Atopic Dermatitis

In patients with moderate-to-severe atopic dermatitis, abrocitinib showed consistent treatment responses and no new safety issues, whether or not they had already been treated with the biologic dupilumab, an industry-sponsored study reports.

“In this post hoc analysis, both the efficacy and the safety profiles of abrocitinib were consistent in patients with moderate-to-severe atopic dermatitis, regardless of prior biologic therapy use,” lead author Melinda Gooderham, MD, medical director of the SKiN Centre for Dermatology, Peterborough, Ont., said during an oral presentation at the Society for Investigative Dermatology (SID) 2022 Annual Meeting.

“These results ... support the use of abrocitinib in patients who might have received biologic therapy prior,” she added.

“Prior biologic use did not reveal any new safety signals ... keeping in mind the key limitation of this analysis is that it was done post hoc,” she noted.

Guidelines for moderate-to-severe atopic dermatitis refractory to topical or systemic therapy include systemic immunosuppressants and dupilumab, a monoclonal antibody that inhibits interleukin-4 and interleukin-13 cytokine-induced responses, Dr. Gooderham said.

The Food and Drug Administration recently approved abrocitinib, an oral once-a-day Janus kinase 1 (JAK1) inhibitor, to treat the disease. The approval came with a boxed warning about increased risk for serious infections, mortality, malignancy, and lymphoproliferative disorders, major adverse cardiovascular events, thrombosis, and laboratory abnormalities.
 

Comparing the bio-experienced with the bio-naive

Dr. Gooderham and colleagues investigated whether patients who’d been treated with a biologic would respond to abrocitinib differently than patients who had not received prior biologic treatment.

Researchers pooled data from two phase 3 placebo-controlled trials of abrocitinib that led to approval and an earlier phase 2b study. They identified 67 patients previously treated with dupilumab and 867 patients who were bio-naive. They repeated their analysis using data from another phase 3 study of abrocitinib on 86 patients previously treated with dupilumab and 1,147 who were bio-naive. On average, the bio-experienced patients were in their mid-30s to early 40s, and the bio-naive group was several years younger.

In the pooled phase 2b and phase 3 JADE MONO-1 and JADE MONO-2 monotherapy trials, patients received once-daily abrocitinib 100 or 200 mg or placebo for 12 weeks. In the phase 3 JADE REGIMEN, which they analyzed separately, eligible patients were enrolled in a 12-week open-label run-in period during which they received an induction treatment of abrocitinib 200 mg once a day.

Researchers compared results of two assessments: the IGA (Investigator Global Assessment) and EASI-75 (Eczema Area and Severity Index, 75% or greater improvement from baseline).

• At week 12, IGA 0/1 dose-dependent response rates were similar in the pooled groups, regardless of whether they had received prior biologic therapy. With abrocitinib 200 mg, 43.5% of those with prior dupilumab therapy responded versus 41.4% of bio-naive patients; with abrocitinib 100 mg, 24.1% versus 26.7% responded. In JADE REGIMEN, corresponding response rates with abrocitinib 200 mg were 53.5% versus 66.9%, respectively.
• At week 12, EASI-75 responses were also comparable. In the pooled groups by dose, with abrocitinib 200 mg, EASI-75 response rates were 65.2% in patients with prior dupilumab therapy versus 62.4% in those without; at abrocitinib 100 mg, 34.5% versus 42.7% responded. Corresponding rates in JADE REGIMEN were 64.0% versus 76.4%, respectively.
• Treatment-emergent adverse event rates among patients with versus without prior biologic therapy were, respectively, 71.7% versus 69.9% (abrocitinib 200 mg + 100 mg groups) in the pooled population. Rates in JADE REGIMEN with abrocitinib 200 mg were, respectively, 66.3% versus 66.5%.
• Abrocitinib efficacy and safety were consistent in patients with moderate-to-severe atopic dermatitis, regardless of prior biologic therapy. Adverse events in the pooled monotherapy trials and in JADE REGIMEN included acne, atopic dermatitis, diarrhea, headache, nasopharyngitis, nausea, upper abdominal pain, and upper respiratory tract infection.

The authors acknowledge that the post hoc study design is a limitation and recommend confirming these findings in a large, long-term prospective study.
 

JAK inhibitors expand treatment options

The results will help doctors treat their patients, Jami L. Miller, MD, associate professor of dermatology and dermatology clinic medical director at Vanderbilt University Medical Center, Nashville, Tenn., told this news organization.

“Because JAK inhibitors have potentially more side effects than inhibitors of interleukin-4 and interleukin-13, in clinical practice most dermatologists are more likely to treat patients first with dupilumab or similar meds and step up to a JAK inhibitor if they do not respond,” she added in an email. 

“With more meds coming out to meet the needs of this population, this is an exciting time for patients with moderate-to-severe atopic dermatitis,” she commented.

Lindsay C. Strowd, MD, associate professor and vice chair of the department of dermatology at Wake Forest University, Winston-Salem, N.C., said JAK inhibitors are increasingly being studied and approved for use in various dermatologic diseases.

An oral JAK inhibitor (upadacitinib) is currently FDA approved for moderate-to-severe atopic dermatitis, and a topical JAK inhibitor (ruxolitinib) is also approved for use in atopic dermatitis, Dr. Strowd noted.

“The study results give providers important practical information,” added Dr. Strowd, who also was not involved with the study. “Those of us who care for patients with severe atopic dermatitis need to know how patients with prior biologic exposure will respond as newer agents come to market and the options for biologic use in atopic dermatitis continue to grow.”

The study was sponsored by Pfizer. All study authors have reported relevant financial relationships with, and several authors are employees of, Pfizer, the developer of abrocitinib. Dr. Strowd and Dr. Miller have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

In patients with moderate-to-severe atopic dermatitis, abrocitinib showed consistent treatment responses and no new safety issues, whether or not they had already been treated with the biologic dupilumab, an industry-sponsored study reports.

“In this post hoc analysis, both the efficacy and the safety profiles of abrocitinib were consistent in patients with moderate-to-severe atopic dermatitis, regardless of prior biologic therapy use,” lead author Melinda Gooderham, MD, medical director of the SKiN Centre for Dermatology, Peterborough, Ont., said during an oral presentation at the Society for Investigative Dermatology (SID) 2022 Annual Meeting.

“These results ... support the use of abrocitinib in patients who might have received biologic therapy prior,” she added.

“Prior biologic use did not reveal any new safety signals ... keeping in mind the key limitation of this analysis is that it was done post hoc,” she noted.

Guidelines for moderate-to-severe atopic dermatitis refractory to topical or systemic therapy include systemic immunosuppressants and dupilumab, a monoclonal antibody that inhibits interleukin-4 and interleukin-13 cytokine-induced responses, Dr. Gooderham said.

The Food and Drug Administration recently approved abrocitinib, an oral once-a-day Janus kinase 1 (JAK1) inhibitor, to treat the disease. The approval came with a boxed warning about increased risk for serious infections, mortality, malignancy, and lymphoproliferative disorders, major adverse cardiovascular events, thrombosis, and laboratory abnormalities.
 

Comparing the bio-experienced with the bio-naive

Dr. Gooderham and colleagues investigated whether patients who’d been treated with a biologic would respond to abrocitinib differently than patients who had not received prior biologic treatment.

Researchers pooled data from two phase 3 placebo-controlled trials of abrocitinib that led to approval and an earlier phase 2b study. They identified 67 patients previously treated with dupilumab and 867 patients who were bio-naive. They repeated their analysis using data from another phase 3 study of abrocitinib on 86 patients previously treated with dupilumab and 1,147 who were bio-naive. On average, the bio-experienced patients were in their mid-30s to early 40s, and the bio-naive group was several years younger.

In the pooled phase 2b and phase 3 JADE MONO-1 and JADE MONO-2 monotherapy trials, patients received once-daily abrocitinib 100 or 200 mg or placebo for 12 weeks. In the phase 3 JADE REGIMEN, which they analyzed separately, eligible patients were enrolled in a 12-week open-label run-in period during which they received an induction treatment of abrocitinib 200 mg once a day.

Researchers compared results of two assessments: the IGA (Investigator Global Assessment) and EASI-75 (Eczema Area and Severity Index, 75% or greater improvement from baseline).

• At week 12, IGA 0/1 dose-dependent response rates were similar in the pooled groups, regardless of whether they had received prior biologic therapy. With abrocitinib 200 mg, 43.5% of those with prior dupilumab therapy responded versus 41.4% of bio-naive patients; with abrocitinib 100 mg, 24.1% versus 26.7% responded. In JADE REGIMEN, corresponding response rates with abrocitinib 200 mg were 53.5% versus 66.9%, respectively.
• At week 12, EASI-75 responses were also comparable. In the pooled groups by dose, with abrocitinib 200 mg, EASI-75 response rates were 65.2% in patients with prior dupilumab therapy versus 62.4% in those without; at abrocitinib 100 mg, 34.5% versus 42.7% responded. Corresponding rates in JADE REGIMEN were 64.0% versus 76.4%, respectively.
• Treatment-emergent adverse event rates among patients with versus without prior biologic therapy were, respectively, 71.7% versus 69.9% (abrocitinib 200 mg + 100 mg groups) in the pooled population. Rates in JADE REGIMEN with abrocitinib 200 mg were, respectively, 66.3% versus 66.5%.
• Abrocitinib efficacy and safety were consistent in patients with moderate-to-severe atopic dermatitis, regardless of prior biologic therapy. Adverse events in the pooled monotherapy trials and in JADE REGIMEN included acne, atopic dermatitis, diarrhea, headache, nasopharyngitis, nausea, upper abdominal pain, and upper respiratory tract infection.

The authors acknowledge that the post hoc study design is a limitation and recommend confirming these findings in a large, long-term prospective study.
 

JAK inhibitors expand treatment options

The results will help doctors treat their patients, Jami L. Miller, MD, associate professor of dermatology and dermatology clinic medical director at Vanderbilt University Medical Center, Nashville, Tenn., told this news organization.

“Because JAK inhibitors have potentially more side effects than inhibitors of interleukin-4 and interleukin-13, in clinical practice most dermatologists are more likely to treat patients first with dupilumab or similar meds and step up to a JAK inhibitor if they do not respond,” she added in an email. 

“With more meds coming out to meet the needs of this population, this is an exciting time for patients with moderate-to-severe atopic dermatitis,” she commented.

Lindsay C. Strowd, MD, associate professor and vice chair of the department of dermatology at Wake Forest University, Winston-Salem, N.C., said JAK inhibitors are increasingly being studied and approved for use in various dermatologic diseases.

An oral JAK inhibitor (upadacitinib) is currently FDA approved for moderate-to-severe atopic dermatitis, and a topical JAK inhibitor (ruxolitinib) is also approved for use in atopic dermatitis, Dr. Strowd noted.

“The study results give providers important practical information,” added Dr. Strowd, who also was not involved with the study. “Those of us who care for patients with severe atopic dermatitis need to know how patients with prior biologic exposure will respond as newer agents come to market and the options for biologic use in atopic dermatitis continue to grow.”

The study was sponsored by Pfizer. All study authors have reported relevant financial relationships with, and several authors are employees of, Pfizer, the developer of abrocitinib. Dr. Strowd and Dr. Miller have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

In patients with moderate-to-severe atopic dermatitis, abrocitinib showed consistent treatment responses and no new safety issues, whether or not they had already been treated with the biologic dupilumab, an industry-sponsored study reports.

“In this post hoc analysis, both the efficacy and the safety profiles of abrocitinib were consistent in patients with moderate-to-severe atopic dermatitis, regardless of prior biologic therapy use,” lead author Melinda Gooderham, MD, medical director of the SKiN Centre for Dermatology, Peterborough, Ont., said during an oral presentation at the Society for Investigative Dermatology (SID) 2022 Annual Meeting.

“These results ... support the use of abrocitinib in patients who might have received biologic therapy prior,” she added.

“Prior biologic use did not reveal any new safety signals ... keeping in mind the key limitation of this analysis is that it was done post hoc,” she noted.

Guidelines for moderate-to-severe atopic dermatitis refractory to topical or systemic therapy include systemic immunosuppressants and dupilumab, a monoclonal antibody that inhibits interleukin-4 and interleukin-13 cytokine-induced responses, Dr. Gooderham said.

The Food and Drug Administration recently approved abrocitinib, an oral once-a-day Janus kinase 1 (JAK1) inhibitor, to treat the disease. The approval came with a boxed warning about increased risk for serious infections, mortality, malignancy, and lymphoproliferative disorders, major adverse cardiovascular events, thrombosis, and laboratory abnormalities.
 

Comparing the bio-experienced with the bio-naive

Dr. Gooderham and colleagues investigated whether patients who’d been treated with a biologic would respond to abrocitinib differently than patients who had not received prior biologic treatment.

Researchers pooled data from two phase 3 placebo-controlled trials of abrocitinib that led to approval and an earlier phase 2b study. They identified 67 patients previously treated with dupilumab and 867 patients who were bio-naive. They repeated their analysis using data from another phase 3 study of abrocitinib on 86 patients previously treated with dupilumab and 1,147 who were bio-naive. On average, the bio-experienced patients were in their mid-30s to early 40s, and the bio-naive group was several years younger.

In the pooled phase 2b and phase 3 JADE MONO-1 and JADE MONO-2 monotherapy trials, patients received once-daily abrocitinib 100 or 200 mg or placebo for 12 weeks. In the phase 3 JADE REGIMEN, which they analyzed separately, eligible patients were enrolled in a 12-week open-label run-in period during which they received an induction treatment of abrocitinib 200 mg once a day.

Researchers compared results of two assessments: the IGA (Investigator Global Assessment) and EASI-75 (Eczema Area and Severity Index, 75% or greater improvement from baseline).

• At week 12, IGA 0/1 dose-dependent response rates were similar in the pooled groups, regardless of whether they had received prior biologic therapy. With abrocitinib 200 mg, 43.5% of those with prior dupilumab therapy responded versus 41.4% of bio-naive patients; with abrocitinib 100 mg, 24.1% versus 26.7% responded. In JADE REGIMEN, corresponding response rates with abrocitinib 200 mg were 53.5% versus 66.9%, respectively.
• At week 12, EASI-75 responses were also comparable. In the pooled groups by dose, with abrocitinib 200 mg, EASI-75 response rates were 65.2% in patients with prior dupilumab therapy versus 62.4% in those without; at abrocitinib 100 mg, 34.5% versus 42.7% responded. Corresponding rates in JADE REGIMEN were 64.0% versus 76.4%, respectively.
• Treatment-emergent adverse event rates among patients with versus without prior biologic therapy were, respectively, 71.7% versus 69.9% (abrocitinib 200 mg + 100 mg groups) in the pooled population. Rates in JADE REGIMEN with abrocitinib 200 mg were, respectively, 66.3% versus 66.5%.
• Abrocitinib efficacy and safety were consistent in patients with moderate-to-severe atopic dermatitis, regardless of prior biologic therapy. Adverse events in the pooled monotherapy trials and in JADE REGIMEN included acne, atopic dermatitis, diarrhea, headache, nasopharyngitis, nausea, upper abdominal pain, and upper respiratory tract infection.

The authors acknowledge that the post hoc study design is a limitation and recommend confirming these findings in a large, long-term prospective study.
 

JAK inhibitors expand treatment options

The results will help doctors treat their patients, Jami L. Miller, MD, associate professor of dermatology and dermatology clinic medical director at Vanderbilt University Medical Center, Nashville, Tenn., told this news organization.

“Because JAK inhibitors have potentially more side effects than inhibitors of interleukin-4 and interleukin-13, in clinical practice most dermatologists are more likely to treat patients first with dupilumab or similar meds and step up to a JAK inhibitor if they do not respond,” she added in an email. 

“With more meds coming out to meet the needs of this population, this is an exciting time for patients with moderate-to-severe atopic dermatitis,” she commented.

Lindsay C. Strowd, MD, associate professor and vice chair of the department of dermatology at Wake Forest University, Winston-Salem, N.C., said JAK inhibitors are increasingly being studied and approved for use in various dermatologic diseases.

An oral JAK inhibitor (upadacitinib) is currently FDA approved for moderate-to-severe atopic dermatitis, and a topical JAK inhibitor (ruxolitinib) is also approved for use in atopic dermatitis, Dr. Strowd noted.

“The study results give providers important practical information,” added Dr. Strowd, who also was not involved with the study. “Those of us who care for patients with severe atopic dermatitis need to know how patients with prior biologic exposure will respond as newer agents come to market and the options for biologic use in atopic dermatitis continue to grow.”

The study was sponsored by Pfizer. All study authors have reported relevant financial relationships with, and several authors are employees of, Pfizer, the developer of abrocitinib. Dr. Strowd and Dr. Miller have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

PORTLAND, ORE. – For those who hesitate to prescribe Janus kinase inhibitors for patients with moderate to severe atopic dermatitis (AD) because of the boxed warnings on currently approved agents, it’s time to reconsider, according to Andrew Blauvelt, MD, MBA.

“In dermatology, you need to know about JAK inhibitors, and you need to know how to use them,” Dr. Blauvelt, president of Oregon Medical Research Center, Portland, said at the annual meeting of the Pacific Dermatologic Association. “Making the choice, ‘I’m not going to use those drugs because of safety concerns,’ may be okay in 2022, but we are going to be getting a lot more indications for these drugs. So instead of avoiding JAK inhibitors, I would say try to learn [about] them, understand them, and get your messaging out on safety.”

It’s difficult to imagine a clinician-researcher who has more experience with the use of biologics and JAK inhibitors in AD than Dr. Blauvelt, who has been the international investigator on several important trials of treatments that include dupilumab, tralokinumab, abrocitinib, and upadacitinib for AD such as CHRONOS, ECZTEND, JADE REGIMEN, and HEADS UP. At the meeting, he discussed his clinical approach to selecting systemic agents for AD and shared prescribing tips. He began by noting that the approval of dupilumab for moderate to severe AD in 2017 ushered in a new era of treating the disease systemically.

“When it was approved, experts went right to dupilumab if they could, and avoided the use of cyclosporine or methotrexate,” said Dr. Blauvelt, who is also an elected member of the American Society for Clinical Investigation and the International Eczema Council. “I still think that dupilumab is a great agent to start with. We’ve had a bit of difficulty improving upon it.”

Following dupilumab’s approval, three other systemic options became available for patients with moderate to severe AD: the human IgG4 monoclonal antibody tralokinumab that binds to interleukin-13, which is administered subcutaneously; and, more recently, the oral JAK inhibitors abrocitinib and upadacitinib, approved in January for moderate to severe AD.

“I’m a big fan of JAK inhibitors because I think they offer things that biologic and topical therapies can’t offer,” Dr. Blauvelt said. “Patients like the pills versus shots. They also like the speed; JAK inhibitors work faster than dupilumab and tralokinumab. So, if you have a patient with bad AD who wants to get better quickly, that would be a reason to choose a JAK inhibitor over a biologic if you can.”

When Dr. Blauvelt has asked AD clinical trial participants if they’d rather be treated with a biologic agent or with a JAK inhibitor, about half choose one over the other.

“Patients who shy away from the safety issues would choose the biologic trial while the ones who wanted the fast relief would choose the JAK trial,” he said. “But if you present both options and the patients prefer a pill, I think the JAK inhibitors do better with a rapid control of inflammation as well as pruritus – the latter within 2 days of taking the pills.”

When counseling patients initiating a JAK inhibitor, Dr. Blauvelt mentioned three advantages, compared with biologics: the pill formulation, the rapidity of response in pruritus control, and better efficacy. “The downside is the safety,” he said. “Safety is the elephant in the room for the JAK inhibitors.”

The risks listed in the boxed warning in the labeling for JAK inhibitors include: an increased risk of serious bacterial, fungal, and opportunistic infections such as TB; a higher rate of all-cause mortality, including cardiovascular death; a higher rate of MACE (major adverse cardiovascular events, defined as cardiovascular death, MI, and stroke); the potential for malignancy, including lymphoma; and the potential for thrombosis, including an increased incidence of pulmonary embolism (PE).

“Risk of thrombosis seems to be a class effect for all JAK inhibitors,” Dr. Blauvelt said. “As far as I know, it’s idiosyncratic. For nearly all the DVT [deep vein thrombosis] cases that have been reported, patients had baseline risk factors for DVT and PE, which are obesity, smoking, and use of oral contraceptives.”

Dr. Blauvelt pointed out that the boxed warning related to mortality, malignancies, and MACE stemmed from a long-term trial of the JAK inhibitor tofacitinib in RA patients. “Those patients had to be at least 50 years old, 75% of them were on concomitant methotrexate and/or prednisone, and they had to have at least one cardiac risk factor to get into the trial,” he said.

“I’m not saying those things can’t happen in dermatology patients, but if you look at the safety data of JAK inhibitors in the AD studies and in the alopecia areata studies, we are seeing a few cases of these things here and there, but not major signals,” he said. To date, “they look safer in dermatologic diseases compared to tofacitinib in RA data in older populations.”

He emphasized the importance of discussing each of the risks in the boxed warning with patients who are candidates for JAK inhibitor therapy.

Dr. Blauvelt likened the lab monitoring required for JAK inhibitors to that required for methotrexate. This means ordering at baseline, a CBC with differential, a chem-20, a lipid panel, and a QuantiFERON-TB Gold test. The JAK inhibitor labels do not include information on the frequency of monitoring, “but I have a distinct opinion on this because of my blood test monitoring experience in the trials for many years,” he said.

“I think it’s good to do follow-up testing at 1 month, then every 3 months in the first year. In my experience, the people who drop blood cell counts or increase their lipids tend to do it in the first year.”

After 1 year of treatment, he continued, follow-up testing once every 6 months is reasonable. “If CPK [creatine phosphokinase] goes up, I don’t worry about it; it’s not clinically relevant. There is no recommendation for CPK monitoring, so if you’re getting that on your chem-20, I’d say don’t worry about it.”

Dr. Blauvelt reported that he is an investigator and a scientific adviser for several pharmaceutical companies developing treatments for AD, including companies that are evaluating or marketing JAK inhibitors for AD, including AbbVie, Incyte, and Pfizer, as well as dupilumab’s joint developers Sanofi and Regeneron.

PORTLAND, ORE. – For those who hesitate to prescribe Janus kinase inhibitors for patients with moderate to severe atopic dermatitis (AD) because of the boxed warnings on currently approved agents, it’s time to reconsider, according to Andrew Blauvelt, MD, MBA.

“In dermatology, you need to know about JAK inhibitors, and you need to know how to use them,” Dr. Blauvelt, president of Oregon Medical Research Center, Portland, said at the annual meeting of the Pacific Dermatologic Association. “Making the choice, ‘I’m not going to use those drugs because of safety concerns,’ may be okay in 2022, but we are going to be getting a lot more indications for these drugs. So instead of avoiding JAK inhibitors, I would say try to learn [about] them, understand them, and get your messaging out on safety.”

It’s difficult to imagine a clinician-researcher who has more experience with the use of biologics and JAK inhibitors in AD than Dr. Blauvelt, who has been the international investigator on several important trials of treatments that include dupilumab, tralokinumab, abrocitinib, and upadacitinib for AD such as CHRONOS, ECZTEND, JADE REGIMEN, and HEADS UP. At the meeting, he discussed his clinical approach to selecting systemic agents for AD and shared prescribing tips. He began by noting that the approval of dupilumab for moderate to severe AD in 2017 ushered in a new era of treating the disease systemically.

“When it was approved, experts went right to dupilumab if they could, and avoided the use of cyclosporine or methotrexate,” said Dr. Blauvelt, who is also an elected member of the American Society for Clinical Investigation and the International Eczema Council. “I still think that dupilumab is a great agent to start with. We’ve had a bit of difficulty improving upon it.”

Following dupilumab’s approval, three other systemic options became available for patients with moderate to severe AD: the human IgG4 monoclonal antibody tralokinumab that binds to interleukin-13, which is administered subcutaneously; and, more recently, the oral JAK inhibitors abrocitinib and upadacitinib, approved in January for moderate to severe AD.

“I’m a big fan of JAK inhibitors because I think they offer things that biologic and topical therapies can’t offer,” Dr. Blauvelt said. “Patients like the pills versus shots. They also like the speed; JAK inhibitors work faster than dupilumab and tralokinumab. So, if you have a patient with bad AD who wants to get better quickly, that would be a reason to choose a JAK inhibitor over a biologic if you can.”

When Dr. Blauvelt has asked AD clinical trial participants if they’d rather be treated with a biologic agent or with a JAK inhibitor, about half choose one over the other.

“Patients who shy away from the safety issues would choose the biologic trial while the ones who wanted the fast relief would choose the JAK trial,” he said. “But if you present both options and the patients prefer a pill, I think the JAK inhibitors do better with a rapid control of inflammation as well as pruritus – the latter within 2 days of taking the pills.”

When counseling patients initiating a JAK inhibitor, Dr. Blauvelt mentioned three advantages, compared with biologics: the pill formulation, the rapidity of response in pruritus control, and better efficacy. “The downside is the safety,” he said. “Safety is the elephant in the room for the JAK inhibitors.”

The risks listed in the boxed warning in the labeling for JAK inhibitors include: an increased risk of serious bacterial, fungal, and opportunistic infections such as TB; a higher rate of all-cause mortality, including cardiovascular death; a higher rate of MACE (major adverse cardiovascular events, defined as cardiovascular death, MI, and stroke); the potential for malignancy, including lymphoma; and the potential for thrombosis, including an increased incidence of pulmonary embolism (PE).

“Risk of thrombosis seems to be a class effect for all JAK inhibitors,” Dr. Blauvelt said. “As far as I know, it’s idiosyncratic. For nearly all the DVT [deep vein thrombosis] cases that have been reported, patients had baseline risk factors for DVT and PE, which are obesity, smoking, and use of oral contraceptives.”

Dr. Blauvelt pointed out that the boxed warning related to mortality, malignancies, and MACE stemmed from a long-term trial of the JAK inhibitor tofacitinib in RA patients. “Those patients had to be at least 50 years old, 75% of them were on concomitant methotrexate and/or prednisone, and they had to have at least one cardiac risk factor to get into the trial,” he said.

“I’m not saying those things can’t happen in dermatology patients, but if you look at the safety data of JAK inhibitors in the AD studies and in the alopecia areata studies, we are seeing a few cases of these things here and there, but not major signals,” he said. To date, “they look safer in dermatologic diseases compared to tofacitinib in RA data in older populations.”

He emphasized the importance of discussing each of the risks in the boxed warning with patients who are candidates for JAK inhibitor therapy.

Dr. Blauvelt likened the lab monitoring required for JAK inhibitors to that required for methotrexate. This means ordering at baseline, a CBC with differential, a chem-20, a lipid panel, and a QuantiFERON-TB Gold test. The JAK inhibitor labels do not include information on the frequency of monitoring, “but I have a distinct opinion on this because of my blood test monitoring experience in the trials for many years,” he said.

“I think it’s good to do follow-up testing at 1 month, then every 3 months in the first year. In my experience, the people who drop blood cell counts or increase their lipids tend to do it in the first year.”

After 1 year of treatment, he continued, follow-up testing once every 6 months is reasonable. “If CPK [creatine phosphokinase] goes up, I don’t worry about it; it’s not clinically relevant. There is no recommendation for CPK monitoring, so if you’re getting that on your chem-20, I’d say don’t worry about it.”

Dr. Blauvelt reported that he is an investigator and a scientific adviser for several pharmaceutical companies developing treatments for AD, including companies that are evaluating or marketing JAK inhibitors for AD, including AbbVie, Incyte, and Pfizer, as well as dupilumab’s joint developers Sanofi and Regeneron.

PORTLAND, ORE. – For those who hesitate to prescribe Janus kinase inhibitors for patients with moderate to severe atopic dermatitis (AD) because of the boxed warnings on currently approved agents, it’s time to reconsider, according to Andrew Blauvelt, MD, MBA.

“In dermatology, you need to know about JAK inhibitors, and you need to know how to use them,” Dr. Blauvelt, president of Oregon Medical Research Center, Portland, said at the annual meeting of the Pacific Dermatologic Association. “Making the choice, ‘I’m not going to use those drugs because of safety concerns,’ may be okay in 2022, but we are going to be getting a lot more indications for these drugs. So instead of avoiding JAK inhibitors, I would say try to learn [about] them, understand them, and get your messaging out on safety.”

It’s difficult to imagine a clinician-researcher who has more experience with the use of biologics and JAK inhibitors in AD than Dr. Blauvelt, who has been the international investigator on several important trials of treatments that include dupilumab, tralokinumab, abrocitinib, and upadacitinib for AD such as CHRONOS, ECZTEND, JADE REGIMEN, and HEADS UP. At the meeting, he discussed his clinical approach to selecting systemic agents for AD and shared prescribing tips. He began by noting that the approval of dupilumab for moderate to severe AD in 2017 ushered in a new era of treating the disease systemically.

“When it was approved, experts went right to dupilumab if they could, and avoided the use of cyclosporine or methotrexate,” said Dr. Blauvelt, who is also an elected member of the American Society for Clinical Investigation and the International Eczema Council. “I still think that dupilumab is a great agent to start with. We’ve had a bit of difficulty improving upon it.”

Following dupilumab’s approval, three other systemic options became available for patients with moderate to severe AD: the human IgG4 monoclonal antibody tralokinumab that binds to interleukin-13, which is administered subcutaneously; and, more recently, the oral JAK inhibitors abrocitinib and upadacitinib, approved in January for moderate to severe AD.

“I’m a big fan of JAK inhibitors because I think they offer things that biologic and topical therapies can’t offer,” Dr. Blauvelt said. “Patients like the pills versus shots. They also like the speed; JAK inhibitors work faster than dupilumab and tralokinumab. So, if you have a patient with bad AD who wants to get better quickly, that would be a reason to choose a JAK inhibitor over a biologic if you can.”

When Dr. Blauvelt has asked AD clinical trial participants if they’d rather be treated with a biologic agent or with a JAK inhibitor, about half choose one over the other.

“Patients who shy away from the safety issues would choose the biologic trial while the ones who wanted the fast relief would choose the JAK trial,” he said. “But if you present both options and the patients prefer a pill, I think the JAK inhibitors do better with a rapid control of inflammation as well as pruritus – the latter within 2 days of taking the pills.”

When counseling patients initiating a JAK inhibitor, Dr. Blauvelt mentioned three advantages, compared with biologics: the pill formulation, the rapidity of response in pruritus control, and better efficacy. “The downside is the safety,” he said. “Safety is the elephant in the room for the JAK inhibitors.”

The risks listed in the boxed warning in the labeling for JAK inhibitors include: an increased risk of serious bacterial, fungal, and opportunistic infections such as TB; a higher rate of all-cause mortality, including cardiovascular death; a higher rate of MACE (major adverse cardiovascular events, defined as cardiovascular death, MI, and stroke); the potential for malignancy, including lymphoma; and the potential for thrombosis, including an increased incidence of pulmonary embolism (PE).

“Risk of thrombosis seems to be a class effect for all JAK inhibitors,” Dr. Blauvelt said. “As far as I know, it’s idiosyncratic. For nearly all the DVT [deep vein thrombosis] cases that have been reported, patients had baseline risk factors for DVT and PE, which are obesity, smoking, and use of oral contraceptives.”

Dr. Blauvelt pointed out that the boxed warning related to mortality, malignancies, and MACE stemmed from a long-term trial of the JAK inhibitor tofacitinib in RA patients. “Those patients had to be at least 50 years old, 75% of them were on concomitant methotrexate and/or prednisone, and they had to have at least one cardiac risk factor to get into the trial,” he said.

“I’m not saying those things can’t happen in dermatology patients, but if you look at the safety data of JAK inhibitors in the AD studies and in the alopecia areata studies, we are seeing a few cases of these things here and there, but not major signals,” he said. To date, “they look safer in dermatologic diseases compared to tofacitinib in RA data in older populations.”

He emphasized the importance of discussing each of the risks in the boxed warning with patients who are candidates for JAK inhibitor therapy.

Dr. Blauvelt likened the lab monitoring required for JAK inhibitors to that required for methotrexate. This means ordering at baseline, a CBC with differential, a chem-20, a lipid panel, and a QuantiFERON-TB Gold test. The JAK inhibitor labels do not include information on the frequency of monitoring, “but I have a distinct opinion on this because of my blood test monitoring experience in the trials for many years,” he said.

“I think it’s good to do follow-up testing at 1 month, then every 3 months in the first year. In my experience, the people who drop blood cell counts or increase their lipids tend to do it in the first year.”

After 1 year of treatment, he continued, follow-up testing once every 6 months is reasonable. “If CPK [creatine phosphokinase] goes up, I don’t worry about it; it’s not clinically relevant. There is no recommendation for CPK monitoring, so if you’re getting that on your chem-20, I’d say don’t worry about it.”

Dr. Blauvelt reported that he is an investigator and a scientific adviser for several pharmaceutical companies developing treatments for AD, including companies that are evaluating or marketing JAK inhibitors for AD, including AbbVie, Incyte, and Pfizer, as well as dupilumab’s joint developers Sanofi and Regeneron.

Key clinical point: Childhood maltreatment (CM) is associated with poor physical and mental health outcomes in adults; however, it was not found to be a risk factor for the development of adult atopic dermatitis (AD).

Major finding: Similar proportion of adults with and without AD (20.6% and 21.6%, respectively; P  =  .80) reported experiencing ≥1 type of moderate-to-severe CM, such as emotional, physical, and sexual abuse and emotional and physical neglect. Neither type of CM was associated with the development of AD in adults.

Study details: Findings are from an analysis of a cross-sectional population-based study including 2973 adults, of which 131 were diagnosed with AD.

Disclosures: This study was funded by the Federal Ministry of Education and Research and other sources. Some authors declared receiving honoraria, research funding, consulting fees, or support for attending meetings or travel from several sources.

Source: Piontek K et al. J Childhood maltreatment is not associated with atopic dermatitis in adults: Results from a cross-sectional population-based cohort study. Eur Acad Dermatol Venereol. 2022 (Aug 3). Doi: 10.1111/jdv.18480

Key clinical point: Childhood maltreatment (CM) is associated with poor physical and mental health outcomes in adults; however, it was not found to be a risk factor for the development of adult atopic dermatitis (AD).

Major finding: Similar proportion of adults with and without AD (20.6% and 21.6%, respectively; P  =  .80) reported experiencing ≥1 type of moderate-to-severe CM, such as emotional, physical, and sexual abuse and emotional and physical neglect. Neither type of CM was associated with the development of AD in adults.

Study details: Findings are from an analysis of a cross-sectional population-based study including 2973 adults, of which 131 were diagnosed with AD.

Disclosures: This study was funded by the Federal Ministry of Education and Research and other sources. Some authors declared receiving honoraria, research funding, consulting fees, or support for attending meetings or travel from several sources.

Source: Piontek K et al. J Childhood maltreatment is not associated with atopic dermatitis in adults: Results from a cross-sectional population-based cohort study. Eur Acad Dermatol Venereol. 2022 (Aug 3). Doi: 10.1111/jdv.18480

Key clinical point: Childhood maltreatment (CM) is associated with poor physical and mental health outcomes in adults; however, it was not found to be a risk factor for the development of adult atopic dermatitis (AD).

Major finding: Similar proportion of adults with and without AD (20.6% and 21.6%, respectively; P  =  .80) reported experiencing ≥1 type of moderate-to-severe CM, such as emotional, physical, and sexual abuse and emotional and physical neglect. Neither type of CM was associated with the development of AD in adults.

Study details: Findings are from an analysis of a cross-sectional population-based study including 2973 adults, of which 131 were diagnosed with AD.

Disclosures: This study was funded by the Federal Ministry of Education and Research and other sources. Some authors declared receiving honoraria, research funding, consulting fees, or support for attending meetings or travel from several sources.

Source: Piontek K et al. J Childhood maltreatment is not associated with atopic dermatitis in adults: Results from a cross-sectional population-based cohort study. Eur Acad Dermatol Venereol. 2022 (Aug 3). Doi: 10.1111/jdv.18480

Key clinical point: Maternal exposure to nickel was associated with increased serum interleukin (IL)-2 levels but decreased serum eotaxin-1 levels and was negatively associated with the development of atopic dermatitis (AD) in children aged 3 years.

Major finding: Maternal nickel exposure was associated with increased serum levels of IL-2 (β 16.820; P < .001) but decreased serum levels of eotaxin-1 (β −5.065; P < .01) and was negatively associated with the development of AD (P  =  .024) in children aged 3 years.

Study details: Findings are from the analysis of an ongoing birth cohort study including 140 mother-child pairs.

Disclosures: This work was supported by grants from the Ministry of Science and Technology, Taiwan, and National Health Research Institutes. The authors declared no conflicts of interest.

Source: Ho JC et al. Prenatal exposure to nickel and atopic dermatitis at age 3 years: A birth cohort study with cytokine profiles. J Eur Acad Dermatol Venereol. 2022 (Jul 16). Doi: 10.1111/jdv.18425

Key clinical point: Maternal exposure to nickel was associated with increased serum interleukin (IL)-2 levels but decreased serum eotaxin-1 levels and was negatively associated with the development of atopic dermatitis (AD) in children aged 3 years.

Major finding: Maternal nickel exposure was associated with increased serum levels of IL-2 (β 16.820; P < .001) but decreased serum levels of eotaxin-1 (β −5.065; P < .01) and was negatively associated with the development of AD (P  =  .024) in children aged 3 years.

Study details: Findings are from the analysis of an ongoing birth cohort study including 140 mother-child pairs.

Disclosures: This work was supported by grants from the Ministry of Science and Technology, Taiwan, and National Health Research Institutes. The authors declared no conflicts of interest.

Source: Ho JC et al. Prenatal exposure to nickel and atopic dermatitis at age 3 years: A birth cohort study with cytokine profiles. J Eur Acad Dermatol Venereol. 2022 (Jul 16). Doi: 10.1111/jdv.18425

Key clinical point: Maternal exposure to nickel was associated with increased serum interleukin (IL)-2 levels but decreased serum eotaxin-1 levels and was negatively associated with the development of atopic dermatitis (AD) in children aged 3 years.

Major finding: Maternal nickel exposure was associated with increased serum levels of IL-2 (β 16.820; P < .001) but decreased serum levels of eotaxin-1 (β −5.065; P < .01) and was negatively associated with the development of AD (P  =  .024) in children aged 3 years.

Study details: Findings are from the analysis of an ongoing birth cohort study including 140 mother-child pairs.

Disclosures: This work was supported by grants from the Ministry of Science and Technology, Taiwan, and National Health Research Institutes. The authors declared no conflicts of interest.

Source: Ho JC et al. Prenatal exposure to nickel and atopic dermatitis at age 3 years: A birth cohort study with cytokine profiles. J Eur Acad Dermatol Venereol. 2022 (Jul 16). Doi: 10.1111/jdv.18425

Key clinical point: Interleukin (IL)-13 inhibitors, such as lebrikizumab and tralokinumab, rapidly reduced disease severity and were well tolerated in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: A significantly higher proportion of patients receiving lebrikizumab or tralokinumab vs placebo achieved ≥75% improvement in the Eczema Area and Severity Index as early as week 4 (risk ratio [RR] 2.09; P  =  .006) and ≥4-point improvement in the Pruritus Numerical Rating Scale score (RR 1.59; 95% CI 1.23-2.05). Lebrikizumab/tralokinumab was associated with a higher risk for conjunctivitis than placebo (RR 2.318; P < .001).

Study details: Findings are from a meta-analysis of 7 randomized controlled trials including 2946 adults with moderate-to-severe AD who were randomly assigned to receive lebrikizumab, tralokinumab, or placebo for 12-16 weeks.

Disclosures: This study was supported by the Natural Science Foundation of China and other sources. The authors declared no conflicts of interest.

Source: Zhang Y et al. The efficacy and safety of IL-13 inhibitors in atopic dermatitis: A systematic review and meta-analysis. Front Immunol. 2022;13:923362 (Jul 27). Doi: 10.3389/fimmu.2022.923362

Key clinical point: Interleukin (IL)-13 inhibitors, such as lebrikizumab and tralokinumab, rapidly reduced disease severity and were well tolerated in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: A significantly higher proportion of patients receiving lebrikizumab or tralokinumab vs placebo achieved ≥75% improvement in the Eczema Area and Severity Index as early as week 4 (risk ratio [RR] 2.09; P  =  .006) and ≥4-point improvement in the Pruritus Numerical Rating Scale score (RR 1.59; 95% CI 1.23-2.05). Lebrikizumab/tralokinumab was associated with a higher risk for conjunctivitis than placebo (RR 2.318; P < .001).

Study details: Findings are from a meta-analysis of 7 randomized controlled trials including 2946 adults with moderate-to-severe AD who were randomly assigned to receive lebrikizumab, tralokinumab, or placebo for 12-16 weeks.

Disclosures: This study was supported by the Natural Science Foundation of China and other sources. The authors declared no conflicts of interest.

Source: Zhang Y et al. The efficacy and safety of IL-13 inhibitors in atopic dermatitis: A systematic review and meta-analysis. Front Immunol. 2022;13:923362 (Jul 27). Doi: 10.3389/fimmu.2022.923362

Key clinical point: Interleukin (IL)-13 inhibitors, such as lebrikizumab and tralokinumab, rapidly reduced disease severity and were well tolerated in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: A significantly higher proportion of patients receiving lebrikizumab or tralokinumab vs placebo achieved ≥75% improvement in the Eczema Area and Severity Index as early as week 4 (risk ratio [RR] 2.09; P  =  .006) and ≥4-point improvement in the Pruritus Numerical Rating Scale score (RR 1.59; 95% CI 1.23-2.05). Lebrikizumab/tralokinumab was associated with a higher risk for conjunctivitis than placebo (RR 2.318; P < .001).

Study details: Findings are from a meta-analysis of 7 randomized controlled trials including 2946 adults with moderate-to-severe AD who were randomly assigned to receive lebrikizumab, tralokinumab, or placebo for 12-16 weeks.

Disclosures: This study was supported by the Natural Science Foundation of China and other sources. The authors declared no conflicts of interest.

Source: Zhang Y et al. The efficacy and safety of IL-13 inhibitors in atopic dermatitis: A systematic review and meta-analysis. Front Immunol. 2022;13:923362 (Jul 27). Doi: 10.3389/fimmu.2022.923362

Key clinical point: A 2-week treatment with a test cream (TC) containing a steroid and pseudoceramide rapidly improved skin barrier function compared with a control cream (CC) containing only steroids in patients with mild-to-moderate atopic dermatitis (AD).

Major finding: In the TC group, the mean skin hydration value (48.0; P < .01) and transepidermal water loss (−2.1; P < .05) improved significantly as early as at 1 week after application, with similar improvements observed at 2 weeks; however, no significant improvements were observed in the CC group.

Study details: Findings are from a parallel, double-blind study including 36 patients with mild-to-moderate AD skin symptoms on the inner forearm who were randomly assigned to receive a TC containing 0.15% prednisolone valerate acetate (PVA)+3% synthetic pseudoceramide or a CC containing 0.15% PVA for 2 weeks.

Disclosures: This study was fully funded by Kao Corporation, Japan. The authors declared no conflicts of interest.

Source: Okoshi K et al. Efficacy of pseudo-ceramide-containing steroid lamellar cream in patients with mild to moderate atopic dermatitis: A randomized, double-blind study. Dermatol Ther (Heidelb). 2022;12:1823–1834 (Jul 19). Doi: 10.1007/s13555-022-00766-2

Key clinical point: A 2-week treatment with a test cream (TC) containing a steroid and pseudoceramide rapidly improved skin barrier function compared with a control cream (CC) containing only steroids in patients with mild-to-moderate atopic dermatitis (AD).

Major finding: In the TC group, the mean skin hydration value (48.0; P < .01) and transepidermal water loss (−2.1; P < .05) improved significantly as early as at 1 week after application, with similar improvements observed at 2 weeks; however, no significant improvements were observed in the CC group.

Study details: Findings are from a parallel, double-blind study including 36 patients with mild-to-moderate AD skin symptoms on the inner forearm who were randomly assigned to receive a TC containing 0.15% prednisolone valerate acetate (PVA)+3% synthetic pseudoceramide or a CC containing 0.15% PVA for 2 weeks.

Disclosures: This study was fully funded by Kao Corporation, Japan. The authors declared no conflicts of interest.

Source: Okoshi K et al. Efficacy of pseudo-ceramide-containing steroid lamellar cream in patients with mild to moderate atopic dermatitis: A randomized, double-blind study. Dermatol Ther (Heidelb). 2022;12:1823–1834 (Jul 19). Doi: 10.1007/s13555-022-00766-2

Key clinical point: A 2-week treatment with a test cream (TC) containing a steroid and pseudoceramide rapidly improved skin barrier function compared with a control cream (CC) containing only steroids in patients with mild-to-moderate atopic dermatitis (AD).

Major finding: In the TC group, the mean skin hydration value (48.0; P < .01) and transepidermal water loss (−2.1; P < .05) improved significantly as early as at 1 week after application, with similar improvements observed at 2 weeks; however, no significant improvements were observed in the CC group.

Study details: Findings are from a parallel, double-blind study including 36 patients with mild-to-moderate AD skin symptoms on the inner forearm who were randomly assigned to receive a TC containing 0.15% prednisolone valerate acetate (PVA)+3% synthetic pseudoceramide or a CC containing 0.15% PVA for 2 weeks.

Disclosures: This study was fully funded by Kao Corporation, Japan. The authors declared no conflicts of interest.

Source: Okoshi K et al. Efficacy of pseudo-ceramide-containing steroid lamellar cream in patients with mild to moderate atopic dermatitis: A randomized, double-blind study. Dermatol Ther (Heidelb). 2022;12:1823–1834 (Jul 19). Doi: 10.1007/s13555-022-00766-2

Key clinical point: Dupilumab demonstrated comparable long-term efficacy and safety in patients with moderate-to-severe atopic dermatitis (AD) and other major comorbidities (special population) as well as patients with only AD.

Major finding: Patients with AD and concomitant comorbidities achieved significant improvements in the Eczema Area and Severity Index at weeks 4, 16, and 52 (all P < .0001), with comparable outcomes observed in patients with only AD. Patients with vs without concomitant comorbidities reported injection site reactions (12.0% vs 17.22%) and conjunctivitis (8.0% vs 11.34%) as the main adverse events.

Study details: Findings are from a 52-week retrospective study including 263 adults with moderate-to-severe AD who received dupilumab for 16 weeks, including 25 patients with severe kidney failure, hepatitis B/C, neurological diseases, AIDS, or a history of cancer or organ transplantation who were classified as the special population.

Disclosures: This study did not receive any funding. Some authors declared serving as investigators, speakers, consultants, or advisory board members for several sources.

Source: Patruno C et al. Dupilumab for the treatment of adult atopic dermatitis in special populations. J Dermatolog Treat. 2022 (Jul 19). Doi: 10.1080/09546634.2022.2102121

Key clinical point: Dupilumab demonstrated comparable long-term efficacy and safety in patients with moderate-to-severe atopic dermatitis (AD) and other major comorbidities (special population) as well as patients with only AD.

Major finding: Patients with AD and concomitant comorbidities achieved significant improvements in the Eczema Area and Severity Index at weeks 4, 16, and 52 (all P < .0001), with comparable outcomes observed in patients with only AD. Patients with vs without concomitant comorbidities reported injection site reactions (12.0% vs 17.22%) and conjunctivitis (8.0% vs 11.34%) as the main adverse events.

Study details: Findings are from a 52-week retrospective study including 263 adults with moderate-to-severe AD who received dupilumab for 16 weeks, including 25 patients with severe kidney failure, hepatitis B/C, neurological diseases, AIDS, or a history of cancer or organ transplantation who were classified as the special population.

Disclosures: This study did not receive any funding. Some authors declared serving as investigators, speakers, consultants, or advisory board members for several sources.

Source: Patruno C et al. Dupilumab for the treatment of adult atopic dermatitis in special populations. J Dermatolog Treat. 2022 (Jul 19). Doi: 10.1080/09546634.2022.2102121

Key clinical point: Dupilumab demonstrated comparable long-term efficacy and safety in patients with moderate-to-severe atopic dermatitis (AD) and other major comorbidities (special population) as well as patients with only AD.

Major finding: Patients with AD and concomitant comorbidities achieved significant improvements in the Eczema Area and Severity Index at weeks 4, 16, and 52 (all P < .0001), with comparable outcomes observed in patients with only AD. Patients with vs without concomitant comorbidities reported injection site reactions (12.0% vs 17.22%) and conjunctivitis (8.0% vs 11.34%) as the main adverse events.

Study details: Findings are from a 52-week retrospective study including 263 adults with moderate-to-severe AD who received dupilumab for 16 weeks, including 25 patients with severe kidney failure, hepatitis B/C, neurological diseases, AIDS, or a history of cancer or organ transplantation who were classified as the special population.

Disclosures: This study did not receive any funding. Some authors declared serving as investigators, speakers, consultants, or advisory board members for several sources.

Source: Patruno C et al. Dupilumab for the treatment of adult atopic dermatitis in special populations. J Dermatolog Treat. 2022 (Jul 19). Doi: 10.1080/09546634.2022.2102121

Key clinical point: Dupilumab was effective against pruritus and improved itch and sleep scores in patients with atopic dermatitis (AD).

Major finding: By 36 months, the mean numerical rating scale peak of pruritus (NRSpp) score dropped from 8.6 to 1.7 and the mean NRS sleep disturbance (NRSsd) score dropped from 7 to 0. The Eczema Area and Severity Index and Dermatology Life Quality Index scores were significantly correlated with both NRSpp and NRSsd scores (P < .001).

Study details: Findings are from a retrospective, observational study including 356 patients with AD who received dupilumab.

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

Source: Mastorino L et al. Chronic pruritus in atopic patients treated with dupilumab: Real life response and related parameters in 354 patients. Pharmaceuticals (Basel). 2022;15(7):883 (Jul 17). Doi: 10.3390/ph15070883

Key clinical point: Dupilumab was effective against pruritus and improved itch and sleep scores in patients with atopic dermatitis (AD).

Major finding: By 36 months, the mean numerical rating scale peak of pruritus (NRSpp) score dropped from 8.6 to 1.7 and the mean NRS sleep disturbance (NRSsd) score dropped from 7 to 0. The Eczema Area and Severity Index and Dermatology Life Quality Index scores were significantly correlated with both NRSpp and NRSsd scores (P < .001).

Study details: Findings are from a retrospective, observational study including 356 patients with AD who received dupilumab.

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

Source: Mastorino L et al. Chronic pruritus in atopic patients treated with dupilumab: Real life response and related parameters in 354 patients. Pharmaceuticals (Basel). 2022;15(7):883 (Jul 17). Doi: 10.3390/ph15070883

Key clinical point: Dupilumab was effective against pruritus and improved itch and sleep scores in patients with atopic dermatitis (AD).

Major finding: By 36 months, the mean numerical rating scale peak of pruritus (NRSpp) score dropped from 8.6 to 1.7 and the mean NRS sleep disturbance (NRSsd) score dropped from 7 to 0. The Eczema Area and Severity Index and Dermatology Life Quality Index scores were significantly correlated with both NRSpp and NRSsd scores (P < .001).

Study details: Findings are from a retrospective, observational study including 356 patients with AD who received dupilumab.

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

Source: Mastorino L et al. Chronic pruritus in atopic patients treated with dupilumab: Real life response and related parameters in 354 patients. Pharmaceuticals (Basel). 2022;15(7):883 (Jul 17). Doi: 10.3390/ph15070883

Key clinical point: Adults with moderate-to-severe atopic dermatitis (AD) who continued tralokinumab and topical corticosteroids (TCS) as needed showed progressive and sustained improvement in disease extent and severity and quality-of-life over 32 weeks.

Major finding: Longer use of tralokinumab was associated with a higher proportion of patients achieving ≥75% improvement in the Eczema Area and Severity Index (week 16: 56%; week 32: 70.2%) and sustained improvement in the Dermatology Life Quality Index scores (week 16: 65.4%; week 32: 66.8%).

Study details: This post hoc analysis of the phase 3 ECZTRA 3 trial included 380 patients with moderate-to-severe AD who were randomized to receive tralokinumab or placebo every 2 weeks, both with TCS as needed, for 16 weeks followed by tralokinumab every 2-4 weeks with TCS until week 32 after re-randomization.

Disclosures: The ECZTRA 3 trial was sponsored by LEO Pharma A/S. Two authors declared being employees and owning stocks in LEO Pharma. The other authors reported ties with several sources, including LEO Pharma.

Source: Silverberg JI et al. Tralokinumab plus topical corticosteroids as needed provides progressive and sustained efficacy in adults with moderate-to-severe atopic dermatitis over a 32-week period: An ECZTRA 3 post hoc analysis. Am J Clin Dermatol. 2022;23:547–559 (Jul 20). Doi: 10.1007/s40257-022-00702-2

Key clinical point: Adults with moderate-to-severe atopic dermatitis (AD) who continued tralokinumab and topical corticosteroids (TCS) as needed showed progressive and sustained improvement in disease extent and severity and quality-of-life over 32 weeks.

Major finding: Longer use of tralokinumab was associated with a higher proportion of patients achieving ≥75% improvement in the Eczema Area and Severity Index (week 16: 56%; week 32: 70.2%) and sustained improvement in the Dermatology Life Quality Index scores (week 16: 65.4%; week 32: 66.8%).

Study details: This post hoc analysis of the phase 3 ECZTRA 3 trial included 380 patients with moderate-to-severe AD who were randomized to receive tralokinumab or placebo every 2 weeks, both with TCS as needed, for 16 weeks followed by tralokinumab every 2-4 weeks with TCS until week 32 after re-randomization.

Disclosures: The ECZTRA 3 trial was sponsored by LEO Pharma A/S. Two authors declared being employees and owning stocks in LEO Pharma. The other authors reported ties with several sources, including LEO Pharma.

Source: Silverberg JI et al. Tralokinumab plus topical corticosteroids as needed provides progressive and sustained efficacy in adults with moderate-to-severe atopic dermatitis over a 32-week period: An ECZTRA 3 post hoc analysis. Am J Clin Dermatol. 2022;23:547–559 (Jul 20). Doi: 10.1007/s40257-022-00702-2

Key clinical point: Adults with moderate-to-severe atopic dermatitis (AD) who continued tralokinumab and topical corticosteroids (TCS) as needed showed progressive and sustained improvement in disease extent and severity and quality-of-life over 32 weeks.

Major finding: Longer use of tralokinumab was associated with a higher proportion of patients achieving ≥75% improvement in the Eczema Area and Severity Index (week 16: 56%; week 32: 70.2%) and sustained improvement in the Dermatology Life Quality Index scores (week 16: 65.4%; week 32: 66.8%).

Study details: This post hoc analysis of the phase 3 ECZTRA 3 trial included 380 patients with moderate-to-severe AD who were randomized to receive tralokinumab or placebo every 2 weeks, both with TCS as needed, for 16 weeks followed by tralokinumab every 2-4 weeks with TCS until week 32 after re-randomization.

Disclosures: The ECZTRA 3 trial was sponsored by LEO Pharma A/S. Two authors declared being employees and owning stocks in LEO Pharma. The other authors reported ties with several sources, including LEO Pharma.

Source: Silverberg JI et al. Tralokinumab plus topical corticosteroids as needed provides progressive and sustained efficacy in adults with moderate-to-severe atopic dermatitis over a 32-week period: An ECZTRA 3 post hoc analysis. Am J Clin Dermatol. 2022;23:547–559 (Jul 20). Doi: 10.1007/s40257-022-00702-2

Key clinical point: A patient-centered dose reduction after 52 weeks of dupilumab therapy helped maintain low disease activity in a subgroup of patients with persistently controlled atopic dermatitis (AD).

Major finding: After ≥3 months of dupilumab dose reduction, >80% and 93.3% of patients receiving dupilumab every 4 weeks (Q4W) and every 6-8 weeks (Q6W/Q8W) maintained an Eczema Area and Severity Index score of ≤7, respectively.

Study details: Findings are from an observational cohort study including 90 adult patients with AD from the BioDay registry who were treated with dupilumab every 2 weeks (Q2W) for 52 weeks, after which the dosing interval was prolonged to Q4W (n = 60) and subsequently to Q6W/Q8W (n = 30) in patients with controlled disease.

Disclosures: The BioDay registry was sponsored by Sanofi Genzyme. Some authors declared receiving research funding or grants from or serving as advisors, consultants, speakers, investigators, or advisory board members for several sources, including Sanofi Genzyme.

Source: Spekhorst LS et al. Patient-centered dupilumab dosing regimen leads to successful dose reduction in persistently controlled atopic dermatitis. Allergy. 2022 (Jul 15). Doi: 10.1111/all.15439 

Key clinical point: A patient-centered dose reduction after 52 weeks of dupilumab therapy helped maintain low disease activity in a subgroup of patients with persistently controlled atopic dermatitis (AD).

Major finding: After ≥3 months of dupilumab dose reduction, >80% and 93.3% of patients receiving dupilumab every 4 weeks (Q4W) and every 6-8 weeks (Q6W/Q8W) maintained an Eczema Area and Severity Index score of ≤7, respectively.

Study details: Findings are from an observational cohort study including 90 adult patients with AD from the BioDay registry who were treated with dupilumab every 2 weeks (Q2W) for 52 weeks, after which the dosing interval was prolonged to Q4W (n = 60) and subsequently to Q6W/Q8W (n = 30) in patients with controlled disease.

Disclosures: The BioDay registry was sponsored by Sanofi Genzyme. Some authors declared receiving research funding or grants from or serving as advisors, consultants, speakers, investigators, or advisory board members for several sources, including Sanofi Genzyme.

Source: Spekhorst LS et al. Patient-centered dupilumab dosing regimen leads to successful dose reduction in persistently controlled atopic dermatitis. Allergy. 2022 (Jul 15). Doi: 10.1111/all.15439 

Key clinical point: A patient-centered dose reduction after 52 weeks of dupilumab therapy helped maintain low disease activity in a subgroup of patients with persistently controlled atopic dermatitis (AD).

Major finding: After ≥3 months of dupilumab dose reduction, >80% and 93.3% of patients receiving dupilumab every 4 weeks (Q4W) and every 6-8 weeks (Q6W/Q8W) maintained an Eczema Area and Severity Index score of ≤7, respectively.

Study details: Findings are from an observational cohort study including 90 adult patients with AD from the BioDay registry who were treated with dupilumab every 2 weeks (Q2W) for 52 weeks, after which the dosing interval was prolonged to Q4W (n = 60) and subsequently to Q6W/Q8W (n = 30) in patients with controlled disease.

Disclosures: The BioDay registry was sponsored by Sanofi Genzyme. Some authors declared receiving research funding or grants from or serving as advisors, consultants, speakers, investigators, or advisory board members for several sources, including Sanofi Genzyme.

Source: Spekhorst LS et al. Patient-centered dupilumab dosing regimen leads to successful dose reduction in persistently controlled atopic dermatitis. Allergy. 2022 (Jul 15). Doi: 10.1111/all.15439