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Biologic approved for moderate to severe psoriasis in adolescents
The Food and Drug Administration approval of ustekinumab has been expanded to include adolescents aged 12 and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, based on the results of a phase 3 study.
The manufacturer, Janssen Biotech, announced the expanded indication in a press release on Oct. 13.
Ustekinumab, an interleukin-12 and -23 antagonist administered subcutaneously, was first approved by the FDA in 2009 for the same indication in adults; it is also approved for adults with active psoriatic arthritis, and for adults with moderately to severely active Crohn’s disease.
Ustekinumab is marketed as Stelara.
The Food and Drug Administration approval of ustekinumab has been expanded to include adolescents aged 12 and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, based on the results of a phase 3 study.
The manufacturer, Janssen Biotech, announced the expanded indication in a press release on Oct. 13.
Ustekinumab, an interleukin-12 and -23 antagonist administered subcutaneously, was first approved by the FDA in 2009 for the same indication in adults; it is also approved for adults with active psoriatic arthritis, and for adults with moderately to severely active Crohn’s disease.
Ustekinumab is marketed as Stelara.
The Food and Drug Administration approval of ustekinumab has been expanded to include adolescents aged 12 and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, based on the results of a phase 3 study.
The manufacturer, Janssen Biotech, announced the expanded indication in a press release on Oct. 13.
Ustekinumab, an interleukin-12 and -23 antagonist administered subcutaneously, was first approved by the FDA in 2009 for the same indication in adults; it is also approved for adults with active psoriatic arthritis, and for adults with moderately to severely active Crohn’s disease.
Ustekinumab is marketed as Stelara.
Genital psoriasis is the worst: Patients sound off
GENEVA – The great majority of patients with genital psoriasis say their symptoms in the genital area are worse than elsewhere on the body, Kim A. Meeuwis, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
She presented a qualitative study in which 20 patients with longstanding genital psoriasis sounded off, sharing their perspectives on the disease in one-on-one, semistructured, face-to-face interviews.
Genital psoriasis is common. Epidemiologic studies show 30%-60% of psoriasis patients experience genital involvement at some point in the course of their disease. Yet patients seldom discuss their genital psoriasis with their physicians, and the patient perspective on how the experience of genital psoriasis differs from that of having psoriasis at other locations has been addressed only sparsely in the literature. This lack of attention was the impetus for the current study, she explained.
The 20 participants in the study had an average 18-year history of plaque psoriasis, with an average 7.5-year history of genital involvement. The genital psoriasis was rated moderate or severe in 70% of subjects at the time of the study.
The most commonly reported symptoms of genital psoriasis were itch and discomfort, each of which was cited by all study participants. This was followed by erythema, cited by 95%; stinging and burning, also cited by 95%; pain, cited by 85%; scaling, by 75%; and cracking, by 30%.
Of the patients in the study, 85% reported that their pain and/or discomfort were worse in the genital area than at other sites, and 10% said they were highly self-conscious about their genital psoriasis because others had misidentified them as having a sexually transmitted infection.
Since this was a qualitative study, Dr. Meeuwis provided representative quotes from several patients, including one who asserted, “I really only have discomfort on my psoriasis on the rest of my body ... in my genitals is the only place that actually has pain, or the itching is ... really, really bad.”
Dr. Meeuwis said the study results hold an important lesson for physicians who treat psoriasis: “Due to differences in patient experiences between genital and nongenital skin, it’s really important to make time for the specific evaluation of genital involvement in taking care of patients with psoriasis – and to be sure to ask about it.”
Dr. Meeuwis reported serving as a consultant to Eli Lilly, which sponsored the study, as well as being on an advisory board to Beiersdorf.
GENEVA – The great majority of patients with genital psoriasis say their symptoms in the genital area are worse than elsewhere on the body, Kim A. Meeuwis, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
She presented a qualitative study in which 20 patients with longstanding genital psoriasis sounded off, sharing their perspectives on the disease in one-on-one, semistructured, face-to-face interviews.
Genital psoriasis is common. Epidemiologic studies show 30%-60% of psoriasis patients experience genital involvement at some point in the course of their disease. Yet patients seldom discuss their genital psoriasis with their physicians, and the patient perspective on how the experience of genital psoriasis differs from that of having psoriasis at other locations has been addressed only sparsely in the literature. This lack of attention was the impetus for the current study, she explained.
The 20 participants in the study had an average 18-year history of plaque psoriasis, with an average 7.5-year history of genital involvement. The genital psoriasis was rated moderate or severe in 70% of subjects at the time of the study.
The most commonly reported symptoms of genital psoriasis were itch and discomfort, each of which was cited by all study participants. This was followed by erythema, cited by 95%; stinging and burning, also cited by 95%; pain, cited by 85%; scaling, by 75%; and cracking, by 30%.
Of the patients in the study, 85% reported that their pain and/or discomfort were worse in the genital area than at other sites, and 10% said they were highly self-conscious about their genital psoriasis because others had misidentified them as having a sexually transmitted infection.
Since this was a qualitative study, Dr. Meeuwis provided representative quotes from several patients, including one who asserted, “I really only have discomfort on my psoriasis on the rest of my body ... in my genitals is the only place that actually has pain, or the itching is ... really, really bad.”
Dr. Meeuwis said the study results hold an important lesson for physicians who treat psoriasis: “Due to differences in patient experiences between genital and nongenital skin, it’s really important to make time for the specific evaluation of genital involvement in taking care of patients with psoriasis – and to be sure to ask about it.”
Dr. Meeuwis reported serving as a consultant to Eli Lilly, which sponsored the study, as well as being on an advisory board to Beiersdorf.
GENEVA – The great majority of patients with genital psoriasis say their symptoms in the genital area are worse than elsewhere on the body, Kim A. Meeuwis, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
She presented a qualitative study in which 20 patients with longstanding genital psoriasis sounded off, sharing their perspectives on the disease in one-on-one, semistructured, face-to-face interviews.
Genital psoriasis is common. Epidemiologic studies show 30%-60% of psoriasis patients experience genital involvement at some point in the course of their disease. Yet patients seldom discuss their genital psoriasis with their physicians, and the patient perspective on how the experience of genital psoriasis differs from that of having psoriasis at other locations has been addressed only sparsely in the literature. This lack of attention was the impetus for the current study, she explained.
The 20 participants in the study had an average 18-year history of plaque psoriasis, with an average 7.5-year history of genital involvement. The genital psoriasis was rated moderate or severe in 70% of subjects at the time of the study.
The most commonly reported symptoms of genital psoriasis were itch and discomfort, each of which was cited by all study participants. This was followed by erythema, cited by 95%; stinging and burning, also cited by 95%; pain, cited by 85%; scaling, by 75%; and cracking, by 30%.
Of the patients in the study, 85% reported that their pain and/or discomfort were worse in the genital area than at other sites, and 10% said they were highly self-conscious about their genital psoriasis because others had misidentified them as having a sexually transmitted infection.
Since this was a qualitative study, Dr. Meeuwis provided representative quotes from several patients, including one who asserted, “I really only have discomfort on my psoriasis on the rest of my body ... in my genitals is the only place that actually has pain, or the itching is ... really, really bad.”
Dr. Meeuwis said the study results hold an important lesson for physicians who treat psoriasis: “Due to differences in patient experiences between genital and nongenital skin, it’s really important to make time for the specific evaluation of genital involvement in taking care of patients with psoriasis – and to be sure to ask about it.”
Dr. Meeuwis reported serving as a consultant to Eli Lilly, which sponsored the study, as well as being on an advisory board to Beiersdorf.
AT THE EADV CONGRESS
Key clinical point:
Major finding: Of the participants in a study of genital psoriasis, 100% reported that a hallmark of their genital disease was itching and discomfort.
Data source: A qualitative study that involved one-on-one interviews with 20 patients with genital psoriasis, who shared their experiences as to how genital involvement differs from their psoriasis elsewhere.
Disclosures: The study was sponsored by Eli Lilly. The presenter reported serving as a consultant to the company.
Ixekizumab has profound impact on genital psoriasis
GENEVA – The interleukin-17A inhibitor ixekizumab provided rapid clearance of genital psoriasis in a phase 3b clinical trial, with significant improvement seen as early as week 1, Caitriona Ryan, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
The highly targeted monoclonal antibody also improved the intense itching that’s a particularly prominent feature of genital psoriasis.
“Genital psoriasis is a hidden part of psoriasis. Unfortunately, as dermatologists we do a bad job of evaluating our patients for it. They are ashamed and embarrassed to bring up the topic with their dermatologists. Hopefully, this study will create some awareness around the topic,” she said.
This was the first-ever randomized trial to evaluate the effect of a biologic agent specifically on genital psoriasis. It was also the first study of a biologic in psoriasis patients with less than 10% body surface area involved.
“That’s a very important thing,” according to the dermatologist. “There are lots of patients with genital psoriasis who have less than 10% body surface area involved and therefore don’t qualify for biologic therapy, even though their genital psoriasis can be incredibly debilitating.”
The 12-week, multicenter, double-blind trial included 149 patients with a baseline static Physician’s Global Assessment of Genitalia (sPGA-G) score of at least 3 on a 0-5 scale. All participants had failed to respond to at least one topical therapy for their genital psoriasis, such as a corticosteroid, a calcineurin inhibitor, or a vitamin D analog. The subjects averaged a 16-year history of psoriasis and a 9-year history of genital psoriasis. Thirty-eight percent of participants had an involved body surface area of at least 1% but less than 10%.
Patients were randomized to ixekizumab (Taltz) given in the usual way – a subcutaneous loading dose of 160 mg, followed by repeat 80-mg injections every 2 weeks – or placebo.
The primary study endpoint was achievement of an sPGA-G score of 0 or 1, meaning clear or almost clear, as assessed by blinded investigators. At the 12-week mark, the rate was 73% in the ixekizumab group and 8% in controls. The sPGA-G score already differed significantly between the two study arms at the first assessment, after 1 week. The treatment success rate was closely similar in patients with or without at least 10% total body surface area involved.
A key secondary endpoint concerned sexual health. Among patients who at baseline indicated that in the past week, their genital psoriasis “sometimes,” “often,” or “always” limited the frequency of their sexual activity, at week 12, 78% of those in the ixekizumab group answered the same question on the Sexual Frequency Questionnaire “never” or “rarely,” compared with 21% of controls.
“This is huge. It’s such an important part of our patients’ lives, and there was a big difference by week 1,” Dr. Ryan noted.
On another secondary endpoint, 60% of the ixekizumab group reported at least a 3-point improvement in the 0-10 Genital Itch Numeric Rating Scale at week 12, compared with 8% of controls, with a statistically significant difference apparent at week 2.
“Itch is the most frequently reported symptom in our patients with genital psoriasis, and it seems to be much more impactful than itch from psoriasis elsewhere,” Dr. Ryan commented.
The side effect profile of ixekizumab was the same as has been seen in larger, longer-term studies. There were no serious ixekizumab-related adverse events, and no cases of candidiasis.
The study was sponsored by Eli Lilly. Dr. Ryan reported serving as an advisory board member to and/or receiving honoraria from that company and more than half a dozen other pharmaceutical companies.
GENEVA – The interleukin-17A inhibitor ixekizumab provided rapid clearance of genital psoriasis in a phase 3b clinical trial, with significant improvement seen as early as week 1, Caitriona Ryan, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
The highly targeted monoclonal antibody also improved the intense itching that’s a particularly prominent feature of genital psoriasis.
“Genital psoriasis is a hidden part of psoriasis. Unfortunately, as dermatologists we do a bad job of evaluating our patients for it. They are ashamed and embarrassed to bring up the topic with their dermatologists. Hopefully, this study will create some awareness around the topic,” she said.
This was the first-ever randomized trial to evaluate the effect of a biologic agent specifically on genital psoriasis. It was also the first study of a biologic in psoriasis patients with less than 10% body surface area involved.
“That’s a very important thing,” according to the dermatologist. “There are lots of patients with genital psoriasis who have less than 10% body surface area involved and therefore don’t qualify for biologic therapy, even though their genital psoriasis can be incredibly debilitating.”
The 12-week, multicenter, double-blind trial included 149 patients with a baseline static Physician’s Global Assessment of Genitalia (sPGA-G) score of at least 3 on a 0-5 scale. All participants had failed to respond to at least one topical therapy for their genital psoriasis, such as a corticosteroid, a calcineurin inhibitor, or a vitamin D analog. The subjects averaged a 16-year history of psoriasis and a 9-year history of genital psoriasis. Thirty-eight percent of participants had an involved body surface area of at least 1% but less than 10%.
Patients were randomized to ixekizumab (Taltz) given in the usual way – a subcutaneous loading dose of 160 mg, followed by repeat 80-mg injections every 2 weeks – or placebo.
The primary study endpoint was achievement of an sPGA-G score of 0 or 1, meaning clear or almost clear, as assessed by blinded investigators. At the 12-week mark, the rate was 73% in the ixekizumab group and 8% in controls. The sPGA-G score already differed significantly between the two study arms at the first assessment, after 1 week. The treatment success rate was closely similar in patients with or without at least 10% total body surface area involved.
A key secondary endpoint concerned sexual health. Among patients who at baseline indicated that in the past week, their genital psoriasis “sometimes,” “often,” or “always” limited the frequency of their sexual activity, at week 12, 78% of those in the ixekizumab group answered the same question on the Sexual Frequency Questionnaire “never” or “rarely,” compared with 21% of controls.
“This is huge. It’s such an important part of our patients’ lives, and there was a big difference by week 1,” Dr. Ryan noted.
On another secondary endpoint, 60% of the ixekizumab group reported at least a 3-point improvement in the 0-10 Genital Itch Numeric Rating Scale at week 12, compared with 8% of controls, with a statistically significant difference apparent at week 2.
“Itch is the most frequently reported symptom in our patients with genital psoriasis, and it seems to be much more impactful than itch from psoriasis elsewhere,” Dr. Ryan commented.
The side effect profile of ixekizumab was the same as has been seen in larger, longer-term studies. There were no serious ixekizumab-related adverse events, and no cases of candidiasis.
The study was sponsored by Eli Lilly. Dr. Ryan reported serving as an advisory board member to and/or receiving honoraria from that company and more than half a dozen other pharmaceutical companies.
GENEVA – The interleukin-17A inhibitor ixekizumab provided rapid clearance of genital psoriasis in a phase 3b clinical trial, with significant improvement seen as early as week 1, Caitriona Ryan, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
The highly targeted monoclonal antibody also improved the intense itching that’s a particularly prominent feature of genital psoriasis.
“Genital psoriasis is a hidden part of psoriasis. Unfortunately, as dermatologists we do a bad job of evaluating our patients for it. They are ashamed and embarrassed to bring up the topic with their dermatologists. Hopefully, this study will create some awareness around the topic,” she said.
This was the first-ever randomized trial to evaluate the effect of a biologic agent specifically on genital psoriasis. It was also the first study of a biologic in psoriasis patients with less than 10% body surface area involved.
“That’s a very important thing,” according to the dermatologist. “There are lots of patients with genital psoriasis who have less than 10% body surface area involved and therefore don’t qualify for biologic therapy, even though their genital psoriasis can be incredibly debilitating.”
The 12-week, multicenter, double-blind trial included 149 patients with a baseline static Physician’s Global Assessment of Genitalia (sPGA-G) score of at least 3 on a 0-5 scale. All participants had failed to respond to at least one topical therapy for their genital psoriasis, such as a corticosteroid, a calcineurin inhibitor, or a vitamin D analog. The subjects averaged a 16-year history of psoriasis and a 9-year history of genital psoriasis. Thirty-eight percent of participants had an involved body surface area of at least 1% but less than 10%.
Patients were randomized to ixekizumab (Taltz) given in the usual way – a subcutaneous loading dose of 160 mg, followed by repeat 80-mg injections every 2 weeks – or placebo.
The primary study endpoint was achievement of an sPGA-G score of 0 or 1, meaning clear or almost clear, as assessed by blinded investigators. At the 12-week mark, the rate was 73% in the ixekizumab group and 8% in controls. The sPGA-G score already differed significantly between the two study arms at the first assessment, after 1 week. The treatment success rate was closely similar in patients with or without at least 10% total body surface area involved.
A key secondary endpoint concerned sexual health. Among patients who at baseline indicated that in the past week, their genital psoriasis “sometimes,” “often,” or “always” limited the frequency of their sexual activity, at week 12, 78% of those in the ixekizumab group answered the same question on the Sexual Frequency Questionnaire “never” or “rarely,” compared with 21% of controls.
“This is huge. It’s such an important part of our patients’ lives, and there was a big difference by week 1,” Dr. Ryan noted.
On another secondary endpoint, 60% of the ixekizumab group reported at least a 3-point improvement in the 0-10 Genital Itch Numeric Rating Scale at week 12, compared with 8% of controls, with a statistically significant difference apparent at week 2.
“Itch is the most frequently reported symptom in our patients with genital psoriasis, and it seems to be much more impactful than itch from psoriasis elsewhere,” Dr. Ryan commented.
The side effect profile of ixekizumab was the same as has been seen in larger, longer-term studies. There were no serious ixekizumab-related adverse events, and no cases of candidiasis.
The study was sponsored by Eli Lilly. Dr. Ryan reported serving as an advisory board member to and/or receiving honoraria from that company and more than half a dozen other pharmaceutical companies.
AT THE EADV CONGRESS
Key clinical point: First-ever trial of a biologic agent in genital psoriasis shows heartening results.
Major finding: 73% of patients with moderate to severe genital psoriasis were clear or almost clear of their genital disease after 12 weeks of ixekizumab, vs. 8% of controls.
Data source: This was a randomized, double-blind, placebo-controlled, multicenter, 12-week clinical trial in 149 patients with moderate to severe genital psoriasis.
Disclosures: The study was sponsored by Eli Lilly. The presenter reported serving as an advisory board member to and/or receiving honoraria from that company and more than half a dozen other pharmaceutical companies.
Innovations in Dermatology: Brodalumab for Plaque Psoriasis
Baseline lab data is class specific for biologics to treat psoriasis patients
said April Armstrong, MD, of the University of Southern California, Los Angeles.
Keep class-specific considerations in mind when collecting baseline lab data to help support the success of biologics in treating psoriasis, Dr. Armstrong said at the annual Coastal Dermatology Symposium.
When clinicians consider biologics, they must balance efficacy, safety, convenience, and costs of treatment, Dr. Armstrong said.
She addressed general considerations when selecting biologics for psoriasis and stressed the importance of assessing patients for tuberculosis and reviewing underlying cancer risk. Confirm that a patient has no active infections and consider whether a patient has completed all age-appropriate immunizations. Consider a complete blood count and metabolic panel for the following biologics:
- Ustekinumab: Baseline HIV or pregnancy test, and a TB evaluation at baseline as well as annual monitoring.
- Etanercept, adalimumab, infliximab: Baseline TB evaluation and screening hepatitis panel, liver function tests, and blood count, with option to add pregnancy test or HIV test. A liver function test/hepatitis panel is indicated annually, and TB should be monitored annually. Be cautious about using this class of drugs in patients with heart failure, and verify the absence of demyelinating disease in patients prior to prescribing this class of drugs.
- Guselkumab: Baseline TB evaluation, possible pregnancy or HIV tests, followed by annual TB evaluation.
- Secukinumab, ixekizumab, and brodalumab: Baseline TB evaluation, consider HIV or pregnancy tests, followed by annual TB evaluation. Be cautious about using this class of drugs in patients with ulcerative colitis or Crohn’s disease; assess and counsel for increased risk of suicidality when considering brodalumab.
Beyond the general considerations, several other factors can help maximize success with particular biologics, Dr. Armstrong said at the meeting, which is jointly presented by the University of Louisville and Global Academy for Medical Education.
The number of injections given in the first year, which range from 5 (ustekinumab) to 64 (etanercept) is an important consideration for some patients, Dr. Armstrong noted; the number of injections for the remaining biologics are guselkumab, 8; ixekizumab, 17; brodalumab and adalimumab, both 27, and secukinumab, 32. In addition, the IL-17 inhibitors carry some risk of oral candidiasis and inflammatory bowel disease.
This publication and the Global Academy for Medical Education are owned by Frontline Medical News.
Dr. Armstrong disclosed relationships with multiple companies including AbbVie, Janssen, Novartis, Lilly, Regeneron, Sanofi, Modernizing Medicine, and Valeant.
said April Armstrong, MD, of the University of Southern California, Los Angeles.
Keep class-specific considerations in mind when collecting baseline lab data to help support the success of biologics in treating psoriasis, Dr. Armstrong said at the annual Coastal Dermatology Symposium.
When clinicians consider biologics, they must balance efficacy, safety, convenience, and costs of treatment, Dr. Armstrong said.
She addressed general considerations when selecting biologics for psoriasis and stressed the importance of assessing patients for tuberculosis and reviewing underlying cancer risk. Confirm that a patient has no active infections and consider whether a patient has completed all age-appropriate immunizations. Consider a complete blood count and metabolic panel for the following biologics:
- Ustekinumab: Baseline HIV or pregnancy test, and a TB evaluation at baseline as well as annual monitoring.
- Etanercept, adalimumab, infliximab: Baseline TB evaluation and screening hepatitis panel, liver function tests, and blood count, with option to add pregnancy test or HIV test. A liver function test/hepatitis panel is indicated annually, and TB should be monitored annually. Be cautious about using this class of drugs in patients with heart failure, and verify the absence of demyelinating disease in patients prior to prescribing this class of drugs.
- Guselkumab: Baseline TB evaluation, possible pregnancy or HIV tests, followed by annual TB evaluation.
- Secukinumab, ixekizumab, and brodalumab: Baseline TB evaluation, consider HIV or pregnancy tests, followed by annual TB evaluation. Be cautious about using this class of drugs in patients with ulcerative colitis or Crohn’s disease; assess and counsel for increased risk of suicidality when considering brodalumab.
Beyond the general considerations, several other factors can help maximize success with particular biologics, Dr. Armstrong said at the meeting, which is jointly presented by the University of Louisville and Global Academy for Medical Education.
The number of injections given in the first year, which range from 5 (ustekinumab) to 64 (etanercept) is an important consideration for some patients, Dr. Armstrong noted; the number of injections for the remaining biologics are guselkumab, 8; ixekizumab, 17; brodalumab and adalimumab, both 27, and secukinumab, 32. In addition, the IL-17 inhibitors carry some risk of oral candidiasis and inflammatory bowel disease.
This publication and the Global Academy for Medical Education are owned by Frontline Medical News.
Dr. Armstrong disclosed relationships with multiple companies including AbbVie, Janssen, Novartis, Lilly, Regeneron, Sanofi, Modernizing Medicine, and Valeant.
said April Armstrong, MD, of the University of Southern California, Los Angeles.
Keep class-specific considerations in mind when collecting baseline lab data to help support the success of biologics in treating psoriasis, Dr. Armstrong said at the annual Coastal Dermatology Symposium.
When clinicians consider biologics, they must balance efficacy, safety, convenience, and costs of treatment, Dr. Armstrong said.
She addressed general considerations when selecting biologics for psoriasis and stressed the importance of assessing patients for tuberculosis and reviewing underlying cancer risk. Confirm that a patient has no active infections and consider whether a patient has completed all age-appropriate immunizations. Consider a complete blood count and metabolic panel for the following biologics:
- Ustekinumab: Baseline HIV or pregnancy test, and a TB evaluation at baseline as well as annual monitoring.
- Etanercept, adalimumab, infliximab: Baseline TB evaluation and screening hepatitis panel, liver function tests, and blood count, with option to add pregnancy test or HIV test. A liver function test/hepatitis panel is indicated annually, and TB should be monitored annually. Be cautious about using this class of drugs in patients with heart failure, and verify the absence of demyelinating disease in patients prior to prescribing this class of drugs.
- Guselkumab: Baseline TB evaluation, possible pregnancy or HIV tests, followed by annual TB evaluation.
- Secukinumab, ixekizumab, and brodalumab: Baseline TB evaluation, consider HIV or pregnancy tests, followed by annual TB evaluation. Be cautious about using this class of drugs in patients with ulcerative colitis or Crohn’s disease; assess and counsel for increased risk of suicidality when considering brodalumab.
Beyond the general considerations, several other factors can help maximize success with particular biologics, Dr. Armstrong said at the meeting, which is jointly presented by the University of Louisville and Global Academy for Medical Education.
The number of injections given in the first year, which range from 5 (ustekinumab) to 64 (etanercept) is an important consideration for some patients, Dr. Armstrong noted; the number of injections for the remaining biologics are guselkumab, 8; ixekizumab, 17; brodalumab and adalimumab, both 27, and secukinumab, 32. In addition, the IL-17 inhibitors carry some risk of oral candidiasis and inflammatory bowel disease.
This publication and the Global Academy for Medical Education are owned by Frontline Medical News.
Dr. Armstrong disclosed relationships with multiple companies including AbbVie, Janssen, Novartis, Lilly, Regeneron, Sanofi, Modernizing Medicine, and Valeant.
EXPERT ANALYSIS FROM THE COASTAL DERMATOLOGY SYMPOSIUM
New psoriasis therapies coming of age
The pathogenesis theories and treatment approaches to psoriasis have evolved over the past 3 decades, and the latest treatments continue to show safety and effectiveness, according to Alan Menter, MD, chairman of dermatology at Baylor University Medical Center, Dallas.
Before the 1980s, psoriasis was seen as a disease of keratinocyte dysfunction, with treatments that included methotrexate, UVB, and retinoids, Dr. Menter said in a presentation at the annual Coastal Dermatology Symposium. In the 1980s, it was considered an immunologic disease, and then an interleukin (IL)–12/Th1–mediated disease, with anti-CD2, anti-CD11a, and tumor necrosis factor–alpha blocker treatments from 1990 to 2004.
These include risankizumab, which targets the p19 subunit of IL-23 and is being studied for treatment of moderate to severe psoriasis. After one intravenous or subcutaneous dose of risankizumab in a phase 1 study, 16% of patients achieved a Psoriasis Area and Severity Index (PASI) 100, 58% achieved a PASI 90, and 87% achieved a PASI 75, and the publication of phase 2 results are pending, Dr. Menter said. The most common side effects included mild to moderate upper respiratory infections, mild nasopharyngitis, and mild to moderate headaches.
Psoriasis patients treated with guselkumab, which also targets the p19 subunit of IL-23 and was approved in July 2017 for patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, were significantly more likely to be clear or almost clear at 16 weeks, compared with those on placebo in a phase 2 randomized, controlled trial.
“Both IL-23 and IL-17 are promising targets in the treatment of moderate to severe plaque psoriasis,” said Dr. Menter. “It is important to be vigilant in following the safety profile of these drugs both in clinical trials and in postmarketing registries to ensure their long-term safety,” he added.
Additional research on how to curb side effects associated with these new and emerging therapies should target receptors downstream along the IL-23/Th17 pathway, Dr. Menter explained. Findings from a 2015 study suggest that deficiencies in cytokines and receptors further downstream in the IL-23/Th17 pathway “are associated with fewer disorders than deficiencies in upstream components of the pathway,” he said (J Invest Dermatol. 2015 Aug;135[8]:1946-53).
Although concerns about safety remain, avoiding biologics may have a negative impact as well, as moderate to severe psoriasis patients may experience deformed joints, decreased quality of life, heart attacks, strokes, and early death, Dr. Menter said.
Dr. Menter disclosed having received research support and/or serving as a consultant and/or lecturer for AbbVie, Allergan, Amgen, Anacor, Celgene, Dermira, Eli Lilly, Galderma, Janssen Biotech, LEO Pharma, Merck, Neothetics, Novartis, Pfizer, Regeneron, Stiefel, Symbio/Maruho, Vitae, and Xenoport.
The symposium was jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are both owned by Frontline Medical News.
The pathogenesis theories and treatment approaches to psoriasis have evolved over the past 3 decades, and the latest treatments continue to show safety and effectiveness, according to Alan Menter, MD, chairman of dermatology at Baylor University Medical Center, Dallas.
Before the 1980s, psoriasis was seen as a disease of keratinocyte dysfunction, with treatments that included methotrexate, UVB, and retinoids, Dr. Menter said in a presentation at the annual Coastal Dermatology Symposium. In the 1980s, it was considered an immunologic disease, and then an interleukin (IL)–12/Th1–mediated disease, with anti-CD2, anti-CD11a, and tumor necrosis factor–alpha blocker treatments from 1990 to 2004.
These include risankizumab, which targets the p19 subunit of IL-23 and is being studied for treatment of moderate to severe psoriasis. After one intravenous or subcutaneous dose of risankizumab in a phase 1 study, 16% of patients achieved a Psoriasis Area and Severity Index (PASI) 100, 58% achieved a PASI 90, and 87% achieved a PASI 75, and the publication of phase 2 results are pending, Dr. Menter said. The most common side effects included mild to moderate upper respiratory infections, mild nasopharyngitis, and mild to moderate headaches.
Psoriasis patients treated with guselkumab, which also targets the p19 subunit of IL-23 and was approved in July 2017 for patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, were significantly more likely to be clear or almost clear at 16 weeks, compared with those on placebo in a phase 2 randomized, controlled trial.
“Both IL-23 and IL-17 are promising targets in the treatment of moderate to severe plaque psoriasis,” said Dr. Menter. “It is important to be vigilant in following the safety profile of these drugs both in clinical trials and in postmarketing registries to ensure their long-term safety,” he added.
Additional research on how to curb side effects associated with these new and emerging therapies should target receptors downstream along the IL-23/Th17 pathway, Dr. Menter explained. Findings from a 2015 study suggest that deficiencies in cytokines and receptors further downstream in the IL-23/Th17 pathway “are associated with fewer disorders than deficiencies in upstream components of the pathway,” he said (J Invest Dermatol. 2015 Aug;135[8]:1946-53).
Although concerns about safety remain, avoiding biologics may have a negative impact as well, as moderate to severe psoriasis patients may experience deformed joints, decreased quality of life, heart attacks, strokes, and early death, Dr. Menter said.
Dr. Menter disclosed having received research support and/or serving as a consultant and/or lecturer for AbbVie, Allergan, Amgen, Anacor, Celgene, Dermira, Eli Lilly, Galderma, Janssen Biotech, LEO Pharma, Merck, Neothetics, Novartis, Pfizer, Regeneron, Stiefel, Symbio/Maruho, Vitae, and Xenoport.
The symposium was jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are both owned by Frontline Medical News.
The pathogenesis theories and treatment approaches to psoriasis have evolved over the past 3 decades, and the latest treatments continue to show safety and effectiveness, according to Alan Menter, MD, chairman of dermatology at Baylor University Medical Center, Dallas.
Before the 1980s, psoriasis was seen as a disease of keratinocyte dysfunction, with treatments that included methotrexate, UVB, and retinoids, Dr. Menter said in a presentation at the annual Coastal Dermatology Symposium. In the 1980s, it was considered an immunologic disease, and then an interleukin (IL)–12/Th1–mediated disease, with anti-CD2, anti-CD11a, and tumor necrosis factor–alpha blocker treatments from 1990 to 2004.
These include risankizumab, which targets the p19 subunit of IL-23 and is being studied for treatment of moderate to severe psoriasis. After one intravenous or subcutaneous dose of risankizumab in a phase 1 study, 16% of patients achieved a Psoriasis Area and Severity Index (PASI) 100, 58% achieved a PASI 90, and 87% achieved a PASI 75, and the publication of phase 2 results are pending, Dr. Menter said. The most common side effects included mild to moderate upper respiratory infections, mild nasopharyngitis, and mild to moderate headaches.
Psoriasis patients treated with guselkumab, which also targets the p19 subunit of IL-23 and was approved in July 2017 for patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, were significantly more likely to be clear or almost clear at 16 weeks, compared with those on placebo in a phase 2 randomized, controlled trial.
“Both IL-23 and IL-17 are promising targets in the treatment of moderate to severe plaque psoriasis,” said Dr. Menter. “It is important to be vigilant in following the safety profile of these drugs both in clinical trials and in postmarketing registries to ensure their long-term safety,” he added.
Additional research on how to curb side effects associated with these new and emerging therapies should target receptors downstream along the IL-23/Th17 pathway, Dr. Menter explained. Findings from a 2015 study suggest that deficiencies in cytokines and receptors further downstream in the IL-23/Th17 pathway “are associated with fewer disorders than deficiencies in upstream components of the pathway,” he said (J Invest Dermatol. 2015 Aug;135[8]:1946-53).
Although concerns about safety remain, avoiding biologics may have a negative impact as well, as moderate to severe psoriasis patients may experience deformed joints, decreased quality of life, heart attacks, strokes, and early death, Dr. Menter said.
Dr. Menter disclosed having received research support and/or serving as a consultant and/or lecturer for AbbVie, Allergan, Amgen, Anacor, Celgene, Dermira, Eli Lilly, Galderma, Janssen Biotech, LEO Pharma, Merck, Neothetics, Novartis, Pfizer, Regeneron, Stiefel, Symbio/Maruho, Vitae, and Xenoport.
The symposium was jointly presented by the University of Louisville and Global Academy for Medical Education. This publication and Global Academy for Medical Education are both owned by Frontline Medical News.
FROM THE COASTAL DERMATOLOGY SYMPOSIUM
TNF inhibitors associated with fewer side effects than methotrexate in children with psoriasis
Treatment with tumor necrosis factor (TNF) inhibitors was associated with fewer adverse events (AEs) than with methotrexate, in an international, retrospective study of children with psoriasis.
“Patients with pediatric psoriasis treated with methotrexate had a greater risk of having one or more AEs than those treated with TNF-I [tumor necrosis factor inhibitors], although fewer AEs occurred with methotrexate or TNF-I than with other drug classes,” Inge M.G.J. Bronckers, MD, of the department of dermatology at Radboud University, Nijmegen, the Netherlands, and his coauthors reported.
Among those treated with methotrexate, administration of folic acid six to seven times a week was more protective against methotrexate-associated gastrointestinal AEs, than when administered only once a week. The study was published on Sept. 13 in JAMA Dermatology (2017. doi: 10.1001/jamadermatol.2017.3029).
The study evaluated 390 children with moderate to severe psoriasis, treated with at least one systemic medication at 20 centers in Canada, Europe, and the United States, during December 1990-September 2014. They were diagnosed at a mean age of about 8 years, and started systemic therapy a mean of 3 years later. Of the 390 children treated for psoriasis, 270 were treated with methotrexate and 106 were treated with biologics, most often the TNF inhibitor etanercept. The remaining treatments were acitretin, cyclosporine, and fumaric acid esters; almost 19% were treated with more than one medication.
Of those treated with methotrexate, 130 (48.1%) experienced one or more treatment-related AEs, compared with 41 (38.7%) of those treated with a biologic agent (odds ratio, 1.76; P = .03). Almost 25% of those on methotrexate had GI-related AEs, the most common AE; other AEs included elevated transaminase levels and fatigue. Among those on biologics, injection site reactions were the most common (in 18.9%); 12 patients (11.3%) of those on biologics had infections, primarily airway infections.
Compared with those on a TNF inhibitor, patients on methotrexate were more likely to experience GI-related AEs (OR, 11.49; P less than .001) or to discontinue treatment (OR, 5.69; P = .02), the investigators said. But associated infections were more common with TNF inhibitors (OR, 0.36; P = .03), compared with methotrexate. There were no cases of malignancies or tuberculosis.
Folic acid was prescribed to 239 patients receiving methotrexate in one of three regimens: once weekly; six times weekly, avoiding the methotrexate day; and seven times weekly, according to the investigators. Compared with once-weekly treatment, administration six or seven times weekly was associated with a lower probability of developing a GI-related AE (OR, 0.16; P less than .001; OR, 0.21; P = .003, respectively).
“Data are sparse on the relative use of systemic agents and their toxic effects in the pediatric population,” Dr. Bronckers and his coauthors wrote, adding that standardized guidelines and more data concerning children are needed. “Our data suggest that a weekly administration of folic acid could be replaced with a daily or six times weekly administration to reduce GI AEs, although the potential efficacy of six vs. seven times weekly dosing deserves further investigation,” they concluded.
The study was supported by a grant from the International Psoriasis Council. Of the 23 authors, 11 had financial disclosures with various pharmaceutical manufacturers.
Treatment with tumor necrosis factor (TNF) inhibitors was associated with fewer adverse events (AEs) than with methotrexate, in an international, retrospective study of children with psoriasis.
“Patients with pediatric psoriasis treated with methotrexate had a greater risk of having one or more AEs than those treated with TNF-I [tumor necrosis factor inhibitors], although fewer AEs occurred with methotrexate or TNF-I than with other drug classes,” Inge M.G.J. Bronckers, MD, of the department of dermatology at Radboud University, Nijmegen, the Netherlands, and his coauthors reported.
Among those treated with methotrexate, administration of folic acid six to seven times a week was more protective against methotrexate-associated gastrointestinal AEs, than when administered only once a week. The study was published on Sept. 13 in JAMA Dermatology (2017. doi: 10.1001/jamadermatol.2017.3029).
The study evaluated 390 children with moderate to severe psoriasis, treated with at least one systemic medication at 20 centers in Canada, Europe, and the United States, during December 1990-September 2014. They were diagnosed at a mean age of about 8 years, and started systemic therapy a mean of 3 years later. Of the 390 children treated for psoriasis, 270 were treated with methotrexate and 106 were treated with biologics, most often the TNF inhibitor etanercept. The remaining treatments were acitretin, cyclosporine, and fumaric acid esters; almost 19% were treated with more than one medication.
Of those treated with methotrexate, 130 (48.1%) experienced one or more treatment-related AEs, compared with 41 (38.7%) of those treated with a biologic agent (odds ratio, 1.76; P = .03). Almost 25% of those on methotrexate had GI-related AEs, the most common AE; other AEs included elevated transaminase levels and fatigue. Among those on biologics, injection site reactions were the most common (in 18.9%); 12 patients (11.3%) of those on biologics had infections, primarily airway infections.
Compared with those on a TNF inhibitor, patients on methotrexate were more likely to experience GI-related AEs (OR, 11.49; P less than .001) or to discontinue treatment (OR, 5.69; P = .02), the investigators said. But associated infections were more common with TNF inhibitors (OR, 0.36; P = .03), compared with methotrexate. There were no cases of malignancies or tuberculosis.
Folic acid was prescribed to 239 patients receiving methotrexate in one of three regimens: once weekly; six times weekly, avoiding the methotrexate day; and seven times weekly, according to the investigators. Compared with once-weekly treatment, administration six or seven times weekly was associated with a lower probability of developing a GI-related AE (OR, 0.16; P less than .001; OR, 0.21; P = .003, respectively).
“Data are sparse on the relative use of systemic agents and their toxic effects in the pediatric population,” Dr. Bronckers and his coauthors wrote, adding that standardized guidelines and more data concerning children are needed. “Our data suggest that a weekly administration of folic acid could be replaced with a daily or six times weekly administration to reduce GI AEs, although the potential efficacy of six vs. seven times weekly dosing deserves further investigation,” they concluded.
The study was supported by a grant from the International Psoriasis Council. Of the 23 authors, 11 had financial disclosures with various pharmaceutical manufacturers.
Treatment with tumor necrosis factor (TNF) inhibitors was associated with fewer adverse events (AEs) than with methotrexate, in an international, retrospective study of children with psoriasis.
“Patients with pediatric psoriasis treated with methotrexate had a greater risk of having one or more AEs than those treated with TNF-I [tumor necrosis factor inhibitors], although fewer AEs occurred with methotrexate or TNF-I than with other drug classes,” Inge M.G.J. Bronckers, MD, of the department of dermatology at Radboud University, Nijmegen, the Netherlands, and his coauthors reported.
Among those treated with methotrexate, administration of folic acid six to seven times a week was more protective against methotrexate-associated gastrointestinal AEs, than when administered only once a week. The study was published on Sept. 13 in JAMA Dermatology (2017. doi: 10.1001/jamadermatol.2017.3029).
The study evaluated 390 children with moderate to severe psoriasis, treated with at least one systemic medication at 20 centers in Canada, Europe, and the United States, during December 1990-September 2014. They were diagnosed at a mean age of about 8 years, and started systemic therapy a mean of 3 years later. Of the 390 children treated for psoriasis, 270 were treated with methotrexate and 106 were treated with biologics, most often the TNF inhibitor etanercept. The remaining treatments were acitretin, cyclosporine, and fumaric acid esters; almost 19% were treated with more than one medication.
Of those treated with methotrexate, 130 (48.1%) experienced one or more treatment-related AEs, compared with 41 (38.7%) of those treated with a biologic agent (odds ratio, 1.76; P = .03). Almost 25% of those on methotrexate had GI-related AEs, the most common AE; other AEs included elevated transaminase levels and fatigue. Among those on biologics, injection site reactions were the most common (in 18.9%); 12 patients (11.3%) of those on biologics had infections, primarily airway infections.
Compared with those on a TNF inhibitor, patients on methotrexate were more likely to experience GI-related AEs (OR, 11.49; P less than .001) or to discontinue treatment (OR, 5.69; P = .02), the investigators said. But associated infections were more common with TNF inhibitors (OR, 0.36; P = .03), compared with methotrexate. There were no cases of malignancies or tuberculosis.
Folic acid was prescribed to 239 patients receiving methotrexate in one of three regimens: once weekly; six times weekly, avoiding the methotrexate day; and seven times weekly, according to the investigators. Compared with once-weekly treatment, administration six or seven times weekly was associated with a lower probability of developing a GI-related AE (OR, 0.16; P less than .001; OR, 0.21; P = .003, respectively).
“Data are sparse on the relative use of systemic agents and their toxic effects in the pediatric population,” Dr. Bronckers and his coauthors wrote, adding that standardized guidelines and more data concerning children are needed. “Our data suggest that a weekly administration of folic acid could be replaced with a daily or six times weekly administration to reduce GI AEs, although the potential efficacy of six vs. seven times weekly dosing deserves further investigation,” they concluded.
The study was supported by a grant from the International Psoriasis Council. Of the 23 authors, 11 had financial disclosures with various pharmaceutical manufacturers.
FROM JAMA DERMATOLOGY
Key clinical point:
Major finding: Almost half (48.1%) of the children treated with methotrexate experienced one or more treatment-related adverse events, compared with 41 (38.7%) of those treated with a biologic agent (OR, 1.76; P = .03).
Data source: An international, retrospective study of 390 children with moderate to severe psoriasis compared the adverse events associated with different systemic therapies.
Disclosures: The study was supported by a grant from the International Psoriasis Council.
Launch of adalimumab biosimilar Amjevita postponed
Amgen, maker of the adalimumab biosimilar Amjevita (adalimumab-atto) has reached an agreement with AbbVie, manufacturer of the originator adalimumab Humira, that halts marketing of Amjevita in the United States until 2023 and in Europe until 2018, according to a company statement.
The deal between the two manufacturers settles a patent infringement lawsuit that AbbVie brought against Amgen after it received Food and Drug Administration approval in September 2016 for seven of Humira’s nine indications: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and polyarticular juvenile idiopathic arthritis. Amjevita is not approved for two of Humira’s indications, hidradenitis suppurativa and uveitis.
Amgen said in its statement that AbbVie will grant patent licenses for the use and sale of Amjevita worldwide, on a country-by-country basis, with current expectations that marketing will begin in Europe on Oct. 16, 2018, and in the United States on Jan. 31, 2023. Amjevita is named Amgevita in Europe.
Amgen, maker of the adalimumab biosimilar Amjevita (adalimumab-atto) has reached an agreement with AbbVie, manufacturer of the originator adalimumab Humira, that halts marketing of Amjevita in the United States until 2023 and in Europe until 2018, according to a company statement.
The deal between the two manufacturers settles a patent infringement lawsuit that AbbVie brought against Amgen after it received Food and Drug Administration approval in September 2016 for seven of Humira’s nine indications: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and polyarticular juvenile idiopathic arthritis. Amjevita is not approved for two of Humira’s indications, hidradenitis suppurativa and uveitis.
Amgen said in its statement that AbbVie will grant patent licenses for the use and sale of Amjevita worldwide, on a country-by-country basis, with current expectations that marketing will begin in Europe on Oct. 16, 2018, and in the United States on Jan. 31, 2023. Amjevita is named Amgevita in Europe.
Amgen, maker of the adalimumab biosimilar Amjevita (adalimumab-atto) has reached an agreement with AbbVie, manufacturer of the originator adalimumab Humira, that halts marketing of Amjevita in the United States until 2023 and in Europe until 2018, according to a company statement.
The deal between the two manufacturers settles a patent infringement lawsuit that AbbVie brought against Amgen after it received Food and Drug Administration approval in September 2016 for seven of Humira’s nine indications: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and polyarticular juvenile idiopathic arthritis. Amjevita is not approved for two of Humira’s indications, hidradenitis suppurativa and uveitis.
Amgen said in its statement that AbbVie will grant patent licenses for the use and sale of Amjevita worldwide, on a country-by-country basis, with current expectations that marketing will begin in Europe on Oct. 16, 2018, and in the United States on Jan. 31, 2023. Amjevita is named Amgevita in Europe.
Swedish study finds low risk of developing psoriasis in bariatric surgery patients
Obese patients who undergo bariatric surgery have a lower risk of later developing psoriasis, according to results of nonrandomized, longitudinal intervention trial.
Cristina Maglio, MD, of the University of Gothenburg, Sweden, and her associates found that over a 26-year follow-up period, the adjusted hazard ratio (HR) of developing psoriasis was 0.65 (95% confidence interval [CI], 0.47-0.89; P = .008) for patients who underwent bariatric surgery, compared with those who received conventional, nonsurgical obesity treatments. Psoriasis developed in 3.6% of 1,991 patients in the surgery group during follow-up and in 5.1% of 2,018 control patients during follow-up.
Conversely, the difference in the risk of developing psoriatic arthritis (PsA), experienced by up to one-third of patients with psoriasis, was not statistically significant (HR, 0.77; 95% CI, 0.43-1.37; P = .287). PsA developed in 1% of subjects from the surgery group and 1.3% from the control group.
To understand how surgery affected the development of psoriasis or psoriatic arthritis, the researchers conducted a trial with a control group and surgery group. In the control group, 2,018 patients received standard obesity treatments that included recommendations on eating behavior, food selection, and physical activity. The 1,991 patients in the surgery group underwent gastric banding (375), vertical banded gastroplasty (1,354), or gastric bypass (262). At the start of the study, patients were evaluated for baseline measurements, then again at 6 months. After the 6-month mark, patients were reevaluated at 1, 2, 3, 4, 6, 8, 10, 15, and 20 years, respectively. All study participants, regardless of trial group, were examined and presented patient health questionnaires at each follow-up. The endpoint for this study was the first diagnosis of either psoriasis or PsA. Body mass index decreased significantly in the surgery group, compared with virtually no change in the control group.
Vertical banded gastroplasty was found to significantly lower the incidence of psoriasis, compared with usual treatment. But using gastric banding as a reference, vertical banded gastroplasty (HR, 0.80; 95% CI, 0.46-1.39; P = .418) and gastric bypass (HR, 0.71; 95% CI, 0.29-1.71; P = 0.439) were found to have similar effects on the prevention of psoriasis.
The researchers also identified several risk factors that significantly increased the risk of developing psoriasis. Smoking (HR, 1.75; 95% CI, 1.26-2.42; P = .001), a known risk factor in the development of psoriasis, and the length of time a patient had been obese (HR, 1.28; 95% CI, 1.05-1.55; P = .014) were found to be independently associated with an increased risk of psoriasis.
As part of their risk analysis, Dr. Maglio and her colleagues analyzed the interactions of baseline risk factors such as BMI and obesity duration with the bariatric surgery. This analysis found no significant interactions between baseline risk factors and bariatric surgery. It did reveal that patients who were older at baseline evaluation had slightly better responses to bariatric surgery with lower incidences of psoriasis, compared with younger patients, but the differences were not statistically significant.
“The preventive role of bariatric surgery on the risk of psoriasis has been recently highlighted by a retrospective Danish study (JAMA Surg. 2017 Apr 1;152[4]:344-9),” noted Dr. Maglio and her colleagues. “However, we lent strength to the previous results by confirming this association in a large prospective intervention trial designed to examine the effect of bariatric surgery on obesity-related comorbidities in comparison with usual obesity care.
This study was funded in part by the National Institutes of Diabetes and Digestive and Kidney Diseases, the Swedish Rheumatism association, the Swedish Research Council, the University of Gothenburg, and the Swedish federal government. Dr. Anna Rudin reported that part of her salary at Sahlgrenska University is supported by a grant from AstraZeneca. Dr. Lena M.S. Carlsson has received lecture fees from AstraZeneca, Johnson & Johnson, and Merck Sharp and Dohme. Dr. Maglio and Dr. Markku Peltonen had no relevant financial disclosures.
SOURCE: Maglio et al. Obesity. 2017. Dec; 25[12]:2068-73.
Obese patients who undergo bariatric surgery have a lower risk of later developing psoriasis, according to results of nonrandomized, longitudinal intervention trial.
Cristina Maglio, MD, of the University of Gothenburg, Sweden, and her associates found that over a 26-year follow-up period, the adjusted hazard ratio (HR) of developing psoriasis was 0.65 (95% confidence interval [CI], 0.47-0.89; P = .008) for patients who underwent bariatric surgery, compared with those who received conventional, nonsurgical obesity treatments. Psoriasis developed in 3.6% of 1,991 patients in the surgery group during follow-up and in 5.1% of 2,018 control patients during follow-up.
Conversely, the difference in the risk of developing psoriatic arthritis (PsA), experienced by up to one-third of patients with psoriasis, was not statistically significant (HR, 0.77; 95% CI, 0.43-1.37; P = .287). PsA developed in 1% of subjects from the surgery group and 1.3% from the control group.
To understand how surgery affected the development of psoriasis or psoriatic arthritis, the researchers conducted a trial with a control group and surgery group. In the control group, 2,018 patients received standard obesity treatments that included recommendations on eating behavior, food selection, and physical activity. The 1,991 patients in the surgery group underwent gastric banding (375), vertical banded gastroplasty (1,354), or gastric bypass (262). At the start of the study, patients were evaluated for baseline measurements, then again at 6 months. After the 6-month mark, patients were reevaluated at 1, 2, 3, 4, 6, 8, 10, 15, and 20 years, respectively. All study participants, regardless of trial group, were examined and presented patient health questionnaires at each follow-up. The endpoint for this study was the first diagnosis of either psoriasis or PsA. Body mass index decreased significantly in the surgery group, compared with virtually no change in the control group.
Vertical banded gastroplasty was found to significantly lower the incidence of psoriasis, compared with usual treatment. But using gastric banding as a reference, vertical banded gastroplasty (HR, 0.80; 95% CI, 0.46-1.39; P = .418) and gastric bypass (HR, 0.71; 95% CI, 0.29-1.71; P = 0.439) were found to have similar effects on the prevention of psoriasis.
The researchers also identified several risk factors that significantly increased the risk of developing psoriasis. Smoking (HR, 1.75; 95% CI, 1.26-2.42; P = .001), a known risk factor in the development of psoriasis, and the length of time a patient had been obese (HR, 1.28; 95% CI, 1.05-1.55; P = .014) were found to be independently associated with an increased risk of psoriasis.
As part of their risk analysis, Dr. Maglio and her colleagues analyzed the interactions of baseline risk factors such as BMI and obesity duration with the bariatric surgery. This analysis found no significant interactions between baseline risk factors and bariatric surgery. It did reveal that patients who were older at baseline evaluation had slightly better responses to bariatric surgery with lower incidences of psoriasis, compared with younger patients, but the differences were not statistically significant.
“The preventive role of bariatric surgery on the risk of psoriasis has been recently highlighted by a retrospective Danish study (JAMA Surg. 2017 Apr 1;152[4]:344-9),” noted Dr. Maglio and her colleagues. “However, we lent strength to the previous results by confirming this association in a large prospective intervention trial designed to examine the effect of bariatric surgery on obesity-related comorbidities in comparison with usual obesity care.
This study was funded in part by the National Institutes of Diabetes and Digestive and Kidney Diseases, the Swedish Rheumatism association, the Swedish Research Council, the University of Gothenburg, and the Swedish federal government. Dr. Anna Rudin reported that part of her salary at Sahlgrenska University is supported by a grant from AstraZeneca. Dr. Lena M.S. Carlsson has received lecture fees from AstraZeneca, Johnson & Johnson, and Merck Sharp and Dohme. Dr. Maglio and Dr. Markku Peltonen had no relevant financial disclosures.
SOURCE: Maglio et al. Obesity. 2017. Dec; 25[12]:2068-73.
Obese patients who undergo bariatric surgery have a lower risk of later developing psoriasis, according to results of nonrandomized, longitudinal intervention trial.
Cristina Maglio, MD, of the University of Gothenburg, Sweden, and her associates found that over a 26-year follow-up period, the adjusted hazard ratio (HR) of developing psoriasis was 0.65 (95% confidence interval [CI], 0.47-0.89; P = .008) for patients who underwent bariatric surgery, compared with those who received conventional, nonsurgical obesity treatments. Psoriasis developed in 3.6% of 1,991 patients in the surgery group during follow-up and in 5.1% of 2,018 control patients during follow-up.
Conversely, the difference in the risk of developing psoriatic arthritis (PsA), experienced by up to one-third of patients with psoriasis, was not statistically significant (HR, 0.77; 95% CI, 0.43-1.37; P = .287). PsA developed in 1% of subjects from the surgery group and 1.3% from the control group.
To understand how surgery affected the development of psoriasis or psoriatic arthritis, the researchers conducted a trial with a control group and surgery group. In the control group, 2,018 patients received standard obesity treatments that included recommendations on eating behavior, food selection, and physical activity. The 1,991 patients in the surgery group underwent gastric banding (375), vertical banded gastroplasty (1,354), or gastric bypass (262). At the start of the study, patients were evaluated for baseline measurements, then again at 6 months. After the 6-month mark, patients were reevaluated at 1, 2, 3, 4, 6, 8, 10, 15, and 20 years, respectively. All study participants, regardless of trial group, were examined and presented patient health questionnaires at each follow-up. The endpoint for this study was the first diagnosis of either psoriasis or PsA. Body mass index decreased significantly in the surgery group, compared with virtually no change in the control group.
Vertical banded gastroplasty was found to significantly lower the incidence of psoriasis, compared with usual treatment. But using gastric banding as a reference, vertical banded gastroplasty (HR, 0.80; 95% CI, 0.46-1.39; P = .418) and gastric bypass (HR, 0.71; 95% CI, 0.29-1.71; P = 0.439) were found to have similar effects on the prevention of psoriasis.
The researchers also identified several risk factors that significantly increased the risk of developing psoriasis. Smoking (HR, 1.75; 95% CI, 1.26-2.42; P = .001), a known risk factor in the development of psoriasis, and the length of time a patient had been obese (HR, 1.28; 95% CI, 1.05-1.55; P = .014) were found to be independently associated with an increased risk of psoriasis.
As part of their risk analysis, Dr. Maglio and her colleagues analyzed the interactions of baseline risk factors such as BMI and obesity duration with the bariatric surgery. This analysis found no significant interactions between baseline risk factors and bariatric surgery. It did reveal that patients who were older at baseline evaluation had slightly better responses to bariatric surgery with lower incidences of psoriasis, compared with younger patients, but the differences were not statistically significant.
“The preventive role of bariatric surgery on the risk of psoriasis has been recently highlighted by a retrospective Danish study (JAMA Surg. 2017 Apr 1;152[4]:344-9),” noted Dr. Maglio and her colleagues. “However, we lent strength to the previous results by confirming this association in a large prospective intervention trial designed to examine the effect of bariatric surgery on obesity-related comorbidities in comparison with usual obesity care.
This study was funded in part by the National Institutes of Diabetes and Digestive and Kidney Diseases, the Swedish Rheumatism association, the Swedish Research Council, the University of Gothenburg, and the Swedish federal government. Dr. Anna Rudin reported that part of her salary at Sahlgrenska University is supported by a grant from AstraZeneca. Dr. Lena M.S. Carlsson has received lecture fees from AstraZeneca, Johnson & Johnson, and Merck Sharp and Dohme. Dr. Maglio and Dr. Markku Peltonen had no relevant financial disclosures.
SOURCE: Maglio et al. Obesity. 2017. Dec; 25[12]:2068-73.
FROM OBESITY
Key clinical point:
Major finding: Obese patients who underwent bariatric surgery had a lower incidence of psoriasis over a 26-year period (HR, 0.65; 95% CI: 0.47-0.89; P = .008), compared with usual care.
Study details: Swedish Obese Subjects study, a longitudinal, nonrandomized intervention trial comprising 1,991 surgery group patients and 2,018 control patients.
Disclosures: This study was funded in part by the National Institutes of Diabetes and Digestive and Kidney Diseases, the Swedish Rheumatism association, the Swedish Research Council, the University of Gothenburg, and the Swedish federal government. Dr. Anna Rudin reported that part of her salary at Sahlgrenska University is supported by a grant from AstraZeneca. Dr. Lena M.S. Carlsson has received lecture fees from AstraZeneca, Johnson & Johnson, and Merck Sharp and Dohme. Dr. Maglio and Dr. Markku Peltonen had no relevant financial disclosures.
Source: Maglio et al. Obesity. 2017. Dec; 25[12]:2068-2073.
Smoking linked to increased psoriasis risk
Current and former smokers were significantly more likely to have psoriasis than were nonsmokers in an analysis of the Korean National Health Insurance database.
Multivariate analyses produced adjusted incidence rates of 1.14 for current smokers (n = 132,566) and 1.11 for former smokers (n = 47,477), compared with nonsmokers (n = 320,435), indicating “that smoking status is an independent potential risk factor for psoriasis,” reported Eun Joo Lee, PhD, of the National Health Insurance Service in Wonjusi, South Korea, and associates (J Am Acad Dermatol. 2017;77[3]:573-5).
The study was supported by a grant from the National Research Foundation of Korea that was funded by the Korean government. The investigators did not declare any conflicts of interest.
Current and former smokers were significantly more likely to have psoriasis than were nonsmokers in an analysis of the Korean National Health Insurance database.
Multivariate analyses produced adjusted incidence rates of 1.14 for current smokers (n = 132,566) and 1.11 for former smokers (n = 47,477), compared with nonsmokers (n = 320,435), indicating “that smoking status is an independent potential risk factor for psoriasis,” reported Eun Joo Lee, PhD, of the National Health Insurance Service in Wonjusi, South Korea, and associates (J Am Acad Dermatol. 2017;77[3]:573-5).
The study was supported by a grant from the National Research Foundation of Korea that was funded by the Korean government. The investigators did not declare any conflicts of interest.
Current and former smokers were significantly more likely to have psoriasis than were nonsmokers in an analysis of the Korean National Health Insurance database.
Multivariate analyses produced adjusted incidence rates of 1.14 for current smokers (n = 132,566) and 1.11 for former smokers (n = 47,477), compared with nonsmokers (n = 320,435), indicating “that smoking status is an independent potential risk factor for psoriasis,” reported Eun Joo Lee, PhD, of the National Health Insurance Service in Wonjusi, South Korea, and associates (J Am Acad Dermatol. 2017;77[3]:573-5).
The study was supported by a grant from the National Research Foundation of Korea that was funded by the Korean government. The investigators did not declare any conflicts of interest.
FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY