Key clinical point: Patients with metastatic colorectal cancer (mCRC) who initiated trifluridine/tipiracil (FTD/TPI) had better tumor response and disease control than those who initiated regorafenib.

Major finding: Patients who initiated FTD/TPI vs regorafenib as index therapy had better real-world overall response rate (odds ratio [OR], 2.57; 95% confidence interval [CI], 1.38-4.80) and real-world disease control (OR, 2.52; 95% CI, 1.36-4.68). Overall, a similar proportion of patients treated with FTD/TPI and regorafenib discontinued treatment because of disease progression (P = .162), but discontinuation because of toxicity/intolerance was significantly lower with FTD/TPI than regorafenib (8.2% vs 24.2%; P < .001).

Study details: Findings are from a retrospective study of patients with mCRC who initiated FTD/TPI (n=126) or regorafenib (n=95) at a US tertiary oncology center.

Disclosures: This study was funded by Taiho Oncology Inc., Princeton, NJ, USA. No conflict of interests was disclosed.

Source: Patel AK et al. Oncologist. 2021 Aug 18. doi: 10.1002/onco.13942.

Key clinical point: Patients with metastatic colorectal cancer (mCRC) who initiated trifluridine/tipiracil (FTD/TPI) had better tumor response and disease control than those who initiated regorafenib.

Major finding: Patients who initiated FTD/TPI vs regorafenib as index therapy had better real-world overall response rate (odds ratio [OR], 2.57; 95% confidence interval [CI], 1.38-4.80) and real-world disease control (OR, 2.52; 95% CI, 1.36-4.68). Overall, a similar proportion of patients treated with FTD/TPI and regorafenib discontinued treatment because of disease progression (P = .162), but discontinuation because of toxicity/intolerance was significantly lower with FTD/TPI than regorafenib (8.2% vs 24.2%; P < .001).

Study details: Findings are from a retrospective study of patients with mCRC who initiated FTD/TPI (n=126) or regorafenib (n=95) at a US tertiary oncology center.

Disclosures: This study was funded by Taiho Oncology Inc., Princeton, NJ, USA. No conflict of interests was disclosed.

Source: Patel AK et al. Oncologist. 2021 Aug 18. doi: 10.1002/onco.13942.

Key clinical point: Patients with metastatic colorectal cancer (mCRC) who initiated trifluridine/tipiracil (FTD/TPI) had better tumor response and disease control than those who initiated regorafenib.

Major finding: Patients who initiated FTD/TPI vs regorafenib as index therapy had better real-world overall response rate (odds ratio [OR], 2.57; 95% confidence interval [CI], 1.38-4.80) and real-world disease control (OR, 2.52; 95% CI, 1.36-4.68). Overall, a similar proportion of patients treated with FTD/TPI and regorafenib discontinued treatment because of disease progression (P = .162), but discontinuation because of toxicity/intolerance was significantly lower with FTD/TPI than regorafenib (8.2% vs 24.2%; P < .001).

Study details: Findings are from a retrospective study of patients with mCRC who initiated FTD/TPI (n=126) or regorafenib (n=95) at a US tertiary oncology center.

Disclosures: This study was funded by Taiho Oncology Inc., Princeton, NJ, USA. No conflict of interests was disclosed.

Source: Patel AK et al. Oncologist. 2021 Aug 18. doi: 10.1002/onco.13942.

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. 

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.