Psoriasis

The Food and Drug Administration (FDA) has approved spesolimab-sbzo, an interleukin (IL)-36 receptor antagonist, for the treatment of generalized pustular psoriasis (GPP) in adults and in pediatric patients aged ≥ 12 years who weigh ≥ 40 kg, according to an announcement from the manufacturer. 

This is an expanded indication for spesolimab-sbzo, first approved in September 2022 for treating GPP flares. Developed by Boehringer Ingelheim and marketed under the name Spevigo, the product is an injectable antibody that blocks the IL-36 receptor, a key part of the pathway shown to be involved in the cause of GPP, which is rare and is a potentially-life-threatening disease.

According to a press release from the company, the FDA’s approval of the expanded indication was based on the results of a 48-week clinical trial of 123 patients (Effisayil 2), which showed that individuals who received spesolimab experienced a significant 84% reduction in GPP flares compared with those who received placebo. Among 30 study participants who received a high treatment dose, no flares were observed after week 4. Among all patients who received spesolimab-sbzo, treatment was associated with an increased incidence (defined as ≥ 9 cases per 100 patient-years) of injection site reactions, urinary tract infections, arthralgia, and pruritus compared with placebo. 

Spesolimab-sbzo is currently available in 48 countries, according to the Boehringer Ingelheim release, which states that the approval makes it the first targeted therapy that is available for the acute and chronic treatment of patients with GPP.

A version of this article appeared on Medscape.com.

The Food and Drug Administration (FDA) has approved spesolimab-sbzo, an interleukin (IL)-36 receptor antagonist, for the treatment of generalized pustular psoriasis (GPP) in adults and in pediatric patients aged ≥ 12 years who weigh ≥ 40 kg, according to an announcement from the manufacturer. 

This is an expanded indication for spesolimab-sbzo, first approved in September 2022 for treating GPP flares. Developed by Boehringer Ingelheim and marketed under the name Spevigo, the product is an injectable antibody that blocks the IL-36 receptor, a key part of the pathway shown to be involved in the cause of GPP, which is rare and is a potentially-life-threatening disease.

According to a press release from the company, the FDA’s approval of the expanded indication was based on the results of a 48-week clinical trial of 123 patients (Effisayil 2), which showed that individuals who received spesolimab experienced a significant 84% reduction in GPP flares compared with those who received placebo. Among 30 study participants who received a high treatment dose, no flares were observed after week 4. Among all patients who received spesolimab-sbzo, treatment was associated with an increased incidence (defined as ≥ 9 cases per 100 patient-years) of injection site reactions, urinary tract infections, arthralgia, and pruritus compared with placebo. 

Spesolimab-sbzo is currently available in 48 countries, according to the Boehringer Ingelheim release, which states that the approval makes it the first targeted therapy that is available for the acute and chronic treatment of patients with GPP.

A version of this article appeared on Medscape.com.

The Food and Drug Administration (FDA) has approved spesolimab-sbzo, an interleukin (IL)-36 receptor antagonist, for the treatment of generalized pustular psoriasis (GPP) in adults and in pediatric patients aged ≥ 12 years who weigh ≥ 40 kg, according to an announcement from the manufacturer. 

This is an expanded indication for spesolimab-sbzo, first approved in September 2022 for treating GPP flares. Developed by Boehringer Ingelheim and marketed under the name Spevigo, the product is an injectable antibody that blocks the IL-36 receptor, a key part of the pathway shown to be involved in the cause of GPP, which is rare and is a potentially-life-threatening disease.

According to a press release from the company, the FDA’s approval of the expanded indication was based on the results of a 48-week clinical trial of 123 patients (Effisayil 2), which showed that individuals who received spesolimab experienced a significant 84% reduction in GPP flares compared with those who received placebo. Among 30 study participants who received a high treatment dose, no flares were observed after week 4. Among all patients who received spesolimab-sbzo, treatment was associated with an increased incidence (defined as ≥ 9 cases per 100 patient-years) of injection site reactions, urinary tract infections, arthralgia, and pruritus compared with placebo. 

Spesolimab-sbzo is currently available in 48 countries, according to the Boehringer Ingelheim release, which states that the approval makes it the first targeted therapy that is available for the acute and chronic treatment of patients with GPP.

A version of this article appeared on Medscape.com.

SAN DIEGO — Home-based phototherapy is non-inferior to office-based phototherapy for the treatment of plaque and guttate psoriasis across all skin types and was associated with improved Physician’s Global Assessment (PGA) and Dermatology Life Quality Index (DLQI) scores, results from a pragmatic, multicenter study showed.

“In 2024, we have a lot of ways to treat moderate-to-severe psoriasis, and phototherapy remains relevant,” lead investigator Joel M. Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania in Philadelphia, told attendees of a late-breaking abstract session at the annual meeting of the American Academy of Dermatology. 

Courtesy Dr. Gelfand

“Office phototherapy is 10 to 100 times less expensive than biologics for psoriasis, and in head-to-head trials, it’s about as effective as adalimumab and achieves better patient-reported outcomes. It may have some cardiovascular benefits by lowering IL-6 and improving HDL-P,” he said. “And, compared to secukinumab, it has no risk of infection.”

Although phototherapy is a preferred as a treatment by patients with psoriasis, he continued, inconvenience of traveling to a clinician’s office for the treatment and lack of coverage by health insurance plans remain major barriers to this option. According to Dr. Gelfand, office-based phototherapy is not available in 90% of counties in the United States, “and a lack of US data has resulted in many insurance companies not covering home phototherapy. As a result, many providers are uncertain about prescribing it.”
 

LITE Study Data

In 2019, Dr. Gelfand and colleagues Light Treatment Effectiveness (LITE) study, a patient-centered study that tested the hypothesis that narrowband UVB phototherapy of psoriasis at home is non-inferior to office treatment, based on outcomes that matter to patients, clinicians, and payers. The co-primary outcomes were a PGA score of 0/1 (clear, almost clear) and a DLQI score of 5 or less (small, no effect on health-related quality of life).

Dr. Gelfand and colleagues at 42 sites in the United States enrolled 783 patients aged 12 years and older who had plaque or guttate psoriasis and were candidates for phototherapy at home or in an office setting. New or established patients to the practices were accepted into the trial, while those treated with phototherapy within 14 days before the baseline visit were not. These entry criteria “are highly pragmatic and reflect routine clinical practice,” he said.

The researchers evenly stratified patients by skin types I and II, III and IV, and V and VI. They collected data from medical records or from an app on the patient’s cell phone, which captured the DLQI data. Study participants were randomly assigned 1:1 to office- or home-based phototherapy for 12 weeks at doses recommended in the 2019 AAD-National Psoriasis Foundation guidelines. This was followed by a 12-week observation period, which ended at 24 weeks. 

At baseline, the mean DLQI score of patients was 12.2, the mean PGA score was 3, and their mean body surface area affected was 12.5%. “These patients had pretty severe disease, long-standing disease, and about 12% were on biologics or nonbiologic systemic therapy during the study,” said Dr. Gelfand, also the director of the Psoriasis and Phototherapy Treatment Center at Penn. In addition, he said, “the average round-trip to receive phototherapy in the office was about 60 minutes.”
 

An Improvement in Health Equity

Following treatment at 12 weeks, 25.6% of patients in the office-based phototherapy group achieved a PGA of 0/1, compared with 32.8% of patients in the home-based phototherapy group (P >.0001 for non-inferiority). Similarly, 33.6% of patients in the office-based phototherapy group achieved a score of 5 or less on the DLQI, compared with 52.4% of patients in the home-based phototherapy group (P >.0001 for non-inferiority).

In subgroup analyses, patients with darkly pigmented skin did especially well on home phototherapy relative to office treatment. “This finding is an example of how the LITE study was specifically designed to improve health equity through an intentionally inclusive approach,” Dr. Gelfand said. Perhaps not surprisingly, patients in the home-based phototherapy arm were more adherent to treatment compared with those in the office-based arm (a mean of 26.8 sessions during the study period, compared with a mean of 17.9, respectively; P < .0001). “They also had higher cumulative doses of phototherapy and therefore higher episodes of treatments with erythema,” he noted.

Among patients who reported “itchy, sore, painful, or stinging” skin in the previous week, 63% characterized the degree of discomfort as “not at all or a little,” while 28% said “a lot,” and 9% said “very much.” No patients withdrew or stopped phototherapy during the trial because of treatment-related side effects, “so it’s very well tolerated,” Dr. Gelfand said.

“If a patient never had phototherapy before, they did just as well at home as they did in the office. This suggests that there’s no reason to insist that a patient use office-based phototherapy before using home phototherapy.”

The researchers studied the efficacy of narrow-band UVB in patients who had at least two treatments per week for 12 weeks. In this subgroup of patients, 60% achieved clear or almost clear skin and nearly 50% achieved the equivalent of a Psoriasis Area and Severity Index (PASI) 90 score.

“Home phototherapy is clearly non-inferior to office-based phototherapy across all skin types and both primary outcomes, PGA and DLQI, and both have excellent effectiveness and safety in real-world settings,” Dr. Gelfand concluded. “These data support the use of home phototherapy as a first-line treatment option for psoriasis, including those with no prior phototherapy experience.”

LITE Study Described as “Groundbreaking”

One of the session moderators, dermatologist Andrew Blauvelt, MD, MBA, of the Oregon Medical Research Center, Portland, asked about the impact that lockdowns during the early phase of the COVID-19 pandemic had on the trial. “The study shut down for a couple weeks during the initial lockdown, but we got back up and running pretty quickly,” Dr. Gelfand responded. “We didn’t study that specific period of time, but the study was going on well before COVID and well after COVID restrictions were lifted. We’ll have to analyze that period of time you question but I suspect that it’s not driving the results we see.”

Asked to comment, Henry W. Lim, MD, a dermatologist with Henry Ford Health in Detroit, characterized the findings of the study as “groundbreaking, because it looked at a real-life situation in the use of phototherapy at home vs in the office, showing that the home phototherapy is not inferior to office-based phototherapy.”

A version of this article appeared on Medscape.com.

SAN DIEGO — Home-based phototherapy is non-inferior to office-based phototherapy for the treatment of plaque and guttate psoriasis across all skin types and was associated with improved Physician’s Global Assessment (PGA) and Dermatology Life Quality Index (DLQI) scores, results from a pragmatic, multicenter study showed.

“In 2024, we have a lot of ways to treat moderate-to-severe psoriasis, and phototherapy remains relevant,” lead investigator Joel M. Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania in Philadelphia, told attendees of a late-breaking abstract session at the annual meeting of the American Academy of Dermatology. 

Courtesy Dr. Gelfand

“Office phototherapy is 10 to 100 times less expensive than biologics for psoriasis, and in head-to-head trials, it’s about as effective as adalimumab and achieves better patient-reported outcomes. It may have some cardiovascular benefits by lowering IL-6 and improving HDL-P,” he said. “And, compared to secukinumab, it has no risk of infection.”

Although phototherapy is a preferred as a treatment by patients with psoriasis, he continued, inconvenience of traveling to a clinician’s office for the treatment and lack of coverage by health insurance plans remain major barriers to this option. According to Dr. Gelfand, office-based phototherapy is not available in 90% of counties in the United States, “and a lack of US data has resulted in many insurance companies not covering home phototherapy. As a result, many providers are uncertain about prescribing it.”
 

LITE Study Data

In 2019, Dr. Gelfand and colleagues Light Treatment Effectiveness (LITE) study, a patient-centered study that tested the hypothesis that narrowband UVB phototherapy of psoriasis at home is non-inferior to office treatment, based on outcomes that matter to patients, clinicians, and payers. The co-primary outcomes were a PGA score of 0/1 (clear, almost clear) and a DLQI score of 5 or less (small, no effect on health-related quality of life).

Dr. Gelfand and colleagues at 42 sites in the United States enrolled 783 patients aged 12 years and older who had plaque or guttate psoriasis and were candidates for phototherapy at home or in an office setting. New or established patients to the practices were accepted into the trial, while those treated with phototherapy within 14 days before the baseline visit were not. These entry criteria “are highly pragmatic and reflect routine clinical practice,” he said.

The researchers evenly stratified patients by skin types I and II, III and IV, and V and VI. They collected data from medical records or from an app on the patient’s cell phone, which captured the DLQI data. Study participants were randomly assigned 1:1 to office- or home-based phototherapy for 12 weeks at doses recommended in the 2019 AAD-National Psoriasis Foundation guidelines. This was followed by a 12-week observation period, which ended at 24 weeks. 

At baseline, the mean DLQI score of patients was 12.2, the mean PGA score was 3, and their mean body surface area affected was 12.5%. “These patients had pretty severe disease, long-standing disease, and about 12% were on biologics or nonbiologic systemic therapy during the study,” said Dr. Gelfand, also the director of the Psoriasis and Phototherapy Treatment Center at Penn. In addition, he said, “the average round-trip to receive phototherapy in the office was about 60 minutes.”
 

An Improvement in Health Equity

Following treatment at 12 weeks, 25.6% of patients in the office-based phototherapy group achieved a PGA of 0/1, compared with 32.8% of patients in the home-based phototherapy group (P >.0001 for non-inferiority). Similarly, 33.6% of patients in the office-based phototherapy group achieved a score of 5 or less on the DLQI, compared with 52.4% of patients in the home-based phototherapy group (P >.0001 for non-inferiority).

In subgroup analyses, patients with darkly pigmented skin did especially well on home phototherapy relative to office treatment. “This finding is an example of how the LITE study was specifically designed to improve health equity through an intentionally inclusive approach,” Dr. Gelfand said. Perhaps not surprisingly, patients in the home-based phototherapy arm were more adherent to treatment compared with those in the office-based arm (a mean of 26.8 sessions during the study period, compared with a mean of 17.9, respectively; P < .0001). “They also had higher cumulative doses of phototherapy and therefore higher episodes of treatments with erythema,” he noted.

Among patients who reported “itchy, sore, painful, or stinging” skin in the previous week, 63% characterized the degree of discomfort as “not at all or a little,” while 28% said “a lot,” and 9% said “very much.” No patients withdrew or stopped phototherapy during the trial because of treatment-related side effects, “so it’s very well tolerated,” Dr. Gelfand said.

“If a patient never had phototherapy before, they did just as well at home as they did in the office. This suggests that there’s no reason to insist that a patient use office-based phototherapy before using home phototherapy.”

The researchers studied the efficacy of narrow-band UVB in patients who had at least two treatments per week for 12 weeks. In this subgroup of patients, 60% achieved clear or almost clear skin and nearly 50% achieved the equivalent of a Psoriasis Area and Severity Index (PASI) 90 score.

“Home phototherapy is clearly non-inferior to office-based phototherapy across all skin types and both primary outcomes, PGA and DLQI, and both have excellent effectiveness and safety in real-world settings,” Dr. Gelfand concluded. “These data support the use of home phototherapy as a first-line treatment option for psoriasis, including those with no prior phototherapy experience.”

LITE Study Described as “Groundbreaking”

One of the session moderators, dermatologist Andrew Blauvelt, MD, MBA, of the Oregon Medical Research Center, Portland, asked about the impact that lockdowns during the early phase of the COVID-19 pandemic had on the trial. “The study shut down for a couple weeks during the initial lockdown, but we got back up and running pretty quickly,” Dr. Gelfand responded. “We didn’t study that specific period of time, but the study was going on well before COVID and well after COVID restrictions were lifted. We’ll have to analyze that period of time you question but I suspect that it’s not driving the results we see.”

Asked to comment, Henry W. Lim, MD, a dermatologist with Henry Ford Health in Detroit, characterized the findings of the study as “groundbreaking, because it looked at a real-life situation in the use of phototherapy at home vs in the office, showing that the home phototherapy is not inferior to office-based phototherapy.”

A version of this article appeared on Medscape.com.

SAN DIEGO — Home-based phototherapy is non-inferior to office-based phototherapy for the treatment of plaque and guttate psoriasis across all skin types and was associated with improved Physician’s Global Assessment (PGA) and Dermatology Life Quality Index (DLQI) scores, results from a pragmatic, multicenter study showed.

“In 2024, we have a lot of ways to treat moderate-to-severe psoriasis, and phototherapy remains relevant,” lead investigator Joel M. Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania in Philadelphia, told attendees of a late-breaking abstract session at the annual meeting of the American Academy of Dermatology. 

Courtesy Dr. Gelfand

“Office phototherapy is 10 to 100 times less expensive than biologics for psoriasis, and in head-to-head trials, it’s about as effective as adalimumab and achieves better patient-reported outcomes. It may have some cardiovascular benefits by lowering IL-6 and improving HDL-P,” he said. “And, compared to secukinumab, it has no risk of infection.”

Although phototherapy is a preferred as a treatment by patients with psoriasis, he continued, inconvenience of traveling to a clinician’s office for the treatment and lack of coverage by health insurance plans remain major barriers to this option. According to Dr. Gelfand, office-based phototherapy is not available in 90% of counties in the United States, “and a lack of US data has resulted in many insurance companies not covering home phototherapy. As a result, many providers are uncertain about prescribing it.”
 

LITE Study Data

In 2019, Dr. Gelfand and colleagues Light Treatment Effectiveness (LITE) study, a patient-centered study that tested the hypothesis that narrowband UVB phototherapy of psoriasis at home is non-inferior to office treatment, based on outcomes that matter to patients, clinicians, and payers. The co-primary outcomes were a PGA score of 0/1 (clear, almost clear) and a DLQI score of 5 or less (small, no effect on health-related quality of life).

Dr. Gelfand and colleagues at 42 sites in the United States enrolled 783 patients aged 12 years and older who had plaque or guttate psoriasis and were candidates for phototherapy at home or in an office setting. New or established patients to the practices were accepted into the trial, while those treated with phototherapy within 14 days before the baseline visit were not. These entry criteria “are highly pragmatic and reflect routine clinical practice,” he said.

The researchers evenly stratified patients by skin types I and II, III and IV, and V and VI. They collected data from medical records or from an app on the patient’s cell phone, which captured the DLQI data. Study participants were randomly assigned 1:1 to office- or home-based phototherapy for 12 weeks at doses recommended in the 2019 AAD-National Psoriasis Foundation guidelines. This was followed by a 12-week observation period, which ended at 24 weeks. 

At baseline, the mean DLQI score of patients was 12.2, the mean PGA score was 3, and their mean body surface area affected was 12.5%. “These patients had pretty severe disease, long-standing disease, and about 12% were on biologics or nonbiologic systemic therapy during the study,” said Dr. Gelfand, also the director of the Psoriasis and Phototherapy Treatment Center at Penn. In addition, he said, “the average round-trip to receive phototherapy in the office was about 60 minutes.”
 

An Improvement in Health Equity

Following treatment at 12 weeks, 25.6% of patients in the office-based phototherapy group achieved a PGA of 0/1, compared with 32.8% of patients in the home-based phototherapy group (P >.0001 for non-inferiority). Similarly, 33.6% of patients in the office-based phototherapy group achieved a score of 5 or less on the DLQI, compared with 52.4% of patients in the home-based phototherapy group (P >.0001 for non-inferiority).

In subgroup analyses, patients with darkly pigmented skin did especially well on home phototherapy relative to office treatment. “This finding is an example of how the LITE study was specifically designed to improve health equity through an intentionally inclusive approach,” Dr. Gelfand said. Perhaps not surprisingly, patients in the home-based phototherapy arm were more adherent to treatment compared with those in the office-based arm (a mean of 26.8 sessions during the study period, compared with a mean of 17.9, respectively; P < .0001). “They also had higher cumulative doses of phototherapy and therefore higher episodes of treatments with erythema,” he noted.

Among patients who reported “itchy, sore, painful, or stinging” skin in the previous week, 63% characterized the degree of discomfort as “not at all or a little,” while 28% said “a lot,” and 9% said “very much.” No patients withdrew or stopped phototherapy during the trial because of treatment-related side effects, “so it’s very well tolerated,” Dr. Gelfand said.

“If a patient never had phototherapy before, they did just as well at home as they did in the office. This suggests that there’s no reason to insist that a patient use office-based phototherapy before using home phototherapy.”

The researchers studied the efficacy of narrow-band UVB in patients who had at least two treatments per week for 12 weeks. In this subgroup of patients, 60% achieved clear or almost clear skin and nearly 50% achieved the equivalent of a Psoriasis Area and Severity Index (PASI) 90 score.

“Home phototherapy is clearly non-inferior to office-based phototherapy across all skin types and both primary outcomes, PGA and DLQI, and both have excellent effectiveness and safety in real-world settings,” Dr. Gelfand concluded. “These data support the use of home phototherapy as a first-line treatment option for psoriasis, including those with no prior phototherapy experience.”

LITE Study Described as “Groundbreaking”

One of the session moderators, dermatologist Andrew Blauvelt, MD, MBA, of the Oregon Medical Research Center, Portland, asked about the impact that lockdowns during the early phase of the COVID-19 pandemic had on the trial. “The study shut down for a couple weeks during the initial lockdown, but we got back up and running pretty quickly,” Dr. Gelfand responded. “We didn’t study that specific period of time, but the study was going on well before COVID and well after COVID restrictions were lifted. We’ll have to analyze that period of time you question but I suspect that it’s not driving the results we see.”

Asked to comment, Henry W. Lim, MD, a dermatologist with Henry Ford Health in Detroit, characterized the findings of the study as “groundbreaking, because it looked at a real-life situation in the use of phototherapy at home vs in the office, showing that the home phototherapy is not inferior to office-based phototherapy.”

A version of this article appeared on Medscape.com.

TOPLINE: 

The results of a recent study suggest that biologics and small molecule inhibitors (SMIs) do not impair the protective effect of COVID-19 vaccine against hospitalization in patients with psoriasis and hidradenitis suppurativa (HS).

METHODOLOGY:

• It remains unknown whether immunomodulatory therapies impair COVID-19 vaccine efficacy and increase hospitalization rates linked to COVID-19 in patients with inflammatory skin conditions such as psoriasis or HS.
• Researchers conducted a cross-sectional study using data from the Epic Cosmos database from January 2020 to October 2023, identifying 30,845 patients with psoriasis or HS.
• Overall, 22,293 patients with documented completion of their primary COVID-19 vaccine series were included in the analysis.
• Of the vaccinated patients, they compared 7046 patients with psoriasis on SMIs and 2033 with psoriasis or HS on biologics with 13,214 patients who did not receive biologics or SMIs.
• The primary outcome was the COVID-19 hospitalization rate.
• Treatment with biologics did not increase COVID-19-related hospitalization rates in vaccinated patients with psoriasis or HS (hospitalization rate, 6.0% for both those taking and those not taking a biologic; P > .99).
• Similarly, hospitalization rates did not significantly differ between vaccinated patients who received SMIs vs those who did not (7.1% vs 6.0%; P = .0596).

IN PRACTICE:

These findings “encourage dermatologists to continue treating [psoriasis]/HS confidently despite the ongoing COVID-19 pandemic,” the authors concluded.

SOURCE:

The study led by Bella R. Lee from Ohio State University Wexner Medical Center, Columbus, was published online on March 13, 2024, in the Journal of the American Academy of Dermatology. 

LIMITATIONS:

Multivariable adjustments could not be performed in this study due to unavailability of individual-level data, and hospital admissions that occurred outside the Epic system were not captured.

DISCLOSURES:

The study did not receive any funding. All authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE: 

The results of a recent study suggest that biologics and small molecule inhibitors (SMIs) do not impair the protective effect of COVID-19 vaccine against hospitalization in patients with psoriasis and hidradenitis suppurativa (HS).

METHODOLOGY:

• It remains unknown whether immunomodulatory therapies impair COVID-19 vaccine efficacy and increase hospitalization rates linked to COVID-19 in patients with inflammatory skin conditions such as psoriasis or HS.
• Researchers conducted a cross-sectional study using data from the Epic Cosmos database from January 2020 to October 2023, identifying 30,845 patients with psoriasis or HS.
• Overall, 22,293 patients with documented completion of their primary COVID-19 vaccine series were included in the analysis.
• Of the vaccinated patients, they compared 7046 patients with psoriasis on SMIs and 2033 with psoriasis or HS on biologics with 13,214 patients who did not receive biologics or SMIs.
• The primary outcome was the COVID-19 hospitalization rate.
• Treatment with biologics did not increase COVID-19-related hospitalization rates in vaccinated patients with psoriasis or HS (hospitalization rate, 6.0% for both those taking and those not taking a biologic; P > .99).
• Similarly, hospitalization rates did not significantly differ between vaccinated patients who received SMIs vs those who did not (7.1% vs 6.0%; P = .0596).

IN PRACTICE:

These findings “encourage dermatologists to continue treating [psoriasis]/HS confidently despite the ongoing COVID-19 pandemic,” the authors concluded.

SOURCE:

The study led by Bella R. Lee from Ohio State University Wexner Medical Center, Columbus, was published online on March 13, 2024, in the Journal of the American Academy of Dermatology. 

LIMITATIONS:

Multivariable adjustments could not be performed in this study due to unavailability of individual-level data, and hospital admissions that occurred outside the Epic system were not captured.

DISCLOSURES:

The study did not receive any funding. All authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE: 

The results of a recent study suggest that biologics and small molecule inhibitors (SMIs) do not impair the protective effect of COVID-19 vaccine against hospitalization in patients with psoriasis and hidradenitis suppurativa (HS).

METHODOLOGY:

• It remains unknown whether immunomodulatory therapies impair COVID-19 vaccine efficacy and increase hospitalization rates linked to COVID-19 in patients with inflammatory skin conditions such as psoriasis or HS.
• Researchers conducted a cross-sectional study using data from the Epic Cosmos database from January 2020 to October 2023, identifying 30,845 patients with psoriasis or HS.
• Overall, 22,293 patients with documented completion of their primary COVID-19 vaccine series were included in the analysis.
• Of the vaccinated patients, they compared 7046 patients with psoriasis on SMIs and 2033 with psoriasis or HS on biologics with 13,214 patients who did not receive biologics or SMIs.
• The primary outcome was the COVID-19 hospitalization rate.
• Treatment with biologics did not increase COVID-19-related hospitalization rates in vaccinated patients with psoriasis or HS (hospitalization rate, 6.0% for both those taking and those not taking a biologic; P > .99).
• Similarly, hospitalization rates did not significantly differ between vaccinated patients who received SMIs vs those who did not (7.1% vs 6.0%; P = .0596).

IN PRACTICE:

These findings “encourage dermatologists to continue treating [psoriasis]/HS confidently despite the ongoing COVID-19 pandemic,” the authors concluded.

SOURCE:

The study led by Bella R. Lee from Ohio State University Wexner Medical Center, Columbus, was published online on March 13, 2024, in the Journal of the American Academy of Dermatology. 

LIMITATIONS:

Multivariable adjustments could not be performed in this study due to unavailability of individual-level data, and hospital admissions that occurred outside the Epic system were not captured.

DISCLOSURES:

The study did not receive any funding. All authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

SAN DIEGO — In published trials, both an interleukin (IL)–17 inhibitor and an IL-23 inhibitor achieved impressive rates of clear or almost clear responses in patients with moderate to severe plaque psoriasis, but late-breaker data presented at the annual meeting of the American Academy of Dermatology show that these types of responses are sustained for as long as patients have remained on therapy.

Of the two, the longer follow up is with the IL-17 inhibitor bimekizumab (Bimzelx). In a 4-year open-label extension study, the Psoriasis Area and Severity Index (PASI) 90 rate was approximately 85% in treated patients, according to Mark Lebwohl, MD, professor and chairman emeritus of the Department of Dermatology, Icahn School of Medicine at Mount Sinai in New York City

A PASI 90 score signifies that 90% of skin surface area is cleared. The proportion of patients who achieved a PASI 100 score, signifying total clearance, approached 70% at 4 years in the group with the greatest response. PASI 90 and PASI 100 rates at this point were only modestly lower than those reported at the end of the double-blind phase 3 trial when evaluated 3 years earlier. 

Follow-up with a novel oral anti-IL-23 inhibitor JNJ-2113 (JNJ-77242113) was only 52 weeks, far shorter. But again, the response for the most effective dose at the end of this period was essentially unchanged from that at 16 weeks. Among those on the highest and most effective test dose of once-daily 100 mg, the PASI 90 at 1 year was 64.3%, a rate that was essentially unchanged from week 16.

No Apparent Loss of Benefit Over Time

“We can really look at those dose-response curves and see that there is, overall, a maintenance of response,” reported Laura K. Ferris, MD, PhD, professor and director of clinical trials, Department of Dermatology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. In her presentation of the data, she showed similar sustained control for the most effective doses of JNJ-2113 for multiple clinical outcomes, including an investigator’s global assessment (IGA) score of 0 or 1, also signifying clear or near clear skin.

Bimekizumab, a monoclonal antibody that inhibits both IL-17A and IL-17F, is already approved for the treatment of plaque psoriasis. The 52-week BE SURE trial, which provided the 478 patients who entered into the BE BRIGHT open label extension study, was published in The New England Journal of Medicine in July 2021. 

In the 4-year data reported by Dr. Lebwohl, three groups were compared: Those initially randomized to an every-4-week dosing schedule of bimekizumab over the course of the 52-week BE SURE trial; those randomized to an every-4-week bimekizumab schedule who were then subsequently switched to an every-8-week schedule; and those initiated on the TNF-inhibitor adalimumab (Humira) and were then switched at week 24 to every-4-week bimekizumab.

The PASI 90 responses at 52 weeks in these three groups, respectively, were 91.2%, 89.3%, and 95.2%. At 4 years, this almost clear response was observed in 82.4%, 83.2%, and 87.6%, respectively. At 52 weeks, the PASI 100 responses in these three groups, respectively, were 75.3%, 74.2%, and 72.9%. At 4 years, 61.9%, 58.5%, and 69.5% still had complete skin clearance.

Bimekizumab was well tolerated during the randomized trial, reported Dr. Lebwohl. The rates of nasopharyngitis and oral candidiasis, which were observed in approximately 12% and 8%, respectively, of treated patients during the randomized phase remained at about the same level in the long-term follow up. There were no new safety signals, he said.
 

JNJ-2113 Is First Potential Oral IL-23 Inhibitor

JNJ-2113 is a first-in-class oral peptide that binds to the IL-23 receptor, blocking the IL-23 signaling pathway. If approved, it would be the first oral therapy targeting IL-23. The 16-week outcomes of the dose-finding FRONTIER 1 phase 2b trial were published in The New England Journal of Medicine earlier this year. The primary endpoint was PASI 75, achieved by 79% of those on the 100 mg twice daily dose at week 16, vs 9% on placebo, and at 52 weeks, was 76%. 

“The proportion of patients achieving the FRONTIER 1 primary endpoint was maintained from week 16 to the end of week 52 in the extension study,” Dr. Ferris said, but further pointed out that rates of near or complete clearance achieved at week 16 were also essentially unchanged at week 52. This was true of PASI scores and IGA. 

Clearance of psoriatic lesions on the scalp was particularly impressive. By scalp-specific IGA, rates of clear or near clear (0/1) were not just maintained but improved over the course of follow-up, reaching 75.1% at 52 weeks in the highest dose group, she said.

JNJ-2113 was well tolerated in FRONTIER 1 and remained so during long-term follow-up, in the FRONTIER 2 extension study, according to Dr. Ferris. The most common complaints with JNJ-2113, such as nasopharyngitis (18.1% vs 25.7% in placebo), did not appear to differ significantly from placebo and the treatment remained well tolerated over the course of the extended follow-up.

There are limited direct comparisons of different biologics active in the treatment of plaque psoriasis for efficacy and safety, but these data appear to show a depth and durability of benefit for psoriasis that is exceptional, Dr. Lebwohl told this news organization. “The PASI 100 scores achieved by bimekizumab exceed anything we have seen to date,” he said. “And the durability of those exceedingly high scores is remarkable.”

Dr. Lebwohl reports financial relationships with approximately 40 pharmaceutical companies, including UCB Pharma, which developed bimekizumab. Dr. Ferris reports financial relationships with more than 20 pharmaceutical companies, including Janssen, which is developing JNJ-2113. 

A version of this article appeared on Medscape.com.

SAN DIEGO — In published trials, both an interleukin (IL)–17 inhibitor and an IL-23 inhibitor achieved impressive rates of clear or almost clear responses in patients with moderate to severe plaque psoriasis, but late-breaker data presented at the annual meeting of the American Academy of Dermatology show that these types of responses are sustained for as long as patients have remained on therapy.

Of the two, the longer follow up is with the IL-17 inhibitor bimekizumab (Bimzelx). In a 4-year open-label extension study, the Psoriasis Area and Severity Index (PASI) 90 rate was approximately 85% in treated patients, according to Mark Lebwohl, MD, professor and chairman emeritus of the Department of Dermatology, Icahn School of Medicine at Mount Sinai in New York City

A PASI 90 score signifies that 90% of skin surface area is cleared. The proportion of patients who achieved a PASI 100 score, signifying total clearance, approached 70% at 4 years in the group with the greatest response. PASI 90 and PASI 100 rates at this point were only modestly lower than those reported at the end of the double-blind phase 3 trial when evaluated 3 years earlier. 

Follow-up with a novel oral anti-IL-23 inhibitor JNJ-2113 (JNJ-77242113) was only 52 weeks, far shorter. But again, the response for the most effective dose at the end of this period was essentially unchanged from that at 16 weeks. Among those on the highest and most effective test dose of once-daily 100 mg, the PASI 90 at 1 year was 64.3%, a rate that was essentially unchanged from week 16.

No Apparent Loss of Benefit Over Time

“We can really look at those dose-response curves and see that there is, overall, a maintenance of response,” reported Laura K. Ferris, MD, PhD, professor and director of clinical trials, Department of Dermatology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. In her presentation of the data, she showed similar sustained control for the most effective doses of JNJ-2113 for multiple clinical outcomes, including an investigator’s global assessment (IGA) score of 0 or 1, also signifying clear or near clear skin.

Bimekizumab, a monoclonal antibody that inhibits both IL-17A and IL-17F, is already approved for the treatment of plaque psoriasis. The 52-week BE SURE trial, which provided the 478 patients who entered into the BE BRIGHT open label extension study, was published in The New England Journal of Medicine in July 2021. 

In the 4-year data reported by Dr. Lebwohl, three groups were compared: Those initially randomized to an every-4-week dosing schedule of bimekizumab over the course of the 52-week BE SURE trial; those randomized to an every-4-week bimekizumab schedule who were then subsequently switched to an every-8-week schedule; and those initiated on the TNF-inhibitor adalimumab (Humira) and were then switched at week 24 to every-4-week bimekizumab.

The PASI 90 responses at 52 weeks in these three groups, respectively, were 91.2%, 89.3%, and 95.2%. At 4 years, this almost clear response was observed in 82.4%, 83.2%, and 87.6%, respectively. At 52 weeks, the PASI 100 responses in these three groups, respectively, were 75.3%, 74.2%, and 72.9%. At 4 years, 61.9%, 58.5%, and 69.5% still had complete skin clearance.

Bimekizumab was well tolerated during the randomized trial, reported Dr. Lebwohl. The rates of nasopharyngitis and oral candidiasis, which were observed in approximately 12% and 8%, respectively, of treated patients during the randomized phase remained at about the same level in the long-term follow up. There were no new safety signals, he said.
 

JNJ-2113 Is First Potential Oral IL-23 Inhibitor

JNJ-2113 is a first-in-class oral peptide that binds to the IL-23 receptor, blocking the IL-23 signaling pathway. If approved, it would be the first oral therapy targeting IL-23. The 16-week outcomes of the dose-finding FRONTIER 1 phase 2b trial were published in The New England Journal of Medicine earlier this year. The primary endpoint was PASI 75, achieved by 79% of those on the 100 mg twice daily dose at week 16, vs 9% on placebo, and at 52 weeks, was 76%. 

“The proportion of patients achieving the FRONTIER 1 primary endpoint was maintained from week 16 to the end of week 52 in the extension study,” Dr. Ferris said, but further pointed out that rates of near or complete clearance achieved at week 16 were also essentially unchanged at week 52. This was true of PASI scores and IGA. 

Clearance of psoriatic lesions on the scalp was particularly impressive. By scalp-specific IGA, rates of clear or near clear (0/1) were not just maintained but improved over the course of follow-up, reaching 75.1% at 52 weeks in the highest dose group, she said.

JNJ-2113 was well tolerated in FRONTIER 1 and remained so during long-term follow-up, in the FRONTIER 2 extension study, according to Dr. Ferris. The most common complaints with JNJ-2113, such as nasopharyngitis (18.1% vs 25.7% in placebo), did not appear to differ significantly from placebo and the treatment remained well tolerated over the course of the extended follow-up.

There are limited direct comparisons of different biologics active in the treatment of plaque psoriasis for efficacy and safety, but these data appear to show a depth and durability of benefit for psoriasis that is exceptional, Dr. Lebwohl told this news organization. “The PASI 100 scores achieved by bimekizumab exceed anything we have seen to date,” he said. “And the durability of those exceedingly high scores is remarkable.”

Dr. Lebwohl reports financial relationships with approximately 40 pharmaceutical companies, including UCB Pharma, which developed bimekizumab. Dr. Ferris reports financial relationships with more than 20 pharmaceutical companies, including Janssen, which is developing JNJ-2113. 

A version of this article appeared on Medscape.com.

SAN DIEGO — In published trials, both an interleukin (IL)–17 inhibitor and an IL-23 inhibitor achieved impressive rates of clear or almost clear responses in patients with moderate to severe plaque psoriasis, but late-breaker data presented at the annual meeting of the American Academy of Dermatology show that these types of responses are sustained for as long as patients have remained on therapy.

Of the two, the longer follow up is with the IL-17 inhibitor bimekizumab (Bimzelx). In a 4-year open-label extension study, the Psoriasis Area and Severity Index (PASI) 90 rate was approximately 85% in treated patients, according to Mark Lebwohl, MD, professor and chairman emeritus of the Department of Dermatology, Icahn School of Medicine at Mount Sinai in New York City

A PASI 90 score signifies that 90% of skin surface area is cleared. The proportion of patients who achieved a PASI 100 score, signifying total clearance, approached 70% at 4 years in the group with the greatest response. PASI 90 and PASI 100 rates at this point were only modestly lower than those reported at the end of the double-blind phase 3 trial when evaluated 3 years earlier. 

Follow-up with a novel oral anti-IL-23 inhibitor JNJ-2113 (JNJ-77242113) was only 52 weeks, far shorter. But again, the response for the most effective dose at the end of this period was essentially unchanged from that at 16 weeks. Among those on the highest and most effective test dose of once-daily 100 mg, the PASI 90 at 1 year was 64.3%, a rate that was essentially unchanged from week 16.

No Apparent Loss of Benefit Over Time

“We can really look at those dose-response curves and see that there is, overall, a maintenance of response,” reported Laura K. Ferris, MD, PhD, professor and director of clinical trials, Department of Dermatology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. In her presentation of the data, she showed similar sustained control for the most effective doses of JNJ-2113 for multiple clinical outcomes, including an investigator’s global assessment (IGA) score of 0 or 1, also signifying clear or near clear skin.

Bimekizumab, a monoclonal antibody that inhibits both IL-17A and IL-17F, is already approved for the treatment of plaque psoriasis. The 52-week BE SURE trial, which provided the 478 patients who entered into the BE BRIGHT open label extension study, was published in The New England Journal of Medicine in July 2021. 

In the 4-year data reported by Dr. Lebwohl, three groups were compared: Those initially randomized to an every-4-week dosing schedule of bimekizumab over the course of the 52-week BE SURE trial; those randomized to an every-4-week bimekizumab schedule who were then subsequently switched to an every-8-week schedule; and those initiated on the TNF-inhibitor adalimumab (Humira) and were then switched at week 24 to every-4-week bimekizumab.

The PASI 90 responses at 52 weeks in these three groups, respectively, were 91.2%, 89.3%, and 95.2%. At 4 years, this almost clear response was observed in 82.4%, 83.2%, and 87.6%, respectively. At 52 weeks, the PASI 100 responses in these three groups, respectively, were 75.3%, 74.2%, and 72.9%. At 4 years, 61.9%, 58.5%, and 69.5% still had complete skin clearance.

Bimekizumab was well tolerated during the randomized trial, reported Dr. Lebwohl. The rates of nasopharyngitis and oral candidiasis, which were observed in approximately 12% and 8%, respectively, of treated patients during the randomized phase remained at about the same level in the long-term follow up. There were no new safety signals, he said.
 

JNJ-2113 Is First Potential Oral IL-23 Inhibitor

JNJ-2113 is a first-in-class oral peptide that binds to the IL-23 receptor, blocking the IL-23 signaling pathway. If approved, it would be the first oral therapy targeting IL-23. The 16-week outcomes of the dose-finding FRONTIER 1 phase 2b trial were published in The New England Journal of Medicine earlier this year. The primary endpoint was PASI 75, achieved by 79% of those on the 100 mg twice daily dose at week 16, vs 9% on placebo, and at 52 weeks, was 76%. 

“The proportion of patients achieving the FRONTIER 1 primary endpoint was maintained from week 16 to the end of week 52 in the extension study,” Dr. Ferris said, but further pointed out that rates of near or complete clearance achieved at week 16 were also essentially unchanged at week 52. This was true of PASI scores and IGA. 

Clearance of psoriatic lesions on the scalp was particularly impressive. By scalp-specific IGA, rates of clear or near clear (0/1) were not just maintained but improved over the course of follow-up, reaching 75.1% at 52 weeks in the highest dose group, she said.

JNJ-2113 was well tolerated in FRONTIER 1 and remained so during long-term follow-up, in the FRONTIER 2 extension study, according to Dr. Ferris. The most common complaints with JNJ-2113, such as nasopharyngitis (18.1% vs 25.7% in placebo), did not appear to differ significantly from placebo and the treatment remained well tolerated over the course of the extended follow-up.

There are limited direct comparisons of different biologics active in the treatment of plaque psoriasis for efficacy and safety, but these data appear to show a depth and durability of benefit for psoriasis that is exceptional, Dr. Lebwohl told this news organization. “The PASI 100 scores achieved by bimekizumab exceed anything we have seen to date,” he said. “And the durability of those exceedingly high scores is remarkable.”

Dr. Lebwohl reports financial relationships with approximately 40 pharmaceutical companies, including UCB Pharma, which developed bimekizumab. Dr. Ferris reports financial relationships with more than 20 pharmaceutical companies, including Janssen, which is developing JNJ-2113. 

A version of this article appeared on Medscape.com.

Hidradenitis suppurativa (HS)—a chronic, relapsing, inflammatory disorder involving terminal hair follicles in apocrine gland–rich skin—manifests as tender inflamed nodules that transform into abscesses, sinus tracts, and scarring.^1,2 The etiology of HS is multifactorial, encompassing lifestyle, microbiota, hormonal status, and genetic and environmental factors. These factors activate the immune system around the terminal hair follicles and lead to hyperkeratosis of the infundibulum of the hair follicles in intertriginous regions. This progresses to follicular occlusion, stasis, and eventual rupture. Bacterial multiplication within the plugged pilosebaceous units further boosts immune activation. Resident and migrated cells of the innate and adaptive immune system then release proinflammatory cytokines such as tumor necrosis factor, IL-1β, and IL-17, which further enhance immune cell influx and inflammation.^3,4 This aberrant immune response propagates the production of deep-seated inflammatory nodules and abscesses.^3-8

The estimated prevalence of HS is 1% worldwide.⁹ It is more prevalent in female and Black patients (0.30%) than White patients (0.09%) and is intermediate in prevalence in the biracial population (0.22%).¹⁰ Hidradenitis suppurativa is thought to be associated with lower socioeconomic status (SES). In a retrospective analysis of HS patients (N=375), approximately one-third of patients were Black, had advanced disease, and had a notably lower SES.¹¹ Furthermore, HS has been reported to be associated with systemic inflammation and comorbidities such as morbid obesity (38.3%) and hypertension (39.6%) as well as other metabolic syndrome–related disorders and depression (48.1%).¹

Hidradenitis suppurativa may contribute to the risk for depression through its substantial impact on health-related quality of life, which culminates in social withdrawal, unemployment, and suicidal thoughts.¹² The high prevalence of depression in individuals with HS¹ and its association with systemic inflammation¹³ increases the likelihood that a common genetic predisposition also may exist between both conditions. Because depression frequently has been discovered as a concomitant diagnosis in patients with HS, we hypothesize that a shared genetic susceptibility also may exist between the 2 disorders. Our study sought to explore data on the co-occurrence of depression with HS, including its demographics and racial data.

Methods

We conducted a PubMed search of articles indexed for MEDLINE as well as Google Scholar using the terms depression and hidradenitis suppurativa to obtain all research articles published from 2000 to 2022. Articles were selected based on relevance to the topic of exploration. English-language articles that directly addressed the epidemiology, etiology, pathophysiology, and co-occurrence of both depression and HS with numerical data were included. Articles were excluded if they did not explore the information of interest on these 2 disorders or did not contain clear statistical data of patients with the 2 concurrent medical conditions.

Results

Twenty-two cross-sectional, prospective, and retrospective studies that fit the search criteria were identified and included in the analysis (eTable).^1,14-34 Sixteen (72.7%) studies were cross-sectional, 5 (22.7%) were retrospective, and only 1 (4.5%) was a prospective study. Only 6 of the studies provided racial data,^{1,14,17,26,28,32} and of them, 4 had predominately White patients,^1,14,26,32 whereas the other 2 had predominantly Black patients.^17,28

Hidradenitis suppurativa was found to coexist with depression in all the studies, with a prevalence of 1.2% to 48.1%. There also was a higher prevalence of depression in HS patients than in the control patients without HS. Furthermore, a recent study by Wright and colleagues¹⁴ stratified the depression prevalence data by age and found a higher prevalence of depression in adults vs children with HS (30% vs 12%).

Comment

Major depression—a chronic and debilitating illness—is the chief cause of disability globally and in the United States alone and has a global lifetime prevalence of 17%.³⁵ In a study of 388 patients diagnosed with depression and 404 community-matched controls who were observed for 10 years, depressed patients had a two-thirds higher likelihood of developing a serious physical illness than controls. The depression-associated elevated risk for serious physical illness persisted after controlling for confounding variables such as alcohol abuse, smoking, and level of physical activity.³⁶ Studies also have demonstrated that HS is more prevalent in Black individuals¹⁰ and in individuals of low SES,³⁷ who are mostly the Black and Hispanic populations that experience the highest burden of racial microaggression³⁸ and disparities in health access and outcomes.^39,40 The severity and chronicity of major depressive disorder also is higher in Black patients compared with White patients (57% vs 39%).⁴¹ Because major depression and HS are most common among Black patients who experience the highest-burden negative financial and health disparities, there may be a shared genetic disposition to both medical conditions.

Moreover, the common detrimental lifestyle choices associated with patients with depression and HS also suggest the possibility of a collective genetic susceptibility. Patients with depression also report increased consumption of alcohol, tobacco, and illicit substances; sedentary lifestyle leading to obesity; and poor compliance with prescribed medical treatment.⁴² Smoking and obesity are known contributors to the pathogenesis of HS, and their modification also is known to positively impact the disease course. In a retrospective single-cohort study, 50% of obese HS patients (n=35) reported a substantial decrease in disease severity after a reduction of more than 15% in body mass index over 2 years following bariatric surgery (n=35).⁴³ Patients with HS also have reported disease remission following extensive weight loss.⁴⁴ In addition, evidence has supported smoking cessation in improving the disease course of HS.⁴³ Because these detrimental lifestyle choices are prevalent in both patients with HS and those with depression, a co-genetic susceptibility also may exist.

Furthermore, depression is characterized by a persistent inflammatory state,^13,45 similar to HS.⁴⁶ Elevated levels of a variety of inflammatory markers, such as C-reactive protein (CRP), IL-6, and soluble intercellular adhesion molecule 1, have been reported in patients with depression compared with healthy controls.^13,45 Further analysis found a positive correlation and a strong association between depression and these inflammatory markers.⁴⁷ Moreover, adipokines regulate inflammatory responses, and adipokines play a role in the pathogenesis of HS. Adipokine levels such as elevated omentin-1 (a recently identified adipokine) were found to be altered in patients with HS compared with controls.⁴⁸ Results from clinical studies and meta-analyses of patients with depression also have demonstrated that adipokines are dysregulated in this population,^49,50 which may be another potential genetic link between depression and HS.

In addition, genetic susceptibility to depression and HS may be shared because the inflammatory markers that have a strong association with depression also have been found to play an important role in HS treatment and disease severity prediction. In a retrospective cohort study of 404 patients, CRP or IL-6 levels were found to be reliable predictors of HS disease severity, which may explain why anti–tumor necrosis factor antibody regimens such as adalimumab and infliximab have clinically ameliorated disease activity in several cases of HS.⁵¹ In a study evaluating these drugs, high baseline levels of high-sensitivity CRP and IL-6 were predictive of patient response to infliximab.⁵² In a meta-analysis evaluating 20,791 participants, an association was found between concurrent depression and CRP. Furthermore, inflammation measured by high levels of CRP or IL-6 was observed to predict future depression.⁵³ If the same inflammatory markers—CRP and IL-6—both play a major role in the disease activity of depression and HS, then a concurrent genetic predisposition may exist.

Conclusion

Understanding the comorbidities, etiologies, and risk factors for the development and progression of HS is an important step toward improved disease management. Available studies on comorbid depression in HS largely involve White patients, and more studies are needed in patients with skin of color, particularly the Black population, who have the highest prevalence of HS.¹⁰ Given the evidence for an association between depression and HS, we suggest a large-scale investigation of this patient population that includes a complete medical history, onset of HS in comparison to the onset of depression, and specific measures of disease progress and lifetime management of depression, which may help to increase knowledge about the role of depression in HS and encourage more research in this area. If shared genetic susceptibility is established, aggressive management of depression in patients at risk for HS may reduce disease incidence and severity as well as the psychological burden on patients.

Hidradenitis suppurativa (HS)—a chronic, relapsing, inflammatory disorder involving terminal hair follicles in apocrine gland–rich skin—manifests as tender inflamed nodules that transform into abscesses, sinus tracts, and scarring.^1,2 The etiology of HS is multifactorial, encompassing lifestyle, microbiota, hormonal status, and genetic and environmental factors. These factors activate the immune system around the terminal hair follicles and lead to hyperkeratosis of the infundibulum of the hair follicles in intertriginous regions. This progresses to follicular occlusion, stasis, and eventual rupture. Bacterial multiplication within the plugged pilosebaceous units further boosts immune activation. Resident and migrated cells of the innate and adaptive immune system then release proinflammatory cytokines such as tumor necrosis factor, IL-1β, and IL-17, which further enhance immune cell influx and inflammation.^3,4 This aberrant immune response propagates the production of deep-seated inflammatory nodules and abscesses.^3-8

The estimated prevalence of HS is 1% worldwide.⁹ It is more prevalent in female and Black patients (0.30%) than White patients (0.09%) and is intermediate in prevalence in the biracial population (0.22%).¹⁰ Hidradenitis suppurativa is thought to be associated with lower socioeconomic status (SES). In a retrospective analysis of HS patients (N=375), approximately one-third of patients were Black, had advanced disease, and had a notably lower SES.¹¹ Furthermore, HS has been reported to be associated with systemic inflammation and comorbidities such as morbid obesity (38.3%) and hypertension (39.6%) as well as other metabolic syndrome–related disorders and depression (48.1%).¹

Hidradenitis suppurativa may contribute to the risk for depression through its substantial impact on health-related quality of life, which culminates in social withdrawal, unemployment, and suicidal thoughts.¹² The high prevalence of depression in individuals with HS¹ and its association with systemic inflammation¹³ increases the likelihood that a common genetic predisposition also may exist between both conditions. Because depression frequently has been discovered as a concomitant diagnosis in patients with HS, we hypothesize that a shared genetic susceptibility also may exist between the 2 disorders. Our study sought to explore data on the co-occurrence of depression with HS, including its demographics and racial data.

Methods

We conducted a PubMed search of articles indexed for MEDLINE as well as Google Scholar using the terms depression and hidradenitis suppurativa to obtain all research articles published from 2000 to 2022. Articles were selected based on relevance to the topic of exploration. English-language articles that directly addressed the epidemiology, etiology, pathophysiology, and co-occurrence of both depression and HS with numerical data were included. Articles were excluded if they did not explore the information of interest on these 2 disorders or did not contain clear statistical data of patients with the 2 concurrent medical conditions.

Results

Twenty-two cross-sectional, prospective, and retrospective studies that fit the search criteria were identified and included in the analysis (eTable).^1,14-34 Sixteen (72.7%) studies were cross-sectional, 5 (22.7%) were retrospective, and only 1 (4.5%) was a prospective study. Only 6 of the studies provided racial data,^{1,14,17,26,28,32} and of them, 4 had predominately White patients,^1,14,26,32 whereas the other 2 had predominantly Black patients.^17,28

Hidradenitis suppurativa was found to coexist with depression in all the studies, with a prevalence of 1.2% to 48.1%. There also was a higher prevalence of depression in HS patients than in the control patients without HS. Furthermore, a recent study by Wright and colleagues¹⁴ stratified the depression prevalence data by age and found a higher prevalence of depression in adults vs children with HS (30% vs 12%).

Comment

Major depression—a chronic and debilitating illness—is the chief cause of disability globally and in the United States alone and has a global lifetime prevalence of 17%.³⁵ In a study of 388 patients diagnosed with depression and 404 community-matched controls who were observed for 10 years, depressed patients had a two-thirds higher likelihood of developing a serious physical illness than controls. The depression-associated elevated risk for serious physical illness persisted after controlling for confounding variables such as alcohol abuse, smoking, and level of physical activity.³⁶ Studies also have demonstrated that HS is more prevalent in Black individuals¹⁰ and in individuals of low SES,³⁷ who are mostly the Black and Hispanic populations that experience the highest burden of racial microaggression³⁸ and disparities in health access and outcomes.^39,40 The severity and chronicity of major depressive disorder also is higher in Black patients compared with White patients (57% vs 39%).⁴¹ Because major depression and HS are most common among Black patients who experience the highest-burden negative financial and health disparities, there may be a shared genetic disposition to both medical conditions.

Moreover, the common detrimental lifestyle choices associated with patients with depression and HS also suggest the possibility of a collective genetic susceptibility. Patients with depression also report increased consumption of alcohol, tobacco, and illicit substances; sedentary lifestyle leading to obesity; and poor compliance with prescribed medical treatment.⁴² Smoking and obesity are known contributors to the pathogenesis of HS, and their modification also is known to positively impact the disease course. In a retrospective single-cohort study, 50% of obese HS patients (n=35) reported a substantial decrease in disease severity after a reduction of more than 15% in body mass index over 2 years following bariatric surgery (n=35).⁴³ Patients with HS also have reported disease remission following extensive weight loss.⁴⁴ In addition, evidence has supported smoking cessation in improving the disease course of HS.⁴³ Because these detrimental lifestyle choices are prevalent in both patients with HS and those with depression, a co-genetic susceptibility also may exist.

Furthermore, depression is characterized by a persistent inflammatory state,^13,45 similar to HS.⁴⁶ Elevated levels of a variety of inflammatory markers, such as C-reactive protein (CRP), IL-6, and soluble intercellular adhesion molecule 1, have been reported in patients with depression compared with healthy controls.^13,45 Further analysis found a positive correlation and a strong association between depression and these inflammatory markers.⁴⁷ Moreover, adipokines regulate inflammatory responses, and adipokines play a role in the pathogenesis of HS. Adipokine levels such as elevated omentin-1 (a recently identified adipokine) were found to be altered in patients with HS compared with controls.⁴⁸ Results from clinical studies and meta-analyses of patients with depression also have demonstrated that adipokines are dysregulated in this population,^49,50 which may be another potential genetic link between depression and HS.

In addition, genetic susceptibility to depression and HS may be shared because the inflammatory markers that have a strong association with depression also have been found to play an important role in HS treatment and disease severity prediction. In a retrospective cohort study of 404 patients, CRP or IL-6 levels were found to be reliable predictors of HS disease severity, which may explain why anti–tumor necrosis factor antibody regimens such as adalimumab and infliximab have clinically ameliorated disease activity in several cases of HS.⁵¹ In a study evaluating these drugs, high baseline levels of high-sensitivity CRP and IL-6 were predictive of patient response to infliximab.⁵² In a meta-analysis evaluating 20,791 participants, an association was found between concurrent depression and CRP. Furthermore, inflammation measured by high levels of CRP or IL-6 was observed to predict future depression.⁵³ If the same inflammatory markers—CRP and IL-6—both play a major role in the disease activity of depression and HS, then a concurrent genetic predisposition may exist.

Conclusion

Understanding the comorbidities, etiologies, and risk factors for the development and progression of HS is an important step toward improved disease management. Available studies on comorbid depression in HS largely involve White patients, and more studies are needed in patients with skin of color, particularly the Black population, who have the highest prevalence of HS.¹⁰ Given the evidence for an association between depression and HS, we suggest a large-scale investigation of this patient population that includes a complete medical history, onset of HS in comparison to the onset of depression, and specific measures of disease progress and lifetime management of depression, which may help to increase knowledge about the role of depression in HS and encourage more research in this area. If shared genetic susceptibility is established, aggressive management of depression in patients at risk for HS may reduce disease incidence and severity as well as the psychological burden on patients.

Hidradenitis suppurativa (HS)—a chronic, relapsing, inflammatory disorder involving terminal hair follicles in apocrine gland–rich skin—manifests as tender inflamed nodules that transform into abscesses, sinus tracts, and scarring.^1,2 The etiology of HS is multifactorial, encompassing lifestyle, microbiota, hormonal status, and genetic and environmental factors. These factors activate the immune system around the terminal hair follicles and lead to hyperkeratosis of the infundibulum of the hair follicles in intertriginous regions. This progresses to follicular occlusion, stasis, and eventual rupture. Bacterial multiplication within the plugged pilosebaceous units further boosts immune activation. Resident and migrated cells of the innate and adaptive immune system then release proinflammatory cytokines such as tumor necrosis factor, IL-1β, and IL-17, which further enhance immune cell influx and inflammation.^3,4 This aberrant immune response propagates the production of deep-seated inflammatory nodules and abscesses.^3-8

The estimated prevalence of HS is 1% worldwide.⁹ It is more prevalent in female and Black patients (0.30%) than White patients (0.09%) and is intermediate in prevalence in the biracial population (0.22%).¹⁰ Hidradenitis suppurativa is thought to be associated with lower socioeconomic status (SES). In a retrospective analysis of HS patients (N=375), approximately one-third of patients were Black, had advanced disease, and had a notably lower SES.¹¹ Furthermore, HS has been reported to be associated with systemic inflammation and comorbidities such as morbid obesity (38.3%) and hypertension (39.6%) as well as other metabolic syndrome–related disorders and depression (48.1%).¹

Hidradenitis suppurativa may contribute to the risk for depression through its substantial impact on health-related quality of life, which culminates in social withdrawal, unemployment, and suicidal thoughts.¹² The high prevalence of depression in individuals with HS¹ and its association with systemic inflammation¹³ increases the likelihood that a common genetic predisposition also may exist between both conditions. Because depression frequently has been discovered as a concomitant diagnosis in patients with HS, we hypothesize that a shared genetic susceptibility also may exist between the 2 disorders. Our study sought to explore data on the co-occurrence of depression with HS, including its demographics and racial data.

Methods

We conducted a PubMed search of articles indexed for MEDLINE as well as Google Scholar using the terms depression and hidradenitis suppurativa to obtain all research articles published from 2000 to 2022. Articles were selected based on relevance to the topic of exploration. English-language articles that directly addressed the epidemiology, etiology, pathophysiology, and co-occurrence of both depression and HS with numerical data were included. Articles were excluded if they did not explore the information of interest on these 2 disorders or did not contain clear statistical data of patients with the 2 concurrent medical conditions.

Results

Twenty-two cross-sectional, prospective, and retrospective studies that fit the search criteria were identified and included in the analysis (eTable).^1,14-34 Sixteen (72.7%) studies were cross-sectional, 5 (22.7%) were retrospective, and only 1 (4.5%) was a prospective study. Only 6 of the studies provided racial data,^{1,14,17,26,28,32} and of them, 4 had predominately White patients,^1,14,26,32 whereas the other 2 had predominantly Black patients.^17,28

Hidradenitis suppurativa was found to coexist with depression in all the studies, with a prevalence of 1.2% to 48.1%. There also was a higher prevalence of depression in HS patients than in the control patients without HS. Furthermore, a recent study by Wright and colleagues¹⁴ stratified the depression prevalence data by age and found a higher prevalence of depression in adults vs children with HS (30% vs 12%).

Comment

Major depression—a chronic and debilitating illness—is the chief cause of disability globally and in the United States alone and has a global lifetime prevalence of 17%.³⁵ In a study of 388 patients diagnosed with depression and 404 community-matched controls who were observed for 10 years, depressed patients had a two-thirds higher likelihood of developing a serious physical illness than controls. The depression-associated elevated risk for serious physical illness persisted after controlling for confounding variables such as alcohol abuse, smoking, and level of physical activity.³⁶ Studies also have demonstrated that HS is more prevalent in Black individuals¹⁰ and in individuals of low SES,³⁷ who are mostly the Black and Hispanic populations that experience the highest burden of racial microaggression³⁸ and disparities in health access and outcomes.^39,40 The severity and chronicity of major depressive disorder also is higher in Black patients compared with White patients (57% vs 39%).⁴¹ Because major depression and HS are most common among Black patients who experience the highest-burden negative financial and health disparities, there may be a shared genetic disposition to both medical conditions.

Moreover, the common detrimental lifestyle choices associated with patients with depression and HS also suggest the possibility of a collective genetic susceptibility. Patients with depression also report increased consumption of alcohol, tobacco, and illicit substances; sedentary lifestyle leading to obesity; and poor compliance with prescribed medical treatment.⁴² Smoking and obesity are known contributors to the pathogenesis of HS, and their modification also is known to positively impact the disease course. In a retrospective single-cohort study, 50% of obese HS patients (n=35) reported a substantial decrease in disease severity after a reduction of more than 15% in body mass index over 2 years following bariatric surgery (n=35).⁴³ Patients with HS also have reported disease remission following extensive weight loss.⁴⁴ In addition, evidence has supported smoking cessation in improving the disease course of HS.⁴³ Because these detrimental lifestyle choices are prevalent in both patients with HS and those with depression, a co-genetic susceptibility also may exist.

Furthermore, depression is characterized by a persistent inflammatory state,^13,45 similar to HS.⁴⁶ Elevated levels of a variety of inflammatory markers, such as C-reactive protein (CRP), IL-6, and soluble intercellular adhesion molecule 1, have been reported in patients with depression compared with healthy controls.^13,45 Further analysis found a positive correlation and a strong association between depression and these inflammatory markers.⁴⁷ Moreover, adipokines regulate inflammatory responses, and adipokines play a role in the pathogenesis of HS. Adipokine levels such as elevated omentin-1 (a recently identified adipokine) were found to be altered in patients with HS compared with controls.⁴⁸ Results from clinical studies and meta-analyses of patients with depression also have demonstrated that adipokines are dysregulated in this population,^49,50 which may be another potential genetic link between depression and HS.

In addition, genetic susceptibility to depression and HS may be shared because the inflammatory markers that have a strong association with depression also have been found to play an important role in HS treatment and disease severity prediction. In a retrospective cohort study of 404 patients, CRP or IL-6 levels were found to be reliable predictors of HS disease severity, which may explain why anti–tumor necrosis factor antibody regimens such as adalimumab and infliximab have clinically ameliorated disease activity in several cases of HS.⁵¹ In a study evaluating these drugs, high baseline levels of high-sensitivity CRP and IL-6 were predictive of patient response to infliximab.⁵² In a meta-analysis evaluating 20,791 participants, an association was found between concurrent depression and CRP. Furthermore, inflammation measured by high levels of CRP or IL-6 was observed to predict future depression.⁵³ If the same inflammatory markers—CRP and IL-6—both play a major role in the disease activity of depression and HS, then a concurrent genetic predisposition may exist.

Conclusion

Understanding the comorbidities, etiologies, and risk factors for the development and progression of HS is an important step toward improved disease management. Available studies on comorbid depression in HS largely involve White patients, and more studies are needed in patients with skin of color, particularly the Black population, who have the highest prevalence of HS.¹⁰ Given the evidence for an association between depression and HS, we suggest a large-scale investigation of this patient population that includes a complete medical history, onset of HS in comparison to the onset of depression, and specific measures of disease progress and lifetime management of depression, which may help to increase knowledge about the role of depression in HS and encourage more research in this area. If shared genetic susceptibility is established, aggressive management of depression in patients at risk for HS may reduce disease incidence and severity as well as the psychological burden on patients.

Tools to screen for spondyloarthritis (SpA) among people with the extra-musculoskeletal conditions that commonly co-occur with SpA — psoriasis, uveitis, and inflammatory bowel disease (IBD) — show potential for their use in target populations but have limited generalizability for patients at risk for SpA, according to findings from a scoping review of 18 tools.

Prior to the review comparing available tools, first author Vartika Kesarwani, MBBS, of the University of Connecticut, Farmington, and colleagues wrote that the performance of SpA screening tools in dermatology, ophthalmology, and gastroenterology contexts had not been evaluated.

“Given the evolving landscape of therapeutics for spondyloarthritis, recognizing the full spectrum of disease manifestations in individual patients becomes increasingly important. This knowledge can inform treatment decisions, potentially altering the course of the disease,” corresponding author Joerg Ermann, MD, of Brigham and Women’s Hospital, Boston, said in an interview.

In the study, published on February 1 in Arthritis Care & Research, the investigators identified 13 SpA screening tools for psoriasis (screening specifically for psoriatic arthritis), two for uveitis, and three for IBD. All tools with the exception of one for uveitis were patient-oriented questionnaires with an average completion time of less than 5 minutes.

Overall, the researchers found significant variability in the nature of the questions used to identify clinical features of SpA; 15 tools included at least one question on back pain or stiffness; 16 tools had at least one question on joint pain, swelling, or inflammation; 10 included questions about heel or elbow pain; and 10 included questions about swelling of digits.

All 13 of the psoriasis tools were screened for peripheral arthritis, while 10 screened for axial involvement, eight screened for enthesitis, and eight screened for dactylitis.

All three of the IBD tools were screened for axial involvement and peripheral arthritis, and two were screened for enthesitis and dactylitis.

Both of the uveitis tools were screened for axial involvement, but neither was screened for peripheral arthritis, enthesitis, or dactylitis.

Sensitivities in the primary validation groups were similar for the 16 tools for which sensitivities were reported, ranging mainly from 82% to 92% for 11 psoriasis tools, 91% to 96% for uveitis tools, and 83% to 93% for IBD tools.

Specificities for psoriasis tools ranged from 69% to 83% for all but two of the tools, which was 46% for one and 35%-89% for another across three geographical cohorts. For uveitis tools, specificities were 91%-97% for uveitis tools, and for IBD tools, 77%-90%. Most of the secondary validations involved psoriasis tools, and these were generally lower and also more variable.
 

The Case for a Generic Tool

The relatively few SpA tools for patients with uveitis and IBD, compared with psoriasis, may be attributable to a lack of awareness of the association between these conditions on the part of ophthalmologists and gastroenterologists, the researchers wrote in their discussion. Therefore, a generic SpA screening tool that could apply to any extra-articular manifestation might increase screening across clinical settings and streamline rheumatology referrals, they noted.

The review’s findings were limited by several factors, including the inclusion of only articles in English and the relatively few tools for uveitis and IBD patients, the researchers noted.

The findings suggested that although the performances of the tools are similar, their degree of variability supports the value of a generic tool, they concluded.
 

Streamlining to Increase Screening

“Compared to the large amount of research in psoriasis and psoriatic arthritis, relatively little has been done with regard to screening for spondyloarthritis in patients with uveitis or IBD,” Dr. Ermann told this news organization. “Despite the numerous screening tools developed for psoriatic arthritis, no ideal screening tool has emerged, and the implementation of effective screening strategies in clinical practice is challenging,” he said. In the current study, the compartmentalization of research into individual conditions like psoriasis, uveitis, and IBD was notable despite the interconnected nature of these conditions with SpA, he added.

In practice, Dr. Ermann advised clinicians to maintain a high index of suspicion for SpA in patients presenting with psoriasis, uveitis, or IBD and proactively ask patients about symptoms outside their primary specialty.

“Future research should focus on developing a universal spondyloarthritis screening tool that is comprehensive, easily understandable, and can be used across various clinical settings,” he said.
 

Need for Early Identification and Closer Collaboration

A delay in SpA diagnosis of as little as 6 months can lead to worse outcomes, Rebecca Haberman, MD, a rheumatologist at NYU Langone Health, New York City, said in an interview. “Patients with these conditions may first present to dermatologists, gastroenterologists, and/or ophthalmologists before rheumatologic evaluation. If we can identify these patients early at this stage, we might be able to improve outcomes, but the question remains of how we get these patients to the proper care,” she said.

The review examined the currently available screening tools for use in patients with psoriasis, IBD, and uveitis and highlights the heterogeneity of these tools in terms of use and disease characteristics, as well as the lack of tools for use in gastroenterology and ophthalmology offices, Dr. Haberman said.

The review “proposes several important ideas, such as creating a unified screening tool that can be used across diseases and fields, to reduce confusion by providers and help provide standardization of the referral process to rheumatologists,” she said.

“Even though SpA is prevalent in many patients with psoriasis, IBD, and uveitis, it remains very underdiagnosed, and often referrals to rheumatologists are not made,” Dr. Haberman told this news organization. Diagnostic challenges likely include SpA’s heterogeneous presentation, the specialists’ lack of knowledge regarding the connection between these conditions and joint disease, and time pressures in clinical settings, she said.

“Other practitioners are not always trained to ask about joint pain and often have limited time in their exams to ask additional questions. To overcome this, more collaboration is needed between dermatologists, gastroenterologists, ophthalmologists, and rheumatologists, as many of our diseases live in the same family,” Dr. Haberman said.

Improving clinician education and creating relationships can help facilitate questions and referrals, she said. Short, effective screening tools that can be filled out by the patient may also help overcome specialists’ discomfort about asking musculoskeletal-related questions and would save time in the clinical visit, she said.

More research is needed to identify the best screening tools and questions and which are the most highly sensitive and specific, Dr. Haberman said. “This will allow for rheumatologists to see patients who may have SpA earlier in their course without overwhelming the system with new referrals.” In addition, more work is needed on how and whether screening tools are being used in clinical practice, not just in research studies, she said.

The study was supported by a grant from the National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases. The researchers and Dr. Haberman had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Tools to screen for spondyloarthritis (SpA) among people with the extra-musculoskeletal conditions that commonly co-occur with SpA — psoriasis, uveitis, and inflammatory bowel disease (IBD) — show potential for their use in target populations but have limited generalizability for patients at risk for SpA, according to findings from a scoping review of 18 tools.

Prior to the review comparing available tools, first author Vartika Kesarwani, MBBS, of the University of Connecticut, Farmington, and colleagues wrote that the performance of SpA screening tools in dermatology, ophthalmology, and gastroenterology contexts had not been evaluated.

“Given the evolving landscape of therapeutics for spondyloarthritis, recognizing the full spectrum of disease manifestations in individual patients becomes increasingly important. This knowledge can inform treatment decisions, potentially altering the course of the disease,” corresponding author Joerg Ermann, MD, of Brigham and Women’s Hospital, Boston, said in an interview.

In the study, published on February 1 in Arthritis Care & Research, the investigators identified 13 SpA screening tools for psoriasis (screening specifically for psoriatic arthritis), two for uveitis, and three for IBD. All tools with the exception of one for uveitis were patient-oriented questionnaires with an average completion time of less than 5 minutes.

Overall, the researchers found significant variability in the nature of the questions used to identify clinical features of SpA; 15 tools included at least one question on back pain or stiffness; 16 tools had at least one question on joint pain, swelling, or inflammation; 10 included questions about heel or elbow pain; and 10 included questions about swelling of digits.

All 13 of the psoriasis tools were screened for peripheral arthritis, while 10 screened for axial involvement, eight screened for enthesitis, and eight screened for dactylitis.

All three of the IBD tools were screened for axial involvement and peripheral arthritis, and two were screened for enthesitis and dactylitis.

Both of the uveitis tools were screened for axial involvement, but neither was screened for peripheral arthritis, enthesitis, or dactylitis.

Sensitivities in the primary validation groups were similar for the 16 tools for which sensitivities were reported, ranging mainly from 82% to 92% for 11 psoriasis tools, 91% to 96% for uveitis tools, and 83% to 93% for IBD tools.

Specificities for psoriasis tools ranged from 69% to 83% for all but two of the tools, which was 46% for one and 35%-89% for another across three geographical cohorts. For uveitis tools, specificities were 91%-97% for uveitis tools, and for IBD tools, 77%-90%. Most of the secondary validations involved psoriasis tools, and these were generally lower and also more variable.
 

The Case for a Generic Tool

The relatively few SpA tools for patients with uveitis and IBD, compared with psoriasis, may be attributable to a lack of awareness of the association between these conditions on the part of ophthalmologists and gastroenterologists, the researchers wrote in their discussion. Therefore, a generic SpA screening tool that could apply to any extra-articular manifestation might increase screening across clinical settings and streamline rheumatology referrals, they noted.

The review’s findings were limited by several factors, including the inclusion of only articles in English and the relatively few tools for uveitis and IBD patients, the researchers noted.

The findings suggested that although the performances of the tools are similar, their degree of variability supports the value of a generic tool, they concluded.
 

Streamlining to Increase Screening

“Compared to the large amount of research in psoriasis and psoriatic arthritis, relatively little has been done with regard to screening for spondyloarthritis in patients with uveitis or IBD,” Dr. Ermann told this news organization. “Despite the numerous screening tools developed for psoriatic arthritis, no ideal screening tool has emerged, and the implementation of effective screening strategies in clinical practice is challenging,” he said. In the current study, the compartmentalization of research into individual conditions like psoriasis, uveitis, and IBD was notable despite the interconnected nature of these conditions with SpA, he added.

In practice, Dr. Ermann advised clinicians to maintain a high index of suspicion for SpA in patients presenting with psoriasis, uveitis, or IBD and proactively ask patients about symptoms outside their primary specialty.

“Future research should focus on developing a universal spondyloarthritis screening tool that is comprehensive, easily understandable, and can be used across various clinical settings,” he said.
 

Need for Early Identification and Closer Collaboration

A delay in SpA diagnosis of as little as 6 months can lead to worse outcomes, Rebecca Haberman, MD, a rheumatologist at NYU Langone Health, New York City, said in an interview. “Patients with these conditions may first present to dermatologists, gastroenterologists, and/or ophthalmologists before rheumatologic evaluation. If we can identify these patients early at this stage, we might be able to improve outcomes, but the question remains of how we get these patients to the proper care,” she said.

The review examined the currently available screening tools for use in patients with psoriasis, IBD, and uveitis and highlights the heterogeneity of these tools in terms of use and disease characteristics, as well as the lack of tools for use in gastroenterology and ophthalmology offices, Dr. Haberman said.

The review “proposes several important ideas, such as creating a unified screening tool that can be used across diseases and fields, to reduce confusion by providers and help provide standardization of the referral process to rheumatologists,” she said.

“Even though SpA is prevalent in many patients with psoriasis, IBD, and uveitis, it remains very underdiagnosed, and often referrals to rheumatologists are not made,” Dr. Haberman told this news organization. Diagnostic challenges likely include SpA’s heterogeneous presentation, the specialists’ lack of knowledge regarding the connection between these conditions and joint disease, and time pressures in clinical settings, she said.

“Other practitioners are not always trained to ask about joint pain and often have limited time in their exams to ask additional questions. To overcome this, more collaboration is needed between dermatologists, gastroenterologists, ophthalmologists, and rheumatologists, as many of our diseases live in the same family,” Dr. Haberman said.

Improving clinician education and creating relationships can help facilitate questions and referrals, she said. Short, effective screening tools that can be filled out by the patient may also help overcome specialists’ discomfort about asking musculoskeletal-related questions and would save time in the clinical visit, she said.

More research is needed to identify the best screening tools and questions and which are the most highly sensitive and specific, Dr. Haberman said. “This will allow for rheumatologists to see patients who may have SpA earlier in their course without overwhelming the system with new referrals.” In addition, more work is needed on how and whether screening tools are being used in clinical practice, not just in research studies, she said.

The study was supported by a grant from the National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases. The researchers and Dr. Haberman had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Tools to screen for spondyloarthritis (SpA) among people with the extra-musculoskeletal conditions that commonly co-occur with SpA — psoriasis, uveitis, and inflammatory bowel disease (IBD) — show potential for their use in target populations but have limited generalizability for patients at risk for SpA, according to findings from a scoping review of 18 tools.

Prior to the review comparing available tools, first author Vartika Kesarwani, MBBS, of the University of Connecticut, Farmington, and colleagues wrote that the performance of SpA screening tools in dermatology, ophthalmology, and gastroenterology contexts had not been evaluated.

“Given the evolving landscape of therapeutics for spondyloarthritis, recognizing the full spectrum of disease manifestations in individual patients becomes increasingly important. This knowledge can inform treatment decisions, potentially altering the course of the disease,” corresponding author Joerg Ermann, MD, of Brigham and Women’s Hospital, Boston, said in an interview.

In the study, published on February 1 in Arthritis Care & Research, the investigators identified 13 SpA screening tools for psoriasis (screening specifically for psoriatic arthritis), two for uveitis, and three for IBD. All tools with the exception of one for uveitis were patient-oriented questionnaires with an average completion time of less than 5 minutes.

Overall, the researchers found significant variability in the nature of the questions used to identify clinical features of SpA; 15 tools included at least one question on back pain or stiffness; 16 tools had at least one question on joint pain, swelling, or inflammation; 10 included questions about heel or elbow pain; and 10 included questions about swelling of digits.

All 13 of the psoriasis tools were screened for peripheral arthritis, while 10 screened for axial involvement, eight screened for enthesitis, and eight screened for dactylitis.

All three of the IBD tools were screened for axial involvement and peripheral arthritis, and two were screened for enthesitis and dactylitis.

Both of the uveitis tools were screened for axial involvement, but neither was screened for peripheral arthritis, enthesitis, or dactylitis.

Sensitivities in the primary validation groups were similar for the 16 tools for which sensitivities were reported, ranging mainly from 82% to 92% for 11 psoriasis tools, 91% to 96% for uveitis tools, and 83% to 93% for IBD tools.

Specificities for psoriasis tools ranged from 69% to 83% for all but two of the tools, which was 46% for one and 35%-89% for another across three geographical cohorts. For uveitis tools, specificities were 91%-97% for uveitis tools, and for IBD tools, 77%-90%. Most of the secondary validations involved psoriasis tools, and these were generally lower and also more variable.
 

The Case for a Generic Tool

The relatively few SpA tools for patients with uveitis and IBD, compared with psoriasis, may be attributable to a lack of awareness of the association between these conditions on the part of ophthalmologists and gastroenterologists, the researchers wrote in their discussion. Therefore, a generic SpA screening tool that could apply to any extra-articular manifestation might increase screening across clinical settings and streamline rheumatology referrals, they noted.

The review’s findings were limited by several factors, including the inclusion of only articles in English and the relatively few tools for uveitis and IBD patients, the researchers noted.

The findings suggested that although the performances of the tools are similar, their degree of variability supports the value of a generic tool, they concluded.
 

Streamlining to Increase Screening

“Compared to the large amount of research in psoriasis and psoriatic arthritis, relatively little has been done with regard to screening for spondyloarthritis in patients with uveitis or IBD,” Dr. Ermann told this news organization. “Despite the numerous screening tools developed for psoriatic arthritis, no ideal screening tool has emerged, and the implementation of effective screening strategies in clinical practice is challenging,” he said. In the current study, the compartmentalization of research into individual conditions like psoriasis, uveitis, and IBD was notable despite the interconnected nature of these conditions with SpA, he added.

In practice, Dr. Ermann advised clinicians to maintain a high index of suspicion for SpA in patients presenting with psoriasis, uveitis, or IBD and proactively ask patients about symptoms outside their primary specialty.

“Future research should focus on developing a universal spondyloarthritis screening tool that is comprehensive, easily understandable, and can be used across various clinical settings,” he said.
 

Need for Early Identification and Closer Collaboration

A delay in SpA diagnosis of as little as 6 months can lead to worse outcomes, Rebecca Haberman, MD, a rheumatologist at NYU Langone Health, New York City, said in an interview. “Patients with these conditions may first present to dermatologists, gastroenterologists, and/or ophthalmologists before rheumatologic evaluation. If we can identify these patients early at this stage, we might be able to improve outcomes, but the question remains of how we get these patients to the proper care,” she said.

The review examined the currently available screening tools for use in patients with psoriasis, IBD, and uveitis and highlights the heterogeneity of these tools in terms of use and disease characteristics, as well as the lack of tools for use in gastroenterology and ophthalmology offices, Dr. Haberman said.

The review “proposes several important ideas, such as creating a unified screening tool that can be used across diseases and fields, to reduce confusion by providers and help provide standardization of the referral process to rheumatologists,” she said.

“Even though SpA is prevalent in many patients with psoriasis, IBD, and uveitis, it remains very underdiagnosed, and often referrals to rheumatologists are not made,” Dr. Haberman told this news organization. Diagnostic challenges likely include SpA’s heterogeneous presentation, the specialists’ lack of knowledge regarding the connection between these conditions and joint disease, and time pressures in clinical settings, she said.

“Other practitioners are not always trained to ask about joint pain and often have limited time in their exams to ask additional questions. To overcome this, more collaboration is needed between dermatologists, gastroenterologists, ophthalmologists, and rheumatologists, as many of our diseases live in the same family,” Dr. Haberman said.

Improving clinician education and creating relationships can help facilitate questions and referrals, she said. Short, effective screening tools that can be filled out by the patient may also help overcome specialists’ discomfort about asking musculoskeletal-related questions and would save time in the clinical visit, she said.

More research is needed to identify the best screening tools and questions and which are the most highly sensitive and specific, Dr. Haberman said. “This will allow for rheumatologists to see patients who may have SpA earlier in their course without overwhelming the system with new referrals.” In addition, more work is needed on how and whether screening tools are being used in clinical practice, not just in research studies, she said.

The study was supported by a grant from the National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases. The researchers and Dr. Haberman had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Many factors may influence fatigue in patients with psoriasis and psoriatic arthritis (PsA), researchers report.

METHODOLOGY:

• The individual components of fatigue in psoriasis and PsA have not been examined thoroughly.
• Researchers drew from the nationwide prospective Danish Skin Cohort to identify 2741 adults with dermatologist-diagnosed psoriasis (of which 593 also had PsA) and 3788 controls in the general population.
• All adults in the analysis completed the multidimensional fatigue inventory (MIF-20), a validated 20-item tool that measures five dimensions of fatigue: General fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue. A higher score indicates more severe fatigue.
• All adults were also asked about their current intensity of joint pain over the previous 7 days, severity of pruritus and skin pain over the previous 24 hours, and sleep problems over the previous 72 hours on a numerical rating scale (NRS). The researchers applied linear regression models to continuous outcomes and adjusted for age, sex, socioeconomic status, psoriasis severity, and joint pain intensity, and beta coefficients (β) for the slopes were estimated with 95% CIs.

TAKEAWAY:

• Compared with the general population, higher total MFI-20 scores were observed for psoriasis and PsA, respectively. However, on the adjusted analysis, the impact on total fatigue was greatest for those with PsA (β = 5.23; 95% CI, 3.55-6.90), followed by psoriasis (β = 2.10; 95% CI, 0.96-3.25) compared with the general population (P trend < .0001).
• Increasing age was associated with a lower impact on total fatigue in psoriasis (β = −0.13; 95% CI, −0.18 to −0.08) and in PsA (β = −0.10; 95% CI, −0.19 to −0.01).
• Among patients with psoriasis with or without PsA, increasing joint pain intensity was associated with overall fatigue (β = 2.23; 95% CI, 2.03-2.44) for each one-point increase in joint pain on the NRS.
• In other findings, greater intensity of itch was associated with higher fatigue scores for both psoriasis and PsA, while skin pain was significantly associated with fatigue in PsA (β = 0.65; 95% CI, 0.08-1.22) but not in psoriasis without PsA (P = .2043).

IN PRACTICE:

“The observation that joint pain and itch, rather than psoriasis severity, appear to be major drivers of fatigue in psoriasis and PsA highlights the importance of a symptom-based approach when treating psoriasis, rather than focusing on objective severity measures alone,” the authors wrote.

SOURCE:

Corresponding author Alexander Egeberg, MD, of the Department of Dermatology at Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark, and colleagues conducted the research, which was published in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The researchers were unable to assess whether the pain was inflammatory or noninflammatory or the number of affected joints. They also lacked information about the use of methotrexate, which commonly causes fatigue.

DISCLOSURES:

Dr. Egeberg is now an employee at LEO Pharma. He has received research funding from Pfizer, Eli Lilly, the Danish National Psoriasis Foundation, and the Royal Hofbundtmager Aage Bang Foundation, and honoraria as a consultant and/or speaker from AbbVie, Almirall, Bristol-Myers Squibb, Leo Pharma, Samsung Bioepis Co., Ltd., Pfizer, Eli Lilly, Novartis, UCB, Union Therapeutics, Horizon Therapeutics, Galderma, and Janssen Pharmaceuticals. Three of the coauthors reported being a consultant to, an adviser for, and/or having received research support from many pharmaceutical companies.

A version of this article appeared on Medscape.com.

TOPLINE:

Many factors may influence fatigue in patients with psoriasis and psoriatic arthritis (PsA), researchers report.

METHODOLOGY:

• The individual components of fatigue in psoriasis and PsA have not been examined thoroughly.
• Researchers drew from the nationwide prospective Danish Skin Cohort to identify 2741 adults with dermatologist-diagnosed psoriasis (of which 593 also had PsA) and 3788 controls in the general population.
• All adults in the analysis completed the multidimensional fatigue inventory (MIF-20), a validated 20-item tool that measures five dimensions of fatigue: General fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue. A higher score indicates more severe fatigue.
• All adults were also asked about their current intensity of joint pain over the previous 7 days, severity of pruritus and skin pain over the previous 24 hours, and sleep problems over the previous 72 hours on a numerical rating scale (NRS). The researchers applied linear regression models to continuous outcomes and adjusted for age, sex, socioeconomic status, psoriasis severity, and joint pain intensity, and beta coefficients (β) for the slopes were estimated with 95% CIs.

TAKEAWAY:

• Compared with the general population, higher total MFI-20 scores were observed for psoriasis and PsA, respectively. However, on the adjusted analysis, the impact on total fatigue was greatest for those with PsA (β = 5.23; 95% CI, 3.55-6.90), followed by psoriasis (β = 2.10; 95% CI, 0.96-3.25) compared with the general population (P trend < .0001).
• Increasing age was associated with a lower impact on total fatigue in psoriasis (β = −0.13; 95% CI, −0.18 to −0.08) and in PsA (β = −0.10; 95% CI, −0.19 to −0.01).
• Among patients with psoriasis with or without PsA, increasing joint pain intensity was associated with overall fatigue (β = 2.23; 95% CI, 2.03-2.44) for each one-point increase in joint pain on the NRS.
• In other findings, greater intensity of itch was associated with higher fatigue scores for both psoriasis and PsA, while skin pain was significantly associated with fatigue in PsA (β = 0.65; 95% CI, 0.08-1.22) but not in psoriasis without PsA (P = .2043).

IN PRACTICE:

“The observation that joint pain and itch, rather than psoriasis severity, appear to be major drivers of fatigue in psoriasis and PsA highlights the importance of a symptom-based approach when treating psoriasis, rather than focusing on objective severity measures alone,” the authors wrote.

SOURCE:

Corresponding author Alexander Egeberg, MD, of the Department of Dermatology at Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark, and colleagues conducted the research, which was published in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The researchers were unable to assess whether the pain was inflammatory or noninflammatory or the number of affected joints. They also lacked information about the use of methotrexate, which commonly causes fatigue.

DISCLOSURES:

Dr. Egeberg is now an employee at LEO Pharma. He has received research funding from Pfizer, Eli Lilly, the Danish National Psoriasis Foundation, and the Royal Hofbundtmager Aage Bang Foundation, and honoraria as a consultant and/or speaker from AbbVie, Almirall, Bristol-Myers Squibb, Leo Pharma, Samsung Bioepis Co., Ltd., Pfizer, Eli Lilly, Novartis, UCB, Union Therapeutics, Horizon Therapeutics, Galderma, and Janssen Pharmaceuticals. Three of the coauthors reported being a consultant to, an adviser for, and/or having received research support from many pharmaceutical companies.

A version of this article appeared on Medscape.com.

TOPLINE:

Many factors may influence fatigue in patients with psoriasis and psoriatic arthritis (PsA), researchers report.

METHODOLOGY:

• The individual components of fatigue in psoriasis and PsA have not been examined thoroughly.
• Researchers drew from the nationwide prospective Danish Skin Cohort to identify 2741 adults with dermatologist-diagnosed psoriasis (of which 593 also had PsA) and 3788 controls in the general population.
• All adults in the analysis completed the multidimensional fatigue inventory (MIF-20), a validated 20-item tool that measures five dimensions of fatigue: General fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue. A higher score indicates more severe fatigue.
• All adults were also asked about their current intensity of joint pain over the previous 7 days, severity of pruritus and skin pain over the previous 24 hours, and sleep problems over the previous 72 hours on a numerical rating scale (NRS). The researchers applied linear regression models to continuous outcomes and adjusted for age, sex, socioeconomic status, psoriasis severity, and joint pain intensity, and beta coefficients (β) for the slopes were estimated with 95% CIs.

TAKEAWAY:

• Compared with the general population, higher total MFI-20 scores were observed for psoriasis and PsA, respectively. However, on the adjusted analysis, the impact on total fatigue was greatest for those with PsA (β = 5.23; 95% CI, 3.55-6.90), followed by psoriasis (β = 2.10; 95% CI, 0.96-3.25) compared with the general population (P trend < .0001).
• Increasing age was associated with a lower impact on total fatigue in psoriasis (β = −0.13; 95% CI, −0.18 to −0.08) and in PsA (β = −0.10; 95% CI, −0.19 to −0.01).
• Among patients with psoriasis with or without PsA, increasing joint pain intensity was associated with overall fatigue (β = 2.23; 95% CI, 2.03-2.44) for each one-point increase in joint pain on the NRS.
• In other findings, greater intensity of itch was associated with higher fatigue scores for both psoriasis and PsA, while skin pain was significantly associated with fatigue in PsA (β = 0.65; 95% CI, 0.08-1.22) but not in psoriasis without PsA (P = .2043).

IN PRACTICE:

“The observation that joint pain and itch, rather than psoriasis severity, appear to be major drivers of fatigue in psoriasis and PsA highlights the importance of a symptom-based approach when treating psoriasis, rather than focusing on objective severity measures alone,” the authors wrote.

SOURCE:

Corresponding author Alexander Egeberg, MD, of the Department of Dermatology at Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark, and colleagues conducted the research, which was published in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The researchers were unable to assess whether the pain was inflammatory or noninflammatory or the number of affected joints. They also lacked information about the use of methotrexate, which commonly causes fatigue.

DISCLOSURES:

Dr. Egeberg is now an employee at LEO Pharma. He has received research funding from Pfizer, Eli Lilly, the Danish National Psoriasis Foundation, and the Royal Hofbundtmager Aage Bang Foundation, and honoraria as a consultant and/or speaker from AbbVie, Almirall, Bristol-Myers Squibb, Leo Pharma, Samsung Bioepis Co., Ltd., Pfizer, Eli Lilly, Novartis, UCB, Union Therapeutics, Horizon Therapeutics, Galderma, and Janssen Pharmaceuticals. Three of the coauthors reported being a consultant to, an adviser for, and/or having received research support from many pharmaceutical companies.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration has approved the first interchangeable, high-concentration, citrate-free adalimumab biosimilar, adalimumab-ryvk (Simlandi).

This is the 10th adalimumab biosimilar approved by the regulatory agency and the first biosimilar approval in the US market for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals.

“An interchangeable citrate-free, high-concentration biosimilar adalimumab has the potential to change the market dynamics in a rapidly evolving environment for biosimilars in the U.S.,” said Robert Wessman, chairman and CEO of Alvotech, in a company press release on February 23.

Adalimumab-ryvk was approved in the European Union in 2021 and in Australia and Canada in 2022. 

Adalimumab-ryvk is indicated for adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, Crohn’s disease, plaque psoriasis, hidradenitis suppurativa, and noninfectious intermediate and posterior uveitis and panuveitis. In pediatric patients, it is indicated for polyarticular juvenile idiopathic arthritis in children 2 years of age and older and Crohn’s disease in children 6 years of age and older.

Adalimumab-ryvk is the third Humira biosimilar overall granted interchangeability status, which allows pharmacists (depending on state law) to substitute the biosimilar for the reference product without involving the prescribing clinician. Adalimumab-adbm (Cyltezo), manufactured by Boehringer Ingelheim, and adalimumab-afzb (Abrilada), manufactured by Pfizer, were previously granted interchangeability status; however, they both are interchangeable with the low-concentration formulation of Humira, which make up only an estimated 15% of Humira prescriptions, according to a report by Goodroot. 

Adalimumab-ryvk will be launched “imminently” in the United States, according to the press release, but no specific dates were provided. It is also not yet known how the biosimilar will be priced compared with Humira. Other adalimumab biosimilars have launched with discounts from 5% to 85% of Humira’s list price.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration has approved the first interchangeable, high-concentration, citrate-free adalimumab biosimilar, adalimumab-ryvk (Simlandi).

This is the 10th adalimumab biosimilar approved by the regulatory agency and the first biosimilar approval in the US market for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals.

“An interchangeable citrate-free, high-concentration biosimilar adalimumab has the potential to change the market dynamics in a rapidly evolving environment for biosimilars in the U.S.,” said Robert Wessman, chairman and CEO of Alvotech, in a company press release on February 23.

Adalimumab-ryvk was approved in the European Union in 2021 and in Australia and Canada in 2022. 

Adalimumab-ryvk is indicated for adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, Crohn’s disease, plaque psoriasis, hidradenitis suppurativa, and noninfectious intermediate and posterior uveitis and panuveitis. In pediatric patients, it is indicated for polyarticular juvenile idiopathic arthritis in children 2 years of age and older and Crohn’s disease in children 6 years of age and older.

Adalimumab-ryvk is the third Humira biosimilar overall granted interchangeability status, which allows pharmacists (depending on state law) to substitute the biosimilar for the reference product without involving the prescribing clinician. Adalimumab-adbm (Cyltezo), manufactured by Boehringer Ingelheim, and adalimumab-afzb (Abrilada), manufactured by Pfizer, were previously granted interchangeability status; however, they both are interchangeable with the low-concentration formulation of Humira, which make up only an estimated 15% of Humira prescriptions, according to a report by Goodroot. 

Adalimumab-ryvk will be launched “imminently” in the United States, according to the press release, but no specific dates were provided. It is also not yet known how the biosimilar will be priced compared with Humira. Other adalimumab biosimilars have launched with discounts from 5% to 85% of Humira’s list price.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration has approved the first interchangeable, high-concentration, citrate-free adalimumab biosimilar, adalimumab-ryvk (Simlandi).

This is the 10th adalimumab biosimilar approved by the regulatory agency and the first biosimilar approval in the US market for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals.

“An interchangeable citrate-free, high-concentration biosimilar adalimumab has the potential to change the market dynamics in a rapidly evolving environment for biosimilars in the U.S.,” said Robert Wessman, chairman and CEO of Alvotech, in a company press release on February 23.

Adalimumab-ryvk was approved in the European Union in 2021 and in Australia and Canada in 2022. 

Adalimumab-ryvk is indicated for adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, Crohn’s disease, plaque psoriasis, hidradenitis suppurativa, and noninfectious intermediate and posterior uveitis and panuveitis. In pediatric patients, it is indicated for polyarticular juvenile idiopathic arthritis in children 2 years of age and older and Crohn’s disease in children 6 years of age and older.

Adalimumab-ryvk is the third Humira biosimilar overall granted interchangeability status, which allows pharmacists (depending on state law) to substitute the biosimilar for the reference product without involving the prescribing clinician. Adalimumab-adbm (Cyltezo), manufactured by Boehringer Ingelheim, and adalimumab-afzb (Abrilada), manufactured by Pfizer, were previously granted interchangeability status; however, they both are interchangeable with the low-concentration formulation of Humira, which make up only an estimated 15% of Humira prescriptions, according to a report by Goodroot. 

Adalimumab-ryvk will be launched “imminently” in the United States, according to the press release, but no specific dates were provided. It is also not yet known how the biosimilar will be priced compared with Humira. Other adalimumab biosimilars have launched with discounts from 5% to 85% of Humira’s list price.

A version of this article appeared on Medscape.com.

TOPLINE:

Pooled data from 9225 adults with psoriasis (PsO), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) showed no new safety signals with extended exposure to ixekizumab (Taltz).

METHODOLOGY:

• Researchers combined patient data from 25 randomized, controlled trials of the safety and effectiveness of at least one dose of ixekizumab in adults with PsO (n = 6892), PsA (n = 1401), and axSpA (n = 932).
• The study population included patients with a mean age of approximately 43-49 years; at least 49% were male and at least 74% were White across the three conditions.
• Patients’ median duration of ixekizumab exposure was 1.3 years for PsO, 1.4 years for PsA, and 2.7 years for axSpA, with data up to 6 years for PsO and up to 3 years for PsA and axSpA.
• The primary outcomes were exposure-adjusted incidence rates per 100 patient-years overall and at successive year intervals for treatment-emergent adverse events, serious adverse events, and selected adverse events of interest.

TAKEAWAY:

• The incidence rate per 100 person-years for any treatment-emergent adverse event was 32.5 for PsO, 50.3 for PsA, and 38.0 for axSpA; these did not increase with lengthier exposure.
• The incidence rates for serious adverse events for patients with PsO, PsA, or axSpA were 5.4, 6.0, and 4.8 per 100 person-years, respectively.
• A total of 45 deaths were reported across the studies, including 36 in patients with PsO, six with PsA, and three with axSpA.
• Infections were the most common treatment-emergent adverse events across all patient groups, reported in patients at rates of 62.5% with PsO, 52.4% with PsA, and 57.9% with axSpA; incidence of infections did not increase over time.

IN PRACTICE:

“These final, end-of-study program results surrounding the long-term use of [ixekizumab] in patients with PsO, PsA, and axSpA should serve as an important point of reference for physicians considering [ixekizumab],” the researchers wrote.

SOURCE:

The lead author on the study was Atul Deodhar, MD, of Oregon Health & Science University, Portland. The study was published online on February 12 in Arthritis Research & Therapy.

LIMITATIONS:

Study limitations included the small sample sizes and short treatment durations in some studies, the primarily White study population, the inability to stratify risk, the lack of a long-term comparator, and potential survivor bias.

DISCLOSURES:

The studies in the review were supported by Eli Lilly. Lead author Dr. Deodhar disclosed an honorarium and serving on advisory boards at AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, as well as research grants from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, MoonLake, Novartis, Pfizer, and UCB.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Pooled data from 9225 adults with psoriasis (PsO), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) showed no new safety signals with extended exposure to ixekizumab (Taltz).

METHODOLOGY:

• Researchers combined patient data from 25 randomized, controlled trials of the safety and effectiveness of at least one dose of ixekizumab in adults with PsO (n = 6892), PsA (n = 1401), and axSpA (n = 932).
• The study population included patients with a mean age of approximately 43-49 years; at least 49% were male and at least 74% were White across the three conditions.
• Patients’ median duration of ixekizumab exposure was 1.3 years for PsO, 1.4 years for PsA, and 2.7 years for axSpA, with data up to 6 years for PsO and up to 3 years for PsA and axSpA.
• The primary outcomes were exposure-adjusted incidence rates per 100 patient-years overall and at successive year intervals for treatment-emergent adverse events, serious adverse events, and selected adverse events of interest.

TAKEAWAY:

• The incidence rate per 100 person-years for any treatment-emergent adverse event was 32.5 for PsO, 50.3 for PsA, and 38.0 for axSpA; these did not increase with lengthier exposure.
• The incidence rates for serious adverse events for patients with PsO, PsA, or axSpA were 5.4, 6.0, and 4.8 per 100 person-years, respectively.
• A total of 45 deaths were reported across the studies, including 36 in patients with PsO, six with PsA, and three with axSpA.
• Infections were the most common treatment-emergent adverse events across all patient groups, reported in patients at rates of 62.5% with PsO, 52.4% with PsA, and 57.9% with axSpA; incidence of infections did not increase over time.

IN PRACTICE:

“These final, end-of-study program results surrounding the long-term use of [ixekizumab] in patients with PsO, PsA, and axSpA should serve as an important point of reference for physicians considering [ixekizumab],” the researchers wrote.

SOURCE:

The lead author on the study was Atul Deodhar, MD, of Oregon Health & Science University, Portland. The study was published online on February 12 in Arthritis Research & Therapy.

LIMITATIONS:

Study limitations included the small sample sizes and short treatment durations in some studies, the primarily White study population, the inability to stratify risk, the lack of a long-term comparator, and potential survivor bias.

DISCLOSURES:

The studies in the review were supported by Eli Lilly. Lead author Dr. Deodhar disclosed an honorarium and serving on advisory boards at AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, as well as research grants from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, MoonLake, Novartis, Pfizer, and UCB.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Pooled data from 9225 adults with psoriasis (PsO), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) showed no new safety signals with extended exposure to ixekizumab (Taltz).

METHODOLOGY:

• Researchers combined patient data from 25 randomized, controlled trials of the safety and effectiveness of at least one dose of ixekizumab in adults with PsO (n = 6892), PsA (n = 1401), and axSpA (n = 932).
• The study population included patients with a mean age of approximately 43-49 years; at least 49% were male and at least 74% were White across the three conditions.
• Patients’ median duration of ixekizumab exposure was 1.3 years for PsO, 1.4 years for PsA, and 2.7 years for axSpA, with data up to 6 years for PsO and up to 3 years for PsA and axSpA.
• The primary outcomes were exposure-adjusted incidence rates per 100 patient-years overall and at successive year intervals for treatment-emergent adverse events, serious adverse events, and selected adverse events of interest.

TAKEAWAY:

• The incidence rate per 100 person-years for any treatment-emergent adverse event was 32.5 for PsO, 50.3 for PsA, and 38.0 for axSpA; these did not increase with lengthier exposure.
• The incidence rates for serious adverse events for patients with PsO, PsA, or axSpA were 5.4, 6.0, and 4.8 per 100 person-years, respectively.
• A total of 45 deaths were reported across the studies, including 36 in patients with PsO, six with PsA, and three with axSpA.
• Infections were the most common treatment-emergent adverse events across all patient groups, reported in patients at rates of 62.5% with PsO, 52.4% with PsA, and 57.9% with axSpA; incidence of infections did not increase over time.

IN PRACTICE:

“These final, end-of-study program results surrounding the long-term use of [ixekizumab] in patients with PsO, PsA, and axSpA should serve as an important point of reference for physicians considering [ixekizumab],” the researchers wrote.

SOURCE:

The lead author on the study was Atul Deodhar, MD, of Oregon Health & Science University, Portland. The study was published online on February 12 in Arthritis Research & Therapy.

LIMITATIONS:

Study limitations included the small sample sizes and short treatment durations in some studies, the primarily White study population, the inability to stratify risk, the lack of a long-term comparator, and potential survivor bias.

DISCLOSURES:

The studies in the review were supported by Eli Lilly. Lead author Dr. Deodhar disclosed an honorarium and serving on advisory boards at AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, as well as research grants from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, MoonLake, Novartis, Pfizer, and UCB.
 

A version of this article appeared on Medscape.com.

Among patients with psoriasis, the risk of mortality was strongly associated with hepatic injury, cardiovascular disease, and psychiatric affective disorders, but was reduced among those who received systemic therapy with biologics, researchers from Canada report.

Those are key findings from a large retrospective registry study of patients with psoriasis, published in The Journal of the American Academy of Dermatology.

“Psoriasis, a chronic inflammatory condition affecting approximately 3% of the western populations, bears a higher risk of mortality compared to healthy individuals, possibly by inducing systemic inflammation associated with numerous comorbidities, especially cardiovascular diseases, metabolic syndrome, and others,” wrote corresponding author Robert Gniadecki, MD, PhD, of the division of dermatology at the University of Alberta, Canada, and colleagues. “It has been argued that the use of systemic immunomodulatory agents quenches systemic inflammation and potentially improves patient survival. However, the evidence to support this hypothesis is limited.”

To investigate the impact of comorbidities and systemic therapies on all-cause mortality in psoriasis, the researchers used the Alberta Health Services Data Repository of Reporting database from January 1, 2012, to June 1, 2019, which represents a population base of 4.47 million individuals. They extracted data on 18,618 psoriasis cases and 55,854 controls, stratified cases according to the Charlson Comorbidity Index (CCI), a surrogate measure for comorbidity burden, and by the type of therapy received, and conducted statistical analyses including Cox proportional hazards regression to determine absolute hazard ratios representing relative effects of specific demographic and comorbidity factors on mortality within groups.

The median age in both cohorts was 48 years, and 51% were male. The researchers observed that mortality in the psoriasis cohort was significantly higher than in the controls (5.7% vs. 3.8%, respectively; P < .05), with a median age at the time of death of 72 vs. 74.4 years.

The CCI and comorbidities strongly predicted mortality, especially drug-induced liver injury (hazard ratio [HR], 1.78), bipolar disorder and suicidal ideation (HR, 1.24-1.58), and major cardiovascular diseases, which included myocardial infarction (MI), congestive heart failure (CHF), and cerebrovascular disease (CVA) (HR, 1.2-1.4).

Among patients in the psoriasis cohort, survival of those treated with biologic agents was higher than in controls, even after matching for CCI (3.2% vs. 4.4%, respectively, P < .05). “These patients also exhibit reduced overall mortality compared to those treated with methotrexate or topical agents,” Dr. Gniadecki and colleagues wrote. “There was no difference in mortality between methotrexate patients and the topical therapy patients, but any of those treatment groups had superior survival compared to the no-treatment cohort.”

They added that despite better survival among patients treated with biologic agents, no significant improvements were detected in their comorbidity profiles. “Notably, the frequency of major cardiovascular disease (MI, CHF, CVA) was the same as in the controls, and overall, the frequency of diseases coded as cardiovascular was slightly increased,” they wrote.

The fact that some factors could not be measured, including the type and severity of psoriasis, response to treatment, smoking history, and alcohol intake, was a study limitation, they noted.

Joel M. Gelfand, MD, director of the psoriasis and phototherapy treatment center at the University of Pennsylvania, Philadelphia, who was asked to comment on the analysis, said the study confirms prior work indicating that having psoriasis is a predictor of mortality. In addition, “there is a strong healthy user affect among patients who take and stay on biologics for psoriasis,” he told this news organization.

Courtesy Dr. Gelfand

Among patients with psoriasis, the risk of mortality was strongly associated with hepatic injury, cardiovascular disease, and psychiatric affective disorders, but was reduced among those who received systemic therapy with biologics, researchers from Canada report.

Those are key findings from a large retrospective registry study of patients with psoriasis, published in The Journal of the American Academy of Dermatology.

“Psoriasis, a chronic inflammatory condition affecting approximately 3% of the western populations, bears a higher risk of mortality compared to healthy individuals, possibly by inducing systemic inflammation associated with numerous comorbidities, especially cardiovascular diseases, metabolic syndrome, and others,” wrote corresponding author Robert Gniadecki, MD, PhD, of the division of dermatology at the University of Alberta, Canada, and colleagues. “It has been argued that the use of systemic immunomodulatory agents quenches systemic inflammation and potentially improves patient survival. However, the evidence to support this hypothesis is limited.”

To investigate the impact of comorbidities and systemic therapies on all-cause mortality in psoriasis, the researchers used the Alberta Health Services Data Repository of Reporting database from January 1, 2012, to June 1, 2019, which represents a population base of 4.47 million individuals. They extracted data on 18,618 psoriasis cases and 55,854 controls, stratified cases according to the Charlson Comorbidity Index (CCI), a surrogate measure for comorbidity burden, and by the type of therapy received, and conducted statistical analyses including Cox proportional hazards regression to determine absolute hazard ratios representing relative effects of specific demographic and comorbidity factors on mortality within groups.

The median age in both cohorts was 48 years, and 51% were male. The researchers observed that mortality in the psoriasis cohort was significantly higher than in the controls (5.7% vs. 3.8%, respectively; P < .05), with a median age at the time of death of 72 vs. 74.4 years.

The CCI and comorbidities strongly predicted mortality, especially drug-induced liver injury (hazard ratio [HR], 1.78), bipolar disorder and suicidal ideation (HR, 1.24-1.58), and major cardiovascular diseases, which included myocardial infarction (MI), congestive heart failure (CHF), and cerebrovascular disease (CVA) (HR, 1.2-1.4).

Among patients in the psoriasis cohort, survival of those treated with biologic agents was higher than in controls, even after matching for CCI (3.2% vs. 4.4%, respectively, P < .05). “These patients also exhibit reduced overall mortality compared to those treated with methotrexate or topical agents,” Dr. Gniadecki and colleagues wrote. “There was no difference in mortality between methotrexate patients and the topical therapy patients, but any of those treatment groups had superior survival compared to the no-treatment cohort.”

They added that despite better survival among patients treated with biologic agents, no significant improvements were detected in their comorbidity profiles. “Notably, the frequency of major cardiovascular disease (MI, CHF, CVA) was the same as in the controls, and overall, the frequency of diseases coded as cardiovascular was slightly increased,” they wrote.

The fact that some factors could not be measured, including the type and severity of psoriasis, response to treatment, smoking history, and alcohol intake, was a study limitation, they noted.

Joel M. Gelfand, MD, director of the psoriasis and phototherapy treatment center at the University of Pennsylvania, Philadelphia, who was asked to comment on the analysis, said the study confirms prior work indicating that having psoriasis is a predictor of mortality. In addition, “there is a strong healthy user affect among patients who take and stay on biologics for psoriasis,” he told this news organization.

Courtesy Dr. Gelfand

Among patients with psoriasis, the risk of mortality was strongly associated with hepatic injury, cardiovascular disease, and psychiatric affective disorders, but was reduced among those who received systemic therapy with biologics, researchers from Canada report.

Those are key findings from a large retrospective registry study of patients with psoriasis, published in The Journal of the American Academy of Dermatology.

“Psoriasis, a chronic inflammatory condition affecting approximately 3% of the western populations, bears a higher risk of mortality compared to healthy individuals, possibly by inducing systemic inflammation associated with numerous comorbidities, especially cardiovascular diseases, metabolic syndrome, and others,” wrote corresponding author Robert Gniadecki, MD, PhD, of the division of dermatology at the University of Alberta, Canada, and colleagues. “It has been argued that the use of systemic immunomodulatory agents quenches systemic inflammation and potentially improves patient survival. However, the evidence to support this hypothesis is limited.”

To investigate the impact of comorbidities and systemic therapies on all-cause mortality in psoriasis, the researchers used the Alberta Health Services Data Repository of Reporting database from January 1, 2012, to June 1, 2019, which represents a population base of 4.47 million individuals. They extracted data on 18,618 psoriasis cases and 55,854 controls, stratified cases according to the Charlson Comorbidity Index (CCI), a surrogate measure for comorbidity burden, and by the type of therapy received, and conducted statistical analyses including Cox proportional hazards regression to determine absolute hazard ratios representing relative effects of specific demographic and comorbidity factors on mortality within groups.

The median age in both cohorts was 48 years, and 51% were male. The researchers observed that mortality in the psoriasis cohort was significantly higher than in the controls (5.7% vs. 3.8%, respectively; P < .05), with a median age at the time of death of 72 vs. 74.4 years.

The CCI and comorbidities strongly predicted mortality, especially drug-induced liver injury (hazard ratio [HR], 1.78), bipolar disorder and suicidal ideation (HR, 1.24-1.58), and major cardiovascular diseases, which included myocardial infarction (MI), congestive heart failure (CHF), and cerebrovascular disease (CVA) (HR, 1.2-1.4).

Among patients in the psoriasis cohort, survival of those treated with biologic agents was higher than in controls, even after matching for CCI (3.2% vs. 4.4%, respectively, P < .05). “These patients also exhibit reduced overall mortality compared to those treated with methotrexate or topical agents,” Dr. Gniadecki and colleagues wrote. “There was no difference in mortality between methotrexate patients and the topical therapy patients, but any of those treatment groups had superior survival compared to the no-treatment cohort.”

They added that despite better survival among patients treated with biologic agents, no significant improvements were detected in their comorbidity profiles. “Notably, the frequency of major cardiovascular disease (MI, CHF, CVA) was the same as in the controls, and overall, the frequency of diseases coded as cardiovascular was slightly increased,” they wrote.

The fact that some factors could not be measured, including the type and severity of psoriasis, response to treatment, smoking history, and alcohol intake, was a study limitation, they noted.

Joel M. Gelfand, MD, director of the psoriasis and phototherapy treatment center at the University of Pennsylvania, Philadelphia, who was asked to comment on the analysis, said the study confirms prior work indicating that having psoriasis is a predictor of mortality. In addition, “there is a strong healthy user affect among patients who take and stay on biologics for psoriasis,” he told this news organization.

Courtesy Dr. Gelfand