arm, phase 2 CAVE trial including 77 patients with RAS wild-type mCRC with a major response to first-line chemotherapy and anti-EGFR drug cetuximab or panitumumab, progressed and further received avelumab+cetuximab until disease progression or unacceptable toxic effects.
Disclosures: This study was supported by Merck and Regione Campania. Some of the authors declared serving as advisor, speaker, and consultant and/or receiving research grants from various sources.
Source: Martinelli E et al. JAMA Oncol. 2021 Aug 12. doi: 10.1001/jamaoncol.2021.2915.
Key clinical point: Rechallenge therapy with cetuximab and avelumab was effective and well tolerated in patients with RAS wild-type metastatic colorectal cancer (mCRC) who experienced a response to first-line antiepidermal growth factor receptor (EGFR) therapy.
Major finding: The trial achieved its primary endpoint with a median overall survival of 11.6 (95% confidence interval [CI], 8.4-14.8) months. Overall, 65% of patients achieved disease control with a median progression-free survival of 3.6 (95% CI, 3.2-4.1) months. Cutaneous eruption (14%) and diarrhea (4%) were the most common grade 3 toxic effects.
Study details: Findings are from a single-arm, phase 2 CAVE trial including 77 patients with RAS wild-type mCRC with a major response to first-line chemotherapy and anti-EGFR drug cetuximab or panitumumab, progressed and further received avelumab+cetuximab until disease progression or unacceptable toxic effects.
Disclosures: This study was supported by Merck and Regione Campania. Some of the authors declared serving as advisor, speaker, and consultant and/or receiving research grants from various sources.
Source: Martinelli E et al. JAMA Oncol. 2021 Aug 12. doi: 10.1001/jamaoncol.2021.2915.
Key clinical point: Rechallenge therapy with cetuximab and avelumab was effective and well tolerated in patients with RAS wild-type metastatic colorectal cancer (mCRC) who experienced a response to first-line antiepidermal growth factor receptor (EGFR) therapy.
Major finding: The trial achieved its primary endpoint with a median overall survival of 11.6 (95% confidence interval [CI], 8.4-14.8) months. Overall, 65% of patients achieved disease control with a median progression-free survival of 3.6 (95% CI, 3.2-4.1) months. Cutaneous eruption (14%) and diarrhea (4%) were the most common grade 3 toxic effects.
Study details: Findings are from a single-arm, phase 2 CAVE trial including 77 patients with RAS wild-type mCRC with a major response to first-line chemotherapy and anti-EGFR drug cetuximab or panitumumab, progressed and further received avelumab+cetuximab until disease progression or unacceptable toxic effects.
Disclosures: This study was supported by Merck and Regione Campania. Some of the authors declared serving as advisor, speaker, and consultant and/or receiving research grants from various sources.
Source: Martinelli E et al. JAMA Oncol. 2021 Aug 12. doi: 10.1001/jamaoncol.2021.2915.
Atopic dermatitis: Meta-analysis confirms benefits of topical JAK and PDE4 inhibitors
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.
Atopic dermatitis and cardiovascular diseases: Is there a link?
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.
Atopic dermatitis could be a risk factor for rheumatoid arthritis
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.
Dupilumab is effective for pediatric atopic dermatitis across different anatomical regions
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.
Atopic dermatitis: Continuous long-term use of crisaborole safe and effective
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.
Abrocitinib safe for long-term management of moderate-to-severe atopic dermatitis
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.
Atopic dermatitis: Abrocitinib effective as flexible dose in phase 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.
Atopic dermatitis: Upadacitinib and topical corticosteroids combo shows long-term efficacy and safety in phase 3
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.
Atopic dermatitis tied to symptoms of depression and internalizing behavior in early childhood
Key clinical point: Severe atopic dermatitis (AD) is associated with an almost 2-fold higher risk for depression and internalizing behavior in early childhood.
Major finding: Children with vs. without severe AD were more prone to experience depressive (adjusted odds ratio [aOR], 2.38; 95% confidence interval [CI], 1.21-4.72) and internalizing (aOR, 1.90; 95% CI, 1.14-3.16) symptoms.
Study details: Findings are from a longitudinal, population-based birth cohort study including 11,181 children who were followed up from birth for a mean duration of 10 years.
Disclosures: This study was funded by Wellcome Trust, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Center for Advancing Translational Sciences, and National Institutes of Health. Dr. Wan and Dr. Abuabara declared receiving research funding from Pfizer.
Source: Kern C et al. JAMA Dermatol. 2021 Sep 1. doi: 10.1001/jamadermatol.2021.2657.
Key clinical point: Severe atopic dermatitis (AD) is associated with an almost 2-fold higher risk for depression and internalizing behavior in early childhood.
Major finding: Children with vs. without severe AD were more prone to experience depressive (adjusted odds ratio [aOR], 2.38; 95% confidence interval [CI], 1.21-4.72) and internalizing (aOR, 1.90; 95% CI, 1.14-3.16) symptoms.
Study details: Findings are from a longitudinal, population-based birth cohort study including 11,181 children who were followed up from birth for a mean duration of 10 years.
Disclosures: This study was funded by Wellcome Trust, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Center for Advancing Translational Sciences, and National Institutes of Health. Dr. Wan and Dr. Abuabara declared receiving research funding from Pfizer.
Source: Kern C et al. JAMA Dermatol. 2021 Sep 1. doi: 10.1001/jamadermatol.2021.2657.
Key clinical point: Severe atopic dermatitis (AD) is associated with an almost 2-fold higher risk for depression and internalizing behavior in early childhood.
Major finding: Children with vs. without severe AD were more prone to experience depressive (adjusted odds ratio [aOR], 2.38; 95% confidence interval [CI], 1.21-4.72) and internalizing (aOR, 1.90; 95% CI, 1.14-3.16) symptoms.
Study details: Findings are from a longitudinal, population-based birth cohort study including 11,181 children who were followed up from birth for a mean duration of 10 years.
Disclosures: This study was funded by Wellcome Trust, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Center for Advancing Translational Sciences, and National Institutes of Health. Dr. Wan and Dr. Abuabara declared receiving research funding from Pfizer.
Source: Kern C et al. JAMA Dermatol. 2021 Sep 1. doi: 10.1001/jamadermatol.2021.2657.